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Agenda for 246th Meeting of Registration Board to be held

on 10-11th December, 2014.


Item No.

Detail of Item

Item No.I

Confirmation of minutes of 245th meeting Registration Board

Item No.II

Agenda points referred by Members, Registration Board

Item No.III

Cases for conduction of Clinical Trials Pharmacy Services Division

Item No.IV

Matters referred for deliberation by Registration Board

Item No.V

Registration of drugs - Pharmaceutical Evaluation Cell

Item No.VI

Miscellaneous cases - Pharmaceutical Evaluation & Registration Division

Item No.VII

Registration of Biological Drugs Biological Evaluation & Research


Division

Item No.VIII Quality Control Cases Quality Assurance & Lab Testing Division
Item No.IX

Registration of Medical Devices Medical Devices Division


Any other item with permission of Chair

Item No I: Confirmation of minutes of 245th meeting Registration Board.


245th meeting of Registration Board was held on 28-29th September, 2014 and minutes
were circulated to all members through e-mail. Two members forwarded following comments, as
follows:

Dr. Amanullah Khan (Director, DTL, Quetta):

Agenda Item No II:


The following comments may be added as discussed in the 245 th Registration Board Meeting regarding
Registration of Sofosbuvier which is very important drug and very badly required for the country man.
The stability study shall be conducted by the manufacturer and accordingly stability data must be
submitted to the Registration Board before the launch of their product into the market, my point is this
that registration may be granted to the firms with the undertaking that they will provide stability study
before the launch of their product into the market as per previous practice.
Case No. 50. Cases deferred by Registration Board.
M/s Ideal Pharma, Lahore- Product Specific InspectionThere is typographic error and needs correction for record purpose, the inspection for product specific
inspection was carried out by two members only that is Director DTL, Quetta and area FID.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

g. Import of raw materials for experimental purpose and stability studies etc.
Director QA stated that any such Import for trial batch is not discouraged subject to meet all codal
formalities required for the production of commercial batch as per defined policy
Item No.VII: Miscellenous cases. Case No.15.

Change in company name from M/s.


Bayer Schering Pharma AG to M/s. Bayer Pharma AG.
Company also informed that German authorities have confirmed the GMP of manufacturer of this
product & product is available in Switzerland and UK which is part of EMA/ SRA.

Minutes were approved after incorporation of above points.


Registration Board in 245th meeting discussed and approved following case but erroneously
decision was not recorded in minutes. However, later on Chairman, Registration Board approved
correction in minutes as decided by the Board.

Registration of Drugs for export purpose-Not me too Drugs.

Case No.30

Following firms have requested for registration of following drugs for export purpose
only which are not me-too. Details are as under:S.
No.
1.

Name of
Company
M/s
PharmEv
o Karachi

Name of product(s)
Procoxam Forte 1500mg
Tablet
Each tablet contains:Glucosamine HCl ....1500mg

Date of application,
Diary No. & Form
13-05-2014
688
Rs.20,000/-

2.

-do-

Procoxam 625mg Tablet


Each tablet contains:Glucosamine HCl ..625mg

13-05-2014
686
Rs.20,000/-

3.

M/s
Medisure
Labs,
Karachi

15-04-2014
668
Rs.20,000/-

4.

M/s
Kaizen
Pharma,
Karachi

Calvita Syrup
Each 5ml contains:Calcium lacatate
Gluconate..40mg
Vitamin A .1200IU
Vitamin D3 .100IU
Vitamin B1 HCl .1mg
Vitamin B2 5-sodium
phosphate .. .1mg
Vitamin B5 HCl.. 0.5mg
Nicotinamide ..5mg
Dexpanthenol .2mg
Vitamin C.. .50mg
Vitamin E acetate 1mg
Vitacal Syrup
Calcium lacatate
Gluconate..40mg
Vitamin A .1200IU
Vitamin D3 .100IU
Vitamin B1 HCl .1mg
Vitamin B2 5-sodium
phosphate .. .1mg
Vitamin B5 HCl.. 0.5mg
Nicotinamide ..5mg
Dexpanthenol .2mg
Vitamin C.. .50mg

26-06-2014
701
Rs.20,000/-

5.

M/s
Genix
Pharma,
Karachi

6.

-do-

7.

-do-

Vitamin E acetate 1mg


Apitonic Syrup
Each 5ml contains:Cyproheptadine HCl
(anhydrous) BP ..2mg
Thiamine HCl (B-1) ...2mg
Riboflavin BP (as 5phosphate sodium)2mg
Pyridoxine HCl .0.75mg
D-Panthenol BP .2.5mg
Nicotinamide BP .22.5mg
Calceg Injection 100mg/ml
Each ml contains:Calcium gluconate (10%)
. .10mg
Tyca Tablet 90
Each tablet contains:Ticagrelor 90mg

27-08-2014
719
Rs.20,000/-

27-08-2014
720
Rs.20,000/27-08-2014
726
Rs.20,000/-

Submitted for information of Registration Board.


Item No II:

Agenda points referred by Members, Registration Board.

Dr. Amanullah Khan, Director DTL, Quetta:

a. PPMA Representation from North zone.


Reference to the above , it is submitted that for the last few DRB Meetings it is observed that
PPMA from North Zone/Region nominates that member for to attend the DRB Meetings whose case is
part of the agenda and in my opinion its a matter of conflict of interest. Therefore it is requested that in
the forthcoming meeting of DRB , this matter may be placed as agenda item before the DRB and take
decision whether such conflict of interest nomination may be allowed or otherwise. Furthermore it is
expected that PPMA from both the regions may nominate(s) a member for DRB for a specified period.
b. Registration of drugs under Drugs Act, 1976.
Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited above,
in this regard it is submitted that DRAP has constituted a panel to carryout inspection abroad at
Argentina , the panel comprised of the following officials,

(i) Dr. Amanullah khan , Director Drugs Testing Laboratory Government of Balochistan, Quetta/
Member Drug Registration Board DRAP.
(II) Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.
As per said letter there were four (04) importers / firms who have requested for the import of their
products from Argentina and accordingly on the request of the importers/firms the panel was constituted
to carry out inspections of their Principals abroad for the purpose of registration of drugs under Drugs
Act, 1976. The following is the list of firms/importers who had requested for registration of drugs under
the Drugs Act 1976.
i.
ii.
iii.
iv.

M/s Pine International Lahore.


M/s Atco Pharma International (Pvt) Ltd Karachi.
M/s Oncogene Pharmaceuticals Karachi.
M/s Nawab Sons, Karachi.
As per procedure of the DRAP the letter for inspection is issued only when all the prerequisite

documents/information for the Registration of the Drugs is completed and accordingly the said letter is
also issued on the same grounds by the competent authority, however regret to mention that M/s Pine
International Lahore has declined to carryout inspection of their Principal abroad so there is need that the
Firm has to clear their position and explain their position for refusing inspection abroad and why action
may not be taken against them in wasting the time of the officials/inspectors and by enlarge of the DRAP.
Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed their
principal without approval from the DRAP which is not accepted ethically and officially. They kept the
inspection in grey and at any stage never accepted their mistake of change of Principal and ultimately on
16th October 2014 the coordinator of the inspection team from Atco Pharma has forwarded an e-mail
from Mr Zubair Khalil owner of M/s Oncogene Pharmaceuticals Karachi, and explained that DRAP has
refused our request for change of Principal and further added that i will be obliged if Atco Pharma etc
takes my case to DRAP for not carryout inspection abroad. As a Member Drug Registration Board i am
not comfortable with such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and
there is need to ask them explain their position on such offended statement.
M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also declined to
carry out their inspection abroad by giving no reason.
Keeping in view an exercise of more than six months wherein the Inspectors from time to time
has to reschedule their official activities for the purpose to carryout inspection abroad smoothly , but
regret to say that the inspectors have been kept in dark by the firms/importers and there was nobody who

could come up with truth that we are not in position to carryout inspection , as from the beginning it
was apparent that the importers/firms were not interested to carryout inspection abroad and it was also
apparent that among the firms/importers blame game has started which was not a good sign for
inspection.
I would like that the case may be kept as Agenda Point in the forthcoming meeting of DRB and a
decision may be taken against the firm/importers who are responsible for this Act. The cases may be dealt
as per Drug Act and as per Policy of DRAP to stop such practices in future and the offenders may be
treated as per policy/Drug Act and i also request for the cancellation of their requested products.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

c. This point should be brought into discussion of next meeting that Board should define uniform
guidelines to scrutinize variations if it is related to API / quality of Drug substance in light of
ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well. Moreover
the all respective change should be assessed under the scope of applied variations.
Item No.III

Cases for conduction of Clinical Trials Pharmacy Services Division

Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm
Community Based Randomized Trial, Karachi. Pakistan.
Aga Khan University has applied for the clinical trial to be conducted in collaboration
with WHO in assistance with EPI Programme.
The key feature of the trial is as under:

Title
Phase
Background

Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm


Community Based Randomized Trial, Karachi. Pakistan.
III
Polio disease is present in only three countries including Pakistan. Since the

Objective

Participating
Country/Sites.
Number of
participants
Duration of
Trial.
Study
Interventions.

Study
Outcomes
Quantity of
Drug to be
Imported.
Registration
Status of drugs
in Pakistan.
Monitor of the
Trial.
Sponsor

injectable polio vaccine has better results, WHO Polio Endgame Strategy
is to slowly withdraw the current vaccines replace all oral polio vaccine with
injectable polio vaccine.
The over all purpose of this study is to compare the suggested five different
polio vaccine strategies to see which produces the best immunity for Pakistani
Children and prevents the spread of polio.
Pakistan
Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,
Ibrahim Hyderi and Bhains Colony.
1000 children each study group (arm) will have 200 children.
One year (June 2014-15)

Oral Bivalent vaccine Available from EPI


Oral Trivalent Vaccine Available from EPI
Inactivated Polio Vaccine (IPV) To be imported
Inactivated Polio Vaccine2 (IPV2) To be imported
Oral Monovalent Vaccine2 (mOPV2) To be imported at a later stage
in the study. An amendment and request will be sent to DRA at that
time.
To determine which vaccine best protects the children from polio

IPV= 1510 Doses


IPV= 230 Doses
Other vaccines are already registered and standard of care. These will
be purchased from EPI.
Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.

Dr. Maha Mohamed Saadeldine Salama


Head Clinical Research Sector/VACSERA, Cairo Egypt.
World Health Organization (Geneva)

Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk
components since 1994. The company has now developed an investigational monovalent high
dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication
Initiative (GPEI) and World Health Organization (WHO)s strategic advisory group of experts
(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-

antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type
2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen
should permit the one step immunization of children against type 2 polioviirus while avoiding
the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus
vaccine (OPV).
Bulk virus was initially produced in monkey kidney cells and is now produced in Vero
cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.
Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were
also obtained for this formulation. When production of IPV was switched from sub cultured
monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were
conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to the
safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A
nonclinical toxicology study in rats showed no unexpected toxicological findings.
There are currently no clinical data with the m-IPV-HD. However, clinical studies
showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune
response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further
supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million
IPV-Vero vaccine doses distributed worldwide in close to 60 countries.
As per procedure in vogue the submitted trial was referred to three experts for expert
opinion to facilitate the decision making process by the Registration Board. The same is
summarized as under:
S.No.
1.

Expert Name
Syed Sohail Zahoor Zaidi,
Chief Scientist (Virology)
Head of Department of
Virology

Opinion
It is hereby informed that the subject study is well planned to
determine the improved effect of vaccination with combined
formulations i.e bivalent OPV + IPV vaccines to fill-in the gaps in
immunity type 2 polioviruses among Pakistani Children.
The study will be conducted with the financial and technical support
of WHO Head Quarters, Geneva and does not pose any apparent
burden on the GoP/National or international stake holders providing
assistance for the Polio Eradication program in the country.
I hope that the findings and outcomes of this interventional study
will improve our understanding and help to devise progressive
recommendations for vaccination to achieve the goal of Polio

eradication.
2.

Mr.Mazharullah Memon,
The five arms plan for End Game Polio Virus, the pattern of dosing
Principal Scientific
as described are suitable for the subject study and the subject
Officer/Manager Quality
clinical trial is suggested in my opinion and there is no financial
Control Laboratory.
burden on the Government of Pakistan.
3.
Dr. Haider Sherazi,
Comments are still awaited in spite of reminders
Neonatology, PIMS,
Islamabad.
The institution has also requested for import of the following trial material to supplied by the WHO
through EPI:
Drug Name
Inj IPV
Inj IPV2

Quantity required
1510 Doses
230 Doses

The case is placed before the Registration Board for authorization to conduct the trial and
to import the above quantities in accordance with the Import Export Rules 1973.
Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and
detoxification of injectable drug users in Pakistan.
Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that
Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most
recommendation intervention to halt the spread of HIV/AIDs infections among the group of
injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,
treatment or at lease substitute the other injectable drugs with oral dosage form.
National AIDs Control Programme, Ministry of National Health Services, Regulation &
Coordination Islamabad has submitted a project proposal to the subject cited above. It is
hypothesized that Buprenorphine has challenges of misuse considering the non regulated
environment if produced and made available in higher doses.. Safety, as reflected by Adverse
Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and
treatment retention during the study will also be explored.
This is an open-label study, 1,000 (One Thousand) IDUs seeking treatment for opiate
dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be

predominantly males and non-pregnant and non-lactating females who are at least 18 years-ofage at the time of enrollment. Following screening, there will be a 28 day stabilization period
on Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with
doses not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until
the end of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16,
24mg based on clinical need, as judged by the treating physician/investigator. The duration of
study participation for each participant will be a maximum of approximately 6 months, including
screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to
the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide
clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.
Principal investigator has submitted ethical approval issued by the National Bioethics
Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two
following sources if approved by the Registration Board:S.N

Name of Firms

2mg tablets

8mg tablets

o
1.
2.

M/s. Valor Pharmaceutical, Islamabad


M/s. Wilshire Labs, Lahore

1,80,000 tabs
1,80,000 tabs

1,80,000 tabs
1,80,000 tabs

Case is placed before the Registration Board for comments of the Antinarcotics Force (ANF) and
3 experts on Narcotics.

Item No.IV

Matters referred for deliberation by Registration Board

a. Comments of Director Malaria Control, Islamabad regarding injectable antimalarial therapy.


Registration Board in 245th meeting discussed following comments of Director Malaria
Control, Islamabad.
The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan
and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East
Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental
Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium case
and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th Inter
Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13 th 14th
August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin
monotherapy and injectable chloroquine in Pakistan. According to the approved National AntiMalaria Drug Policy only Injection Artesunate is recommended for confirmed severe
Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.
Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of
Pakistan along-with other stake holders to share the views on emerging artemisinin resistance
and irrational use of antimalarial drugs in the country. It is also requested to halt further
registration Antimalarial Drugs.
Registration Board in 245th meeting deferred all injectable anti-malarial drugs and invited
Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.
b. Transfer of registered drugs.
Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a
certificate for registration is issued for a period of five years unless earlier suspended or
cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are
transferred according to the following provisions incorporated in schedule F vide SRO
877(I)/2000 dated 09th December, 2000:An application for:-

(i)
(ii)
(iii)
(iv)

transfer of registration from one importer or manufacturer to another,


transfer from import to local manufacture,
import in bulk and repacking locally, and
change of name of registered drug, shall be considered as for grant of a new
registration and shall be made as per rule 26(1).

Registration Board in its 240th meeting also approved the following SOPs to stream line
the transfer of registrations and delegated its powers to the Chairman Registration Board to
approve such cases:Transfer of registration:
i) With change in manufacturing site:
a.
Application with Form-5 and required fee as per relevant SRO.
b.
Copy of registration letter and renewal status.
c.
NOC for CRF clearance.
d.
Copy of approved section by Central Licensing Board.
e.
Copy of last inspection report.
f.
NOC from existing manufacturer / registration holder permitting
for transfer of product.
g.
Statement / undertaking that applicant do not have registration
of same products. If so, it
has to apply for cancellation of product.
h.
Accelerated stability studies of 6 months with to conduct real
time stability studies up to assigned shelf life & report if any
result falls outside shelf life specifications with proposed action).
i.
Validated method of analysis, master formula and product
development data
ii) Change in name / title of manufacturer (site of manufacturing remains the same)
a.
Application on Form-5 with required fee as per relevant SRO.
b.
Copy of registration letter and renewal status.
c.
NOC for CRF clearance.
d.
Approval of new name / title from CLB.
e.
Undertaking that the formulation, API source & Specifications,
manufacturing process, analytical test methods, release & shelf
life specifications have not changed.
However, schedule F was amended as per SRO 1117(I)/2012 dated 10th September, 2012
and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09 th
December, 2000 have been omitted now.

In view of above, directions /guidance of Registration Board is solicited to process cases


of transfer of registration of drugs.
c. Re-registration of drugs.
Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate
of registration, shall unless earlier suspended or cancelled, be in force for a period of five
years from the date of registration of the drug and may thereafter be renewed for periods not
exceeding five years. Provided that an application for the renewal of registration shall not be
entertained unless it has been made within sixty days after the expiry of the registration and
when and application has been made as aforesaid the registration shall subject to the orders
passed on the application for renewal continue in force for the next period of five years.
Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal
of registration of a drug, such cases were processed for re-registration on payment of full
registration fee and submission of form-5. Chairman Registration Board was authorized to
approve such cases on file.
Submitted for directions / guidelines of the Board to define modalities to process
cases for re-registration of drug.
d. Registration of 10 Products per section for New Drug Manufacturing Licence/
Additional Section.
Registration Board in 245th meeting constituted following committee to review policy of
registration of 10 products per section to new manufacturers/ additional sections.
-

Prof. Muzamil Hassan Najmi, Member Registration Board


Mr. A Q Javed, Director QA, DRAP.
Mr. Arif Chowdhry, DDC Reg-I

The Committee forwarded following recommendations:

To achieve the standards as laid down in GMP, the present practice of granting
registrations of ten products in a section to the new licensees may be continued.

The operational status of the manufacturer may be assessed by a panel inspection after 60
days of commencement of manufacturing activity.

Subject to compliance of GMP, as determined by the inspection panel, another ten


products per section may be granted to the new licensees on priority.

Submitted for consideration of Registration Board.


e. Non-Availability of finished drugs in country of origin.
Registration Board in 245th meeting discussed that in some cases, finished drug of a
manufacturing site is neither available / authorized for sale in country of origin / manufacture
nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but
applicant intend to import finished product from that site. The Board constituted following
committee to look into the matter keeping in view international practices in such cases and
frame its recommendations.
-

Prof. Muzamil Hassan Najmi, Member Registration Board.


Mr. A Q Javed, Director QA & LT
Mrs. Sara Mahreen ADC, PEC

Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and
Mr.Ammad Zaka, ADC was assigned the task.
The Committee forwarded following recommendations:

If any such drug which is not available in country of origin and not approved by reference
regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered
for registration or approval of post registration variation, provided:
o Its registration has not been cancelled / withdrawn by any ICH member countries,
which are considered SRA, for safetyreasons.
o There is no new toxicity data reported about the drug requiring re-evaluation of its
status.
o It is available in atleast threeSRAcountries as notified by International Conference
onHarmonization of Technical Requirements for Registration of Pharmaceuticals
for Human use (ICH) on www.ich.org.

Submitted for consideration of Registration Board.


f. Export of drugs with same brand name of different manufacturers

M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported
following drug:Name of product

Regn No. for M/s


Ambrosia
in
Pakistan

Regn No. for M/s


Ambrosia
in
Kingdom
of
Combodia

Util
Capsule
40mg
(Esomeprazole)

046889

CAM 0279-10

Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi
exporting their same molecule Esomeprazole with same brand name Util to Kingdom of
Combodia with printed same registration number granted to them in Cambodia. This kind of act
is not only hurting their marketing and market share and image in Kingdom of Combodia as their
product are more effective and superior quality but more importantly damaging the image of
DRAP. At this time their distributor in Combodia has refused to place any further orders or
accept shipments of above products till such time they receive letter from DRAP stating that
DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand
name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export
purposes in the future.
g. Registration of generic Nilotinib
Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed
that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP
that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a
breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has
come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the
trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a
generic Nilotinib would be a violation intellectual property rights.
Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute
a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection
of intellectual property rights. He requested that application filed by Genix Pharma for generic

registration of a Novartis product may be rejected and Drug Registration Board should not even
entertain any application for generic registration Nilotinib under any trade name. Submitted for
consideration of Registration Board.

e.

Recommendation of Review committee.


Registration Board in 245th meeting considered following recommendations of review

committee and advised PPMA and Pharma Bureau to forward their comments for consideration
of Registration Board. Now both stake holders forwarded their comments on these
recommendations, as follows:

PPMA:

A. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.


i.

Products Containing Phloroglucinol are available in many countries of the world, including Italy,
France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42
Companies including Multinationals have market since many years.

ii.

In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further


guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious
HAS, France as recommended continued inclusion on the list of medicines refundable by national
health insurance and on the list of medicines approved for hospital uses in the indication of
Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract
including IBS and dosages given in the marketing authorization.

iii.

The product containing this molecule in France has been in the market since very long and is one
of the highest used specialties in gynaecology. Today about 15 French and multinational
companies have marketed their brands in France only.

iv.

Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal
colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and
efficacy.

v.

All the leading medical specialists of Pakistan in related fields confirm its usefulness and are
completely satisfied.

vi.

The clinical trials conducted within Pakistan have been included in International Literatures.
Volumes of data speak about its safety and efficacy.

vii.

Phloroglucinol is well documented in well reputed medical reference books including Extra
pharmacopeia Martindale and Merck Index.

viii.

The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and
FDA (Food and Drug Authority of America).

ix.

Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety
Update Report), which confirms the safety of the product.
B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.

i.

The product is safe for use to cure GERD. Authentic clinical trials/study attached to your
reference to use product for short term only (4 to 8 weeks) depending upon the patient health
severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only
related with long term use. Companies already not recommended product for long term use.

ii.

Product is approved in USFDA and on under prescription.

C. Citicoline.
i.

Availability in Multiple Countries:


Citicoline is available in multiple European, North America and Asia Pacific Countries. It
highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with
established efficacy and safety.

ii.

Evidence of Citicolines Mode of Action as Neuroprotective:


A study of International Society for Neurochemistry in Journal of Neurochemistry has established
Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial
effects in number of CNS injury models and patholological conditions of brain.

iii.

Reference of Citicoline in Authentic & Reputable Journals:


a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of
stroke than placebo while referring the study of clinical trial Stroke Management by Elizabeth
Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris.
b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the
long term treatment of Citicoline in acute cerebral infarction.
c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective
and well tolerated in patients with mild vascular cognitive impairment.

iv.

Citicoline Granted Novel Food Ingredient Status in EU

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition
and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI),
which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.
The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko,
New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of
the European Parliament and of the Council.
v.

Huge prescription base in Pakistan

According to the latest Sales data, around 700,000 injections of 250mg whereas 1,000,000 tablets
have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and
neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.
D. Diacerein.
i.
ii.
iii.

The molecule is registered with the European Medicines Agency.


The product is very effective for the treatment of Osteoarthritis Specially in advanced age
The product is available and authorized to be used in the European Union Including France.

E. Calcium Dobesilate.
i.
ii.
iii.
iv.

The molecule is included in the European Pharmacopoeia.


Molecule is registered and available in Switzerland (COPP available)
Molecule is registered in more than sixty countries of the world and marketed in more than fifty
countries.
The molecule has been registered and marketed since 1972 and available in European Union
since 1975.

F. Smectite.
i.
ii.
iii.
iv.

The molecule is available in France, Greek and USA.


The molecule is extremely useful in the treatment of Acute Diarrhea.
It is a time tested and important product for treatment of Dierrhea specially in children.
The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,
Spain and countries of Eastern Europe as well as South America and South Anastasia.
v. It is an important molecule to prevent Hepatotoxicity.

G. Saccharomyces Boulardi.
i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis,
Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related
Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause lifethreatening symptoms.
ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for
consideration as OTC product and recommended product monograph for antidiarrheal drug..
iii. Product is already approved and recommended by TGA.
iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is
under price control and if product transfers to OTC division then market price might be change
and ultimately effect on patient.

H. Piracetam.

i. Availability in Multiple Countries:


Piracetam is available as Central Stimulant and Nootropic Agent in large number of countries
including multiple European, South America and Asia Pacific Countries. Among them the most
significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.
ii. Authentic References:
-

Assay method given in British Pharmacopoeia highlighting the authenticity of the product.
Piracetam has been mentioned in Martindale - The extra Pharmacopoeia 36 th Edit on with
mode of action and its therapeutic uses.

iii. Mode of Action:


Mode of Action of Piracetam is well-explained which highlights its beneficial influence on
neuronal and vascular functions. Further Piracetam also improves the function of
neurotransmitter acetylcholine.
iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:
There are significant number of Piracetam users all around the Pakistan who are very much
satisfy with therapeutic results as Nootropic and Neurotonic Agent.
v. Huge Prescription Base in Pakistan:
According to the latest Sales data, around 400,000 syrups have been selling in a year in
Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and
safety of the product which leads to such a massive prescription base.
I. Thiocolchicoside.
i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in
its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following
conclusion.
a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,
published literature, post-marketing experience on the safety of thiocolchicoside containing
medicinal products for systemic use with regards to its genotoxicity, the Committee considered
that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant
treatment of painful muscle contractures in acute spinal pathology.
b. However, having considered the risks, thiocolchicoside containing medicinal products for
systemic use should only be administered to patients over 16 years of age in acute conditions.
With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the
CHMP was of the view that the indication in Parkinsons disease and drug-induced
Parkinsonism with special consideration to neurodyslectic syndrome should be removed as this
is a chronic condition which requires longer treatment duration. The package size should be
adapted to new recommended treatment-days.

c. The committee considered also that thiocolchicoside containing medicinal products for systemic
use should be contraindicated during the entire pregnancy period. These products should also be
contraindicated in women of childbearing potential not using contraception and during lactation.
The CHMP also recommended further changes to the product information including information
on fertility.
d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside
containing medicinal products for systemic use as adjuvant treatment of painful muscle
contractures acute spinal pathology in adults and adolescents from 16 years onwards remains
favorable, subject to the restrictions, warnings, other changes to the products information,
additional pharmacovigilance activities and risk minimization measures agreed.

ii.
The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary,
Czech Republic, India and many countries of the Fareast.
iii.
The molecule has been in use in Europe since last more than 30 years.

J. Dry Powder Suspension of Famotidine.


Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared
to liquid suspension due to the following reasons.
i. International Availability of Dry Powder Suspension by the Innovator: Please see the
attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is
manufacturing Famotidine in Dry Powder Suspension. We have attached Product information
available freely on internet for your perusal and record.
ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II
IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock
Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and
marketing their products in USA which is approved by USA FDA. We have attached the product
details downloaded from Internet.
iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is
mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in
the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is
very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if
provided in the form of liquid suspension.
iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent,
therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI).
Various studies are available in the literature which supports termal degradation of Famotidine in
Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at
room temperature.
v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more
stable and is used within 30 days after reconstitution (USA product brief). Therefore this
formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room
temperature is not stable and should be look into for patient safety.

K.

Silymarin

Silymarin is mentioned in more than one standards books like:


1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference
source on drug & medicines used throughout the world.
2) U.S.P 34:

Silymarin is prescribed in more than 50 countries of the world, we are enclosing

herewith reference of substantial internationally available brands.


S.No

Brand name

Manufacturing/Availability

Lagalon

Austria,Bahrain,Balgaria,China,Colombia,Georgia
Germany, Italy,Hungary,Mexico,Philippine, Poland,
Portugal,Romania,
South
Africa,
Spain,
Switzeland,Slovakia,Thailand, Venezuela.

Simepar

Switzerland

Cefasilymarin

Germany

Samarin 140

Thailand

Doindi

Vietnam

Silymarin Forte Romania

Silymarin Duo

Macedonia

Hepasil

Bangladesh

Esimerin Plus

India

10

Good Liver

India

11

Heptosil 200ml

India

12

Livoriv-B

India

13

Livosil-B

India

14

Silyvit

India

15

Tezaliv

India

It is an important molecule used in various liver disorders. Various studies regarding


usage of Silymarin are available in different medical Journals.

Various manufacturers have also forwarded their comments on various formulations:


Recommendations of review committee considered by Registration Board in 245 th meeting
are as follows:
S.
No

Drug Name
Generic (Brands)

Approv
al by
Internat
ional
Regulat
ory
Bodies

1.

Keto Injection
Each vial contains:Ketamine HCl

Yes
FDA
EMA &

Status in
Authentic
Textbooks
(Pharmacol
ogical basis
of
therapeutic
s-Goodman
& Gilman,
Basic &
Clinical
pharmacolo
gy-B G
Katzung,
Current
Medical
Diagnosis &
Treatment
2013)
Recommend
ed for use in
general

Research
published in
Reputed/
Authentic
Journals

Concluding
Remarks
&
Recommendation

Numerous

Ketamine
is
chemically related to
phencyclidine
and

2.

Ketamine 500 mg
(General Anesthetics)

others

anesthesia.

Fluoxetine + Olenzapine
Citrate
Each capsule contains:Fluoxetine HCl 25 mg
Olenzapine Citrate
Olenzapine 12 mg
(Antidepressant)

FDA
only

The
Available
individual
drugs are
recommende
d but the
combination
has not been
mentioned.

therefore
has
a
potential for abuse.
The drug is included
in the controlled list
and is placed in
Schedule III in USA.
In view of its useful
role in anesthesia,
Ketamine
is
recommended to be
retained
as
a
registered
drug.
However, it should
be
dealt
with
narcotics
and
appropriate
restrictions may be
applied to prevent
its abuse.
Recommended for
registration.
Fluoxetine is an
SSRI
and
can
interact with MOAIs
to cause serotonin
syndrome. Since it is
converted into a very
long
acting
metabolite,
the
interaction can occur
during 4 weeks after
cessation
of
Fluoxetine. The risk
of QT prolongation
and causing Torsade
de
pointes
also
exists.
The
Fixed-Dose
combination may
be allowed with
relevant
warning
and to be dispensed
on prescription by
qualified
psychiatrist only.
Recommended for

3.

Each capsule contains:Omeprazole 20 mg


Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)

Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

No independent
scientifically
designed studies
available
to
support
the
combination of
these two drugs.

4.

Each capsule contains:Omeprazole 40 mg


Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)

Tentativ
e
approval
by FDA
only.

The
individual
drugs
are
recommende
d but the

No independent
scientifically
designed studies
available
to
support
the

registration.
Omeprazole, a PPI,
is a prodrug which
requires
acidic
environment
for
conversion
into
active form. It blocks
the H/K ATPase
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Omeprazole, a PPI,
is a prodrug which
requires
acidic
environment
for
conversion
into

Not
approve
d by
EMA,
PMDA,
TGA

5.

U-Fit 10 mg Dry
Suspension
Each 5ml contains:Famotidine 10 mg
(Antiulcer)

combination combination of active form. It blocks


has not been these two drugs. the H/K ATPase
mentioned.
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory
drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Famotidi NA
NA
Famotidine is widely
ne in dry
available in Tablet,
suspensi
Capsule, Suspension,
on form
Chewable
&
is not
Dispersible
tablet
approve
forms.
Dry
d by any
suspension does not
reputed
seem to offer any
internati
advantage over the
onal
existing formulations
agency
and is not supported

by
international
market scenario.
Not Recommended
for registartion.
6.

Sacopan Sachets
Each sachet contains:Saccharomyces
Boulardii 250mg
(anti Diarrhoeal)

Not
approve
d by
FDA,
EMA,
PMDA
Approve
d by
TGA
only

Some
studies
about the role of
probiotics
in
IBS and CD
infection have
been published
but their role
requires more
elucidation.

7.

Ritocin-B Dry Suspension


200 mg
Each 5ml contains:Erythromycin Ethyl
Succinate.
Erythromycin 200mg
Bromhexine HCl 4mg
(Macrolide)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA.

Erythromyci
n as single
drug
is
recommende
d by books
for
infections by
susceptible
organisms.
Bromhexine
is not even
mentioned.

8.

Spardix Tablets 100mg


Each tablet contains:Sparfloxacin 100 mg

Not
approve
d by

Mentioned
as member
of

Studies
have
been published
showing in vitro
effect
of
bromhexine as
mucolytic.
There is no
evidence
for
such action in
vivo after oral
administration.

The probiotics are in


evaluation stage and
their benefits in IBS,
Crohns disease, C.
difficle infection etc.
have
not
been
established.
In
immune-compromised
patients these may
cause life-threatening
infection. In most of
the countries these are
available as foodsupplements or OTCs.
Some of these are
already available as
additives
in
milk
formulas for infants.
May be de-registered
as drug and allowed
as food supplements.

Mucolytics
are
useful
in
management
of
COPD
after
administration
by
inhalation. Evidence
is lacking for any
benefit after oral
administration.
All
oral
formulations
containing
bromhexine
as
single drug or in
combination with
other drugs, are
recommended to be
de-registered.
Studies
have Several
of
the
been published Fluoroquinolones
showing activity have been reported

(Anti-infective,
Fluoroquinolone)

FDA,
EMA,
TGA &
PMDA.

9.

ES ZIN 20mg Tablets Each


tablet contains:Esomeprazole 20mg
Magnesium 700mg
Sodium Bicarbonate 20mg

Not
approve
d
by
FDA,
EMA,
TGA &
PMDA.

10.

ES ZIN 40mg Tablets Each


tablet contains:Esomeprazole 40 mg
Magnesium 700 mg
Sodium Bicarbonate 40mg

11.

Calzob-500 Capsules
Each capsule contains:Calcium dobesilate 500mg
(Vasotherapeutics,
Coagulants, Haemostatics)

fluoroquinol
one group.

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.
Not
The
approve individual
d
by drugs
are
FDA,
recommende
EMA,
d but the
TGA & combination
PMDA. has not been
mentioned.
Not
Not
approve mentioned
d
by in any
FDA,
standard
EMA,
textbook.
TGA &
PMDA.

of sparfloxacin
against
Gram
positive
bacteria.
Reports
are
published
describing
potassium
channel
blocking
activity causing
QT prolongation
and
lifethreatening
torsade
de
pointes
arrhythmias.
No independent
scientifically
designed studies
available
to
support
the
combination of
these drugs.

to
cause
QT
prolongation
and
cardiac arrhythmias.
The potential is
highest
for
Sparfloxacin.
In view of the
unfavorable
risk/benefit ratio,
the drug is not
recommended for
registration.

No independent
scientifically
designed studies
available
to
support
the
combination of
these drugs.

The comments given


above at No.3 also
hold good for this
preparation.
All dosage strengths
recommended for
de-registration.

The published
clinical
trials
have shown that
calcium
dobesilate does
not reduce the
occurrence of
diabetic
retinopathy in
patients.

Calcium dobesilate
was developed for
prevention
of
diabetic retinopathy.
Theoretically
its
mechanism of action
(inhibition of aldose
reductase
and
reduction
of
capillary
permeability)
supports its use for
this
purpose.

The comments given


above at No.3 also
hold good for this
preparation.
All dosage strengths
recommended for
de-registration.

However,
in
evidence-based
medicine, benefits of
this drug could not
be established.
Recommended for
de-registration.
12.

Ciprozan Tablets 1gm


Each film coated SR-tablet
contains:Ciprofloxacin 1 gm
(Quinolone Antibiotic)

One Gm
SR
dosage
form not
approve
d by
FDA,
EMA,
TGA &
PMDA.

One
Gm
extendedrelease
tablet
mentioned
by B G
Katzung

The strength is
within
the
therapeutic
range of dose
described
in
published
studies.

13.

Diacin 50mg
Capsules Each capsule
contains:Diacerein 50mg
( Anti-Rheumatic )

Not
approved
by FDA,
TGA &
PMDA.
Approve
d by
EMA for
use in
epidermo
lysis
bullosa
only

Not
mentioned
in any
standard
textbook

Some in vitro
studies
on
chondrocytes
have
been
published.
Clinical
trials
have reported
slight
but
statistically
significant
superiority over
placebo.

The slow release


tablet of 1 Gm is not
in vogue but has
been described by
the
standard
textbook and lies
within
the
therapeutic range of
dose. The applicant
may be asked to
provide
full
justification for the
formulation, quoting
examples
of
countries
where
similar forms are
available.
Final decision may
be pended till point
of view of the
applicant
is
evaluated.
Diacerein is an antiinflammatory drug
acting by inhibition
of Interleukin-1beta.
It has been used in
osteoarthritis where
it may produce slight
improvement.
In
limited number of
countries where it is
available, it is being
reviewed
and
withdrawn due to
hepatotoxicity.
In view of the
limited usefulness

and concerns of
toxicity, diacerein is
not recommended
for registration.
14.

Swanliag 5 mg Tablet
Each tablet contains:Cyclobenzaprine 5mg
(Skeletal Muscle Relaxant)

Not
Mentioned
approved by BG
by EMA, Katzung
TGA &
PMDA.
5
mg
dosageform
discontin
ued
by
FDA.

Studies
have
been published
in
which
cyclobenzaprine
was found to be
superior
to
placebo
and
equivalent
to
other
spasmolytics.

Although 5 mg dosage
form
has
been
discontinued by FDA,
but other dosage forms
contain higher doses
which
may
be
associated with more
side effects. By virtue
of its non-addictive
nature It may be
superior
to
benzodiazepines.
In view of the
scientific evidence for
efficacy of the drug,
Cyclobenzaprine may
be retained as a
registered drug.

15.

Mepridone 20mg Capsules


Each capsule contains:Esomeprazole Magnesium
Trihydrate Pellets eq. to
Esomeprazole 20 mg
Domperidone 30mg
(Proton Pump Inhibitor /
Anti-Dopaminergic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

Studies on
individual drugs
are available but
not on this
combination.

16.

Each Sachet contains:Omeprazole 20 mg


Sodium Bicarbonate 1100
mg
(Proton Pump Inhibiter)

Tentativ
e
approval
by FDA
only.
Not
approve
d by
EMA,
PMDA,
TGA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

No independent
scientifically
designed studies
available
to
support
the
combination of
these two drugs.

Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Omeprazole, a PPI,
is a prodrug which
requires
acidic
environment
for
conversion
into
active form. It blocks
the H/K ATPase
irreversibly
and
reduces the gastric
acid secretion to very
low levels (most
potent among all
antisecretory

17.

Floronol Tablets
Each tablet contains:Phloroglucinol hydrate 80
mg Trimethyl
Phloroglucinol 80 mg (Anti
Spasmodic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

Not
mentioned
by any
standard
textbook

No scientifically
designed
clinical studies
are available. In
vitro
and
toxicological
studies
have
been published.

drugs).
Sodium bicarbonate
is a rapidly acting
systemic antacid. It
absorbs into blood
and long-term use
may cause systemic
alkalosis,
besides
other toxicity.
It is irrational to
combine the two
drugs as the antacid
may
impair
activation
of
Omeprazole. Further,
in the face of strong
acid-inhibiting effect
of Omeprazole, it is
superfluous
to
administer an antacid
on regular basis.
The
combination
adds to the cost and
increases
adverse
effects.
Not Recommended
for registration.
Phloroglucinol is a
synthetic
phenol
having
antispasmodic
properties. However
its use in medicine
has
remained
restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure,
metabolic
acidosis,
hyperkalemia
and
allergic reactions.

18.

EsmoDome 20 Tablets
Each tablet contains:Esomeprazole Magnesium
Esomeprazole 20 mg
Domperidone Maleate
Domperidone 30 mg
(Antiemetics &
Antinauseants)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

Studies on
individual drugs
are available but
not on this
combination.

19.

EsmoDome 40 Tablets Each


tablet contains:Esomeprazole as
Magnesium..40mg
Domperidone Maleate
Domperidone 30 mg
(Antiemetics &
Antinauseants)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

Studies on
individual drugs
are available but
not on this
combination.

20.

Piram 1 gm Syrup
Each 5 ml contains:Piracetam 1g
(Psychostimulants,
Nootropic, Neurotonic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

Not
mentioned
by any
standard
textbook

Scientifically
conducted
clinical studies
have not shown
any benefit of
piracetam.

In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
recommended to be
de-registered.
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Piracetam is used in
treatment
of
cognitive disorders
and myoclonus but
scientific evidence
for
efficacy
is
lacking. Side effects
including
anxiety,
insomnia, irritability,
headache, agitation,
nervousness, tremor,
and
hyperkinesia,

21.

Wincoline 250 mg Injection


Each 2ml ampoule
contains:- Citicoline
Sodium
Citicholine 250 mg
(Nootropics & Neurotonic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

Not
mentioned
by any
standard
textbook.

Efficacy has not


been established
in scientifically
conducted
clinical trials.

22.

Each film coated tablet


contains:- Citicoline
Sodium
Citicholine 500 mg
(Nootropics and
Vasotherapeutic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

Not
mentioned
by any
standard
textbook.

Efficacy has not


been established
in scientifically
conducted
clinical trials.

23.

Esso Forte Tablets Each


tablet contains:Naproxen USP 500 mg
Esomeprazole Magnesium
Trihydrate
Esomeprazole 20mg
( NSAID + PPI )

Delayed
release
tablets
are
approve
d by
FDA and
TGA.
Not
approve
d by
EMA &
PMDA.

This
particular
combination
is not
mentioned
but
combining
NSAIDs
with PPIs
and H2
blockers is
recommende
d in general
for

Studies on this
particular
combination are
not found.

have been reported


with its use.
Not Recommended
for registration.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
Citicoline is cytidine
diphosphate choline
which is said to
increase
dopaminergic
receptor density in
brain. It has been
used in cognitive and
some other disorders
on this basis but
evidence for efficacy
is lacking.
Not recommended
for registration.
It is rational to
combine
NSAIDs
with
PPIs
for
prevention
of
gastropathy. Both the
drugs
individually
are well established
in their respective
categories.
Recommended for
registration.

prevention
of
gastropathy.
Not
mentioned
by any
standard
textbook

24.

Valex Talets
Each film coated tablet
contains:- Phloroglucinol
hydrate 80 mg Trimethyl
Phloroglucinol 80 mg
(Gastrointestinal/Antispasm
odics)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

No scientifically
designed
clinical studies
are available. In
vitro
and
toxicological
studies
have
been published.

25.

S.OM-D 30mg Capsules


Each capsule contains:Esomeprazole Enteric
Coated Pellets eq.
Esomeprazole 40 mg
Domperidone 30mg
(Proton Pump Inhibitor /
antiemetic)

Not
approve
d by
FDA,
EMA,
TGA &
PMDA

The
individual
drugs
are
recommende
d but the
combination
has not been
mentioned.

Studies on
individual drugs
are available but
not on this
combination.

26.

Thicol 4mg Capsules


Each capsule contains:Thiocolchicoside..4 mg

Not
approve
d by

Not
mentioned
by any

No reference
found in
authentic

Phloroglucinol is a
synthetic
phenol
having
antispasmodic
properties. However
its use in medicine
has
remained
restricted due to
toxicity concerns. It
is mainly used in
explosive industry.
The adverse effects
reported by FDA
include neutropenia,
hepatotoxicity, renal
failure,
metabolic
acidosis,
hyperkalemia
and
allergic reactions.
In view of severely
unfavorable
benefit/risk ratio all
preparations
containing
phloroglucinol are
Recommended to
be de-registered.
Besides
the
combination,
Domperidone as an
individual drug is not
approved by FDA. It
has been associated
with
cardiac
arrhythmias.
The
combination
is
irrational and carries
the risk of toxicity.
Recommended to
be de-registered.
Thiocolchicosideis a
muscle relaxant with
anti-inflammatory and
analgesic effects. It

(Muscle Relaxant)

FDA,
EMA &
TGA

standard
textbook.

journals

acts as a competitive
GABAA
receptor
antagonist and also
glycine
receptor
antagonist. A variety of
adverse effects have
been reported with this
drug. Particularly of
concern are its ability
to cause seizures and
potential to cause
tratogenecity and male
infertility.
Not recommended for
registration.

27.

Darcin ER 15mg Tablets


Each extended release tablet
contains:Darifenacin 15 mg
(Anti-Cholinergic)

Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.

Recommend
ed for use in
genitourinary
disorders.

Available.

28.

Darcin ER 7.5mg Tablets


Each extended release tablet
contains:Darifenacin . 7.5mg
(Anti-Cholinergic)

Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.

Recommend
ed for use in
genitourinary
disorders.

Available.

29.

CarionJect 500mg Injection


Each 10 ml injection
contains:- Iron Ferric
Carboxymaltose
Iron Element 500mg
(Haematinic)

This
particular
preparation
not
mentioned.

Few but
available.

30.

C-Zyme Tablet
Each tablet contains:Metoclopramide HCl 6mg

Approve
d by
FDA
(750mg/
15 ml)
& TGA
(500mg/
10ml)
Not
approve
d by

Not
mentioned
by any

No reference
found in
authentic

Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in
adults.
A
congener, solifenacin
is already registered.
Recommended for
registration.
Darifenacin is a M 3
selective
antimuscarinic drug
used for control of
urinary incontinence
in
adults.
A
congener, solifenacin
is already registered.
Recommended for
registration.
It is a new parenteral
form
of
iron.
Comparable to the
existing formulations
in efficacy and safety
profiles.
Recommended for
registration.
A
completely
irrational
combination

Sodium dehydrocholate 20
mg Bromelain 35000 PU
Pancreatin 210 FIPPU
Simethicone 50 mg

FDA,
EMA,
TGA &
PMDA.

standard
textbook.

journals.

31.

Carolate Injection
Each 1ml ampoule
contains:- Glycopyrrolate
0.5 mg Neostigmine
methylsulphate 2.5mg

Not
approve
d by
FDA,
EMA,
TGA &
PMDA.

This
Available
particular
combination
is not
mentioned
but use of
atropine-like
drugs to
counter the
muscarinic
effects of
anticholinest
erases is
recommende
d.

32.

Isotretinoin Cap/
Isotretinoin Tablet

Recdommen
ded for
severe acne
and certain
malignant
disorders.

33.

Amoxicillin + Sulbactum

The general
principal for
combining

Available

containing
drugs
whose efficacy is not
established.
Not recommended
for registration.
Neostigmine
is
generally used to
reverse
muscle
paralysis induced by
curare-like
drugs
during
anesthesia.
This action is exerted
on
nicotinic
receptors
but is
accompanied
with
unwanted muscarinic
stimulation. This is
countered
by
administration
of
antimuscarinic drugs
like glycopyrrolate.
Recommended for
registration.
Isotretinoin is 13-cis
retinoic acid. It is
used in treatment of
cystic
acne,
squamous
cell
carcinoma of skin
and certain other
malignancies.
In
view
of
its
established efficacy,
the
drug
is
recommended to be
retained.
Any issues related
to
dosage
form/formulation
may be resolved
after obtaining view
point
of
manufacturers.
It is rational to
combine penicillin
with beta lactamase

penicillins
with beta
lacatmase
inhibitors is
described.

34.

Silymarin

Not
approve
d by
FDA,
EMA,
TGA &
PMDA.

Not
mentioned
by any
standard
textbook.

35.

Aescin

Not
approve
d by
FDA,
EMA,
TGA &
PMDA.

Not
mentioned
by any
standard
textbook.

36.

Solcoseryl

Not
approve
d by
FDA,

Not
mentioned
by any
standard

inhibitors
but
Amoxicillin
is
generally combined
with
clavulanate.
The manufacturers
may be asked to
provide reasons for
using
sulbactam
along
with
references in the
favor
of
this
combination.
May be deferred for
the time being.
No scientifically Silymarin is a dried
designed studies extract
obtained
available in
from Milk thistle
authentic
plant. Efficacy in
journals.
hepatic disorders has
not been proved in
authentic
clinical
trials.
Adverse
effects have been
reported in patients
using milk thistle
capsules.
Not recommended
for registration.
No scientifically Aescin is a mixture
designed studies of saponins present
available in
in horse chestnut
authentic
plant. It is claimed to
journals.
have
anti
inflammatory
and
vasoprotective
effects but this has
not been proved in
scientifically
designed
clinical
studies
Not recommended
for registration.
No scientifically Solcoseryl
is
designed studies deproteinated blood
available in
of calves. It has been
authentic
used in a variety of

37.

Serratiopeptidase

38.

Smectite

f.

EMA,
TGA &
PMDA.

textbook.

Not
approve
d by
FDA,
EMA,
TGA &
PMDA.

Not
mentioned
by any
standard
textbook.

Not
mentioned
by any
standard
textbook.

journals.

formulations
for
various purposes but
scientific evidence
for
efficacy
is
lacking.
Not
recommended for
registration.
No scientifically Serratiopeptidase is a
designed studies proteolytic enzyme
available in
present in silkworm
authentic
gut which helps it to
journals.
dissolve the cocoon.
It has been used as
an anti-inflammatory
agent without any
scientific evidence of
efficacy.Takeda
Pharmaceuticals, the
brand
leader
Japanese company,
had
agreed
for
voluntary withdrawal
from market in 2011.
Not recommended
for registration.
No clinical
studies available
to support
efficacy.

Smectite is mineral
clay
having
adsorbent properties.
It is similar to kaolin
in its medicinal
value.
Not recommended
for registration.

Manufacturing requirement for various classes of drugs.


Registration Board in 245th meeting discussed manufacturing requirements for various

classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their
scientific comments and relevant references on manufacturing requirements for following classes
of drugs:
-

Steroids.
Immunosuppresants.

Clomiphene and letrozole


Prostaglandins and its analogues.
Storage requirement of Misoprostol
Vancomycin

Two members and PPMA has forwarded their comments on manufacturing requirements for
steroids, as follows:

Dr. Amanullah Khan (Director, DTL, Quetta).


For all steroidal preparations except topical preparations must have separate

manufacturing area, so it may be added that topical preparations may be manufactured in the
same approved area and exempted from separate area.

Lt General (R) Karamat Ahmed Karamat.


Reference to the Board meeting proceedings, all non-inflammatory steroids like

prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.
Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured
through wet process and should be allowed to manufacture across the board as everywhere in the
world. However, sensitive steroids which fall under category A like penicillin, cytotoxic
substances, Beta lactam and sex hormones may be considered to be manufactured in the
dedicated area.

PPMA.

M/s Sante Pharmaceuticals, Karachi.

1. Drugs (Licensing, Registration & Advertisement) Rules 1976.


Dedicated Facility for production states that:

Schedule B- 5.2.

Dedicated and self -contained facilities for the production of particular drugs shell be provided in
addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological
preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations
or sterile products or for that matter such other highly active pharmaceutical products, antibiotics,
hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk
of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of
campaign working in the same facilities may be allowed by the Central Licensing Board provided that
specific precautions are taken and necessary validations are made.
2. In 195th Meeting of Central Licensing & Registration Board held on 24 th Nov. 2005 a
presentation was made by PPMA and Pharma Bureau
Item No.3.

Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was
discussed.
A team of Pharma Bureau and PPMA members presented their view about the matter of segregated
facilities for Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs.
They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin,
Cephalosporin, and Biological which fall under category A drugs.
Decision of Registration Board:
It was decided that the permission to manufacture the Quinolone products will be allowed on the
basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation.
HVAC system and cleaning validation is mandatory.
3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter
5:Production
Section 3.6: Production Area states that:
Dedicated facilities are required for manufacturing when a medicinal product present a risk;
a) Which cannot be adequately controlled by operational and/ technical measures.
b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing
materials such as beta lactam) or
c) Threshold values derived from toxicological evaluation are below the level of detection

4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL


PRODUCTS
PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA
SCHEDULE M.

Production area.

In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities
shall be made available for the production of sensitive pharmaceutical products like penicillin or
biological preparations with live micro-organisms. Separate dedicated facilities shall be provided
for the manufacture of contamination causing and potent products such as Beta lactam, Sex
Hormones and Cytotoxic substances.

5. ICH guideline
Self-contained facilities shall be made available for the production of highly
sensitive pharmaceutical products like penicillin or biological preparations with live microorganisms. Separate dedicated facilities shall be provided for the manufacture of
contamination causing and potent products such as Beta lactam, Sex Hormones and
Cytotoxic substances.

6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi
FDA and others;

Dedicated facility is required for highly sensitive products like Beta lactam, Sex
Hormones, Cephalosporin and Cytotoxic products

DEFINITION OF HOMONES
1. Different types of steroid hormones, a class of hormones chemically similar to each other, have
different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar
to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or
inflammation.
2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the
major male hormone testosterone, which is produced in the testes in men and in the adrenal
glands in both men and women. These chemicals are recognized for their effects on building up
muscle.
3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as antiinflammatory medications to help treat illnesses in which inflammation is part of the disease
process.
4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the
anti-inflammatory drug Dexamethasone.
5. Steroid: One of a large group of chemical substances classified by a specific carbon structure.
Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and
Cortisone.
IMPACT OF CROSS CONTAMINATION
There are certain categories of hormones
1. Sex Hormones
Sex hormones comes under category A. In category A, Sex hormones like progesterone (female
sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall
under Highly sensitizing materials where cross contamination in very less quantity (microgram)
can cause risk of serious health hazard. The cross contamination of male sex hormone with in a
manufacturing process can produce changes in the secondary behavior in female like extra hair
growth, voice change etc. and vice versa female sex hormone cross contamination during
manufacturing operation can cause serious health hazard like diminishing of sexual desire,
enlargement of mammary glands etc. therefore in order to minimize the risk of serious health
hazard due to cross contamination addition control during manufacturing operation, used of
closed system, dedicated product contact equipment parts, HVAC control are necessary.
2. Anabolic Steroids
They also fall in category A and are those used for muscle building weight gain and weak
anabolic activities. Same principal followed during the manufacturing operation for cross
contamination.

3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)


Corticosteroids should not be confused with sex hormones as they do not fall in category A of
highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye
preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of
corticosteroids during the manufacturing operation can not impact the same health hazards as sex
hormones even in micro grams quantities hence no dedicated self contained facility is suggested
by international guideline agencies like Eur. ICH, and orange guide where they recommend use of
same facility with following instructions on campaign bases and cleaning validation.
RISK
ASSESSMENT
/
ANALYSIS
MANUFACTURING OPERATION

OF

CROSS

CONTAMINATION

DURING

What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing
operation in spite of observing instructions and guidelines provided by the international agencies due to
certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients
i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e.
in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it
is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water
dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size
finally blend was transferred to main bulk container in liquid form there is no less chances of dust
generation during the process. During the product change over a cleaning validation procedure is
followed by QC who only allows next batch processing after their approval.
There are two strong arguments in favor of using the same facility for steroid and non-steroid
preparations.
1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during
the manufacturing operation the international agencies like European Union (Orange Guide),
WHO and ICH will never recommend the same facility on campaign basis following the cleaning
validation method as in case of sex hormones because corticosteroids are not classified under the
highly sensitizing materials even the cross contamination of corticosteroids cannot impact any
bad health hazard.
2. Currently topical steroid containing preparations are produced in same facility (Non Steroids)
under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch &
Lomb etc. and there audit for facility will also conducted by their corporate office under
international GMP guidelines, who allows them to manufacture steroids and non steroids in the
same facility. So far no adverse drug reaction was reported internationally and nationally which is
due to cross contamination.
CONCLUSION
1. All Steroids do not fall in the category of Highly sensitizing materials.
2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in
category A.

3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and
sportsmen may be classified in category A
4. Corticosteroids
(Dexamethasone,
Prednisolone,
Mometasone,
Betamethasone,
and
Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing
materials.
Corticosteroids do not fall in the category of highly sensitive materials and the companies
like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye
drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone,
Mometasone, Betamethasone and Triamcenolone in the same facility with following the
instructions on campaign basis.
MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS
In eye drops the entire manufacturing method is wet process except dispensing of materials.
The concentration of steroids in Topical and Tropical preparations
Ophthalmic Preparation is 0.1 to 0.2 %
Otic Preparations (Drops and Ointments) is 0.1 to 0.2%
The steroids are dispensed in dispensing booth with laminar flow having strong extraction
system.
These steroids are immediately transferred under laminar flow, into glass jars containing a
mixture of water and HPMC
Tightly close Jars are placed on ball mill to reduce the particle size of steroids.
Then ready slurry is transferred into bulk under laminar flow.
Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers
having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last
many years.

Storage requirement of Misoprostol.


-

M/s Pfizer Pakistan, Karachi.

There is an obligation to maintain a temperature of -20 0C and has to kept in an air tight
container.
-

M/s Rasco Pharma, Lahore.

The firm has provided assessment report (EMA) of misoprostol API which is reproduced as
under:-

Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol
dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol
tablet. The dispersion consists of a powder that can be stored at 5+3 C, whereas the
actual active substance is an oily liquid that needs to be stored at -20 C.

The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 28 C.

Item No. V

Registration of drugs Pharmaceutical Evaluation Cell.

Case No.01.

Correction in minutes M-245

S/N

Name
and
address
of
manufacturer /
Applicant

1. Brand Name
2. Dosage Form
3. Composition
4. Pharmacological
group

1.

M/s. Ali Gohar &


Company
(Pvt)
Limited, Karachi.
Manufacturer
M/s. Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Located in Binger
Strasse
173,
55216 Ingelheim
am
Rhein,
Germany.

Jentadueto
2.5mg/850mg
Tablets
Each Film Coated
Tablets contains:Linagliptin..2.5
mg
Metformin
Hydrochloride.
850mg
(Drugs
used
in
Diabetes,
combination of oral
blood
glucose
lowering drugs).
Jentadueto
2.5mg/1000mg
Tablets
Each Film Coated
Tablets contains:Linagliptin..2.5
mg
Metformin
Hydrochloride.
1000mg

2.

M/s. Ali Gohar &


Company
(Pvt)
Limited, Karachi.
Manufacturer
M/s. Boehringer
Ingelheim Pharma
GmbH & Co. KG,
Located in Binger
Strasse
173,
55216 Ingelheim
am
Rhein,
Germany.

(Drugs
used
in
Diabetes,
combination of oral
blood
glucose
lowering drugs).

1. Type of Form
2.
Type
of
application
3.
Demanded
Price / Pack size
4. Initial date,
diary. 5. Date on
which
fee
becomes
complete
according to type
of application /or
Form
Form 5 A
01-07-2013
Rs.50000/Rs. 7130/
Per packs of 60
Tablets.

1.Finished
Product
Specification
2. Facility where
drug has to be
manufactured
with
status
whether approved
by CLB or not
3. Last GMP
inspection report
with
date
&
status.
International:
Jantadueto 2.5/850
(FDA)
Local: Me too (M
243)

Decision in
245th
meeting of
the
Registratio
n Board

Correction required by the


applicant

Approved.

The firm applied for packs


of 10s & 30s as under just
before
meeting
of
Registration Board thats
why it was missed in
agenda & minutes.
Rs. 0.9 x 10 USD for 10s
Rs. 0.9 x 30 USD for 30s &
Rs. 7130/
Per packs of 60 Tablets.

Form 5 A
01-07-2013
Rs.50000/Rs.7130/
Per packs of 60
Tablets

International:
Jantadueto
2.5/1000 (FDA)
Local: Me too (M
243)

Approved.

The firm applied for packs


of 10s & 30s as under just
before
meeting
of
Registration Board thats
why it was missed in
agenda & minutes.
Rs. 0.9 x 10 USD for 10s
Rs. 0.9 x 30 USD for 30s &
Rs. 7130/
Per packs of 60 Tablets.

Evaluator II
S/N

Name and address Brand Name


of manufacturer /
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group

Type of Form

Decision
of Remarks on the formulation
Previous Meeting any) including Internation
Initial
date,
status in stringent dr
diary
regulatory
agencies
authorities.
Fee including
differential fee
Demanded
Price / Pack
size

Finished
product
Specification

M/s. Medisearch
Pharmacal (Pvt) ltd,
5-Km, Raiwind
Manga Road,
Lahore.

M/s Allmed Pvt. Ltd.


(Formerly, EverGreen
Pharmaceuticals, Pvt.
Ltd.
Plot.No.590,
Sundar
Industrial
Estate Lahore.

Molus
Dry
Suspension
When
reconstituted
Each 5ml
contains:Montelukast
Sodium..5m
g
(antiasthmatic)
(Manufacturer
s Spec.s)

Form-5

Reevo Tablets
Each
tablet
contains:
Levocarnitin...2
50mg
(Aminoacid
derivative/suppli
ment)

Form5

20-122013(1308)
Rs.20,000/-

Approved. Letter
will be issued
after rectification
of shortcomings.
(M-243)

The
Formulation
w
erroneously approved by t
Drug Registration Board. Th
Formulation is under revie
by the Review Committee.

Deferred
for
confirmation
of
pharmacological
group as applied
by firm.
(M-244)

Initially the Firm had appli


for Levocarnitine250mg p

As per
SRO/60ml

06-08-2010
Rs.8000/11-10-2012
Rs.12,000/Rs.350/10s

Tablet formulation on Form


Before
the
formation
Pharmaceutical Evaluation C
some Registration applicatio
were sent to various DRA
officers for evaluation includi
this one. Agenda of the
applications was prepared for M
242 but could not be discuss
Later on the Firm submitt
Form 5-D for this formulati
and changed the formulation
Levocarnitine330mg mg p
Tablet. The left over agenda
M-244 was discussed in M-2

but the change was n


incorporated. The Registrati
Board
considered
formulation as Levocarnitine
250mg per Tablet and deffered
merely
for confirmation
pharmacological
group
applied by firm. Registrati
Board may ask the firm
submit the firm to subm
differential fee required
application on Form 5-D a
evaluate
the
applicati
accordingly.

Case No.02. Registration of a Patent Drug Iodine Complex


M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex
molecule in their Research & Development Laboratories and the said molecule has been awarded patent in
Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary
& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these
studies have been published in international and national journals which show that addition of iodine complex
with standard therapy of Hepatitis gives significant results.
S/N

Brand Name
(Proprietary name
Dosage
Form
Strength)

Composition
+
+ Pharmacological
Group
submitted by the firm)

Type of Form
(as Initial date, diary
Fee including differential fee

Finished product Specification


Demanded Price / Pack size
1.

IODIRIN Tablets 200mcg

Each tablet contains:


Iodine complex equivalent
elemental Iodine.200mcg
Iodine
deficiency
Antithyroid

Form-5E
to
23-10-14 Dy. No: 1271

disorder/ 50,000/Not provided

2.

3.

IDOMARINE
50mg

RENESSANS
200mg

Manufacturer
Capsules Each capsule contains:
Iodine complex equivalent
elemental Iodine.50mg

Form-5E
to
23-10-14 Dy. No: 1271

Iodine
deficiency
disorder/ 50,000/Antithyroid/ Immunomodulator
Not provided
Manufacturer
Capsule Each capsule contains:
Form-5E
Iodine complex equivalent to
elemental Iodine.200mg
23-10-14 Dy. No: 1271
Antiviral/
Hepatic
Preps/
Antithyroid/ Immunomodulator

50,000/Not provided

4.

RENESSANS
Suspension 15mg/ 5ml

Manufacturer
Each 5ml contains:
Iodine complex equivalent
elemental Iodine.15mg

Form-5E
to

Antiviral/
Hepatic
Preps/
Antithyroid/ Immunomodulator

23-10-14 Dy. No: 1271


50,000/Not provided

Manufacturer

The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and
treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on
fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in
different dosage forms. Details of which are tabulated below.
2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following
observations have been noticed:
a. The applicant has been granted patent for the said molecule named as Iodine Complex for cure
against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting
the registration for a patent drug or not.
b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and
currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There
are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation
reports clearly depicts the same.
c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being
new molecule not else- where approved in the world). At present, the Cell for the said purpose
(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference
Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA Japan
etc. While the drug under discussion has no such approval from any of the drug regulatory agency
in the world.
5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has
taken up the case. The said Division has forwarded the submitted clinical trial data / research publication
of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.
Their reply is awaited. The case is therefore, placed for consideration before Registration Board.

Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).
Evaluator II
S/N

Name
and Brand Name
Type of Form
address
of
name
+ Initial date, diary
manufacturer / (Proprietary
Dosage
Form
+
Strength)
Applicant
Fee
including
Composition
differential fee
Pharmacological Group
Finished
Specification

1.

2.

3.

M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Tablet General:
No. F.6-6/2014Lic (M-237 dated
17-10-2014)
-do-

-do-

product

Demanded
Pack size

Price

Remarks on the formulation (i


any) including
Internationa
status
in
stringent
drug
regulatory agencies / authorities
Me-too status

/ GMP status as depicted in lates


inspection report (with date) by
the Evaluator

Klar 250mg Tablet


Each film coated Tablet
contains:Clarithromycin(USP)
250mg
(Macrolide Antibiotic)
(USP Spec,s)

Form 5
17-11-2014 (232)
Rs. 20,000/As Per SRO/
Pack 10s

BNF: Klaricid (Abbott


Healthcare)

Klar 500mg Tablet


Each film coated Tablet
contains:Clarithromycin(USP)
500mg
(Macrolide Antibiotic)
(USP Spec,s)
Monti 10mg Tablet
Each film coated Tablet
contains:Montelukast Sodium as
Montelukast10mg
(Bronchodilators & Antiasthma
(Leukotriene
antagonist))
(Manufacturers Spec.s)

Form 5
17-11-2014(228)
Rs. 20,000/As Per SRO/

BNF: Klaricid (Abbott


Healthcare)

Pack 10s

New Licensee

Form 5
17-11-2014(229)
Rs. 20,000/As Per SRO/
Pack 14s

Singulair 10mg Tablet of Merck &


Co. Inc. USA

Claritek 250mg Tablet Getz


Pharma Pvt. Ltd. Karachi
New Licensee

Claritek 250mg Tablet Getz


Pharma Pvt. Ltd. Karachi

Myteka 10mg Tablet Hilton


Pharma Pvt. Ltd. Karachi
New Licensee

4.

5.

6.

7.

8.

-do-

-do-

-do-

-do-

-do-

Cip 250mg Tablet


Each film coated Tablet
contains:-Ciprofloxacin as
Ciprofloxacin HCl250mg
(Quinolones Antibiotic)
(B.P Spec,s)

Form 5
17-11-2014(235)
Rs. 20,000/As Per SRO/

CIPROXIN 250mg Tablet Baye


Australia Limited

Pack 10s

New Licensee

Cip 500mg Tablet


Each film coated Tablet
contains:-Ciprofloxacin as
Ciprofloxacin HCl500mg
(Quinolones Antibiotic)
(B.P Spec,s)

Form 5
17-11-2014
Rs. 20,000/As Per SRO/

CIPROXIN 500mg Tablet Baye


Australia Limited

Pack 10s

New Licensee

Levof 250mg Tablet


Each film coated Tablet
contains:Levofloxacin
(as
hemihydrate)250mg
(Quinolones Antibiotic)
(USP Spec,s)

Form 5
17-11-2014(234)
Rs. 20,000/As Per SRO/
Pack 10s

LEVAQUIN 250mg Tablet Janssen


Pharma USA

Levof DS 500mg Tablet


Each film coated Tablet
contains:Levofloxacin
(as
hemihydrate)500mg
(Quinolones Antibiotic)
(USP Spec,s)
Moxif 400mg Tablet
Each film coated Tablet
contains:Moxifloxacin
(as
Moxifloxacin
HCl)
400mg
(Quinolones Antibiotic)
(Manufacturers Spec.s)

Form 5
17-11-2014(233)
Rs. 20,000/As Per SRO/
Pack 10s

GETCIPRO 250mg Tablet Getz


Pharma (Pvt.) Ltd. Karachi

GETCIPRO 500mg Tablet Getz


Pharma (Pvt.) Ltd. Karachi

LEFLOX 250mg Tablet Getz


Pharma (Pvt.) Ltd Karachi
New Licensee

LEVAQUIN 500mg Tablet Janssen


Pharma USA
LEFLOX 500mg Tablet
Pharma (Pvt.) Ltd Karachi

Getz

New Licensee
Form 5
17-11-2014(237)
Rs. 20,000/As Per SRO/
Pack 5s

VIGAMOX 400mg Tablet Alcon


Lab, USA
MOXIGET 400mg Tablet Getz
Pharma (Pvt.) Ltd.
New Licensee

9.

10.

11.

12.

-do-

-do-

M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Capsule General:
No. F.6-6/2014Lic (M-237 dated
17-10-2014)
-do-

Mecob 500mcg Tablet


Each sugar coated Tablet
contains:Mecobalamin (JP)500mcg
(Co-enzyme Vitamin B12)
(Manufacturers Spec.s)

Form 5
17-11-2014(230)
Rs. 20,000/As Per SRO/
Pack 20s
50s & 100s

METHYCOBAL 500mcg Tablet


Eisai Co Ltd. JAPAN

Trump 37.5/325mg Tablet


Each film coated Tablet
contains:Tramadol HCl37.5mg
Paracetamol325mg
(Opiate analogue/analgesic )
(USP Spec,s)

Form 5
17-11-2014(231)
Rs. 20,000/As Per SRO/
Pack 10s

BNF: Tramacet (Grunenthal)

Coxib 200mg Capsule


Each Capsule Contains:Celecoxib200mg
(Cox-2 Inhibitor)
(Manufacturers Spec.s)

Form 5
17-11-2014 (196)
Rs. 20,000/As Per SRO/
Pack 20s

METHYCOBAL 500mcg Tablet


Hilton Pharma (Pvt.) Ltd Karachi
New Licensee

TONOFLEX Tablet Sami


Pharmaceuticals Karachi
New Licensee

CELEBREX 200mg Capsule of


Pfizer Laboratories USA
CELBEX 200mg Capsule Getz
Pharma Pvt. Ltd. Karachi
New Licensee

Coxib 100mg Capsule Each


Capsule Contains:Celecoxib100mg
(Cox-2 Inhibitor)
(Manufacturers Spec.s)

Form 5
18-11-2014(Nil)
Rs. 20,000/As Per SRO/
Pack 20s

CELEBREX 100mg Capsule of


Pfizer Laboratories USA
CELBEX 100mg Capsule Getz
Pharma Pvt. Ltd. Karachi
New Licensee

13.

