Detail of Item
Item No.I
Item No.II
Item No.III
Item No.IV
Item No.V
Item No.VI
Item No.VII
Item No.VIII Quality Control Cases Quality Assurance & Lab Testing Division
Item No.IX
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.
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-
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-
27-08-2014
719
Rs.20,000/-
27-08-2014
720
Rs.20,000/27-08-2014
726
Rs.20,000/-
(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.
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.
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
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
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)
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.
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
(i)
(ii)
(iii)
(iv)
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.
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.
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.
M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported
following drug:Name of product
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.
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:
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.
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.
C. Citicoline.
i.
ii.
iii.
iv.
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.
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.
E. Calcium Dobesilate.
i.
ii.
iii.
iv.
F. Smectite.
i.
ii.
iii.
iv.
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.
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.
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.
K.
Silymarin
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 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
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.
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.
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)
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.
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.
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.
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.
Not
approve
d
by
FDA,
EMA,
TGA &
PMDA.
10.
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 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.
However,
in
evidence-based
medicine, benefits of
this drug could not
be established.
Recommended for
de-registration.
12.
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.
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.
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.
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.
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.
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
22.
Not
approve
d by
FDA,
EMA,
TGA &
PMDA
Not
mentioned
by any
standard
textbook.
23.
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.
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.
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.
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.
Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.
Recommend
ed for use in
genitourinary
disorders.
Available.
28.
Approve
d by
EMA &
TGA.
Tentativ
e
approval
granted
by FDA.
Recommend
ed for use in
genitourinary
disorders.
Available.
29.
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.
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.
Two members and PPMA has forwarded their comments on manufacturing requirements for
steroids, as follows:
manufacturing area, so it may be added that topical preparations may be manufactured in the
same approved area and exempted from separate area.
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.
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
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.
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.
There is an obligation to maintain a temperature of -20 0C and has to kept in an air tight
container.
-
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
Case No.01.
S/N
Name
and
address
of
manufacturer /
Applicant
1. Brand Name
2. Dosage Form
3. Composition
4. Pharmacological
group
1.
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.
(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
Approved.
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.
Evaluator II
S/N
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.
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)
As per
SRO/60ml
06-08-2010
Rs.8000/11-10-2012
Rs.12,000/Rs.350/10s
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
Form-5E
to
23-10-14 Dy. No: 1271
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
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
Form 5
17-11-2014 (232)
Rs. 20,000/As Per SRO/
Pack 10s
Form 5
17-11-2014(228)
Rs. 20,000/As Per SRO/
Pack 10s
New Licensee
Form 5
17-11-2014(229)
Rs. 20,000/As Per SRO/
Pack 14s
4.
5.
6.
7.
8.
-do-
-do-
-do-
-do-
-do-
Form 5
17-11-2014(235)
Rs. 20,000/As Per SRO/
Pack 10s
New Licensee
Form 5
17-11-2014
Rs. 20,000/As Per SRO/
Pack 10s
New Licensee
Form 5
17-11-2014(234)
Rs. 20,000/As Per SRO/
Pack 10s
Form 5
17-11-2014(233)
Rs. 20,000/As Per SRO/
Pack 10s
Getz
New Licensee
Form 5
17-11-2014(237)
Rs. 20,000/As Per SRO/
Pack 5s
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-
Form 5
17-11-2014(230)
Rs. 20,000/As Per SRO/
Pack 20s
50s & 100s
Form 5
17-11-2014(231)
Rs. 20,000/As Per SRO/
Pack 10s
Form 5
17-11-2014 (196)
Rs. 20,000/As Per SRO/
Pack 20s
Form 5
18-11-2014(Nil)
Rs. 20,000/As Per SRO/
Pack 20s
13.
-do-
Form 5
17-11-2014 (192)
Rs. 100,000/As Per SRO/
Pack 14s
15.
16.
-do-
-do-
-do-
required.
Form 5
17-11-2014(193)
Rs. 100,000/As Per SRO/
Pack 14s
NEXIUM
Capsule AstraZeneca
40mg
NEXIUM
Capsule AstraZeneca
40mg
17.
-do-
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.
20.
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-
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/
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.
Form 5
17-11-