-do-

Profile 20mg Capsule


Each Capsule Contains:Omeprazole enteric coated
Pellets 8.5% equivalent to
Omeprazole20mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC, Mahad
Village Jite District, Raigad,
Maharashtra, India)

Form 5
17-11-2014 (192)
Rs. 100,000/As Per SRO/
Pack 14s

BNF: Losec (AstraZeneca)


RISEK 20mg Capsule Getz
Pharma (Pvt.) Ltd
New Licensee

1.Original Legalized Copy of Valid


GMP
certificate
o
manufacturer of Pellets i

(Proton pump inhibitor)


(Manufacturers Spec.s)
14.

15.

16.

-do-

-do-

-do-

Profile 40mg Capsule


Each Capsule Contains:Omeprazole enteric coated
Pellets 8.5% equivalent to
Omeprazole40mg
(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC, Mahad
Village Jite District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturers Spec.s)
Somep 40mg Capsule
Each Capsule Contains:Esomeprazole enteric coated
Pellets 22.50% equivalent to
Esomeprazole40mg
(Source of Pellets:
M/s
Titan
Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC, Mahad
Village Jite District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturers Spec.s)
Somep 20mg Capsule
Each Capsule Contains:Esomeprazole enteric coated
Pellets 22.50% equivalent to
Esomeprazole20mg
(Source of Pellets:
M/s
Titan
Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC, Mahad
Village Jite District, Raigad,
Maharashtra, India)
(Proton pump inhibitor)
(Manufacturers Spec.s)

required.

Form 5
17-11-2014(193)
Rs. 100,000/As Per SRO/
Pack 14s

BNF: Losec (AstraZeneca)


RISEK 40mg Capsule Getz
Pharma (Pvt.) Ltd
New Licensee

1.Original Legalized Copy of Valid


GMP
certificate
o
manufacturer of Pellets i
required.
Form 5
17-11-2014(191)
Rs. 100,000/As Per SRO/
Pack 14s

NEXIUM
Capsule AstraZeneca

40mg

E-CAP 40mg Capsule Brookes


Pharmaceutical Laboratories
New Licensee

1.Original Legalized Copy of Valid


GMP
certificate
o
manufacturer of Pellets i
required.
Form 5
17-11-2014(190)
Rs. 100,000/As Per SRO/
Pack 14s

NEXIUM
Capsule AstraZeneca

40mg

E-CAP 40mg Capsule Brookes


Pharmaceutical Laboratories
New Licensee

1.Original Legalized Copy of Valid


GMP
certificate
o
manufacturer of Pellets i
required.

17.

-do-

Zith 250mg Capsule


Each Capsule contains:Azithromycin (as Dihydrate)
250mg
(Macrolide Antibiotic)
(USP Spec,s)

Form 5
17-11-2014(194)
Rs. 20,000/As Per SRO/
Pack 6's & 10's

ZITHROMAX
250mg
Capsule Pfizer Laboratories
ZETRO 250mg Capsule Getz
Pharma (Pvt.) Ltd.
New Licensee

18.

-doMalrid Capsule
Each Capsule contains:Dihydroartemisinin 40mg
Piperaquine
Phosphate
320mg
(Anti-Malarial)
(Manufacturers Spec.s)

19.

-doTranex 500mg Capsule


Each Capsule contains:Tranexamic Acid500mg
(Haemostatic/
Fibrinolytic)
(Manufacturers Spec.s)

20.

-doFlucap 150mg Capsule


Each Capsule contains:Fluconazole 150mg
(Antifungal)
(Manufacturers Spec.s)

Form 5
17-11-2014(195)
Rs. 20,000/As Per SRO/
Pack 8's

Not confirmed
DIPIP 40/320mg Capsule Hilton
Pharma (Pvt.) Ltd
New Licensee

1.Availability in SRAs no
confirmed. Firm has provided
international availability in
Italy.
Form 5
17-11-2014(197)
Rs. 20,000/As Per SRO/
Pack 20's & 100's

Not confirmed
XED 500mg Capsule Indus
Pharma
New Licensee

1.Availability in SRAs no
confirmed. Firm has provided
international availability in
Bangladesh.
Form 5
17-11-2014(198)
Rs. 20,000/As Per SRO/
Pack 1's

CANESTEN
150mg
Capsule Bayer Healthcare
FLUDERM 150mg Capsule
Nabiqasim Industries (Pvt.) Ltd
New Licensee

21.

22.

M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Sachet General:
No. F.6-6/2014Lic (M-237 dated
17-10-2014)
-do-

Onitum 2gm Sachet


Each Sachet contains:Strontium Ranelate 2g
(Anti-osteoporotic)
(Manufacturers Spec.s)

Monti 4mg Sachet

23.

24.

-do-

-do-

Form 5
17-11-2014(204)
Rs. 20,000/As Per SRO/
Pack 7s

Form 5
17-11-2014(218)
Rs. 20,000/As Per SRO/

Each Sachet contains:Montelukast


Sodium
equivalent to Montelukast Pack 14s
4mg
(Bronchodilators & Antiasthma
(Leukotriene
antagonist)
(Manufacturers Spec.s)
Form 5
Malrid 15/120mg Sachet
17-11-2014(206)
Rs. 20,000/Each Sachet contains:As Per SRO/
Dihydroartemisinin 15mg
Piperaquine Phosphate Pack 16s
120mg
(Anti-Malarial)
(Manufacturers Spec.s)
Citrosalt 4mg Sachet
Each Sachet contains:Sodium Bicarbonate
1.716gm Sodium Citrate
Anhydrous 0.613gm
Citric Acid Anhydrous
0.702gm
Tartaric Acid 0.856gm
(Antacids, Anti-flatulents)
(Manufacturers Spec.s)

Form 5
17-11-2014(217)
Rs. 20,000/As Per SRO/
Pack 20s & 100s

PROTELOS
Sachet
Le
Laboratoires Servier Industrie
ONITA Sachet PharmEVO
New Licensee

Singulair (MSD
MONTIKA 4mg Sachet Sami
Pharmaceutical (Pvt.) Ltd
New Licensee

Not confirmed
ARMIQIN Sachet PharmEVO
New Licensee

1.Availability in SRAs no
confirmed. Firm has provided
international availability in
Taiwan
Not confirmed
CITRO SODA Sachet Abbott
Laboratories, Pakistan
New Licensee

1.Availability in SRAs no
confirmed. Firm has provided
international availability in
India.

25.

-doProfile 20mg Sachet

Form 5
17-11-2014(206)
Rs. 20,000/As Per SRO/

Each Sachet contains:Omeprazole 20mg


Sodium
Bicarbonate
1680mg
Pack 10s
(Proton
pump
inhibitor/antacid)
(Manufacturers Spec.s)
26.

-doProfile 40mg Sachet

Form 5
17-11-2014(212)
Rs. 20,000/As Per SRO/

Each Sachet contains:Omeprazole 40mg


Sodium Bicarbonate
1680mg
Pack 10s
(Proton
pump
inhibitor/antacid)
(Manufacturers Spec.s)
27.

-doORES Sachet

Form 5
17-11-2014(213)
Rs. 20,000/As Per SRO/

Each Sachet contains:Sodium Chloride 2.6g


Sodium Citrate2.9g
Potassium Chloride 1.50g Pack 20's
Glucose
Anhydrous
13.50g

FDA: Zegerid
RISEK INSTA Powder 20mg
Sachet Getz Pharma (Pvt.) Ltd
New Licensee

1.Formulation is under review by


the Review Committee o
DRB.
FDA: Zegerid
RISEK INSTA Powder 40mg
Sachet Getz Pharma (Pvt.) Ltd
New Licensee

1.Formulation is under review by


the Review Committee o
DRB.

BNF:
Oral Rehydration Salt
(Non-proprietary)
WHO
Formulation

OEM Sachet Indus Pharma Pvt


Ltd.
New Licensee

(Electrolytes)
(BP Spec,s)
28.

-doCysteine Sachet
Each Sachet contains:Acetylcysteine 200mg
(Mucolytic Agent)
(Manufacturers Spec.s)

Form 5
17-11-2014 (210)
Rs. 20,000/As Per SRO/

Pack 30s

Not confirmed (ACC


Switzerland by Firm)

Sandoz

MUCOLATOR 200mg Sachet


Abbott Laboratories (Pakistan) Ltd
New Licensee

1.Availability in SRAs no
confirmed. Firm has provided

international
Switzerland.

29.

-doLaxit Sachet

30.

31.

-do-

M/s
Sigma
Pharma
International Pvt.
Limited
E-50,
N.W.I.Z.,
Port
Qasim Karachi
(Oral Dry Powder
Suspension
General: No. F.66/2014-Lic
(M237 dated 17-102014)

Form 5
17-11-2014 (211)
Rs. 20,000/As Per SRO/

Each Sachet contains:Polyethylene Glycol 3350


13.125g
Sodium Chloride 0.3507g Pack 10s
Sodium
Bicarbonate
0.1785g
Potassium
chloride
0.0466g
(Laxatives)
(Manufacturers Specs)
Form 5
Gastolyte Sachet
17-11-2014(216)
Rs. 20,000/Each Sachet contains:As Per SRO/
Rice Powder 6g
Sodium Citrate 0.580g
Sodium Chloride 0.350g Pack
Potassium Chloride 0.3g
(Electrolytes)
1 x 10s
(Manufacturers Spec.s)
Klar
125mg/5ml
Dry Form 5
Suspnsion
17-11-2014(222)
Each 5ml contains:Rs. 20,000/Clarithromycin125mg
As Per SRO/
(Macrolide Antibiotic)
Pack 30ml & 60ml
(USP Spec.s)

availability

in

Not confirmed
MOVCOL Sachet Genix Pharma
Private Limited
New Licensee

1.Availability in SRAs no
confirmed in same strength.

BNF: Dioralyte Relief (SanofiAventis)


GASTROLYTE Sachet SanofiAventis Pakistan Limited
New Licensee

BNF . Klaricid (Abbott)


(Klaricid (Abbott))
New Licensee

32.

33.

-do-

-do-

Klar
250mg/5ml
Dry
Suspnsion
Each 5ml contains:Clarithromycin250mg
(Macrolide Antibiotic)
(USP Spec.s)
{Source of Clarithromycin
taste masked Granules: M/s
Surge
Lab10th
KM
Faisalabad
road
Sheikhupura}
Fantin 15mg/90mg/5ml
Dry Suspnsion
Each 5ml contains:Artemether 15mg
Lumefantrine 90mg
(Antimalarial )
(Manufacturers Spec.s)

Form 5
17-11-2014(223)
Rs. 20,000/As Per SRO/
Pack 60ml

BNF . Klaricid (Abbott)


(Klaricid (Abbott))
New Licensee

Stability studies of zone IV-A o


granules
Valid GMP certificate.
Form 5
17-11-2014(225)
Rs. 20,000/As Per SRO/
Pack 15ml
30ml & 60ml

ATRENAM
Suspension
Belgium

15/90mg/5ml Dry
Areneco
Pharma

ARTHEGET 15/90mg/5ml Dry


Suspension Getz Pharma (Pvt.)
Ltd. Karachi
New Licensee

34.

35.

36.

-do-

-do-

-do-

Fantin DS 30mg/180mg/5ml
Dry Suspnsion
Each 5ml contains:Artemether 30mg
Lumefantrine 180mg
(Antimalarial )
(Manufacturers Spec.s)

Form 5
17-11-2014(221)
Rs. 20,000/As Per SRO/

Cip 250mg/5ml
Dry Suspnsion
Each 5ml contains:Ciprofloxacin
(as
Ciprofloxacin
HCl
Monohydrate) 250mg
( Quinolones Antibiotic )
(Manufacturers Spec.s)

Form 5
17-11-2014(220)
Rs. 20,000/As Per SRO/
Pack 60ml

Zith 200mg/5ml
Dry Suspnsion
Each 5ml contains:Azithromycin
(as
Azithromycin Dihydrate)
200mg

Form 5
17-11-2014(224)
Rs. 20,000/As Per SRO/

Pack 30ml & 60ml

ATRENAM 30/180mg/5ml Dry


Suspension Areneco Pharma
Belgium ARTHEGET
30/180mg/5ml Dry Suspension
Getz Pharma (Pvt.) Ltd. Karachi

New Licensee
CIPROXIN Bayer (Formulation i
different)

HIFLOX Hilton Pharma (Pvt.) Ltd


Karachi
New Licensee

1.Formualtion is under review


by the Review Committee
of DRB.

Pack 15ml, 22.5ml,

BNF: Zithromax (Pfizer)


ZETRO Getz Pharma (Pvt.) Ltd
Karachi.
New Licensee

(Macrolide Antibiotic )
(USP Spec.s)
37.

-do-

Eryt 200mg/5ml
Dry Suspnsion

25ml, 30ml, & 60ml

Form 5
17-11-2014(225)
Rs. 20,000/contains:- As Per SRO/

Each
5ml
Erythromycin
Ethylsuccinate Monohydrate Pack 60ml
equivalent
to
Erythromycin 200mg
( Macrolide Antibiotic )
(USP Spec.s)
38.

-do-

Fosil 250mg/5ml
Dry Suspnsion
Each
5ml
contains:Fosfomycin (as Fosfomycin
Calcium)250mg
(Anti Bacterial Agent )
(Manufacturers Spec.s)

Form 5
17-11-2014 (219)
Rs. 20,000/As Per SRO/
Pack 60ml

Not confirmed
ERYTHROCIN Indus Pharma
Karachi.
New Licensee

1.Availability in same strength in


SRAs not confirmed. Firm ha
provided
internationa
availability in Jordan.
FOSFOCINA Laboratories ERN
Spain
MIFOS 250mg/5ml Dry
Suspension Remington Pharma
Lahore
New Licensee

1.Availability in same strength in

39.

-do-

Flucap 50mg/5ml
Dry Suspnsion
Each
5ml
contains:Fluconazole50mg
(Antifungal)
(USP Spec.s)

Form 5
17-11-2014(227)
Rs. 20,000/As Per SRO/
Pack 35ml

SRAs not confirmed. Firm ha


provided
internationa
availability in Spain.
BNF: Diflucan (Pfizer)
FLUCANOL 50mg/5ml Dry
Suspension Rock Pharma
Nawshehra
New Licensee

40.

-do-

Linz 100mg/5ml
Dry Suspnsion

Form 5
20-11-2014(Nil)
Rs. 20,000/contains:- As Per SRO/

Each
5ml
Linezolid 100mg
(Antibacterial )
(Manufacturers Spec.s)

Pack 60ml

BNF: Zyvox(Pharmacia)
NEZOCIN 100mg/5ml Dry
Suspension Brookes Pharma
(Private) Limited
New Licensee

Evaluator III
S/N

Name
and
address
of
manufacturer
/ Applicant

Brand Name
(Proprietary
name
+
Dosage Form + Strength)

Type of Form
Initial
diary

date,

Composition
Pharmacological Group

Fee
including
differential fee

Finished
Specification

Demanded Price
/ Pack size

product

Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator

41.

42.

M/s
MTI
Medical (Pvt)
Limited, 586587
Sunder
Industrial
Estate,
Raiwind Road
Lahore.

LOFAMIN Tablet 250mg

Form-5

Each film coated tablet


contains:
Levofloxacin
as
hemihydarte..250mg

Dy No:
dated 20-10-2014

Fluoroquinolone

As per SRO/
Pack of 10s

(Tablet
General)

Manufacture

-do-

LOFAMIN Tablet 500mg

Form-5

Each film coated tablet


contains:
Levofloxacin
as
hemihydarte..500mg

Dy No:
dated 20-10-2014

Fluoroquinolone

As per SRO/
Pack of 10s

Manufacture

Levaquin Tablet of
Janssen
Pharms
1258 (USFDA)
Leflox of
Karachi.

20,000/-

Getz

The CLB in its 236th


meeting approved
the grant of DML
by the way of
formulation
with
sections namely:
a. Oral
Liquid
General
b. Tablet General
c. Capsule General
d. Oral Dry Powder
suspension
General
Levaquin Tablet of
Janssen
Pharms
1262 (USFDA)

20,000/-

Leflox of
Karachi.

Getz

Recommendations
by the Evaluator

43.

-do-

TEMURIN Tablet 100mg

Form-5

Each film coated tablet


contains:
Iron
III
Hydroxide
Polymatose
Complex
equivalent to elemental
Iron..100mg

Dy No:
dated 26-09-2014

Anti- Anemic

International
availability requires
1018 confirmation.

20,000/As per SRO/


Pack of 1x10s,
2x10s

Rubifer Chewable
Tablets of AGP
(Pvt)
Limited,
Karachi.

Manufacturer
44.

-do-

TEMURIN-F Tablet 100mg

Form-5

Each film coated tablet


contains:
Iron
III
Hydroxide
Polymaltose
Complex
equivalent to elemental
Iron..100mg
Folic acid0.35mg

Dy No:
dated 20-10-2014

International
availability requires
1261 confirmation.

20,000/As per SRO


Pack of 1x10s,
2x10s

Rubifer-F Chewable
Tablet of AGP (Pvt)
Limited Karachi.

Anti- Anemic
45.

-do-

Manufacturer
CYTO Tablet 250mg

Form-5

Cipro of
Health Care

Each film coated tablet


contains:Ciprofloxacin
as
hydrochloride.250mg

Dy No: 1019
dated 26-09-2014 Cipro

Fluoroquinolone

As per SRO
1x10s

20,000/-

Bayer

of Bayer
Health Care Karachi

BP
46.

-do-

CYTO Tablet 500mg

Form-5

Each film coated tablet


contains:Ciprofloxacin
as
hydrochloride.500mg

Dy No: 1017
dated 26-09-2014

Fluoroquinolone

As per SRO/
Pack of 1x10s

BP

20,000/-

Cipro of
Health Care

Bayer

Cipro of Bayer
Health Care Karachi

47.

-do-

PRIZO Tablets 100mg

Form-5

Each film coated tablet


contains:Flurbiprofen..100mg

Dy No: 1054
dated 26-09-2014
20,000/-

Cyclo-oxygenase
Analgesic,
inflammatory
48.

-do-

Inhibitor,
Anti- As per SRO/
Pack of 3x10s

BP
OSTIM Tablets 50mg

Form-5

Each film coated tablet


contains:
Clomiphene Citrate..50mg

Dy No: 1020
dated 26-09-2014
20,000/-

Ansaid
Pharmacia
(USFDA)

of

Ansaid of Pfizer
Karachi

Serophene of EMD
Serno (USFDA)
Cerophene of Hilton
Pharma Karachi.

Antioestrogen
As per SRO/
Pack of 1x10s,
2x10s
and
3x10s
Form-5

USP
49.

-do-

MOZEX Tablet 400mg


Each tablet contains:
Moxifloxacin
HCL.400mg

as

Dy No: 1046
dated 26-09-2014
20,000/-

Avelox Tablet of
Bayer Health Care
Avelox of Bayer
Health Care Karachi

Fluoroquinolone
50.

-do(Capsule
General)

Manufacturer
ESTO Capsules 20mg
Each capsules contains:Esomeprazole Magnesium
Trihydrate
enteric coated
pellets (22.5%) equivalent to
Esomeprazole20mg
PPI

As per SRO/
Pack of 5s
Form-5

Nexium
AstraZeneca
1047 USFDA

of

Dy No:
dated 26-09-2014

Esso Capsules of
Shaigan
As per SRO/ Pharmaceuticals,
Islamabad.
1x10s & 1x7s
20,000/-

Manufacturer

51.

-do-

Source:
M/s
Vision
Pharmaceuticals, Islamabad.
ESTO Capsules 40mg
Each capsules contains:Esomeprazole Magnesium
Trihydrate
enteric coated

Form-5

Nexium
AstraZeneca
1048 USFDA

of

Dy No:
dated 26-09-2014

Esso Capsules of

pellets (22.5%) equivalent to


Esomeprazole40mg

20,000/As per SRO/


1x10s & 1x14s

Shaigan
Pharmaceuticals,
Islamabad.

PPI
Manufacturer

52.

-do-

Source:
M/s
Vision
Pharmaceuticals, Islamabad.
AZOl Capsules 250mg
Each capsule contains:
Azithromycin
dihydrate..250mg

as

Form-5

Zithromax of Pfizer
(USFDA).

Dy No: 1050
dated 26-09-2014 Zithromax of Pfizer
20,000/-

Karachi.

Macrolide
53.

54.

-do-

-do-

USP
GRIBOL Capsules 150mg

As per SRO/
1x6s & 1x10s
Form-5

Each capsule contains:


Fluconazole..150mg

Dy No: 1260
dated 20-10-2014

Antifungal

20,000/-

Manufacturer

As per SRO/
1x4s
Form-5

GOTEC Capsules 40mg


Each capsule contains:
Omeprazole enteric coated
pellets (8.5%) equivalent to
Omeprazole 40mg

Dy No: 1055
dated 26-09-2014

PPI

As per SRO/
1x10s, 1x14s

Diflucan of Pfizer a.
(USFDA)
Diflucan Of Pfizer
Karachi.

Prilosec
AstraZeneca
(USFDA)

of

Risek of Getz Karachi


20,000/-

BP

55.

-do-

Source:
M/s
Vision
Pharmaceuticals, Islamabad.
GOTEC Capsules 20mg

Form-5

Each capsule contains:


Omeprazole enteric coated
pellets (8.5%) equivalent to
Omeprazole 20mg

Dy No: 1044
dated 26-09-2014

PPI

As per SRO/
1x10s, 1x14s

Prilosec
AstraZeneca
(USFDA)

of

Risek of Getz Karachi


20,000/-

BP
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
56.

-doOral
liquid
(General)

APRIN Syrup

Form-5

Each ml contains:
Cetirizine
dihydrochloride 1mg

Dy No: 1051
dated 26-09-2014
20,000/-

Benadryl
Allergy
Oral
Syrup
of
McNeil Products UK
Baydal of Bayer
Health Care Karachi.

Antihistamine
Manufacturer
57.

-do-

APHOLAC Suspension
Each 5ml contains:
Lactulose..3.35gm
Laxative
BP

58.

TEMURIN Syrup
Each 5ml contains:
Iron
III
Hydroxide
Polymatose
Complex
equivalent to elemental
Iron.50mg
Anti-anemic

59.

60.

-do(Oral
Dry
Powder
Suspension
General)

-do-

Manufacturer
AZOL Suspension

As per SRO
Pack of 30ml
and 60ml bottle
Form-5
Duphalac of Solvay
(USFDA)
Dy No: 1052
dated 26-09-2014 Duphalac of Abbot
Pharma, Karachi
20,000/As per SRO/
Pack of 120ml &
240ml bottle
Form-5
Availability in SRAs

need confirmation

Dy No: 1053
dated 26-09-2014 Engfer
20,000/-

Form-5
Dy No: 1257
dated 20-10-2014

Macrolide

As per SRO/
Pack of 15ml
bottle
Form-5

Each 5ml contains:


Ciprofloxacin as HCL taste
masked
pellets
25%

Syrup of
Pharma

As per SRO/
Pack of 60ml &
120ml bottle

Each 5ml contains:


Azithromycin
dihydrate
equivalent to Azithromycin
..200mg

USP
CYTO Suspension

English
Lahore

Zithromax of Pfizer
(USFDA)
Zithromax of Pfizer
Karachi

20,000/-

Dy No: 1259
dated 20-10-2014

Not
available
SRAs

in

Novidat of Sami
Pharma Karachi

Firm has submitted


invoice of purchase
of Refractive Index
detector.

equivalent to Ciprofloxacin..
..250mg

20,000/As per SRO/


60ml bottle

Fluoroquinolone
Manufacturer

Evaluator III (Veterinary New DML)


S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

M/s
Izfaar
Pharmaceutical
Industries,
Lahore
Veterinary Liquid
Injection
(General
Antibiotic)

-do-

Initial
diary

date,

Demanded Price
/ Pack size

product

Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator

TRIOZIN Injection

Form-5

Each ml contains:
Sulphadiazine..400mg
Trimethoprim80mg

10-07-14 Dy. No:


64
20,000/-

Antibiotic
Manufacturer

Decontrolled/
50ml vial

TYLOGEN Injection

Form-5

Each ml contains:
Tylosin Tartrate.10mg
Gentamicin
as
sulphate..50mg

03-07-14 Dy. No:


15

Antibiotic

Decontrolled/
50ml vial

Manufacturer

Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities

20,000/-

Trisolizin of Star Labs


Lahore.
The CLB in its 236th
meeting
of
Registration
Board
approved the grant of
DML with following
sections namely:
a. Veterinary Liquid
Injection (General
Antibiotic)
b. Veterinary Liquid
Injection (General)
Tygent Injection
Selmore
Pharmaceuticals
Lahore

of

Recommendations
by the Evaluators

-do-

-do-

-do-

-do-

OXY FAR LA Injection

Form-5

Each ml contains:
Oxytetracycline
as
Hydrochloride.200
mg

10-07-14 Dy. No:


63

Antibiotic

Decontrolled/
100ml vial

Manufacturer
OXY FAR Injection

20,000/-

Form-5

Each ml contains:
Oxytetracycline
as
Hydrochloride.50m
g

10-07-14 Dy. No:


63

Antibiotic

Decontrolled/
50ml Vial
Form-5

Each ml contains:
Enrofloxacin.100mg

03-07-14 Dy. No:


17

Fluoroqunolone
Antibacterial

20,000/-

Each ml contains:
Oxytetracycline
HCL..300mg

Decontrolled/
50ml vial
Form-5
as

Oxy-5 injection
Selmore
Pharmaceuticals,
Lahore

of

20,000/-

Manufacturer
ENRO-100 Injection

FLOXIN Injection

Oxy-LA injection of
Selmore
Pharmaceuticals,
Lahore

Enroxsel of Selmore
Pharmaceuticals
Lahore

I-Fom of International
Pharma Labs Lahore

03-07-14 Dy. No:


19
20,000/-

Flunixin
as
Meglumine20mg

Decontrolled/
50ml vial

Antibiotic/ Analgesic,
Anti-inflammatory
-do-

Manufacturer
TYLOFAR Injection
Each ml contains:
Tylosin
Tartrate
200mg

Form-5
03-07-14 Dy. No:
15
20,000/-

Antibiotic
Decontrolled/

Tylosel of Selmore
Pharmaceuticals,
Lahore

-do-

50ml vial
Form-5

Ketoxay LA
Each ml contains:
Oxytetracycline
HCL.200mg
Ketoprofen.30mg

as

Antibiotic/ Analgesic
-do-

Manufacturer
TYLOPRIM Injection
Each ml contains:
Sulphamethoxypyridazi
ne150mg
Trimethoprim30mg
Tylosin tartrate..50mg

-do-

-do-

Decontrolled/
50ml vial
Form-5
03-07-14 Dy. No:
15

Manufacturer
DICOTYL Injection

Form-5

Anti-

Tylotrim of Selmore
Pharmaceuticals
Lahore

20,000/-

Antibiotic

Antibiotic/
Protozoal

of

20,000/-

Decontrolled/
50ml vial

Each ml contains:
Tylosin tartrate.50mg
Colistin
sulphate..10mg
Dimetridazole..100mg

-do-

03-07-14 Dy. No:


19

Oxyfen-LA
Selmore
Pharmaceuticals,
Lahore

03-07-14 Dy. No:


17

Bacticom of Selmore
Pharmaceuticals
Lahore

20,000/Decontrolled/,
50ml vial

Manufacturer
IVERIN Injection

Form-5

Each ml contains:
Ivermectin.10mg

03-07-14 Dy. No:


14

Anthelmintic

20,000/-

BP
PARACTIN Injection

Decontrolled/
50ml vial
Form-5

Each ml contains:
Ivermectin.20mg

03-07-14 Dy. No:


14

Anthelmintic

20,000/-

Actimec Injection of
Selmore
Pharmaceuticals
Lahore

Elvomec D/S of Elko


Karachi

BP
-do-

-do-

MELOXAM Injection

Decontrolled/
50ml vial
Form-5

Each ml contains:
Meloxicam.7.5mg

03-07-14 Dy. No:


14

Analgesic/
inflammatory

20,000/-

Anti-

Decontrolled/ 50
ml vial
Form-5

BP
B-Vita Injection
Each ml contains:
Cyanocobalamin..125
mcg

Calimox of Selmore
Pharma

B-Vita of Kakasian
Pharma Lahore

03-07-14 Dy. No:


15
20,000/-

Vitamin
USP
-do-

ADE-FAR Injection
Each ml contains:
Vitamin
A.100,000IU
Vitamin
D3
40,000IU
Vitamin E.40mg
Vitamin and
promoters

-do-

Decontrolled/
Pack of 50 ml
vial
Form-5

Nawan
Karachi

Laboratories

03-07-14 Dy. No:


17
20,000/Decontrolled/
50ml vial

Growth

Manufacturer
VITOBION Injection
Each ml contains:
Thiamine HCL5mg
Riboflavin2.5mg
Pyridoxine
HCL
2.5mg
Nicotinamide
37.5mg

Form-5

Thiaprin Injection of
Star Labs Karachi

03-07-14 Dy. No:


15
20,000/Decontrolled/ 50
ml vial

Vitamin
-do-

Manufacturer
HEPAFAR Injection

Form-5

Each ml contains:

03-07-14 Dy. No:

Hepaguard of
Labs Lahore

Star

Phenoxy-2-methyl-2propionic acid..100mg

15
20,000/-

Hepatoprotectant/ Liver
Tonic
-do-

-do-

Manufacturer
IMIDO-FAR Injection

Decontrolled/
50ml vial
Form-5

Each ml contains:
Imidocarb
dipropionate.120m
g

03-07-14 Dy. No:


15

Antiprotozoal

Decontrolled/
50ml vial
Form-5

AAVIL Injection
Each ml contains:
Pheniramine
maleate..11.35mg

IMIPRO of Selmore
Pharmaceuticals,
Lahore

20,000/-

Anril Injection of
Syman Pharma Lahore

03-07-14 Dy. No:


15
20,000/-

Antihistamine
-do-

Manufacturer
ATRO Injection
Each ml contain:
Atropine
Sulphate..1mg

Decontrolled/
50ml vial
Form-5
03-07-14 Dy. No:
15
20,000/-

Anti-muscarinic
BP

Decontrolled/
Pack of 50ml vial

Atrovet Injection of
Selmore
Pharmaceuticals
Lahore

Case No.04.

Grant of registrations for additional sectionsof already licensed manufacturers.


Evaluator II

S/N

Name
and Brand Name
address
of
manufacturer / (Proprietary
name
+
Applicant
Dosage Form
+ Strength)
Composition

M/s
Pharmatec
Pakistan
(Pvt.)
Limited, D-86/A,
S.I.T.E., Karachi75700.
(Cream/Oint
General: No. F.66/2014-Lic
(M237 dated 14-102014)

-do-

Type
Form
Initial
date,
diary

of Remarks on the formulation (if any) including


International status in stringent drug regulatory
agencies / authorities
Me-too status
GMP status as depicted in latest inspection report (with
date) by the Evaluator

Pharmacologi
cal Group

Fee
including
differenti
al fee

Finished
product
Specification

Demande
d Price /
Pack size

Adagel Gel
Contains:Adapalene
(B.P)
0.1%w/w
Benzoyl
Peroxide (B.P)
2.5%w/w
(Anti-acne
Preperation)
(Manufacturer
s Spec.s)
Pamulin
Ointment
Contains:Retapamulin
1.0%w/w
(Antibiotic and
chemotherapeu
tic
for
dermatological
use)
(Manufacturer
s Spec.s)

Form 5
13-102014 (31)
Rs.
20,000/As
Per
SRO/15g
m, 30gm

BNF: Epiduo (Galderma)

Form 5
13-102014 (34)
Rs.
50,000/As
Per
SRO/5gm,
15gm

BNF: Altargo (GSK)

ADAPLUS (BIOGEN PHARMA,Islamabad)


Grant of additional section Cream/Ointment (General)
recommended.(24-07-2014)

Altapam Ointment of M/s Atco Lab


Grant of additional section Cream/Ointment (General)
recommended.(24-07-2014)

1.Me-too status has been given as Altapam Ointment of


M/s Atco Lab (Reg. No 061764) that needs
confirmation. Pricing of formulation has been done
in 9th PAC.

M/s Sami
Pharmaceuticlas
(Pvt.) Limited, F95, S.I.T.E.
Karachi-Pakistan
Tablet
(Psychotropic)
Section (No. F.65/2014-Lic (M236) dated 8th Sep,
2014.
-do-

-doTablet (General)
Section (No. F.65/2014-Lic (M236) dated 8th Sep,
2014.

Pralzo 0.25mg
Tablets
Each
tablet
contains:Alprazolam
(USP)
0.25mg
(Benzodiazepin
e)
(USP Spec.s)

Form 5
09-092014
(240)
Rs.
20,000/Rs.157.47
/30s

BNF: Alprazolam (Non-proprietary)

Pralzo 0.5mg
Tablets
Each
tablet
contains:Alprazolam
(USP)0.5mg
(Benzodiazepin
e)
(USP Spec.s)

Form 5
09-092014
(239)
Rs.
20,000/Rs.157.47
/30s

BNF: Alprazolam (Non-proprietary)

Gasicol
Chewable
Tablets
Each
Chewable
tablet
contains:Sodium
Alginate(BP)
500mg
Potassium
Bicarbonate
(BP)100mg
(Antacid)
(Manufacturer
s Spec.s)

Form 5
03-042014
(201)
Rs.
20,000/Rs. 5 per
Tablet, Rs.
80/16s

BNF: Gaviscon Advance

XANAX (PFIZER LABORATORIES LTD.,Karachi)


Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

1.Alprazolam is a controlled drug substance.

XANAX (PFIZER LABORATORIES LTD.,Karachi)


Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

1.Alprazolam is a controlled drug substance.

Not confirmed
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

1.Verification of photocopy of fee receipt is required.


2.Me-too status needs confirmation.

-do-

-do-

-do-

Solfy
5mg
Tablets
Each
film
coated
tablet
contains:Solifenacin
Succinate
5mg
(Muscarinic
antagonist)
(Manufacturer
s Spec.s)
Urigo
80mg
Tablets
Each
film
coated
tablet
contains:Febuxostat
80mg
(Xanthine
Oxidase
Inhibitor)
(Manufacturer
s Spec.s)
Urigo
40mg
Tablets
Each
film
coated
tablet
contains:Febuxostat
40mg
(Xanthine
Oxidase
Inhibitor)
(Manufacturer
s Spec.s)

Form 5
21-102014 (72)
Rs.
20,000/As
per
PRC

BNF: Vesicare (Astellas)

Form 5
21-102014 (73)
Rs.
20,000/As
per
PRC

FDA: Uloric

Form 5
21-102014 (71)
Rs.
20,000/As
per
PRC

FDA: Uloric

Fenaso (Highnoon)
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

Zurig (Getz)
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

Zurig (Getz)
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

-doCapsule (General)
Section (No. F.65/2014-Lic (M236) dated 8th Sep,
2014.

Beritex 150mg
Capsules
Each capsule
contains:Polysaccharide
Iron Complex
equivalent to
Elemental
Iron150mg
(Iron
compound)
(Manufacturer
s Spec.s)

Form 5
09-092014
(241)
Rs.
20,000/As
per
PRC

Not confirmed
Ferricure (S J . & G)
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)

1.Availability in SRAs not confirmed. Firm has provided


international availability of un approved products in
USA, Canada, UK.

Evaluator III
S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee including
differential fee

Pharmacological
Group
Finished
Specification

M/s Rasco Pharma,


5.5 Km Raiwind
Road, Lahore
Liquid
Injection
General
(Small
Volume Vial)

product

date,

Demanded
Price / Pack
size

Form-5
vial

(BP)

Dy No: 659
dated
22-092014

Me-too status

PERFALGAN
10
mg/ml, solution for
infusion (100 ml
vial contains 1000
mg paracetamol) of
BMS UK

20,000/Antipyretic/ Analgesic
Manufacturer

Recommendations
by the Evaluator

GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

PARA-RAS Infusion
Each
100ml
contains;
Paracetamol
..1000mg

Initial
diary

Remarks on the
formulation
(if
any)
including
International
status in stringent
drug
regulatory
agencies
/
authorities

As per SRO
1x 100ml

Provas of
Karachi

Sami

The inspection of
firm was carried out
on 03-06-2014 by
the
panel
of
inspectors
and

Firm has submitted


the
invoices
of
purchase of Liquid
Particle counter and
TOC analyzer.

recommended the
renewal of DML
and
additional
section
namely
Liquid
Injection
General
(Small
Volume Vial)

-do-

LEVOFLOXA Infusion

Form-5

Each
100ml
vial
contains:
Levofloxacin
hemihydarte equivalent
to
Levofloxacin
USP..500mg

Dy No: 660
dated
22-092014

Quinolone

Tevanic of Sanofi
Aventis (BNF)
Levocil of CCL
Pharma Lahore.

20,000/As per SRO


1x 100ml

Manufacturer
-do-

LEVOFLOXA Infusion

Form-5

Each
100ml
vial
contains:
Levofloxacin
hemihydarte equivalent
to
Levofloxacin
USP..250mg

Dy No: 665
dated
22-092014

Quinolone

20,000/-

250mg levofloxacin
(as hemihydarte) in
50ml
solution
(Tavanic of sanofi)
Levocil of CCL
Pharma Lahore

As per SRO
1x 100ml

Manufacturer
-do-

CIP-RX Infusion

Form-5

Each
100ml
vial
contains:
Ciprofloxacin
lactate
equivalent
to
Ciprofloxacin
USP.400mg

Dy No: 656
dated
22-092014

Quinolone
USP

Ciprofloxacin
2
mg/ml Solution for
Infusion
400mg/200ml vial
of Hospira UK
Limited

20,000/As per SRO


1x 100ml

Novidat
Karachi

of

Sami

-do-

CIP-RX Infusion

Form-5

Each
100ml
vial
contains:
Ciprofloxacin
lactate
equivalent
to
Ciprofloxacin
USP.200mg

Dy No: 660
dated
22-092014

Quinolone

Ciprofloxacin
2
mg/ml Solution for
Infusion
200mg/100ml vial
of Hospira UK
Limited

20,000/As per SRO


1x 100ml

Novidat
Karachi

of

Sami

USP
-do-

LINZO Infusion

Form-5

Zyvox
USA

of

Pfizer

Each 100ml contains:


Linezolid.200mg

Dy No: 654
dated
22-09- Nezocin of Brookes
2014
Pharma

Oxazolidinone
20,000/Manufacturer
-do-

RESGYL Infusion
Each 100ml contains:
Metronidazole500mg

As per SRO
1x 100ml
Form-5

Flagyl of
(USFDA)

Sanofi

Dy No: 657
dated
22-09- Metrozine of Searle
2014
Karachi

Antiprotozoal
20,000/Manufacturer
-do-

RE-VED Infusion
Each 100ml contains:
Ofloxacin
HCL
equivalent
to
Ofloxacin200mg

As per SRO
1x 100ml
Form-5

Dy No: 658
dated
22-09- Loxat
2014
Lahore
20,000/-

Quinolone
Manufacturer

Teravid of Sanofi
USA

As per SRO
1x 100ml

of

Siza

-do-

M/s
Arsons
Pharmaceuticals
Industries
(Pvt)
Limited, Lahore
(Tablet
Psychotropic)

-do-

-do-

MOXILINE Infusion

Form-5

Each
250ml
vial
contains:
Moxifloxacin
HCL
equivalent
to
Moxifloxacin
400mg

Dy No: 662
dated
22-092014

As per SRO
1x 250ml

Manufacturer
RELAXIM Tablet 3mg

Form-5

Each tablet contains:


Bromazepam.3mg

23-09-14
No: 793

Benzodiazepine

20,000/-

Manufacturer

As per SRO
3x10s

Tablets

Form-5
Dy No: 788
dated
23-092014

Benzodiazepine

20,000/-

BP

As per SRO
5x10s
Form-5

Each tablet contains:


Clonazepam2mg

of

Getz

Lexotan Tablets of
Roche
(TGA
Dy. Approved)

Each tablet contains:


Clonazepam0.5mg

ARVOTRIL Tablets 2mg

Moxiget
Karachi

20,000/-

Quinolone Antibiotic

ARVOTRIL
0.5mg

Avelox of Bayer
Health Care USA

Dy No: 790
dated
23-092014

Benzodiazepine
20,000/BP
As per SRO
3x10s

Tensium Tablets of
Werrick
Pharma
Islamabad.
The inspection of
the
firm
was
conducted on 08-052014 by the panel of
inspectors
and
recommended the
renewal of DML
and
grant
of
additional section of
tablets psychotropic.
Clonazepam Tablet
of Teva (USFDA)
Clonzil of English
Pharma Lahore

Clonazepam Tablet
of Teva (USFDA)
Clonzil of English
Pharma Lahore

Applied volume is
250ml however the
approval of section is
for Liquid Injection
General
(Small
Volume Vial)

-do-

ARTIVAN Tablets 1mg

Form-5

Each tablet contains:


Lorazepam1mg

Dy No: 792
dated
23-092014

Ativan of
(USFDA)

Pfizer

Ativan of
Karachi

Pfizer

Ativan of
(USFDA)

Pfizer

Ativan of
Karachi

Pfizer

Benzodiazepine
20,000/BP
-do-

ARTIVAN Tablets 2mg


Each tablet contains:
Lorazepam2mg

As per SRO
10x10s
Form-5
Dy No: 791
dated
23-092014

Benzodiazepine
20,000/BP
-do-

XALLIUM Tablets 5mg


Each tablet contains:
Diazepam5mg

As per SRO
10x10s
Form-5
Dy No: 794
dated
23-092014

Diazeoam
Wockhardt UK

of

Valium of Martin
Dow Karachi

Benzodiazepine
20,000/BP
-do-

ARMICUM
7.5mg

Tablet

Each tablet contains:


Midazolam
meleate7.5mg

as

As per SRO
3x10s
Form-5
Dy No: 794
dated
23-092014
20,000/-

Benzodiazepine
Manufacturer

As per SRO
3x10s

Hypnovel tablets of
Roche New Zealand
Dormicum
of
Martin Dow Karachi

5. Left-over agenda (245)


a)

Remaining application of previously approved new sections


Evaluator - II

S/N

Name
and Brand Name
address
of
manufacturer / (Proprietary name + Dosage
Form + Strength)
Applicant
Composition
Pharmacological Group
Finished product Specification

106.

107.

M/s Herbion
Pakistan (Pvt)
Ltd., Kahuta
Road, industrial
Triangle, Humak,
RawalpindiIslamabad.

-do-

Type of Form

Remarks
on
th
formulation
(if
any
Initial date, diary
including
Internation
status
in
stringent
dru
Fee including differential
regulatory
agencies
fee
authorities
Demanded Price / Pack
Me-too status
size

GMP status as depicted i


latest inspection repo
(with
date)
by
th
Evaluator

EsNovex/AciNovex/GastriNovex
Capsules 20mg
Each capsule contains:-Enteric
coated pellets of Esomeprazole
Magnesium Trihydrate
eq. to Esomeprazole20mg
( Antipeptic Ulcerants / Proton
Pump Inhibitor)
(Manufacturers Spec.s)
{Source of Pellets:
M/s Glukem Pharmaceuticals (P)
Ltd Plot # 205/2A, 1st Floor ,
IDA, Phase-II, Cherlapally,
Hyderabad-Andhra Pradesh,
India}

Form 5
02-05-2014
Dy.No.2076
Rs.20,000/=+Rs.
80,000/- (05-09-2014)
Rs.200.00/
2x7s

EsNovex/AciNovex/GastriNovex
Capsules 40mg
Each capsule contains:-Enteric
coated pellets of Esomeprazole
Magnesium Trihydrate
eq. to Esomeprazole 40 mg
( Antipeptic Ulcerants / Proton
Pump Inhibitor)
(Manufacturers Spec.s)
{Source of Pellets:
M/s Glukem Pharmaceuticals

Form 5
02-05-2014
Dy.No.2077
Rs.20,000/- + Rs.
80,000/- (05-09-2014)
Rs.371.00/2x7s

Nexium of AstraZeneca
Esso
of
Pharmaceuticals
Islamabad.
Grant
of
recommended
January 2014)

Shaiga

DM
(23-24

1.Valid and legalized GM


Certificate of Sourc
COA
and
stabili
studies according
zone IV-a of pellets a
required.
Nexium of AstraZeneca
Esso
of
Pharmaceuticals
Islamabad.
Grant
of
recommended
January 2014)

Shaiga

DM
(23-24

1.Valid and legalized GM

(P) Ltd Plot # 205/2A, 1st Floor ,


IDA, Phase-II, Cherlapally,
Hyderabad-Andhra Pradesh,
India}
108.

109.

110.

-do-

-do-

-do-

OmeNovex / SecNovex /
PeptiNovex
Capsules 20mg
Each capsule contains:Omeprazole enteric coated
Pellets eq. to Omeprazole
20mg
( Antipeptic Ulcerants / Proton
Pump Inhibitor)
(Manufacturers Spec.s)
{Source of Pellets:
M/s Vision Pharmaceuticals,
Plot No.224, Street No.1, I10/3, Industrial Area,
Islamabad.}
OmeNovex / SecNovex /
PeptiNovex
40mg Capsules
Each capsule contains:Omeprazole enteric coated
Pellets
eq. to Omeprazole 40mg
( Antipeptic Ulcerants / Proton
Pump Inhibitor)
(Manufacturers Spec.s)
{Source of Pellets:
M/s Vision Pharmaceuticals, Plot
No.224, Street No.1, I-10/3,
Industrial Area, Islamabad.}

Form 5
02-05-2014
Dy.No.2078
Rs.20,000/=
Rs.290.00/
2x7s

FluNovex / CF-Novex /
TheraNovex
Extra Tablets
Each film coated tablet contains:Paracetamol BP ...650mg
Chlorphenirmine Maleate
BP....4mg
Phenylephrine HCl BP10mg
(Analgesic + Decongestant
Combination)
(Manufacturers Spec.s)

Form 5-D
24-02-2014
Dy.No.194
Rs.20,000+Rs. 30,000/(07-05-14)

Form 5
02-05-2014
Dy.No.2079
Rs.20,000/=
Rs.354.00/
2x7s

Rs.230.00/
10x10s

Certificate of Sourc
COA
and
stabili
studies according
zone IV-a of pellets a
required.
Losec (Astrazeneca)
Omega(Ferozsons)
Grant
of
recommended
January 2014)

DM
(23-24

Losec (Astrazeneca)
Omega(Ferozsons)
Grant
of
recommended
January 2014)

DM
(23-24

Not confirmed
Form 5-D
Grant
of
recommended
January 2014)

DM
(23-24

1.The firm had applied o


Form 5 , after evaluatio
the Firm applied o
Form 5-D and submitte

111.

-do-

VitaNovex / CilaNovex /
BonNovex Suspension
Each 5ml contains:Ossein Mineral Complex
250mg
Vitamin D 400 i.u
(Calcium-Phosphorus
Supplements)
(Manufacturers Spec.s)

Form 5
26-02-2014
Dy.No.211
Rs.20,000
Rs.144.00/
60ml

additional fee of R
30,000/2.International availabili
not
confirmed
stringent DRSs.
Not confirmed
Not confirmed
Grant
of
recommended
January 2014)

DM
(23-24

1.International availabili
not
confirmed
stringent DRAs.
2.Me-too
status
n
confirmed.
3.Firm has claimed that the
possess
Atom
Absorption
(PerkinElmer- A Analy
300)
spectrophomet
and has submitted that
can be verified by are
FID.

Evaluator 1
S/N

Name
and
address
of
Manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
form
+
Strength)

Type of Form
Initial date,
diary.

International status in
stringent
regulatory
agencies

Remarks / Observations

Me-too status
Composition
Pharmacological
Group
Finished
product
specification
M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.

M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.

M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.

Fee including
differential fee
Demanded
Price / Pack
size

Acen
Effervescent
Tablet 200mg
Each effervescent
tablet contains:
N-acetylcysteine
..200mg

Form-5D

(Manufacturers
Specs)

Rs. 800 / per


10s

Mucolytic agent

Rs. 50,000/-

Glucort S.R. Tablet


5mg Each enteric
coated
tablet
contains:Beclomethasone
Dipropionate ... 5mg

Form-5D

(Manufacturers
Specs)

Rs. 1,000 / per


10s

Corticosteroid

Rs. 50,000/-

Lafelax
Liquid
Sachet
Each 15ml sachet
contains:Lactulose67%
w/v

Form-5D

(USP Specification)

Rs. 250 / per


10s

New License

GMP status as depicted


in inspection report
(dated)

ACC 200 effervescent


tablets
N-acetylcysteine 200mg
South Africa

References and data of


various
international
clinical studies has been
provided along with 06
months accelerated and
real
time
stability
summary.

CLIPPER
Gastro-resistant
prolonged release tablet
5mg
MHRA

References and data of


various
international
clinical studies has been
provided along with 06
months accelerated and
real
time
stability
summary.
Firm has also submitted
undertaking to submit
comparative dissolution
profile with established
brand before marketing
the product.
References and data of
various
international
clinical studies / literature
have been provided along
with
06
months
accelerated and real time
stability summary.

28-05-2014
804 R&I

New License
28-05-2014
808 R&I

New License
28-05-2014
811 R&I

Laxative
Rs. 50,000/-

LAEVOLAC
10g/15ml Sachet
MHRA

GMP certificate of the


source of Lactulose dated
13-02/2012 with the

Source:
Fresenius
Austria

M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot
No. E-145 E149,
North
Western
Industrial Zone,
Port
Qasim,
Karachi.

M/s
Kabi,

28/05/2014
Rs. 50,000/24/09/2014
Total fee: Rs.
100,000/-

Diolyte Rice Sachet

Form 5

Each sachet
contains:-

New License

Rice Powder6g

05-05-2014
662 R&I

Sodium
Citrate. 0.58g

As per PRC
10s

Sodium Chloride
.. 0.35g

Rs. 20,000/-

statement
that
this
certificate reflects the
status of manufacturer at
the time of inspection
(31-01-2012) and should
not be relied upon to
reflect the compliance
status if more than three
years have elapsed since
the
date
of
that
inspection.
DIAROLYTE

GASTROLYTE
Sanofi

Potassium Chloride
0.3g
(Manufacturers
Specs)
ORS
M/S
Pharma
Lord (Pvt) Ltd.,
12 Km, Lahore
Road, Layyah.

CPRO
125mg/5ml
Suspension

Tablet (General)
Capsule
(General)
Oral Dry Powder
Suspension
(General)

Each
reconstituted
5ml contains:

Dry Suspension

Ciprofloxacin
..... 125mg
(Anti-infective /
Quinolone)

Form 5
Rs. 125/- per
60ml
R&I diary No.
and date not
available
Rs.20,000
(Duplicate)

NOVIDAT
125mg/5ml
Sami
Panel inspection report
for grant of DML dated
14th December, 2012
attached.

1. Under international
availability Cipro of M/s
Bayer, Italy has been
mentioned.
2. Role of ingredients has
not been provided.
3. Ciprofloxacin 25%
granules
had
been
proposed
earlier.
However, now firm has
proposed dry powder
suspension
containing
Ciprofloxacin (base) with
water as diluent which is
different
from
the
reference
international
brand*.
4. Copy of latest GMP

report required.
CIPRO Oral
Suspension (M/s Bayer
HealthCare
Pharmaceuticals Inc.)
Ciprofloxacin
Oral
Suspension is available in
5% (5 g ciprofloxacin in
100 mL) and 10% (10 g
ciprofloxacin in 100 mL)
strengths. Ciprofloxacin
Oral Suspension is a
white
to
slightly
yellowish
suspension
with strawberry flavor
which
may
contain
yellow-orange droplets. It
is
composed
of
ciprofloxacin
microcapsules and diluent
which are mixed prior to
dispensing.
The
components
of
the
suspension have the
following compositions:
Microcapsules
ciprofloxacin, povidone,
methacrylic
acid
copolymer, hypromellose,
magnesium stearate, and
Polysorbate 20.
Diluentmedium-chain
triglycerides, sucrose,
lecithin, water, and
strawberry flavor.

Evaluator III
S/
N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name
Dosage
Form
Strength)

Type of Form
+
+

Pharmacological Group

M/s
Faas
Pharmaceuticals
(Pvt) Limited, F748/
L
S.I.T.E.
Karachi

Initial date, diary


Fee
including
differential fee

Composition

Finished
Specification

Remarks on the formulation (if any)


including
International status in
stringent drug regulatory agencies /
authorities

Demanded
Pack size

Price

product

Me-too status
GMP status as depicted in latest
inspection report (with date) by the
Evaluator

Ciploxin Tablet 250mg

Form-5

Cipro of Byaer Health Care

Each film coated tablet


contains:
Ciprofloxacin
as
HCL..250mg

Dy No:977 dated 1206-2014

Cipro of Bayer Healthcare Karachi

Anti-Infective

As per SRO

20,000/-

(Tablet General)

Inspection of the firm was conducted on


18-03-2014 by the area FID and GMP
compliance was found satisfactory.

USP
-do-

-do-

Ciploxin Tablet 500mg

Form-5

Cipro of Byaer Health Care

Each film coated tablet


contains:
Ciprofloxacin
as
HCL..500mg

Dy No:975 dated 1206-2014

Cipro of Bayer Healthcare Karachi

Anti-Infective

As per SRO

USP
Levoquin Tablet 250mg

Form-5

Levaquin Approved USFDA

Each film coated tablet


contains:
Levofloxacin
as
hemihydarte..250mg

Dy No:976 dated 1206-2014

Leflox of Getz Pharma Karachi

Anti-Infective

As per SRO

20,000/-

20,000/-

Manufacturer
-do-

Levoquin Tablet 500mg

Form-5

Levaquin Approved USFDA

Each film coated tablet


contains:
Levofloxacin
as

Dy No:974 dated 1206-2014

Leflox of Getz Pharma Karachi

hemihydarte..500mg

20,000/-

Anti-Infective

As per SRO

Manufacturer
-doCapsule (General)

Omezole-D Capsule

Form-5

Each capsule contains:-

Dy No:974 dated 1206-2014

Blended
pellets
of
Omeprazole
20mg
EC.20mg
Domperidone
IR
.10mg

100,000/-

Not available in stringent SRA,s


Me too status is not submitted by the
firm.
a

As per SRO
b

Anti-Ulcer
Emetic

and

Anti-

Evidence of approval of same


dosage form and strength in FDA,
TGA, EMA, MHLW, and Health
Canada is required.
GMP certificate of the source
(which shall be legalized) and
stability studies as per ZONE-IV A
needs to be submitted.

Manufacturer

M/s Martin Dow


Limited, Plot No. 37,
Sector 19, Korangi
Industrial
Area,
Karachi

Source: M/s Glukem


Pharmaceuticals,
Plot
No. 205/2A, IDA, Phase
II,
Chedapally,
Hyderabad, India
Sparta Sachet
Form-5
Each sachet conatins:L-Ornithine
LAspartate3gm
Cholagogues and Hepatic
Protectors\

-do-

-do-

Manufacturer
Olyte Sachet
Each sachet contains:Precooked Rice Powder
6gm
Sodium
citrate..0.58gm
Sodium
chloride..0.35gm
Potassium chloride
0.30gm
Evrease Sachet
Each sachet contains:
Mebeverine
as

Dy No. 1067 dated :


30-06-2014

Hepa-MerzMerz
Germany

Pharmaceuticals

Hepa-Merz of Brookes Pharma, Karachi.

As per brand leader


price/ Pack of 5,10 &
30s
Form-5
Dy No. 1069 dated :
30-06-2014

Doalyte Relief Black current sachet of


Aventis Pharma UK
Diarolyte of Sanofi Avnetis Karachi

As per brand leader


price/ Pack of 6,10 &
20s
Form-5
Dy No. 1070 dated :
30-06-2014

Fybogel Mebeverine of Reckitt Benkiser


UK
Ispamer Sachet of Getz, Karachi

Hydrochloride:
135mg
Physillium
Husk..3.5gm
Antispasmodic
Laxative
M/s Elite Pharma
(Pvt) Limited, 9.5
Km
Sheikhupura
Road Lahore

-do-

and

Rs.155.52 per pack of


10s
Rs. 310.50 per pack of
20s
Rs.465.75 per pack of
30s

Manufacturer
Flucolite Infusion 50ml

Form-5

Diflucan of Pfizer.

Each ml contains:Fluconazole2mg

Dy No. 885 dated : 2511-2013

Diflucan of Pfizer Labs Karachi

Antifungal

20,000/-

Manufacturer

Price not submitted


/Pack of 100ml of 1s

Percemol
1gm/100ml

Infusion

Each 100ml conatins:Paracetamol1gm

Form-5

Panel inspection of the firm was


conducted on 28-01-13 and the panel
recommended the liquid injectable
infusion (100ml)
Perfalgan of BMS, UK

Dy No. 883 dated : 2511-2013

Provas of
Karachi

20,000/-

Evidence of availability of TOC is


required as BP specifications are
claimed.

Analgesic
-do-

Manufacturer
Capronic
50mg/ml

Infusion

Each ml contains:Aminocaproic
acid..50mg
Hemostatis
-do-

Elite Reserbelakta
Each ml contains:Sorbitol..200mg
Sodium Lactate..1.9mg
So+dium
chloride..6mg
Calcium
chloride..0.1mg
Potassium Chloride
0.3mg

Evidence of availability of TOC is


required as BP specifications are
claimed.

Price not submitted


/Pack of 100ml of 1s
Form-5
Dy No. 883 dated : 2511-2013
20,000/Price not submitted
/Pack of 100ml of 1s
Form-5
Dy No. 884 dated : 2511-2013

SAMI

Pharmaceuticals

Not available in SRA,s.


Me too is not provided by the company.
Evidence of availability of TOC is
required as BP specifications are
claimed.
Not available in stringent SRAs. Firm
has submitted the applied product is
available in Ukraine (Saorbilactum
infusion of Yuria Pharma) which also
needs verification.

20,000/Price not submitted


/Pack of 400ml of 1s

Firm submitted that product is not


available locally.
Evidence of availability of TOC is
required as BP specifications are

Magnesium
Chloride..0.2mg

claimed.

Hyperosmoler complex
and infusion solution
Manufacturer
Elite Reserbelakta

-do-

Each ml contains:Sorbitol..200mg
Sodium Lactate..1.9mg
Sodium chloride..6mg
Calcium
chloride..0.1mg
Potassium Chloride
0.3mg
Magnesium
Chloride..0.2mg

Form-5
Dy No. 888 dated : 2511-2013

Not available in stringent SRAs. Firm


has submitted the applied product is
available in Ukraine (Saorbilactum
infusion of Yuria Pharma) which also
needs verification.

20,000/Price not submitted


/Pack of 200ml of 1s

Firm submitted that product is not


available locally.
Evidence of availability of TOC is
required as BP specifications are
claimed.

Hyperosmoler complex
and infusion solution
Manufacturer
b) Routine applications
Evaluator II
S/N

Name and address of Brand Name


Type of Form
manufacturer
/
(Proprietary name + Initial date, diary
Applicant
Dosage
Form
+
Fee
including
Strength)
differential fee
Composition
Demanded Price / Pack
Pharmacological
size
Group
Finished
product
Specification

Remarks on the formulation (


any) including
Internation
status
in
stringent
dru
regulatory agencies / authorities
Me-too status

GMP status as depicted in late


inspection report (with date) b
the Evaluator

130.

131.

132.

M/s Maple
Pharmaceuticals (Pvt.)
Ltd., 147/23, Korangi
Industrial Area,
Karachi.

-do-

M/s Sami
Pharmaceuticlas (Pvt.)
Limited, F-95, S.I.T.E.
Karachi-Pakistan

Faxim-E 200mg Tablet


Each film coated
Tablet contains:Rifaximin (B.P)
200mg
(Antibacterial)
(Manufacturers
Spec.s)

Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(14-05-2013)
As per PAC

Faxim 550mg Tablet


Each Tablet contains:Rifaximin (B.P)
550mg
(Antibacterial)
(Manufacturers
Spec.s)

Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(25-07-2013)
As per PAC

Neege 20mg Tablets


Each delayed release
Tablet contains:Pantoprazole Sodium
Sesuiquihydrate
equivalent to
Pantoprazole (USP)
20mg
(Proton Pump
Inhibitor) USP Spec.s)

BNF: Xifaxanta (Norgine)


Nimixa (Getz Pharma)

Overall cGMP measures are


followed in the Firm (31-03-2014)

1.Verification of photocopies of fe
challan is required.
BNF: Xifaxanta (Norgine)
Nimixa (Getz Pharma)

Overall cGMP measures are


followed in the Firm (31-03-2014)
1. Verification of photocopies of
fee challan is required.

Form 5
06-07-2010 Rs.8,000/
(69)
+Rs. 12000 (10-05-2013)
As Per PRC

BNF. Pantoprazole (Nonproprietary)


Zentro (Bosch)
Good (28-11-2013)
Very good (24-06-2014) Grant of
Additional sections
Satisfactory (07-11-2013) Routine

1.Verification of photocopy of fe
of Rs. 12000/- is required.

1. The Routine applications checked by the Field Officers before establishment of Cell
Evaluator - II
S/N

Name
and
address
of
manufacturer/
Applicant

1. Brand Name
2. Dosage Form
3. Composition
4.
Pharmacologica
l
group

1.Type of Form
1. Finished Product
2. Type of
Specification
application
2. Me-too status
3. Demanded
Price / Pack size
4. Initial date,
diary.
5. Date on which
fee
becomes
complete
according
to
type
of
application /or
Form (total Fee)

Comments
/
observation on the
product (if any)

Registration-II
M/s Barrett
Hodgson
Pakistan Pvt.
Ltd. F/423,
SITE, Karachi

1.DutaBar
2.Capsule
3.Each Capsule
contain:
Dutasteride
.0.5mg
4.AlphaReductase
Inhibitors

-do-

1.MindSet
2.Capsules
3.Each Capsule
contains:
Ziprasidone
.20mg
4.Atypical AntiPsychotropic
Agent

-do-

-do-

-do-

1.MindSet
2.Capsules
3.Each Capsule
contains:
Ziprasidone
.40mg
4.Atypical AntiPsychotropic
Agent
1.MindSet
2.Capsules
3.Each Capsule
contains:
Ziprasidone
.60mg
4.Atypical AntiPsychotropic
Agent
1.MindSet
2.Capsules
3.Each Capsule
contains:
Ziprasidone

1.Form5
2.Routine
3. Rs. 1200/20s
4.28/09/2010
Dy. No. 1738
Form 5
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs. 900/14s
4.28/09/2010
Dy. No. 1742
Form 5
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs. 1500/14s
4.28/09/2010
Dy. No. 1741
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs. 2100/14s
4.28/09/2010
Dy. No. 1740
Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3. Rs. 2800/14s
4.28/09/2010
Dy. No. 1739

Me too confirmed
Advodart of GSK

FDA
:
(GSK)

Avodart

Me
too
confirmed.

status FDA
:
(Pfizer)

Geodon

Me
too
confirmed.

status FDA
:
(Pfizer)

Geodon

Ziprox of Nabi qasim

Me
too
confirmed

FDA
:
(Pfizer)

Geodon

status FDA
:
(Pfizer)

Geodon

.80mg
4.Atypical AntiPsychotropic
Agent
M/s Macter
International Ltd.
F-216, SITE,
Karachi

1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan
.40mg
Amlodipine
...5mg
4.antihypertensiv
e

-do-

1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan
.80mg
Amlodipine
...5mg
4.antihypertensiv
e

-do-

1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan
.40mg
Amlodipine
..
.10mg
4.antihypertensiv
e
1.Amlotel
2.Tablet
3.Each tablet
contains:
Telmisartan
.80mg
Amlodipine
..
.10mg
4.antihypertensiv
e

-do-

Rs. 8000/(Original)
21-5-2013
Rs.12,000/(Photo copy)
1.Form5
2.Routine
3.14s / As per
PRC
4.22/09/2010
Dy. No. 1709
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not attached)
1.Form5
2.Routine
3.14s / As per
PRC
4.22/09/2010
Dy. No. 1708
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not attached)
1.Form5
2.Routine
3.14s / As per
PRC
4.22/09/2010
Dy. No. 1710
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not attached)
1.Form5
2.Routine
3.14s / As per
PRC
4.22/09/2010
Dy. No. 1707
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not attached)

Me too confirmed

FDA:
Generic
(TORRENT
PHARMS LTD)

Me too confirmed

FDA:
Generic
(TORRENT
PHARMS LTD)

Me too confirmed

FDA:
Generic
(TORRENT
PHARMS LTD)

Me
too
confirmed

status FDA:
Generic
(TORRENT
PHARMS LTD)

-do-

M/s Nabiqasim
Industries Pvt
Ltd. 17/24,
Korangi
industrial Area,
Karachi.

-do-

1.Prophed
2.Suspension
3.Each 5ml
contains:
Ibuprofen.100mg
Pseudoephedrine
HCI15mg
4.Pain reliever
/fever reducer
nasal
decongestant)

1.Form5
2.Routine
3. 60ml/As per
PRC
4.22/09/2010
Dy. No. 1711
Rs. 8000/(Original)
22-5-2013
Rs.12,000/(Not attached)

Rovinac of Rock Int.


avail
pharmaceutical
confirmed in
DRAs.

1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.100m
g
4.anti psychotic,
dibenzothiazepin
e)
Specs:
NabiQasim
1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
...125
mg
4.Pulmonary
arterial
hypertension)
(PAH), systemic
sclerosis with
ongoing digital
ulcer disease
Specs:
NabiQasim

1.Form5
2.Routine
3. 10s, 30s/ As
per PRC
4.16/09/2010
Dy. No. 1699
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)

Me
too
confirmed

1.Form5D
2.Routine
3. Rs.
30,000/10s
4.16/09/2010
Dy. No. 1690
Rs. 15000/(Original)
14-5-2013
Rs.5000/(Photo copy)

1. It is a me too
FDA: Tracleer
2. At the time of
filing application, the
drug was new. The
firm submitted Form
5-D with fee Rs.
15,000/-. Now the
drug has become
registered. The firm
has submitted the
from 5.

not
Str

Psychotropic
precursor

status FDA: Generic(DR


REDDYS
LABS
LTD)

-do-

1.Qrist
2.Tablets
3.Each extended
release tablet
contains:
Desvenlafaxine
succinate eq to
desvenlafaxine
.50mg
4.Antidepressant
Specs:
NabiQasim

1. Form 5
2.Routine
3. 10s, 14s, /
As per PRC
4.16/09/2010
Dy. No. 1689
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)

-do-

1.Qrist
2.Tablets
3.Each extended
release tablet
contains:
Desvenlafaxine
succinate eq to
desvenlafaxine
..
.100mg
4.antidepressant
Specs:
NabiQasim

1. Form 5
2.Routine
3. 10s,14s/As
per PRC
4.16/09/2010
Dy. No. 1693
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)

-do-

1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine..25mg
4.anti psychotic,
dibenzothiazepin
e
Specs:
NabiQasim

1. Form 5
2.Routine
3. 10s,30s/As
per PRC
4.16/09/2010
Dy. No. 1698
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)

1.Me
too
status FDA : Khedezla
confirmed
Denla
XR
50mg&100mg of M/s
Semos
Pharma,
(Reg.No.070433&07
0434)
2.The
firm
has
submitted
the
undertaking
regarding submission
of
comparative
dissolution
profile
before marketing of
the product
1.Me
too
status FDA : Kheedezla
confirmed
Denla
XR
50mg&100mg of M/s
Semos
Pharma,
(Reg.No.070433&07
0434)
2.The
firm
has
submitted
the
undertaking
regarding submission
of
comparative
dissolution
profile
before marketing of
the product
Me
too
status FDA: Seroquel
confirmed

-do-

1.Qutex
2.Tablet
3.Each film
coated tablet
contains:
Quetiapine
fumarate eq to
quetiapine.200m
g
4.anti psychotic,
dibenzothiazepin
e
Specs:
NabiQasim
1.Bepcor
2.Tablet
3.Each film
coated tablet
contains:
Bosentan (as
monohydrate)
..62.5mg
4.Pulmonary
arterial
hypertension
(PAH)
Specs:
NabiQasim

-do-

1. Form 5
2.Routine
3. 10s, 30s / As
per PRC
4.16/09/2010
Dy. No. 1695
Rs. 8000/(Original)
14-5-2013
Rs.12,000/(Photo copy)

Me
too
confirmed

1. Form 5
2.Routine
3. Rs. 19000/10s
4.16/09/2010
Dy. No. 1696
Rs. 15000/(Original)
14-5-2013
Rs.5000/(Photo copy)

1. It is a me too.

status FDA: Seroquel

FDA: Tracleer

2. The firm has now


submitted form 5.

Registration-V
M/s Care
Pharmaceuticals,
8Km, Thokor
Raiwind Road,
Lahore

1.Sinocare
2.Cream
3.Each gm
contains:
Fluocinolone
acetonide..2.5mg
4.Corticosteroid

-do-

1.Fusidcare
2.Cream
3.Each gm
contains:
Fusidic Acid
(2%).20 mg
4.Antibacterial

1.Form5
2.Routine
3.Rs.50/15gm,
Rs.90/30gm
4.30-09-2010
Dy.No.4032
Rs.8000/Rs.12,000/13-5-2013
1.Form5
2.Routine
3.Rs.65/5gn,
Rs.165/15gm
4.30-09-2010
Dy.No.4033
Rs.8000/15-05-2013
Rs.12,000/-

Reply
has
received.

been FDA: Generic (Taro)

Reply
is
still BNF: Fucidin (Leo)
awaited.
The
firm
was
communicated twice.
They have stated that
they are no more
interested in the
product registration.

-do-

1.Clomezole
2.Cream
3.Each gm
contains:
Clotrimazole
.10 mg
4.Antifungal

1.Form5
2.Routine
3. Rs.41/10gn,
Rs.70/20gm
4.30-09-2010
Dy.No.4029
Rs.8000/15-05-2013
Rs.12,000/-

M/s CCL
Pharmaceuticals,
Pvt. Ltd.
62-Industrial
Estate, Kot
Lakhpat, Lahore

1.Cip
2.Suspension
3.Each 5ml
contains:
Ciprofloxacin
hydrochloride
eq. to
ciprofloxacin..
................125mg
4.Antibiotic.

1.Form5
2.Routine
3.60ml/ Price not
mentioned
4.06-09-2010
Rs.8000/(Photo copy)
20-05-2013
20-05-2013
Rs.12,000/(Original)

M/s Schazoo
Pharmaceuticals
Laboraories Pvt.
Ltd. Kaolawala
Stop, 20, KM
Jaranwala Road,
District
Shehikhupura.

1.Cavrex
2.Tablet
3.Each film
coated tablet
contains:
Entecavir as
monohydrate
(M.S)1 mg
4.Anti viral.

1.Form5
2.Routine
3.Rs.15,000/30s
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)

Reply
is
still FDA: Generic (Taro)
awaited.
The
firm
was
communicated twice.
They have stated that
they are no more
interested in the
product registration.
FDA:
(Different
formulation)

Tacavair
of
Consolidated
chemical Lab.

Cipro

The
originators
(M/s
Bayer)
formulation contains
ciprofloxacin in base
form, however the
firm has submitted
that a number of
products in Pakistan
are registered in
which ciprofloxacin
is present in HCl
form. The firm has
also
provided
labeling and outer
packaging
of
Novidate (product of
Sami
pharmaceuticals,
Karachi)
which
confirms the stance
of the firm.
M/s FDA: Baraclude
Me
too
confirmed

status

-do-

1.Ceretek
2.Injection
3.Each 1ml
contains:
Haloperidol as
lactate5mg
4.Anti Psychotic

-do-

1.Ceretek
2.Tablet
3.Each tablet
contains:
Haloperidol
Usp.20m
g
4. Anti Psychotic

M/s Genix
Pharma (Pvt.)
Ltd;
44, 45-B,
Korangi Creek
Road,
Karachi

-do-

Diphos Dry
Suspension
Each 5ml
contains:
Dihydroartemis
inin
15mg
Piperaquine
Phosphate.
..120mg
Diphos DS
Sachet
30/240mg
Each Sachet
contains:
Dihydroartemis
inin (Ph.I)
...30mg
Piperaquine
Phosphate
Anhydrous
... 240mg

1.Form5
2.Routine
3.Rs.300/(2x5)
1ml Ampoule
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)
1.Form5D
2.Routine
3.Rs.300/3x10s
4.24-09-2010
Rs.8000/(Original)
28-05-2013
Rs.12,000/(Original)

1.Form5
2.Routine
3. 30 ml Rs.
250/60 ml Rs. 500/80 ml Rs. 667/4.14-09-2010
5.Dy. No.72
Rs.8,000/Rs.12,000/21-05-2013
1.Form5
2. Routine
3. per sachet
Rs. 45/10s Rs.450/16s Rs. 720/4.14-09-2010
5.Dy. No.64
Rs.8,000/Rs.12,000/(21-5-2013)

FDA:
Generic
(Sagent Pharms)
Me
too
status
confirmed

1. It is new drug.
2. Differential fee of
Rs.
30,000/is
required
to
be
deposited by the
applicant.

FDA:
(Sandoz)

Generic

Me too confirmed

Int.
avail
not
confirmed
in
Stringent DRAs.

The firm has been


asked for submission
of fee. Her responses
still awaited.

The
firm
has
submitted reference
of Me too as Poart
susp. of Neutro
pharma (62770)

1. Time quin of Sami Int.


avail
is available in sachet. confirmed in
2. Me too status DRAs.
needs confirmation

not
Str

-do-

1.Diphos
2. Syrup
3.Each 5ml
contains:
Dihydroartemis
inin..15mg
Piperaquin
Phosphate
120mg
4.Anti Malarial

1.Form5-D
2. Routine
3. 30 ml Rs.
250/60 ml Rs. 500/80 ml Rs. 667/4.14-09-2010
Dy. No.73
Rs.8,000/Rs.12,000/(21-5-2013)

-do-

1.Diapil
2.Tabs
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin
.
5mg
4.Anti Malarial
1.Diapil
2.Tablet
3.Each film
coated tablet
contains:
Saxagliptin
HCl e.q to
Saxagliptin
..
2.5mg
4.Anti Malarial
1.Diphos DS
2.Tablet
3.Each Tablet
contains:
Dihydroartemis
inin (Ph.I)
.80mg

Me too available
1.Form5D
2.Routine
3. Rs. 4500/10s
Rs. 9000/20s
Rs. 13500/30s
4.14/09/2010
Dy. No. 1684
Rs. 15000/Rs.12,000/21-5-2013

Int.
avail
confirmed in
DRAs.

Me too available
1.Form5D
2.Routine
3. Rs. 2500/10s
Rs. 5000/20s
Rs. 7500/30s
4.14/09/2010
Dy. No. 1681
Rs. 15000/Rs.12,000/21-5-2013

FDA: Onglyza

-do-

-do-

1.Form-D
2.Routine
3. Rs.800/8s
4.14/09/2010
Dy. No. 67
(Moh)
Rs. 8000/-

1. Me too status Int.


avail
needs confirmation
confirmed in
DRAs.

Me too status needs Int.


avail
confirmation.
confirmed in
DRAs.

not
Str

not
Str

not
Str

-do-

Piperaquine
Phosphate
(M.S) 640mg
4.Anti Malarial
1.Diphos DS
2.Suspension
3.Each 5ml
contains:
Dihydroartemis
inin (PhI)
.30mg
Piperaquine
Phosphate
Anhydrous
..240mg
4.Anti Malarial

Rs.12,000/21-5-2013

1.Form-5
2.Routine
3. Rs. 450/10s
Rs. 720/16s
4.16/09/2010
Dy. No. 69
(Moh)
Rs. 8000/Rs.12,000/21-5-2013

Me too status needs Int.


avail
confirmation.
confirmed in
DRAs.

not
Str

M/s Noa Hemis


Pharmaceuticals, Plot
No. 154, Sector-23,
Korangi Industrial
Area, Karachi-74900

Loxicam 4mg Tablet


Each film coated
tablet contains:
Lornoxicam
4 mg
(NSAID)

Form-5
30-7-2010

Loxicam-DS 8mg
Tablet
Each film coated
tablet contains:
Lornoxicam
8 mg
(NSAID)

Xefast (Pharmevo)

Dy.No.1507
Rs.8000/-+Rs. 12000/(10-05-13)
Rs.1200/-/10s

(Manufacturers
Spec.s)
-do-

Not confirmed

Form-5

Good (09-06-2014)
2.Verification of photocopy of fee
of Rs. 8000/- is required.
3.International
availability
in
stringent DRA,s not confirmed.
Not confirmed

30-7-2010

Xefast (Pharmevo)

Dy.No.1505

Good (09-06-2014)

Rs.8000/+Rs. 12000/- (10-05-13)


Rs.2300/-/10s

1.Verification of photocopy of fee


of Rs. 8000/- is required.
2.International
availability
in
stringent DRA,s not confirmed.

(Manufacturers
Spec.s)
-do-

Resipa 1mg Tablet


Each film coated
tablet contains:
Risperidone 1 mg
(Antipsychotic)
(Manufacturers
Spec.s)

-do-

Resipa 2mg Tablet


Each film coated
tablet contains:
Risperidone2 mg
(Antipsychotic)
(Manufacturers

Form-5
30-7-2010

BNF : Risperdal
(Janssen)

Dy.No.1500

Risperdal

Rs.8000/-+Rs. 12000/(14-05-13)

(Janssen)

As per PRC

Form-5

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.
BNF : Risperdal

30-7-2010

(Janssen)

Dy.No.1509

Risperdal

Rs.8000/-+Rs. 12000/(14-05-13)

(Janssen)

Spec.s)

As per PRC

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.

-do-

Resipa 3mg Tablet


Each film coated
tablet contains:
Risperidone
3 mg
(Antipsychotic)

Form-5
30-7-2010

(Janssen)

Dy.No.1503

Risperdal

Rs.8000/-+Rs. 12000/(14-05-13)

(Janssen)

As per PRC

(Manufacturers
Spec.s)
-do-

Gasiton 50mg Tablet

Form-5

Each tablet contains:

30-7-2010

Itopride
Hydrochloride50
mg

Dy.No.1508

(Gastroprokinetic)

Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC

(Manufacturers
Spec.s)

-do-

Etecav 0.5 mg Tablet


Each film coated
tablet contains:
Entecavir (as
monohydrate).0.5
mg

BNF : Risperdal

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.

Not confirmed

GANATON
(ABBOTT)
Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.
2.International
availability
in
stringent DRA,s not confirmed.
3.Formulation is under review by
the review committee.

Form-5
30-7-2010

BNF : Baraclude (Bristol-Myers


Squibb)

Dy.No.1506
Rs.8000/-+Rs. 12000/(10-05-13)

Centauru S (Ferozsons)

(Anti Viral)

As per PRC

(Manufacturers
Spec.s)

-do-

Proxat 20mg Tablet


Each film coated
tablet contains:
Paroxetine (as HCl)
20 mg
(Antidepressant,
selective serotonin
reuptake inhibitor)

Good (09-06-2014)

Form-5
30-7-2010

1.Verification of photocopy of fee


of Rs. 8000/- is required.
2.Amount of active drug is very less
(500mcg), may be considered
for Product specific inspection.
BNF : Seroxat (GSK)
Seroxat (GSK)

Dy.No.1504
Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.

(B.P Spec.s)
-do-

Muscolex 4mg
Capsule
Each capsule contains:
Thiocolchicoside.
.4 mg
(Muscle relaxant)

Form-5
30-7-2010

Gabagyl 200mg
Capsule
Each capsule contains:
Gabapentin...200 mg
(Anticonvulsant)
(Manufacturers
Spec.s)

Muscoril (Searle)

Dy.No.1502
Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC

(Manufacturers
Spec.s)

-do-

Not confirmed

Form-5
30-7-2010
Dy.No.1510
Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.
2.International
availability
in
stringent DRA,s not confirmed.
3.Formulation is under review by
the review committee.
Gebapentin in 200mg strength Not
found in FDA & UK
Gabin of PharmEvo

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.

-do-

Zofen 0.25mg/5ml
Syrup
Each 5ml contains:
Pizotifen( as
Hydrogen Maleate)

..0.25 mg
(Appetite stimulant)
(Manufacturers
Spec.s)

Form-5
30-7-2010

2.International
availability
in
stringent DRA,s not confirmed.
BNF : Sanomigran (Novartis)
Not confirmed

Dy.No.1501
Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC

Good (09-06-2014)
1.Verification of photocopy of fee
of Rs. 8000/- is required.
2.The firm has applied the
formulation
as
appetite
stimulant which is not rational.

2. Veterinary applications
S
/
N

Name of Applicant

175. M/s. Nawan


Laboratories (Pvt)
Ltd., Karachi.

Name of Drug(s)/Composition

Pameron Injection
Each ml contains:Methampyrone..100mg

Price/Pack
Size

Shelf
Life

Date of
application
receiving.

Decontrolled
10ml
50ml
100ml

2 years

24-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

Chlorpheniramine Maleate..1mg
Caffeine..10mg
(Antipyretic and Analgesic).
176. M/s. Mallard
Pharmaceuticals
(Pvt) Ltd., Multan.

Shina Gold Drench

Decontrolled

Each ml contains:-

100ml

Oxyclozanide...62.50mg

250ml

Oxfendazole.25mg

500ml

Cobalt Sulphate....2mg

1000ml

Sodium Selenite..0.5mg

2.5 Liter

2 years

15-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

(Anthelmentic).
177. M/s. Mallard
Pharmaceuticals
(Pvt) Ltd., Multan.

Shinazan Plus Drench

Decontrolled

Each ml contains:-

100ml

Oxyclozanide...30mg

150ml

Levamisole HCI...15mg

250ml

Cobalt Sulphate....0.75mg

500ml

Sodium Selenite....0.35mg

1000ml

Vitamin K....3mg

2.5 Liter

2 years

15-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

(Anthelmentic).
178. M/s. Mallard
Pharmaceuticals
(Pvt) Ltd., Multan.

Shina Fax Liquid

Decontrolled

Each ml contains:-

100ml

Oxfendazole..22.65mg

250ml

2 years

15-12-2010
Rs.8000 +
Rs. 12000 =

Zinc Sulphate2.6mg

450ml

(Anthelmentic).

500ml

Rs.20,000/-

1000ml
2.5 Liter
179. M/s. Mallard
Pharmaceuticals
(Pvt) Ltd., Multan.

Shina Zole 12.5% SC Liquid

Decontrolled

Each ml contains:-

30ml

Albendazole..125mg

100ml

Sodium Selenite ..1.67mg

250ml

Cobalt Sulphate0.50mg

500ml

(Anthelmentic).

1000ml

2 years

15-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

2.5 Liter

180. M/s. Sanna


Laboratories,
Faisalabad.

Sanoxicam Injection
Each ml contains:Meloxicam..7.5mg

Decontrolled
10ml
30ml
50ml
100ml

2 years

Decontrolled
50ml
100ml

2 years

Rs.8000 +
Rs. 12000 =
Rs.20,000/-

(Analgesic).
181. M/s. Sanna
Laboratories,
Faisalabad.

SCS-Forte Injection
Each ml contains:Colistin Sulphate...1 MIU
(Polymyxin Antibiotic).

30-12-2010

30-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

182. M/s. Sanna


Laboratories,
Faisalabad.

183. M/s. Sanna


Laboratories,
Faisalabad.

Sanacol-50 Water Soluble Powder


Each gram contains:Colistin Sulphate.50,00,000 IU
(Polymyxin Antibiotic).

ECS-150 Oral Liquid


Each 100ml contains:Enrofloxacin 10gm
Colistin Sulphate50,000,000 IU
(Antibiotic).

Decontrolled
100gm
300gm
500gm
1 Kg

2 years

Decontrolled
100ml
500ml
1 Liter

2 years

30-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/30-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-

Evaluator I
S. N

Name
and
address
of
Manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
form
+
Strength)

Type of Form
Initial date, diary.

Composition

Fee
including
differential fee

Pharmacological
Group

Demanded Price /
Pack size

International status in
stringent regulatory
agencies
Me-too status
GMP
status
as
depicted in inspection
report (dated)

Finished
product
specification
M/s Ray Pharma
(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi

Raylox Tablet

Form 5

Film Coated Tablet

10s /Rs.299/-

Each Film Coated


Tablet Contains.

Dy. No. Not


mentioned (Duplicate
Dossier) Dossier
dated 29-06-2010
Rs.8000/- (17-052010)

Levofloxacin as
Hemihydrate ..........750
mg
(Quinolone group
Antibacterial)
Manufacturers
Specifications

Dy. No. Not


mentioned
Rs.12,000/- dated 2609-2013 (Fee
challans are
duplicate)

LEVAQUIN
750mg Film
tablet
US FDA

coated

LEFLOX
750mg
Getz
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.

Total Rs.20,000/M/s Ray Pharma


(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi

Rayart DS Tablet

Form 5

Tablet

8s /Rs.264/-

Each Tablet Contains.

Dy. No. Not


mentioned (Duplicate
Dossier) Dossier
dated 29-06-2010
Rs.8000/- (17-052010)

Artemether
.40mg
Lumefantrine.240
mg
(Anti Malarial)

Dy. No. Not


mentioned

ARTHEGET
40/240mg tablet
Getz
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.

Remarks /
Observations

Manufacturers
Specifications

Rs.12,000/- dated 2609-2013 (Fee


challans are
duplicate)
Total Rs.20,000/-

M/s Ray Pharma


(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi

Rayart Tablet

Form 5

Tablet

4s /Rs.220/-

Each Tablet Contains.

Dy. No. Not


mentioned (Duplicate
Dossier) Dossier
dated 19-07-2010
Rs.8000/- (17-052010)

Artemether
.80mg
Lumefantrine.480
mg
(Anti Malarial)

Manufacturers
Specifications

ARTHEGET
80/480mg tablet
Getz
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.

Dy. No. Not


mentioned
Rs.12,000/- dated 2609-2013 (Fee
challans are
duplicate)
Total Rs.20,000/-

M/s Ray Pharma


(Pvt.) Ltd, S-58,
S.I.T.E.
Extension
Hawksbay
Road, Karachi

Rayaz Tablet

Form 5

Tablet

3s /Rs.160/-

Each Film Coated


Tablet Contains.

Dy. No. Not


mentioned (Duplicate
Dossier) Dossier
dated 29-06-2010
Rs.8000/- (17-052010)

Azithromycin as
dihydrate
.
500mg
(Macrolide Antibiotic)
Manufacturers
Specifications

Dy. No. Not


mentioned
Rs.12,000/- dated 2609-2013 (Fee
challans are
duplicate)
Total Rs.20,000/-

ZITHROMAX
500mg tablets
US FDA
AZOMAX
500mg tablet
Novartis
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.

M/s
Macter
International
(Pvt.) Ltd. F216,
S.I.T.E.,
Karachi

M/s
Bosch
Pharmaceutical,
221,
Bosch
House, Sector
23,
Korangi
Industrial Area,
Karachi.

Micam

Form 5

Tablet

5s and 10s/As Per


PRC

Each film coated tablet


Contains:Lornoxicam ..4mg

Dy No 255 R&I
dated 23-07-2010
Rs.8000/-

(Analgesic and antiinflammatory)

Rs.12,000/22-05-2013

Falgan 500mg/50ml

Form 5-D

Infusion

1,s /Rs.60/-

Each Vial Contains.

Dy No.1386/R&I
dated 22-07-2010/
Rs.15,000/-

Paracetamol .(B.P)
500mg/50ml
(Analgesics and
Antipyretics)
(Manufacturers Specs)

Copy of cashiers
cheque amounting to
168,000/(Rs.
12,000/- each for 14
products, including
Falgan 500mg/50ml).
However, the cheque
or the covering is not
endorsed by STO and
is also not the
prescribed fee for
Form-5D
applications.

VICTRA
4mg tablet
Scitech
Lornoxicam
4mg f/c tablet
EMA
Inspection report dated
10-04-2014 considered
to be operating at
satisfactory level of
GMP.
Capsule
section
mentioned in inspection
report.
PERFALGAN
10mg/ml (50ml Vial)
MHRA
Injectable
Liquid
section granted vide
letter No. F. 2-4/91-Lic
(Vol-II) (M-196).
Routine
GMP
inspection report dated
12-08-2014
cGMP
level rated as good.

1. Copy of cashiers
cheque amounting to
168,000/(Rs.
12,000/- each for 14
products, including
Falgan 500mg/50ml).
However, the cheque
or the covering is not
endorsed by STO and
is also not the
prescribed fee for
Form-5D
applications.
2.
Pyrogen
free
distilled water has
been mentioned in
the
master
formulation whereas,
the reference brand
contains WFI for
which evidence of
TOC analyzer and
liquid
particle
counter is required.
However, firm has
provided copies of
operators manual of
particle counter only,
as evidence.
3. Stability summary
at 30 C and 65% RH
for only one batch of
3,000/vials
submitted.

M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi

Pioglit 15mg + 2mg


Tablet
Tablet
Each Tablet Contains.
Pioglitazone .
15mg
Glimepiride .. 2mg
(Anti-Hyperglycemic)

Form 5
Dy. No. Not
mentioned / R&I date
not mentioned
(Covering letter dated
07/07/2010)
Rs.8000/(19/07/2010)
Rs.12,000/(15/05/2013) fee
challans are duplicate

Glibetic
15/2mg
ICI
GMP inspection report
dated 13/02/2013

Total Rs.20,000/14s / Rs. 10 per


tablet
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi

Glitter 4mg Tablet

Form 5

Tablet

Dy. No Not
mentioned / R&I
dated not mentioned
(Covering letter dated
20/07/2010)

Each Tablet Contains.


Glimepiride .. 4mg
(Anti-Hyperglycemic)

Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total Rs.20,000/-

M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi

Glitter 3mg Tablet


Tablet
Each Tablet Contains.
Glimepiride .. 3mg

20s As per PRC


Form 5
Dy. No. Not
mentioned / R&I
dated not mentioned
(Dossier dated
20/07/2010)

(Anti-Hyperglycemic)
Rs.8000/(22/07/2010)

Amaryl
MHRA
Amaryl
Sanofi-Aventis
GMP inspection report
dated 13/02/2013

Amaryl
MHRA
Amaryl
Sanofi-Aventis

GMP inspection report


dated 13/02/2013

Evidence of approval
of same formulation
by
stringent
regulatory authority
e.g., FDA, TGA,
MHLW, EMA and
Health
Canada
required.

Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total Rs.20,000/20s / As per PRC
M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi

Glitter 2mg Tablet

Form 5

Tablet

Dy. No. Not


mentioned / R&I
dated not mentioned
(Dossier dated
20/07/2010)

Each Tablet Contains.


Glimepiride .. 2mg
(Anti-Hyperglycemic)

Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total Rs.20,000/-

Amaryl
MHRA
Amaryl
Sanofi-Aventis
GMP inspection report
dated 13/02/2013

20s / As per PRC


M/s
Pakistan
Pharmaceutical
Products (Pvt)
Ltd.
D-122,
Sindh Industrial
Trading Estate,
Karachi

Glitter 1mg Tablet

Form 5

Tablet

Dy. No. Not


mentioned / R&I
dated not mentioned
(Dossier dated
20/07/2010)

Each Tablet Contains.


Glimepiride .. 1mg
(Anti-Hyperglycemic)

Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total Rs.20,000/20s / As per PRC

6. Routine drug registration applications

Amaryl
MHRA
Amaryl
Sanofi-Aventis
GMP inspection report
dated 13/02/2013

Evaluator II
S.N
o

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary
name
+
Dosage Form + Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary

Remarks
on
the
formulation
(if
any)
including
International
status in stringent drug
regulatory
agencies
/
authorities

Pharmacological Group
Finished
Specification

M/s
Macter
International (Pvt)
Ltd. F-216, S.I.T.E,
Karachi.

product

Affient 5mg Tablet


Each film coated tablet
contains:
Prasugrel HCl eq. to
Prasugrel.5
mg
(Inhibitor of platelet
activation and
aggregation)
(Manufacturers Spec.s)

Demanded Price /
Pack size

Me-too status
GMP status as depicted in
latest inspection report
(with
date)
by
the
Evaluator

Form 5
0572010(54)
Rs.15000/
2252013
Rs.5,000/
Rs. 8.42/Tab
Rs. 118/14s
Rs.236/28s

BNF: Efient(Lilly)
Prasu (Amson)
Satisfactory level of GMP
compliance. (10-04-14)
1.Verification of photocopy
of differential fee (Rs.
5000/-) paid is required.
2.The Firm had applied

on Form 5-D initially


but
has
now
submitted Form 5.
1.Approval of section /
manufacturing facility
of applied drug from
licensing section is
required. The Firm
has submitted GMP
insp. Report dated 10-

-do-

Affient 10mg Tablet


Each film coated tablet
contains:
Prasugrel HCl eq. to
Prasugrel.10
mg
(Inhibitor of platelet

Form 5
0572010(46)
Rs.15000/
2252013
Rs.5,000/

04-14 which mentions


Tablet
(General)
Section.
BNF: Efient(Lilly)
Prasu (Amson)
Satisfactory level of GMP
compliance. (10-04-14)

activation and
aggregation)
(Manufacturers Spec.s)

-do-

-do-

Tamsyl Tablets
Each Tablet contains:
Etamsylate (B.P)
.250mg
(Antifibrinolytic, synthetic
antihaemorrhagic and
angioprotective)
(Manufacturers Spec.s)

Tamsyl Tablets
Each Tablet contains:
Etamsylate (B.P)
.500mg
(Antifibrinolytic, synthetic
antihaemorrhagic and
angioprotective)
(Manufacturers Spec.s)

Rs. 14/Tab
Rs. 96/14s
Rs.392/28s

1.Verification of photocopy
of differential fee (Rs.
5000/-) paid is required.
2.The Firm had applied

on Form 5-D initially


but
has
now
submitted Form 5.

Form 5

Not confirmed

0572010(N/A)
Rs.15000/
2252013
Rs.5,000/

Not confirmed

Rs. 7.5/Tab
Rs. 75/10s
Rs.150/20s

Form 5
0572010(N/A)
Rs.15000/
2252013
Rs.5,000/

Rs. 15/Tab
Rs. 150/10s
Rs.300/20s

Satisfactory level of GMP


compliance. (10-04-14)

1.Verification

of
photocopies of fee (Rs.
15000/- + Rs. 5000/-)
paid is required.

2.The Firm had applied


on Form 5-D initially
but
has
now
submitted Form 5.
3.International
availability
not
confirmed in same
strength.
4.Me-too status given as
Dicynone of French
Pharmaceuticals
Group (Reg. No.
004229)
needs
confirmation.
BNF: Dicynene
(Sanofi-Aventis)
Not confirmed
Satisfactory level of GMP
compliance. (10-04-14)

1.Verification

of
photocopies of fee (Rs.
15000/- + Rs. 5000/-)
paid is required.

2.The Firm had applied

-do-

Valsitan Tablets
Each film coated tablet
contains:
Amlodipine (as besilate)
5mg
Valsartan.160mg
(Calcium Antagonist)
(Manufacturers Spec.s)

Form 5
0672010(N/A)
Rs.8000/
2252013
Rs.12,000/
AS per PRC

on Form 5-D initially


but
has
now
submitted Form 5.
BNF: Exforge
(Novartis)
Exforge
(Novartis)
Satisfactory level of GMP
compliance. (10-04-14)

1.Verification

-do-

Valsitan Plus Tablets


Each tablet contains:
Amlodipine (as besilate)
10mg
Valsartan.160mg
(Calcium Antagonist)
(Manufacturers Spec.s)

Form 5
0672010(N/A)
Rs.8000/
2252013
Rs.12,000/
AS per PRC

-do-

-do-

Alozin Tablets
Each film coated extended
release tablet
contains:
Ranolazine1000mg
(antiischemic And
antianginal)
(Manufacturers Spec.s)

Tamsyl 2ml Injection


Each 2ml ampoule
contains:
Etamsylate.250 mg
(Antifibrinolytic synthetic
antihaemorrhagic and
angioprotective)
(Manufacturers Spec.s)

Form 5
0672010(N/A)
Rs.8000/
2252013
Rs.12,000/
AS per PRC

Form 5-D

of
photocopies of fee (Rs.
8000/- + Rs. 12000/-)
paid is required.
BNF: Exforge
(Novartis)
Exforge
(Novartis)
Satisfactory level of GMP
compliance. (10-04-14)
1.Verification
of
photocopies of fee (Rs.
8000/- + Rs. 12000/-)
paid is required.
FDA: Ranexa (Gilead)
Ranola (Highnoon)
Satisfactory level of GMP
compliance. (10-04-14)

1.Verification

of
photocopies of fee (Rs.
8000/- + Rs. 12000/-)
paid is required.
Not confirmed

0672010(N/A)
Rs.15,000/
2252013
Rs.5,000/

Not confirmed

AS per PRC/4s,
100s

1.Verification

Satisfactory level of GMP


compliance. (10-04-14)
of

photocopies of fee (Rs.


15000/- + Rs. 5000/-)
paid is required.

2.The Firm had applied


on Form 5-D initially
but
has
now
submitted Form 5.
3.Approval of section /
manufacturing facility
of applied drug from
licensing section is
required. The Firm
has submitted GMP
insp. Report dated 1004-14 which mentions
Sterile Products (Liquid
injections,
Opthalmic/Otic drops).

4.International
availability
not
confirmed.
5.Verification of Total
Organic
Testing
Facility is required.
M/s. WelMark
Pharmaceuticals
Plot # 122, BlockB, Phase-V
Industrial Estate
Hattar.

Rismek 3mg Tablets


Each film coated tablet
contains:Risperidone(USP).3mg
(Antipsychotic)
(USP Spec.s)

Form 5
12-07-2010 (17)
Rs.8,000/
+Rs. 12000 (09-052013)
As Per PRC

-do-

Welfam 40mg Tablets


Each tablet contains:Famotidine (USP)40mg
(H2 receptor Blocker,
Antipeptic ulcerate)
(USP Spec.s)

Form 5
12-07-2010 (16)
Rs.8,000/
+Rs. 12000 (09-052013)
As Per PRC/10s

BNF. Risperdal (Janssen)


Benzisox (Highnoon)
No conclusion of inspection
report, recommendations of
some corrections (24-05-14
routine GMP inspection)
BNF: Famotidine (Nonproprietary)
Acicon (Barrett Hodgson)
No conclusion of inspection
report, recommendations of
some corrections (24-05-14
routine GMP inspection)

1.BNF describes the


product as uncoated
while the Firm has
applied for the film
coated formulation.
M/s Atco
Laboratories
Limited B-18,
S.I.T.E, Karachi.

Combinol-D Sugar Free


Syrup
Each 5ml contains:Dextromethorphan
Hydrobromide (B.P)
10mg
Ephedrine Hydrochloride
(B.P)7.5mg
Chlorphenamine Maleate
(B.P)4mg
Terpin Hydrate (USP)
3.5 mg
Ammonium Chloride (B.P)
90mg

Form 5

Not confirmed

06-07-2010
Rs.8,000/ (N/A)
+Rs. 12000 (22-052013)

Combinol-D Syrup (Atco


Laboratories)

Rs. 38/- Per 120ml


bottle

1.Verification

Good level of GMP (18-062014)


of
photocopies of fee (Rs.
8000/- + Rs. 12000/-)
paid is required.

2.Approval of section /
manufacturing facility
of applied drug from
licensing section was
asked. The Firm has
submitted GMP insp.
Report dated 18-06-14

(Bronchodilator)
(Manufacturers Spec.s)

which mentions Oral


Liquid
(Syrup/Suspension)
section Non Antibiotic.

3.International
availability
of
formulation in SRAs
not confirmed.
4.Formulation contains

M/s Nenza
Pharmaceuticals,
33 A Industrial
Estate Hayatabad
Peshawar

NenKast 5mg Tablets


Each Chewable Tablet
contains:Montulekast Sodium
Equivalent to
Montelukast(B.P)5mg
(Antiasthmatic)

Form 5
16-07-2010
Rs.8,000/ (80)
+Rs. 12000 (23-052013)

Ephedrine
Hydrochloride,
a
controlled
drug
substance.
BNF: Singulair (MSD)
Montiget (Getz)
No conclusion regarding
GMP of the Firm, some
minor observations at which
the management was agreed

-do-

(Manufacturers Spec.s)

As Per SRO/- 14s

to rectify. (routine GMP 1004-2014)

Nenmether DS Tablets
Each Tablet contains:Artemether40mg
Lumefantrine240mg
(Antimalarial)
(USP Salmous Spec.s)

Form 5

WHO approved formulation

16-07-2010
Rs.8,000/ (79)
+Rs. 12000 (23-052013)

A-Fantrine 40/240 by M/s


Atco

As Per SRO/- 8s

M/s PharmEvo
(Private Limited
Plot #A-29, North
West Industrial
Zone, Port Qasim,
Karachi-75020

M/s Maple
Pharmaceuticals
(Pvt.) Ltd., 147/23,
Korangi Industrial
Area, Karachi.

Evorox 1.5g Injection


(Powder for reconstitution)
Each Vial contains:Cefuroxime Sodium
equivalent to Cefuroxime
(USP) 1.5g
(Antibiotic)
(USP Spec.s)

Form 5
06-07-2010, Rs.
8000/- + Rs. 12,000
(22-05-2013)

Defrinac Plus Tablets


Each film coated tablet
contains:Dexibuprofen (M.S)
300mg
Pseudoephidrine
Hydrochloride(B.P)60mg

Form 5-D
01-072010(11)Rs.8,000/+Rs. 12,000 (25-072013)+Rs. 30,000/(01-12-2014)

As per PRC

No conclusion regarding
GMP of the Firm, some
minor observations at which
the management was agreed
to rectify. (routine GMP 1004-2014)
BNF: Zinacef (GSK)
Zecef (Bosch)
Good, GMP compliance
(01-04-14) Provincial Drug
Inspector

1.Verification of copies of
fee
challans
are
required.
2.Evidence of approval of
technical staff from
licensing section is
required.
3.Firm has submitted
inspection report of
provincial
drug
inspector and has
informed that they
will submitt latest
inspection report of
FID when inspection
report
would
be
received.
Form 5-D
Overall cGMP measures are
followed in the Firm (3103-2014)

-do-

M/s
Nabiqasim
Industries
(Pvt)
Ltd.
17/24,
Korangi Industrial
Area, Karachi.

(NSAID+Decongestant)
(Manufacturers Spec.s)

Rs. As per PRC /


310s

1.The Firm had applied


on Form 5, but after
evaluation the Firm
has
deposited
differential fee for
application on Form
5-D. Form 5-D is
incorrect.
2.Verification of fee of
Rs.
12000/is
required.
3.Formulation contains
controlled
drug
substance.

Fastofen Tablets
Each film coated tablet
contains:Ibuprofen lysinate342mg
(NSAID)
(Manufacturers Spec.s)

Form-5
05-072010(44)Rs.8,000/+Rs. 12,000 (14-052013) Rs. 30,000/(01-12-2014)
Rs. As per PAC /
30s

Form 5-D

Misocot 50 mg Tablets
Each tablet contains:Diclofenac Sodium (B.P)
50mg
Misoprostol200mcg
(NSAIDs)
(Manufacturers Spec.s)

Form 5

BNF: Arthrotec (Pharmacia)

01/07/10(Nil)
Rs.8000/+Rs.12000/(14/05/13)

Arthrotec (Pfizer)

As per
10s,20s

PRC

Overall cGMP measures are


followed in the Firm (3103-2014)

1.The Firm had applied


on Form 5, but after
evaluation the Firm
has
deposited
differential fee for
application on Form
5-D. Form 5-D is
incorrect.
2.Verification of fee of
Rs.
12000/is
required.

Good GMP compliance (1812-13)


/

1.Verification
of
photocopies of fee
submitted is required.
2.Other strength of the
product Misocot 75

mg
Tablets
has
already been deferred
for Product specific
inspection by panel
comprising
of
Director DTL, DDG
(E&M) and area FID

Evaluator II
Applications checked by Evaluator IV (human)
S.N
o

Name and address of


manufacturer
/
Applicant

Brand Name
(Proprietary
name
+
Dosage Form + Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary

Remarks on the formulation (if


any) including
International
status
in
stringent
drug
regulatory agencies / authorities
Me-too status

Pharmacological Group
Finished
Specification

M/s Pfizer Pakistan


Limited.
B-2, S.I.T.E., Karachi

product

Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP
.500mg
Antibiotic

Demanded Price /
Pack size

GMP status as depicted in latest


inspection report (with date) by
the Evaluator

Form 5
23-07-2010
Dy. No. 264
Rs. 8000 + 12000
Rs 340/ 6s

International: BNF: Azithromycin


(Non-proprietary)
Local:
Azitor of Macter Int Pvt Limited
Karachi
According to inspection report dated
16-05-2012, factory premises and
manufacturing operations were
found in line and good with GMP
compliance standards at time of
inspection.
Latest inspection report is required.

Finished product
specifications are USP

-do-

Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP

Form 5
05-07-2010
Dy. No. 37
Rs. 8000 + 12000
Rs 240/ 6s

According to BNF Azithromycin


occurs
as
Azithromycin
monohydrate hemi-ethanolate in
Tablet dosage form.
International: BNF: Azithromycin
(Non-proprietary)
Local:
Azitor of Macter Int Pvt Limited
Karachi

.250mg
Antibiotic

According to inspection report dated


16-05-2012, factory premises and
manufacturing operations were
found in line and good with GMP
compliance standards at time of
inspection.
Latest inspection report is required.

Finished product
specifications are USP

According to BNF Azithromycin


occurs
as
Azithromycin
monohydrate hemi-ethanolate in
Tablet dosage form.
M/s Genome
Pharmaceuticals (Pvt)
Limited., Plot No.
16/I- Phase IV,
Industrial Estate,
Hattar

Ovulin Tablet
Each tablet contains
Clomiphene Citrate USP
50mg
Anti estrogen

Form 5
17-08-2010
Rs 20,000/As per PRC

BNF: Clomid (Sanofi-Aventis)


Ovi-F (Merck)
Grant of GMP for
recommended (27-12-13)

Export

Finished product
specifications are USP
M/s Rotexmedica
Pakistan (Pvt) Ltd.,
Plot no 206 & 207,
Industrial triangle,
Kahuta Road,
Islamabad

Texpami Capsule
Each capsule contains
Pamidronate as disodium
USP ..100 mg
(bone Resorption Inhibitor)

Form 5
19-05-2010
Rs 8000 + 12000
10s as per SRO

Not confirmed
Aminomux Cap 100mg by M/s
Seignior
A compliance report was asked to
be submitted for follow up
inspection. (13-02-14)

Finished product
specifications are
Manufacturer

Firm has not given international


availability. It is required as it is part
of Form 5. Firm has replied
reference of argentina.
Latest satisfactory GMP inspection
report is required. A compliance
report was asked to be submitted for
follow up inspection. (13-02-14)
M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.

Zincasa Syrup 10 mg/ 5 ml


Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc10 mg
Antidiarrheal
Finished Product

Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC

Me too Zegen Syrup 10 mg/5ml by


Genera
International available in India,
China, Bangladesh
According to inspection report dated
10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.

Specifications are
Manufacturer

M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.

International availability in SRAs


not confirmed. USP mentions the
formulation as Oral Solution with
pH of 2.5to 4.5 while Manuf. Spec.s
for this formulation has pH of 5 to
6.

Mclevo Infusion 250mg

Form 5

Each 100 ml contains

21-07-2010

FDA has not approved strength of


2.5mg/ml. FDA approved 5ml/ml
with Dextrose5%.

Levofloxacin USP 250 mg

Dy. No. 1371

Firm has not submitted undertaking

Broad Spectrum
Antibacterial Agent

Rs. 8000 + 12000

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.

Finished Product
Specifications are
Manufacturer

Rs 500

International: FDA
approved 2.5 mg/ml

has

not

Local: Bexus Inf 250mg/100ml by


M/s Shaigan
M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.

M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.

Mclevo Infusion 250mg

Form 5

Firm has not submitted undertaking

Each 50 ml contains

21-07-2010

Levofloxacin 250 mg

Dy. No. 1371

Broad Spectrum
Antibacterial Agent

Rs. 8000 + 12000

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.
International:
250mg/50 ml (FDA)

Levaquine

Finished Product
Specifications are
Manufacturer

Rs 400/ 50 ml

Mclevo Infusion 750mg

Form 5

Firm has not submitted undertaking

Each 100 ml contains

21-07-2010

Levofloxacin 750 mg

Dy. No. 1371

Broad Spectrum
Antibacterial Agent

Rs. 8000 + 12000

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.

Finished Product
Specifications are

Local: Xeflox Inf 250mg/50ml by


M/s Helix

International: FDA
approved 7.5 mg/ml
Rs 800/ 100 ml

has

not

Manufacturer
M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.

M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.

Local: Bexus Inf 750mg/100ml by


M/s Shaigan

Mclevo Infusion 500mg

Form 5

Firm has not submitted undertaking

Each 20 ml contains

21-07-2010

Levofloxacin 500 mg

Dy. No. 1373

Broad Spectrum
Antibacterial Agent

Rs. 8000 + 12000

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.
International:
500mg/20 ml (FDA)

Finished Product
Specifications are
Manufacturer

Rs 500/ 20 ml

Kirin Tablet

Form 5

Each film coated tablet


contains

30-08-2010

Aliskirin hemifumarate
MS150 mg
Hydrochlorothiazide USP
..12.5 mg

Dy. No. 191


Rs. 8000
As per PRC
1 14s

Non peptide, direct rennin


inhibitor

Local: Me
confirmation

too

Levaquine
status

needs

Me too Co-Kiren Tablet by Tabros


Pharma
International Tekturna HCT tablet
(USA)
According to inspection report dated
10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.
Firm has not submitted undertaking.

Finished Product
Specifications are
Manufacturer
M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.

Mimin Tablet 200 mg

Form 5

Me too Xerifax Tablet 200 mg

Each film coated tablet


contains

30-08-2010

International Xifaxan Tablet 200


mg (FDA)

Rifaximin..200 mg
Non systemic Antibiotic

M/s Macter
International (Pvt.)

Dy. No. 196


Rs. 8000
As per PRC

Finished Product
Specifications are
Manufacturer

1 10s

Mirin Capsule 50 mg

Form 5

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.
Firm has not submitted undertaking.

Me too Diora Capsule 50 mg by

Limited.

Each capsule contains

30-08-2010

Getz

F-216, S.I.T.E.,
Karachi.

Diacerein MS ..50 mg

Dy. No. 198

Antirheumatics/ Pain
Management

Rs. 8000 + 12000

International Diacerein Capsule 50


mg available in India. EMA
approved Diacerein for rare disease
(epidermolysis bullosa).

As per PRC

Finished Product
Specifications are
Manufacturer

According to inspection report dated


10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.
Firm has not submitted undertaking.
Firm has given assay limit for
finished product as 288-368
mg/capsule.
Firm has given assay for tablets
while applied product is capsule.

M/s Macter
International (Pvt.)
Limited.

Micam Injection 8 mg

Form 5

Each vial contains

30-08-2010

F-216, S.I.T.E.,
Karachi.

Lornoxicam.8 mg

Dy. No. 200

Analgesic & Anti


inflammatory

Rs. 8000 + 12000


As per PRC

Finished Product
Specifications are

Firm has not provided reference to


specifications of finished product.
Firm has written Glenmark as
reference to specifications of active
raw material for description,
identification, solubility and Aydin/
Turkey for assay of active raw
material.
QC tests for injections have not
been provided.
Me too Xefast tablet 8 mg by
PharmEvo
International Xefo powder for
injection 8 mg (EMA)

-do-

Zincasa DS Syrup 20 mg/ 5


ml
Each 5 ml contains
Zinc Sulphate Monohydrate
USP eq to elemental
Zinc20 mg
Antidiarrheal
Finished Product

Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC

Me too Zegen Syrup 10 mg/5ml by


Genera
International available in India,
China, Bangladesh
According to inspection report dated
10-04-2014, firm was considered to
be operating at satisfactory level of
compliance with GMP guidelines.

Specifications are
Manufacturer

M/s Pharmatec
Pakistan (Pvt.) Ltd.
D- 86/A., S.I.T.E.,
Karachi.

International availability in SRAs


not confirmed. USP mentions the
formulation as Oral Solution with
pH of 2.5to 4.5 while Manuf. Spec.s
for this formulation has pH of 5 to
6.

Alptec 0.25mg Tablet

Form 5

Each tablet contains

31-05-2013

Alprazolam USP .0.25mg

Rs 60,000/-

Anxiolytic

3 10

According to inspection report dated


23-10- 2013, firm was considered to
be operating at good level of
compliance with GMP guidelines.

Form 5
09-06-2010
Rs 8000 + 12000
5s as per SRO

BNF: Avelox (Bayer)

Finished product
specifications are USP

M/s Benson
Pharmaceuticals.
Plot No 119, street
No 8, I-10/3,
Industrial area
Islamabad.

Moxi Tablet
Each film coated tablet
contains
Moxifloxacin (as
hydrochloride)
(USP...400mg
(Fluroquinolone)
(Manufacturers Spec.s)

International: Alprazolam 0.25mg


(FDA)
Me too: Alloram 0.25 mg by M/s
Global

Local: Morax tab 400mg by M/s


Global
Firm is operating at satisfactory
level of GMP compliance (15-0414)
Assay method had not been given in
Finished Product specifications.

-do-

Piclo Tablet
Each film coated tablet
contains
Piroxicam (as beta
cyclodextrin)20
mg
(NSAID)
(Manufacturers Spec.s)

Form 5
09-06-2010
Rs 8000 + 12000
5s as per SRO

BNF: Brexidol(Chiesi)
Local: Brexidol cap 20mg by M/s
Genome
Firm is operating at satisfactory
level of GMP compliance (15-0414)
Originators formulation is uncoated
while the Firm has applied Film
coated formulation.
Firm has not given active raw
material specifications.
Finished product specifications are
incomplete and without reference.
Assay, identification, dissolution

methods have not been provided.


M/s WnsFeild
Pharmaceuticals
Plot no. 122, Block B,
Phase V, Industrial
Estate, Hattar
-do-

-do-

-do-

-do-

Venlax tablet 37.5 mg


Each extended release film
coated tablet contains
Venlafaxine (as HCl)
..37.5 mg
(Anti depressant)
(B.P Spec.s)
Venlax tablet 75mg
Each extended release film
coated tablet contains
Venlafaxine (as HCl)
..75 mg
(Anti depressant)
(B.P Spec.s)

Form 5
04-08-2010
Rs 20,000/Pack of 20s
As fixed by Govt

BNF: Venlafaxine (Non-proprietary)

Form 5
04-08-2010
Rs 20,000/Pack of 2 7s
As fixed by Govt

BNF: Venlafaxine (Non-proprietary)

Venlax tablet
Each film coated tablet
contains
Venlafaxine (as HCl) (USP)
..50 mg
(Anti depressant)
(BP Spec.s)

Form 5
04-08-2010
Rs 20,000/Pack of 20s
As fixed by Govt

FDA: Venlafaxine (as HCl) by Teva

Artidoxin DS co-blister
Tablet
(i) 3Tablets of which Each
coblister tablet contains
Sulphadoxin USP ..
500mg
Pyrimethamine USP
..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate100mg
(Antimalarial)
Finished product
specifications are
(Manufacturers Spec.s)

Form 5
04-08-2010
Rs 20,000/2 10s tab
As fixed by Govt

International: Not confirmed.

Artidoxin co-blister Tablet


(i) 3Tablets of which Each
coblister tablet contains

Form 5
04-08-2010
Rs 20,000/-

Local: Zaxine (Araf Pharma)


Grant of GMP Certificate for Export
recommended (04-09-14)

Local: Zaxine (Araf Pharma)


Grant of GMP Certificate for Export
recommended (04-09-14)

Amfax (Amson)
Grant of GMP Certificate for Export
recommended (04-09-14)

Local:Fansi Plus (Wilshire)


Grant of GMP Certificate for Export
recommended (04-09-14)
International availability in SRAs
not confirmed. Firm has provided
reference from China.
For verification of Facility (Coblister Machine etc) Firm has
submitted that they possesses the
Chinese made blister machine
which has the capability of
blistering different size of tablets
together I to one blister. The machie
is convertible from Alu Alu to Alu
PVC and vice versa. The have given
undertaking that they will procure
the specific dye for the purpose if
the product is registered.
International: Not confirmed.
Local: Arteka of Hemis

-do-

M/s Qintar
Pharmaceuticals,
14-A P.S.I.E.,
Lahore road,
Sargodha

Sulphadoxin USP ..
500mg
Pyrimethamine USP
..25mg
(USP Spec.s)
(ii) 6Tablets of which Each
tablet contains
Artisunate50mg
(Antimalarial)
Finished product
specifications
are(Manufacturers Spec.s)

2 10s tab
As fixed by Govt

Winprid Tablet
Each film coated tablet
contains:Itopride HCl..50mg
Gastroprokinetic
(Manufacturers Spec.s)

Form 5
04-08-2010
Rs 20,000/1 10s tab
As fixed by Govt

HEMA Chewable (Sugar


Free) Tablets
Each chewable tablet
contains
Mecobalamin (J.P)500
mcg
(Co enzyme type vitamin
B12)
(Manufacturers Spec.s)

Form 5
27-03-2010
Rs 8000 + 12000
Rs 178 for 20s
Rs 267 for 30s
Rs 890 for 100s

Grant of GMP Certificate for Export


recommended (04-09-14)
International availability in SRAs
not confirmed. Firm has provided
reference from China.
Me-too status needs confirmation.
(Arteka of Hemis), Pricing of
formulation has been fixed in 19th
PRC.
For verification of Facility (Coblister Machine etc) Firm has
submitted that they possesses the
Chinese made blister machine
which has the capability of
blistering different size of tablets
together I to one blister. The machie
is convertible from Alu Alu to Alu
PVC and vice versa. The have given
undertaking that they will procure
the specific dye for the purpose if
the product is registered.
International: Ganaton
Local:Ganaton (Abbot)
Grant of GMP Certificate for Export
recommended (04-09-14)
Formulation is under review by the
review committee.
International: Not confirmed
Local: Hicobal 500mcg by M/s
Himont
Renewal of DML recommended
(08-10-12)
International
availability
not
confirmed in SRAs. Firm has given
reference
of
international
availability from India.
Formulation given is not of
chewable Tablets

Latest inspection report is required.

-do-

Gexin Tablets
Each film coated tablet
contains:-

Form 5
27-03-2010
Rs 8000 + 12000

International: FDA Factive


Local: Actigem tab 320mg by M/s
Ferozsons

Gemifloxacin as
mesylate 320 mg
(Fluroquinolone)

Rs 625 for 7s
Renewal of DML recommended
(08-10-12)

(Manufacturers Spec.s)

-do-

-do-

-do-

M/s Nenza
Pharmaceuticals, Plot
No. 33 A, Phase- V,
Industrial Estate,
Hayatabad, Peshawar.

Latest inspection report is required.

Smart XR Tablets
Each film coated XR tablet
contains
Fexofenadine HCL (USP)
as immediate Layer..60
mg
Pseudoephedrine HCL
(USP) as extended
release.. 120 mg
(Histamine H1 receptor
antagonist & adrenergic
vasoconstrictor)
Finished product
specifications are USP

Form 5
27-03-2010
Rs 8000 + 12000
Rs 120 for 10s

Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin.. ..5mg
(Hypolipidaemics)
(Manufacturers Spec.s)

Form 5
27-03-2010
Rs 8000 + 12000
Rs 100 for 10s

Rovax Tablet
Each film coated tablet
contains
Rosuvastatin Calcium eq to
Rosuvastatin..
..10mg
(Hypolipidaemics)
(Manufacturers Spec.s)
Flotin Tablet 20 mg
Each tablet contains
Fluoxetin HCl USP eq to
Fluoxetin.
20 mg
(Antidepressant)

Form 5
27-03-2010
Rs 8000 + 12000
Rs 180 for 10s

Finished product
specifications are
Manufacturer

International:

ALLEGRA-D 12 HOUR
ALLERGY AND CONGESTION (Sanofi)

Local: Fexet D by M/s Getz


Renewal of DML recommended
(08-10-12)
Formulations is specialized dosage
form, Product specific inspection
may be carried out for the product
for verification of facility etc.
Confirmation of section is required.
Latest inspection report is required.
BNF: Crestor (AstraZeneca)
Local: Rast 5mg by M/s Tabros
Renewal of DML recommended
(08-10-12)
Latest inspection report is required.
BNF: Crestor (AstraZeneca)
Local: Rast 5mg by M/s Tabros
Renewal of DML recommended
(08-10-12)

Form 5
15-07-2010
8000 + 12000
As fixed by govt
1 10 pack

Latest inspection report is required.


Me too Floxac tablet 20 mg by
Schazo
International Selfemra tablet 20
mg (FDA)
No conclusion regarding GMP of
the Firm, some minor observations
at which the management was
agreed to rectify. (routine GMP 1004-2014)

M/s Genix Pharma


(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road, Karachi.

Triptan Tablet
Each film coated tablet
contains
Frovatriptan (as Succinate
monohydrate).. 2.5 mg
Anti migraine
Finished product
specifications are
Manufacturer.

Form 5 D
10-08-2010(52)
Rs 15000/-+ Rs.
12000/- (21-0513)+Rs. 23000/- 2111-2014
Rs. 200 per tablet
Pack of 10s for Rs
2000/-

International: Frova Tablet 2.5 mg


(FDA)
Local: Form 5-D
Good GMP (30-04-2014)
Verification of copy of Rs.12000/fee challan is required.
No authentic reference to clinical
use & doses given in clinical part of
dossier
Stability studies conducted under
Zone IV A conditions as per ICH/
WHO guidelines, Clinical data/
clinical trials are required.

M/s Genix Pharma


(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road, Karachi.

Eltram Tablet
Each film coated tablet
contains
Eltrambopag (as olamine)
.. 50 mg
Haematopoietic
Finished product
specifications are
Manufacturer.

Form 5-D
10-08-2010
Rs 15000/-+ Rs.
12000/- (21-05-13)
Rs. 200 per tablet
Pack of 10s for Rs
2000/Pack of 20s for Rs
4000/-

Reference of specifications/testing
methods of finished product is
required.
International: Promacta Tablet 50
mg (FDA)
Local:
Good GMP (30-04-2014)
Verification of copy of Rs.12000/fee challan is required.
Firm has requested to change Form
5-D to Form 5 as at the time of
initial application, the product was
new but now it has become me-too.
Form 5 is required.

M/s Genix Pharma


(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road, Karachi.

Eltram Tablet
Each film coated tablet
contains
Eltrambopag (as olamine)
.. 25 mg
Haematopoietic
Finished product
specifications are
Manufacturer.

Form 5 D
10-08-2010
Rs 15000/-/-+ Rs.
12000/- (21-05-13)
Rs. 150 per tablet
Pack of 10s for Rs
1500/Pack of 20s for Rs
3000/-

Evidence of Me-too status is


required.
International: Promacta Tablet 50
mg (FDA)
Local:
Good GMP (30-04-2014)
Verification of copy of Rs.12000/fee challan is required.
Firm has requested to change Form
5-D to Form 5 as at the time of

initial application, the product was


new but now it has become me-too.
Form 5 is required.

M/s Genix Pharma


(Pvt.) Ltd.
44, 45- B, Korangi
Creek Road, Karachi.

Art-M Tablet
Each tablet contains
Artesunate .60 mg
Pyronaridine Phosphate eq
to Pyronaridine180 mg
Anti malarial
Finished product
specifications are
Manufacturer.

Form 5 D
10-08-2010(52)
Rs 15000/-+ Rs.
12000/- (21-0513)+Rs. 23000/- 2111-2014
Rs. 300 per tablet
Pack of 10s for Rs
3000/Pack of 20s for Rs
6000/Pack of 30s for Rs
9000/-

Evidence of
required.
International:

Me-too

status

is

Local: Form 5-D


Good GMP (30-04-2014)
Verification of copy of Rs.12000/fee challan is required.
No authentic reference to clinical
use & doses given in clinical part of
dossier
Stability studies conducted under
Zone IV A conditions as per ICH/
WHO guidelines, Clinical data/
clinical trials are required.
Reference of specifications/testing
methods of finished product is
required.

M/s Helix Pharma


(Pvt) Ltd., Hakimsons
House, A/ 56,
S.I.T.E., Karachi

M/s AGP (Private)


Limited.
B-23, S.I.T.E.,
Karachi

Primavera/ Omni Plus/


Ristor/ Omnita Omitag/
OSB Capsule
Each capsule contains
Omeprazole..20mg
Sodium Bicarbonate
.110mg
Proton Pump Inhibitor &
Antacid
(Manufacturers Spec.s)
Maxna Injection
Each ml contains
Tranexamic acid BP
.100mg
Anti Fibrinolytic Agent
Finished product
specifications are BP

Form 5
30-08-2010
Dy No 203
Rs 8000+Rs. 12000/(22-07-13)
MRP of 10 capsules
as per PRC

Form 5
30-08-2010
Rs. 8000 + 12000
As fixed by DPC
5 10 ml ampoules

Evidence of Availability in Stringent


SRAs is required.
International: Zegerid (FDA)
Local: Rapid (global)
Satisfactory GMP compliance (1108-14)
Verification of copy of Rs.12000/fee challan is required.

International:
Local:
Satisfactory GMP compliance (2611-13)
Verification of copy of fee challans
is required.
Verification of TOC analyzer &
liquid particle counter is required.
Confirmation of Me too status in

1g/10ml is required.

M/s Bloom
pharmaceuticals (Pvt)
Ltd. Phase I & II
Industrial Estate,
Hattar

Surfen Plus Tablet


Each film coated tablet
Contains:
Hyoscine N
Butylbromide BP..
10 mg
Paracetamol BP
500mg
Anticholinergic &
Analgesic

Form 5
05-08-2010
Rs 20,000/10 10s tab
As per SRO

Amalar Suspension
Each 5 ml contains
Artemether..15mg
Lumefantrine..90mg
Antimalarial

Form 5
05-08-2010
Rs 20,000/As per SRO
30 ml & 60 ml

Finished product
specifications are
Manufacturer.

Rogen
Pharmaceuticals.

Olirag 10 mg Tablet
Each film coated tablet

Local: Buscopan Plus Tablets


NO conclusion , routine GMP
inspection , Shortcomings have
been improved (25-07-14)
International availability has not
been written. It is required as it is
part of Form 5.
Reference to finished product
specifications has been given as B.P
while the formulation is not
included in B.P.

(B.P Spec.s)

M/s Bloom
Pharmaceuticals (Pvt)
Ltd. Phase
I & II Industrial
Estate, Hattar

Letter of approval of injection


section is required. Inspection report
dated
26-09-2012
mentions
Injectable (Antibiotic, Analgesic,
Spasmolytics etc) Section.
International:

Form 5

Undertaking on desired format has


not been submitted.
International:
Local: Buscopan Plus Tablets
NO conclusion , routine GMP
inspection , Shortcomings have
been improved (25-07-14)
Firm has written that we will
surrender our already registered
product Benol Capsule Reg No.
022525 in case of fast track
registration of our this product
Amalar
Suspension.
No
clarification has been given in reply.
International availability has not
been written. It is required as it is
part of Form 5.
Active raw material specifications
have been given as B.P while these
are not included in B.P.
Undertaking on desired format has
not been submitted.
International: Olanzapine 52 mg
(FDA)

Plot No. 30, St No. S4


National Industrial
Zone (RCCI), Rawat,
Islamabad.

contains:

19-07-2010

Olanzapine 10 mg

20,000

(Tranquilizers, Sedative,
Hypnotics)

As per SRO for 10s

Me too: Amprex tablet 5 mg by


Amarant
The firm has rectified the shortcomings conveyed to him.

USP Specifications
Rogen
Pharmaceuticals.

Olirag 5 mg Tablet

Form 5

Each tablet contains:

19-07-2010

Olanzapine 5 mg

20,000

National Industrial
Zone (RCCI), Rawat,
Islamabad.

(Tranquilizers, Sedative,
Hypnotics)

As per SRO for 10s

Rogen
Pharmaceuticals.

Rocep 250 mg Capsule

Form 5

Each capsule contains:

19-07-2010

Ciprofloxacin HCL USP


250 mg

20,000

Plot No. 30, St No. S4

Plot No. 30, St No. S4


National Industrial
Zone (RCCI), Rawat,
Islamabad.

Rogen
Pharmaceuticals.
Plot No. 30, St No. S4
National Industrial
Zone (RCCI), Rawat,
Islamabad.

Rogen
Pharmaceuticals.
Plot No. 30, St No. S4

International: Olanzapine 5 mg
(FDA)
Me too: Amprex tablet 5 mg by
Amarant

USP Specifications
International: Not approved by
reference DRAs
Local: Ciprocin cap 250mg by M/s
Miracle

As per SRO for 10s

(Quinolone)
Finished product
specifications are
Manufacturer
Rocep 500 mg Capsule

Form 5

Each capsule contains:

19-07-2010

Ciprofloxacin HCL 500


mg

20,000

International: Not approved by


reference DRAs
Local: Ciprocin cap 250mg by M/s
Miracle

As per SRO for 10s

(Quinolone)
Finished product
specifications are
Manufacturer
Sulrog Tablet 25 mg

Form 5

Each tablet contains:

19-07-2010

International: Not approved by


reference DRAs
Local: levopraid tablet 25mg by

National Industrial
Zone (RCCI), Rawat,
Islamabad.

Levosulpride 25 mg

20,000

(Antidepressant/
Gastroprokinetic)

As per SRO for 20s

M/s Pacific

Finished product
specifications are
Manufacturer
Rogen
Pharmaceuticals.

Sulrog Tablet 50 mg

Form 5

Each tablet contains:

19-07-2010

Levosulpride 50 mg

20,000

National Industrial
Zone (RCCI), Rawat,
Islamabad.

(Antidepressant/
Gastroprokinetic)

As per SRO for 20s

Rogen
Pharmaceuticals.

Sulrog Tablet 100 mg

Form 5

Each tablet contains:

19-07-2010

Levosulpride 100 mg

20,000

National Industrial
Zone (RCCI), Rawat,
Islamabad.

(Antidepressant/
Gastroprokinetic)

As per SRO for 20s

Rogen
Pharmaceuticals.

Mecrogen 500 mcg Tablet

Form 5

Each film coated tablet


contains

19-07-2010

Plot No. 30, St No. S4

Plot No. 30, St No. S4

Plot No. 30, St No. S4


National Industrial
Zone (RCCI), Rawat,
Islamabad.

International: Not approved by


reference DRAs
Local: levopraid tablet 50mg by
M/s Pacific

Finished product
specifications are
Manufacturer.
International: Not approved by
reference DRAs
Local: levopraid tablet 100mg by
M/s Pacific

Finished product
specifications are
Manufacturer

Macobalamin..500
mcg
Vitamin B12
Finished product
specifications are
Manufacturer

20,000
As per SRO for 30s

International: Methycobal tablet


(Japan)
Local: levopraid tablet 100mg by
M/s Pacific

Evaluator II
Applications of impot checked by Evaluator IV
S.N
o

Name and address of


manufacturer
/
Applicant

Brand Name
(Proprietary
name
+
Dosage Form + Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary

Remarks on the formulation (if


any) including
International
status
in
stringent
drug
regulatory agencies / authorities
Me-too status

Pharmacological Group
Finished
Specification

M/s. Novartis Pharma


(Pvt) Ltd, Karachi. /
Product License
Holder:M/s. Novartis Pharma
Schweiz Ltd
Monbijoustrasse
Bern, Switzerland.
Manufacturing Site:M/s. Novartis Pharma
SAS, rue la Chapelle,
Huningue, France.

product

Sebivo Oral Solution


20mg/ml
Each ml of oral solution
contains: Telbivudine20mg
(Hepatitis B)

Demanded Price /
Pack size

GMP status as depicted in latest


inspection report (with date) by
the Evaluator

Form 5-A

FDA: Tyzeka (Novartis)

11-11-2009
Diary No. 659
Rs.15000/12-02-2014
Rs.35000/Total Rs.50,000/-

New Application

Demanded Price/Pack
Size Rs.3915/300ml

N/A
Following objections were raised on
the applications:

1. Firm has not provided Studies


like
process
validation,
pharmaceutical
development
studies, validation of analytical
methods.
2.Firm
has
not
provided
chromatographs for sample and
reference of active ingredient,
benzoic
acid,
degradation
products in analytical procedures
and stability studies.
3.Clinical trial data/ clinical data
Firm had objected on these
observations
and
regarding
limited time period provided for
reply of these objections but now
has submitted the reply of these
observations.
Assessment of reply reveals that
the Firm has not submitted the
validation reports regarding
process and analytical methods
in a prescribed manner viz.

without contents like specificity ,


linearity, precision, accuracy,
limit of detection, Range ,
Robustness etc. Further, the Firm
has also not submitted the
chromatograms of sample and
standard of :
(i)
API
(ii)
Benzoic Acid
(iii)
Degradation products.
Applicant:
M/s. Mehran Dental,
Karachi.
M No. Al Noor
Centre Randle Road,
ADJ-ANKLE Seria
Hospital, Karachi
Manufacturer:
M/s.
Laboratorios
Zeyco S.A. DE C.V.
CAMINO A SANTA
ANA TEPETITLAN
NO. 2230 COLONIA
SANTA
ANA
TEPETITLAN 45230
ZAPOPAN
JALISCO, Mexico.

FD Injection IV
Each 1.8ml ampoule
contains: Lidocaine HCl36.0mg
Epinephrine0.018mg
Local Anesthetic
/Adrenergic agonist

Applicant:
M/s.
Haroon
Brothers,
1/
A,
Karimjee
Building,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.

Mydriaticum Stulln UD
Eye Drops
Each ml contains: Tropicamide Ph. Eur. .
5mg
Ophthalmic Preparation /
Mydriatic & Cycloplegic

Manufacturer:
M/s. Pharma Stulln
GmbH Werksstrasse

Finished product
specifications are

Finished product
specifications are USP

Form 5-A
17-02-2009
Diary
No.153
Rs.15000/18-06-2013
Rs.85000/Rs.1200 /
1 x 10 cartridge in
each blister
Total 5 blister in
packet
Total 50 Pieces of
cartridges in Packet

Form 5-A
30-04-2009
Rs.15000 + Rs.85000
=
Rs.100000/
Rs.30/ Per Vial
(0.4ml), depending on
pack size

International:
Local:
Sole agency agreement has been
expired.
GMP certificate of manufacturer has
been expired.
Firm has not provided original &
legalized
Certificate
of
Pharmaceutical
Product
with
english translation.
Firm has not provided long term
stability studies under zone IV A
conditions
are
ICH/
WHO
guidelines.
Chromatograms
in
analytical methods & stability
studies have not been provided
along with data.
Firm gave reference of USP for
finished product specifications
while given assay method is not as
same as given in USP 35.
Firm has not provided active raw
material specifications.
Firm has not provided specifications
of primary packaging material
(glass vial).
Undertaking on desired format has
not been submitted.
Reply of the Firm needs further
evaluation.

3, D-92551 Stulln,
Germany.
Applicant:
M/s.
Haroon
Brothers,
1/
A,
Karimjee
Building,
Opposite HBL Napier
Rd Branch, Near
Denso Hall,
Karachi.
Manufacturer:
M/s.
Penta
Arzneimittel GmbH
Werksstrasse
3,
Germany.

Blupan UD Eye Drops


Each ml contains: Sodium
Hyaluronate Ph. Eur.
1.5057mg
Dexpanthenol (Vitamin B5)
USP.20.0000 mg
Ophthalmic Preparation
Finished product
specifications are

Form 5-A
30-04-2009
Rs.15000 + Rs.85000
=
Rs.100000/
Rs.36/
per
vial
(0.5ml)

Reply of the Firm needs further


evaluation.

Evaluator III
S/
N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary
name
+
Dosage Form + Strength)
Composition
Pharmacological Group
Finished
Specification

M/s
Atco
Laboratories
(Pvt)
Limited
Karachi.

product

Type
Form

of

Initial
diary

date,

Fee including
differential
fee

Remarks on the
formulation
(if
any)
including
International
status in stringent
drug
regulatory
agencies
/
authorities

Me-too status
Demanded
Price / Pack GMP status as
size
depicted in latest
inspection report
(with date) by the
Evaluator

ADVOCORT
Ointment 0.1%

Fatty Form-5

Each gram contains:


Methylprednisolone
aceponate.1mg

Dy. No: 126


dated
14th
October 2010
8,000/-

Advantan
Fatty
Ointment of CSL
Limited
(TGA
Approved)
Advantan of Bayer
Pakistan Karachi.

Synthetic corticosteroid
Manufacturer

-do-

ADVOCORT
0.1%

Ointment

Each gram contains:


Methylprednisolone
aceponate.1mg

Rs. 95/- per


5gm tube
Rs. 176/- per
10gm tube
Rs. 250/- per
15gm tube
Form-5

Inspection of the
firm was conducted
on 18-06-14 by the
area FID and GMP
Compliance
was
found good.
Advantan Ointment
of CSL Limited
(TGA Approved)

Dy. No: 125


dated
14th
October 2010 Advantan of Bayer
Pakistan Karachi
8,000/-

Synthetic corticosteroid
Manufacturer

Recommendations by the
Evaluator

Rs. 95/- per


5gm tube
Rs. 176/- per
10gm tube
Rs. 250/- per
15gm tube

Firm has submitted that they


are in process of establishing
the steroidal section facility.
The firm has also submitted
letter regarding approval of
proposed layout plan for
Ointment (Steroid) and Oral
Liquid Section (General).

-do-

ADVOCORT Lotion 0.1%

Form-5D

Each ml contains:
Methylprednisolone
aceponate.1mg

Dy. No: 127


dated
14th
October 2010

Synthetic corticosteroid

15,000/- dated
14-10-10
35000/- dated
05-12-13

Manufacturer

M/s
Linear
Pharma, Rawat
Islamabad.

PYRETIC
Effervescent
Tablets 500mg
Each tablet contains:
Paracetamol.500mg
Analgesic/ Antipyretic
Manufacturer

Rs.
225/30ml
Rs. 330/- per
60ml
Form-5
06-10-2010
Dy. No.9220
8,000/28-02-2014
Dy. No.595
12000/As per SRO/
Pack of 100s

-do-

MEFQUINE Tablets 250mg

Form-5

Each tablet contains:


Mefloquine
Hydrochloride..250mg

06-10-2010
Dy. No.9226
8,000/-

Antimalarial

28-02-2014
Dy. No.594
12000/-

Manufacturer

As per SRO/
Pack of 25s

Advantan Lotion of a. Stability studies needs to


CSL Limited (TGA
be submitted as per ICH/
Approved)
WHO guidelines.
b. Clinical trial data is
Inspection of the
required along with clinical
firm was conducted
justification.
on 18-06-14 by the
area FID and GMP
Compliance
was
found good.

Paracetamol
effervescent tablet
of Accord Health
Care UK.
Acetosol of Shigan
Pharma Islamabad.
Inspection of the
firm was conducted
by the area FID on
13-11-14 and the
was complying the
GMP
Lariam Tablet of
Roche UK
Meflogen
of
Genome
Pharmaceuticals

-do-

PENTO Capsule 40mg

Form-5

Each capsule contains:


Pentoprazole sodium 22.5
% pellets equivalent to
Pantoprazole..40mg

06-10-2010
Dy. No.9226
8,000/-

Not available
SRAs

in

Pentoloc of Aeries
Pharma

28-02-2014
Dy. No.596
12000/-

PPI
Manufacturer

M/s
Innvotek
Pharmaceuticals
Islamabad.

Source:
Vision
Pharmaceuticals Islamabad.
LETRO Tablets
Each film coated tablet
contains:
Letrozole2.5mg
Non steroidal
Inhibitor

As per SRO/
Pack of 14s
Form-5

Femara of Novartis

Dy. No: 1037/


20-10-10

Femara of Novartis
Karachi

20,000/-

Inspection of the
firm was conducted
on 04-07-14 by the
area FID and GMP
compliance
was
found satisfactory.

aromatase
As per PRC/
Pack of 10s

USP

-do-

M/s
Fedro
Pharmaceutical
Labs. Peshawar

MILTEFO Capsules

Form-5

Each capsule contains:


Miltefosine..50mg

Dy. No: 1036/


20-10-10

Antiprotozoal

20,000/-

Manufacturer

As per PRC/
Pack of 8x7s

RANIDOL Tablets 150mg

Form-5

Each film coated tablet


contains:
Ranitidine
as
hydrochloride150mg

20-09-2010
Dy. No. 1148

H2 Blocker

As per SRO
1x10s

BP

20,000/-

Impavido of Knight
Theraps (USFDA)
Fosin Capsules of
Nimral Labs

Ranitidine tablets a. Evidence of approval of


of
Aurobindo
section
from
Drug
Pharma.
Licensing division is not
submitted.
Zantac of GSK
b. Inspection of the Firm was
conducted by the area FID
on 23-07-14 and certain
shortcomings were found,
which are discussed with
the management of which
they agreed to rectify.
(drainage line found not
cleaned properly in tablet

section, three blistering


and
one
stripping
machines found kept in
one
room
without
segregation and advised to
provided partition and AC
facilities
to
control
temperature
and
humidity.)

-do-

RANIDOL Tablets 300mg

Form-5

Each film coated tablet


contains:
Ranitidine
as
hydrochloride300mg

20-09-2010
Dy. No. 1137

H2 Blocker

As per SRO
1x10s

Ranitidine tablets
of
Aurobindo
Pharma.
Zantac of GSK

20,000/-

BP
-do-

FEKAST Tablets 4mg

Form-5

Each film coated tablet


contains:
Montelukast as sodium
4mg

20-09-2010
Dy. No. 1138

Leukotriene
Antagonist
-do-

Receptor

Manufacturer
FEKAST Tablets 5mg

20,000/As per SRO


2x7s
Form-5

Each film coated tablet


contains:
Montelukast as sodium
5mg

20-09-2010
Dy. No. 1146

Leukotriene
Antagonist

As per SRO
2x7s

Manufacturer

Receptor

Not
found
in
SRAs,
(applied
strength
is
approved
as
chewable tablet.)
Me too status needs
confirmation

Not
found
in
SRAs,
applied
strength
is
approved
as
chewable tablet.

20,000/Me too status needs


confirmation

-do-

-do-

FEKAST Tablets 10mg

Form-5

Each film coated tablet


contains:
Montelukast as sodium
10mg

20-09-2010
Dy. No. 1143

Leukotriene
Antagonist

As per SRO
2x7s

Receptor

Manufacturer
FINFLEX-S Tablets 50mg

20,000/-

Form-5

Each enteric coated tablet 20-09-2010


contains:
Dy. No. 1147
Diclofenac
Sodium
BP.50mg
20,000/Antirehumatic
-do-

BP
FINFLEX-S Tablets 75mg

-do-

BP
FEDRACAM-BCD Tablets
20mg
Each tablet contains:
Piroxicam
as
Beta
Cyclodextrin20mg
NSAID

-do-

Manufacturer
CERIGEX-L Tablet 5mg

Aerokast of Barrett
& Hodgson (Pvt)
Limited Karachi

Voltral of Novartis
Fastaid of Platinum
Pharma Karachi

Master formulation submitted


is of film coated tablets
however applied product is
enteric coated.

As per SRO
2x10s
Form-5

Each enteric coated tablet 20-09-2010


contains:
Dy. No. 1142
Diclofenac
Sodium
BP.75mg
20,000/Antirehumatic

Motelukast
of
Accord Healthcare

Diclofenac sodium
of
Sandoz
(USFDA)

Master formulation submitted


is of film coated tablets
however applied product is
enteric coated.

Fastaid of Platinum
Pharma Karachi

As per SRO
2x10s
Form-5
20-09-2010
Dy. No. 1140

Brexidol of Chesi
(BNF)
Brexin of Chiesi
Karachi.

20,000/As per SRO


2x10s
Form-5

Each film coated tablet


contains:
Levocetirizine
as
dihydrochloride..5mg

20-09-2010
Dy. No. 1139

Antihistamine
Manufacturer

As per SRO
Pack of 10s

20,000/-

Levocetirizine
Actavis UK

of

Alergocit of Global
Pharma Islamabad.

Master formulation needs


rectification
regarding
quantity of API.

-do-

DI- METHER Tablets

Form-5

Each tablet contains:


Artemether 40mg
Lumefantrine.240mg

20-09-2010
Dy. No. 1145

WHO
recommended
Formulation
Artem DS of Hilton

20,000/Antimalarial
M/s
Asian
Continental (Pvt)
Limited, Karachi

USP (Salmus)
FEVEREN
Suspension

Plus

Each 5ml contains:


Paracetamol..250mg
Analgesic and Antipyretic
USP

As per SRO
Pack of 10s
Form-5
Dated: 08-102010
8,000/Dated: 31-072013
12000/As per SRO/
Pack of 1s
90ml bottle

-do-

ATIZA Syrup 2.5mg/ 5ml

Form-5

Each 5ml contains


Levocetirizine
dihydrochloride..2.5m
g

Dated: 12-102010
8,000/-

Antihistamine

Calpol
(BNF)

Plus

Calpol 6 Plus GSK


Karachi
Inspection of the
firm was conducted
on 09-09-14 by the
area
FID
and
concluded that the
firm is working at
acceptable level of
GMP compliance.
Xyzal Oral Solution
(USFDA)
T-Day of Novartis
Karachi

Dated: 31-072013
12000/-

Manufacturer

-do-

FEVEREN Tablet 500mg

As per SRO/
Pack of 1s
90ml bottle
Form-5

Panadol GSK USA

Each tablet contains:


Pracetamol500mg

Dy. No: 1916/


29-10-10

Panadol
Karachi

Analgesic

8,000/-

Manufacturer

As per PRC

GSK

-do-

FEVEREN
500mg

Extra

Tablet

Form-5
Dy. No: Not
provided

Each tablet contains:


Pracetamol500mg
Caffiene.65mg

Panadol Extra GSK


USA
Panadol Extra GSK
Karachi.

8,000/- dated
27-10-10

Analgesic
As per PRC
M/s
Linear
Pharma, Rawat
Islamabad

FACAL Tablet

Form-5

Each tablet contains:


Alfacalcidol.0.25mg

Dy. No: 9229


dated 06-1010

Elemental
Calcium..50mg

20,000/-

Vitamin D supplement

As per SRO/
Pack of 10s

Manufacturer
-do-

ALEND Tablets
Each tablet contains:
Alendronate
sodium..10mg

-do-

Form-5
as

Dy. No: 1139


dated 03-1110

Biphosphonates

20,000/-

Manufacturer

As per SRO/
Pack of 10s
Form-5

DOMELATE-C Tablet
Each tablet contains:
Domperidone
meleate.15mg
Cinnarizine25mg

as

Dy. No: 1148


dated 03-1110
20,000/-

Antidopaminergic/
Antihistamine
Manufacturer

As per SRO/
Pack
of
2x10s

Not available
SRAs

in

Me too status needs


confirmation.
Inspection of the
firm was conducted
by the area FID on
13-11-14 and the
was complying the
GMP
Alendronic acid of
Accord HealthCare
UK
Alendrate of Global
Pharma

Not available
SRAs

in

Me too status needs


confirmation

-do-

DIVAL Tablets

Form-5

Depakote of Abbive

Each delayed release tablet


contains:
Divalproex
sodium.500mg

Dy. No: 1147


dated 03-1110

Divarex of Medera
Pharma

20,000/Antiepileptic
USP
-do-

DIVAL Tablets
Each delayed release tablet
contains:
Divalproex
sodium.250mg

As per SRO/
Pack
of
10x10s
Form-5
Dy. No: 1146
dated 03-1110

Depakote of Abbive
Divarex of Medera
Pharma

20,000/Antiepileptic
USP
-do-

-do-

LINQUE Tablets

As per SRO/
Pack
of
10x10s
Form-5

Each film coated tablet


contains:
Quetiapine
Fumarate
equivalent
to
Quetiapine.200mg

Dy. No: 1151


dated 03-1110

Hypnotic

As per SRO/
Pack
of
3x10s
Form-5

LINQUE Tablets

of

Dequit of Shaheen
Pharma

20,000/-

Each film coated tablet


contains:
Quetiapine
Fumarate
equivalent
to
Quetiapine.400mg

Dy. No: 1150


dated 03-1110

Hypnotic

As per SRO/
Pack of 10s

Manufacturer

Seroquel
AstraZeneca
(USFDA)

20,000/-

Seroquel
AstraZeneca
(USFDA)

of

Dequit of Shaheen
Pharma

-do-

-do-

-do-

-do-

-do-

ALMOVAL Tablets

Form-5

Each film coated tablet


contains:
Amlodipine as besylate
5mg
Valsartan.80mg

Dy. No: 1142


dated 03-1110

Antihypertensive

As per SRO/
Pack of 14s

Exforge of Novartis
Karachi

20,000/-

Manufacturer
AMEASAID Tablets

Form-5

Each sugar coated tablet


contains:
Flurbiprofen.100mg

Dy. No: 1152


dated 03-1110

Antirheumatic

20,000/-

Manufacturer
ALDONATE Tablet

As per SRO/
Pack of 30s
Form-5

Each film coated tablet


contains:
Methyldopa.250mg

Dy. No: 1155


dated 03-1110

Antihypertensive

20,000/-

Manufacturer

As per SRO/
Pack of 100s

LINESTIN Tablet

Form-5

Each film coated tablet


contains:
Ebastine10mg

Dy. No: 1149


dated 03-1110

Antihistamine

20,000/-

L-FENAC Capsule

As per SRO/
Pack of 10s
Form-5

Each capsule contains:


Acitretin..10mg

Exforge of Novartis
(USFDA)

Dy. No: 1136


dated 03-1110

Vitamin A Derivative
20,000/-

Froben Tablet of
Abbot HealthCare
UK
Ansaid of
Karachi

Pfizer

Aldomet of Aspen
UK
Aldomet of MSD

Aerius
of
Dermagen Pharma
Islamabad

Acitretin Capsules
of
Genus
Pharmaceuticals
UK
Neotigason
Roche Karachi

of

-do-

-do-

-do-

TOLFERID Tablet

As per SRO/
Pack
of
3x10s
Form-5

Each film coated tablet


contains:
Tolterodine tartrate..2mg

Dy. No: 1153


dated 03-1110

Urinary antispasmodic

20,000/-

Manufacturer
OFLOX Tablet

As per SRO/
Pack of 28s
Form-5

Each film coated tablet


contains:
Ofloxacin200mg

Dy. No: 9221


dated 06-1010

Fluoroquinolone

20,000/-

Manufacturer

As per SRO/
Pack of 10s
Form-5

CITAL Tablet
Each
chewable
contains:
Escitalopram
oxalate10mg

tablet
as

Dy. No: 9228


dated 06-1010

Detrusitol Tablet of
Pfizer UK
Detrusitol Tablet of
Pfizer Karachi

Terivid of Sanofi
UK
Treivid of Sanofi
Karachi

Not available
SRAs

in

Me too status needs


confirmation

20,000/Antidepressant
-do-

Manufacturer
LEVRINE Tablets
Each film coated tablet
contains:
Alverine Citrate..60mg
Simethicone.300mg

As per SRO/
Pack of 10s
Form-5
Dy. No: 1140
dated 03-1110
20,000/-

Antispasmodic
Manufacturer

As per SRO/
Pack
of
2x10s

Not available
SRAs

in

Me too status needs


confirmation.

-do-

TAMSIN Capsule

Form-5

Each capsule contains:


Tamsulosin
HCL
as
modified release pellets
(0.2%)
equivalent
to
Tamsulosin0.4mg

Dy. No: 1154


dated 03-1110

Alpha-1 Blocker

As per SRO/
Pack of 10s

20,000/-

Flomax
MR
Capsules
of
Boehringer
Inghelheim UK
Tamsolin of Getz
Karachi

Manufacturer

-do-

Source:
Vision
Pharmaceuticals Islamabad
LINAKSAT Tablets
Each film coated tablet
contains:
Montelukast as sodium
10mg

Form-5

Singulair of MSD

Dy. No: 9222


dated 06-1010

Montiget of Getz
Karachi

20,000/Antihistamine
-do-

Manufacturer
GEMNILOX Tablets
Each film coated tablet
contains:
Gemifloxacin
as
mesylate..320mg

As per SRO/
Pack of 30s
Form-5
Dy. No: 1157
dated 03-1110

Factive of LG Life
Sciences (USFDA)
Factiflox of Envoy
Pharma

20,000/Quinolone
-do-

Manufacturer
LINPRIDE Tablets
Each tablet contains:
Amisulpride..50mg

As per SRO/
Pack of 7s
Form-5
Dy. No: 1141
dated 03-1110

Antipsycotic
20,000/Manufacturer
As per SRO/
Pack
of
2x10s

Solian Tablet
Solian Tablet
Sanofi Karachi

of

-do-

DOB-C Capsules

Form-5

Each capsule contains:


Calcium
dobisilate.500mg

Dy. No: 1138


dated 03-1110

Vasotherapeutic

20,000/-

M/s
Caraway ONDENLES Injection 8mg
Pharmaceuticals,
Islamabad.
Each ml contains:
Ondansetron hydrochloride
dihydrate equivalent to
Ondansetron2mg

As per SRO/
Pack
of
2x10s
Form-5
Dy. No: 9773
dated
18th
October 2010
20,000/-

5HT-3 Antagonist
As per SRO
USP

-do-

M/s
Pharma
Limited,
Karachi.

Genix
(Pvt)

Not available in
SRAs
Doxium
Karachi

of AGP

Zofran of GSK

a. Evidence of availability of
TOC and liquid particle
Zofran of GSK,
counter is not provided by
Karachi
the firm.
b. Latest inspection report is
The inspection of
required.
the
firm
was
conducted on 2409-12 by the panel
of inspectors and
they concluded that
the
firm
is
operating at good
level
of
GMP
compliance.

ONDENLES Tablet 8mg

Form-5

Each film coated tablet


contains:
Ondansetron hydrochloride
dihydrate equivalent to
Ondansetron8mg

Dy. No: 9774 Zofran of


dated
18th Karachi
October 2010

5HT-3 Antagonist

As per SRO

USP
GRANI Tablet

Form-5

Each film coated tablet


contains:
Granisetron HCL equivalent
to Granisetron.1mg

Latest inspection report is


required.

GSK,

20,000/-

Dy. No: 1899


dated 29-1010
8,000/-

Antiemetic
Manufacturer

Zofran of GSK

Rs.
3250/Pack of 10s
Rs.
6500/Pack of 20s

Kytril
Roche

Tablet

of

Kytril Tablets
Roche Karachi

of

Inspection of the
firm was conducted
on 30-04-14 by the
area FID and GMP
compliance is rated
as GOOD

-do-

GRANI Syrup

Form-5

Each 5ml contains:


Granisetron HCL equivalent
to Granisetron.1mg

Dy. No: 1907


dated 29-1010

Antiemetic

8,000/-

Manufacturer

Rs.
210/Pack of 30ml
Rs.
420/Pack of 60ml

Kytril
Roche

Syrup

of

Graniset Syrup of
SJ & G Fazul Elahi
Karachi

Evaluator III (Veterinary Cases)


S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

Initial
diary

date,

Demanded Price
/ Pack size

product

Remarks on the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities
Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

M/s
Noble
Pharma, Mirpur
Azad Kashmir

NOBI-LINCOL Powder

Form-5

Each 1gm contains:


Lincomycin
Sulphate..100mg
Colistin Sulphate
8,00,000IU

Dy. No: 05 dated


02-10-10

Manufacturer
TRIDOX-TD
Powder

20,000/Decontrolled/
100gm, 500gm
and 1kg

Antibacterial
-do-

Vety
Lincon
Powder of Leads
Pharma Karachi.

Oral

Each 1000gm contains:


Doxycycline HCL
200gm
Tylosin
Tartrate..100gm
Bromohexine
HCL..5ogm
Colistin
sulphate..48MIU

Form-5
Dy. No: 85 dated
08th
November
2010
20,000/Decontrolled/
100gm, 500gm,
and 1Kg

Pulmotin
Water
Soluble Powder of
Attabak Pharma
Islmabad.

Recommendations
the Evaluators

by

Evaluator III (Import applications)


S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

Initial
diary

date,

Demanded Price
/ Pack size

product

Remarks on the
formulation
(if
any)
including
International
status
in
stringent
drug
regulatory
agencies
/
authorities

Recommendations
the Evaluators

by

Me-too status
GMP status as
depicted in latest
inspection report
(with date) by the
Evaluator

Applicant
M/s Bajwa Sons,
129
Circular
Road,
Lohari
Lahore
Manufacturer
Shanghai
Transfusion
Technology Co.
Ltd.
Add: No.500 You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China

Famous Brand Single


Blood Bags

Form-5A
Dy No:
provided

Each 100ml of CPDA


(Citrate
Phosphate
Dextrose
Adenine
Solution, Anticoagulant)
contains:
Citric
acid
monohydrate0.299g
Sodium
citrate
dihydrate2.63g
Sodium
biphosphate
monohydrate0.222g
Dextrose
monohydrate..3.19g
Adenine.0.0275g
Water for Injection.Qs

Not

15000/- dated 0810-10


Rs 150/ Blood
Bag of 250ml
Rs 150/ Blood
Bag of 450ml
Rs 160/ Blood
Bag of 500ml

Disposable
Applicant
M/s Bajwa Sons,
129
Circular
Road,
Lohari
Lahore
Manufacturer
Shanghai
Transfusion
Technology Co.

Famous Brand Double


Blood Bags
Each 100ml of CPDA
(Citrate
Phosphate
Dextrose
Adenine
Solution, Anticoagulant)
contains:
Citric
acid
monohydrate0.299g

Form-5A
Dy No: 29 dated
08-10-10
15000/- dated 0810-10
Rs 300/ Blood
Bag of 450ml

a. Evidence of Balance fee


is not submitted.
b. Stability studies as per
Zone-IV-A conditions
as per ICH/ WHO
guidelines need to be
submitted.
c. Original Legalized and
valid COPP as per
WHO
format
or
original and legalized
GMP certificate along
with
Free
sale
certificate
from
regulatory body of
country of origin, needs
to be submitted.
d. Clinical trial data is not
submitted.
e. Packaging
material
specification are not
provided
a. Evidence of Balance fee
is not submitted.
b. Stability studies as per
Zone-IV-A conditions
as per ICH/ WHO
guidelines need to be
submitted.
c. Original Legalized and
valid COPP as per
WHO
format
or

Ltd.
Add: No.500 You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China

Sodium
citrate
dihydrate2.63g
Sodium
biphosphate
monohydrate0.222g
Dextrose
monohydrate..3.19g
Adenine.0.0275g
Water for Injection.Qs

Rs 315/ Blood
Bag of 500ml

Disposable
Applicant
M/s Bajwa Sons,
129
Circular
Road,
Lohari
Lahore
Manufacturer
Shanghai
Transfusion
Technology Co.
Ltd.
Add: No.500 You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China

Famous Brand
Blood Bags

triple

Each 100ml of CPD


(Citrate
Phosphate
Dextrose
Solution,
Anticoagulant)
contains:
Citric
acid
monohydrate0.299g
Sodium
citrate
dihydrate2.63g
Sodium
biphosphate
monohydrate0.222g
Dextrose
monohydrate..3.19g
Water for Injection.Qs
to 100ml

Form-5A
Dy No:
provided

Not

15000/- dated 0810-10


Rs 510/ Blood
Bag of 450ml
Rs 525/ Blood
Bag of 500ml

Each 100ml of SAGM


(Saline Adenine Glucose
Mannitol, Red Blood
Cell
Preservative)
contains:
Dextrose
monohydrate..0.900g
Sodium
chloride..0.877g
Adenine.0.0169g
D-Mannitol.0.525g
Water for Injection.qs
to 100ml
Applicant
M/s Bajwa Sons,
129
Circular
Road,
Lohari
Lahore

Disposable
Famous
Quadruple
Blood Bags

Brand
Double

Each 100ml of CPD

Form-5A
Dy No:
provided

Not

original and legalized


GMP certificate along
with
Free
sale
certificate
from
regulatory body of
country of origin, needs
to be submitted.
d. Clinical trial data is not
submitted.
e. Packaging
material
specification are not
provided
a. Evidence of Balance
fee is not submitted.
b. Stability studies as per
Zone-IV-A conditions
as per ICH/ WHO
guidelines need to be
submitted.
c. Original Legalized and
valid COPP as per
WHO
format
or
original and legalized
GMP certificate along
with
Free
sale
certificate
from
regulatory body of
country of origin,
needs to be submitted.
d. Clinical trial data is
not submitted.
e. Packaging
material
specification are not
provided

a. Evidence of Balance
fee is not submitted.
b. Stability studies as per
Zone-IV-A conditions
as per ICH/ WHO

Manufacturer
Shanghai
Transfusion
Technology Co.
Ltd.
Add: No.500 You
Dong
Road,
Minhang,
Shanghai,
201100, P.R of
China

(Citrate
Phosphate
Dextrose
Solution,
Anticoagulant)
contains:
Citric
acid
monohydrate0.299g
Sodium
citrate
dihydrate2.63g
Sodium
biphosphate
monohydrate0.222g
Dextrose
monohydrate..3.19g
Water for Injection.Qs
to 100ml
Each 100ml of SAGM
(Saline Adenine Glucose
Mannitol, Red Blood
Cell
Preservative)
contains:
Dextrose
monohydrate..0.900g
Sodium
chloride..0.877g
Adenine.0.0169g
D-Mannitol.0.525g
Water for Injection.qs
to 100ml
Disposable

15000/- dated 0810-10


Rs 440/ Blood
Bag of 450ml
Rs 445/ Blood
Bag of 500ml

guidelines need to be
submitted.
c. Original Legalized and
valid COPP as per
WHO
format
or
original and legalized
GMP certificate along
with
Free
sale
certificate
from
regulatory body of
country of origin,
needs to be submitted.
d. Clinical trial data is
not submitted.
e. Packaging
material
specification are not
provided

Case No.07.

Remaining drug registration applications of previously approved new sections


Evaluator I

M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in
244th meeting of Registration Board held on 8th and 9th May, 2014 due to confirmation of manufacturing
facility and that they are now under process of developing a dedicated Carbapenem facility and that the
04 deferred products may be considered of their approved manufacturing facility. The firm has requested
consideration of the following 04 products on priority basis (according to 10 products per section policy).
S.
N

Name and address


of Manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage form + Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary.

Pharmacological Group
Finished
specification

M/s.
Stallion
Pharmaceuticals (Pvt)
Ltd, 581- Sunder
Industrial
Estate,
Lahore
New License
1.Capsule.(Penicillin)
2.Dry
Powder
Suspension
(Penicillin)
3.Dry
Powder
Injection (Penicillin)

product

Me-too status
Demanded Price / Pack
size

Fluclox Injection 500mg

Form-5

Dry Powder Injection

27-10-2014
1336 R&I

Each vial contains:Flucloxacillin


Sodium
(B.P) eq. to Flucloxacillin
.. 500mg
(Penicillin)

International
status
in
stringent
regulatory
agencies

GMP status as
depicted
in
inspection
report (dated)
FLOXAPEN
Injection
500mg
MHRA UK

Rs. 20,000/Pack of one Rs. 90/Pack of 5 Rs. 450/Pack of 10 Rs. 900/-

A-FLOX
500mg
Injection
Laderly

BP Specifications
Vide letter No. F. 133/2009 Lic dated
6th February, 2014
-do-

N/A
(New
License)

Staclox Injection

Form-5

Dry Powder Injection

27-10-2014
1337 R&I

Each vial contains:Ampicillin Sodium (B.P)


eq.
to
Ampicillin
.. 250mg
Cloxacillin Sodium (B.P)

AMPICLOX
250/250mg
Injection
MHRA

Rs. 20,000/Pack of one Rs. 70/-

AMPICLOX
500mg
Injection

Remarks /
Observations

eq. to Cloxacillin 250mg

Pack of 5 Rs. 350/Pack of 10 Rs. 700/-

(Penicillin)

-do-

Manufacturers
Specifications
Flustal Injection
Dry Powder Injection
Each vial contains:Ampicillin Sodium (B.P)
eq.
to
Ampicillin
.. 250mg
Flucloxacillin
Sodium
(B.P) eq. to Flucloxacillin
250mg

Gsk
N/A
(New
License)

Form-5
27-10-2014
1338 R&I
Rs. 20,000/Pack of one Rs. 144/Pack of 5 Rs. 720/Pack of 10 Rs. 1440/-

FLUMOX
250/250mg Inj
EIPICO, Egypt
Biflocin
500mg Inj
Zam Zam Corp
N/A
(New
License)

(Penicillin)

-do-

Manufacturers
Specifications
Amoxi Injection 500mg
(BP)
Dry Powder Injection
Each Vial Contains:
Amoxicillin Sodium ( BP)
eq. to
Amoxicillin 500mg
(Penicillin)
BP Specifications

Form-5
25-10-2013
643 R&I

Amoxil 500 mg
Vial
MHRA

Rs. 20,000/-

Amoxil 500 mg
GSK, Pakistan

Rs. 90.0 / 1s,


Rs. 900.0 / 10s

N/A
(New
License)

1) Evidence of
approval of same
formulation
in
Egypt has been
provided instead
of
stringent
regulatory
authority
e.g.,
FDA,
TGA,
MHLW, EMA and
Health Canada.

Evaluator II
The Registration Board has been granting 10 products per section to newly approved sections. Following
are the remaining products of the applicants as per above policy.
S/
N

Name
and Brand Name
Type of Form
address
of
name
+ Initial date, diary
manufacturer / (Proprietary
Dosage Form + Strength)
Applicant
Fee including differential
Composition
fee
Pharmacological Group
Finished
Specification

M/s
Rogen
Pharmac
euticals
Plot No.
30 Street
No. # S4
National
Industria
l Zone
Rawat
Islamab
ad.
Semi
Solid
(Cream/
Ointmen
t)
General
Section
(No. F.
127/2009
-Lic
Dated
19-0710 )

product

Efrog 13.9%Cream
Each gram contains:Eflornithine (as eflornithine
Hydrochloride 139mg
(Enzyme Inhibitor)
(Manufacturers Spec.s)

Remarks on the formulation


any) including Internation
status
in
stringent
dr
regulatory agencies / authorit
Me-too status

Demanded Price / Pack


size

GMP status as depicted in lat


inspection report (with date)
the Evaluator

Form 5

BNF: Vaniqa (Almirall), but in


11.5% strength

26/11/2014 Dy. No. 1907


Rs. 20000/As per SRO

Vanika (Crystollite) 13.9 % ,


Depilus Cream (Atco) in 11.5%
strength but no pricing
The company may be issued
cGMP Certificate for export
purpose. (09-06-2014)

1.The product is available


11.5 % strength as p
BNF. In Pakistan product
available in both 13.9
and 11.5 % strengths b
pricing of 11.5 % streng
could not be traced. T
Firm has submitted mas
formulation
of
bo
strength after evaluation
initial dossier and h
requested to grant the
registration of any o
strength.

M/s
Faas
Pharmac
euticals
(Pvt.)
Limited
F-784/L
S.I.T.E.
Karachi

Antisec Sachet
Each Sachet contains:Racecadotril (B.P)10mg
(Anti-Diarrheal)
(Manufacturers Spec.s)

Form 5
29/10/2014 Dy. No. 117 Rs.
20000/As per SRO/110s

Sachet
Section:
F. 22/2009Lic
dated
15-022013
-do- Antisec Sachet
Each Sachet contains:Racecadotril (B.P)15mg
(Anti-Diarrheal)
(Manufacturers Spec.s)

BNF: Hidrasec (Abbott


Healthcare)
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)

1.Me-too
status
confirmation.

Form 5

Not confirmed

29/10/2014 Dy. No. 116 Rs.


20000/-

Not confirmed

As per SRO/110s

nee

Satisfactory level of GMP


compliance(18-03-14)

1.International availability
formulation in SRAs n
confirmed.
2.Me-too
status
nee
confirmation.
-do-

Antisec Sachet
Each Sachet contains:Racecadotril (B.P)30mg
(Anti-Diarrheal)
(Manufacturers Spec.s)

Form 5
29/10/2014 Dy. No. 115 Rs.
20000/As per SRO/110s

BNF: Hidrasec (Abbott


Healthcare)
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)

1.Me-too
status
confirmation.

nee

-do-

Uronol Sachet 3G
Each Sachet contains:Fosfomycin (as
Tromethamine 30gm
(Anti-bacterial)
(Manufacturers Spec.s)

Form 5
29/10/2014 Dy. No. 114 Rs.
20000/As per SRO/110s

Health Canada: Monurol (Triton


Pharma Inc.)
Not confirmed
Satisfactory level of GMP
compliance(18-03-14)

1.Me-too
status
confirmation.
-do-

Ostrolife Sachet
Each Sachet contains:Cholecalciferol (USP)
60,000IU
(Vitamin)
(Manufacturers Spec.s)

Form 5

Not confirmed

29/10/2014 Dy. No. 276 Rs.


20000/-

Not confirmed

As per SRO/110s

nee

Satisfactory level of GMP


compliance(18-03-14)

1.International availability
formulation in SRAs n
confirmed.
2.Me-too
status
nee
confirmation.
-do-

-do-

Oraltral Sachet (Orange


Flavor)
Each Sachet contains:Sodium Chloride3.5g
Sodium Citrate
Dihydrate2.9g
Potassium Chloride1.5
Glucose Anhydrous20g
(Electrolytes)
(Manufacturers Spec.s)

Oraltral Sachet (Lemon and


Lime Flavor)
Each Sachet contains:Sodium Chloride3.5g
Sodium Citrate
Dihydrate2.9g
Potassium Chloride1.5
Glucose Anhydrous20g
(Anti-Malarial)
(B.P Spec.s)

Form 5
29/10/2014 Dy. No. 271 Rs.
20000/As per SRO/120s

Not confirmed
Peditral (Searle)
Satisfactory level of GMP
compliance(18-03-14)

1.International availability
formulation in SRAs n
confirmed.
WH

Form 5
17/09/2014 Dy. No. 274 Rs.
20000/As per SRO/120s

formulation
is
sodiu
chloride 2.6 g, potassiu
chloride 1.5 g, sodium citr
2.9 g, anhydrous glucose 13
g
Not confirmed
Peditral (Searle)
Satisfactory level of GMP
compliance(18-03-14)

1.International availability
formulation in SRAs n
confirmed.
WH

-do-

Neomecta Sachet
Each Sachet contains:Dioctahedral Smectite
3000mg
(Anti-diarrhioeals)
(Manufacturers Spec.s)

Form 5
17/09/2014 Dy. No. 275 Rs.
20000/As per SRO/130s

formulation
is
sodiu
chloride 2.6 g, potassiu
chloride 1.5 g, sodium citr
2.9 g, anhydrous glucose 13
g.
Not confirmed
Smecta (Atco)
Satisfactory level of GMP
compliance(18-03-14)

1.International availability
formulation in SRAs n
confirmed.
-doCapsule
Section:
F. 22/2009Lic
dated
15-022013

Itometic Capsule
Each capsule contains:
Itopride hydrochloride
150mg
(as sustained release
pellets)
(Gastoprokinetic /
antiemetic)
(Manufacturers Spec.s)

Form 5
17/09/2014 Dy. No. 270 Rs.
20000/As per SRO/110s

Azobact Capsule 250mg


Each capsule contains:
Azithromycine (As
dihydrate) (USP)..250mg
(Anti-Infective)
(USP Spec.s)

Ganaton OD (Abbott)
Satisfactory level of GMP
compliance(18-03-14)

1.Formulation is under revie


by the Review Committe
2.Fee for import of pelle
Legalized Copy of Va
GMP
certificate
manufacturer of Pelle
stability studies accordi
to zone of Pakistan
Pellets are required.

(Source of Pellets:
M/s Titan Laboratories
Private Limited Plot No.
E27/1, E27/2, MIDC,
Mahad Village Jite District,
Raigad, Maharashtra, India)
-do-

Not confirmed

Form 5
17/09/2014 Dy. No. 266 Rs.
20000/As per SRO/110s

BNF : Zithromax (Pfizer)


Azomax (Novartis)
Satisfactory level of GMP
compliance(18-03-14)

-do-

-do-

Pirotrin 20mg Capsule


Each capsule contains:
Piroxicam beta
cyclodextrin eq. to
Piroxicam..20 mg
(Analgesic / antirheumatic/ anti pyretic)
(Manufacturers Spec.s)
Tamsol 0.4mg Capsule
Each capsule contains:Tamsulosin
hydrochloride(as
modified release pellets)
.0.4 mg
(Anti BPH)
(USP Spec.s)
{Source: M/s Vision
Pharmaceuticals, Plot No
224, Street No. 01, I-10/3
, Industrial area,
Islamabad}

Form 5
17/09/2014 Dy. No. 267 Rs.
20000/As per SRO/110s

Form 5
17/09/2014 Dy. No. 268 Rs.
20000/As per SRO/110s

BNF : Feldene (Pfizer)


Pirobet (Highnoon)
Satisfactory level of GMP
compliance(18-03-14)

BNF: Tamsulosin hydrochloride


(Non-proprietary)
Tamsolin (Getz)
Satisfactory level of GMP
compliance(18-03-14)

1.Certificate
of
Analys
stability studies accordi
to zone of Pakistan
Pellets are required.

Evaluator III
S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group
Finished
Specification

product

Initial
diary

date,

Demanded Price
/ Pack size

Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator

Recommendations by
the Evaluator

M/s
Wenovo
Pharmaceuticals,
Taxila
(Dry Powder
Injectable)

Vial

CLARITHREM
Injection
Each vial contains:
Clarithromycin
.500mg

Form-5
Dy No: 864 dated
24-09-2014
.

-do-

of

Mediate

As fixed by Govt.
Pack of 1s

BP
LANSOP Injection 30mg

Form-5

Each vial contains:


Lansoprazole30mg

Dy No: 863 dated


24-09-2014

PPI

20,000/-

Manufacturer

As fixed by Govt.
Pack of 1s
Form-5

PANTOWEN Injection
Each vial contains:
Pantoprazole
sodium..40mg

Clariset
Pharma

20,000/-

Macrolide
-do-

Klaricid of Abbott UK
(Lyophilized Powder)

as

Dy No: 862 dated


24-09-2014
20,000/-

Prevacid of Takeds
Pharm (USFDA)
Lyophilized Powder
Lansit of SJ & G Fazul
Elhahi Karachi

Protonix of Wyeth
(USFDA) Lyophilized
powder
Lesprot of Nabiqasim
Karachi

PPI
-do-

-do(Capsule General)

Manufacturer
AZINOV Injection

As fixed by Govt.
Pack of 1s
Form-5

Each vial contains:


Azithromycin.500mg

Dy No: 862 dated


24-09-2014

Macrolide

20,000/-

Manufacturer

As fixed by Govt.
Pack of 1s
Form-5

WENOLOX Capsule
Each capsule contains:
Duloxetine as HCL
enteric coated pellets
(17%)
eq.
to
Duloxetine..30mg
Antidepressant
Manufacturer
Source: Vision Pharma

Dy No: 1277
dated 24-10-2014
20,000/As per policy of
MOH
1x10s

Zithromax of Pfizer
(USFDA) Lyophilized
Powder
Azimycin of Medicina
Pharma Lahore

Cymbalta of EliLilly
Netherlands
Duxafit of Wnsfield
Hattar

Islamabad

-do-

WENOLOX Capsule

Form-5

Each capsule contains:


Duloxetine as HCL
enteric coated pellets
(17%)
eq.
to
Duloxetine..60mg

Dy No: 1276
dated 24-10-2014

Antidepressant

-do-

-do-

Cymbalta of Eli Lilly


Netherlands
Duxafit of Wnsfield
Hattar

20,000/As per policy of


MOH
1x10s

Manufacturer
GABANOV Capsules

Form-5

Each capsule contains:


Gabapentin..300mg

Dy No: 1274
dated 24-10-2014

Anticonvulsant

20,000/-

USP
GABANOV Capsules

As per policy of
MOH
1x10s
Form-5

Each capsule contains:


Gabapentin..400mg

Dy No: 1275
dated 24-10-2014

Anticonvulsant

20,000/-

USP

As per policy of
MOH
1x10s

Gabapentin Capsules
of Sandoz UK
Nerogabin of Merck

Gabapentin
Arrow
400mg Hard Capsules
of Actavis UK
Nerogabin of Merck

-do(Liquid
SVP)

TRAMANOV Injection

Form-5

Tramdol Injection of
Beacon Pharma UK

Each
2ml
contains:
Tramadol
100mg

Dy No: 1273
dated 23-10-2014

Ampoule
ampoule
HCL

Synthetic
analogue

opiate

Each 2ml of amber glass


ampoule contains:
Diclofenac
Sodium..75mg
Lidocaine HCl..20mg
Analgesic,
anesthetic

of

Brooks

20,000/-

Manufacturer
WENOFEN Injection

-do-

Lamadol
Karachi

Evidence
of
availability of TOC
analyzer and liquid
particle counter is
required.

Local

As per policy of
MOH
Pack of 5s &
10s
Form-5
Dy No: 1272
dated 23-10-2014

Availability in SRAs Evidence


of
needs confirmation
availability of TOC
analyzer and liquid
Dinopen of Global particle counter is
Pharma, Islamabad.
required.

20,000/As per policy of


MOH
Pack of 5s &
10s

Manufacturer

Evaluator III (Veterinary applications)


S/N

Name
and
address
of
manufacturer /
Applicant

Brand Name
(Proprietary name
Dosage
Form
Strength)

+
+

Type
Form

of

Initial
diary

date,

Composition
Pharmacological Group
Finished
Specification

M/s
Noble
Pharma, Mirpur
Azad Kashmir
Liquid Injection
Section
(Veterinary)
Approved vide
letter No. F.5-

Fee including
differential
fee

product
Demanded
Price / Pack
size

Nobivec Injection 2%

Form-5

Each ml contains:
Ivermectin..20mg

Dy. No: 65
dated 20-0714

Antiparasitic
20,000/BP
Decontrolled/

Remarks
on
the
formulation
(if
any)
including International
status in stringent drug
regulatory agencies /
authorities
Me-too status
GMP status as depicted
in latest inspection report
(with date) by the
Evaluator
Elvomec
Karachi

D/S

of

Elko

Inspection of the firm was


conducted by the area FID
and firm was found GMP
compliant.

Remarks
Evaluator

by

the

2/207 Lic dated:


18-02-13

-do-

Pack of 50ml

Nobivec Injection 1%

Form-5

Each ml contains:
Ivermectin..10mg

Dy. No: 66
dated 20-0714

Actimec
Selmore
Lahore.

Injection
of
Pharmaceuticals

Antiparasitic
20,000/BP
Decontrolled/
Pack of 50ml
Case No.08.
Registration applications of Pregabalin deferred in previous meetings of
Registration Board
Sr.
No
.

Name and address


of Manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage form + Strength)

Type of Form
Initial date,
diary.

Composition

Me-too status

Pharmacological Group
Finished
specification
M/S
CCL
Pharmaceutical (Pvt.)
Ltd.
62-Industrial
Estate , Kot Lakhpat,
Lahore.

product

Fee including
differential fee
Demanded
Price / Pack
size

Achlin Capsule 25mg

Form 5

Capsule
Each Capsule Contains:
Pregabalin25mg

14-11-2005
Rs.8000/Dy. No. Not
mentioned

(Antiepileptics, other
antiepileptics)
Manufacturers
specifications

International status in
stringent
regulatory
agencies

14-02-2014
Dy. No.596
Rs.12000/14s/ As Per
Brand Leader

GMP status as depicted


in inspection report
(dated)

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection for the
grant of GMP certificate
conducted
on
06/11/2013, 12/12/2013

Remarks /
Observations

& 18/12/2013.

M/S
CCL
Pharmaceutical (Pvt.)
Ltd.
62-Industrial
Estate , Kot Lakhpat,
Lahore.

Achlin Capsule 50mg

Form 5

Capsule
Each Capsule Contains:
Pregabalin50mg

14-11-2005
Rs.8000/Dy. No. Not
mentioned

(Antiepileptics, other
antiepileptics)
Manufacturers
specifications

14-02-2014
Dy. No.596
Rs.12000/14s/ As Per
Brand Leader

M/S
CCL
Pharmaceutical (Pvt.)
Ltd.
62-Industrial
Estate , Kot Lakhpat,
Lahore.

Achlin Capsule 100mg

Form 5

Capsule
Each Capsule Contains:
Pregabalin100mg

14-11-2005
Rs.8000/Dy. No. Not
mentioned

(Antiepileptics, other
antiepileptics)
Manufacturers
specifications

14-02-2014
Dy. No.596
Rs.12000/14s/ As Per
Brand Leader

Capsule
(General)
section mentioned in
Issuance
of
/
Revalidation of DML
vide letter No. F. 1-8/84Lic (Vol. II)
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection for the
grant of GMP certificate
conducted
on
06/11/2013, 12/12/2013
& 18/12/2013.
Capsule
(General)
section mentioned in
Issuance
of
/
Revalidation of DML
vide letter No. F. 1-8/84Lic (Vol. II)
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection for the
grant of GMP certificate
conducted
on
06/11/2013, 12/12/2013
& 18/12/2013.
Capsule
(General)
section mentioned in
Issuance
of
/

M/S NabiQasim (Pvt)


Ltd. 17/24, Korangi
Industrial
Area,
Karachi-Pakistan.

Preka Capsule 150mg


Capsule
Each Capsule Contains:
Pregabalin150mg

Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
Specifications

09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate
dossier /
10s, / Rs.
288/20s / Rs. 547/30s / 799/-

M/S NabiQasim (Pvt)


Ltd. 17/24, Korangi
Industrial
Area,
Karachi-Pakistan.

Preka Capsule 75mg


Capsule
Each Capsule Contains:
Pregabalin75mg

Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
Specifications

M/S NabiQasim (Pvt)


Ltd. 17/24, Korangi
Industrial
Area,
Karachi-Pakistan.

Preka Capsule 50mg


Capsule
Each Capsule Contains:
Pregabalin50mg

09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate
dossier /
10s / Rs.160/20s / Rs. 304/30s / Rs. 444/Form 5
24-04-2008
Rs.8000/Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
Specifications

09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate

Revalidation of DML
vide letter No. F. 1-8/84Lic (Vol. II)
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
18-12-2013.
Capsule
section mentioned in
report
and
cGMP
certificate.

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
18-12-2013.
Capsule
section mentioned in
report
and
cGMP
certificate.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated

dossier /

M/S NabiQasim (Pvt)


Ltd. 17/24, Korangi
Industrial
Area,
Karachi-Pakistan.

Preka Capsule 100mg


Capsule
Each Capsule Contains:
Pregabalin100mg

10s / Rs.144/20s / Rs. 273/30s / Rs. 400/Form 5


24-04-2008
Rs.8000/Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
Specifications

M/S
Linz
Pharmaceuticals (Pvt)
Ltd., 31-G/H, Sector
15 Korangi Industrial
Area,
KarachiPakistan.

Pegab 300mg Capsule


Capsule
Each Capsule Contains:
Pregabalin300mg
(Anticonvulsant Agent)
Manufacturers
specifications

09-09-2013
Rs.12000/Dy. No. not
mentioned
duplicate
dossier /
10s / Rs.201/20s / Rs. 382/30s / Rs. 558/Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/Dy. No. 802
duplicate
dossier /
14s/ Rs.390/-

M/S
Linz
Pharmaceuticals (Pvt)
Ltd., 31-G/H, Sector
15 Korangi Industrial
Area,
KarachiPakistan.

Pegab 100mg Capsule


Capsule
Each Capsule Contains:
Pregabalin100mg

Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008

(Anticonvulsant Agent)
Manufacturers
specifications

Dy. No. Not


mentioned
28-05-2014
Rs.12000/Dy. No. Not

18-12-2013.
Capsule
section mentioned in
report
and
cGMP
certificate.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
18-12-2013.
Capsule
section mentioned in
report
and
cGMP
certificate.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated
27-05-2014.
Capsule
section mentioned. Panel
recommended grant of
renewal.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated

mentioned
14s/ Rs.291/M/S
Linz
Pharmaceuticals (Pvt)
Ltd., 31-G/H, Sector
15 Korangi Industrial
Area,
KarachiPakistan.

Pegab 75mg Capsule


Capsule
Each Capsule Contains:
Pregabalin75mg
(Anticonvulsant Agent)
Manufacturers
specifications

Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
Dy. No. Not
mentioned
28-05-2014
Rs.12000/Dy. No. Not
mentioned
14s/ Rs.237/-

M/S Bosch 221,


Bosch House , Sector
23,
Korangi
Industrial
Area,Karachi.

Gablin 100mg Capsule


Capsule
Each Capsule Contains:
Pregabalin100mg
(Anticonvulsant Agent)
Manufacturers
specifications

M/S Bosch 221,


Bosch House , Sector
23,
Korangi
Industrial
Area,Karachi.

Gablin 75mg Capsule


Capsule
Each Capsule Contains:
Pregabalin75mg
(Anticonvulsant Agent)
Manufacturers
specifications

Form 5
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. Not
mentioned
28-05-2014
Rs.12000/803 R&I
14s / Rs.291/Form 5
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. Not
mentioned
28-05-2014
Rs.12000/803 R&I
14s/ Rs.237/-

27-05-2014.
Capsule
section mentioned. Panel
recommended grant of
renewal.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated
27-05-2014.
Capsule
section mentioned. Panel
recommended grant of
renewal.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
12-08-2014.
Capsule
section approved
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
12-08-2014.
Capsule
section approved

M/S Bosch 221,


Bosch House , Sector
23,
Korangi
Industrial
Area,Karachi.

Gablin 300mg Capsule


Capsule
Each Capsule Contains:
Pregabalin300mg
(Anticonvulsant Agent)
Manufacturers
specifications

Form 5
Covering letter
not attached.
June, 2008
Rs.8000/Dy. No. 803
28-05-2014
Rs.12000/803 R&I
14s/ Rs.390/-

M/S
Sami
Pharmaceutical Pvt.,
Limited
F-95,
S.I.T.E. Karachi.

Pregy 50mg Capsule


Capsule
Each Capsule Contains:
Pregabalin50mg

Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned

(Anticonvulsant)
Manufacturer
Specifications

Rs.12000/- fee
challan is
missing
As per PRC
duplicate
dossier

M/S
Sami
Pharmaceutical Pvt.,
Limited
F-95,
S.I.T.E. Karachi.

Pregy 75mg Capsule


Capsule
Each Capsule Contains:
Pregabalin75mg

Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned

(Anticonvulsant)
Manufacturer
Specifications

M/S
Sami
Pharmaceutical Pvt.,
Limited
F-95,
S.I.T.E. Karachi.

Pregy 100mg Capsule


Capsule
Each Capsule Contains:
Pregabalin100mg

Rs.12000/29-07-2013
Dy. No. Not
mentioned
As per PRC
duplicate
dossier
Form 5
Rs.8000/22-12-2009
Dy. No. not

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
12-08-2014.
Capsule
section approved
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection report
dated 24-06-2014. Panel
recommended grant of
additional
sections.
Capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13th 15th January, 2009
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

mentioned
(Anticonvulsant)
Manufacturers
specifications

M/S
Sami
Pharmaceutical Pvt.,
Limited
F-95,
S.I.T.E. Karachi.

Pregy 150mg Capsule


Capsule
Each Capsule Contains:
Pregabalin150mg
(Anticonvulsant)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 75mg


Capsule
Each Capsule Contains:
Pregabalin75mg

Rs.12000/29-07-2013
Dy. No. Not
mentioned
As per PRC
Duplicate
dossier
Form 5
Rs.8000/22-12-2009
Dy. No. not
mentioned
Rs.12000/29-07-2013
Dy. No. Not
mentioned
As per PRC
Duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 50mg


Capsule
Each Capsule Contains:
Pregabalin50mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s / Rs.565/Duplicate
dossier
Form 5

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13th 15th January, 2009
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13th 15th January, 2009
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.

Rs.8000/17-07-2009
Dy. No. not
mentioned

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/19-03-2014
Dy. No. Not
mentioned

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

14s / Rs.450/-

Inspection report dated

(Anti-Epileptic)
Manufacturers
specifications

duplicate
dossier
M/S AGP (Private)
Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 200mg


Capsule
Each Capsule Contains:
Pregabalin200mg

Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 225mg


Capsule
Each Capsule Contains:
Pregabalin225mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s /
Rs.1225/duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 300mg


Capsule
Each Capsule Contains:
Pregabalin 300mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s /
Rs.1370/duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s/Rs.1560/duplicate
dossier

26/11/2013.
Capsule
section mentioned in FID
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
SYNGAB
Capsules 200mg
Atco
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
Evidence of Me
status required

too

Inspection report dated


26/11/2013.
Capsule
section mentioned in FID
report.

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.

1) Evidence of
me too status
required.

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 100mg


Capsule
Each Capsule Contains:
Pregabalin100mg

Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 25mg


Capsule
Each Capsule Contains:
Pregabalin25mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s/Rs.735/duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/S AGP (Private)


Limited,
B-23,
S.I.T.E., Karachi

Hi-Gab Capsules 150mg


Capsule
Each Capsule Contains:
Pregabalin150mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s / Rs.270/duplicate
dossier
Form 5
Rs.8000/17-07-2009
Dy. No. not
mentioned

(Anti-Epileptic)
Manufacturers
specifications

M/s Neutro Pharma


(Pvt) Ltd., 9.5 Km,
Sheikhupura Road,
Lahore

Gabin Capsules 300mg


Capsule
Each Capsule Contains:
Pregabalin300mg

Rs.12000/19-03-2014
Dy. No. Not
mentioned
14s/Rs.940/duplicate
dossier
Form 5
Rs.8000/17-08-2009
Dy. No. not
mentioned

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
26/11/2013.
Capsule
section mentioned in FID
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

(GABA Analogue)
Manufacturers
Specifications

Rs.12000/07-07-2014
Dy. No. 66
As per PRC

M/s
Atco
Laboratories Limited,
B-18,
S.I.T.E.,
Karachi

Syngab Capsules75mg
Capsule
Each Capsule Contains:
Pregabalin75mg

Form 5
Rs.8000/29-04-2008
Dy. No. not
mentioned

(Anti Epileptic)
Manufacturers
Specifications

M/s
Atco
Laboratories Limited,
B-18,
S.I.T.E.,
Karachi

Syngab Capsules 150mg


Capsule
Each Capsule Contains:
Pregabalin150mg

Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14s
Form 5
Rs.8000/29-04-2008
Dy. No. not
mentioned

(Anti Epileptic)
Manufacturers
Specifications

M/s
Atco
Laboratories Limited,
B-18,
S.I.T.E.,
Karachi

Syngab Capsules 300mg


Capsule
Each Capsule Contains:
Pregabalin300mg

Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14s
Form 5
Rs.8000/22-04-2008
Dy. No. not
mentioned

(Anti Epileptic)
Manufacturers
Specifications

Rs.12000/08-04-2014
Dy. No. not
mentioned
As per leader
price per 14s

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection to check
GMP
compliance
conducted on 6th & 7th
January, 2014.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
18-06-2014
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
18-06-2014
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
18-06-2014

M/S Tabros Pharma


L-20/B,
Industrial
Karachi.

F.B.
Area,

Grelin Capsule 75mg


Capsule
Each Capsule Contains:
Pregabalin75mg

Form 5
Rs.8000/30-06-2008
Dy. No. Not
mentioned

(Anti-Epileptic.)
Manufacturers
specifications

M/S Tabros Pharma


L-20/B,
Industrial
Karachi.

F.B.
Area,

Grelin Capsule 100mg


Capsule
Each Capsule Contains:
Pregabalin100mg

Rs.12000/Dated 20-032014
Dy. No. not
mentioned
14s / Rs.1100/(Rs. 78.57 per
capsule)
(duplicate
dossier)
Form 5
Rs.8000/30-06-2008
Dy. No. Not
mentioned

(Anti-Epileptic.)
Manufacturers
specifications

M/S Tabros Pharma


L-20/B,
Industrial
Karachi.

F.B.
Area,

Grelin Capsule 150mg


Capsule
Each Capsule Contains:
Pregabalin150mg

Rs.12000/Dated.20-032014
Dy. No. not
mentioned
14s/Rs.1300/(duplicate
dossier)
Form 5
Rs.8000/30-06-2008
Dy. No. Not
mentioned

(Anti-Epileptic.)
Manufacturers
specifications

M/S Tabros Pharma

Grelin Capsule 300mg

Rs.12000/Dated.20-032014
Dy. No. not
mentioned
14s/Rs.1600/(duplicate
dossier)
Form 5

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
11/03/2014.
Overall
conditions
noted
improved as compared to
last visit.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
11/03/2014.
Overall
conditions
noted
improved as compared to
last visit.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
11/03/2014.
Overall
conditions
noted
improved as compared to
last visit.
LYRICA

Capsule
L-20/B,
Industrial
Karachi.

F.B.
Area,

Each Capsule Contains:


Pregabalin300mg

Rs.8000/30-06-2008
Dy. No. Not
mentioned

(Anti-Epileptic.)
Manufacturers
specifications

M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.

Foxril Capsule 75mg


Capsule
Each Capsule Contains:
Pregabalin75mg
(Anticonvulsant.)
Manufacturers
specifications

M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.

Foxril Capsule 100mg


Capsule
Each Capsule Contains:
Pregabalin100mg
(Anticonvulsant.)
Manufacturers
specifications

Rs.12000/Dated.20-032014
Dy. No. not
mentioned

Capsules (25, 50, 75,


100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Rs.8000/15-07-2008
Dy. No. 186

Inspection report dated


11/03/2014.
Overall
conditions
noted
improved as compared to
last visit.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.08-072014
Dy. No. 1244

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

14s / Rs. 16.95


/ Capsule

Rs.8000/15-07-2008
Dy. No.176

Inspection report dated


12-04-2013.
Good
compliance.
Capsule
section
mentioned
in
panel
inspection report dated
02-12-2008.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.08-072014
Dy. No. 1244

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

14s/Rs.20.85/
Capsule

Inspection report dated


12-04-2013.
Good
compliance.
Capsule
section
mentioned
in
panel
inspection report dated
02-12-2008.

14s/Rs.2600/(duplicate
dossier)
Form 5

Form 5

M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.

Foxril Capsule 150mg


Capsule
Each Capsule Contains:
Pregabalin150mg
(Anticonvulsant.)
Manufacturers
specifications

M/S OBS Pakistan


(Pvt.) Ltd. C-14,
S.I.T.E., Manghopir
Road Karachi-75700

Pregalin Capsule
Capsule
Each Capsule Contains:
Pregabalin150mg
(Antiepileptics)
Manufacturers
specifications

M/S OBS Pakistan


(Pvt.) Ltd. C-14,
S.I.T.E., Manghopir
Road Karachi-75700

Pregalin Capsule
Capsule
Each Capsule Contains:
Pregabalin300mg
(Antiepileptics)
Manufacturers
specifications

Form 5
Rs.8000/15-07-2008
Dy No.181

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.08-072014
Dy. No. 1244

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Rs.33.90/Capsu
le
14s

Rs.8000/18-10-2008
Not mentioned

Inspection report dated


12-04-2013.
Good
compliance.
Capsule
section
mentioned
in
panel
inspection report dated
02-12-2008.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.29-072013 duplicate
dossier

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Dy. No. not


mentioned
14s/Rs.1300/-

Rs.8000/18-10-2008
Not mentioned

Inspection report dated


06-03-2014.
GMP
satisfactory and capsule
section mentioned in
report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.29-072013 duplicate
dossier

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Dy. No. not


mentioned
14s/Rs.2200/-

Inspection report dated


06-03-2014.
GMP
satisfactory and capsule
section mentioned in
report.

Form 5

Form 5

M/S OBS Pakistan


(Pvt.) Ltd. C-14,
S.I.T.E., Manghopir
Road Karachi-75700

Pregalin Capsule
Capsule
Each Capsule Contains:
Pregabalin75mg
(Antiepileptics)
Manufacturers
specifications

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

P-Gab 75
Tablet
Each film coated tablet
Contains:
Pregabalin75mg
(Antiepileptics)
Manufacturers
specifications

Form 5
Rs.8000/18-10-2008
Not mentioned

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.29-072013 duplicate
dossier

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Dy. No. not


mentioned
14s/Rs.900/-

Inspection report dated


06-03-2014.
GMP
satisfactory and capsule
section mentioned in
report.
Inspection report dated
18-03-2013. Satisfactory
GMP and tablet section
mentioned.

Form 5
Rs.8000/31-12-2008
Dy. No.561
Rs.12000/Dated.08-072014
Dy. No. 1239
10x2=20s /As
Per SRO

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

P-Gab 100
Tablet
Each tablet Contains:
Pregabalin100mg
(Antiepileptics)
Manufacturers
specifications

Form 5
Rs.8000/31-12-2008
Dy. No.562
Rs.12000/Dated.08-072014
Dy. No. 1235

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet and
capsule
section
mentioned.

1) Firm had
initially applied
on Form 5 for
registration
of
Pregabalin 75mg
tablet. Since the
product is not me
too, firm was
asked to provide
me too reference
or application on
Form 5D. Now,
firm
has
requested
to
change
the
particulars of the
file to Pregabalin
Oral
Solution
20mg/ml. Firm
has
also
submitted
that
additional fee if
any, will be
deposited.
1) Firm had
initially applied
on Form 5 for
registration
of
Pregabalin
100mg
tablet.
Since the product
is not me too,
firm was asked
to provide me

too reference or
application
on
Form 5D. Now,
firm
has
requested
to
change
the
particulars of the
file to Pregabalin
300mg capsules.
Firm has also
submitted
that
additional fee if
any, will be
deposited.

10x2=20s &
14s /As Per
SRO

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

P-Gab 50
Tablet
Each tablet Contains:
Pregabalin50mg
(Antiepileptics)
Manufacturers
specifications

Form 5
Rs.8000/31-12-2008
Dy. No. 560

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet section
mentioned.

Rs.12000/Dated.08-072014
Dy. No. 1233
10x2=20s /As
Per SRO

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

P-Gab 150mg Tablet


Tablet
Each film coated tablet
Contains:
Pregabalin150mg
(Antiepileptics)
Manufacturers

Form 5
Rs.8000/31-12-2008
Dy. No.563
Rs.12000/Dated.08-072014
Dy. No. 1234

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet section
mentioned.

1) Firm had
initially applied
on Form 5 for
registration
of
Pregabalin
100mg
tablet.
Since the product
is not me too,
firm was asked
to provide me
too reference or
application
on
Form 5D. Now,
firm
has
requested
to
change
the
particulars of the
file to Pregabalin
200mg capsules.
Firm has also
submitted
that
additional fee if
any, will be
deposited.
1) Firm had
initially applied
on Form 5 for
registration
of
Pregabalin
100mg
tablet.
Since the product
is not me too,
firm was asked
to provide me
too reference or

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

specifications

10x2=20s/As
Per SRO

P-Gab 100
Capsule

Form 5

Each capsule Contains:


Pregabalin100mg
(Antiepileptics)
Manufacturers
specifications

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

P-Gab 75
Capsule
Each capsule Contains:
Pregabalin75mg
(Antiepileptics)
Manufacturers
specifications

M/S Glitz Pharma


(Pvt.)
Ltd;
265Industrial Triangle,
Kahuta
Road
Islamabad.

application
on
Form 5D. Now,
firm
has
requested
to
change
the
particulars of the
file to Pregabalin
150mg capsules.
Firm has also
submitted
that
additional fee if
any, will be
deposited.

Rs.8000/31-12-2008
Dy. No.559

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.08-072014
Dy. No. 1236

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

10x2=20s &
14s /As Per
SRO and Rs.
625/- per 20s
Form 5
Rs.8000/31-12-2008
Dy. No.557

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/Dated.08-072014
Dy. No. 1238

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

10x2=20s &
14s/As Per
SRO and Rs.
345/- per 20s
Form 5

Each capsule Contains:


Pregabalin50mg

Rs.8000/31-12-2008
Dy. No.556

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

(Antiepileptics)

Rs.12000/-

GABICA

P-Gab 50
Capsule

Manufacturers
specifications

M/S
Global
Pharmaceuticals
(Pvt.) Ltd., Plot No.
204-205, Industrial
Triangle,
Kahuta
Road, Islamabad.

Pert 50 mg Capsules
Capsule
Each capsule Contains:
Pregabalin50mg

Dated.08-072014
Dy. No. 1237

Capsules (50, 75, 100,


150 and 300mg)
Getz

10x2=20s &
14s/As Per
SRO

Inspection report dated


18-03-2013. Satisfactory
GMP and tablet section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Form 5
Rs.8000/- fee
challan not
attached

(Anticonvulsant)
Manufacturers
Specifications

Rs.12000/Dated.05-062014
Dy. No. 566
R&I
14s As Per
SRO

M/S
Global
Pharmaceuticals
(Pvt.) Ltd., Plot No.
204-205, Industrial
Triangle,
Kahuta
Road, Islamabad.

Pert 75 mg Capsules
Capsule
Each capsule Contains:
Pregabalin75mg

Form 5
Rs.8000/- fee
challan not
attached

(Anticonvulsant)
Manufacturers
Specifications

Rs.12000/Dated.05-062014
Dy. No. 565
R&I

cGMP certificate dated


21-11-2014.
Capsule
section
mentioned in inspection
report
and
GMP
certificate dated 31-052012 and 21-11-2014.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Each Capsule Contains:


Pregabalin150mg

Rs.8000/09-08-2008
Dy. No.287

cGMP certificate dated


21-11-2014.
Capsule
section
mentioned in inspection
report
and
GMP
certificate dated 31-052012 and 21-11-2014.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

(Gaba Analogue)

Rs.12000/-

ZEEGAP

14s As Per
SRO

M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV, Industrial Estate,
Hattar.

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Pregabanome-150 Capsule
Capsule

Form 5

1) Rs. 8,000/- fee


challan
(duly
endorsed
by
Statistical
Officer) has not
been provided.
However, copy
of extracts from
214th meeting of
Registration
Board
as
evidence of fee
submission.

1) Rs. 8,000/- fee


challan
(duly
endorsed
by
Statistical
Officer) has not
been provided.
However, copy
of extracts from
214th meeting of
Registration
Board
as
evidence of fee
submission.

Manufacturers
specifications

16-06-2014
Dy. No. 258
As Per SRO
2x7s (14)

M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV, Industrial Estate,
Hattar.

Pregabanome-75 Capsule
Capsule
Each Capsule Contains:
Pregabalin75mg
(Gaba Analogue)
Manufacturers
specifications

Form 5
Rs.8000/09-08-2008
Dy. No.288
Rs.12000/16-06-2014
Dy. No. 258
As Per SRO
2x7s (14)

M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV, Industrial Estate,
Hattar.

Pregabanome-50 Capsule
Capsule
Each Capsule Contains:
Pregabalin50mg
(Gaba Analogue)
Manufacturers
specifications

Form 5
Rs.8000/09-08-2008
Dy. No. 289
Rs. 12000/16-06-2014
Dy. No. 258
As Per SRO
2x7s (14)

M/S
Genome
Pharmaceutical
Private
Limted,
Factory 16/1-Phase
IV, Industrial Estate,
Hattar.

Pregabanome-100Capsule
Capsule
Each Capsule Contains:
Pregabalin100mg
(Gaba Analogue)
Manufacturers

Capsules (25, 50, 75, 100


and 150mg)
Hilton
Panel inspection for grant
of GMP dated 27-122013.
Capsule
General
/
Antibiotic mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection for grant
of GMP dated 27-122013.
Capsule
General
/
Antibiotic mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton

Rs.8000/09-08-2008
Dy. No.286

Panel inspection for grant


of GMP dated 27-122013.
Capsule
General
/
Antibiotic mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.12000/16-06-2014
Dy. No. 258

ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)

Form 5

specifications

Hilton
As Per SRO
2x7s (14)

M/s Noa Hemis


Pharmaceuticals Plot
No.154, Sector-23,
Korangi Industrial
Area,Karachi

Gabatil-75mg
Capsule
Each Capsule Contains:
Pregabalin 75mg

Form 5
Rs.8000/22-07-2008
Dy. No. not
mentioned

(Anti epileptic)
Manufacturers
specifications

Rs.12000/19-06-2014
1609 R&I
10s, 14s/15%
less then brand
leader

M/s Noa Hemis


Pharmaceuticals Plot
No.154, Sector-23,
Korangi Industrial
Area,Karachi

Gabatil-150mg
Capsule
Each Capsule Contains:
Pregabalin 150mg

Form 5
Rs.8000/22-07-2008
Dy. No. not
mentioned

(Anti epileptic)
Manufacturers
specifications

M/s Noa Hemis


Pharmaceuticals Plot
No.154, Sector-23,
Korangi Industrial
Area,Karachi

Gabatil-300mg
Capsule
Each Capsule Contains:
Pregabalin 300mg
(Anti epileptic)

Rs.12000/19-06-2014
1609 R&I

Panel inspection for grant


of GMP dated 27-122013.
Capsule
General
/
Antibiotic mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
DDG and FID inspection
report dated 09-06-2014
GMP
compliance
considered good.
Capsule
section
mentioned
in
GMP
inspection reports.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

10s, 14s /
15% less then
brand leader

DDG and FID inspection


report dated 09-06-2014
GMP
compliance
considered good.
Capsule
section
mentioned
in
GMP
inspection reports.

Form 5

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.8000/22-07-2008
Dy. No. not
mentioned

GABICA

Manufacturers
specifications

M/S
Sharooq
Pharmaceuticals (Pvt)
Ltd.
21-KM
Ferozepur
Road,
Lahore.

Gabmor Capsule
Capsule
Each Capsule Contains:

Rs.12000/19-06-2014
1609 R&I

Capsules (50, 75, 100,


150 and 300mg)
Getz

10s, 14s /
15% less then
brand leader

DDG and FID inspection


report dated 09-06-2014
GMP
compliance
considered good.
Capsule
section
mentioned
in
GMP
inspection reports.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Form 5
Rs.8000/19-01-2009
Not mentioned

Pregabalin300mg
(Antiepileptic)
Manufacturers
specifications

Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1286
14s/As per
PRC

M/S
Sharooq
Pharmaceuticals (Pvt)
Ltd.
21-KM
Ferozepur
Road,
Lahore.

Gabmor Capsule
Capsule
Each Capsule Contains:
Pregabalin75mg
(Antiepileptic)
Manufacturers
specifications

Form 5
Rs.8000/19-01-2009
Not mentioned
Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1281
14s,10s/As
per PRC

M/S
Sharooq
Pharmaceuticals (Pvt)
Ltd.
21-KM
Ferozepur
Road,

Gabmor Capsule
Capsule
Each Capsule Contains:

Form 5
Rs.8000/19-01-2009

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection after
non-compliance report
and grant of GMP
certificate dated 28-032014. GMP issued and
capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection after
non-compliance report
and grant of GMP
certificate dated 28-032014. GMP issued and
capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)

Lahore.

Pregabalin150mg

Not mentioned

US FDA

(Antiepileptic)

Rs.12000/Dated.19-062014 duplicate
dossier
Dy. No. 1282

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

Manufacturers
specifications

14s, 10s/As
per PRC

M/s Rasco Pharma,


5.5Km Raiwind Road
Lahore.

Pregab Capsule 300mg


Capsule
Each Capsule Contains:
Pregabalin M.s300mg

Form 5
Rs.8000/25-07-2009
Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
specifications

Rs.12000/20-06-2014
Dy. No. 1296
Rs.630/-, 1x14

M/s Rasco Pharma,


5.5Km Raiwind Road
Lahore.

Pregab Capsule 150mg


Capsule
Each Capsule Contains:
Pregabalin M.s150mg

Form 5
Rs.8000/25-07-2009
Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
specifications

Rs.12000/20-06-2014
Dy. No. 1295
Rs.350/-, 1x14

M/s Rasco Pharma,


5.5Km Raiwind Road
Lahore.

Pregab Capsule 50mg


Capsule

Form 5
Rs.8000/-

Panel inspection after


non-compliance report
and grant of GMP
certificate dated 28-032014. GMP issued and
capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated
03-06-2014 where panel
recommended grant of
renewal
of
DML.
Capsule
section
mentioned in said report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated
03-06-2014 where panel
recommended grant of
renewal
of
DML.
Capsule
section
mentioned in said report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and

Each Capsule Contains:


Pregabalin M.s50mg

25-07-2009
Dy. No. Not
mentioned

(Anticonvulsant)
Manufacturers
specifications

Rs.12000/20-06-2014
Dy. No. 1294
Rs.175/-, 1x14

M/s
WnsFeild
Pharmaceuticals,
Plot#122, Block-A,
Phase-V, Industrial
Estate, Hattar

Lyricowin (Pregablin) 75
Tablet
Each capsule Contains:
Pregabalin 75mg

Form 5
Rs.8000/19-04-2009
Dy. No. Not
mentioned

(Anticonvulsants)
Manufacturers
specifications

Rs.12000/19-06-2014
Dy. No. 259
As per SRO

M/s
Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122,
Sindh
Industrial
Trading
Estate, Karachi.

Gablin 150mg Capsule


Capsule
Each capsule Contains:
Pregabalin 150mg
(Anticonvulsants)

Form 5
Rs.8000/17-06-2009
(Challan
submission
date)
Dy. No. Not
mentioned
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
is not attached

M/s
Pakistan
Pharmaceuticals

Gablin 75mg Capsule


Capsule

Rs.25/Capsule /
not mentioned
Form 5

300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection dated
03-06-2014 where panel
recommended grant of
renewal
of
DML.
Capsule
section
mentioned in said report.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel report dated 04-092014. Panel recommends
grant of GMP and
capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13-02-2013.
Firm
considered
to
be
operating at good level of
GMP.

LYRICA
Capsules (25, 50, 75,

Products (Pvt) Ltd.


D-122,
Sindh
Industrial
Trading
Estate, Karachi.

Each capsule Contains:


Pregabalin 75mg

Rs.8000/17-06-2009
Dy. No. Not
mentioned

(Anticonvulsants)
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
is not
attached

M/s
Pakistan
Pharmaceuticals
Products (Pvt) Ltd.
D-122,
Sindh
Industrial
Trading
Estate, Karachi.

Gablin 300mg Capsule


Capsule
Each capsule Contains:
Pregabalin 300mg

Rs.25/Capsule /
not mentioned
Form 5
Rs.8000/17-06-2009
Dy. No. Not
mentioned

(Anticonvulsants)
Rs.12000/26-07-2013
Dy. No. not
mentioned
Covering letter
is not attached

M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.

Gabfast Capsule300mg
Capsule
Each capsule Contains:
Pregabalin 300mg
(Gaba analogue)

Rs.25/Capsule /
not mentioned
Form 5
Rs.8000/08-12-2009
Dy. No. 57
Rs.12000/05-06-2014
Dy. No. 555
10s/As Per
SRO

M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.

Gabfast Capsule75mg
Capsule
Each capsule Contains:
Pregabalin 75mg

Form 5
Rs.8000/08-12-2009
Dy. No. 55

100, 150,200, 225 and


300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13-02-2013.
Firm
considered
to
be
operating at good level of
GMP.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
13-02-2013.
Firm
considered
to
be
operating at good level of
GMP.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
cGMP certificate dated
28-01-2014.
Capsule
section mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

(Gaba analogue)

Rs.12000/05-06-2014
Dy. No. 555
10s/As Per
SRO

M/s Danas
Pharmaceuticals
(Private) Limited,
Islamabad.

Gabfast Capsule150mg
Capsule
Each capsule Contains:
Pregabalin 150mg
(Gaba analogue)

Form 5
Rs.8000/08-12-2009
Dy. No. 56
Rs.12000/05-06-2014
Dy. No. 555
10s/As Per
SRO

M/S
Sami
Pharmaceutical Pvt.,
Limited
F-95,
S.I.T.E. Karachi.

Pregy 25mg Capsule


Capsule
Each Capsule Contains:
Pregabalin25mg

Form 5
Rs.8000/07-09-2010
Dy. No. not
mentioned

(Anticonvulsant)
Manufacturer
Specifications

Rs.12000/10-05-2013
duplicate
dossier
Dy. No. Not
mentioned
As per PRC

M/S Weather Folds


Pharmaceuticals, Plot
No.69/2,
Phase-II,
Industrial
Area,
Hattar, KPK

Gabalin 50mg Cap


Capsule
Each Capsule Contains:
Pregabalin50mg
(Analgesic / Anticonvulsant
Activity)
Manufacturers
specifications

Form 5
Rs.8000/29-12-2010
Dy. No. Not
mentioned
Rs.12000/Dated.11-072014
Dy. No. 323

GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
cGMP certificate dated
28-01-2014.
Capsule
section mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
cGMP certificate dated
28-01-2014.
Capsule
section mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection report
dated 24-06-2014. Panel
recommended grant of
additional
sections.
Capsule
section
mentioned.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection report

M/S Weather Folds


Pharmaceuticals, Plot
No.69/2,
Phase-II,
Industrial
Area,
Hattar, KPK

Gabalin 100mg Cap


Capsule
Each Capsule Contains:
Pregabalin100mg
(Analgesic / Anticonvulsant
Activity)
Manufacturers
specifications

As per SRO

dated 04-09-2014. Panel


recommended grant of
GMP certificate. Capsule
section approved.

Form 5

LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA

Rs.8000/29-12-2010
Dy. No. Not
mentioned
Rs.12000/Dated.11-072014
Dy. No. not
mentioned
As per SRO

M/S Lowitt Pharma


(pvt.)
Ltd.
24Hayatabad Industrial
Estate Peshawar.

P-Gablin 150Capsule
Oral Capsule
Each Capsule Contains:
Pregabalin150mg
(Gaba Analogue,
Anticonvulsant.Analgasic)
Manufacturers
specifications

M/S Lowitt Pharma


(pvt.)
Ltd.
24Hayatabad Industrial
Estate Peshawar.

P-Gablin 50Capsule
Oral Capsule
Each Capsule Contains:
Pregabalin50mg
(Gaba Analogue,
Anticonvulsant.Analgasic)

Form 5
Rs.8000/22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/(for tablet)
Dated 22-052014
Dy. No. Not
mentioned
Both pack size
and price as
Per SRO
Duplicate
Dossier
Form 5
Rs.8000/22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned

ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Panel inspection report
dated 04-09-2014. Panel
recommended grant of
GMP certificate. Capsule
section approved.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
21-08-2014.
Overall
firm in good working
condition.
Capsule
section mentioned in
inspection report and
revised
layout
plan
approval dated 13-122013.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100

1) Balance fee
Rs. 12,000/- has
been submitted
for tablet dosage
form.

Manufacturers
specifications

M/S Lowitt Pharma


(pvt.)
Ltd.
24Hayatabad Industrial
Estate Peshawar.

P-Gablin 100Capsule
Oral Capsule
Each Capsule Contains:
Pregabalin100mg
(Gaba Analogue,
Anticonvulsant.Analgasic)
Manufacturers
specifications

M/s
Rogen
Pharmaceuticals
Plot#30,
S-4,
National
Industrial
Zone,
Rawat,
Islamabad.

P-Roglin 75mg Capsule


Capsule
Each capsule Contains:
Pregabalin 75mg
(Anti-epileptic)
Manufacturers
specifications

Rs.12000/Dated. 22-052014
Dy. No. Not
mentioned
Both pack size
and price as
Per SRO
Duplicate
Dossier
Form 5
Rs.8000/22-03-2010
(Endorsement
date)
Dy. No. Not
mentioned
Rs.12000/Dated.21-052014
Dy. No. Not
mentioned
Both pack size
and price as
Per SRO
Duplicate
Dossier
Form 5
Rs.8000/02-06-2010
Dy. No. 4754
Rs. 12000/16-06-2014
Dy. No.735
10s/As Per
SRO

M/s Focus & Rulz

Pregab 75mg Capsule

Form 5

and 150mg)
Hilton
Inspection report dated
21-08-2014.
Overall
firm in good working
condition.
Capsule
section mentioned in
inspection report and
revised
layout
plan
approval dated 13-122013.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
ZEEGAP
Capsules (25, 50, 75, 100
and 150mg)
Hilton
Inspection report dated
21-08-2014.
Overall
firm in good working
condition.
Capsule
section mentioned in
inspection report and
revised
layout
plan
approval dated 13-122013.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection report
dated 09-06-2014. Tablet
/
capsule
section
mentioned.
General Capsule section
mentioned on the report.
LYRICA

Pharmaceuticals (Pvt)
Ltd. Plot No.4,
Industrial Triangle,
Kahuta Road,
Islamabad.

Capsule
Each capsule Contains:
Pregabalin 75mg
(Analgesic and
Anticonvulsant)
Manufacturers
specifications

M/s Focus & Rulz


Pharmaceuticals (Pvt)
Ltd. Plot No.4,
Industrial Triangle,
Kahuta Road,
Islamabad.

Pregab 50mg Capsule


Capsule
Each capsule Contains:
Pregabalin 50mg
(Analgesic and
Anticonvulsant)
Manufacturers
specifications

M/s Amarant
Pharmaceuticals (Pvt)
LTD 158-D, Toro
Gadap Road, Super
highway, Karachi.

Gabalin Capsule 50mg


Capsule
Each filled Capsule
Contains:
Pregabalin50mg
(Anticonvulsant)
Manufacturers
specifications

Rs.8000/61 R&I
28-06-2010
Fee Rs.12000/challans form
is missing
14s/As Per
SRO

Form 5
Rs.8000/62 R&I
28-06-2010
Fee Rs.12000/challans form
is missing
14s/As Per
SRO

Form 5
Rs.8000/22-11-2010
Dy. No. not
mentioned
Rs.52,000/(fast track)
19-11-2012
Dy. No. Not
mentioned
Rs.36/- capsule
duplicate
dossier

M/s Amarant

Gabalin Capsule 75mg

Form 5

Capsules (25, 50, 75,


100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection report
dated
27-03-2014.
Capsule
section
approved.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Panel inspection report
dated
27-03-2014.
Capsule
section
approved.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
08-08-2014 observed that
management is taking
serious measures to
rearrange and upgrade
their
whole
manufacturing, quality
control
and
storage
facilities as per approved
layout plan.
LYRICA

Pharmaceuticals (Pvt)
LTD 158-D, Toro
Gadap Road, Super
highway, Karachi.

Capsule
Each filled Capsule
Contains:
Pregabalin75mg
(Anticonvulsant)
Manufacturers
specifications

Rs.8000/22-11-2010
Dy. No. not
mentioned
Rs.52,000/(fast track)
19-11-2012
Dy. No. Not
mentioned
Rs.71/- capsule
duplicate
dossier

M/s Amarant
Pharmaceuticals (Pvt)
LTD 158-D, Toro
Gadap Road, Super
highway, Karachi.

Gabalin Capsule 100mg


Capsule
Each filled Capsule
Contains:
Pregabalin100mg
(Anticonvulsant)
Manufacturers
specifications

Form 5
Rs.8000/22-11-2010
Dy. No. not
mentioned
Rs.52,000/(fast track)
18-11-2012
Dy. No. Not
mentioned
Rs.89/- capsule
duplicate
dossier

M/s Amarant
Pharmaceuticals (Pvt)
LTD 158-D, Toro
Gadap Road, Super
highway, Karachi.

Gabalin Capsule 150mg


Capsule
Each filled Capsule
Contains:
Pregabalin150mg
(Anticonvulsant)
Manufacturers

Form 5
Rs.8000/22-11-2010
Dy. No. not
mentioned
Rs.52,000/(fast track)
19-11-2012

Capsules (25, 50, 75,


100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
08-08-2014 observed that
management is taking
serious measures to
rearrange and upgrade
their
whole
manufacturing, quality
control
and
storage
facilities as per approved
layout plan.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Inspection report dated
08-08-2014 observed that
management is taking
serious measures to
rearrange and upgrade
their
whole
manufacturing, quality
control
and
storage
facilities as per approved
layout plan.
LYRICA
Capsules (25, 50, 75,
100, 150,200, 225 and
300mg)
US FDA
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz

specifications

Dy. No. Not


mentioned
Rs.107/capsule
duplicate
dossier

Inspection report dated


08-08-2014 observed that
management is taking
serious measures to
rearrange and upgrade
their
whole
manufacturing, quality
control
and
storage
facilities as per approved
layout plan.

9. Contract manufacturing applications


Evaluator II (Application checked by Evaluator - IV)
S.N
o

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage Form + Strength)

Type of Form

Composition

Fee
including
differential fee

Initial date, diary

Remarks on the formulation (if


any) including
International
status
in
stringent
drug
regulatory agencies / authorities
Me-too status

Pharmacological Group
Finished
Specification

M/s Safe
Pharmaceuticals
(Pvt.) Ltd.
Plot No. C-1-20,
Sector 6-B, North
Karachi Industrial
Area, Karachi
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore, Gadap
Road, Super
Highway, Karachi.

product

Impulse Injection 500


mcg/ml
Each 1 ml ampoule
contains
Mecobalamin (J.P)..500
mcg
(Co-enzyme type Vitamin
B12)
(Manufacturers Spec.s)

Demanded Price /
Pack size

GMP status as depicted in latest


inspection report (with date) by
the Evaluator

Form 5
Not mentioned
Rs 150,000
1 ml 10s

International: Methycobal Inj by


M/s Eisai Co., Ltd. Tokyo
Me too: Elgin Inj by M/s Novartis
According to inspection report
dated 20-08-2014 of M/s Safe
Pharmaceuticals; GMP compliance
level of firm is rated as good.
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
Evidence of TOC analyzer and
liquid particle counter is required.
Firm has replied that these are
under the process of procurement.

-do-

Moxina Infusion 400 mg/


250 ml
Each vial (250 ml) contains
Moxifloxacin (as HCl)
(USP). 400 mg
Quinolone
(Manufacturers Spec.s)

Form 5
Not mentioned
Rs 150,000
As per PAC

International: Avelox Inf (FDA)


Me too: Moxiget Inf 400mg/250ml
According to inspection report
dated 20-08-2014 of M/s Safe
Pharmaceuticals; GMP compliance
level of firm is rated as good.
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
Evidence of TOC analyzer and
liquid particle counter is required.

-do-

Quvoxin Injection 500 mg/


100 ml
Each vial (100ml) contains
Levofloxacin (USP). 500
mg
Quinolone
(Manufacturers Spec.s)

Form 5
Not mentioned
Rs 150,000
As per PAC

Firm has replied that these are


under the process of procurement.
International:
Levaquine
500mg/100ml (FDA)
Me too: Raylox Inf 500mg/100ml
by M/s Ray
According to inspection report
dated 20-08-2014 of M/s Safe
Pharmaceuticals; GMP compliance
level of firm is rated as good.
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
Evidence of TOC analyzer and
liquid particle counter is required.
Firm has replied that these are
under the process of procurement.

-do-

-do-

Amadrol Injection 100 mg/


2 ml
Each 2 ml contains
Tramadol HCl (B.P)
..100 mg
Non Narcotic analgesic
(Manufacturers Spec.s)

Amblum Injection
Each ml ampoule contains
Artemether80 mg
(Anti malarial)
(Manufacturers Spec.s)

Form 5
Not mentioned
Rs 150,000
2 ml 5s
As per PAC

Form 5
Not mentioned
Rs 150,000
1 5 ampoule
As per PAC

International:
Zamadol
Inj
50mg/ml (100mg ampoule) in UK
Me too: Tramadol Inj 50mg/ml by
M/s Highnoon
Latest GMP inspection report of
contract giver is required.
According to inspection report
dated 20-08-2014 of M/s Safe
Pharmaceuticals; GMP compliance
level of firm is rated as good.
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
Evidence of TOC analyzer and
liquid particle counter is required.
Firm has replied that these are
under the process of procurement.
International: Artem Inj in China
Me too: Artem Inj by M/s Hilton
According to inspection report
dated 20-08-2014 of M/s Safe
Pharmaceuticals; GMP compliance
level of firm is rated as good.
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .

M/s Caraway
Pharmaceuticals
Plot No. 12, street #
N-3, National
Industrial Zone,
Rawat, Islamabad.
For
M/s Amarant
Pharmaceuticals
(Pvt.) Ltd.
158, D. Tore, Gadap
Road, Super
Highway, Karachi.

-do-

Amant- D Injection
Each ml contains
Cholecalciferol BP ..5
mg
Vitamin

Form 5
Not mentioned
Rs 150,000
As per PAC

Finished product
specifications are B.P

Amta- Rose Injection


Each ampoule (5ml)
contains
Iron Sucrose 420 mg eq to
elemental Iron .. 100mg
Haematinic

Form 5
Not mentioned
Rs 150,000
As per PAC

Finished product
specifications are USP

Evaluator III

Verification fee challan is required.


Formulation was Deferred in the
light of recommendations by
Malaria Control Programme in M245 of DRB.
International: Required
Me too: Calciferol Inj by M/s
Global
Good level of GMP compliance
(24-09-2012)
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
International
availability
not
confirmed in SRAs.
Letter of approval of injection
section is required. Inspection
report dated 24-09-12 mentions
Ampoule and Vial sections.
Labeling information has been
given for malaria.
International: Venofer Inj (FDA)
Me too: Merofer JInj by M/s Bosch
Good level of GMP compliance
(24-09-2012)
Only Form 5 of the application has
been evaluated. Rest of the
conditions of policy matters have
not been evaluated .
Verification fee challan is required.
Initially on Form 5, firm mentioned
quantity of active as 420 mg/
ampoule, in reply firm mentioned it
as 1873 mg/ ampoule. Clarification
is required. No clarification is
provided in second reply.
Letter of approval of injection
section is required. Not provided in
second reply. Inspection report
dated 24-09-12 mentions Ampoule
and Vial sections.
Evidence of TOC analyzer and
liquid particle counter is required.
Not provided in replies.

S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name
Dosage
Form
Strength)

Type of Form
+
+

Composition

Initial
diary

date,

Fee including
differential fee

Pharmacological Group
Finished
Specification

Contract Giver
M/s
Dyson
Research
Labs,
Lahore.
Contract Acceptor
M/s
McOlson
Research
Laboratories,
Sheikhupura.

Contract Giver
M/s
McOlson
Research
Laboratories,
Sheikhupura.
Contract Acceptor
M/s
Dyson
Research
Labs,
Lahore.

product

OD-CEF Injection 500mg

Suspension

Each
5ml
after
reconstitution contains:
Azithromycin dihydrate
equivalent
to
Azithromycin
USP..200mg

Form-5

As per SRO
Pack of 1s
Form-5
Dy No: 2430
dated: 15-042013
50,000/- dated
15-04-13
1,00,000/- dated
14-05-13

Inspection of M/s
McColson Research
Labs conducted on
26-08-14 and 11-0914 by the panel of
inspectors
and
recommends
the
grant of renewal of
DML to the firm

Inspection of the M/s


Dyson
Research
Labs
Sheikhupura
was conducted on
26-09-14 by the area
FID and overall
hygiene
and
condition is found
good.

Macrolide Antibiotic
As per SRO
Contract Giver
M/s
Masfa
Industries
(Pvt)
Limited, Lahore
Contract Acceptor
M/s
McOlson
Research

USP
M-XIME
100mg/5ml

Suspension

Each 5ml contains:


Cefixime
trihydraye
equivalent
to
Cefixime..100mg

Recommendations by
the Evaluator

Demanded
Price / Pack Me-too status
size
GMP status as
depicted in latest
inspection
report
(with date) by the
Evaluator

Each vial contains:


Dy No: 2437
Ceftriaxone
sodium dated: 15-04equivalent
to 2013
Ceftriaxone..500mg
1,42,000/- dated
Cephalosporin
15-04-13
8,000/dated
USP
18-05-09

AZIBAC
200mg

Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory
agencies
/
authorities

Form-5
Dy No: 2430
dated: 15-042013
1,50,000/-

Inspection of M/s
McColson Research
Labs conducted on
26-08-14 and 11-0914 by the panel of
inspectors
and
recommends
the
grant of renewal of

The applications have


been evaluated as per
Form-5. However the
formalities as per
contract manufacturing
policy may be fulfilled
by the
concerned
section before issuance
of registration letter.

Laboratories,
Sheikhupura.
Contract Giver
M/s
Masfa
Industries
(Pvt)
Limited, Lahore
Contract Acceptor
M/s
McOlson
Research
Laboratories,
Sheikhupura.
Contract Giver
M/s
Arsons
Pharmaceutical
Industries, Lahore.
Contract Acceptor
M/s
Friends
Pharma
(Pvt)
Limited, Lahore for

Cephalosporin

As per SRO

DML to the firm

USP
M-XIME Capsule 400mg

Form-5

Each capsule contains:


Cefixime
as
Trihydrate..400mg

Dy No: 2405
dated: 15-042013

Cephalosporin

1,50,000/-

USP

As per SRO
Pack of 5s
Form-5

Inspection of M/s
McColson Research
Labs conducted on
26-08-14 and 11-0914 by the panel of
inspectors
and
recommends
the
grant of renewal of
DML to the firm

MECOFOL Injection
Each1ml
ampoule
contains:
Mecobalamin
500mcg

Dy No: 2383
dated 12-04-13

Co-Enzyme Vitamin B-12

As per SRO
Pack of 1s

1,50,000/-

IP

Contract Giver
M/s M/s Unison
Chemical
Works
Lahore.
Contract Acceptor
M/s
English
Pharmaceuticals
Lahore

ESUN Injection 40mg

Form-5

Each vial contains:


Sterilized Esomeprazole
Sodium
lyophilized
equivalent
to
Esomeprazole..40mg

Dy No: 3160
dated 17-05-13
1,50,000/As per SRO

PPI
Manufacturer

Contract Giver
M/s M/s Unison
Chemical
Works
Lahore.
Contract Acceptor
M/s
English
Pharmaceuticals

U-MIP Injection 40mg

Form-5

Each vial contains:


Sterilized
Omeprazole
Sodium
lyophilized
equivalent
to
Omeprazole..40mg

Dy No: 3161
dated 17-05-13

Inspection of M/s
Friends
Pharma
Lahore
was
conducted by the
panel of inspectors
on
21-05-14
concluded the firm
GMP compliant.
Liquid
Injection
(general)
section
approval vided letter
No. F.1-18/ 93-Lic
(Vol-II)
(M-227)
dated 17-06-11.
Nexium
of
AstraZeneca
Nexium of BMS
The inspection M/s
English
Pharmaceuticals
Lahore
was
conducted on 14-112012 and 15-112012 by the area FID
and found GMP
complaint
Losec Infusion of
AstraZeneca
Risek
Pharma

of

Getz

1,50,000/As per SRO

The inspection M/s


English

Evidence
of
availability of TOC
and liquid particle
counter
is
not
provided.

a. Quantity of
API
in
master
formulation
needs
rectification.
b. Latest GMP
Inspection
report of M/s
English
Pharma
is
required.
a. Quantity of
API
in
master
formulation
needs
rectification
b. Latest GMP
Inspection

Lahore

PPI
Manufacturer

Contract Giver
M/s
Dyson
Research
Labs,
Lahore.
Contract Acceptor
M/s
English
Pharmaceuticals
Lahore

Contract Giver
M/s
Dyson
Research
Labs,
Lahore.
Contract Acceptor
M/s
English
Pharmaceuticals
Lahore

BEMOX Infusion
Each 250ml contains:
Moxifloxacin
as
hydrochloride.400mg
Fluoroquinolone
Manufacturer

DYPENEM
500mg

Injection

Each vial contains:


Meropenem
trihydrate
equivalent
to
Meropenem500mg
Penicillin Antibiotic
Manufacturer

Contract Giver
M/s
Dyson
Research
Labs,
Lahore.
Contract Acceptor
M/s
English
Pharmaceuticals
Lahore

DYPENEM Injection 1g
Each vial contains:
Meropenem
trihydrate
equivalent
to
Meropenem1g
Penicillin Antibiotic
Manufacturer

Pharmaceuticals
report of M/s
Lahore
was
English
conducted on 14-11Pharma
is
2012 and 15-11required.
2012 by the area FID
and found GMP
complaint
Form-5
Avelox of Bayer a. Specifications of
HealthCare Inc
API needs to be
Dy No: 2417
submitted.
dated: 15-04- Molox Infusion of b. Under
finished
2013
CCL Pharma
product
specifications
1,50,000/assay
method
needs
to
be
As per SRO
submitted.
c. Evidence
of
facility of TOC
analyzer
and
particle
counter
needs
to
be
submitted.
d. Latest
GMP
Inspection report
of M/s English
Pharma is required.
Form-5
Meronem
of a. Evidence
of
AstraZeneca
approval
of
Dy No: 2411
manufacturing
dated: 15-04- Demonem of Rotex
facility for applied
2013
Medica
product needs to be
submitted
50,000/-dated
b. Latest
GMP
15-04-13
Inspection report of
100,000 dated
M/s English Pharma
14-05-13
is required.
As per SRO
Form-5
Dy No: 2412
dated: 15-042013
50,000/-dated
15-04 -13
100,000 dated
14-05-13
As per SRO

Meronem
AstraZeneca

of c. Evidence
of
approval
of
manufacturing
Demonem of Rotex
facility for applied
Medica
product needs to be
submitted
d. Latest
GMP
Inspection report of
M/s English Pharma
is required.

Case No.10.

Replies of deferred applications


Evaluator I

Case No. a: The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s
Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242 nd meeting of the Registration
Board held on 24th 25th February, 2014 for confirmation of approved dosage form (dry powder
suspension or solution) by stringent regulatory bodies.
2.
The firm has now submitted that they have prepared the drugs against LEVAQUIN of
M/s Janssen Pharma USA as oral solution and in parallel conducted accelerated stability
studies. The firm has also submitted revised Form 5 and requested the Board to grant
registration as oral solution.
3.
It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent
regulatory agencies was not submitted by the firm instead comments of some local prescribers in
favor of the same have been submitted.
S/N

Name
and
address
of
manufacturer /
Applicant

M/s
Sami
Pharmaceuticals
(Pvt) Ltd., F-95,
Off. Hub River
Road,
S.I.T.E.,
Karachi.

1. Brand Name
2. Dosage Form
3. Composition
4.
Pharmacological
group

1.Type of Form
2.
Type
of
application
3. Demanded Price /
Pack size
4. Initial date, diary.
5. Date on which fee
becomes complete
according to type of
application
/or
Form
1. Form-5
2. Fast track
3. As per PAC, 60ml.
4. 20/04/2011, 264
(R&I)
5.
24/04/2013
Rs.60,000/-

1.Finished Product
Specification
2. Facility where
drug has to be
manufactured with
status
whether
approved by CLB or
not
3.
Last
GMP
inspection
report
with date & status.
1.
Manufacturers
specification.
2.
Dry
powder
suspension General
Antibiotic available
as per inspection
report
dated
02/05.2013.
3. cGMP report dated
02/05/2013
is
provided
wherein
good level of GMP
compliance
is
reported.

1.
EFFIFLOX
125 mg/5ml
2. Dry powder
suspension
3.
Each 5ml of
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate MS
eq.
to
Levofloxacin
..
125mg
4.
Fluroquinolone.
M/s
Sami 1.
EFFIFLOX 1. Form-5
1.
Manufacturers
Pharmaceuticals
250 mg/5ml
2. Fast track
specification.
(Pvt) Ltd., F-95, 2. Dry powder 3. As per PAC, 60ml. 2.
Dry
powder

Decision in 242nd
Meeting
of
Registration Board

Deferred
for
confirmation
of
approved
dosage
form (dry powder
suspension
or
solution) by stringent
regulatory bodies.

Deferred
for
confirmation
of
approved
dosage

Off. Hub River suspension


Road,
S.I.T.E., 3. Each 5ml of
Karachi.
reconstituted
suspension
contains:
Levofloxacin
Hemihydrate MS
eq.
to
Levofloxacin
..
250mg
4.
Fluroquinolone.

4. 20/04/2011, 263
(R&I)
5.
24/04/2013
Rs.60,000/-

suspension General
Antibiotic available
as per inspection
report
dated
02/05.2013.
3. cGMP report dated
02/05/2013
is
provided
wherein
good level of GMP
compliance
is
reported.

form (dry powder


suspension
or
solution) by stringent
regulatory bodies.

Case No. b:
Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was
deferred in the 243rd meeting of the Registration Board for status of license in light of inspection report
dated 15-04-2013.
2.
The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of
Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its
aforesaid report reached on the following recommendations:
a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson
Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.
b. Recommend the grant of license to the additional tablet Psychotropic Section.
3.
The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated
19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control,
maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules
framed there under.
M/s
Arsons
Pharmaceutical
Industries (Pvt) Ltd.
22 Km Multan
Road off 4 Km
Defence
Road,
Lahore
Anomaly Case:
Capsule (General
Antibiotic)
Vide letter No. F. 114/95 Lic (Vol I)
(M 227) dated
13th June, 2011

DOXICYCLINE
100mg Capsules
Capsule
Each
Capsule
contains:Doxycycline
as
Hyclate..100 mg
Tetracycline

As Per SRO
10 x 10s

Form-5
28-09-2012
2280 R&I
Rs.20,000/-

Vibramycin
100mg
Capsules
US FDA
DOTUR
100mg
Capsule
Novartis

Deferred for status of


lisence
in
light
of
inspection report dated 1504-2013

Case No. c: Following registration application of M/s Araf (Pvt) Ltd., Lahore was deferred in the 242 nd
meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer Saleem.
Now, the firm has informed that same product is already registered in the 214 th meeting of the
Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.
2.

In light of above, firm has requested for registration of their product and to change it to XR.
M/s ARAF (Pvt)
Ltd. (Former M/s
Remedy
Pharmaceutical Pvt
Limited), 23 Km
Raiwind
Road
Lahore.

1. Zaxine SR
150mg tablets 2.
Sustained release
film
coated
tablet
3. Each tablet
contains:
Venlafaxine as
Hydrochloride
. 150mg
4. Serotonin and
Noradrenaline
Reuptake
Inhibitors.

1. Form-5 D
2. Fast track
3. Rs. 1100/- per
14s 4. 30/07/2013,
9209 (R&I)
5. Rs.60,000/- Rs.
90,000/-

1.
B.P.
specifications.
2.
General
Tablet
section available as
per inspection report
dated 19/01/2012.
3. GMP report dated
19/01/2012
attached.

Deferred for expert opinion


of Dr.Rizwan Taj, PIMS;
Brig Jehangeer Saleem

Evaluator - I
S/
N

Name and address


of manufacturer /
Applicant

Brand Name

Decision of Previous Remarks on the


Meeting
formulation (if any)
(Proprietary name Initial
date,
including
+ Dosage Form + diary
International status
Strength)
in stringent drug
Fee including
regulatory agencies /
Composition
differential fee
authorities
Pharmacological
Demanded
Me-too status
Group
Price / Pack
size
GMP
status
as
Finished product
depicted in latest
Specification
inspection
report
(with date) by the
Evaluator

M/s.
P.D.H. Pyrox-B Tablets
Pharmaceuticals,
Lahore
Each
tablet
contains:Piroxicam
Beta
Cyclodextrin
equivalent
to
Piroxicam
.
20mg
(NSAID)
Manufacturers
specifications

Type of Form

Form-5
Fast Track
28/8/2013
9991 R&I
28/8/2013
(Rs. 60,000/-)
Rs.265.22 per
2x10s

Deferred
for
final
reminder for completion
of Form 5

Brexidol,
BNF

Cheisi,

Brexin 20mg, Cheisi


1. An undertaking /
commitment
regarding
the
submission
of
following, as per decision
of the Registration Board,
may be submitted:
a) Label claim and
prescribing information
being same as approved
by
reference
drug
agencies e.g., FDA, TGA,
MHLW, EMA and Health
Canada.
2. Several observations
have been made by the
area FID in the inspection
report dated 05/03/2014
regarding validation of
HVAC, frequency of In
Process
testing,
differential
pressure
maintenance,
old
machinery like fluid bed
dryer, mixer, granulator to
be replaced with latest
version etc.

Inspection
report
dated
30/09/2014
provided.
Firm
showed improvement
regarding
previous
shortcomings
/
observations.

M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.

Giostatin
Tablets

10mg Form 5
Fast Track
12/4/2013 798
Each film coated R&I
tablet contains:13/11/2013
Rosuvastatin
(Rs. 60,000/-)
Calcium equivalent Rs.250/10s
to
Rosuvastatin
..
10mg
Statins
Manufacturers
specifications

M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.

Esogerd
Capsule

20mg Form 5
Fast Track
12/11/2013
Enteric
coated 788 R&I
pellets
12/11/2013
Each
capsule (Rs. 60,000/-)
contains:Rs.231/ 2x7s
Esomeprazole
Magnesium
trihydrate enteric
coated
pellets
equivalent
to
Esomeprazole
..
20mg
Anti-ulcer
Manufacturers

Deferred
for
final
reminder for completion
of Form 5

Crestor 10mg, FDA

1. An undertaking /
commitment
regarding
the
submission
of
following, as per decision
of the Registration Board,
may be submitted:
a) Label claim and
prescribing information
being same as approved
by
reference
drug
agencies e.g., FDA, TGA,
MHLW, EMA and Health
Canada.
2. Several observations
have been made by the
area FID in the inspection
report dated 05/03/2014
regarding validation of
HVAC, frequency of In
Process
testing,
differential
pressure
maintenance,
old
machinery like fluid bed
dryer, mixer, granulator to
be replaced with latest
version etc.

Inspection
report
dated
30/09/2014
provided.
Firm
showed improvement
regarding
previous
shortcomings
/
observations.

Deferred
for
final
reminder for completion
of Form 5

Nexium
20mg
Capsules, FDA

1. An undertaking /
commitment regarding
the
submission
of
following,
as
per
decision
of
the
Registration Board, may
be submitted:
a) Label claim and
prescribing information
being same as approved
by
reference
drug
agencies e.g., FDA,
TGA, MHLW, EMA and
Health Canada.

Rosutrol
Pfizer

Nexum
Capsules

10mg,

20mg,

Inspection
report
dated
30/09/2014
provided.
Firm
showed improvement
regarding
previous
shortcomings
/
observations.
FID mentioned that
automatic
capsule
filling
machine
should be provided in

specifications

2. Several observations capsule filling area.


have been made by the
area
FID
in
the
inspection report dated
05/03/2014
regarding
validation of HVAC,
frequency of In Process
testing,
differential
pressure maintenance,
old machinery like fluid
bed
dryer,
mixer,
granulator to be replaced
with latest version etc.

Source: M/s Vision


Pharmaceuticals,
Islamabad

M/s.
P.D.H
Pharmaceuticals
(Pvt) Ltd., 19 Km,
Ferozpur
Road,
Lahore.

Esogerd
Capsule

40mg Form 5
Fast Track
12/11/2013
Enteric
coated 788 R&I
pellets
12/11/2013
Each
capsule (Rs. 60,000/-)
contains:Rs.360/ 2x7s
Esomeprazole
Magnesium
trihydrate enteric
coated
pellets
equivalent
to
Esomeprazole

40mg
Anti-ulcer
Manufacturers
specifications
Source: M/s Vision
Pharmaceuticals,
Islamabad

M/s
Zanctok Genelor
Pharmaceutical
Syrup
Laboratories, F/5
S.I.T.E
Area,

Form5
Routine

Deferred
for
final
reminder for completion
of Form 5

1. An undertaking /
commitment
regarding
the
submission
of
following, as per decision
of the Registration Board,
may be submitted:
a) Label claim and
prescribing information
being same as approved
by
reference
drug
agencies e.g., FDA, TGA,
MHLW, EMA and Health
Canada.
2. Several observations
have been made by the
area FID in the inspection
report dated 05/03/2014
regarding validation of
HVAC, frequency of In
Process
testing,
differential
pressure
maintenance,
old
machinery like fluid bed
dryer, mixer, granulator to
be replaced with latest
version etc.

Nexium
40mg
Capsules, FDA
Nexum
Capsules

40mg,

Inspection
report
dated
30/09/2014
provided.
Firm
showed improvement
regarding
previous
shortcomings
/
observations.
FID mentioned that
automatic
capsule
filling
machine
should be provided in
capsule filling area.

Deferred
for Firm has informed
confirmation of me too that due to
status
typographic error the

Hyderabad

Each 5ml
Contains:
Desloratadine
2.5mg

23/07/2010
Dy. No. 1411
Rs. 8000/-

Antihistamine

13-05-2013
Rs. 12000/-

Manufacturers
specifications

60ml,120ml/As
per PRC

strength was typed as


5mg/10ml and that
they have corrected
the strength to
2.5mg/5ml. A revised
Form-5 has been
submitted by the
firm.
Clarinex 0.5mg/ml,
Syrup, FDA
Desora 0.5mg/ml
Syrup, Continental
Pharma

M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 E-149,
North
Western
Industrial
Zone,
Port
Qasim,
Karachi.

Relevo
20mg

Sachet Form-5D

Each
contains:

sachet

New License
28-05-2014
810 R&I

Deferred for evidence of


approval
of
same
formulation by reference
drug agencies e.g., FDA,
TGA, MHLW, EMA and
Health Canada.

BREXIN PULVER
20mg powder
Torrex-Chiesi
Pharma,Austria

Deferred for:
1) Evidence of approval
of same formulation by
reference drug agencies
e.g.,
FDA,
TGA,
MHLW,
EMA
and
Health Canada.
2) Stability data.

Now
following
reference in terms of
evidence
of
international
availability has been
submitted:
GAVISCON Liquid
Sachet
MHRA

Piroxicam betaRs. 150 / per


cyclodextrin 191.2
10s
mg eq. to Piroxicam
Rs. 50,000/
20mg

BREXIN
20mg granules for
oral solution (Sachet)
Promedica, Italy

(Manufacturers
Specs)
NSAIDs

M/s
Hiranis
Pharmaceuticals
(Pvt) Ltd., Plot No.
E-145 E-149,
North
Western
Industrial
Zone,
Port
Qasim,
Karachi.

Gastocon Liquid
Sachet
Each 10ml sachet
contains:
Sodium alginate (BP)
500 mg
Sodium bicarbonate

Form-5D
New License
28-05-2014
809 R&I
Rs. 100 / per
10s

(BP) 267mg

Rs. 50,000/-

Calcium carbonate
(BP). 160 mg
(BP Specifications)

Reflux
suppressant/Antacid

M/s
Panadol Sinus
GlaxoSmithKline
Caplets
Pakistan limted, F268
S.I.T.E., Caplets
Karachi
Each Caplet
Contains:
Paracetamol
500mg
Phenylephrine Hcl.
5.00mg

Form 5-D (Fast


Track)
Rs.8,000/09-12-2010
Dy. No. not
mentioned
Rs.60,000/20-03-2013
Dy. No. not
mentioned
Rs.82,000/19-11-2013
Dy. No. not
mentioned
Rs.300/-100s

Registration
Board
referred Panadol sinus
Caplets
to
Pharmaceutical
Evaluation Cell for
scrutinization in light of
check list approved by
Registration Board.

BENYLIN COLD &


SINUS
500/5mg
Health Canada
Inspection dated 0701-2014, 21-01-2014
& 19-02-2014. Well
maintained / retained
unit reported. Tablet
section mentioned in
report.
1. In terms of
Prescribing
information
(PI),
Patient Information
Leaflet (PIL) and
Summary of product
characteristics
(SmPC) as approved
by Drug regulatory
agencies
or
authorities of country
of origin or FDA,
EMA, TGA, etc.,
firm has submitted
international
data
sheet for the product.
2. Data of stability
studies conducted on
three pilot batches at
25C/60%RH,
30C/60%RH,
30C/75%RH
and
40C/75%RH.
However,
it
is
pertinent to mention
that the batches were

manufactured
in
Sydney, Australia as
the raw material and
pharmaceutical
development
was
carried out in firms
R&D
center
in
Australia.

Evaluator II
S/
N

Name and address Brand Name


of manufacturer /
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group

Type of Form

Decision
of Remarks on the formulation (
Previous Meeting any) including Internation
Initial
date,
status in stringent dru
diary
regulatory
agencies
authorities
Fee including
differential fee
Me-too status
Demanded
Price / Pack
size

GMP status as depicted i


latest inspection report (wit
date) by the Evaluator

Finished
product
Specification
M/s Herbion Pakistan
(Pvt) Ltd., Kahuta
Road, industrial
Triangle, Humak,
RawalpindiIslamabad.

LacNovex /
LaxNovex /
ConstiNovex
3.35g Syrup
Each 5ml
contains:Lactulose (BP)
3.35g
(Laxative)
(B.P Spec.s)
{Source
of
Lactulose: M/s
Fresenius Kabi
Austria GmbH
Estermannstra
Be 17 4020
Linz}

Form 5
26-02-2014
Dy.No.208
Rs.20,000+
Rs.80,000/(05-09-2014)
Rs.170.00/
120ml

Deferred for
confirmation of
1. Source &
Fee.
2. Testing
facility by DDG
DRAP and FID
(M-243)

BNF 61 (Lactulose (Non


proprietary)
DUPHALAC(HIGHNOON
LABORATORIES LTD.)

Grant of DML recommende


(23-24th January 2014)

1.The firm has deposited fe


of Rs. 80,000/- an
requested for fixation o
source i.e. M/s Freseniu
Kabi
Austria
Gmb
EstermannstraBe 17 402
Linz.
2.Valid and legalized GM

Certificate of Source, CO
and
stability
studie
according to zone IV-a o
lactulose are required.

-do-

-do-

MonteNovex /
AzmaNovex /
LeukoNovex
5mg Chewable
Tablets
Each chewable
tablet
contains:Montelukast
Sodium BP eq.
to
Montelukast
5mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)
(Manufacturer
s Spec.s)
MonteNovex /
AzmaNovex /
LeukoNovex
10mg
Chewable
Tablets
Each chewable
tablet
contains:Montelukast
Sodium BP eq.
to
Montelukast
.10mg
(Antiasthmatic
Agent
(Leukotriene
Receptor
antagonist)

Form 5
24-02-2014
Dy.No.201

Deferred for
correction in
master
formulation.

Rs.400.00/
14s

24-02-2014
Dy.No.197
Rs.20,000
Rs.460.00/
14s

Aerokast (Barrett Hodgson)

Grant of DML recommende


(23-24th January 2014)

Rs.20,000

Form 5

3.Confirmation of testin
facility by DDG DRA
and FID.
BNF 61: (Singulair (MSD)

1.The firm has correcte


master formulation.

Deferred for
correction in
master
formulation and
confirmation of
international
availability

Not confirmed
Aerokast (Barrett hodgson)

Grant of DML recommende


(23-24th January 2014)

1.The firm has correcte


master formulation.
2.Reference of Internation
availability has been give
from
India
an
Bangladesh.
3.Reference of 5mg chewab
tablets has been give
from Health Canad

(Manufacturer
s Spec.s)
-do-

Neemplast
Plaster
Contains:Acrinol
10.4%
(Disinfectant
and Antiseptic)
(Manufacturer
s)

Form 5
17-03-2014
Dy.No.251
Rs.20,000

Formulation is in film
coated dosage form i
Health Canada.
Not confirmed

Deferred for
confirmation of
me too status and Saniplast (Uniferoz Karachi)
international
availability.
Grant of DML recommende
Rs. 25/
(23-24th January 2014)
1972mm (10
strips)
Rs.
1.The firm has provide
35/1972mm
reference of Saniplast o
(20 strips)
Uniferoz
for
bot
Rs.
international availabilit
160/1972m
and me-too status.
m (100 strips)
2.International
availability no
Rs.
confirmed in stringen
720/1972m
m (500 strips)
DRSs.
3.Discussion is requeste
from honorable Dru
Registration Board abou
the status of formulatio
that whether it is a drug o
HOTC product.

S/
N

Name and address Brand Name


of manufacturer /
(Proprietary
Applicant
name + Dosage
Form
+
Strength)
Composition
Pharmacologic
al Group

Type of Form

Decision
of Remarks on the formulation (
Previous Meeting any) including Internation
Initial
date,
status in stringent dru
diary
regulatory
agencies
authorities
Fee including
differential fee
Me-too status
Demanded
Price / Pack
size

GMP status as depicted i


latest inspection report (wit
date) by the Evaluator

Finished
product
Specification
M/s. Simz
Pharmaceuticals (Pvt)
Ltd, 574-575 Sundar
Industrial Estate,
Raiwind Road
Lahore.

Ibusim DS
200mg
Liquid
Suspension
Each 5ml
contains:Ibuprofen (B.P)
..200mg
(Antirheumatic,
antiinflammatory)
(B.P Spec.s)

Form-5
Rs.20,000/-102-2014
Rs.60.00/90ml

Deferred for
confirmation of
international
availability.
(M-244)

Health Canada: Advil Pediatric


Drops
Brufen DS (Abbot)
GMP compliant (22-11-2013)

1. The product was deferred


because the Firm had not
provided the International
availability especially in
FDA, EMA, Health Canada
TGA & MHLW for same
generic, dosage form &
strength with reference is
required. Firm had provided
Dolan Fp Forte from
Phillipine. Later on same
formulation was approved i
M-245 for M/s Titles
Pharma Karachi because
international availability wa
confirmed. The Firm has
requested to consider their
application for registration.

M/s. Cibex
Batema-F Syrup
(Private) Ltd. Each 15ml
contains:
F-405, SITE, Iron Protein
Karachi
Succinylate
800mg
equivalent to
elemental iron
40mg
Folic Acid5mg
(Anti-Anaemic)
(Manufacturers
Spec.s)

Form-5
30-04-2014
(611)
Rs.20,000/As per
SRO/60ml,
120ml

-do-

Form-5
30-04-2014
(625)
Rs.20,000/As per
SRO/14
Capsules

Cimora 20mg
Capsule
Each Capsule
contains:
Esomeprazole
Magnesium
Trihydrate
enteric coated
pellets equivalent
to
Esomeprazole
20mg
(Anti-Ulcerant)
(Manufacturers
Spec.s)

Deferred for
confirmation of
Me-Too &
International
(especially in
Stringent
Regulatory
Agencies)
registration Status.
(M-245)

Evaluator III

Deferred for
rectification of
following
observation:
1. Fee for import.
2. Legalized and
Valid GMP
3. Certificate of
Analysis
4. Stability Studies
according to zone
assigned to
Pakistan.
(M-245)

Not confirmed
Sucrofer-F Syrup (Nexpharm)
Grant of DML recommended
(22-10-2013)

1.The Firm has submitted th


the product is alread
available
locall
manufactured by CC
under the license o
Nexpharm and the produ
is although not availab
in SRA,s but DRAP ha
granted registration t
several companies. Th
Firm has requested fo
product registration.
BNF: Nexium
(AstraZeneca)
C-ESO (Crown
Pharmaceuticals)
Grant of DML recommended
(22-10-2013)

1.The Firm has submitte


documents for source o
pellets, M/s Surge La
(Pvt. ) Ltd. 10th K.M
Faisalabad
Road
Sheikhupura.
2.cGMP certificate has bee
issued to M/s Surge fo
Enteric
coate
Pellets/Granules and Tas
Masked Granules/ Pellets
3.Evidence of approval o
Esomeprazole
enter
coated pellets by M
Surge is required.

Cases deferred in M-245 meeting


S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Initial date, diary

Composition

Fee
including
differential fee

Pharmacological
Group

Demanded Price /
Pack size

Finished
Specification

M/s Cibex (Pvt)


Limited Karachi.

Type of Form

Decision in 245th
of
Registration
Board.

Me-too status

product

KATAFEN Rapid Gel


1%

GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Form-5
Dated 30/04/14 Dy
No: 602

Each gram contains:Diclofenac


diethylamine.10mg

Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities

Deferred
for
submission
of
finished product
specifications

The firm has submitted


the finished product
specifications
of
applied product.

Deferred
rectification
following
observations:

The firm has submitted


the assay method under
finished
product
specifications
of
applied product.

20,000/-

Anti-Rheumatic

Pack of 1s, 20gm &


50gm/ As per PRC

Manufacturer
-do-

MYBINA Plus Ointment

Form-5

Each gram contains:Polymyxin


sulphate.5000IU
Bacitracin500IU
Neomycin3.5mg
Lidocaine.40mg

Dated 30/04/14 Dy
No: 605

Antibacterial
Manufacturer

20,000/Pack of 1s, 20gm


tube/ As per PRC

for
of

Under
finished
product
specifications
assay method is
not submitted.

M/s.Shawan
Pharmaceuticals, Plot
#37, Road: NS-1,
National Industrial
Zone,
Rawat
Islamabad.

DEXPRO Tablet 300mg

Form 5

Each film coated Tablet


contains:
Dexibuprofen ..
300mg

Fast Track

NSAID

Rs.60,000/-

Manufacturer

As per SRO
Pack of 10s

Dy. No.5246
16-08-2013

dated

Deferred
for
Seractil of Genus
review committee (BNF-61)
for
review of
formulation
Dexib of Tabros Pharma
Karachi
Inspection of the firm
was conducted on 23
July 2013 and GMP
compliance is found
GOOD

Cases deferred in M-242 meeting


S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Initial date, diary

Composition

Fee
including
differential fee

Pharmacological
Group

Demanded Price /
Pack size

Finished
Specification

M/s
Medwell
Pharmaceuticals,
Lawrencepur

Type of Form

Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status

product

GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator

BETADINE Scrub

Form-5

Each 5ml contains:


PovidoneIodine.7.5%

Dy.No: 6382 dated:


07-10-2013
60,000/-

Disinfectant
BP

Decision in 242nd
of
Registration
Board.

As per SRO/ 50ml,


60ml and 450ml
bottle

Deferred as
firm
has
completed
requisite
documentation
Form-5

the
not
the
per

Pyodine of Brookes
Pharma Karachi
The inspection of firm
was carried out on 0104-2014 by the area
FID
and
GMP
compliance was found
good.

Veterinary cases
S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Initial date, diary

Composition

Fee
including
differential fee

Pharmacological
Group

Demanded Price /
Pack size

Finished
Specification

M/s
Jfrin
Pharmaceuticals,
Lasbella Balochistan

Type of Form

Oral

Each 100gm contains:


Tylosin
Tartrate..100mg
Doxycycline
HCL..200mg
Phenyl
Butazone.12gm
Bromohexine
HCL.05gm
Colistin
Sulphate..500MIU

Manufacturer

Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Me-too status

product

JF COLAMINE
Powder

Antibiotic

Decision in 242nd
of
Registration
Board.

GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Form-5
Dy.No: 866 dated: 2407-2013
60,000/Decontrolled/ Jar of
100, 500, 1000gm

Deferred as
firm
has
completed
requisite
documentation
Form-5

the
not
the
per

Broncofas of Zakfas
Pharmaceuticals

Case No. 11.

NEW APPLICATIONS IN LEIU OF REJECTED ONES

Two products of M/s Hiranis Pharmaceuticals are rejected in the 243 rd meeting of Registration Board as
the safety and efficacy has not been established in the stringent SRAs. The firm has submitted new
applications in lieu of the rejected products. The detail is tabulated below:
Sr.
No.
1.

2.

Products Discussed in M243


Acebro
Capsule
(Acebrophylline 100mg)

Acebro syrup
(Acebrophylline
5ml)

50mg/

Decision in M-243

New Products applied

Rejected as safety and


efficacy of formulation has
not been established in
stringent
regulatory
authorities.
Rejected as safety and
efficacy of formulation has
not been established in
stringent
regulatory
authorities.

Fungisaf Capsule
(Fluconazole 150mg)

Levopearl oral suspension


125mg/5ml (Levofloxacin)

The detail of new products is follows:


S/N

Name and address


of manufacturer /
Applicant

Brand Name
(Proprietary name +
Dosage
Form
+
Strength)

Type of Form

Composition

Fee
including
differential fee

Pharmacological
Group

M/s
Hiranis
Pharmaceuticals
Karachi

Finished
Specification

product

FUNGISAF
150mg

Capsule

Each capsule contains


Fluconazole..150mg

Initial
diary

Demanded Price
/ Pack size

Me-too status
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator

Form-5

Diflucan Pfizer Inc

Dy No: 807 dated


28-07-14

Diflucan
Karachi

20,000/Triazole Antifungal
As per PRC
Manufacturer

date,

Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities

of

Pfizer

Recommendations by
the Evaluator

-do-

LEVOPEARL
Solution

Oral

Each 5ml contains:


Levofloxacin
(USP)
.125mg/ 5ml
Quinolone
Manufacturer

Form-5
Dy. No: 2067
dated:16-12-2013
20,000/As per PRC

Levaquin Oral Solution


of Janssen (USFDA)

The
product
was
initially considered as
dry oral suspension in
243rd
meeting
of
Registration Board and
deferred
with
following decision:
Deferred
for
confirmation
of
formulation
The firm then revised
the formulation as
Oral Solution which
was product again
considered in 244th
meeting
of
Registration
Board
and deferred with
decision:
Deferred
as
the
Registration Board has
already granted ten
products in liquid
syrup
section
(general)
The firm has now
requested to consider
applied formulation in
lieu of the rejected
product (Acebro syrup
(Acebrophylline
50mg/ 5ml) in 243rd
meeting of RB

Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.


Registration-I
Case No.01.

Drugs deferred by Registration Board for expert opinion.

a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi

Following drugs deferred for expert opinion. Accordingly product was referred to expert
for views. Comments are as under:S. No.

Name of Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

1.

M/s. Reckitt Benckiser


Healthcare
International,
Karachi. /
M/s. Notting Site,
Nottingham,
Nottinghamshire,
United Kingdom.

Strefen Lozenge
Each one lozenge
contains:Flurbiprofen
BP..8.75mg

Demanded
Price/Pack

Shelf Life

Price not
mentioned.

03 years

Date of
applicatio
n receiving
& fee.
04-06-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-

Dr. M.Ehsan-ul-Haq,
MBBS, DTCD, FCPS,
(Physician (Medicine),
Federal Govt. Services
Hospital, Islamabad.

Prof. Dr. Ejaz Hussain


Malik,
Nishtar Medical Institution,
Multan.

Brig. (R) Prof. Dr.


Muzammil Hasan Najmi,
Chairman, Department of
Pharmacology/Associate
Dean, Basic Sciences
Division, Foundation
University, Medical College,
Rawalpindi.

The drug Strefen Lozenge


containing flurbiprofen BP 8.75
can be useful addition to the list
of pharmaceutical available in
the country. Since the amount of
the active principle is quite small.
It is les likely to cause untoward
dose-related side effects. The
lozenge formulation of this
compound is already in use in the
world market. However the
therapeutic efficacy and the
social
acceptance
in
our
population can only be accessed

I have gone through the literature


of Flurbiprofen. The only is good
and sample and recommended
for registration.

Awaited.

when it is used in our country.


The drug is intended for local use
and has small amount of the
active principle and thus is
expected to be cost effective.

b. AminoFluid Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella

Registration Board in its 238th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.

Name of
Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

Demanded
Price/Pack

Shelf
Life

1.

M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.

Rs.4201/Per
1000ml Soft
bags.

02
years

2.

M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /

AminoFluid Infusion Solution


1000ml
Each 150ml contains:L-Leucine...
2.100g
L-Isoleucine...1.200g
L-Valine.....1.200g
L-Lysine hydrochloride.1.965g
(L-Lysine Equivalent).....(1.573g)
L-Threonine...........................0.855g
L-Tryptophen.0.300g
L-Methionine.0.585g
L-Cystoine.0.150g
L-Phenylalanine.1.050g
L-Tyrosine.....0.075g
L-Arginine.1.575g
L-Histidine.0.750g
L-Alanine...1.200g
L-Proline....0.750g
LSerine
..0.450g
Gylcine...........................0.885
g
L-Aspartic acid..0.150g
L-Glutamic acid.................0.150g
Dipostassium phosphate....0.458g
Water for injection ad.........150ml
(Clinical Parrenteral Nutrition).
Kidmin Injection
Each 1000ml contains:L-Leucine.

Rs.1708/
Per 200ml
bag

02
years

Date of
applicatio
n receiving
& fee.
27-09-2012
Rs.50,000/-

18-10-2012
Rs.15000 +
Rs.35000 =

M/s. PT. Otsuka


Indonesia,
Lawang, Malang.
Indonesia.

3.

M/s Otsuka
Pakistan Ltd.,
Distt. Lasbella. /
M/s. PT. Otsuka
Indonesia,
Lawang, Malang.
Indonesia.

14.0g
L-Isoleucine...9.0g
L-Valine...10.0g
L-Lysine acetate7.1g
(free base)..
(5.05g)
L-Threonine...........................3.5g
L-Tryptophan.....2.5g
L-MEthionine3.0g
L-Phenylalanine.....5.0g
L-Cysteine.1.0g
L-Tyrosin...0.5g
L-Arginine.....4.5g
L-Histidine.....3.5g
L-Alanine...2.5g
L-Proline....3.0g
L-Serine.3.0g
L-Aspartic acid..........................1.0g
L-Glutamic acid.1.0g
(Clinical Parentertal Nutrition).
Amiparen Injection
Each 500ml contains:L-Leucine...
..7.00g
L-Isoleucine.....4.00g
L-Valine...4.00g
Lysine Acetate.7.40g
(L-Lysine equivalent)....(5.25g)
L-Threonine.2.85g
L-Tryptophan...........................1.00g
L-Methionine...........................1.95g
L-Phenylalanine...3.50g
L-Cysteine...0.50g
Total free amino acids50.00g
Essential amino acids (E)..29.55g
Nonessential amino acids (N)20.45g
Total nitrogen..7.84g
L-Tyrosine...........................0.25g
L-Arginine...5.25g
L-Histidine...2.50g
L-Alanine.4.00g
L-Proline..2.50g
L-Serine...1.50g
Aminoacetic acid.2.95g
L-Aspartic Acid.......................0.50g
L-Glutamic acid.......................0.50g
Water for injectionad 500mL
(Clinical Parenteral Nutrition).

Rs.50,000/-

Rs.2512/
Per 500ml
Bag

02
years

24-09-2012
Rs.15000 +
Rs.35000 =
Rs.50,000/-

In charge Intensive Care Unit


(ICU),
Pakistan Institute of Medical Sciences,
Islamabad.

In charge Intensive Care Unit


(ICU),
Military Hospital,
Rawalpindi.

I have evaluated the data provided by Otsuka Pakistan


Limited concerning AminoFluid 1000ml dual
chamber soft bags, Kidmin Injection 200ml soft bag
and Amiparen Injection 500ml soft bag. I have
found that the scientific data supports the therapeutic
efficacy and favorable safety profile. I recommended
that this drug be registered according to the drug
authority regulations.

Awaited

Submitted for consideration of the Drug Registration Board.


c. Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad
Registration Board in its 243rd meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.

Name of
Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

Demanded
Price/Pack

Shelf
Life

1.

Propilen Surgical Suture with


Needle

As per PRC

05
years

2.

M/s. Nishat
Surgical
Hyderabad Sindh
Pakistan
manufactured by
M/s. Dogsan
Tibbi Malzeme
Sanayi A.S.
Trabzon Turkey.
-do-

Date of
application
receiving &
fee.
26-03-2012
Rs.100,000/-

Silk Non Absorbable Surgical


Sutures

As per PRC

05
years

26-03-2012
Rs.100,000/-

3.

-do-

As per PRC

05
years

26-03-2012
Rs.100,000/-

4.

-do-

Pegelak and Pegelak Rapid


Synthetic Absorbable
Surgical Sutures with Needle
Tektel Non Absorbable
Surgical Sutures with Needle

As per PRC

05
years

26-03-2012
Rs.100,000/-

5.

-do-

Pedesente Synthetic

As per PRC

05

26-03-2012

6.

-do-

Absorbable Surgical Sutures


with Needle
Pegesorb and Pegesorb Rapid
Synthetic Absorbable
Surgical Sutures with Needle

Professor Tanwir Khaliq,


Professor
of
Surgery,
Department of General
Surgery, Pakistan Institute
of
Medical
Sciences,
Islamabad.
We have used the surgical
sutures in our procedures. The
tissue penetration, needle,
suture strength, pliability and
knotting quality have been
found satisfactory.

As per PRC

years

Rs.100,000/-

05
years

26-03-2012
Rs.100,000/-

Dr. I.U Baig, FCPS FRCS,


Consultant Surgeon &
HOD, Federal Government
Polyclinic, Islamabad.

Lt. Col. Dr. Farhan Ahmad


Majeed, Surgeon, Combined
Military Hospital,
Rawalpindi

Samples of sutures supplied


by M/s. Nishat Surgical
Hyderabad Sindh Pakistan
manufactured by M/s. Dogsan
Tibbi Malzeme Sanayi A.S.
Trabzon
Turkey
were
used/tested by me and by my
surgeons at FGPC and our
observations regarding the
surgical sutures are :
1.Sterile packing is good.
2.Tensile strength of sutures of
their appropriate types and
sizes is good.
3.Needle anchorage is fine.
4.Needle quality is good.
5.Tissue reaction to sutures is
according to standard.
6.No allergic reaction to
suture material.
7.No postoperative infections
nooted.
In light of above observations
I recommend sutures namely;
Propilen, Silk, Pegalak and
Pegalak
Rapi,
Tektel,
Pedesente and Pegesorb and
Pegesorb Rapid.

Surgical sutures
Nishat Surgical
Sindh
Pakistan
unsatisfactory
specially size of
dispropertmat with
(dia).

Submitted for consideration of the Drug Registration Board.

of M/s.
Hyderabad
are
of
quality,
needle is
thread size

d. Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi
Registration Board in its 244th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.

Name of
Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

Demanded
Price/Pack

Shelf
Life

1.

Applicant:
M/s. Ali Gohar &
Co. (Pvt) Ltd.,
Karachi. /
Manufacturer:
M/s. S.A. AlconCouvreur N.V.
Rijksweg 14,
2870 Puurs,
Belgium.

Azarga Eye Drop Suspension


5ml
Each ml contains:Brinzolamide......10mg
Timolol...............4mg
(Beta Blocking agents).
Finished product
specifications are
Manufacturer.

Rs.1400/
5ml Eye
Drops
packs

24
month
s

Date of
application
receiving &
fee.
02-03-2010
Rs.50, 000/-

Prof. Dr. M. Daud Khan,


Principal & Dean,
Pak International Medical
College, Hayatabad,
Peshawar.

Prof.Dr. Ali Raza,


Head of Eye Department,
RMC and Allied Hospitals,
Rawalpindi.

Maj. Gen. Mazhar Ishaq,


Commandant,
Armed Forces Institute of
Opthalmology,
The Mall, Rawalpindi.

Alcon International is the


leading
international
pharmaceutical
company
dealing with Ophthalmic
drugs and devices. Alcon
drugs are known for quality,
safety and efficacy. Azarga
Eye Drops, which is a
combination of a beta blocker
and
carbonic
anhydrase
inhibitor. It is registered by
FDA and has many studies in
support of its safety, efficacy
and effectiveness. The price
seems to be reasonably
comparable to other antiglaucoma drugs. I therefore

I have reviewed the literature


& references relating to the
above mentioned product with
regard to its safety, efficacy &
cost effectiveness. Azarga
(Brinzolamide, Timolol) is
most comfortable Eye Drops
preferred by patient then
Dorzolomide/Timolol
combination. I have gone
through all references which
have been published in
renowned
International
Medical Journals on regular
intervals. As you all know that
Glaucoma is a second leading
cause of irreversible blindness

Azarga
(Brinzolamide,
Timolol) is already being used
internationally
for
the
management of Glaucoma &
all references given by them
have been published in peer
reviewed
international
Medical Journals on regular
basis. It has a very good
efficacy and is well tolerated
by the patients.
Therefore in the light of data
provided I recommend this
drug for registration in
Pakistan.

recommend that the drug may worldwide & as well as in


kindly be registered in Pakistan & patient has to use
Pakistan.
lifelong. So it needs excellent
tolerability & efficacy both.
We need this product in
Pakistan for the preservation
of sight and prevention of
blindness with Glaucoma. I
always trust the quality of
innovative products & Brands.
I highly recommend this drug
for registration & made
available in Pakistan.

Submitted for consideration of the Drug Registration Board.


e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg
Registration Board in its 245th meeting deferred following products for expert opinion.
Accordingly products were referred for views. Comments are as under:S.
No.

Name of Indenter/
Manufacturer

Name of drug (s)/


Composition
& Therapeutic Group

1.

M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.
M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.

2.

Demanded
Price/Pack

Shelf
Life

Hidrasec 10mg Sachet


Each sachet contains:Racecadotril10mg
(Anti-Diarrheal).

Rs.1046.30/Pe
r 16 Sachets

24
month
s

Hidrasec 30mg Sachet


Each sachet contains:Racecadotril.30mg
(Anti-Diarrheal).

Rs.1046.30/Pe
r 16 Sachets

24
month
s

Date of
application
receiving &
fee.
29-04-2013
Rs.100,000/-

29-04-2013
Rs.100,000/-

3.

M/s. Abbott
Laboratories
(Pakistan) Limited,
Karachi. /
M/s. Laboratoires
SOPHARTEX 21
Rue du Pressoir
Vernouillet,
France.

Hidrasec 100mg
Capsules
Each capsule contains:Racecadotril.100mg
(Anti-Diarrheal).

Prof.Dr. Rauf Niazi,


Head of Unit-2
Pakistan Institute of Medical
Sciences,
Islamabad.
I
strongly
recommend
registration of that Raceadotril
(acetorphan), Capsules and
Sachets, however if the price
of the drug can be brought
down, keeping in mind the
economic status of our
population these drugs would
be very useful addition, to
present drugs, available to
treat acute secretory diarrhea
and reduce morbidity of this
common condition. I highly
recommend registration of the
drug, on fast track basis.

Rs.654/
Per 10
Capsules

Prof.Dr. Syed Irfan Ahmed,


Professor of Medicine,
RMC & Allied Hospitals,
Benazir Bhutto Hospital,
Murree Road, Rawalpindi.
Hidrasec is recommended for
registration for the treatment
of diarrhea in conjunction
with ORS. However it should
not be used to treat infections.
Even in Cholera, which
requires
antibiotics
and
intravenous saline, it should
be used with caution as severe
fluid depletion can be a Prerenal cause of renal failure.
Hidrasec has a renal mode
excretion. Also no studies
have
been
conducted
comparing its safety profile
with Zinc or probiotics. Hence
it can not be claimed superior
to these modes of treatment.

24
month
s

29-04-2013
Rs.100,000/-

Brig.Amjad Salamat,
Military Hospital,
Rawalpindi.

Awaited.

Submitted for consideration of the Drug Registration Board.

Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo
(Pvt) Ltd, Karachi.
Drug Registration Board in 236th meeting held on 20th November, 2012 approved the
registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured
by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,
Nanjing, China subject to inspection of manufacturer abroad:S. No.
1.
2.
3.
4.

Name of drug (s) & composition.


Oncodex 20mg Injection.
Each vial contains:Docetaxel20mg.
Oncodex 40mg Injection.
Each vial contains:Docetaxel40mg.
Oncodex 80mg Injection.
Each vial contains:Docetaxel80mg.
Oncotaxel 100mg Injection.
Each vial contains:Paclitaxel100mg.

In compliance of Drug Registration Boards decision, inspection of the manufacturer M/s.


Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park, Nanjing,
China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director
General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory
Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit separate solvent
application for each product. The panel of inspector has recommended the registration of the
above said products. The storage facility of the importer has already been verified by the area
FID.
In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same
solvent with same composition is being used in all three strengths of docetaxel range with final
concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart
depicting the fill range, approximate extractable volume and final concentration of the product
i.e. 10mg/ml:PRODCUT
NAME

DILUENT 13%
(W/W)

APPROXIMATE
EXTRACTABLE

CONCENTRATION
OF THE INITIAL

ETHANOL IN
WATER FOR
INJECTION
FILL RANGE
(ML)
DOCETAXEL
20MG INJECTION
DOCETAXEL
40MG INJECTION
DOCETAXEL
80MG INJECTION

DILUTED
SOLUTION
(MG/ML
DOCETAXEL)

3.88 3.08 ml

VOLUME OF
DILUENT WHEN
ENTIRE
CONTENTS ARE
WITHDRAWN
(ML)
1.8 ml

3.60 3.86 ml

3.66 ml

10mg/ml

6.96 7.70 ml

7.1 ml

10mg/ml

10mg/ml

M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent
application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted
separate solvent application for each three strengths.
Submitted for consideration of the Drug Registration Board.
Case No.03. Drugs deferred by Registration Board for submission of documents.
a.

Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.


Drug Registration Board deferred the following applications for registration of drugs in

its 243rd meeting and decided as mentioned against each. Accordingly, firm was advised to
provide the same information and the firm has submitted the required information as follows:-

S.#

1.

Name of
Manufacturer /
Importer.

M/s. Novartis
Pharma (Pakistan)
Limited,
Karachi /
M/s. Mipharm
S.p.A., Milan,
Italy.

Name of Drug Demand Shelf


ed
(s)
Life
Composition &
Price &
Therapeutic
Pack
Group.
Size.
Caflam 50mg
Sachets
Each sachet
contains:Diclofenac
potassium
50mg
(Non-steroidal
anti-inflammatory

Rs.198/
Per
packs of
9s
Rs.22/Pe
r Sachet

02
years

Decision

Reply of
the firm.

Deferred
for
submissio
n of COPP
from
regulatory
authority
of Italy

The firm
has
provided
COPP of
Italy
attested by
Pakistan
Embassy.

drug (NSAID)
Analgesic.

Submitted for consideration of the Drug Registration Board.


b.

Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,


Lahore.
Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 considered and

deferred the application of Fluimucil A 600mg Effervescent Tablets (Acetylcysteine 600mg)


applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s. Zambon
Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of the drug
along with complete clinical trial data of the formulation.
Name of Importer /
Manufacturer.

M/s. Angelini
Pharmaceuticals (Pvt)
Ltd., Lahore /
M/s. Zambon
Switzerland Ltd.,
Cadempino,
Switzerland.

Name
of
Drug
Composition
Therapeutic Group.

(s)
&

Fluimucil
A
600mg
Effervescent Tablets.
Each tablets contains:Acetylcysteine........600mg.
(Mucolytics).

Demanded

Shelf Life

Price & Pack


Size.

Rs.561.41/Per
packs of 10
effervescent
tablets.

03 years

Rs.56.14/Per
effervescent
tablets.

Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide
the same. The firm has submitted the documents safety and efficacy data, which needs
deliberation by the Board.
Case No. 04. Registration of imported Inspections of manufacturing units abroad
thereof.
a. Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi.

Drug Registration Board in its 228th meeting held on 12th - 13th October, 2010 approved
the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,
subject to inspection of manufacturer abroad:S. No.
1.
2.

Name of Drug (s) Composition.


PacliBar Injection 30mg.
Each 5ml vial contains:Paclitaxel30mg USP Specs.
PacliBar Injection 100mg.
Each 16.7ml vial contains:Paclitaxel100mg USP Specs.

Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board
and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze River
Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan (Private)
Limited, Karachi was informed for arranging the inspection.
In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed
that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more
interested in getting these products registered in Pakistan due to much delay in the process.
Therefore, the firm has requested for withdrawing the cases for registration of the above
mentioned products.
Submitted for consideration of the Drug Registration Board.
b.

Registration of imported drugs Comments of panel of inspectors.


Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the

registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi
manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongroku, Seoul, Korea, subject to inspection of manufacturer abroad:S. No.
1.

Name of Drug (s) &


Composition.

Fee
deposited.

Price approved by the Price


Advisory Committee.

A.D. Mycin Injection 10mg.

Rs.100,000

Rs.430.00/Per vial.

Each 5ml vial contains:Doxorubicin HCI.10mg.


2.

A.D. Mycin Injection 50mg.


Each 25ml vial contains:Doxorubicin HCI.50mg.

Rs.100,000

Rs.1716.00/Per vial.

3.

E.P. Mycin Injection 10mg.


Each 5ml vial contains:Epirubicin HCI10mg.

Rs.100,000

Rs.670.00Per vial.

4.

E.P. Mycin Injection 50mg.


Each 25ml vial contains:Epirubicin HCI....50mg.

Rs.100,000

Rs.2500.00/Per vial.

5.

Neotabine Injection 1gm.


Each vial contains:Gemcitabine HCI.1.14gm.

Rs.100,000

Rs.8330.00/Per vial.

6.

Neotabine Injection 200mg.


Each vial contains:Gemcitabine HCI.228mg.

Rs.100,000

Rs.1675.00/Per vial.

In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,
Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated
panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem
Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.
The panel of inspectors has recommended the registration of the above said products with the
remarks that registration of the applied products is recommended however import to Pakistan
should be allowed only after confirmation of successful execution of the desired improvement.
The storage facility of the importer has already been verified by the Area FID.
With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi
and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,
Islamabad were requested to inform about type of short coming pointed out whether these are
critical in nature affecting the quality of the product or suggestive / advisory nature for further
processing the case.

In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm
was thoroughly inspected for facilities regarding the production, quality control and storage of
their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based
assessment of the facilities of the firm identified a number of critical, major and minor
observations which can adversely affect the quality of the products intended for registration in
Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical
observations which need be rectified in any stance along with the other stated observations
before importing these products in Pakistan.
The panel informed that the certain observations are very critical and can affect the quality of
the product which is very serious threat for the patients to whom use these products. It should be
the duty of the panel of experts should gave the clear recommendation in light of observation, in
light of these serious observations the panel also recommended these products in final
recommendation, which is not understandable.
Submitted for consideration of Drug Registration Board.
c. Registration of imported drug Issuance of registration letter after inspection of
manufacturer abroad.
i.

M/s. Laderly Bio-Tech Pharma, Karachi

Drug Registration Board in its 244th meeting held on 22-23rd July, 2014 approved the
registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,
manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang
City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities
and price fixation / calculation etc as per policy:S.#

Name of drug (s)/Composition.

Fee deposited.

1.

Meropeon Injection 0.5gm.


Each vial contains: Meropenem USP 0.5gm.

Rs.100000

Prices approved by
the Price
Recommendatory
Committee
Rs.600/Per vial

2.

Meropeon Injection 1gm.


Each vial contains: Meropenem USP 1gm.

Rs.100000

Rs.1100/Per vial.

Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical


(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has
already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director
General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory
Authority of Pakistan. The panel of inspectors has recommended the registration of the above
said products.
Submitted for consideration of Drug Registration Board.
ii.

M/s. Pak China International, Karachi.

Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved
the registration of following drug in the name of M/s. Pak China International, Karachi
manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,
Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,
China subject to inspection of manufacturer abroad, verification of storage facilities and price
fixation / calculation etc as per policy:S.#
1.

Name of drug (s)/Composition.


Sodium Ringer Lactate Injection.
Each 500ml bottle contains:Sodium Chloride.......................3.0gm.
Sodium Lactate, Anhydrous1.55gm.
Potassium Chloride .....................0.15gm.
Calcium Chloride............................0.1gm.

Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888
Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated
panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,
Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors
has recommended the registration of the above said product.
Submitted for consideration of Drug Registration Board.

Case No. 05. Change of manufacturing site of imported registered drug.


a. Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change
of source of manufacturing & supply of their registered imported drug Duac Gel (Reg.
No.043090) from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,
Barnard Castle, UK.
The firm has deposited fee Rs.50000/- and submitted following supporting documents:i)
ii)
iii)
iv)

Original legalized CPP from new source.


Supporting letter from endorsing source change.
Copy of initial registration letter.
Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,
Karachi.
M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee
as per revised Schedule-F for change of source of Duac Gel (Reg. No.043090) and status of
registration with EMA, US-FDA, Japan & Australia.
In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee
as per revised fee structure given in SRO 1117 (I) 2012.
The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized
Certificate of Pharmaceutical Product of Duac Gel issued by Australian Regulatory Authority.
The firm has submitted the all document and required fee as per approved policy of the
Drug Registration Board. Submitted for consideration of the Drug Registration Board.
Case No.06

Transfer of registered drugs.

a. M/s. Getz Pharma (Pvt) Limited, Karachi.


M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the
under-mentioned registered imported drugs from the name of previous importer M/s. Abbott
Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.
AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: S. No.

Reg. No.

1.

015532

Name of Drugs.

Name of Manufacturer.

Survanta Suspension 8ml.

M/s. Abbvie Inc., North Chicago, IL 60064,


USA.

2.

059025

Survanta Suspension 4ml.

3.

011081

Forane Liquid for Inhalation


100ml.

4.

027374

Sevorane Volatile Liquid for


Inhalation 250ml.

M/s.

Getz

Pharma

(Pvt)

Limited,

-doManufactured by:M/s. Aescia Queenborough Limited, U.K.


Marketing Authorization Holder:M/s. Abbvie Limited, U.K.
-do-

Karachi

have

deposited

required

fee

Rs.100000x4=400000/- and submitted the following documents:i)


ii)
iii)
iv)
v)
vi)
vii)
viii)
ix)
x)

Legalized CoPP / GMP Certificate of Survanta Suspension 4ml.


Legalized CoPP of Forane Liquid for Inhalation 100ml.
Legalized GMP Certificate of Forane Liquid for Inhalation 100ml.
Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml.
Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml.
Legalized Termination letter from M/s. AbbVie.
Legalized Authorization letter from M/s. AbbVie
No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,
Karachi.
Registration applications on Form-5-A.
Copy of NOC for CRF.

Submitted for consideration of Drug Registration Board.


b. Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi
M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a
registered drug Xenetix 350mg/ml Solution for Injection (Reg. No.027353) manufactured by
M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,
Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their
distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.
Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in
vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25 th May 2009 either to
submit their NOC in this regard or provide their fresh agency agreement (if any) with the
manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.
Then a show cause notice was issued to them on 29 th July 2009 to submit reply within 15 days
but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to
ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal

Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs
Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and
written reminder thereafter, the firm did not respond to the queries sought.
M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per
revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.
The firm has applied for the renewal neither on time nor after the expiry of the time till to
date. Therefore, the registration is not valid and cannot be transferred.
Submitted for consideration of Drug Registration Board.
Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott
Laboratories (Pakistan) Limited, Karachi
M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of
registration of the under-mentioned registered imported drugs from the name of previous
importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International
Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been
acquired by the Abbott group since February 15, 2010: S#

Reg. No.

1.

018552

2.

018551

3.

018550

Name of Drugs.

Existing Name of
New Name of
Manufacturer.
Manufacturer.
Physiotens 0.2mg
M/s. Eli Lilly S.A., Manufactured by:
Tablets.
Spain.
M/s. Rottendrof Pharma
GmbH, Germany.
Packed by: M/s. Abbott Healthcare
SAS, France.
Physiotens 0.3mg
-do-doTablets.
Physiotens
Tablets.

0.4mg

-do-

-do-

They have deposited required fee and following supporting documents: i)


ii)
iii)
iv)

Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
Copy of the acknowledgement of last renewal of registration of the products
applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore.
Copies of acknowledgement of receipt issued by the German National authority
BfArM & a notification submitted by the Solvay to the Germany authority for the
change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.
Copy of NOC for CRF.

Drug Registration Board in its 239th meeting held on 12th September, 2013 approved the
transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories
(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,
Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished
products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master
file of both sites and panel will inspect the manufacturing sites as well to comply the provisions
of import policy. The Board authorized its chairman to accord approval for issuance of letter
after compliance of aforementioned provisions.
As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)
Limited, Karachi have submitted site master files of both sites attested by an authorized person
of the company.
M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the
Form-5 (A), legalized CoPPs of both Germany and French sources.
In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form
5(A) and following documents for an intermediate International Change of Manufacturing from
M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:i)

CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.

ii)

GMP of the regulatory authority for the manufacturing site legalized by Pakistan
Embassy.

iii)

Justification of Change.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both
manufacturing and release site will be M/s. Abbott Healthcare SAS, France.
This case was discussed in 239th meeting of the Drug Registration Board for the change
of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,
Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested
that all the manufacturing and packaging steps will be carried out at M/s. Abbott Healthcare
SAS, France and for which they have submitted documents as per SOP. Under the Drugs Act,
1976 there is no provision for transfer of registration from one company to another.

Submitted for consideration of the Drug Registration Board.


Case No.08
a.

Change in name of manufacturer.

Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.
M/s. Martin Dow Limited, Karachi has requested to approve the change of

manufacturer name of their following registered imported drugs as follows:S#

Reg. No.

1.

015557

2.

015556

Name of Drug (s)

Current Name of
Manufacturer.
Rocaltrol Capsules M/s. R.P Scherer GmbH,
0.25mcg.
Germany.

Rocaltrol Capsules
0.5mcg.

-do-

New Proposed Name


of Manufacturer.
M/s.
Catalent
Germany
Eberbach
GmbH,
Gammelsbacher
Strasse 2
69412 Eberbach /
Baden, Germany.
-do-

The firm have deposited required fee Rs.100000x2=200000/- and submitted following
supporting documents:i)
ii)
iii)
iv)
v)

Copy of registration letter.


Copy of transfer of registration letter.
Copy of change in manufacturing site.
Copy of NOC for CRF clearance.
Original and legalized CoPP as per WHO format.

M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German
authority as the above said products are being manufactured in Germany and Certificate of Swiss
Medica is irrelevant.
In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules
0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,
Switzerland, under contract manufacturing arrangement with

M/s. R.P Scherer GmbH,

Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for
Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of
Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol
in Germany as such German authorities cannot issue CoPP for the product not marketed by the

company in Germany.
The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules
0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from
Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.
The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is
changed from R.P. Scherer GmbH & Co. KG to Catalent Germany Eberbach GmbH. The
physical address of the facility, the manufacturing process and quality controls for the capsules
as well as the personnel producing & testing of the capsules remains unchanged.
The manufacturing site of the product Rocaltrol Capsules is located in Germany but the
firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked
them but they have not provided the same. The CoPP of country of origin is mandatory for such
approval.
Submitted for consideration of Drug Registration Board.

Case No.09

Exemption from the Drugs (Labeling & Packing) Rules, 1976.

b. Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan


Limited, Karachi.
M/s. Roche Pakistan Limited, Karachi have informed that Kytril Ampoule 3mg/3ml
(Reg. No.020691) was registered in the name of M/s. SmithKline & French Pakistan Limited,
Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche
Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their
principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports
/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption
from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November
10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,
i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu
instructions are being overprinted on the secondary carton using an ink-jet printer.
Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of Kytril
Ampoules in Islamabad, (1000 packs) and have been advised by the concerned ADC to past

stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual
ampoules of the 5s pack. Following find few facts which would reveal that individual ampoule
sticker pasting would be detrimental to the 5s pack and the product:i)

Its a Neo-top secondary carton, (5s pack) with perforated seal, and if open once the
temper evident seal / integrity of the pack would be compromised.

ii)

Pasting of stickers is not possible due to the limited space available on the 3ml
ampoule as the sticker would mask the primary label, hiding the critical information
on the primary label, (ampoule photo attached).

iii)

There would be high risk of ampoule breakage during the excessive handling of the
pack after opening it and while carrying out the manual process of sticker pasting.
Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have

requested for an exemption of overprinting of the primary label (ampoule), since the secondary
label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)
Rules 1986 by ink-jet printing.
M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and
submitted following supporting documents:i)
ii)
iii)
iv)
v)

Copy of transfer of registration letter.


Copy of initial registration letter.
Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986.
Copy of last renewal status.
Copy of labels.

Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in


3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs
(Labeling & Packing) Rules 1986.
Submitted for consideration of Drug Registration Board.
Case No.10

Extension in shelf life of registered drugs.

a. Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn.
No.043068.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the

extension of shelf life of their following registered imported drugs from 24 months to 36 months.
As the current stability studies conducted on this product confirms that the product is well stable
when tested at 36 months time interval:S. No.
1.
2.

Reg. No.
066174
043068

Name of Product.
Alimta 100mg Injection.
Alimta 500mg Injection.

The firm has deposited required fee Rs.5000x2=10,000/- and submitted following
supporting documents:i)
ii)

Copy of registration letter of Alimta 100mg Injection.


Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.

iii)
iv)

Copy of registration letter of Alimta 500mg Injection.


Copy of the acknowledgement of last renewal of registration of Alimta 500mg
Injection.
Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having
approved shelf life of 36 months.
Copies of Stability Studies.
M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether

v)
vi)

stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. EliLilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data
was conducted for Zone-IV and approved by FDA. They have further submitted that original
CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA
specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability
data. Therefore, Zone IV stability data should be considered as approved by the FDA.
As per practice in vogue views of following experts regarding extension of shelf lives of
the products has been obtained:S. No.
1.

2.

Name of Expert.
Prof. Dr. Zafar Iqbal,
Chairman, Department of Pharmacy,
University of Peshawar,
Peshawar.
Dr. Farzana Chowdhary,
Director, Department of Pharmacy,
University of Veterinary & Animal

Opinion
Recommended

Extension in shelf-lives is recommended


on condition that they will be available
only in hospitals / institutions specialized

Sciences, Lahore.
3.

for the treatment of cancer.

Jamil Anwar,
Director,
Drugs Testing Laboratory,
Punjab, Lahore.

Recommended

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these
Pemetrexed containing products are meant for malignant pleural mesotheliona, which indicate
it is a specialized product for tertiary care institution. The one of the expert indicate these
products should be available only in hospitals / institutions specialized for the treatment of
cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to
institution / hospitals or also available in retail out lets as well.
In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta
(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and
malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in
Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of
registration, no restrictions were imposed on the availability of Alimta. They have authorized
their distributor to provide Alimta to hospitals / institutions specialized for the treatment of
Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.
Submitted for consideration of Drug Registration Board.

Case No.11.

Resemblance of brand name Personal hearing thereof.

M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of
brand name of imported drug OZOL-40 Infusion (Reg. No.044854) imported by M/s. United
International, Karachi with the brand name of their already registered locally manufactured drug
O-Zole Capsules 40mg (Reg. No.043642). M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore
submitted that they are facing problems in marketing the product, time and again, and it will be
even more aggravated if the situation continues. Therefore they have humbly requested to take a
check on the situation and to strictly instruct M/s. United International, Karachi to change their
brand name as early as possible, so that they could continue marketing their product smoothly

and without apprehensions.


Accordingly, M/s. United International, Karachi was advised to propose at least three
distinguished alternate names of their drug other than the existing name. Also, submit an
undertaking that the new proposed brands do not have resemblance with any already registered
drug.
In response, M/s. United International, Karachi have submitted that they had been
granted the registration of product OZOL-40 Infusion (Reg. No.044854) on 9 th February, 2007,
i.e. more than seven years before and the said product is already being marketed by them for
more than seven years, therefore, their product is strongly recognized and accepted by their
prevailing customers in the market with the said name since they have incurred substantial
marketing expenditures to create awareness among the customers about the product with the said
brand name. They have therefore requested to consider the additional fact that the nature of the
products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is
different, meaning that the product traded by them is an Injection whereas the product traded by
M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,
Karachi has requested to continue trading of the said product with the same brand name, keeping
in view the these facts.
Registration Board took serious note of firm for not complying the instructions for
change of brand name. The Board decided to suspend the import of OZOL-40 Infusion (Reg.
No.044854) imported by M/s. United International, Karachi immediately and call the firms
representative in next meeting for personal hearing.
Accordingly, the importer M/s. United International, Karachi has been advised to suspend
the import of OZOL-40 Infusion (Reg. No.044854) imported by them immediately, till the
change of name of the product and called for personal hearing in this meeting.
Submitted for consideration of Drug Registration Board.
Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.
Registration Board in its 243rd meeting held on 08th -09th May, 2014 referred all veterinary
applications to a committed comprises of Dr. Muhammad Arshad, Member Registration Board,
Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology Department Arid University
Rawalpindi for expert opinion. The recommendations of expert are as under:-

S. No.

Name of Importer/
Manufacturer.

Name of Drug (s)/Composition.

Recommendations
of Dr. Muhammad
Ashraf, UVAS,
Lahore

Recommendations
of Dr. Muhammad
Arshad, Member
R.B

Recommendatio
ns of Head of
Pharmacology
Department
Arid University
Rawalpindi

1.

M/s. Ghazi Brothers,


Karachi-75350 /
Product License
Holder:M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Manufacturer Under
Product License
Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3Peru.

Metri-CEF 3 Intrauterine
Suspension
Each 30ml contains:Cephalexin monohydrate
(Base).....600mg
Neomycin sulfate (Base)
1.02gm
Cloxacillin
benzathine...1.50gm
Vitamin A.....30.000 IU

Recommended

He endorsed the
recommendations
of Dr. Muhammad
Ashraf.

Dr. Mazhar ul
Haq
Wrote to this
office I am
unable to put
my opinion on
said drugs due
to
certain
unavoidable
reasons.

2.

M/s. Ghazi Brothers,


Karachi-75350 /
Product License
Holder:M/s. Agrovet Market
S.A., San Luis, Lima,
Peru.
Manufacturer Under
Product License
Holder:M/s. Pharmadix Corp.
S.A.C. Urbanizacion La
Aurora-Ate Lima 3Peru.

Catofos B9 + B12 Injectable


Solution
Each ml contains:Butaphosphan100mg
Vitamin B9 (Folic Acid)..15mg
Vitamin B12
(Cyanocobalamin).0.05mg
(Vitamin and Mineral).

Recommended

3.

M/s. Ghazi Brothers,


Karachi. /
M/s. Vetanco S.A.
Buenos Aires,
Argentina.

Recommended

4.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,

Ketoxilen Injection
Each 100ml contains:Oxytetracycline...20gm
Ketoprofen3gm
(Antibiotic/Antiinflammatory).
Geslong Injection
Each ml of solution contains:Metoclopramide HCI5mg
(Antiemetic/ Gastroprokinetic).
Cheil Tonocomp Injection
Each ml of solution contains:Toldimfos sodium200mg

Recommended

5.

Recommended

6.

7.

Moknae-Dong, AnsanSi, Gyeonggi-Do,


Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Cheilbio Co. Ltd.,
Moknae-Dong, AnsanSi, Gyeonggi-Do,
Korea.

8.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.

9.

M/s. Ghazi Brothers,


Karachi. /
M/s. Cheilbio Co.
Ltd.Gyeonggi-Do,
Korea.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng
Pharmaceutical Co.
Ltd., Shijiazhuang City,
Hebei Province, China.
M/s. Ghazi Brothers,
Karachi. /
M/s. Hebei Yuanzheng

10.

11.

12.

13.

Seletoco Injection
Each ml of solution contains:Vitamin E acetate..100mg
Sodium Selenite1mg
(Nutritional additive).

Recommended

Procillin-LA Injection
Each ml contains:Pencillin G
Benzathine 1,00,000 IU
Penicillin G Procaine
1,00,000 IU
Dihydrostreptomycin sulfate
200mg
(Antibacterial).
Oxyneo Powder
Each 1 Kg contains:Oxytetracycline Quaternary
Ammonium Salts110gm
Neomycin sulfate...110gm
(Antibiotic).
Oxyone Powder
Each 1 Kg contains:Oxytetracycline Quaternary
Ammonium Salts.200g
(Antibiotic).
Cefquin Suspension for
Injection
Each ml contains:Cefquinome (as sulfate)..25mg
(Antibiotic).

Recommended

Isomedium Powder for


parental administration
Each sachet contains:Isometamedium chloride
hydrochloride..1g
(Antiprotozoal).
Oxybiotic LA 30% Solution
for Injection
Each ml contains:Oxytetracycline (as dihydrate)
.300mg
(Antibiotic).
Bupaquone Solution for
Injection
Each ml contains:-

Potential of
misuse on feed
additive & drug
interaction.
Potential of
misuse on feed
additive & drug
interaction.
Recommended

Recommended

Recommended

Recommended

Pharmaceutical Co.
Buparvaqone...50mg
Ltd., Shijiazhuang City, (Antiprotozoal).
Hebei Province, China.
14. M/s. Orient Animal
Unimox LA Injection
Health (Pvt) Ltd.,
Each ml contains:Karachi. /
Amoxicillin (as Amoxicillin
M/s. Univet Ireland
Trihydrate) Ph. Eur...150mg
Ltd. Tullyvin, Cootehill, (Antibacterial).
Co. Cavan, Ireland.
15. M/s. Orient Animal
Unicycline LA Injection
Health (Pvt) Ltd.,
Each ml contains:Karachi. /
Oxytetracycline (as
M/s. Univet Ireland
Oxytetracycline Dihydrate Ph.
Ltd. Tullyvin, Cootehill, Eur)...200mg
Co. Cavan, Ireland.
(Antibacterial).

Recommended

Recommended

(Stability Study
of zone IV not
provided)

Recommended

COPP of
Ireland not
provided.

17. M/s. Orient Animal


Health (Pvt) Ltd.
Karachi. /
M/s. V.M.D. N.V, Hoge
Mauw, ArendonkBelgium.

Multivit Injection
Each 1 ml contains:Vitamin B1.10mg
Vitamin B2...5mg
Vitamin B6...3mg
Vitamin B12....0.05mg
Nicotinamide..35mg
D-Panthenol....25mg
Vitamin A15,000 IU
Vitamin D3....1,000 IU
Vitamin E........10mg
(Multivitamins).
Promycin-1000 Injectable
Solution
Each ml contains:Colistin
Sulphate..1,000,000 IU
(Polypeptide Antibiotic).

Recommended

(Mnf. In France
then packaging
in Belgium;
COPP of
France)

18. M/s. Orient Animal


Health (Pvt) Ltd.,
Karachi. /
M/s. V.M.D. N.V, Hoge
Mauw, ArendonkBelgium.

Promycin-4800 Water Soluble


Powder
Each gram contains:Colistin Sulphate4,800,000
IU
(Polypeptide Antibiotic).

Recommended

(Mnf. In France
then packaging
in Belgium;
COPP of
France)

19. M/s. Marush (Pvt) Ltd.,


Lahore. /
M/s. Univet Ltd.
Tullyvin, Cootehill, Co.
Cavan, Ireland.

Ubroloxin Intramammary
Suspension
Each 1 injector with 10g
(12ml) contains:Cefalexin
monohydrate...................200mg
Kanamycin
monosulfate133mg

Recommended

16. M/s. Orient Animal


Health (Pvt) Ltd.,
Karachi. /
M/s. Univet Ireland
Ltd. Tullyvin, Cootehill,
Co. Cavan, Ireland.

(Corresponds to 100,000 I.U).


(Pharmaceuticals).
20. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.

Flumeglu 5gm Injection


Each 100ml contains:Flunixin Meglumine
equivalent to 5.0g of Flunixin.
(Non-steriod, Antinflammatory drug).

Recommended

21. M/s. U.M. Enterprises,


Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
22. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
23. M/s. U.M. Enterprises,
Karachi-74900/
M/s. Qilu Animal
Health Products Co.
Ltd., Jinan, Shandong,
China.
24. M/s. Siddiqui Pharma
(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.

Cefent 1gm Injection


Each 25ml vial contains:Ceftiofur Sodium equivalent to
1.0g Ceftiofur.
(B.Lactum Antibiotics).

Recommended

Cefent 4gm Injection


Each 100ml vial contains:Ceftiofur Sodium equivalent to
4.0g Ceftiofur.
(B.Lactum Antibiotics).

Recommended

Ceftihyde 5gm Injection


Each 100ml contains:Ceftiofur Hydrochloride
equivalent to 5.0g Ceftiofur.
(B.Lactum Antibiotics).

Recommended

Ciroxin 10% Oral Solution


Each Liter contains:Ciprofloxacin100g
(Antibiotics).

Recommended

25. M/s. Siddiqui Pharma


(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.

Kenoxin 10% Oral Solution


Each Liter contains:Enrofloxacin100g
(Antibiotics).

Recommended

26. M/s. Siddiqui Pharma


(Pvt) Ltd., Multan. /
M/s. KBNP, INC,
Dugok-ri, Sinam,
Yesan, Chungnam,
Korea.
27. M/s. Mustafa Brothers
Faisalabad. /

Noroxin 200 Oral Solution


Each Liter contains:Norfloxacin200g
(Antibiotics).

Recommended

Cefalexine Injectable
Suspension 15%

Recommended

M/s. Laboratorio
Centrovet Santiago,
Chile.
28. M/s. Mustafa Brothers
Faisalabad. /
M/s. Laboratorio
Centrovet Santiago,
Chile.
29. M/s. Ghazi Brothers,
Karachi. /
M/s. CEVASA S.A.
Buenos Aires,
Argentina.

30. M/s. Fartal


Pharmaceuticals,
Karachi. /
M/s. Laboratorios
Microsules Uruguay
S.A. Canelones,
Uruguay.

Each 10ml contains: Cefalexine .150/ml


(Beta lactam Antibiotic)
Ceftiofur Hydrochloride
Injectable Suspension 5%
Contains:
Ceftiofur
Hydrochloride...50m
g
(Antibiotic)
Sulfyvit Water Soluble Powder
Each 100gm contains:Sodium
sulfaquinoxaline..15gm
Sodium
sulfamethazine.14gm
Sodium
sulfadimethoxine...2gm
Trimethoprim ...6gm
Prednisolone...0.004gm
Vitamin A....300,000IU
Vitamin E..200 IU
Vitamin D3....60.000IU
Vitamin C.2gm
Vitamin K3..1gm
Excipients....q.s
(Antibiotic, steroids Vitamin).
Ivermic M.O. Injectable
Suspension
Each ml contains:Ivermectin..1,000g
Zinc Sulphate 7H20...0,043g
Magnesum Chloride
6H20...0,650g
Copper Chloride
2H20...0,004g
Magnesium Hypophosphite
6H20..2,670g
Potassium Iodide...0.030g
Vitamin B12..0,010g
Histidine HCI0,420g
Valine...0,420g
Arginine HCI.0,510g
Methionine0,420g
Threonine..0,500g
Sodium monobasic
glutamate....0,840g
(Endectocide, organic

Recommended

More chances of
their misuse, drug
interaction and
development of
resistance. It is
better to have
separate products
for specific
purpose. Need
experimental
verification for
such combination,

More chances of
their misuse, drug
interaction
and
development
of
resistance. It is
better to have
separate products
for
specific
purpose.

31. M/s. International


Chempharma (Pakistan)
Lahore. /
M/s. Biopharmachemie
Co Ltd TangNhon Phu
Vietnam.

32. M/s. Better Traders


International,
Faisalabad. /
M/s. Kepro B.V.
Maagdenburgstraat,
Holland.
33. M/s. Ani Cure
Veterinary Services,
Rawalpindi. /
M/s. Interchemie
Werken De Adelaar
B.V. Metaalweg, CG
Venray, Holland.

34. M/s. Ani Cure


Veterinary Services,
Rawalpindi. /
M/s. Interchemie
Werken De Adelaar
B.V. Metaalweg, CG
Venray, Holland.

CTC Plus Water Soluble


Powder
Contains:Chlortetracycline5500mg
Vitamin A2400IU
Potassium Chloride..760mg
Vitamin B12...280mcg
Lysine60mg
(Antibiotic)
Thiacol 10% Oral Solution
Each ml contains:Thiamphenicol.100mg
(Broad Spectrum
Antimicrobial Agent).

More chances of
their misuse, drug
interaction
and
development of
resistance. It is
better to have
separate products
for
specific
purpose.
Recommended

Nemovit Water Soluble


Powder
Each gm contains: Neomycin
Sulpahte..40mg
Oxytetracycline HCl...60mg
Vitamin A7500IU
Vitamin D3,
Cholecalciferol..1500IU
Vitamin E, a-tocopherol
acetate....5mg
Vitamin B1.thiamine
hydrochloride.....1mg
Vitamin B2,
riboflavine......2mg
Vitamin B6, pyridoxine
hydrochloride.....2mg
Vitamin B12,
cyanocobalamin.....7.5
Vitamin C, Ascorbic
acid..25mg
Ca-pantothenate.7.5mg
Vitamin K3, menadione
sodium bisulfite.5mg
Nicotinamide.5mg
Folic Acid..300g
DL-Methionine30mg
L-Lysine
hydrochloride...50mg
Aliseryl Water Soluble Powder
Each gm contains: Erythromycin
thiocyanate..35mg
Oxytetracycline HCl...50mg
Streptomycin Sulphate35mg
Colistin Sulphate.

More chances of
their misuse, drug
interaction
and
development of
resistance. It is
better to have
separate products
for
specific
purpose.

More chances of
their misuse, drug
interaction
and
development of
resistance. It is
better to have
separate products

..200,000IU
Vitamin A, retinol
acetate3000IU
Vitamin D3,
cholecalciferol1500IU
Vitamin E, a-tocopherol
acetate...2mg
Vitamin B1, thiamine
hydrochloride.2mg
Vitamin B2,
riboflavine..4mg
Vitamin B6, pyridoxine
hydrochloride.2mg
Vitamin B12,
cyanocobalamin..10g
Vitamin C, Ascorbic
Acid..20mg
Ca-pantothenate
10mg
Vitamin K3, menadione
sodium
bisulfite..2mg
Nicotinamide...20mg
Inositol..1mg
Ceftiofur LPU Injectable
Each 100ml vial contains: Ceftiofur HCL50mg
Excipients..100ml
(Antibiotic)

for
specific
purpose.

36. M/s. Seignior Pharma,


Karachi. /
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.

Florfenicol 30% Rosenbusch


Injectable
Each 100ml vial contains:Florfenicol......30gm
Excipients q.s....100ml
(Antibiotic)

Recommended

37. M/s. Bio-Labs (Pvt)


Ltd., Islamabad.

Bio-Enrocol-A Liquid
Each 100ml contains:Enrofloxacin.....10%
Colistin Sulphate..3.5%
Amantadine.....4%
(Antibiotic, Anti-viral).

Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction
and
resistance

35. M/s. Seignior Pharma


Karachi./
M/s. Instituto
Rosenbusch S.A. de
Biologia Experimental
Agropecuaria, San Jose
1469 (1136) Buenos
Aires, Argentina.

Recommended

problem so should
not be used in
these
combinations.
38. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.

Coliflox 20% Liquid


Each 100ml contains:Enrofloxacin20gm
Colistin Sulphate50,000,000
i.u.
(Quinolones).

Recommended

39. M/s. Leads Pharma


(Pvt) Ltd., Islamabad.

Virex CRD Powder


Contains:Tylosin Tartrate.....10%
Doxycycline HCI.
..22%
Colistin Sulphate.4%
Amantadine HCI.3%
(Antibiotic).

Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so should
not be used in
these
combinations.

40. M/s. Elko Organization


(Pvt) Ltd., Karachi.

Fe-Zole SC 5% Oral
Suspension
Each ml contains:Fenbendazole...50mg
Elemental Selenium....1.6mg
Elemental Cobalt.............10mg
(Anthelmintic).

Recommended

41. Noble Pharma Mirpur


Azad Kashmir.

ENTRO-5 Powder
Each 1000gm contains:Tylosin Tartrate BP..10%
Doxycycline Hyclate USP20%
Colistin Sulphate...450 MIU
Bromhexine HCI0.5%
Neomycin SO43.6%
(Antibacterial).

Drug which are


Me too like
drugs with minor
modifications
which may or
may not be
considered.

42. M/s. Mallard


Pharmaceuticals (Pvt)
Ltd., Multan.

Centrum Liquid
Each 100ml contains:Enrofloxacin HCI...7500mg
Sulphamethoxypyridazine
7500mg
Sulphamethazine5000mg
Trimethoprim2500mg

Drug which are


Me too like
drugs with minor
modifications
which may or
may not be
considered.

(Antibiotic).
43. M/s. Intervac (Pvt) Ltd,
Sheikhupura Road,
Sheikhpura.

Tilmodox Liquid
Each 100ml contains:Tilmicosin Phosphate.15gm
Doxycycline HCI15gm
(Antibiotic).

Tissue resistance.

44. M/s. Intervac (Pvt)


Limited, Lahore.

Amprobit Liquid
Each liter contains:Amprolium HCI250gm
Ethopabate..16gm
(Anticoccidial).

Recommended

45. M/s. Attabak


Pharmaceutical,
Islamabad.

Tylothrodox Powder
Each 1000gm contains:Doxycycline HCl..100g
Tylosin tartrate ..50g
Amantadine HCl ...40g
Erythromycin thiocyanate..60g
(Antibacterial, Antiviral).

46. M/s. Attabak


Pharmaceutical,
Islamabad.

Spiralinc-B Powder
Each 100gm powder contains:Lincomycin HCI..5g
Spectinomycin HCI..7.5g
Spiramycin adipate...........2.5g
Bromhexine HCI...0.5g
(Antibacterials).

Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Recommended

47. M/s. D-Maarson


Pharmaceuticals,
Rawat, Islamabad.

CRD-555 Water Soluble


Powder
Each 1000g contains:Doxycycline HCl ............200g
Tylosin tartrate ....100g
Colistin sulphate500MIU
Amantadine HCl ..40g

48. M/s. Symans


Pharmaceuticals (Pvt)
Ltd. Lahore.

SPZ-Plus Feed Additive Oral


Each 100gm contains:Procaine Penicillin B.P
1200mg
Streptomycine Sulphate

Drug which are


Me too like
drugs with minor
modifications
which may or
may not be
considered.
Recommended

49. M/s. Symans


Pharmaceuticals (Pvt)
Ltd. Lahore.

50. M/s. Jfrin


Pharmaceutical
Laboratories, Hub,
Balochistan.

51. M/s. Biogen Pharma.


8th Km Rawat Chak Beli
Road, Rawat.

B.P3600mg
Zinc Bacitracin B.P5200mg
Colistin Sulphate B.P.500 MIU
(Antimicobial).
Cipro Plus Solution
Each Liter Contains:Ciprofloxacin200gm
Colistin Sulphate400MIU
Amantadine.40gm
(Antibiotics).

Jfpidox Oral Powder


Each Kg contains:Tylosin Tartrate100gm
Doxycycline Hcl...200gm
Phyenylbutazone.12gm
Bromhexine Hcl...........5gm
Colistine Sulphate.500 MIU
(Antibacterial/Antibiotic).
Amcocin Liquid
Each 100ml contains:Enrofloxacin.10%
Colistin Sulphate3%
Amantadine HCI4%
(Antibiotic)

52. M/s. Biogen Pharma.


8th Km Rawat Chak Beli
Road, Rawat.

Doxytylodine Powder
Each 1000gm contains:Tylosin Tartrate BP..200gm
Doxycycline HCI BP100gm
Amantadine HCI.40gm

53. M/s. Biogen Pharma,


Rawat.

Advantage Water Soluble


Powder
Each 1000gm contains:-

Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Drug which are
Me too like
drugs with minor
modifications
which may or
may not be
considered.
Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so
should not be
used in these
combinations.
Contains
Amantadine
which is antiviral

Tylosin Tartrate BP..200gm


Doxycycline HCI BP.40gm
Amantadine HCI...100gm
Colistin Sulphate5000 MIU
(Antibiotic/
Antibacterial/Antiviral).
54. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.

55. M/s. Wimits


Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
56. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
57. M/s. Wimits
Pharmaceuticals,
Plot No.129, Sunder
Industrial Estate (P.I.E)
Raiwind Road, Lahore.
58. M/s. D-Maarson
Pharmaceuticals,
Plot # 17, Street # SS2, National Industrial
Zone Rawat, Islamabad.

Wimtox Injection
Each ml of liquid injection
contains:Novaminsulfon....40mg
Etilefrin B.P ...0.2mg
Calcium Gluconate B.P.100mg
Magnesium Gluconate
B.P .10mg
Sodium Salicylate B.P 7mg
Nicotinamide B.P .0.3mg
Caffeine B.P ..10mg
Boric Acid B.P ..10mg
(Analgesic and Antipyretic)
Finished product specifications
are Manufacturer.
Stop Spray
Each 100ml of aerosol
contains:Deltamethrin BP...0.500g
(Insecticide)
Defender Spray
Each 30g of aerosol contains:Neomycin Sulfate BP...150mg
Clostebol Acetate.....150 mg
(Antiseptic)
Methra Spray
Each 100ml of aerosol
contains:Permethrin ..0.5 g
(Insecticide)
NOVA DM INJECTION
Liquid Injection
Each 100ml contains:Novaminsulfon....4g
Etilefrin...0.02g
Calcium Gluconate10g
Magnesium Gluconate...1.0g
Sodium salicylate..0.700g

drug for flu and


may have drug
interaction and
resistance
problem so should
not be used in
these
combinations.
Recommended

Recommended

Recommended

Recommended

Recommended

Nicotinamide....0.3g
Caffeine.1.0g
Boric acid..1.0g
(Analgesic, Antipyretic)

Submitted for consideration of the Drug Registration Board.


Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.

Drugs Appellate Board in its 140th Sitting held on 20-08-2013 in the appeal of M/s.
Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product UROPessaries decided as follows:i)

That the said formulation shall be referred to two veterinary experts, by the
defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal
Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig.
Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.

ii)

The Chairman, Drugs Appellate Board was authorized to take decision on the
aforesaid Appeal in the light of the recommendations of the experts.

iii)

That the fate of other drug(s) / brand(s) of the same formulation available in the
market shall also be decided by the Registration Board in the light of the
recommendations of the experts and the provisions of law / rules, under
intimation to the Drugs Appellate Board.

Accordingly, opinion of following experts regarding registration of product has been


obtained, which are as follows:S.
No.
1.

2.

Name of Expert.
Prof. Dr. Muhammad Ashraf,
Dean, Faculty of Bio-Sciences,
University of Veterinary &
Animal Sciences, Lahore

Recommendations.
URO-Pessaries
having
combination
of
Chlorotetracycline,
Furazolidone
and
Metronidazole is not recommended for approval in
animals.

Ltd. Col. Iftikhar Ahmad Anjum, In order to proceed further, following steps be
for DGRV&F, QMG Branch taken up before the product is registered:RV&F
Directorate,
GHQ, a) A fair trial on animals after cultural sensitivity
Rawalpindi.
test, at least on 50 animals which can be provided
by Military Farms located at Lahore or Okara.

b) Deliberate and authentic recording of readings


and fair evaluation be ensured.
c) Post treatment cultural sensitively in an aseptic
environment.
The Drugs Appellate Board in its 142nd Sitting held on 20-06-2014 keeping in view the
fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the
appeal with the directions to the respondent Registration Board to decide the fact of similar
formulations accordingly. As per record, there is only one product Utacare Pessary (Reg.
No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.
Submitted for consideration of Drug Registration Board.

Case No.14

Registration of imported veterinary drugs - Correction in minutes.

The Drug Registration Board in its 237th meeting held on 26-02-2013 approved the
registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,
Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The
Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee;
S#

Name of Drug (s) /Composition.

1.

Masti Veyxym Suspension for


Intramammary.
Each 10gm contains:All-rac-aTocopheryl acetate (Vitamin E
acetate)120.00mg.
Vitamin A concentrate 100.000 IU.
Chymotrypsin2400 FIP-U.
Trypsin..240 FIP-U.
Papain6-FIP-U.

2.

Veyxyl LA 20% Solution.


Each 1ml contains:Amoxicillin trihydrate229.60mg
(equivalent to 200.00mg Amoxicillin).

Decontrolled /
Pack Size.
Tube of 10ml

Shelf Life

50ml
100ml

03 years

02 years

The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of
registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to
provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ
Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly
endorsed by the Pakistan Embassy/Consulate office in the country of export.
In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of
Masti Veyxym Suspension for Intramammary & Veyxyl LA 20% Solution is
performed in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the
Netherlands for their principal company M/s. Vexy-Pharma GmbH, Germany. However, this
production site only produces bulk (unlabeled bottles / injections) that is shipped subsequently to
their site in Germany M/s. Vexy-Pharma GmbH for finalization the production. At the German
site, the secondary packaging takes place and final batch release is performed. The firm M/s.
Vexy-Pharma GmbH (Germany) is the marketing authorization holder and consequently
responsible for the overall quality, the safety and the efficacy of the products.
The firm has disclosed that the products referred above are being manufactured in bulk at
M/s. Vexy-Pharma B.V, The Netherlands then these will be labeled and packed at M/s. VexyPharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.
Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from
Netherlands in the minutes of 237th meeting of the Registration Board.
Submitted for consideration of Drug Registration Board.
Case No.15

Registration of veterinary drug.

Drug Registration Board in its 236th meeting held on 20th November, 2012 approved the
registration of following imported veterinary drugs in the name of M/s. Vet Line International,
Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,
Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per
policy. The firm has deposited the required fee.
# No.

Name of Drug (s) /Composition.

Decontrolled /
Pack Size.

Shelf Life.

1.

Neomycinsulfat Powder.
Each gm powder contains:Neomycin Sulphate..1000mg.

2.

Belacol 100% Pulver


Each gm powder contains:Colistin Sulphate.1000mg.

100gm.
500gm.
1kg.
5kg.
100gm.
250gm.
1kg. & 2.5kg

3 years

3 years

The storage facility of the importer has also already been verified by the Area FID. The
applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of
the above said drugs. During processing of case for issuance of registration letter, it was
observed that these products are 100% API and under the Drug Act 1976 the drugs which are
ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion
of experts. Accordingly, views of the following experts regarding use of products above in pure
form 100 API with special reference to efficacy, safety, toxicity and residual effects in food
producing animal has been obtained, which are as follows:S.#
1.

Name of Expert.
Dr. Muhammad Ovais Omer,
Chairman,
Department of Pharmacology &
Toxicology,
University of Veterinary and
Animal Sciences, Lahore.

Opinion
i) Based on the pharmacological properties,
Neomycinsulfat is a recommended drug for
treatment of enteric infections in calves, pigs and
chickens.
ii) Based on the pharmacological properties,
Colistin Sulphate is a recommended drug for
treatment of Salmonella, E. coli, Campylobacter,
Pullorum, Paratyphoid infections, Colibacillosis
and Diarrhoea by E.coli in different animal
species.

2.

Brig. Zahid Hussain Abid,


Director Rem & Vet.,
QMG Branch RV & F Dte,
General Headquarters,
Rawalpindi.

As regards efficacy, safety, toxicity and residual


effects in food producing animal, viz a viz both
the products are concerned, in puts of the experts
from University of Veterinary and Animal
Sciences, Lahore would be more valuable and
pertinent. However, it is suggested that a trial
may be conducted at least on 200 animals for
establishment of all above factors. In this regard
Army Veterinary School can be assigned this
task.

3.

Dr. Farzana Chowdhary,

1. Neomycinsulfat this drug contains 100mg

Director,
Department of Pharmacy,
University of Veterinary & Animal
Sciences,
Lahore.

Neomycin Sulphate in 1gm indicating that it is a


pure API and not a veterinary finished dosage
form. According to the Drugs Act, 1976 APIs do
not require registration and can only be imported
by manufacturers possessing a valid Drug
Manufacturing License (Formulation) and
registration of the finished drug of which it is an
ingredient.
2. Belacol 100% Pulver contains Colistin
Sulphate 1000mg per 1gm (1000mg) powder and
does not contain any adjuvant or excepient
which is indicative of the fact that it is a pure
API and not a finished dosage form for
veterinary use. Only finished dosage forms
require registration under the Drugs Act, 1976,
whereas, APIs can be imported only by those
who hold a valid DML (Formulation) and
registration of finished drug containing that API.

Submitted for consideration of Drug Registration Board.


Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection
Regn. No. 074072.
M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of
composition of their registered veterinary Neurozoc Injection (Reg. No.074072). They have
informed that they want to apply below composition as each 1ml contains, pack size of
100ml but by typographically mistake it was mentioned in application dossier as each 100ml
contains, pack size 100ml. The registration letter received for following composition each
100ml contains, pack size 250ml & 500ml. They have therefore requested for correction of
composition from each 100ml contains to each 1ml contains and also change in pack size
from 250ml & 500ml to 100ml:Approved composition
Neurozoc Injection.
Each 100ml contains:Novaminsulfon .. .100mg.
Etilefrin. 0.50mg.
Calcium gluconate 250mg.
Magnesium gluconate 25mg.

Revised composition.
Neurozoc Injection.
Each ml contains:Novaminsulfon .. .100mg.
Etilefrin. 0.50mg.
Calcium gluconate 250mg.
Magnesium gluconate 25mg.

Sodium salicylate .17.5mg.


Nicotinamide 0.75mg.
Caffeine. 25mg.
Boric acid25mg.

Sodium salicylate .17.5mg.


Nicotinamide 0.75mg.
Caffeine. 25mg.
Boric acid25mg.

M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/and submitted following supporting documents:i)
ii)
iii)
iv)

Copy of registration letter.


Copy of old Form-5.
New Stability data.
Copy of new Form-5.

Submitted for consideration of Drug Registration Board.


Case No. 17. Cancellation of registration of drugs and stoppage of production.
Drug Registration Board in its 240 th meeting held on 07-11-2013 considered the
inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad
Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID
has reported that the firm has registration of following (10) injectable products including
(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section
and the Registration Section has granted the registration of the same:S. No.
1.

Reg. No.
035001

2.

035002

3.

035003

4.

035004

5.

035005

Name of Drug (s) / composition.


Gentacen 100 Injectable Solution.
Each ml Contains: Gentamycin Sulphate (eq to 100mg
Gentamycin base).
Moxicol Injectable Suspension.
Each ml contains: Amoxycillin Trihydrate 100mg.
Colistin Sulphate 250,000 IU.
Avimox Injectable Suspension.
Each ml contains: Amoxycillin base (as trihydrate) 150mg.
Tylocen-200 Injectable Solution.
Each ml contains: Tylosin Sulphate 200mg.
Avoxy LA Injectable Suspension.

6.

035006

7.

035127

8.

043166

9.

043167

10.

043168

Each ml contains: Oxytetracycline HCl200mg.


Dexon-5 Injectable Solution.
Each ml contains: Dexamethasone 5mg.
Oxytocen Injectable Solution.
Each ml contains: Oxytocin 10 I.U.
Predexon Injectable Suspension.
Each ml contains:Dexamethasone 2.5mg.
Prednisolon .. 7.5mg.
Lincospec Injectable Solution.
Each ml contains:Spectinomycin Sulphate 100mg base.
Lincomycin Hydrochloride 50mg base.
Avigen-F20 Injectable Solution.
Each ml contains:Gentamycin Sulphate . 10mg.
Flumequine 20mg.

The Drug Registration Board decided that the production of the firm for above mentioned
products should immediately be stopped till the complete investigation of the matter and issue a
show cause notice to the firm for explanation of reasons in their defense. Then place the case
before the Board for further deliberations.
Accordingly, a show cause notice was issued to the firm.
In response to the show cause notice the firm has submitted following documents:i)
ii)
iii)

Approval of layout plan.


Copies of registration letters.
Copy of layout plan.

M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof
of approval of the Injectable Section and also provide proof of renewal of registration of drugs
above said drugs. The firm have submitted copies of the acknowledgement of last renewal of
registration of above said products and also submitted that on April 15, 2014 the panel
constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable

Sections. The report will be submitted in coming board meeting. The firm have further submitted
that they also want to shift all Penicillin products into toll manufacturing.
DDC (RRR) was also requested to confirm renewal status of the above products. DDC
(RRR) have confirmed the renewal of the drugs.
The Chairman, CLB also resumption of production to the firm only in veterinary oral
powder and veterinary oral liquid sections.
Submitted for consideration of the Drug Registration Board.

Case No.18.

Registration of Magnesium Sulphate 15% in veterinary products.

Drug Registration Board in its 243rd meeting held on 08-09th May, 2014 considered and
approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,
Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris
France subject to price fixation / calculation:Name of drug (s)/Composition.
Sulphate De Magnesium Lavoisier (1.5G/10ML) 15%
(I.V) Injectable.
Each ampoule contains: Magnesium as Sulphate. 1.5g/10ml (15%).

Demanded Price
/Pack.
Rs.450/Per ampoule.
Rs.4500/Per 10 ampoules.

Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in
support of above mentioned product which is already under process of registration. The firm has
also submitted the list of countries-organizations in which this product is registered / sponsored
at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.
The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.
EMA, USFDA, TGA or PDMC, except France.
Submitted for consideration of Drug Registration Board.

Registration-II
Case No.19

Registration of drugs deferred by Registration Board.

a. Cases deferred for expert opinions.


i.

Lurisa Tablet 40mg and 80mg M/S Helix Pharma, Karachi.


Registration Board in 242nd meeting deferred following products for expert opinion. Accordingly

products were referred to expert for views. Comments are as under.


S.
No

Name of drug(s) & Composition

Lurisa Tablets
Each film coated tablet contains:
Lurasidone HCl...40 mg
(Antipsychotic for Treatment of Schizophrenia)
Lurisa Oral Tablets
Each tablet contains:
Lurasidone HCl.80 mg
(Antipsychotic for Treatment of Schizophrenia)

Proposed
Pack size

Demanded
Price

10s,
20s,
30s

As per PRC

10s,
20s,
30s

As per PRC

Brig. Saleem Jehangeer

Prof. Dr. Rizwan Taj

Dr. Nadeem Abbas

Armed Forces Institute of


Mental Health,

Psychiatrist,

Fauji Foundation Medical


Centre,

Rawalpindi

Pakistan Institute of Medical


Sciences,

Rawalpindi

Islamabad
Brig for Comdt (Farrukh Hayat
Khan) stated that Maj. Gen
Salim Jehangir, Commandant of
Armed Forces Institute of
Mental Health is not avail due
to official commitments

I have study documents and fee


that this medication should be
available in Pakistan.
It is a new salt which has
shown promising result as
compared to other products in
the market it side effect profile
is better also.
I am recommending
availability in Pakistan

its

Although Lurasidone salt is not


available / introduced in Pakistan,
In the light of above mentioned
facts & data provided, the drugs
Lurasidone (Lurisa) 40mg &
Lurasidone (Lurisa) 80mg are
recommended for Registration
Board

ii.

Roflumilast 500mcg Tablet.


Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of

various firms for expert opinion. Accordingly products were referred to expert for views. Comments are
as under.
S.
No

Name of firm(s)

Name of drug(s), Composition &


Registration Board Meeting

Proposed
Pack size

Demanded
Price

1.

M/s Macter
International
Karachi

Milast Tablet
Each film coated tablet contains:
Roflumilast 500 mcg
(Phosphodiesterase 4 inhibitors)

Per tab.

Rs.17.36/-

( M-242 )
2.

M/s Hiranis
Pharma, Karachi

Roflu Tablet
Each film coated tablet contains:
Roflumilast..500mcg
(Inhibitor of the enzyme PDE-4)

10s

14s

Rs.270/Rs.378/-

( M-243 )
3.

M/s Helix
Pharma, Karachi

Raspro 500mcg Tablet


Each tablet contains:
Roflumilast...500 mcg
(Anti-Inflammatory)

10s

As per PRC

( M-243 )
Brig. Dr. Aslam Khan,
Consultant Pulmonologist,
Military Hospital,
Rawalpindi

Dr. Rehana Kauser,


Consultant Pulmonologist,
Pakistan Institute of Mecial
Sciences, Islamabad

Dr. Shazli Manzoor


Quaid-e-Azam International
Hospital, Islamabad

Regarding expert opinion on


efficacy, safety, quality and
cost
effectiveness
of
Roflumilast
in
the
management of COPD
Roflumilast
is
a
Phosphodiesterase-4 Enzyme
Inhibitor. FDA and EMEA has
approved this drug as an
adjunct
to
bronchodilator
therapy in the maintenance
treatment of severe chronic
obstructive pulmonary disease

Regarding expert opinion on


efficacy, safety, quality and cost
effectiveness of Roflumilast in
the management of COPD.
FDA and EMEA approved this
drug for use in COPD
management
in severe and
very severe COPD. This drug
reduce Exacerbations rate in
COPD also included in GOLD
guidelines

Regarding expert opinion on


efficacy, safety, quality and cost
effectiveness of Roflumilast. In
this
connection
I
would
recommend that Roflumilast
(PDE4 inhibitor), is an FDA and
EMEA approved drug with
established
role
in
the
management of COPD. This has
been proven to reduce COPD
exacerbations in various clinical
trials and also included in GOLD
guidelines 2014. Clinical Studies

However

certain

studies

(COPD)
associated
with
chronic bronchitis given for the
purpose
of
preventing
exacerbations
Roflumilast
significantly
improved
prebronchodilator
FEV1 and decreased the rate of
moderate
to
severe
exacerbations in a 52 week,
randomized trial of 3091
patients
with
COPD
.
Compared
to
placebo,
roflumilast
decreased
exacerbations
(17
percent
[95%, CI 8-25]).
The use of a once daily oral
medication in COPD is
enticing;
however,
the
medication should be used as a
maintenance therapy to prevent
exacerbations rather than to
improve other COPD outcomes
It is a safe drug which is
contraindicated
only
in
moderate or severe hepatic
impairment (Child-Pugh class B
or C)
In view of the above I
recommend this drug for
registration at an affordable
price.

reported no much beneficial


role in the COPD patients.
Clinical Studies have also
demonstrated
higher
pharmacological activity and
better
tolerability
of
as
compared to earlier PDE-4
inhibitors. In my honest opinion
this drug may be helpful in the
management of COPD in
combination with other drugs
so it should be cost effective
and affordable to the patients.

have also demonstrated higher


pharmacological activity and
better tolerability of Roflumilast
as compared to earlier PDE-4
inhibitors. Therefore, Roflumilast
500mcg orally once a day if made
available in Pakistan especially
from Macter platform due to
quality and cost effectiveness
concern; it can held in reducing
suffering due to exacerbations of
COPD.

iii.Cocard Plus 75/75MG Tablet M/S Helix Pharma, Karachi.


Registration Board in 237th meeting approved following product of M/s Helix Pharma,
Karachi subject to reason mentioned in last column. Accordingly provided data was referred to
expert for views. Comments are as under.

S.
No

Name of drug(s) & Composition

Cocard Plus 75/75mg Tablet


Each tablet contains:
Clopidogrel bisulfate eq. to
clopidogrel.75 mg
Aspirin as enteric coated
pellets.75 mg
(Anti coagulant anti platelet)

Proposed
Pack size

Demand
ed Price

10s

As per
PRC

Decision

Approved subject to
confirmation
of
Bilayered
tablet
manufacturing facility

Dr. Amanullah Khan,


Director, Drug Testing
Laboratory,
Government of Baluchistan,
Quetta

Mr. Abdul Razzaq,


Director, Drug Testing
Laboratory,
Government of Sindh,
Karachi

Mr. Muhammad Jamil Anwar,


Director, Drug Testing
Laboratory,
Government of Punjab,
Lahore

COCARD PLUS 75/81MG


TABLET dissolution profile is
different from the originator
brand (OGREL PLUS 81
TABLET OF M/S BOSCH
PHARMA,
Karachi)
and
scientifically the dissolution
method applied is incorrect
because they use separate tablet
of Cocard for acid and buffer
stages rather replacing the
buffer medium from acid to
buffer stage, hence on scientific
grounds of dissolution profile
the product COCARD PLUS
75/81MG TABLET is not
recommended.

Tablet COCARD PLUS is a


bilayered
film
coated
(Antiplatelets) having 02
years shelf life is indicated in
different kind of CV diseases.
The
comparative
dissolution profile of
M/s
Helix
Pharma
Products COCARD
PLUS Tablets with
originator
Brand

OGREL
PLUS
81
TABLETS by M/s
Bosch Pharmaceuticals,
Karachi was thoroughly
checked & evaluated.
The stability profile
shows that stability
studies was carried out,
and there was no
significant physical and
chemical changes when
product was kept at 40 o
C + 2o C /75% RH +
5%, provided proof of
climatic chamber, also
complies the other tests
performed
such
as
weight variation, Assay,

COCARD PLUS 75/81MG


TABLET
It is observed that necessary
equipment, particularly Bilayered
Tableting Machine is available for
manufacturing of Cocard Plus 75mg
/81mg Tablet.
The accelerated stability studies for
the product has been carried out
with the concluded results of active
ingredient within the limits and also
shows that no significant physical
and chemical change occurred
during accelerated stability study
carried out for six months.
The Dissolution Profile of the
product Batch TF001 has been
studied in acidic and buffer stage
and observed satisfactory. The
comparative study with the other
brand Ogrel Plus 81mg Tablets of
M/s Bosch Pharma, Karachi was
also carried out with the acceptable
results.
In the light of above and as per
data / information provide the
drug Cocard Plus 75mg /81mg

disintegration
time,
dissolution and other
aspects that meets the
required
quality
specifications.
The data provided also
reflects
that
manufacturing method /
equipments / instruments
are properly validated
and calibrated.
The last panel inspection
was conducted on 28-062013 & for verification
of bilayered tablets
manufacturing facilities
was conducted 06-122013 wherein they stated
that the firm has good
facilities provided for
manufacturing
and
quality control and GMP
Compliance was found
good / satisfactory.
The data provided is
sufficient regarding raw
material specification &
finished
product
specification
&
analytical
procedures,
labeling, packing is also
available.
So In the light of above
mentioned facts & data
provided the drug
COCARD
PLUS
Tablets
is
recommended
for
registration.

(Clopidogrel 75mg + Aspirin


81mg) Tablet is recommended for
registration.

It is to mention here that following is correct formulation submitted by the firm and same has
been evaluated by experts. However, erroneously wrong formulation has been mentioned in
agenda and minutes of 245th Registration Board meeting:Cocard Plus 75/81mg Tablet
Each tablet contains:

Clopidogrel bisulfate eq. to clopidogrel.75 mg


Aspirin as enteric coated pellets.81 mg
(Anti coagulant anti platelet)
iv.

Dexlansoprazole - M/s OBS Pakistan, Karachi

Registration Board in its 235th meeting deferred following products of M/s OBS Pakistan,
Karachi for reason mentioned in last column.
Name of Drug & Composition

Pack

Kapdex 30mg Capsule


Each capsule contains:Dexlansoprazole ..30mg
(Anti ulcerants)

14s

Demanded
MRP
Rs.840.00

Kapdex 60mg Capsule


Each capsule contains:Dexlansoprazole ...60mg
(Anti ulcerants)

14s

Rs.1260.00

Decision
Deferred.
Not
metoo
product.
May be referred to
expert committee
for new molecule
Deferred.
Not
metoo
product. May be
referred to expert
committee for new
molecule

Registration Board in 245th meeting discussed same formulation and agreed to expert
opinions and advised the firms to provide data for stability studies conducted under zone IV-A
conditions as per ICH / WHO guidelines for consideration of Registration Board.
M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider
their above formulations.
Submitted for consideration of Registration Board.
b. Cases for registration of Tramadol.
Registration Board in its 236th meeting held on 20th November, 2012 had decided
that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the
Board will not consider these cases in light of controlled drug guidelines. However to avoid

misuse potential, their procurement and manufacturing record shall be strictly maintained and
submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)
Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.
In light of above decision for registration of Tramadol containing product of
following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as
per revised schedule for fees. Details are as under:S.
No.
1.

2.

Name of
firm
M/s Safe
Pharmaceutic
als, Karachi

-do-

Name of Drug(s)

Pack

MRP

Decision

Magadol Drops
Each ml contains:Tramadol HCl 2.5mg
(Non Narcotic Analgesic)

10ml

As per PAC

225th RB

Magadol Capsule
Each capsule contains:Tramadol HCl 50mg
(Non Narcotic Analgesic)

1x10s

Deferred for
confirmatio
n of facility

As per PAC

-do-

Submitted for consideration of Registration Board.


c.

Registration of Agomelatine Tablet 25mg.

Registration Board in its 227th meetings deferred following products of M/s Nabiqasim
Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on
Form 5D, fee Rs.15, 000.
M/s Nabiqasim Industries, Karachi
Name of Drug & Composition
Modton Tablet 25mg
Each film coated tablet contains:Agomelatine 25mg
(Antidepressant)

Pack
10s

Demanded
MRP
Rs.1500.00

M/s PharmEvo, Karachi.


Name of Drug & Composition

Pack

Agloda 25mg Tablet


Each tablet contains:Agomelatine ..25mg
(Anti depressant)

Demanded
MRP
Rs.2690/Rs.3750/Rs.7500/-

10s
14s
28s

Later on scrutiny of registration data reveals that the above formulation is already approved by
the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals
(Pakistan) Ltd, Lahore under the brand name Valdoxan 25mg Tablets

M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,
Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 2401-2013) + Rs.5,000/- (dated 06-05-2013)
Submitted for consideration of Registration Board.

d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi


i.

Calcium citrate + Vitamin D.

Registration Board in its 237th meeting deferred following registration application of M/s
Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition

Calvit-D Sachet
Each sachet contains:
Calcium citrate
maleate..2500mg
Vitamin D.400 IU
(Calcium and Vitamin
supplement/replacement preparation)

Proposed
Pack size

10s
20s

Demanded
Price

As per PRC

Date of
application,
Diary No. &
Form
28-01-2013
Dy.No.60
Form-5
Rs.20,000/-

Decision

Deferred
submission
application
form-5D
balance fee

for
of
on
with

Now firm has stated that same formulation is already registered in favour of M/s Maple
Pharmaceuticals, Karachi with the brand name Calcivit Sachet Reg. No.076051 in 234 th
meeting of Registration Board.
ii.

Alfacalcidol + Calcium carbonate


Registration Board in its 237th meeting deferred following registration application of M/s

Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.
Name of drug(s) & Composition

Alfakal Tablet
Each tablet contains:
Alfacalcidol ....0.5 mcg
Calcium carbonate.1000 mg
(Calcium and Vitamin Analogue)

Proposed
Pack size

10s
20s
30s

Demanded
Price

As per PRC

Date of
application,
Diary No. &
Form
28-01 -2013
65
Form-5
Rs.60,000/-

Decision

Deferred
for
Clarification
regarding dosage
of calcium

Now firm has stated that same formulation is available / marketed by M/s SchazooZaka
(Pvt.) Ltd, Lahore with the brand name Bone-Care C Tablet vide Reg. No.062790.
e. Sodium Polystyrene M/s PharmaEvo, Karachi.
Registration Board in its 227th meeting deferred following product of M/s PharmaEvo,
Karachi for expert opinion.
S.
No

Name of drug(s) & Composition

Klenar Sachet
Each sachet contains:Sodium Polystyrene
Sulphonate ..15000mg
(Potassium removing resin)

Proposed
Pack size

15s
30s

Demanded
Price

Rs.3000.00
Rs.6000.00

Date of
application,
Diary No. &
Form
02-11-2009
2229
Form-5
Rs.8000/-

Decision

Deferred for
expert
opinion

Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.
Submitted for consideration of Registration Board.

f. Macter International, Karachi


Following products of M/s Macter International, Karachi was deferred by Registration
Board in 214th meeting for confirmation of atomic absorption spectrophotometer.
Name of Drug & Composition
Mactosin Suspension
Each 5ml contains:Ossien Mineral Complex (Hydroxy Apatite) 800mg
equivalent to
Calcium .
130mg
Phosphorous 68.8mg
Residual Mineral Salts .57.5mg
Collagen 87.5mg
Other Proteins 20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)
Mactosin Tablets
Each tablet contains:Ossien Mineral Complex (Hydroxy Apatite) 250mg
equivalent to
Calcium .53.5mg
Phosphorous .24.8mg
Residual Mineral Salts .7.5mg
Collagen 87.5mg
Other Proteins
Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Pack
60ml

Per tablet

Demanded
MRP
Rs.100.00

Rs.5.33

Later on scrutiny of registration data reveals typographic error in above formulation.


Correct formulation as applied by the firm are as under:Correct Formulation
Mactosin Tablets
Each tablet contains:Ossien Mineral Complex (Hydroxy Apatite) 800mg equivalent to
Calcium .
130mg
Phosphorous 68.8mg
Residual Mineral Salts .57.5mg
Collagen 67.5mg
Other Proteins ..20mg
Trace elements F1,mg,Zn,Fe,Ni,Cu)

Mactosin Suspension
Each 5ml contains:Ossien Mineral Complex (Hydroxy Apatite) 250mg equivalent to
Calcium .53.5mg
Phosphorous .24.8mg
Residual Mineral Salts .7.5mg
Collagen 87.5mg
Other Proteins 20mg
Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic


absorption in the Quality Control Laboratory of the firm. Submitted for consideration of
Registration Board.
g. M/s Bosch Pharmaceuticals, Karachi
Registration Board in 228th & 244th meeting deferred following products of M/s Bosch
Pharmaceuticals, Karachi reason mentioned in last column.
S. No. Name of drug(s) & Composition
1.

2.

3.

4.

Calamox Chewable Tablet 200mg


Each chewable tablet contains:Amoxycillin as Trihydrate ..200mg
Clavulanic Acid as
Potassium ..28.50mg
(Antibiotics)
Calamox Chewable Tablet 400mg
Each chewable tablet contains:Amoxycillin as Trihydrate ..400mg
Clavulanic Acid as
Potassium .57 mg
(Antibiotics)
Calamox Dispersible Tablet 375mg
Each Dispersible tablet contains:Amoxycillin as Trihydrate ..250mg
Clavulanic Acid as
Potassium ...125mg
(Antibiotics)
Calamox ES Oral Suspension
Each ml contains:

Proposed
Pack size
Not
mentioned

Demanded
Price
Not
mentioned

Not
mentioned

Not
mentioned

-Do-

Not
mentioned

Not
mentioned

-Do-

75ml
125ml

Rs.225.00
Rs.375.00

Decision
Deferred for confirmation of
international availability &
expert opinion

Deferred for confirmation of


me too status

Amoxycillin as
Trihydrate.600 mg
Clavulanic acid as potassium salt
42.9 gm
(ntibiotic / antibacterial for microbial
diseases)
5.

Calamox-XR Tablet
Each extended release tablet contains:
Amoxycillin as
trihydrate ....1 gm
Clavulanic acid as
potassium 62.5 mg
(Antibiotic / antibacterial for microbial
diseases)

200ml

6s
14s
28s

Rs.600.00

Rs.180.00
Rs.420.00
Rs.840.00

Deferred for confirmation of


me too status.

Now firm has stated as under:For products at S. No.1 3

Remaining fee @ Rs.35,000/- for each product


Application of Form-5-D

For products at S. No.4 5

Remaining fee @ Rs.23,000/- for each product


Application of Form-5-D

Submitted for consideration of Registration Board.

Case No.20

De-Registration of registered drugs.

M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,
as per following details:S. No.
1.

Name of drug(s)
Tabromide Capsule 2mg
Each capsule contains:Loperamide HCl .2mg

Reg. No.
014296

Reason / Justification
Due
to
some
unavoidable
circumstances and unfeasibility in the
market

2.

Evac 100mg Tablets


Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P 100mg

021801

-do-

3.

Evac 200mg Tablets


Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P 200mg

021802

-do-

4.

Evac 400mg Tablets


Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P 400mg

021803

-do-

5.

Evac 600mg Tablets


Each chewable coated tablet
contains:Alpha Tocopherol
Acetate J.P 600mg

021804

-do-

6.

Pyrazol 500mg Tablet


Each tablet contains:Pyrazolone Magnesium 500mg

014346

-do-

Case No.21

Grant of Registration Mentioning of two MRPs for a formulation.

Registration Board in its 242nd meeting approved following registration in favour of M/s
The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following
details.
S. No

Reg. No.

Name of Drug(s) &


Composition

Packing

MRP

076280

076281

076282

Peditral-R (Bubble Gum Flavor)


Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder...6g
Sodium Chloride .0.35g
Potassium Chloride 0.30g
Sodium Citrate ..0.58g
(Manufacturers Specifications)
Peditral-R (Mango Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder...6g
Sodium Chloride .0.35g
Potassium Chloride 0.30g
Sodium Citrate ..0.58g
(Manufacturers Specifications)
Peditral-R (Orange Flavor)
Powder
(Low Osmolar Formulation)
Each sachet contains:Pre-cooked Rice Powder...6g
Sodium Chloride .0.35g
Potassium Chloride 0.30g
Sodium Citrate ..0.58g
(Manufacturers Specifications)

10s Sachet

Rs.100.00

10s Sachet

Rs.100.00

10s Sachet

Rs.100.00

Later on firm has stated that basically they have filed for pack size of 10s in registration
dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20s
were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for
10 sachets. While minutes of meeting 242nd of RB shows only pack size of 20s instead of
10s.Firm has also submitted that Drug Pricing Committee in its 15 th meeting dated 12-04-2011
has already fixed MRP Rs.140/- for pack size of 10s for same formulation.
Case was referred to Evaluation Cell and they explained that firm has applied for both
packs / prices i.e Rs.200/20s & Rs.200/10s in the same dossier.
Submitted for consideration of Registration Board
Case No.22

Transfer of registered drugs:

a. Transfer of registration from import to local manufacturing:


M/s The Searle Company Ltd, Karachi have requested for transfer of registration
of following drugs from import to local manufacturing at their own facility i.e M/s The Searle
Company Ltd, F-319, S.I.T.E, Karachi
S. No.

Reg. No.

Name of drug (s)

010172

2.

023317

Tramal 100 Injection


(Tramadol)
Tramal SR100mg Tablet
(Tramadol)

As per SOP, supporting documents were sent for expert opinion to three (03) experts and
now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are
as under:-

Prof. Nadeem Irfan Bukhari,


Faculty of Pharmacy,
University of the Punjab,
Lahore

Director,
Drug
Testing
Laboratory,
Government
of
Bluchistan,
Quetta
After thorough review of
the stability data and
validation of analytical
methods of the products of
Tramal SR Tablets 100mg
and
Tramal
Injection
100mg/2ml Injection is
recommended.

Director,
Drug Testing Laboratory,
Government of Punjab,
Lahore

The report sent for the above


Awaited
subject shows the results of
ongoing real time stability
studies of Tramal SR Tablets
and
Tramal
100mg/2ml
Injection. It is understood that
the case has been filed for the
transfer of registration from
import to local manufacturing
at their local facility. My In
this
regard
the
opinion / comments are as undersigned scientifically
follows:and logically comments as
under:The data provided on tablet
formulation indicated that the Stability Studies:
strength (assay) of tramadol
HCl , dissolution test and the The stability studies of
physical characteristics were both Tramal 100 Injection

within
the
limits
and
specifications after the real
time one year and accelerated
studies.
The data given on the injection
formulation showed that the
tramadol was stable in this
formulation during real time as
well as in the accelerated
stability study.
The data on real time and
accelerated study
reflected
some variations which were
minor
and
within
the
acceptable limits.
The HPLC method developed
for each formulations was
linear, precise and accurate,
through LOQ and LOD was not
provided. Meanwhile the drug
peaks were shown to be
resolved
well
without
interference. Furthermore, the
drug peaks seem to be
responsive to the changes in
concentrations of the tramadol
HCl in the samples.

as well as Tramal SR
100mg Tablets have been
carried out against ICH
guidelines.
The results of ongoing real
time
stability
studies
showing
all
physical
parameters and assay of
Tramadol HCl is well
within the specified limits.
Also,
at
accelerated
condition the stability data
is found satisfactory.
The data given on
Tramadol SR Tablets
specified
that
the
dissolution test, assay of
Tramadol and physical
characteristics
of
the
formulation is within the
limits in ongoing stability
studies (real time and
accelerated).
Validation data

The validation studies of


both products have been
Keeping the general reflection, evaluated the results are
the data on the stability and found satisfactory.
HPLC method of Tramal SR
Tablets 100mg and Tramal Therefore keeping in view
Injection 100mg/2ml Injetion the present data provided
seem to be appropriate.
by the firm for both their
products, the undersigned
is of the opinion to
recommend
the
registration of Tramal -100
Injection
(Tramadol)
100mg/2ml
(Reg.
No.010172 and Tramal SR
100mg Tablets (Tramadol)
(Reg.
No.023317)
in
favour of the firm.

As per practice in vogue cases for transfer of registration from import to local
manufacturting are considered at same terms and condition including MRP. Cost & Pricing
Divison was also consulted, who confirmed to proceed as per previous practice.
Submitted for consideration of Registration Board.
b.

Transfer of registrations from M/s Macter International, Karachi to M/s Ray


Pharma, Karachi.
M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs

from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by
Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has
also rectified shortcomings and following recommendations were framed.

S.
No
.
01

Reg. No.

Name of Drug(s)

Recommendations

000482

Genticyn Ear / Eye May be approved subject to confirmation


Drops
of renewal status

02

004298

Genticyn HC Ear / Referred to Review Committee or may be


Eye Drops
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRAs (reference
drug agencies)

03

000497

Genticyn
0.1% w/w

04

000483

Genticyn HC Cream

05

010186

Genticyn B Cream

06

007701

Multigesic Cream

Cream May be approved subject to confirmation


of renewal status
Referred to Review Committee or may be
discussed in Registration Board due to the
reason that these formulations have not
been found approved in SRAs (reference
drug agencies)
-doMay be approved subject to confirmation
of renewal status

Renewal status of products are as follows:-

S.
Reg.
No. No.

Name of Drug(s)

Initial date

01

000483

Genticyn HC Cream

06-09-2006

02
03
04

010186
007701
000482

Genticyn B Cream
Multigesic Cream
Genticyn Ear / Eye Drops

05

004298

Genticyn HC Ear / Eye


Drops
Genticyn Cream 0.1%
w/w

-do-do24-08-1978
Trasnfer of
regn date
18-06-2007
-do-

0 000497
06

06-09-2006

Aplication
receiving
date
Application
received after
expiry date
and grace
period
24-02-2012
-do-do07-06-2012

-doApplication
received after
expiry date
and grace
period
24-02-2012

Renewal
status
Registraion
is not valid

-do-doRegistraion
is valid
upto
17-06-2017
-doRegistraion
is not valid

Submitted for consideration of Registration Board


c.

Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to M/s
Macter International (Pvt.) Ltd, Karachi.
M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi has requested for transfer of their

following registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi
to new name i.e M/s Macter International (Pvt.) Ltd, Karachi.

Sr.
No.
1.

Registration No.

Brand
Name(s)

Formulation/Generic
Name

011206

Relaxin
Tablets 3mg

Bromazepam

Date of
Registration
06-06-1990

Renewal
Status
Valid up to
05-06-2015

Central Licensing Board in its 238th meeting held on 19-11-2014 approved Tablet
(Psychotropic) / Narcotic) Section as segregated section.

Case No.23

Change of Contract Manufacturer M/s B. Braun Pakistan (Pvt.) Ltd, Karachi

M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of
registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains
Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract
manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier
Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to
hiring of their plant by M/s Searle Pakistan.

Applicant

Contract
manufacturer

Reg. No.

Name of drug(s) & Composition

Date of
application,
Diary No. &
Form
03-06-2014
537
Form-5
Rs.50,000/-

Category

M/s B.
Braun
Pakistan
(Pvt.) Ltd,
Karachi

M/s Frontier
Dextrose Ltd,
Haripur

053854

B. Braun-RL Infusion
Each 100ml contains:Sodium Chloride ..0.600gm
Sodium Lactate ..0.32gm
Potassium Chloride0.040gm
Calcium
Chloride 2H2O ...0.027gm

-do-

-do-

053855

B. Braun-RLD Infusion
Each 100ml contains:Sodium Chloride ..0.600gm
Sodium Lactate ..0.32gm
Potassium Chloride0.040gm
Calcium
Chloride 2H2O ...0.027gm
Dextrose Anhydrous for
Parenteral 5.5gm

03-06-2014
538
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053848

B. Braun Paeds Infusion


Each 100ml contains:Sodium Chloride ..0.45gm
Dextrose Anhydrous for

03-06-2014
543
Form-5
Rs.50,000/-

Import to
local
contract

Import to
local
contract

Parenteral use5.0gm
4

-do-

-do-

053849

B. Braun DS Infusion
Each 100ml contains:Sodium Chloride ..0.45gm
Dextrose Anhydrous for
Parenteral use5.00gm

03-06-2014
536
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053850

B. Braun DS Infusion
Each 100ml contains:Sodium Chloride ..0.9gm
Dextrose Anhydrous for
Parenteral use5.00gm

03-06-2014
541
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053851

B. Braun G5 Infusion
Each 100ml contains:Dextrose Anhydrous for
Parenteral use5.00gm

03-06-2014
535
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053852

B. Braun G10 Infusion


Each 100ml contains:Dextrose Anhydrous for
Parenteral use10.00gm

03-06-2014
539
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053856

B. Braun - Mannitol Infusion


Each 100ml contains:Mannitol ..17.5gm
Sorbitol for Parenteral
use.2.5gm

03-06-2014
540
Form-5
Rs.50,000/-

Import to
local
contract

-do-

-do-

053853

B. Braun - NS Infusion
Each 100ml contains:Sodium Chloride 0.90gm

03-06-2014
542
Form-5
Rs.50,000/-

Import to
local
contract

The above case was deferred in 245th meeting of Registration Board for confirmation of TOC
analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,
Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle
counter in the said firms laboratory on 17-11-2014.
Submitted for consideration of Registration Board

Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories


(Pvt.) Ltd, Karachi.
Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi
were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local
repacking at M/s Elko Organization, Karachi.
S. No.

Name of product(s)

Reg. No.

1.

Cyclogest Pessaries 200mg


(Progesterone Pessaries)
Cyclogest Pessaries 400mg
(Progesterone Pessaries)

033181

2.

033182

Now the firm has requested for change of contract manufacturer for above mentioned
product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee
@ Rs.10, 0000/- for each product for the purpose.
Registration Board in 241st meeting discussed and decided as under:The Board deliberated that reapacking is the part of manufacturing and in this case final
quality control release will be granted by local manufacturer, which will be M/s Apex
Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board
constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and
area FID to inspect the premesis for confirmation of repacking and quality control
facilities of the firm. The Board also advised the panel to confirm that status of imported
products whether in pessaries, blister etc. Registration Board will decide the case in light
of report of the panel.
Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi
and concluded as under:During inspection, it was observed that management has provided adequate facilities for
repacking of above named products and quality control that are being imported from M/s
Actavis, United Kingdom in form of strips and management is intended to repack 15
pessaries in one pack. A room with controlled temperature is also reserved for proper
placement of bulk and repacked products.
Based on the observations made, people met, record reviewed and repacking & QC
facilities provided by the management, panel recommends the transfer of the above name

products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd,
D-21-A1, S.I.T.E, Super Highway, Karachi
Submitted for consideration of Registration Board
Case No.25

Issuance of duplicate registration letter.

M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of
their following drugs:S.
No.
1.
2.
3.
4.

Reg. No.
009078
009084
009083
009082

Name of Drug(s)
Daktarin Oral Gel
Daktacort Cream
Sibelium Capsule
Vermox Tablet 500mg

Firm has furnished following documents to support their request:-

a) Copy of entry in roznamcha from concerned policy station


b) Fee @ Rs.5000/- for each product for the purpose.

Case No.26

Grant of Registration for export purpose - Contract Manufacturing.


Following firm has requested for registration of drug for export purpose only,

on basis of contract manufacturing.


Contract giver

Contract
manufacturer

Name of Drug(s) & Composition

M/s Medisure Labs,


Karachi

M/s Cirin Pharma,


Hattar

Rumaclav Tablet 625mg


Each tablet contains:Amoxicillin as Trihydrate 500mg
Clavulanic Acid as Potassium125mg

Case No.27

Grant of Registration for export purpose Controlled Drug.

Date of
application,
Diary No. &
Form
31-12 -2013
Form-5
Rs.50,000/-

M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following
drug for export purpose only:S.
No.

Date of
application
Diary No.
& Form
30-09-2014
753
Form-5
Rs.20,000/-

Name of drug(s) &


Composition
Flu-Gone C&F Tablet
Each tablet contains:Paracetamol ...600mg
Pseudoephedrine
HCl60mg
Chlorpheniramine
Maleate .4mg

Information required & reply of firm

Application on Form 5 with required fee


as per relevant SRO
NOC for CRF clearance
Copy of approved section from CLB
Copy of last inspection report
An undertaking that applied registration
is exclusively for export purpose and
will not be sold in Pakistan.
If formulation / product is not registered
in Pakistan, then export order from
importing country (Registered in
Pakistan)

Above formulation is registered for local manufacturing as per following details:Applied formulations
Flu-Gone C&F Tablet
Each tablet contains:Paracetamol .....600mg
Pseudoephedrine HCl..60mg
Chlorpheniramine Maleate..4mg

Registered in Pakistan
Reltus C&F Tab(Reg. No.024908)
Epinol-CF Tab (Reg. No.023982)

Case No.28 Change in flavour


M/s Sanofi Aventis Pakistan Ltd, Karachi.

Gastrolyte

Rice

Manufacturer
M/s Pharmatec
M/s CCL, Lahore

(Reg.No.070436)

M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product
Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for
change of flavor from Apricot to Raspberry.

Firm has submitted for information to support their request.

Case No.29

O6 months accelerated stability data


Undertaking
Specification & Control Method
Copy of Registration letter
Fee @ Rs.5,000/- for the purpose.

Change of manufacturing site from Contract to own facility.

Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for
import as per following details and then permitted for local contract manufacturing from M/s
Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,
Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &
Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit
manufacturing of products at this facility.
S. No.

Reg. No.

Name of Drug(s)

Date of Registration

1.

015566

Rosiden Injection
Each 1ml ampoule contains:Piroxicam .20mg

23-08-1994

2.

014084

Neurocoline 250mg/2ml Injection


Each 2ml contains:Citicoline .250mg

01-11-1993

Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list
approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to
mention that citicoline is under consideration of Review Committee.

Case No.30

Correction in Minutes:

a. M/s Amarant Pharma, Karachi

Registration Board in 245th meeting approved following registration in favour


of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following
mistake in minutes. Existing and correct formulation are as under:Name of Drug(s) & Composition
Amprexa-F Tablet 12/25mg
Each tablet contains:Olanzapine ..12mg
Fluoxetine HCl .25mg

Correct Composition
Amprexa-F Capsule 12/25mg
Each capsule contains:Olanzapine ..12mg
Fluoxetine HCl ..25mg

Submitted for consideration of Registration Board.

Case No.31

Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export
purpose only which are not me-too. Details are as under:S.
No.
1.

2.

3.

4.

Name of
Company
M/s
Genix
Pharma,
Karachi
-do-

M/s
Tabros
Pharma,
`Karachi
M/s Getz
Pharma,
Karachi

Name of product(s)
Sofos Tablet
Each film coated tablet
contains:Sofosbuvir MS ....400mg
Sofopas Tablet
Each film coated tablet
contains:Ledipasvir MS 90mg
Sofosbuvir MS .......400mg
Vibrenta 400mg Tablet
Each film coated tablet
contains:Sofosbuvir MS ....400mg
Azvira 400mg Tablet
Each film coated tablet
contains:Sofosbuvir ....400mg

Date of application,
Diary No. & Form
23-11-2014
769
Rs.20,000/-

Original Export
Order from
Afghanistan

23-11-2014
770
Rs.20,000/-

Original Export
Order from
Afghanistan

19-11-2014
767
Rs.20,000/-

Copy of Export
Order from
Afghanistan

05-12-2014
771
Rs.20,000/-

Not provided

Submitted for consideration of Registration Board

Export Order

Registration-III

Case No.32
Registration Board in its 229th meeting approved the following product of M/s Global Pharmaceutical,
Islamabad.
S.No.

Name and Composition of Product

1.

Tamsol-D Tablets
Each film coated tablet contains:Tamsulosin Hydrochloride 0.4
mg
(as modified release tablets)
Dutasteride0.5 mg

Pack size
10s

Demanded
Price
As Per SRO
Fee
Rs:8,000/=

The Registration Board reconsidered the decision of 229 th meeting which is as follows:
Decision: Registration Board after considering the technical opinion by its members
decided to ask the manufacturer to appear before Registration Board for presentation
of his opinion regarding efficacy of the above drug formulation. The Board further
ordered that till final decision, the registration of above product would remain
suspended under section 7(11) (ad) of Drug Act, 1976.
The case is placed before the Registration Board to resolve the prevalence of the ambiguity in the
subject matter.
Case No.33
M/s. Amgomed, Islamabad has requested to transfer of the following drug from being imported for
local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:S.N
o.
1

Reg.
No.
053821

Name and Composition of Product

Pack size

Demanded
Price

Amgozole Injection
Each vial contains:Omeprazole Sodium
Omeprazole40 mg
(Proton Pump Inhibitor)

Per vial

As Per SRO

The dossier has been submitted along with fee amounting Rs:50,000 and has been evaluated with the
collaboration of the Incharge Evaluation Cell as per check list.
Submitted for consideration of the Registration Board.

Case No. 34.


M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from M/s.
Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract basis:1.

From
Fassgen
Hattar

To
Mediate
Karachi

054069

Cefein 250 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..250 mg
(Cephalosporin)

2.

Fassgen

Mediate

054077

Cefein 500 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..500 mg
(Cephalosporin)

3.

Fassgen

Mediate

054073

Cefein 250 Injection IV


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..1g
(Cephalosporin)

4.

Fassgen

Mediate

054067

Rayxime 400 mg Capsule


Each capsule contains:Cefixime Trihydrate
Cefixime400 mg
(Cephalosporin)

5.

Fassgen

Mediate

054065

Rayxime 100 mg Dry


Suspension
Each 5ml contains:Cefixime Trihydrate
Cefixime100 mg
(Cephalosporin)

The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated with the
collaboration of the Incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board

Case No.35

Registration Board in 242nd meeting approved the registration of following drug

of M/s. Olive Laboratories, Rawat.


S.N
o
1.

Existing name with approved


Composition
1. Hepatavir 300 mg Tablets
2.Tablets
3. Each film coated Tablet contains:
Tenofovir Disoproxil Fumarate
.30 mg
4. Anti-retroviral / Nucleoside and
Nucleotide Reverse Transcriptase
Inhibitors

Correct formulation/Nomenclature
1. Hepatavir 300 mg Tablets
2.Tablets
3. Each film coated Tablet contains:
Tenofovir Disoproxil Fumarate300
mg
4. Anti-retroviral /
Nucleoside and Nucleotide Reverse
Transcriptase Inhibitors

The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil Fumarate 300
mg film coated tablet but inadvertently incorporated as 30mg in agenda and minutes of 242 nd meeting.
The abovementioned inadvertent typographical error of the strength needs rectification as Tenofovir
Disoproxil Fumarate 300 mg.
Submitted for consideration of the Registration Board.
Case No.36
Registration Board in 244th meeting deferred the following registration applications of M/s. Welwink
Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals, Hattar on contract
basis in view of required GMP inspection as mentioned below:
M/s Welwink
Pharmaceuticals.
G.T Road,
Industrial Estate,
Gujranwala
Cantt.
Gujranwala
Manufacturing
on Contract basis
by
M/s Weather
Folds
Pharmaceuticals.
Plot 69/2, Phase-

Acticef 500 mg Powder for


reconstitution of IM
Injection
Each Vial contains:Ceftriaxone Sodium
Ceftriaxone 500 mg
(Cephalosporin Antibiotic)
(USP Specs)

Form 5
18-07-2012
Dy No 7333
21-05-2013
Rs. 150,000/As Per SRO
1 s
vial

FDA. (Rocephin
(Roche)
SPORCEF(LOWITT
PHARMACEUTICAL
S (PVT) LTD)
Advised for further
improvement in
different sections.
(22-03-2014)

Deferred for GMP


inspection
of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID.
Contract
giver
will
be
inspected by Area
FID
as
last
inspection report is
more than 01 year

2, Industrial
Estate, Hattar
-do-

old
Acticef 250 mg Powder for
reconstitution of IM
Injection
Each Vial contains:Ceftriaxone Sodium
Ceftriaxone.250
mg
(Cephalosporin Antibiotic)

Form 5
18-07-2012
Dy No 7336
21-05-2013
Rs. 150,000/As Per
SRO/1 s
vial

SPORCEF(LOWITT
PHARMACEUTICAL
S (PVT) LTD)
Advised for further
improvement in
different sections. (2203-2014)

-do-

Acticef 250mg Powder for


reconstitution of IV
Injection
Each Vial contains:Ceftriaxone Sodium
Ceftriaxone 250
mg
(Cephalosporin Antibiotic)
USP Specs

Form 5
18-07-2012
Dy No 7338
21-05-2013
Rs. 150,000/As Per SRO
1 s
vial

BNF. (Rocephin
(Roche)
SPORCEF(LOWITT
PHARMACEUTICAL
S (PVT) LTD)
Advised for further
improvement in
different sections. (2203-2014)

Weather Fold
Pharmaceuticals
Hattar

Acticef Injection 500mg


(IV)
Each vial contains:
Ceftriaxone sodium
Ceftriaxone 500mg
(Cephalosporin Antibiotic)
USP Specs

Form 5
18-07-12 Dy
No 7341
Rs 8000/21-05-13 Dy
No 3283
1,42,000/As per SRO/
Pack of 1 s

Rociphen of Gentech
USA
Rociphen of Roche
Karachi
Inspection of the M/s
Weather Folds
Pharmaceuticals, Hattar
was conducted by the
area FID on 22/03/14
and advised firm for
further improvements in
different sections

for
M/s Welwink
Pharmaceuticals,
Gujranwala

Deferred for GMP


inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old

-do-

Acticef Injection 1gm


(I.M.)
Each vial contains:
Ceftriaxone sodium
Ceftriaxone .1g
Cephalosporin Antibiotic
USP specs

Form 5
18-07-12 Dy
No 7334
Rs 8000/21-05-13 Dy
No 3283
1,42,000/As per SRO/
Pack of 1 s

Rociphen of Gentech
USA
Rociphen of Roche
Karachi

-do-

Acticef Injection 1gm( I.V)


Each vial contains
Ceftriaxone sodium
Ceftriaxone .1gm
Cephalosporin Antibiotic
USP Specs

Form 5
18-07-12 Dy
No 7339
Rs 8000/21-05-13 Dy
No 3283
Rs 1,42,000/As per SRO/
Pack of 1 s

Rociphen of Gentech
USA
Rociphen of Roche
Karachi

M/s Weather
Folds
Pharmaceuticals.
Plot 69/2, Phase2, Industrial
Estate, Hattar

Maxoxim 200 mg/5ml


Dry powder suspension
Each 5 ml contains:
Cefixime Trihydrate USP
Cefixime 200 mg
(Cephalosporin antibiotics)
USP Specs

Form 5
18-07-2012
Dy No 7330
Rs. 150,000/As per SRO

International: Suprax
for suspension
200mg/5ml (FDA)
Local: Biozil Dry
Suspension 200 mg/5
ml by M/s BioLabs
According to report of
inspection dated 22-102014 of M/s Weather f
old, firm is advised to
rectify shortcomings in
various sections.
According to report of
inspection dated 13-062013 of M/s Welwink,
inspection book was not
available at time of
inspection and firm was
once again directed to

For
M/s Welwink
Pharmaceuticals.
G.T Road,
Industrial Estate,
Gujranwala
Cantt.
Gujranwala

Deferred for GMP


inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old
Deferred for GMP
inspection of
contract
manufacturer by
panel comprising
of Dr. Muzammal
H. Najmi, Director
QA
& LT and Area
FID. Contract
giver will be
inspected by Area
FID as last
inspection report is
more than 01 year
old

submit their validation


data of areas and
processes before
starting of their
production.
-do-

Maxoxim 100 mg/5ml


Dry Powder Suspension
Each 5 ml contains:
Cefixime Trihydrate USP
Cefixime 100 mg
(Cephalosporin antibiotics)
USP Specs
Maxoxim 400 mg Capsule
Each capsule contains:
Cefixime trihydrate
Cefixime .. 400 mg
(Cephalosporin antibiotics)
Finished product
Manufacturing
specifications

-do-

1.Form 5
2.18-07-2012
Dy No 7335
3. 21-052013
Rs. 150,000/-

-do-

-do-

1.Form 5
2.18-07-2012
Dy No 7335
3. 21-052013
Rs. 150,000/-

-do-

-do-

The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-11-2014 and
recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also inspected the M/s.
Welwink Pharmaceutical Gujranwala and stated that the firm possesses the relevant facility of quality
control.
Submitted for consideration of Registration Board.
Case No.37
Registration Board in 245th meeting considered the following new molecule of M/s. Global
Pharmaceutical, Islamabad
Dlanz 30mg Capsules
Each capsule contains:Dexlansoprazole . 30 mg
(Proton Pump Inhibitor)

30s

As
Per
SRO

Dlanz 60mg Capsules


Each capsule contains:Dexlansoprazole . 60 mg
(Proton Pump Inhibitor)

30s

As
Per
SRO

Zaprin SR 15mg Capsules

60s

As

Per

Registration Board discussed and


agreed to above expert opinions.
However, the Board advised firm to
provide data for stability studies
conducted under zone IV-A conditions
as per ICH / WHO guidelines for
consideration of Registration Board.
-do-

-do-

Each capsule contains:Cyclobenzaprine HCl (USP)


Cyclobenzaprine 15 mg
(Skeletal Muscle Relaxant)

SRO

Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3 (months)
and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already approved in favour
of CCL, Lahore in 242nd meeting of DRB. The firm has requested to grant of registration of above
mentioned drugs in view of the relevant explanation.
Submitted for consideration of Registration Board.
Case No.38
Registration Board in 245th meeting deferred the following application of M/s. Global
Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as per
check list:Anarob Infusion
Each 100 ml contains:Metronidazole B.P500
mg

02698
5

1x100
ml

M/s. Mac &


Rains
Pharmaceuticals
,

M/s. Vision
Pharmaceuticals
,

Ofloquin Infusion
Each 100 ml contains:
Ofloxacin HCl
Ofloxacin.. 200 mg

02698
0

1x100
ml

-do-

-do-

Nafcin Injection
Each 100 ml contains:
Ciprofloxacin Lactate
Ciprofloxacin..200
mg

02697
9

100 ml

-do-

-do-

The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board.
Case No.39
M/s. Vision Pharmaceutical Islamabad has requested for transfer of registration of following drugs
from Mac & Rains Pharmaceuticals, the contract manufacturer to their own manufacturing unit, M/s.
Vision Pharmaceutical Islamabad:Levovis IV Infusion
Each 100 ml contains:Levofloxacin hemihydrate
Levofloxacin

032160

1x100ml

M/s. Mac & Rains


Pharmaceuticals,

M/s. Vision
Pharmaceuticals,

Medicip IV infusion
Each 100 ml contains:Ciprofloxacin lactate
Ciprofloxacin ......200 mg

030701

1x100ml

-do-

-do-

M/s. Vision Pharmaceutical Islamabad has developed the relevant manufacturing facilities and
submitted complete dossier along with fee amounting Rs:50000/dossier. The dossiers have been evaluated
with the collaboration of Incharge of the Evaluation Cell as per check list.
Submitted for consideration of Registration Board.
Case No.40
M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label claim of
the following drugs as mentioned below:Existing /approved formulation
Myzinc Syrup
Each 5ml contains:Zinc Sulfate Monohydrate. 20 mg
(USP Specs)

Correct formulation/Nomenclature
Myzinc Syrup
Each 5ml contains:Zinc Sulphate Monohydrate
Zinc (element)... 20 mg
(USP Specs)

Reg No.
075253

The management has deposited Fee of Rs:5000/- for this purpose. It is pointed out that the strength of the
API is calculated on the basis of content of zinc element.
Submitted for consideration of Registration Board

Registration-IV
Case No.41
M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of following drugs.
Initially these drugs were registered on 2nd August, 2003 and 4th February, 2006 with M/s. Silver Oak
Corporation Hattar. The management was changed and the unit was renamed and registrations of the
products approved for Silver Oak Corporation Hattar were transferred in favour of M/s. Genome
Pharmaceuticals. It is pointed out that at the time of transfer of registration of the products, the brand
name was also changed but the strengths of active pharmaceutical ingredient in the below-mentioned
formulations were inadvertently typed as:
S.N
o
1.

2.

Previous name /
Formulation
Tick-Nil Tablets
Each tablet contains:Cetirizine 2HCl..10
mg

Existing name / Incorrect


Formulation
Citgen Tablets
Each tablet contains:Cetirizine Dihydrate.10
mg

Solifen Tablets
Each tablet contains:Ketoprofen100
mg

Proket Tablets
Each tablet contains:Ketoprofen30 mg

Reg No.

030815

042511

It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet while
transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength of Ketoprofen
was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned below in the right column
of table.
S.N
o
1.

2.

Existing name with


Composition
Citgen Tablet
Each tablet contains:Cetirizine
Dihydrate..
..10mg
Proket Tablet
Each tablet contains:Ketoprofen
30mg

Correct Formulation/
Nomenclature
Citgen Tablet
Each film coated tablet contains:Cetirizine Dihydrochloride 10
mg
Proket Tablet
Each film coated tablet contains:Ketoprofen 100 mg

Reg
No.
030815

042511

Case No.42
Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for Tablets
containing combination of Domperidone Maleate and Cinnarizine in Drug Registration meeting 214 th as
mentioned below:1.

Approved formulations in
214th meeting
Domenome Tablets
Each tablet contains:Domperidone Maleate19.48
mg
Cinnarizine20.40mg

2.

The formulation issued in


the Registration letter)
Zinom Tablets
Each tablet contains:Domperidone
Maleate......19.10 mg
Cinnarizine ...........25mg
(Genomes Specs)

It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as 19.48 mg
and 20.4mg respectively. Moreover, the certificate of registration also contained typographical error
regarding Domperidone maleate 19.10mg and Cinnarizine 25mg.

The firm provided the copy of the

dossier and requested to correct the Minutes of 214th meeting as well as the typographical error of the
respective formulation along with the correction in certificate of registration as mentioned below.
Submitted for consideration of Registration Board
Reg
No
05358
0

Correct formulation /Nomenclature


Domenome Tablets
Each tablet contains:Domperidone Maleate19.1mg
Domperidone..15 mg
Cinnarizine..20 mg
(Approved formulations in 214th meeting )

Case No.43
Registration Board in 243rd meeting approved the registration of following drug of M/s. Wnsfeild
Pharmaceutical Hattar.
S.N
o
1.

Existing name with Composition


1. Alfa-Block
2. Capsule
3. Each capsule contains:Tamsulosin Hydrochloride SR pellets
50mg

Correct formulation/Nomenclature
1. Alfa-Block Capsule
2. Each capsule contains:3.Tamsulosin Hydrochloride SR
pellets 0.2%w/w
Tamsulosin HCl.0.4mg

4. (Selective Alpha-a Adrenergic Blocking


Agents)

4. (USP Specification)

Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly mentioned as 50
mg per capsule. Incharge Evaluation Cell stated that above mentioned error had been pointed to the firm
and it was rectified subsequently and prior to the 243-Meeting. But the agenda and minutes of 243 rd
meeting could not be amended. The management has requested for the appropriate correction and
issuance of the certificate of registration accordingly.
Submitted for consideration of Registration Board.
Case No.44
M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration letter of
Zoramid (Domperidone) Suspension which was approved in 243rd meeting of Registration Board with
the following formulation:Zoramid Suspension
Each 5ml contains:Domperidone Maleate eq. to Domperidone.5mg
The registration letter was not issued due to inappropriate active pharmaceutical ingredient and the
ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson & Johnson) and
BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of Domperidone maleate
equivalent to Domperidone 5mg/5ml.
The management was informed that the inappropriate description of active pharmaceuticals ingredient
and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell because the dossier
was evaluated by the PEC and the management has to apply formally for this rectification.
Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, The management
corrected the formulation and claim of Zormid Suspension and submitted the same to the PEC before the
commencement of DRB meeting-243rd. The correction was neither incorporated in agenda nor in the
relevant minutes and the ambiguity prevailed the approved minutes. Instead of proceeding in the proper
way, ironically, Mr. Tahir CEO wrote in the letter No.WPI/DRAP/40/14 dated 11-11-2014, but due to
unknown reason registration letter of our product has not been issued till to date it is requested to issue
registration letter of our product as soon as possible. If the registration letter is not issued up to 30-112014 the case will be sent to the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,

Moreover, the management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of
Pakistan, C.E.O DRAP and Director PE&R without waiting for the response of the department according
to the stipulated period of 30-11-2014.
Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in formulation and
the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell confirmed from the record
that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected the composition as per reference
product but the same could not be reproduced into the agenda and minutes of 243rd meeting of DRB.
Submitted for consideration of Registration Board
Case No. 45
Registration Board in 227th meeting held on 26th & 27th August, 2010 deferred the following
registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of toll till the
finalization of contract policy:1.

M/s. Cherwel
Pharmaceutical
s, Hattar
Manufacturin
g on Contract
basis by
M/s.Wise
Pharma,
Islamabad

Cherzone 250 mg Injection I.V


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..250
mg
(Cephalosporin)

Per
vial

As Per
SRO

3-10Deferred till
2009 the finalization
of contract
policy

2.

-do-

Per
vial

As Per
SRO

-do-

-do-

3.

-do-

Per
vial

As Per
SRO

-do-

-do-

4.

-do-

Cherzone 500 mg Injection I.V


Each vial contains:Ceftriaxone Sodium
Ceftriaxone..500
mg
(Cephalosporin)
Cherzone 1 g Injection
Each vial contains:Ceftriaxone Sodium
Ceftriaxone .1 g
(Cephalosporin)
Getxime 400 mg Capsules
Each capsule contains:Cefixime Trihydrate
Cefixime...400
mg
(Cephalosporin)

5s

As Per
SRO

-do-

-do-

5.

-do-

Getxime 100 mg Dry


Suspension
Each 5 ml contains:Cefixime Trihydrate
Cefixime ....100mg
(Cephalosporin)

30ml

As Per
SRO

-do-

-do-

6.

-do-

Getxime200mg Dry Suspension


Each 5 ml contains:Cefixime Trihydrate
Cefixime ....200 mg
(Cephalosporin)

30ml

As Per
SRO

-do-

-do-

7.

-do-

Welpime 500mg Injection


Each vial contains:Cefepime HCl with L-Aginine
Cefepime (anhydrous)
500mg
(Cephalosporin)

Per
vial

As Per
SRO

-do-

-do-

8.

-do-

Welpime 1gm Injection


Each vial contains:Cefepime HCl with L-Aginine
Cefepime (anhydrous) 1 g
(Cephalosporin)

Per
vial

As Per
SRO

-do-

-do-

9.

-do-

Biset 1 g Injection
Each vial contains:Cefoperazone Sodium
Cefoperazone. 500 mg
Sulbactam Sodium
Sulbactam. 500 mg
(Cephalosporin)

Per
vial

As Per
SRO

-do-

-do-

10.

-do-

Biset 2g Injection
Each vial contains:Cefoperazone Sodium
Cefoperazone 1g
Sulbactam Sodium
Sulbactam 1g
(Cephalosporin)

Per
vial

As Per
SRO

-do-

-do-

Now contract manufacturing policy has been finalized and the management of the firm has deposited
the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise Pharmaceuticals
Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand name of some product. The
Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board.

Case No.46
M/s. Maxi Care International, Lahore has requested for transfer of following drug from import for
local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:S.N
o.
1

Reg.
No.
059263

Name and Composition of Product

Pack size

Demanded
Price

PE-40 Lyophilized Injection


Each vial contains:Pantoprazole Sodium
Pantoprazole 40 mg
(Proton Pump Inhibitor)

Per vial

Rs.250.00

They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose. The dossier
has been evaluated by the Incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board.
Case No.47
M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs for the
export only:S.N
o.
1

Name and Composition of


Product
Xanek Tablets
Each tablet contains:Alprazolam.0.5 mg
(USP Spec)

Lexonil Tablets
Each tablet contains:Bromazepam3 mg
(Aries Specs)

The management of the firm provide the complete dossier, Fee of Rs,20000/- original export order and
requested for registration of drugs for export purpose only. The dossiers have been evaluated accordingly.
Submitted for consideration of Registration Board
Case No. 48
Registration Board in 243rd meeting deferred the following application of M/s. Genome
Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :-

1.

M/s. Genome
Pharmaceutical,
Hattar.

2.

-do-

Genozal Tablets
Each tablet contains:Balsalazide Disodium
Dihydrate750 mg
(Genome Spec)
(Anti-inflammatory drug)

10s

As Per SRO

Deferred for
expert opinion.

Rebon-X Tablets
Each film coated tablet contains:Strontium citrate680 mg
(Bone stabilizer)

10s

As Per SRO

Deferred
due to
Methylene
Chloride.
Inspectio
n report nil
Form 5/
file partially
signed.

Now the case is again included in the agenda for constitution of panel of expert for expert opinion.
The dossier has been evaluated and rectified by the Evaluation Cell as per check list.
Submitted for consideration of Registration Board.

Case No. 49
M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from M/s.
Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of
the manufacturing facility:
1.

2.

3.

4.

Baxib 250mg Tablets


Each film coated tablet contains:Ciprofloxacin HCl
Ciprofloxacin....250 mg
(Quinolone)
Baxib 500mg Tablets
Each film coated tablet contains:Ciprofloxacin HCl
Ciprofloxacin....500 mg
(Quinolone)
Baxib 750 mg Tablets
Each film coated tablet contains:Ciprofloxacin HCl
Ciprofloxacin....750 mg
(Quinolone)
Sanlevo 250 mg Tablets
Each film coated tablet contains:Levofloxacin Hemihydrate

030449

030450

030451

029883

Levofloxacin.250 mg
(Quinolone)
5.

Sanlevo 500 mg Tablets


Each film coated tablet contains:Levofloxacin Hemihydrate
Levofloxacin.500 mg
(Quinolone)

029884

The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the
above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical, Swat. The Dossiers
have been evaluated with the collaboration of incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board.
Case No. 50
M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site from M/s.
Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of
the manufacturing facility:
1.

Afixim 400 mg Capsule


Each capsule contains:Cefixime Trihydrate
Cefixime 400 mg

060248

2.

Durixil Capsule 500 mg


Each capsule contains:Cefadroxil Monohydrate
Cefadroxil 500 mg

060249

The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the
above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical, Rislapurt. The
Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.
Submitted for consideration of Registration Board
Case No. 51
Registration Board in 228th meeting and 238th meeting deferred the following drugs of M/s.
Genome Pharmaceuticals, Hattar for the reasons mentioned below:

1.

Perilone Tablets
Each tablet contains:Paliperidone.1.5 mg
(Ant-psychotropic)(Genome Spec)

10s

As Per
SRO

Deferred for expert


opinion being a new
chemical entities.
(M-228

2.

Lanso-SR Capsules
Each SR capsule contains:Dexlansoprazole enteric coated Pellets
Dexlansoprazole.30 mg
(Proton Pump Inhibitor)

14s

As Per
SRO

Deferred till
submission of
application on FORM
5-D along with
prerequisite fee
(M-238)

Now the firm has informed that the same formulations and same strength has been registered by the
Registration Board in favour of Pharmatec. The firm deposited the differential fee and dossiers have been
evaluated by the collaboration of Evaluation Cell as per check list.
Submitted for consideration of Registration Board
Case No.52
The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred in 245 th
meeting as mentioned below:1.

Somac 40 mg Injection
Each vial contains:Pantoprazole Sodium
Sesquihydrate
Pantoprazole..40 mg
(Proton pump inhibitor)

Per
vial

As per
SRO
29-1-13

Registration Board
deferred above products
for scrutinization of
registration application
as per check list.

2.

Winomax 500 mg injection


Each vial contains:Azithromycin monohydrate
Azithromycin ..40 mg
(Anti-infective)

Per
vial

As per
SRO
29-1-13

-do-

3.

Lantex 30 mg injection
Each vial contains:Lansoprazole sodium
Lansoprazole ..30 mg
(Proton pump inhibitor)

Per
vial

As per
SRO
29-1-13

-do-

4.

Kalwin 500 mg Injection


Each vial contains:Clarithromycin
Clarithromycin ..500 mg
(Proton pump inhibitor)

Per
vial

As per
SRO
29-1-13

-do-

The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check list and
the term lyophilized will not be claimed by the manufacturer.
Submitted for consideration of Registration Board
Case No.53
The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237 th meeting of
the Drug Registration Board as mentioned below:1.

M/s. Welmark
Pharmaceutical
s, Hattar
New Section

Carimark 500 mg Injection


Each vial contains:Clarithromycin
Clarithromycin 500 mg
(Macrolide)

Per
vial

As
per
SRO

16-0811

Deferred
for
clarification
weather
Lyophilization
procedure
is
mandatory/require
d
for
such
formulation
or
not.

2.

-do-

Ezi-mark 500 mg Injection


Each injection contains:Azithromycin dihydrate
Azithromycin .500 mg
(Macrolide)

Per
vial

As
Per
SRO

19-82011

do

Now the firm has removed the word Lyophilized from the formulation and the dossiers have been
evaluated with the collaboration of Evaluation Cell as per check list.
Submitted for consideration of Registration
Case No.54.
The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered in 225 th
meeting and approved on the ground that the firm develop new separate Psychotropic Section. The
registration letter was not issued.
1.

Zocin 25 mg Tablets
Each tablet contains:Pentazocine HCl
Pentazocine base.. 25

10x10s

REs.2.50
per tablet

Approved

mg
(Benzomarphan derivative)
2.

Fenotal 30mg Tablets


Each tablet contains:Phenobarbital. 30 mg
(Barbiturate)

2x15s

Rs.2.70
per tablet

Approved

3.

Buprex 0.2mg Tablets


Each tablet contains:Buprenorphine HCl
Buprenorphine base0.2
mg
(Thebaine derivative)

50s

Rs.0.68
per tablet

Approved

4.

Gytil 3 mg Tablets
Each tablet contains:Bromazepam3 mg
(Benzodiazepine)

3x10s

Rs.3.50
per tablet

Approved

5.

Gytil 6mg Tablets


Each tablet contains:Bromazepam6 mg
(Benzodiazepine)

3x10s

Rs.7.50
per tablet

Approved

6.

Xafil 0.25mg Tablets


Each tablet contains:Alprazolam0.25 mg
(Benzodiazepine)

3x10s

Rs.4.00
per tablet

Approved

7.

Xafil 0.5mg Tablets


Each tablet contains:Alprazolam 0.5 mg
(Benzodiazepine)
Xafil 1mg Tablets
Each tablet contains:Alprazolam1 mg
(Benzodiazepine)

3x10s

Rs.10.00
per tablet

Approved

3x10s

Rs.10.00
per tablet

Approved

9.

Xolpi 10mg Tablets


Each tablet contains:Zolpidem
Hemitartrate.10mg
(Imidazopyridine)

2x10s

Rs.16.00

Approved

10.

Dilamid 1mg Tablets


Each tablet contains:Lormetazepam 1mg
(Short Acting
Benzodiazepine)

100s

Rs.1.70
per tablet

Approved

8.

Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers. The
dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.
Submitted for consideration of Registration Board

Registration-V
Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.
M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following
products for export purpose only:S. No
1.

2.

Name of Products
Cef-OD Chewable Tablet 100mg
Each chewable tablet contains:Cefixime trihydrate equivalent to
Cefixime .. 100mg
Bicarb Capsule 600mg
Each capsule contains:Sodium Bicarbonate 600mg

The above mentioned products are not available locally. However, product at Sr. No. 1 is
FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the
following documents:a.
b.
c.
d.
e.
f.

Fee of Rs. 20000/- for this purpose.


Form-5.
Under taking stamp paper.
Copy of GMP inspection.
CRF clearance certificate.
Export orders.
Submitted for consideration of Registration Board.

Case No. 56:

M/s. Wilshire Labs Lahore - Case deferred for expert opinion

Registration Board in its 237th deferred the following registration application of M/s.
Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,
member Registration Board and submission of differential fee. Initially the case was deferred for
expert opinion and two experts have already been given their opinions as follows. Now Brig.
(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:Name of Product
Tripoli 400 mg & 800 mg
Each tablet contains:Metaxalone.400 mg & 800 mg

Pack Size.
10s
100s
500s

MRP
15% less
brand leader

S. No.
1.

Name of Expert
Prof. Dr.
Mohammad Hanif
Head Deptt. of
Medicine,
Rawalpindi
Medical College,

2.

Rwp.
Dr. Mughees
Sherani, Agha
khan Hospital
Karachi

3.

Brig.(R).Prof. Dr.
Muzammil Hasan
Najmi

Opinion
The mode of action of this drug has not been clearly identified,
absolute bioavailability is not known. Impact of age, gender,
hepatic and renal disease on the pharmacokinetics, carcinogenic
potential, safety in pregnancy, safety and effectiveness in children
under age of 12 has not determined. Leucopenia and haemolytic
anemia are among the side effects. The drug is not cost-effective.
Tripoli tablets cannot be recommended for registration for the
adjunctive treatment of acute, painful, musculo-skeletal
conditions
I have personal experience of writing this medication as this is
an FDA approved medication and is available in the United State
by the name of Skelaxin. Before moving to Pakistan in 2002, I
was practicing in Midland Texas, USA and use to prescribe this
medication.
It is used as an adjunctive treatment of acute, painful
musculoskeletal conditions and provides earlier relief.
It major side effects include drowsiness. It should be given with
caution in older patients and in patients with chronic disease,
especially in liver and kidney diseases.
I think this medication can be approved as this has long track
record without major complications or problems.
Metaxalone is a skeletal muscle relaxant used in treatment of
painful muscle spasm/sprains. The exact mechanism of action of
the drug is not known but it produce generalized CNS depression,
which is also responsible for its side effects. It has significant
interactions with other centrally acting drugs like
benzodiazepines and antidepressants. It is considered to be unsafe
in elderly. Safety in pregnancy and location has bot been
determined. The drug is available in USA.
Metaxalone may be registered as a prescription drug to be
marketed with precautions as outlined above.

The firm has also deposited remaining fee of Rs. 12,000/- for this purpose.
Submitted for consideration of Registration Board.

Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data
The Registration Board in its 245th meeting deferred the following product of M/s.
Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with
complete clinical trial data of these formulations:Sr.No.

Product Name with


composition

Pack size

Demanded
price

1.

Ebernet 1% Cream
Each gram contains:Eberconazole (as
nitrate).10mg
(anti fungal)

10gm

Rs.320.00

Date of
submission
and fee
21-06-2011
Rs. 8000/27-06-2011
Rs. 7000/10-7-2013
135000/(Total: Rs.
150000/-)
Form-5D

Remarks
Not available
in FDA,
EMA,
Australia and
Japan.

In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has
submitted clinical trial data of the above mentioned product.
Submitted for consideration of Registration Board.
Case No.58 : Permission for Contract Manufacturing due to renovation.
M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their
following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to
continuous improvement and capacity enhancement program of their manufacturing plant, they
have planned for renovation/up gradation of their granulation-I area while granulation-II area
will remain operational. Therefore they have applied for contract manufacturing of the products
manufactured in granulation-I to avoid shortage of these products:S. No.
1.
2.
3.

Name of Drug(s)
Cyrocin Tablet 250mg
Ciprofloxacin
Cyrocin Tablet 500mg
Ciprofloxacin
Hilin Capsule 100mg

Reg. No.
011406
011407
048917

4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

Pregabalin
Hilin Capsule 150mg
Pregabalin
Hilin Capsule 50mg
Pregabalin
Hilin Capsule 75mg
Pregabalin
Oxaquin Tablet 400mg
Moxifloxacin
Aria Tablet 1mg
Ketotfen (Fumarate)
Inhibitol Capsule 30mg
Lansoprazole (pellets)
Neupentin Capsule 100mg
Gabapentin
Neupentin Capsule 300mg
Gabapentin
Voxiquin Tablet 250mg
Levofloxacin Hemihydrate
Voxiquin Tablet 500mg
Levofloxacin Hemihydrate
Senegy-OD Tablet 10mg
Loratidine

048834
048916
047833
043660
014742
020613
035763
035764
038991
038992
017672

They have deposited fee of Rs. 50,000/- for each product and have furnished application
dossiers along with toll agreement.
It is submitted that in total there are 83 registered in tablet and capsule sections, however
firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,
whether such cases can be processed as per new toll policy.
Submitted for orders of Registration Board.
Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to
change of name of the firm without change in manufacturing site.
The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore
to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that
either to change all letters regarding registrations with new name or issue a letter to reflect the
said change in each of the registration letter. However, they had not deposited any fee for this

purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the
Registration Board had decided as under:The request of the firm was not acceded to and the firm was directed to deposit the
requisite fee of Rs. 8000/- for each product for transfer of registration in the new name.
It is submitted that as per practice in vogue, in case a company changes their name / title apply
for transfer of registration from previous name to new name with full registration fee. However,
the owner of the firm has the view that there is no provision in law for transfer of registration on
same premises.
The case was also referred to Law Division for comments. Law Division in their reply
referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan
Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a
fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,
Islamabad would be a valid one for manufacturing of drugs.
In this regard, Law Division was of the opinion that license issued by competent
authority was issued to drug manufacturing facility/plant/premises and inspection was done for
drug manufacturing facility, plants, its premises and also of the qualifications of the management
under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,
be wrong to state that license was issued to the premises and not the management. Law Division
has further referred to Section 196 of the Companies ordinance 1984 which states that business
of a company is run and managed by the Directors of a company. Therefore, lease agreement
between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under
the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the
rules, so that such like complications due to silent position of rules can be averted in future.
Submitted for further orders please.
Case No. 60: M/S. Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case
deferred for confirmation of registration in France

Registration Board in its 245th meeting deferred the following products of M/s. Servier
Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status
of Nartrilam 5 and 10 mg tablets in France:S.
No.
1

Name of Drug(s) with


formulation
Natrilam 10mg Tablets
Each tablet contains:Indapamide SR..1.5mg
AmlodapineBesilate..10mg
(Antihypertensive diuretic +
Calcium antagonist)
Natrilam 5 mg Tablets
Each tablet contains:Indapamide SR..1.5mg
Amlodapineas
Besilate..5mg
(Antihypertensive diuretic +
Calcium antagonist)

Pack
size
30s

Demande
d price
Rs.72.52/
Tablet

30s

Rs.36.26/
Tablet

Fee & form


20-6-2012
Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D
05-04-2011 Rs.8000/30-04-13
Rs. 130,000/Total Fee Rs. 150,000/Form 5-D

The management of the firm has provided legalized free certificate of the products in
France and have requested to grant them registration of above mentioned products.
Submitted for consideration of Drug Registration Board.

Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion
Registration Board in its 243rd meeting deferred the following product of M/s. English
Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir
Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:S. No.
1.

Name of Drug(s)
Ucholin 10mg Tablet
Each tablet contains:Bethanechol
Chloride
. 10mg

equivalent

to

Bethanechol

Two experts have provided their opinion as under:Name of expert


Prof. Ghias-ud-Din Butt,

Comments
Bethanechol chloride is indicated for the treatment of acute

PIMS, Islamabad

postoperative and postpartum non obstructive (functional) urinary


retention and for neurogesic atony of the urinary bladder with
retention. It works by helping the bladder muscle to squeeze better,
thereby improving your ability to urinate.
Because of the selective action of bethanechol, nicotinic symptoms of
cholinergic stimulation are usually absent or minimal when orally or
subcutaneously administered in therapecutic doses, while muscarinic
effects are prominent.
Special care is required if this drug is given to patients receiving
ganglion blocking compounds because a critical fall in blood pressure
may occur. Usually, severe abdominal symptoms appear before there is
such a fall in the blood pressure. Safety and effectiveness in pediatric
patients have not been established.
Price is a matter of regulator authorities but considering the
effectiveness of Molecule or patients Bethanechol HCl availability
in Pakistan must be assured at affordable price. The maximum
price should not exceed Rs. 30 for 10mg tablet.
Prof. Dr. Mumtaz Ahmad
This medicine is used to treat certain bladder problems such as the
Benazir Bhutto Shaheed inability to urinate or empty the bladder completely due to certain
Hospital, Rawalpindi
causes (e.g surgery, bladder muscle problems). It works by helping the
bladder muscle to squeeze better, thereby improving your ability to
urinate.
Synthetic choline ester with effects similar to those of acetylcholine
(ADh). Acts directly on postsynaptic receptor, and since it is not
hydrolyzed by cholinesterase, its actions are more prolonged than those
of Ach.
Dosage must be individualized, depending on the type and severity of
the condition to be treated. Preferably gives the drug when the stomach
is empty. If taken soon after eating, nausea and vomiting may occur.
Due to non availability of local brand price is at a high and
different prices are charged by patients in different areas. I
therefore recommended the immediate allocation of local
manufacturing of the drug so that the patients can also benefit from it.
There also have been incidents reported for high rates and over
charging of drug due the smuggled version of the drug.
Submitted for consideration of Registration Board.
Case No. 62:

Case deferred for confirmation of storage facilities

Registration Board in its 245th meeting deferred the following product of M/s. Rasco
Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,
Registration Board advised members and stakeholders to forward their scientific comments on
storage condition of the Misoprostol API for consideration of Registration Board:Name of Drug(s)
Aerotec-75 Tablet
(Inner core is enteric coated with outer
core as immediate release)
Each tablet contains:Diclofenac Sodium .. 75mg
Misoprostol .. 200mcg
NSAID + mucosal protective

Form & demanded MRP.


1. Form 5
2. Fast Track
3. As per SRO/blister of 210
tablets
4. 29.06.2011/Rs.8000
5.21.05.2013/Rs.52000/4237

Competitor & specification


Arthrotec (Pfizer)
Manufacturerss Specs

The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as
under:Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and
difficult to be process into a drug product in liquid form. The stability of misoprostol is
significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in
hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The
dispersion consists of a powder that can be stored at 5+3 C, whereas the actual active
substance is an oily liquid that needs to be stored at -20 C.
The certificate of analysis of the misoprostol API of the firm shows that the product is
Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 C.
The panel of inspectors has already been recommended the storage facility of the firm for above
mentioned product. They have requested to grant them registration of above mentioned products.
A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on 1806-2014 for verification of manufacturing and storage facilities for misoprostol raw material. The
panel had recommended as under:the management had provided cold cabinet to maintain temperature range from 2 to 8 C at the
time of inspection. The panel member physically inspected the cabinet and found that the
conditions for storage were maintained. The overall sanitation and hygienic in this area was
satisfactory. SOPs for handling the raw material during sampling and dispensing were

available. The panel was satisfied with storage and production facilities at the time of inspection
to manufacture the Aerotec-75 Tablet.
Submitted for consideration Registration Board.

RRR Section
Case No. 63: Applications for Re-Registration of drugs
Following firms have applied for registration of drug as they failed to apply for renewal of
registration in time:M/s. Ambrosia Pharmaceuticals, Islamabad
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.

Renewal
Application
Due Date

1.

035357

Ambrocillin
250mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate).250mg

18-12-2004

17-12-2009

Application
Receiving
Date for
Re-Reg.
17-10-2012

Documents
Provided
by the firm

2.

035358

-do-

-do-

-do-

3.

041411

04-10-2005

03-10-2010

-do-

-do-

4.

041412

-do-

-do-

-do-

-do-

5.

041414

-do-

-do-

-do-

-do-

6.

042917

Ambrocillin
500mg
Tablets
Each tablets contains:Amoxicillin
(as
Trihydrate).500mg
Micozole N Ointment
Contains:Miconazole
Nitrate2%
Isozole Vag Cream
Contains:Isoconazole
Nitrate..1%
Sexatin N Cream
Each
gm
cream
contains:Bufexamac50mg
Neomycin
Sulphate.2500IU
Nystatin100,000IU
Monorate Ointment

(i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-do-

-do-

-do-

Contains:Mometasone
Furoate.0.1% w/w
M/s. Woodward Pakistan (Private) LTD., Karachi.
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.

1.

055717

Bactizith 500mg Capsule 07-04-2009


Each capsule contains:Azithromycin
(as
Dihydrate)..500mg
(USP Specification)
M/s. Macter International Limited, Karachi.
S.
Reg.
Name of Drugs with
Date of
No.
No.
composition
Initial Reg.

Renewal
Application
Due Date
06-04-2014

Documents
Provided
by the firm

Documents
Provided
by the firm

(i). Initial
Reg. Letter
(ii). Fee
Rs.20,000/-

1.

000483

Genticyn HC Cream
Each gm contains:Gentamicin
Sulphate
Hydrocotisone Acetate

06.9.2006

05.9.2011

Application
Receiving
Date for
Re-Reg.
24-11-2014

2.

010186

-do-

-do-

-do-

3.

007701

-do-

-do-

-do-

-do-

4.

000497

Genticyn B Cream
Each gm contains:Gentamicin
Sulphate
Betamethasone Valerate
Multigesic Cream
Each gm contains:Diethylamine Salicylate
Genticyn Cream
Each gm contains:Gentamicin Sulphate

(i). Form-5
(ii). Initial
Reg. Letter
(iii). CRF
NOC
(iv). Fee
Rs.20,000/-do-

-do-

-do-

-do-

-do-

Submitted for orders of Registration Board please.

Renewal
Application
Due Date

Application
Receiving
Date for
Re-Reg.
24-06-2014

Item No. VII Registration of Biological Drugs Biological Evaluation & Research Division
Case No. 01. Expert Committee for Biological Drugs
The Drug Registration Board in its 241st Meeting decided to strength the expert
committees on biological drugs for the technical evaluation of biological drugs. The earlier
committee was not functional due to resignation of 01 member and absence of another member
due to tour abroad. The proposal of constitutions of new expert committees on biological drugs
was floated with draft notifications for separate expert committees for human and veterinary
biological drugs and were processed as per law with the approval of Federal Government.
However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects
regarding composition of committees and role of secretariat officers in the committees, which
needed to be rectified before the notifications are finalized. The notifications were re-visited and
necessary amendments were made in consultation with the Law, Justice and Human Rights
Division. The process of official notification of expert committees is in final stages. However,
due to non functional ECBD, no fresh cases can be placed before the Registration Board.
However, miscellaneous cases of already registered biological drugs are placed before the Board
for its consideration in this meeting.
Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G.
Pharmaceutica (Pvt), Ltd., Karachi.
M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following
applications for change in manufacturing site of their already registered drugs;
S.#
1.

2.

3.

Product &
Registration No.
Ferti-C 5000IU
Chorionic
gonadotrophin for
Injection
(Reg. No070931)
Ferti-C 1000IU
Chorionic
gonadotrophin for
Injection
(Reg. No 070930)
Ferti-M 150IU

Existing Manufacturing
site
Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China

Livzon (Group)
Pharmaceutical Zhohai,
Guangdong, China

Livzon (Group)

New Manufacturing Site


Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
Livzon (Group) Pharmaceutical
Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.
Livzon (Group) Pharmaceutical

4.

Menotropin for
Injection
(Reg. No 070929)

Pharmaceutical Zhohai,
Guangdong, China

Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.

Ferti-M 75IU
Menotropin for
Injection
(Reg. No 070928)

Livzon (Group)
Pharmaceutical,
Zhohai, Guangdong,
China

Livzon (Group) Pharmaceutical


Factory.
Address: No.38, Chuangye Road
North, Liangang Industrial Zone,
Zhuhai, Guangdong, China.

As per SOP defined by the Drug Registration Board in its 240th Meeting, the firm has
provided following documents;
1. Application with required fee as per SRO (Rs.100, 000/- per product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original legalized CoPP, having address of new manufacturing site.
The source is from China, which falls under category, where the inspection abroad is
mandatory. The case is placed before the Board for its decision.
Case No. 03. Request for change of importer and manufacturing site for already registered
drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.
M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of
products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the
manufacturing site is also changed by the foreign principal. The details are as under: S.#
1.

2.

Product &
Registration No.
Tropin 2000iu Inj
Each vial contains:
-Recombinant
Human
Erythropoietin
2000iu
Reg No. 062218
Tropin 4000iu Inj
Each vial contains:
-Recombinant

Existing
Manufacturing site
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd., Harbin China

M/s Harbin
Pharmaceutical Group
of Bioengineering Co.

New Manufacturing Site


M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development

Human
Erythropoietin
4000iu
Reg No. 62219
Tropin 6000iu Inj
Each vial contains:
-Recombinant
Human
Erythropoietin
6000iu
Reg No.066152

Ltd. China

Zone Hulan District, Harbin,


Heilongjiang Province, P.R. of
China

M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China

M/s Harbin Pharmaceutical Group


Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China

4.

Auspogen 300ug per


vial
Recombinant Human
G.CSF
Reg No. 062217

M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China

5.

Refron 3 MIU Inj


Each vial contains
Recombinant Human
Interferon Alpha 2b
3MIU
Reg No. 047665

M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China

M/s Harbin Pharmaceutical Group


Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China
M/s Harbin Pharmaceutical Group
Bioengineering Co., Ltd., No.99
Zhuhai Road Limin Development
Zone Hulan District, Harbin,
Heilongjiang Province, P.R. of
China

M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP
defined by the Drug Registration Board in its 240th Meeting;
i)
Application on Form 5 A along with fee as defined under SRO (Rs.
100,000 per product).
ii)
Copy of registration letters and last renewal status.
iii)
NOC for CRF clearance (Not applicable to importers)
iv)
Termination letter (Original) of previous importer M/s. Global
Pharmaceuticals (Pvt) Ltd
v)
Authority letter/sole agent letter (original) from manufacturer in favour of
M/s Avior Pharmaceuticals (Pvt) Karachi.
vi)
No objection letter from Global Pharmaceuticals in favor of M/s. Avior
Pharmaceuticals for transfer of Registration.
vii)
Original and legalized CoPP of all above products.
viii) Site Master file.
The source is from China, which falls under category, where the inspection abroad is
mandatory. The case is placed before the Board for its decision.

Case No. 04. Change of manufacturing site for already registered drugs of m/s.
Pharmaevo (Pvt) Ltd, Karachi.
M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of
manufacturing site of their already registered drugs. The details are as under: Product / Registration
Previous Name of
New Name of Manufacturing
No.
Manufacturing Site
site
EPOSINO 4000IU/ML Sandong Kexing
Shandong Kexing Bioproducts
Each pre-filled syringe
Bioproducts Co., Ltd.,
Co., Ltd. No.2666, Chuangye
contains: China
Road, Mingshui development
Recombinant Human
Zone, Zhangqiu, Shandong,
Erythropoietin
China.
4000IU
(Reg No. 045690)
EPOSINO 2000IU/ML Sandong Kexing
Shandong Kexing Bioproducts
Each pre-filled syringe
Bioproducts Co., Ltd.,
Co., Ltd. No.2666, Chuangye
contains: China
Road, Mingshui development
Recombinant Human
Zone, Zhangqiu, Shandong,
Erythropoietin
China.
2000IU
Erythropoietin
Reg No. (045689)
M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as
per SOP decided by the DRB in its 240th Meeting:1.
2.
3.
4.
5.

Application with required fee as per SRO (Rs.100, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance.
Original legalized CoPP for new manufacturing site.
Site Master file

The source is from China, which falls under category, where the inspection abroad is
mandatory. The case is placed before the Board for its decision.
Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche
Pakistan, Ltd, Karachi.
M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing
site. The details are as under: -

Product / Registration
No.
Avastin 100mg/4ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043004
Avastin 400mg/16ml
injection
Each ml contains:
Bevacizumab 25mg
Reg No. 043005

Previous Name of
Manufacturing Site
M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland

New Name of Manufacturing


site
M/s F. Hoffmann La-Roche Ltd.,
Wurmisweg 4303, Kaiseraugst,
Switzerland.

M/s F. Hoffmann- La
Roche Ltd., Basel,
Switzerland

M/s F. Hoffmann La-Roche Ltd.,


Wurmisweg 4303, Kaiseraugst,
Switzerland.

M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:1.
2.
3.
4.

Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance (Not required for Importer)
Original CoPP provided for new manufacturing site, however the CoPP is not
notarized and legalized from Embassy of Pakistan
5. Site Master file
The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other
types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed
that the request of the firm may be approved with condition that change of site letter shall be
issued after submission of legalized CoPP through permission from Chairman Registration
Board.
The case is placed before the Registration Board for decision.
Case No. 06. Request for exemption of printing of registration and MRP on vial M/s.
Popular International (Pvt) Limited, Karachi
M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for
exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu
Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th July, 2007. The firm has
informed that their principal print lot number, date of manufacturing and date of expiry on each
vial and outer box and finally print registration number on each box before shipment whereas
MRP is printed locally by us on outer box. However due to limited space on the inner vial the

principal cannot print registration and MRP. Further the company has informed that laser printing
may denature the products. The details of their request are as under: S.
#
1.

Product Name
KOATE DVI

Registration
No.
007965

2.

HyperRAB S/D

007972

3.

HyperHEP B S/D

4.

5.

PLASBUMIN
UMAN
ALBUMIN
IMMUNORHO

012835 &
007971
007967
059249

6.

GAMMARAAS

059296
059297
031350

Generic Name
Antihemophilic Factor
VIII(Human)
Rabies Immune Globulin
(Human)
Hepatitis B Immune Globulin
(Human)
Albumin (human)

Rho (D) Immune Globulin


(Human)
Intravenous Immune Globulin
(Human)

Request of the firm is submitted before the Registration Board for its consideration.
Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore
M/s Snam Pharma, Lahore has requested to approve additional pack against their
already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for
each product. The detail is as under with justification: S.#
1.

2.

Product Name

Regn
No.
Biocan R Injection ad 057167
us vet

Existing
pack size
10x5ml.
5x20ml

Additional
Pack
(1m1)x20
single dose

Ornipet lyof.ad.us.vet

200doses.
500 doses.
1000 doses.
2500 doses.
10x200
doses

5000 x 10 Large dose pack size in poultry is


doses
convenient in the large poultry
formers and dose of 5000 bird
packing is demanded by the
market.

059171

Justification
The single dose of Biocan R is
necessary as it will be used in
single dog vaccination, and it is
demanded by the market.

3.

Ornibron
lyof.ad.us.vet

057169

4.

Orniprim
lyof.ad.us.vet

057170

5.

Ornibur intermediate 059172


lyof.ad.us.vet

10x500
doses
10x1000
doses
10x2500
doses
10x200
doses
10x500
doses
10x100
doses
10x2500
doses
10x200
doses
10x500
doses
10x100
doses
10x2500
doses
500 doses
1000 doses
1000 doses
2000 doses
5000 doses
10x500
doses
10x1000
doses
10x2000
doses
10x5000
doses

5000 x 10 Large dose pack size in poultry is


doses
convenient in the large poultry
formers and dose of 5000 bird
packing is demanded by the
market.

5000 x 10 Large dose pack size in poultry is


doses
convenient in the large poultry
farmers and dose of 5000 bird
packing is demanded by the
market.

2500 x 10 Large dose pack size in poultry is


doses.
convenient in the large poultry
farmers and dose of 2500 bird
packing is demanded by the
market.

The case is placed before the Registration Board for decision.

Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore

M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against
their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.
The detail is as under with justification: S.#
1.

Product Name
CEVAC
TRANSMUNE
IBD VACCINE

Regn
No.
039910

Existing
pack size
1000 doses.

Additional Pack

Justification

2000 vial
4000 vial
8000 vial

More recently market trends


and demand of formers have
changed due to initiation of
multiple
large
sized
commercial
farms
and
integrated units which,
demands
medium
and
bigger packs keeping in
view their convenience and
economy in usage.
To demonstrate the benefits
for
users
regarding
introduction of additional
packs a detailed study as per
DRAs format.

The case is placed before the Registration Board for decision.


Case No. 09

Withdrawal of applications for registration of finished drugs by M/s. Sami


Pharmaceuticals, Karachi.
M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of

applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech
Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M225 dated 15.05.2010 and registration for the same were to be granted after satisfactory
inspection of the manufacturers facility abroad which could not be done till to date. However,
the firm was voluntarily withdrawn these long outstanding applications and will have no
objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.
Ltd and/or to any other party so authorized by them. The details of withdrawn applications are
as under: -

Sl.
#
1.

2.

Name of company
M/s Sami
Pharmaceutical(Pvt
) Ltd, Karachi./M/s
Xiamen Amoytop
Biotech Co., Ltd.,
Xiamen, Fujian,
P.R. China
M/s
Sami
Pharmaceutical(Pvt
) Ltd, Karachi./M/s
Xiamen Amoytop
Biotech Co., Ltd.,
Xiamen,
Fujian,
P.R. China

Drug name with


composition
Relkin 1.5mg Injection
Each vial contains: Oprelvekin Recombinant
Human
Interleukin-11
(rHulL-11)..1.5mg
(Immunostimulants)
Relkin 3mg Injection
Each vial contains: Oprelvekin Recombinant
Human
Interleukin-11
(rHulL-11)..3mg
(immunostimulants)

MRP

Shelf life

Remarks

As per latest
decision
taken by
PAC

24 months

Approved

As per latest
decision
taken by
PAC

24 months

Approved

The case is placed before the Registration Board for a decision.


Case No. 10 Grant of registration of solution for injection - M/s. Macter International
Limited, Karachi
M/s. Macter International Limited, Karachi has requested for registration of
solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.
The composition detail is as under: Name of Company
Raw Material
M/s Macter International Sodium Chloride
Glycine
Limited, Karachi
Polysorbate 80
Water for Injection

Quantity/0.6Ml
3mg
0.225mg
0.06mg
Qs to 0.6mL

The solvent is required to be co-packed with the product free of cost. The case of manufacturing
of locally manufactured biological product was decided in the 244 th Meeting of the Drug
Registration Board including lyophilized pegylated interferon products of the company which is
under implementation process.
Request of the company for grant of registration of solvent is submitted for the approval of
Registration Board.

Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital
Services & Sales, Karachi and change of brand name.
M/s Hospital Services & Sales, Karachi has submitted the applications for change of
manufacture site and brand name of their already registered vaccine for below mentioned
product;
Sl.No
.

Reg.
No.

1.

05381
3

Previous Brand
Name
and
composition.
EASYFIVE
Pentavalent
Vaccine
Each dose 0.5ml
contains: Diphtheria
Toxoid: 20Lf
(30IU)
Tetanus Toxoid:
7.5Lf(40IU in
guinea pig and
60 IU in mice)
Pertussis
Vaccine: 12OU
(4IU)
r-Hepatitis B
surface antigen
(HBsAg):
10mcg
Haemophilus
type b conjugate
vaccine: 10mcg.

Proposed
Name

Brand

EASYFIVE TT
Pentavalent Vaccine
Each dose 0.5ml
contains: Diphtheria Toxoid:
20Lf (30IU)
Tetanus Toxoid:
7.5Lf(40IU in guinea
pig and 60 IU in
mice)
Pertussis Vaccine:
12OU (4IU)
r-Hepatitis B surface
antigen (HBsAg):
10mcg
Haemophilus type b
conjugate vaccine:
10mcg.

Existing
Manufacturin
g Site
M/s. Panacea
Biotech Ltd.,
New Delhi,
India.

New
proposed
manufacturing
site
M/s. Panacea
Biotech Limited,
Malpur, Baddi,
Distt. Solan
(H.P.) 173 205,
Inda.

M/s Hospital Services & Sales, Karachi has provided following documents to support their
request:1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per
product).
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance (Not required for Importer)
4. Original CoPP provided for new manufacturing site.

5. Site Master file


6. The firm has also provided evidence of WHO prequalification of EASYFIVE
TT vaccine.
The case is placed before the Registration Board for a decision.
Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter
International

(Pvt) Ltd., Karachi.

The case was discussed in the 244th Meeting of Drug Registration Board. The decision of the
case was as below:
Decision: Registration Board discussed the matter in detail and advised
investigation officer to further clarify following points:
a) On which documents the firm obtained clearance of Heberon Alfa R-2b Registration No.047675 from DRAP, Karachi along with dates of
invoice, airway bill/BL, LC date and other relevant information.
b) After grant of approval of change of source, what is legal status of
renewal application submitted by the firm from previous source?
c) What is the status of recall of stocks, the legal course of
holding/restricting the stocks from sale was followed or otherwise,
after not to dispose of order on Form-1 dated 28.10.2013?
The decision of the Board was communicated to DDG (E&M) with request to clarify the points
raised by the Drug Registration Board. In response to Directorate of Biologicals letter dated 5 th
November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.
a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b,
Registration No. 047675 from DRAP, Karachi are follows: i. Attested invoices.
ii. Copy of Airway bill/Bill of lading.
iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi
Pakistan.
b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection
(interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II
(M-137).
2.
The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b
3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).
3.

The legal status with justification as I understand is the change of dosage form for

another Registration No.047675 which becomes legal as source was changed only for
Registration No. 047675 of the same product. The first source relates to the Heberon Alpha

3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to
China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid
form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun
Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A. La
Havana, Cuba the basic approved site and the product release authority of both the sources Cuba
and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic value
related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s. Macter
International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the rule 26 of
the Drug renewal for registration on 18.07.2013 and also deposited the required fee under SRO
1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm to allow
them to market the aforesaid lot in favour of the importer in public interest so required as
protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976 (copies
of both the application for registration renewal are enclosed.
As far as the grant of approval of change of source is also valid under rule 26 of
the Drugs renewal for registration dosage form of which is physically different as described
above. On the other hand, the legal status of renewal application submitted by the firm from
previous source is also legal as there is no legal embargo if the previous source is rejuvenated by
the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and
1117(i)/2012.
(i)
(ii)

The status of recall of stocks is laying hold in the cold storage area of the
importer.
The legal course of holding/restriction of the stocks were followed by the
firm. Through, they are now not bound to sell after the expiration of the
period of the order on Form-I dated 28.10.2013 which is only for the
period of 14 days by the undersigned.

Conclusion:
After having sufficient documents evidences for both the sources of same product, having
different registration for different sources and renewal also pending though applied well in
time under rules, suffice the need of legal protection to import from the either source being
the custodian of two registrations originally and subsequently renewed as per law enacted
under condition of registration under Drug Act 1976.

The intention of the importer depicts that the change of source of one registration from
Cuba to China is positive for the adequate / free availability of life saving drugs in public
interest.
Concluding all pros and corns of this investigation the contention and intention of the
importer was found positive professional approach and no evidence was found to
contravene the Drugs Act 1976 and rules prevails thereunder.
Hence the DDG (E&M) has recommended to allow the importer M/s Macter International
(Pvt) LTd, to make this life saving drug available and restriction as imposed after lot
release may also be withdrawn.
The case is placed before the Registration Board for a decision.
Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s N o v o
Nordisk Pharma (Pvt), Clifton Karachi .
The case of the firm was discussed in 244th Meeting of Drug Registration Board. The
case details are as below: M/s Novo Nardisk has applied for the change of source of their registered product
namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the
Registration Board in its 242nd meeting is as follows: S.No Product &
API
Existing
Proposed
.
Regn.No.
Manufactur
secondary
secondary
e Site
packaged
packaged
import site
import site
1
Insulatard
Novo
Novo Nordisk
Novo Nordisk
Penfill
Nordisk A/S
A/S
Production S.A.S.
100 IU/ml 5x3
Novo Alle
Novo Alle
5 bis, rue Edmond
ml
DK-2880
DK-2880
Poillot
(R.No. 010341)
Bagsvaerd
Bagsvaerd
28000 Chartres
Denmark
Denmark
France
Past Decision: The Board approved the new EMA approved site mentioned above for import
of the above mentioned products subject to COPP from new site.
Accordingly the change of source letter was issued to the firm on 7 th April, 2014 clearly
mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,
Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M
(Reg NO. 010341) from Denmark on 20 th May, 2014 which is the earlier source of import. The

ADC, Karachi was requested to submit complete case along with his recommendations. The
ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the
safety, quality and economic value of drug in question. The officer has also stated that sale of the
drug may be allowed in the public interest so required.
It is submitted that the source of import was cancelled by the Drug Registration Board vide letter
No. 2-1/2014-DDC (BD)(M-242), dated 7th April, 2014. Under section 23 subsection 1(a) (vii)
no person shall himself or by any other person on his behalf export, import or manufacture for
sale or sell any drug which is not registered or is not in accordance with the conditions of
registration. The firm has violated the Drugs Act, 1976.
The case of the firm was decided as under: DECISION: Registration Board approved request of the firm. However the
Board advised firm to provide/submit copy of L/C (original or duly certified) for
establishing the fact that the import order was placed well before the date of
grant of change of manufacture site by DRAP and authorized its Chairman for
permission to issue the letter for sale of drug.
The firm was asked to provided the documents as per decision of the Drug Registration Board,
however, the company has provided following documents: i)

ii)

Signed distribution Agreement between Novo Nordisk A/S Novo Alle


2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113,
Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C
the term of payment is 360 days from the date of invoice, which is also
mentioned on custom invoice.
Customs Invoice.

The firm informed that they have not established L/C as per their own system. The case was
submitted to the Chairman Registration Board for decision. The Chairman has desired to place
the case before the Drug Registration Board for decision.
Case No. 14. Deferred case of 241st meeting for Poulvac SE Vaccine by M/s. Hi-tech
Pharmaceutical, Lahore.
The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug
Registration Board reasons mentioned in the last column below: Sl.# Applicant
6.

M/s

Name and Specs

Hi-Tech Poulvac SE Vaccine

ECBD
Recomme

Committee
Recommendation
More data is

Decision
Deferred

Pharmaceutical,
Lahore
Manufactured
by:
M/s Pfizer
Animal Health
(Pfizer Inc),
2000 Rockford
Road, Charles
City, Iova, USA

Each 0.5ml dose


contains: Salmonella enteritidis
Phase Type 4.RP
> 1.0/dose at release.
Salmoella enteritidis
Phase Type 8
RP.>1.0/dose at
release.
Salmonella enteritidis
Phase Type 13a
RP> 1.0/dose at
release 37%
Formaldehyde.
Solution..0.0006ml
White oil.0.1995ml
Arlacel-830.1105ml
Tween-80
0.001105ml
Saline.q.s to 0.3ml
(For Veterinary Use)

nded

required

for
clarification
from the
application
regarding
use of
formalin
concentrati
on and
review by
already
constituted
committee
and
veterinary
expert of
ECBD.

The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and
submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to
DRAP and comments of Animal Husbandry Commissioner are tabulated below: Clarification submitted by the firm to DRAP

For inactivation, formalin is added to the


total volume of the bacterial suspension,
not over 1%
Source of formalin brand used holds 37%
formaldehyde solution, of this 37%
branded formaldehyde stock solution,
maximum upto 1% of formalin is used in
total volume of the bacterial suspension.
Dose of Poulvac SE is 0.3mL/bird and
each dose contains 0.0006mL i.e. 0.2% of
37% formaldehyde solution.

Comments of Animal Husbandry


Commissioner
Formalin is used to produce inactive bacterial
vaccines. For this purpose, 37% formalindehyde
gas is added to water to produce reagent
commonly known as formaline, which is then
used in a very small concentration (as is used in
the subject product Poulvac SE at the rate of
1% to the total volume of bacterial suspension).
Therefore, 37% formaldehyde solution or
formalin at the rate of 1% is part of normal
procedure to produce such inactivated vaccines.

The case is placed before the Registration Board for a decision.

Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer
Pakistan, Karachi.
M/s Pfizer Pakistan, Karachi had submitted the following application along with
prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The
details are as under: S.
#
1.

Product &
Registration No.
Prevenar 13
Suspension for
injection
(Reg # 066110)

Existing
Manufacturing site
Baxter Pharmaceutical
Solutions LLC 927
South City Curry Pike,
Bloomington IN, USA

New Manufacturing
Site
Pfizer Ireland
Pharmaceuticals
Grange Castle
Business Park,
Clondalkin, Dublin 22
Ireland.

M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:1. Application with required fee as per SRO (Rs.50, 000/- per product) being the
innovative.
2. Copy of registration letter and last renewal status.
3. NOC for CRF clearance.
4. Original legalized CoPP for new manufacturing site.
5. GMP of manufacturing site.
6. Site Master file
The case is placed before the Registration Board for a decision.
Case No. 16
M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in
Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for
Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven
100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each
vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for
each product. The composition detail is as under: Name of Company
Novo Nordisk, Karachi

Raw Material
Powder and solvent
for solution for
injection

Quantity/0.6mL
01mg/vial
(50KIU/vial)

Novo Nordisk, Karachi

Powder and solvent


for injection for
injection

02mg/vial
(1000KIU/vial

The case is placed before the Registration Board for a decision.


Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring
Germany.
Atco Laboratories Limited, Karachi have submitted that they are importing
following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the
process of shifting their manufacturing facility and it would not be possible for them during this
period to incorporate all requirements according to their local labeling rules on the packaging
material. As these products are rare/ already in the market and patient needs them, therefore, M/s
Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and
Packing Rules for the Biological Imported Drugs for at least twenty months are more: Sl. #
1.

2.

3.
4.

Reg.
Name of
No.
Drug(s)
016110 Decapeptyl i)
0.1mg injectionii)
iii)
iv)
v)
016111 Decapeptyl
3.75mg
injection
03214 Menogon
3
Injection
01615 Glypressin 1mg
3
Injection

Exemption requested

Quantity

Generic Name not in bracket.


Drug registration number to be printed locally.
MRP to be printed locally.
Urdu instruction to be printed locally.
Pharmaceutical specification.
-do-

924 units.

2638 units.

-do-

6106 units.

-do-

3438 units.

This case has been discussed in 243 Meeting of Drug Registration Board and deferred for
confirmation of pharmacological group. The firm has provided the pharmacological group as per
following details: Sl. #
Product name
Generic Name
Pharmacological Group
1.
Decapeptyl 0.1mg injection
Triptorelin Acetate Eq.
Triptorelin is synthetic form
to 95.6UG
of Gonaderelin. Triptorelin
Triptorelin/ml
causes an increase in the

2.

Decapeptyl 3.75mg injection

Triptorelin Acetate
Corresponding to
3.75mg/Single Dose

3.

Menogon Injection

Menotrophin 75IU

4.

Glypressin 1mg Injection

1mg Terlipressin
Acetate Pentahydrate
In 11mg Dry Substance

amount of FSH and LH


release from the Pituitary
gland.
Triptorelin is synthetic form
of Gonaderelin. Triptorelin
causes an increase in the
amount of FSH and LH
release from the Pituitary
gland.
Gonadotrophic
Hormone
(used in infertility).
Terlinpressin is an analog of
vasopressin used for Bleeding
of esophageal varices, spactic
shock
and
hepato-renal
syndrome.

The case is placed before the Registration Board for a decision.


Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed
Laboratories, Karachi
M/s Allmed Laboratories, Karachi has submitted the following application for change of
name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The
detail is as under: S.
#
1.

Product &
Registration No.
ATG Fresenius S
Concentrate for
solution for
infusion.
Each ml contains:Rabbit
Immunoglobulin
20mg
(Reg No. 033134)

Existing name of
manufacturer
M/s Fresenius Biotech
GmbH Germany

New Manufacturer
name
M/s Neovii Biotech
GmbH, AM Haag 6-7,
82166 Grafelfing
Germany,

M/s Allmed Laboratories, Ltd, Karachi has provided following documents to support their
claim:-

1.
2.
3.
4.

Application with required fee as per SRO (Rs.50, 000/- per product).
Copy of registration letter and last renewal status.
NOC for CRF clearance (Not required for Importer)
Original legalized CoPP for new manufacturing site.

The case is placed before the Registration Board for a decision.


Case No. 19. Change of name of manufacturing site for already registered drug of M/s.
Wyeth Pakistan Limited, Karachi.
M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of
name of manufacture site for their already registered product along with copy of CoPP from new
manufacturer as well as fee of Rs. 100,000/-. The detail is as under: S.
#
1.

1.
2.
3.
4.
5.
6.

Product &
Registration No.
Premarin 0.3mg
tablet Conjugated
Estropgens USP
(Desiccated with
Lactose at 4.29%)
0.3mg.

Existing name of
manufacturer
M/s. Wyeth Medica
Ireland
Little Connell New
bridge Country Kildare,
Ireland

New Manufacturer
name
Pfizer
Ireland
Pharmaceuticals
Little Connell New
Bridge
Country
Kildare, Ireland.

Application with required fee as per SRO (Rs.100,000/- per product).


Copy of registration letter and last renewal status.
NOC for CRF clearance.
Original legalized CoPP for new name of manufacturer.
GMP of manufacturing site.
Site Master file

The case is placed before the Registration Board for a decision.


Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services &
Sales, Karachi.
M/s. Hospital Services & Sales, Karachi has submitted the following application for
extension in shelf life of already registered drug from 24 months to 36 months: Sl.
No.
1.

Name of Drug with Registration No.

Existing Shelf Life

Demanded Shelf Life

Poliomyelitis Vaccines Inactivated,

24 months (02 years)

36 months (03 years)

Suspension for Injection 0.5ml


vial/dose (IM/SC)
The firm has submitted for following documents: a.
b.
c.
d.
e.

Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-).
Copy of registration letter and last renewal status.
NOC for CRF clearance (not required in case of importer).
Justification for proposed change.
Approval of regulatory body of country of origin / Original and legalized
Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36
months.
f. Free sale certificate and GMP certificate
g. Stability studies for product 2-80C.
h. The firm has also provided WHO prequalification evidence indicating the shelf
life from 24month to 36 month at 2-80C.
Usually extension of shelf life case is placed before the Drug Registration Board after
getting the experts opinion from different experts. However considering the polio emergency in
the country and WHO prequalified data of the said drug, the case is placed before the board for a
decision.
Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.
The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was
under consideration of Board. The following products were discussed in different meetings of the
Board.
Applicant

Product specifications

Registration No. of Decision


similar product
already in the
market as
manufactured by
NIH, Islamabad

M/s Pakcure
Pharma, Rawat,
Islamabad.

Allergex-MP

016742

Each ml contains:
Beef protein extract.10mcg
Chicken protein extract. 10mcg
Egg protein
extract...10mcg
Fish protein
extract..10mcg
Mutton protein extract..10mcg

Deferred for
Product specific
inspection by the
panel.

Shelf Life: 6 months when


stored at +2 to +8C

M/s Pakcure
Pharma, Rawat,
Islamabad.

Allergy vaccine,
immunostimulant
Allergex-Px1
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract 10mcg
Shelf Life: 6 months when
stored at +2 to +8C
Allergy vaccine,
immunostimulant

-do-

Deferred for
Product specific
inspection by the
panel.

M/s Pakcure
Pharma, Rawat,
Islamabad.

Allergex-Px2

-do-

Deferred Product
specific inspection
by the panel.

-do-

Deferred for
Product specific
inspection by the
panel.

Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
Mixed grass extract of Lolim
temulentum + Cynodon
dactylon 10mcg
House dust extract ..10mcg
Shelf Life: 6 months when
stored at +2 to +8C

M/s Pakcure
Pharma, Rawat,
Islamabad.

Allergy vaccine,
immunostimulant
Allergex-Px3
Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract10mcg
Thrasher extract10mcg
Raw cotton extract10mcg
Shelf Life: 6 months when
stored at +2 to +8C
Allergy vaccine,
immunostimulant

M/s Pakcure
Pharma, Rawat,
Islamabad.

Allergex-Px4

-do-

Each ml contains:
Cannabis sativa protein extract
10mcg
Acacia niloticaa protein extract
10mcg
Eucalyptus globulus protein
extract 10mcg
Pininus longfolia protein
extract 10mcg
House dust extract ..10mcg
Paper mulberry extract10mcg
Thrasher extract10mcg

Deferred for
Product specific
inspection by the
panel.

Shelf Life: 6 months when


stored at +2 to +8C
Allergy vaccine,
immunostimulant

The product specific inspection of the company was conducted and presented before the board in
its 243rd Meeting wherein the deficiencies of the facility were discussed and the board decided as
under;
Past Decision: The Board decided to defer the case till removal of deficiencies. Reference
may also be sent to the Licensing Board to ensure compliance as per requirement of Biological
Drugs.
The firm after making improvements, approached again for the inspection. The inspection of the
company was again carried out by the panel. The panel observed that the firm has not made
substantial improvements. However, the panel was also of the opinion that the company may be
allowed trial manufacturing to ensure that all necessary requirements are met by the company.
The trial manufacturing is not for utilization of allergy vaccines for human use.
In the light of inspection report and recommendations of the panel, the case is placed before the
Board for a decision.
Case No. 22. Court case of M/s Forward Solution V/S DRAP.
The case of M/s Forward Solution was discussed in 243rd Meeting of the Drug Registration
Board. The board decided that since the case is sub judice and under the consideration of the
Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of
sole agent of the manufacturer in order to satisfy the legal procedure.

The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has
not provided any sole agent agreement.
The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High
Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan
is not granting the Registration due to inaction of the functionary of the Drug Regulatory
Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).
Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization
and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also
directed to appear before them to provide the details of the case, probably on the complain of
aggrieved company for non grant of registrations. The matter is submitted for information of the
Honorable Drug Registration Board and necessary instruction/orders if any.

Item No: VIII Quality Control Cases Quality Assurance & Lab Testing Division
Case No. 01:
Sr.
No
1

Name of
Drugs
Kohsar DS
Tablets
(Artimether &
Lumifantrin)
Tablets

Batch No.001

Deferred Cases
Firm

CDL Report

M/s Kohs
Pharmaceuticals
(Pvt) Ltd

Substandard
regard to :-

with

Assay
Artemether:

for

Hyderabad.

Appellate Testing

Found:- 80.256%

Limit:
110%

90% to

Mfg. Sep-13
Exp. Aug-15

Does not comply

(F. No. 03-

Remarks:-

The

Detail / Decision

Firm challenged the The Board was apprised about


report after 30 days the background of
the case
as
per
record as under:provided by FID so
The Sample of Kohsar
the request was not
DS
Tablets
Batch No. 001
valid for re testing
manufacture by M/s Kohs
by the
Appellate
Pharmaceuticals (Pvt) Ltd
Lab NIH Islamabad
Hyderabad, drawn on 10-10under Section 22(5)
2013 from manufacturers
of Drugs Act 1976
premises by FID Hyderabad,
was declared substandard by
Federal Government Analyst
CDL, Karachi vide Test
report No. 852/2013 dated
10-12-2013. The firm did
not
respond
FIDs
explanation letter dated 1712-2013 so reminder letters
dated 06-01-2014 and 30-01-

63/2013)

sample
is
of
substandard quality
under the Drugs Act
1976.

Test
report
852/2013

2014 were issued by the


FID. The firm vide its
response dated 11-02-2014
disagreed and challenged the
CDL report. As per record
provided by the FID the
report was conveyed to the
firm by the FID vide letter
dated 17th December 2013,
while the firm challenged the
report vide its letter dated
11th February 2014. The FID
nominated following as
responsible persons.
Owner of the firm,
M/s
Kohs
Pharmaceuticals
(Pvt)
Ltd.,
ii. Quality Control Incharge
of M/s Kohs
Pharmaceuticals (Pvt)
Ltd

No.

i.

iii. Mirza
Saleemullah,
Production Manager, M/s
Kohs
Pharmaceuticals
(Pvt) Ltd

The FID has not given


any recommendations nor
made
any
comments
regarding validity of the act
of challenging the CDL
report
by
the
firm.
However, as per record
provided by the FID, it
appears that firm has
challenged the report after
the
30
days
period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.

As per responsibility
fixed by the FID, show
cause notices dated 05-052014 were issued to the

firm and the accused


persons of the firm.

The case was placed


before Drug Registration
Board in its 244th meeting
held on 23-24th July 2014.
The accused of the firm
were also called for
personal hearing in the said
meeting of the Board but
they could not appear
before the Board. The
Board decided to defer the
case and provide a final
opportunity of personal
hearing to the accused.

The case was again


placed
before
Drug
Registration Board in its
245th meeting held on 2930th September 2014. The
accused of the firm were
also called for personal
hearing in the said meeting
of the Board but they
could not appear before
the Board. The Board
decided to defer the case
and provide a final
opportunity of personal
hearing to the accused.

They have been called


for personal hearing again
accordingly
2.

Dozabitol
(Paracetamol
Syrup.

M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad

Batch No. DB
110

Sub-Standard:With regard to assay


for Paracetamol
Found :-82.2984%

Limit:- 90% to 110%

Mfg-Jul -13
Exp. Jun-15

Does not comply

Firm challenged the The Board was apprised about


report after 30 days the background of
the case
as
per
record as under:provided by FID so
The
Samples
of
the request was not
Dozabitol Syrup, Batch No.
valid for re testing
DB110 manufacture by M/s
by the
Appellate
Kohs Pharmaceuticals (Pvt)
Lab, NIH Islamabad
Ltd Hyderabad, drawn on
under section 22(5)
10-10-2013
from
of Drugs Act 1976
manufacturers premises by
FID
Hyderabad,
were
declared substandard by
Federal Government Analyst

(F.No. 0312/2014)-QC

CDL Karachi vide Test


report No. 848/2013 dated
27-11-2013. . In response to
FIDs explanation letter, the
firm
disagreed
and
challenged the CDL report.
As per record provided by
the FID the report was
conveyed to the firm by the
FID vide letter dated 03rd
December
2013
and
reminder was issued vide
letter dated 30-01-2014 for
firms response in the matter.
The firm challenged the
report vide its letter received
in DRAP Karachi office on
13-02-2014. so the request
for retesting was not valid as
the same was received by
FID office after 30 days The
FID
has
nominated
following as responsible
persons.
i. Owner of the firm, M/s
Kohs Pharmaceuticals
(Pvt) Ltd.,

Remarks:The
sample
is
of
substandard quality
under the Drugs Act
1976.

Test
report
848/2013

No.

ii. Quality
Control
Incharge, M/s Kohs
Pharmaceuticals (Pvt)
Ltd
iii. Mirza
Saleemullah,
Production Manager,
M/s
Kohs
Pharmaceuticals (Pvt)
Ltd

The FID has not given


any recommendations nor
made
any
comments
regarding validity of the act
of challenging the CDL
report
by
the
firm.
However, as per record
provided by the FID, it
appears that firm has
challenged the report after

the
30
days
period
prescribed under Section
22(4) of Drugs Act 1976,
therefore, the request was
not valid for retesting by
Appellate Lab.
As per responsibility
fixed by the FID, show case
notices dated 05-05-2014
were issued to the firm and
the accused persons of the
firm.

The case was placed


before Drug Registration
Board in its 244th meeting
held on 23-24th July 2014.
The accused of the firm
were also called for
personal hearing in the
said meeting of the
Board but they could not
appear before the Board.
The Board decided to
defer the case and
provide
a
final
opportunity of personal
hearing to the accused.

The case was again


placed
before
Drug
Registration Board in its
245th meeting held on 2930th September 2014. The
accused of the firm were
also called for personal
hearing in the said
meeting of the Board but
they could not appear
before the Board. The
Board decided to defer
the case and provide a
final
opportunity
of
personal hearing to the
accused.

They
have
been
called
for
personal
hearing
again

accordingly.
.
3.

Dozabitol
(Paracetamol
Syrup.

M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad

Batch No. DB
089

Mfg- Jan-13

Sub-Standard
regard to:Assay
Paracetamol:Found:- 88.62%

with
for

With regard
i. Assay for
paracetamol:-

95.0% to

Does not comply


with BP 2011.

Does not comply


with BP 2011

ii. Description pink


colored
syrup
having un dissolved
masses which do not
disperse even on
shaking

Limit:105%

The Board was apprised about


the background of
the case
as under:-

to:-

85.52%

Exp- Dec-14

(F.No. 0331/2013)-QC

Sub-Standard

Remarks:The
sample
is
of
substandard quality Does not comply
under the Drugs Act with BP 2011, which
1976.
states
that
suspension
may
show
a
sedimentation which
is readily dispersed
Test
report
No. on shaking.
535/2013
Test report No.08MNHRS/2013

The
Sample
of
Dozabitol Syrup Batch No.
DB089 manufacture by M/s
Kohs Pharmaceuticals (Pvt)
Ltd Hyderabad, drawn on
21-03-2013
from
manufacturer premises by
FID
Hyderabad,
was
declared substandard by
Federal
Government
Analyst, CDL Karachi vide
Test report No. 535/2013
dated
06-05-2013.
On
explanation letter issued by
the FID, the firm requested
Appellate testing under
section 22(5) of Drugs Act
1976.
The
Appellate
Laboratories also declared
the sample sub-standard vide
test
report
No.08MNHRS/2013 dated 06th
August 2013. The repot of
Appellate Laboratories was
forwarded to the FID for
sending complete case along
with recommendation and
name of the responsible
persons. The
FID
in
response has nominated
following as responsible
person with request for
permission for prosecution
and
cancellation
of
registration.
i.
Owner of the firm,
M/s Kohs Pharmaceuticals
(Pvt) Ltd., Hyderabad.
ii.
Miss
Rakhshanda
Perveen (Quality Control

Manger).
iii.
Production
of the firm

4.

Stearox 1ml

M/s Gyton
Pharmaceutical

Sub-Standard

Not Challenged

Manager

As per responsibility
fixed by the FID, show
cause notices dated 07-052014 were issued to the firm
and the accused persons of
the firm.

The case was placed


before Drug Registration
Board in its 244th meeting
held on 23-24th July 2014.
The accused of the firm
were also called for
personal hearing in the
said meeting of the Board
but they could not appear
before the Board. The
Board decided to defer the
case and provide a final
opportunity of personal
hearing to the accused.
They have been called for
personal hearing again
accordingly.

The case was again


placed
before
Drug
Registration Board in its
245th meeting held on 2930th September 2014. The
accused of the firm were
also called for personal
hearing in the said meeting
of the Board but they
could not appear before
the Board. The Board
decided to defer the case
and provide a final
opportunity of personal
hearing to the accused.

They have been called


for personal hearing again
accordingly.
.
The
Brief
background of

about
the
the case is as

Injection Batch
No. H110112

Lahore

With regards to:-

Batch No. H110112,

under:-

i. pH

The samples of Stearox


Injection Batch No. H110112,
Manufactured by M/s Guyton
Pharmaceutical Lahore drawn
by FID Karachi from Central
Pharmacy of JPMC, Karachi
on 26-02-2013, was declared
Substandard vide test report
No.261/2013 dated 03-042013 by Federal Government
Analyst.
The
FID
has
identified following persons
responsible in the case.

Determined 5.94
Mfg:-01-12
Exp:-01-14

(F.No.0325/2013 QC)

Limit 7.0 to 8.5


Does not comply
with USP 34
ii.
Assay
Dexamethasone

for

Phosphate 14.59%
Limit 90% to 115%
Does not comply
with USP 34

Mr. Talat
Anjum (Q.C
charge)

Ahmad
In-

Muhammad
Khalil

Imran

(Production In-charge)

As per procedure show


cause notices was issued to
the firm 20th February 2014
and above accused, offering
opportunity of personal
hearing before the Drug
Registration Board. They
have also been called for
personal
hearing
accordingly.
The case was placed
before 244th meeting of
Registration Board which
decided the case as
under:The accused of the firm were
called for personal hearing, but
they could not appear before
the Board. The Board decided
to defer the case and a final
opportunity
of
personal

hearing shall be given in next


meeting of the Board
Accused as identified by FID
Lahore has also been called for
personal hearing accordingly.
The case was again placed
before 245th meeting of
Refistration Board which
decided the case as under:Decision:- Mr. Muhammad
Salman Ali, Advocate High
Court appeared on behalf of
M/s Guyton Pharmaceutical
Lahore. The Board did not
accept power of Attorney on
behalf of the firm. The Board
decided the case as under:i. The production of the
injection
Stearox
1ml
Registration No. 040336 shall
be stopped. One more
opportunity of personal
hearing is granted with the
direction
that
the
Management and Technical
Personnel
shall
appear
before the Board failing
which the ex-parte decision
shall be taken.
ii. The Board further decided
that the firm will recall all the
marketed batches of substandard
drugs
from
distribution / sale outlets /
institutional supplies if any
and area FID shall take report
from the firm and submit a
compliance report to Chairman
Registration Board.
In the light of decision taken
in
245th
meeting
of

Registration Board The One


more
opportunity
of
personal hearing is granted
with the direction that the
Management and Technical
Personnel
shall
appear
before the Board failing
which the ex-parte decision
shall be taken.
Accordingly personal hearing
is granted to firm please

Case No. 02
Sr.
No
1.

Name of Drugs
Rehumetic 50
Tablets (Diclofenac
Potassium)

Batch No. RT012

New Cases.
Firm

CDL Report

Appellate Testing

M/s Rehmat
Pharma
Lahore.

Sub-Standard with regard


to:-

No Challenged

i. Assay for diclofenac


Potassium:Determined
amount/tablet:- 48.44mg

Mfg Date:-03-14

Stated
50mg

Exp Date:- 03-16

Percentage:- 96.88%

(F.No.03-42/2014QC)

amount/tablet:-

Fail on Dissolution test


as under:ii. Dissolution test:Tablet No:- (%)age
1.
2.
3.
4.
5.
6.
Limits:

17.25
14.37
17.82
13.5
12.94
16.10
Not less than

Detail / Decision
The background of
case is as under:-

the

The FID has submitted


the investigation report.
The FID has fixed the
responsibility
and
submitted the name of
Directors,
Production
Incharge, Quality Control
Incharge as under:i. Mr. Bashir Ahmed,
Chief Executive,
M/s Rehmat Pharma,
Sheikhupura Road,
Lahore.
ii. Mr. Muzaffar Bashir
Production Incharge
M/s Rehmat Pharma,
Sheikhupura Road
Lahore.
iii.

Mr.

Muhammad

75.0%
Does not comply with
USP 37

Remarks:- The sample is


of substandard quality
under the Drugs Act 1976.

Test
Report
LHR.136/2014

No.

Sarwar, Quality Control


Incharge, M/s Rehmat
Pharma,
Sheikhupura
Road, Lahore.
The FID has concluded
that the firm has violated
Section 23(1)(a)(v) of the
Drug Act, 1976 and rules
framed there under.
The tablet Rehumetic 50
was declared substandard
by CDL on the basis of
dissolution test. The firm
vide its reply dated 18-082014 to FID did not
challenge the report and
requested to drop the
proceeding against them
in the interest of justice.
The FID has submitted
the copies of recall of the
product from market by
M/s Rehmat pharma,
Lahore.
Keeping in view above
since the firm has not
challenged the report of
CDL therefore the report
dated 21st July, 2014 is the
adducing evidence under
the law.
As per procedure a show
cause notice was issued to
the firm and other
accused,
offering
opportunity of personal
hearing before the Drug
Registration Board.
They have been called for
personal
hearing

accordingly.

2.

D. Dron
(Dexamethason)
Injection (IM/IV)
Batch No. DF.137
Mfg:- 06-13
EXP:- 06-15
&
Batch No. DF.138
Mfg:- 07-13
EXP:- 07-15
(F.No.03-10/2014QC)

M/s Epharm
Laboratories,
Karachi.

Adulterated
&
Substandard with regards
to Description:Finding of Lab:Colorless solution in clear
glass ampoule. Out of 25
ampoules (referred portion
of sample) one ampoule
contain black particles and
another ampoule contains
white fibers.
Does not comply with
Description
Remarks:The
sample
is
of
Adulterated
&
Substandard under the
Drugs Act 1976.
Adulterated
&
Substandard with regards
to Description:Finding of Lab:Clourless solution in clear
glass ampoule. Out of 15
ampoules (referred portion
of sample) two ampoules
contain black particles.
Does not comply with
Description
Remarks:The
sample
is
of
Adulterated
&
Substandard under the
Drugs Act 1976.

Not challenged

The background of
the
case as under:
The samples of
D-Dron
Injection
Batch No DF.137 &
DF-138 manufactured
by
M/S
Epharm
Laboratories, Karachi
were taken by FID
Hyderabad at Karachi
on 29-01-2014 from
manufacturers
premises. The samples
were
declared
Adulterated
&
Substandard by Federal
Government Analyst
vide
test
reports
No.KQ.60/2014
&
KQ.61/2014 dated 18th
February
2014
respectively.

The
FID
communicated the test
reports to the firm vide
his
letter
No.0510/2014-FID-H
(K)
255-257 dated 19-022014. The firm in their
reply mentioned about
their right of exercise
the
power
under
subsection
(4)
of
Section 22 of Drugs
Act 1976 for retesting
of their samples from
appellate
lab
Islamabad. As per
submission
of
complete case by the
FID, the firms reply
was received in the
office
of
DRAP
Karachi on 08-04-2014
which was well after
the expiry of time

allowed under section


22(4) of the Drugs Act
1976 and hence not
valid as per FIDs
remarks.
The FID has
furnished the names of
the following persons
of the firm responsible
for committing the
offence under the law.

i.

M/S
Epharm
Laboratories
Karachi.
ii.
Mr. Asad
Ilyas
Nainitalwala,
Director,
iii.
Mr. Ahmed
Nadeem Qasmi,
QC Manager,
iv
Dr. Mohammad
Khokhar
Production
Manager,

Show
cause
notices were issued to
the firm and other
accused,
offering
opportunity of personal
hearing before the
Drug
Registration
Board
after
the
approval
of
the
competent
authority.
They have been also
called for personal
hearing accordingly.
3.

i. Loose pink
cloured tabletsRumin (Ibuprofen)
400mg Tablets
Batch No. Nil
Mfg Date:- Nil

M/s Ankaz
Pharmex (Pvt)
Ltd Karachi

Substandard with regard to


Assay
for Ibuprofen:
Determined
=49.512mg

amount/Tab

Stated

amount/tab

Substandard with
regard to Assay for
Ibuprofen (BP)
Stated:400mg/Tab
Found:- 313mg/tab.

The background of
case as under:

the

The
Federal
Inspector of Drug,
Karachi-III vide his
letter dated 21-04-2014
informed
that
he
alongwith Dr. Shahid

Exp Date:- Nil

=400mg

Percentage:- 78.29%

Percentage:- 12.378%

Limit: 95% to 105%

Limit: 95% to 105%

Does not comply with


BP 2011

Does not comply


Remarks:- The sample is
of substandard quality
under the Drugs Act 1976.
Test
Report
RKQ.212/2014.

No.

Hussain, FID Karachi


and others raided the
premises of M/s Ankaz
Pharmax (Pvt) Ltd.,
Karachi on 19-04-2014
at 07.45 AM. The raid
was conducted on the
source information of
FIA Crime
Circle
Karachi.
Deputy
Director
FIA
Mr.
Fakeer
Muhammad
headed
the
raid
alongwith his team.
Ten
samples
of
different products were
taken
from
the
manufacturers
premises
for
test/analysis on the
prescribed Form-3.

Conclusion:The sample is of
substandard quality
on the basis of tests
performed.

The FID vide his


investigation report of
the case intimated that
eight samples of the
drugs taken have been
declared
to
be
substandard by the
Federal Government
Analyst, CDL Karachi.
In the light of the
same, the FID issued
explanation
letter
regarding the matter of
manufacture and sale
of substandard drugs to
the firm. As per
documents provided by
the FID, the firm
challenged the steports
requested to get the
samples retested from
the
Appellate
Laboratory,
NIH
Islamabad.
The
Appellate Laboratory
also declared the drug
sample under reference
as Substandard.

The
FID
concluded that the
manufacturer is guilty
of
manufacturing
substandard drugs and
de-registered drug in
violation
to
the
provisions of Drugs
Act 1976 and rules
framed there under. He
has
requested
for
cancellation DML of
the firm or permission
to
lodge
the
prosecution against the
firm.

Following
persons of the firm
have
been
held
responsible
for
committing the offence
by the FID.
i. Ali
Abbass,
Managing Director
of the firm.
ii. Akbar
Ali
Production Incharge.
iii. Safdar Alam,
Quality Control
Incharge.

As per procedure
Show cause notices
were issued to the firm
and other accused, in
the light of the test
reports of the Appellate
Lab and report of the
FID, offering them
opportunity of personal
hearing before the
Drug
Registration
Board.

ii. Loose pink


cloured tabletsRumin (Ibuprofen)
200mg Tablets
Batch No. Nil
Mfg Date:- Nil
Exp Date:- Nil

Substandard with
regard to Assay for
Ibuprofen (BP)
Substandard with regard to
:-

Stated:200mg/tab

Assay for Ibuprofen:

Found:- 153.38mg/tab.

Determined amount/Tablet
=24.756mg

Percentage:- 76.69%

Stated
=200mg

amount/tablet

Limit: 95% to 105%

(Blister packing)

Does not comply

Batch No. 1105


Mfg Date:- 1-12
Exp Date:- 12-14

v. Tablet Rumin
(Ibuprofen) 200mg
Batch No. 640
(Jar Packing)
Mfg Date:- 2-13
Exp Date:- 01-16

-Do -

Limit: 90% to 105%


Does not comply with
BP 2011

Percentage:- 12.378%
iv. Tablet Rumin
(Ibuprofen) 400mg

Conclusion:-

The sample is of
substandard quality
Remarks:- The sample is on the basis of tests
of substandard quality performed.
under the Drugs Act 1976.
Test
Report
RKQ.213/2014

No.

Substandard with regard to


:Assay for Ibuprofen:
Determined amount/Tablet
=350.71mg

Stated:400mg/tab

Stated
=400mg

Found:- 319.24mg/tab.

amount/tablet

-Do-

Test Report No.09MNHSR/2014


Substandard with
regard to Assay for
Ibuprofen (BP)

-Do-

Percentage:- 79.81%

Percentage:- 87.6775%

Limit: 95% to 105%

Limit: 95% to 105%

Does not comply with


BP 2011

Does not comply

They have also


been
called
for
personal
hearing
accordingly.

Remarks:- The sample is Conclusion:of substandard quality The sample is of


under the Drugs Act 1976. substandard quality

The
Inspector

Federal
of Drugs,

Test
Report
RKQ.215/2014

No.

on the basis of tests


performed.

Substandard with regard to


:-

Test Report No.08MNHSR/2014

Assay for Ibuprofen:

Substandard with
regard to Assay for
Ibuprofen (BP)

Determined amount/Tablet
=30.945mg
Stated
=200mg

amount/tablet

Stated:200mg/tab
Found:-145.60mg/tab.

Percentage:- 15.4725%

Percentage:- 72.80%

Limit: 95% to 105%

Limit: 95% to 105%

Does not comply

Does not comply with


BP 2011
Remarks:- The sample is Conclusion:of substandard quality
under the Drugs Act 1976. The sample is of
substandard quality
on the basis of tests
performed.

vi.. Biprim (CoTrimoxazole) DS


Tablets
Batch No. 305
(Blister packing)
Mfg Date:- 11-13
Exp Date:- 10-16

Test Report No.012NHSR/2014

-do.
Test
Report
RKQ.206/2014

No.

Substandard with regard to


:Assay
Sulphamethoxazole:

for

Determined amount/Tablet
=101.328 mg
Stated
=800mg

amount/tablet

Percentage:- 12.666%

Misbranded with the


following remarks:Labeling on the
immediate pack is
not legible. More
over batch number
and expiry date is
printed
with
removable ink and
some strips found
without
batch
numbers and expiry
date
which
is
violation
of
the
labeling and packing

Karachi-III vide his


letter dated 21-04-2014
informed
that
he
alongwith Dr. Shahid
Hussain, FID Karachi
and others raided the
premises of M/s Ankaz
Pharmax (Pvt) Ltd.,
Karachi on 19-04-2014
at 07.45 AM. The raid
was conducted on the
source information of
FIA Crime
Circle
Karachi.
Deputy
Director
FIA
Mr.
Fakeer
Muhammad
headed
the
raid
alongwith his team.
The FID vide his
investigation report of
the case intimated that
eight samples of the
drugs taken have been
declared
to
be
substandard by the
Federal Government
Analyst, CDL Karachi.
In the light of the
same, the FID issued
explanation
letter
regarding the matter of
manufacture and sale
of substandard drugs to
the firm. As per
documents provided by
the FID, the firm
challenged the test
reports and requested
to get the samples
retested
from
the
Appellate Laboratory,
NIH Islamabad. The
Appellate Laboratory
declared
the
drug
sample under reference
as Misbranded.
The

FID

Does not comply

rules of Drugs Act


1976.

concluded that the


manufacturer is guilty
Remarks:- The sample is
of
manufacturing
substandard drugs and
of substandard quality Conclusion:The
de-registered drug in
under the Drugs Act 1976. sample
is
violation
to
the
misbranded.
provisions of Drugs
Act 1976 and rules
Test Report No.06framed there under. He
MNHSR/2014
has
requested
for
cancellation DML of
the firm or permission
to
lodge
the
prosecution against the
firm.

Following
persons of the firm
have
been
held
responsible
for
committing the offence
by the FID.
i. Ali
Abbass,
Managing Director
of the firm.
Test
Report
No.
RKQ.207/2014
ii. Akbar
Ali
Production Incharge.
The sample is of standard
quality with regard to tests
performed.
Test
report
RKQ.210/2014.

Quality Control
Incharge.

No.

Substandard with regard to


:Assay
Sulphamethoxazole:

iii. Safdar Alam,

As per procedure
Show cause notices
were issued to the firm
and other accused, in
the light of the test
reports of the Appellate
Lab and report of the
FID, offering them
opportunity of personal
hearing before the
Drug
Registration
Board.

They have also


been
called
for
personal
hearing

for

Determined amount/Tablet
=101.328 mg
Stated
=800mg
-do-

amount/tablet

Percentage:- 12.666%
Does not comply

Remarks:- The sample is


of substandard quality
under the Drugs Act 1976.

Test
Report
RKQ.209/2014

accordingly.
The
FID
vide
his
investigation report of the
above case also reported
that the firm was found
manufacturing its one of
de-registered
product
namely syrup Rumin
mentioning
the
old
manufacturing date on the
label.
It
has
been
intimated that Syrup
Rumin was found stored
in bulk in big vessel
placed
in
liquid
manufacturing areas of
the firm. A huge quantity
of finished goods of same
de-registered syrup was
also seen placed in
finished good wear house

No.

Substandard with regard to


:Assay
Sulphamethoxazole:

for

Determined amount/Tablet
=101.328 mg
Stated
=800mg

amount/tablet

Percentage:- 12.666%
Does not comply
Remarks:- The sample is
of substandard quality
under the Drugs Act 1976.

vii. Rumin
(Iburofen)
Suspension
Batch No.408
Mfg Date:-03-13
Exp Date:-02-16

-doTest
Report
RKQ.208/2014

No.

Substandard with regard to


:Assay for Ibuprofen:
Determined amount/Tablet
=30.945mg
Stated
=200mg

amount/tablet

Percentage:- 15.4725%

The
FID
concluded that the
manufacturer is guilty
of
manufacturing
substandard drugs and
de-registered drug in
violation
to
the
provisions of Drugs
Act 1976 and rules
framed there under. He
has
requested
for
cancellation DML of
the firm or permission
to
lodge
the
prosecution against the
firm.
Following
persons of the firm
have
been
held
responsible
for
committing the offence
by the FID.

Limit: 95% to 105%

i.

Does not comply


Remarks:- The sample is
of substandard quality
under the Drugs Act 1976.
Test
Report
RKQ.214/2014

ii. Akbar
Ali
Production Incharge.
iii. Safdar Alam,

No.

Quality Control
Incharge.

viii. Biprim DS
(Co-Trimoxazole)
Tablets

-Do-

The Sample has been

declared of Standard
Quality of the basis of
tests performed

(Jar packing)
Mfg Date:- 11-13

Test Report No.07MNHSR/2014

Exp Date:- 10-16

ix. Biprim

-do-

(Co-Trimoxazole)
Tablets
Batch No. 524

The Sample has been


declared of Standard
Quality on the basis of
tests performed by the
Appellate Lab, NIH,
Islamabad.

-Do-

The Board was apprised


about the background of
the case as under:-

Exp Date:- 12-15

x. Loose white
cores

As per record of
Quality
Control
Section, registration of
this
product
was
cancelled by DRB in
its 237th meeting held
on 26-02-2013, which
was communicated of
the firm vide their
officer letter bearing
No.03-16/2012-QC,
dated 22-03-2013.
As per procedure
Show cause notices
were issued to the firm
and other accused, in
the light of report of
the FID, and record of
QC Section regarding
the de-registration of
the product offering
them opportunity of
personal hearing before
the Drug Registration
Board.
They have also been
called
for
personal
hearing accordingly

(Test Report No.010MNHSR/2014)

(Blister packing)
Mfg Date:- 01-13

The Sample has been


declared of Standard
Quality on the basis of
tests performed.
Test Report No.013MNHSR/2014

Batch No. 305

Ali
Abbass,
Managing Director
of the firm.

The
Federal
Inspector of Drug,
Karachi-III vide his

claimed/suspected
of Tablets- Rumin
(Ibuprofen) 200mg

-Do-

letter dated 21-04-2014


informed
that
he
alongwith Dr. Shahid
Hussain, FID Karachi
and others raided the
premises of M/s Ankaz
Pharmax (Pvt) Ltd.,
Karachi on 19-04-2014
at 07.45 AM. The raid
was conducted on the
source information of
FIA Crime
Circle
Karachi.
Deputy
Director
FIA
Mr.
Fakeer
Muhammad
headed
the
raid
alongwith his team.
Ten
samples
of
different products were
taken
from
the
manufacturers
premises
for
test/analysis on the
prescribed Form-3.

Batch No. Nil


Mfg Date:- Nil
Exp Date:- Nil
(F.No.03-17/2014QC)

The FID vide his


investigation report of
the case intimated that
eight samples of the
drugs taken have been
declared
to
be
substandard by the
Federal Government
Analyst,
CDL
Karachi. In the light of
the same, the FID
issued
explanation
letter regarding the
matter of manufacture
and
sale
of
substandard drugs to
the firm. As per
documents provided
by the FID, the firm
challenged the test
reports and requested
to get the samples
retested from the
Appellate Laboratory,
NIH Islamabad. The

Appellate Laboratory
declared the drug
sample
under
reference
as
of
standard quality.
As per Section 22
(5) of the Drugs Act
1976 and the report of
conclusive evidence so
in the light of the same
the present case with
regard to drug under
reference may be filed.
Submitted
for
Information of the Board
please.
The Board was apprised
about the background of
to:- the case as under:

4.

Kemycillin
(Ampicillin) Syrup
Batch No. A-1028

M/s Alkemy
Pharmaceutical
Laboratories
Hyderabad.

Mfg. Oct-13
Exp. Use with in
three years

(F. No. 0334/2014)

Substandard with regard to


:Assay for Ampicillin
Determined amount/5ml:=103.32mg

Sub-Standard
With
regard
Assay for
Ampicillin:-

The
Sample
of
Kemycillin Syrup Batch
Stated amount /5ml
No A-1028, manufactured
i. First day Found
by
M/s
Alkemy
=125mg
Pharmaceutical
=101.14mg/5ml
Laboratories P/9, SITE
Hyderabad Sindh was
Percentage:- 82.66%
taken by FID Hyderabad
Percentage:- 80.91%
at Karachi on 24-04-2014
from
manufacturers
Limit: 90% to 120%
premises. It was declared
substandard by Federal
ii.
On 07th Day
Found
= Government Analyst vide
Does not comply
Test
report
No.
78.53mg/5ml
KQ.230/2014 dated 27th
May 2014. In response to
Remarks:- The sample is Percentage:- 62.82%
the explanation letter
of substandard quality
issued by the FID, the
under the Drugs Act 1976.
firm challenged the CDL
report and requested for
Appellate Testing under
Limit:- 80-120%
Section 22(5) of Drugs
Test
report
No.
Act, 1976. The Appellate
KQ.230/2014
Laboratory also declared
Stated 125mg/5ml

Does not comply with


BP 2011.

Conclusion:The sample is of
substandard quality
on the basis of tests
performed.

Test report No. 015MNHSR/2014

the sample as Substandard


vide test report No. 015MNHSR/2014 dated 08th
August 2014. The FID in
response to this office
letter dated 29th August
2014 concluded that the
firm has violated Section
23(1)(a)(v) of Drugs Act
1976.
FID
has
recommended immediate
action under Section 7(11)
of the Drugs Act 1976 and
has furnished the names
of the following persons
of the firm responsible for
the offence.

i.

M/s Alkemy
Pharmaceutical
Laboratories (Pvt.)
Ltd Hyderabad,
ii. Mr.Fraz Ahmed
Sheikh,
Managing Director,
iii. Mr. Asif Najeeb
Laghari,
QC Manager,
iv.

Mr.Abid Ali Khoso


Production Incharge,

As
per
responsibility fixed by
the FID, show case
notices dated 05-052014 were issued to
the firm and the
accused persons of the
firm.

They have been


called for personal
hearing accordingly.

5.

Empoir 500mg

M/s Alkemy

Sub-Standard:-

Substandard with

The Board was apprised

(Ciprofloxacin)
Tablets.

Pharmaceutical
Laboratories
Hyderabad.

Batch No. 283

With regard to Dissolution


test

57.71% (repeated)

Tablet 02= 48.94%

Limit:- Not less than


80% of the stated
amount

Tablet 03= 39.30%

Exp Date. 02-17

Tablet 04= 32.26%


Tablet 05= 39.15%

Does not Complies


with USP 32

Tablet 06= 39.15%

Limit:- Not less than 80%


Conclusion:Does not comply with
USP 35.

The sample is of
substandard quality
on the basis of tests
performed.

Remarks:- The sample is


of substandard quality
under the Drugs Act 1976.
Test report No. 014MNHSR/2014
Test
report
KQ.228/2014

No.

about the background of


the case as under:-

Determined:- 59.9%

Tablet 01= 38.23%

Mfg Date- 03-14

(F.No. 0333/2014)-QC

regard to Dissolution
test

The Sample of Empoir


500mg Tablets Batch 283
manufactured by M/s
Alkemy Pharmaceutical
Laboratories (Pvt.) Ltd,
P/9, SITE Hyderabad was
taken by FID Hyderabad
at Karachi on 24-04-2014
from
manufacturers
premises. The Sample
was declared substandard
by Federal Government
Analyst CDL Karachi
vide Test report No.
KQ.228/2014 dated 15th
May 2014. In response to
the explanation letter
issued by the FID, the
firm challenged the CDL
report and requested for
Appellate Testing under
Section 22(5) of Drugs
Act, 1976. The Appellate
Laboratory also declared
the sample as Substandard
vide test report No. 014MNHSR/2014 dated 12th
August 2014. The FID in
response to this office
letter
dated
18th
September
2014
has
concluded that the firm
has violated Section 23(1)
(a)(v) of Drugs Act 1976.
FID has furnished the
names of the following
persons of the firm
responsible
for
the
offence.

i.

M/s
Alkemy Pharmaceutical
Laboratories (Pvt.) Ltd
Hyderabad,
ii.
Mr.Fraz
Ahmed Sheikh,
Managing Director,
iii.
Mr. Asif
Najeeb Laghari,
QC Manager,
iv.
Mr.Abid
Ali Khoso
Production Incharge,

.As
per
responsibility fixed by
the FID, show case
notices have been
issued to the firm and
other accused persons
of the firm.
They have been
called for personal
hearing accordingly

Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s


Pharmawise Labs Pvt Ltd Lahore
Brief Background

The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152
of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for
test/analysis. The samples were declared substandard by the F.G Analyst vide test report
No.T.B.64/2012 dated 01-08-2012.

The firm did not challenge the report and case was

accordingly processed and decided by the Registration Board in its 237 th meeting, held on 26-022013 and cancelled the registration of the product under reference. The firm filed an appeal
before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,
which was dismissed by the Appellate Board in its 140th sitting.

.The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,

Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate
Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan
which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.
Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the
sample is of Sub-standard quality.
S.No
.
1.

CDL Test Report No.


TB.64/2012 & Findings
i. pH Determined 5.18
ii. Limits:- 4.2 to 4.8 Does not
comply with BP 2011

Appellate Test Report No.016MNHSR/2014 & Findings


i. pH Determined 4.75
ii. Limits:- 4.2 to 4.8 Comply with
BP 2011 .
iii. Volume Determined 60ml
Assay for Rifampicin
Complies with volume stated on the
i. Determined amount per ml label
=15.514mg/ml
Assay for Rifampicin
i.
Determined amount per ml
ii.
Stated amount / ml= =17.31mg/ml
20mg/ml
ii. Stated amount / ml= 20mg/ml
iii. Percentage:- 77.57%
iv. Limits:- 90% to 110%
iii. Percentage:- 86.63%
Does not comply with BP iv. Limits:- 90% to 110%
2011
Does not comply with BP 2011

Remarks
The sample is of
Substandard
quality on the
basis
of
test
performed
by
FGA
CDL
Karachi
and
Appellate Testing
Lab Islamabad.

The case is submitted of the consideration / decision of Registration Board under intimation to
Assistant Registrar motion for Deputy Registrar Judicial in the light of brief background please.

Case No. 04 Deaths of persons allegedly due to consumption of cough syrup


manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal
Laboratories Lahore
The Registration Board in its 245th meeting decided the case as under:Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board,
Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions
filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the
Board in its up-coming meeting

The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore
have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and
Islamabad as communicated to them.
Case No. 05

Damage Samples for Board Portion

Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage
conditions
S.
No.
1.
2.
3.
4.
5.
6.
7.

(File No.13-09/2013-QC)
Product & Batch No.

Manufacturer

Condition

Canrce Tablets
Q18
Optifam Tablets
38
Naproxen Imported Raw
Material
Metformin-Hcl Imported
Raw Material
Tablet Klaribact 250mg
Q64
Liquid Glucose
014270-Bulk
Liquid Serbetol
00470114

M/s Merck (Pvt) Ltd


Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
M/s Merck (Pvt) Ltd
Quetta
Rafhan Maiz Pakistan

Badly damaged, broken carton


and seal.
Badly damaged, broken carton
and seal.
Badly damaged, glass broken
bottle and seal.
Badly damaged, glass broken
bottle and seal.
Badly damaged, broken carton
and seal.
Badly damaged, leaked bottles
and torn memorandum.
Badly damaged, leaked bottles
and torn memorandum

Made in China

The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta

whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been
informed telephonically about the status of these samples.
.

The Registration Board in its 238th meeting allowed the QC Section to get fresh samples

from the inspectors if they are received in damage conditions. In view of above following
proposal is submitted.
i.

The FID Peshawar and ADC Quetta may be advised to take special care for
packing and transportation of the Boards portion of samples in future all the
DDGs in the field offices may also be advised to instruct FIDs/ADCs to
ensure appropriate packing and sealing of such samples.

ii.

FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same
batches/raw materials, of damaged drugs for test analysis.

Submitted for perusal/ consideration of the Board

Case No. 06
Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic,
Lahore to Govt of Khyber Pakhtoonkhawa
BRIEF BACK GROUND:
The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with
reference to the decision taken in also 243 rd & 244th meeting of Registration Board which is reproduced
as under.

Decision taken in 243rd Meeting of Registration Board


i

The Federal Inspector of Drugs Peshawar is advised to get the case completed
covering details of findings, conclusion fixation of responsibilities with his
recommendations.

ii.

The Board further decided to get update regarding Suo Moto notice taken by
Hounrable Peshawar High Court Peshawar and fate of case referred to NAB
Khyber Pakhtoon Khawa.

The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of
persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 8087 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of
Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.
Name of accused persons.
i.
ii.
iii.

Mr. Iftikhar Ahmed Shiekh


Mr. Mazhar Hussain
Mr. Asim Mehmood

Director/C.E.O
Production Incharge.
Quality Control Inchage

Name of Co-accused persons.


Dr. Chuhan Director
Dr. Sharif, Director
Dr. Ghulam Subhani Director Hapatitis Program
Mubarik Shah, Store Keeper LRH Hapatitis Program
Dr. Nigar Ahmed, Ms DHQ Mardan.
Mr. Aurengzaib, Store Incharge, DHQ Mardan.
The case was again presented before 244th meeting of the Board in the light of recommendations of
the FID Peshawer as above which decided the instant case as under:-

Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic Laboratories
(Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection Hepaferon (3MIU)
Interferon Alpha 2a to government of KhyberPakhtoonKhawa.
The The FID Peshawar has submitted the complete investigation of the case fixing the
responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon
Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23
(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are
employees of Government of Khyber Pakhtoon Khawa.
As directed by Chairman Registration Board the case is again submitted for consideration of the
Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High
Court, & NAB investigation in instant case please.

Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital
Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga
Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad
(35600 bottles).
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad
has forwarded two recommendations to DRAP as under:i.
The Federal Government Cancel the Drug Manufacturing License of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Substandard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000
vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore
which supplied substandard Almajax 120ml Suspension to DHQ Hospital
Hafizabad (35600 bottles).
ii.
The Federal Government Cancel the Registrations of the said drugs of M/s
Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch
Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.
Brief Background
The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government
analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax
suspension, and statement of the Drug Inspector observed that this is a criminal negligence on
the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)
observed that there is a dire need to take quick action against the said firms to safeguard the
public health at large and submitted the above mentioned recommendations.
The case is placed before Registration Board for decision on the recommendations of
(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these
firms as per law with the proposal that recommendations may also be send to Division of
Licensing for further necessary action at their end so that public health may be saved from risk.
Submitted for consideration of Registration Board please.

Item No.IX

Registration of Medical Devices Medical Devices Division

Case No.01.

Applications for registration of medical devices for import.


The Expert Committee on Medical Devices in its 11 th meeting held on

26th November, 2014, considered the following applications for registration of medical devices
for import and decided as mentioned against each for consideration of Registration Board:A)

CANNULAS

S.No Name of Importer and


.
Manufacturer/Exporter.

1.

2.

Name of Medical
Device

M/s Kaf Surgical &


Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
Manufactured by
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,
P.O.Box 70407, Beruit,
Lebanon.

JRZ Intravenous
Canula without
Wings without
Injection Port
(Pencil Type).

M/s Kaf Surgical &


Disposable Equipments,
GF-116, Panorama Centre,
Plot No.248, Staff Lines,
Fatima Jinnah Road,
Karachi/
Manufactured by
M/s Plasti Lab S.A.R.L,
Roumieh El Metn,
Industrial Area, Main
Road, Khoury Bldg,

JRZ Intravenous
Canula without
Wings without
Injection Port
(Pen Type)

Price

Pack size

Decontrolled
till policy
decision by
the Policy
Board/
Federal
Government.

(14G,
16G, 18G,
20G,
22G, 24G,
26)

-do-

(14G,
16G, 18G,
20G,
22G, 24G,
26)

Shelf
life

Recommendations of
ECMD

5
years

Recommended
for
Consideration
of Registration
Board.

5
years

Recommended
for
Consideration
of Registration
Board

50 per box

50 per box

P.O.Box 70407, Beruit,


Lebanon.
3.

4.

5.

M/s Lab Link Enterprises,


192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.

Nipro Safelet
Cath (I.V Cannula
Pen Type)

M/s Lab Link Enterprises,


192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.

Nipro Wing Cath


(I.V Cannula with
Injection Port &
Wing)

M/s. A. Feroz & Co.,


Star IV. Catheter
Medicine Street No.1,
with Injection
Marriot Road, Karachi
Port.
Manufactured by
M/s. Engineering Technical
Plastic Industries
(Enteplin-Egypt) 10th of
Ramadan City, Industrial
Zone, A-1 Part 41/3.
Sharqia, Egypt.
B:

INFUSION SET:

Decontrolled
till policy
decision by
the Policy
Board/
Federal
Government

(16G,18G,
20G,
22G, 24G)

-do-

(16G,
18G, 20G,
22G, 24G)

5
years

Recommended
for
Consideration
of Registration
Board.

5
years

Recommended
for
Consideration
of Registration
Board.

5
years

Recommended
for
Consideration
of Registration
Board.

50 per box

50 per box

-do-

(14G,
16G, 18G,
20G, 22G,
24G)
100 per
box

S.No Name of Importer and


.
Manufacturer/Exporter.

1. M/s Lab Link Enterprises,


192-N, Block-II, PECHS,

Name of Medical
Device

Nipro Infusion
Set

Karachi.
Manufactured by:

(with needle)

M/s PT Nipro Indonesia


Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.

C:

Decontrolled
till policy
decision by
the Policy
Board/
Federal
Government

Pack
size

Shelf
life

Recommendations of
ECMD

1s

5
years

Recommended
for
consideration of
Registration
Board.

SYRINGES

S.No Name of Importer and


.
Manufacturer/Exporter.

1.

Price

M/s Lab Link Enterprises,


192-N, Block-II, PECHS,
Karachi.
Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,

Name of Medical
Device

Price

Nipro Disposable
Syringe (with
needle)

Decontrolled
till policy
decision by
the Policy
Board/Federal
Government

Pack
size

1ml
3ml
5ml
10ml
20ml

Shelf
life

5
years

Recommendations of
ECMD

1ml, 3ml and


5ml
recommended
for
consideration of
Registration
Board.

10ml and 20 ml
not

Indonesia.

2.

recommended
due to poor
physical
parameters like
the marking of
the syringe is
not permanent
and is with
delible ink.

M/s Lab Link Enterprises,


192-N, Block-II, PECHS,
Karachi.

Nipro Disposable
Syringe
(without needle)

-do-

Nipro Disposable
Syringe U-100
Insulin with
needle

-do-

30ml
50ml

5
years

Not
recommended
due to poor
physical
parameters like
the marking of
the syringe is
not permanent
and is with
delible ink.

5
years

Recommended
for
consideration of
Registration
Board.

Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.

3.

M/s Lab Link Enterprises,


192-N, Block-II, PECHS,
Karachi.

1 ml

Manufactured by:
M/s PT Nipro Indonesia
Jaya, Kawaran Industri
Suryacipta, JI Surya Utama
Kav, 122B, 23 & 24, Desa
Kutamekar, Kec, Ciampel,
Karawang, Jawa Barat,
Indonesia.

Case No.02.

Withdrawal of registration applications of medical devices.

The following importing firms are withdrawing their registration applications of


medical devices as mentioned against each. The firms have also not deposited differential fee as
per revised fee schedule for their products:S.No

Name of Importer and


Manufacture/Exporter.

Name of Medical
Device (s)

1.

M/s Otsuka Pakistan Ltd.


30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.
M/s Otsuka Pakistan Ltd.
30-B Sindhi Muslim
Cooperative Housing
Society, Karachi.
Manufactured by
M/s Micro Port Medical
(Shanghai) Co. Ltd.,
China.

Jive Stent (PTCA


Balloon Catheter)

2.

3.

4.

Demanded
price & Pack
size
Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.

Shelf
life

Remarks

2
years

Reference
No.27/12/
Stent-Reg.

Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.

12
month
s

Firebird-2 (Rapamycin Decontrolled till


Cobalt Chromium
policy decision
Coronary Stent
by the Policy
System)
Board/ Federal
Government.

09
month
s

Mustang Stent
(Stainless Steel
Coronary Stent
System)

2
years

Firebird (Rapamycin
Eluting Stainless Steel
Coronary Stent
System)

Decontrolled till
policy decision
by the Policy
Board/ Federal
Government.

Dated:
26-12-2011.

Reference
No.26/12/
Stent-Reg.
Dated:
26-12-2011.

Reference
No.30/12/
Stent-Reg.
Dated:
26-12-2011.

Reference
No.28/12/
Stent-Reg.
Dated :
26-12-2011.

5.

M/s. Intek Corporation,


Rawalpindi. /
Manufacturer:
M/s. OrbusNeich
Medical B.V. Drs, W. Van
Royenstraat, AN
Hoevelaken, The
Netherlands.
Shipped From:M/s. Asia Cardiovascular
Products Ltd., Kwai
Chung, N.T. Hong Kong.

Blazer CoCr Alloy


Coronary Stent
Delivery System
(Cobalt Chromium
Stent).
(Medical Device).

Decontrolled till
24
policy decision months
by the Policy
Board/ Federal
Government.

The firm has


informed that
further action
on
this
product is no
more
required.

Submitted for consideration of Registration Board please.


Case No.03.

Cancellatiuon of sole agency agreement.


M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had

applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for
import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351
VC

leek

the

Netherlands.

The

importing

firm

was

advised

to

complete

the

documents/information including fresh authorization letter and differential fee as per revised fee
schedule but the importing firm has not responded till now. The authorization letter of principal
manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-122011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination
letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug
Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed
that they terminated the business relationship with A.H Distributors, Rawalpindi.
Submitted for consideration of Registration Board please.
Case No.04.

Case remanded back by the Appellate Board.

The Registration Board in its 240th meeting held on 7th November, 2013 considered and
rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned
below against the product:-

S.No.

Name of Importer and


Manufacturer/Exporter.
M/s Mana & Co,
204 New Medicine Market, Near
Densohall, Karachi.
Manufactured by
M/s Jiangxi Huali Medical
Instrument Co.Ltd. Yudu
Industrial Zone,Ganzhou, Jiangxi,
China.

Name of Medical Demanded


Device
price &
Pack size
Medicare IV
Decontrolled
Catheter with
(14G, 16G,
Injection Port.
18G, 20G,
22G, 24G )

Shelf
life
5
years

Decision

Rejected due to
incomplete and
unsatisfactory
stability profile.

Rejection letter was issued to the importing firm. The said firm filed an appeal against the
decision of Registration Board before Appellate Board. The Appellate Board in its 142 nd meeting
held on 24th June, 2014 decided as under:The Board in light of the stability data submitted before it and taking a lenient view
decided to remand the case to the Registration Board for decision under the rules.
Submitted for consideration of Registration Board please.

Case No.05

Miscellaneous Cases.

a. Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred
in 245th meeting of Registration Board).
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in
condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration
Number and MRP of their already registered imported Prowler Micro Catheters (Registration
No.074692).
The firm has submitted that Prowler family of Micro Catheters being labeled as
per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As

Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in
sterile peel open packages after carrying out all recommended package integrity and sterility
validation tests. To ensure the sterility of product till it is received by key user, packaging
qualification testing is performed on all Prowler Micro Catheters which are packaged in a
preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized
pack being supplied in all International countries. The firm has deposited the required fee for
above mentioned product.
The firm has further submitted that the demand forecast of Prowler Micro Catheters in
Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to
produce country specific packs for such a small volume. Therefore, the firm requested for the
following approval:That they may be allowed to import Prowler Micro Catheters in international
packs provided that company will perform ink jet printing of Urdu version, Pak
Registration No. and maximum retail price at their locally licensed premises.
The case was placed before Registration Board in its 245 th meeting and the Board
deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,
Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the
Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of
samples.
Submitted for consideration of Registration Board please.

b.

Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte


Ltd., Kampong Ubi, Industrial Estate, Singapore.

The Registration Board in its 238 th meeting held on 5TH & 6TH August, 2013
considered and approved the following medical devices of M/s Promed International, Islamabad
subject to inspection of manufacturer abroad, local storage facility etc:-

S.
No
1.

Name of Importer and


Manufacturer/Exporter
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad.
Manufacturer:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.

Name
of
Device (s)

Medical Demanded
Shelf
Price &
Life
Pack Size
TM
Power Line PTCA
Decontrolled
36
Catheter
months
1s
Balloon Dia (mm):
1.5, 2.0, 2.5, 2.75, 3.0,
3.5, 4.0.
Balloon Length (mm):
10,15, 20, 25, 30.
(Many product codes)

2.

3.

M/s. Promed International,


Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors Europe SA, Ch1110 Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.
M/s. Promed International,
Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors Europe SA, Ch1110 Morges, Switzerland.
Manufacturing Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.

Bio Matrix TM Drug


Eluting Coronary Stent
System.

Decontrolled

19
months

1s

Stent Inner Dia (mm):


2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)
BioMetrix Flex TM Drug
Eluting Coronary Stent
System
Stent Inner Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.50,
4.0.
Stent Length (mm):
8, 11, 14, 18, 24, 28, 33,
36.
(Many product codes)

Decontrolled
1s

24
months

4.

M/s. Promed International,


Ground Floor, Jamil Mohsin
Mansion, G-6 Markaz,
Islamabad
Legal Manufacturer:
Biosensors International Pte.
Ltd, 21 Kallang Avenue,
Singapore Manufacturing
Site:
Biosensors Interventional
Technologies Pte Ltd.,
Kampong Ubi, Industrial
Estate, Singapore.

Gazelle Coronary Stent


System

Decontrolled

24
months

1s
Stent Dia (mm):
2.25, 2.5, 2.75, 3.0, 3.25,
3.50, 4.0.
Stent Length (mm):
8, 11, 14, 18, 23, 24, 28.
(Many product codes)

Accordingly the inspection of manufacturer abroad has been carried out by the panel
comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,
Islamabad on 1st and 2nd September, 2014. The panel has not recommended the products for
registration on the basis of following major concerns:(i)
(ii)
(iii)

(iv)

Firm is importing stents in finish form either from Germany or from China. So
there was no way to verify their manufacturing standard.
Sterility testing is outsourced and either performed in Malaysia or Germany. So
the panel was not able to check the process of sterilization for the applied
products. However, final release of the products is firm itself.
As the firm was shifting to their own constructed new premises and few
operations including microbiological testing had already been shifted to the new
premises. So the panel was not able to check their microbiological testing
process as inspection of new premises was not the mandate of the panel.
One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent
is not on free sale in the country of origin, which is one of the conditions for
registration of imported drugs in Pakistan.

Submitted for consideration and decision of Registration Board please.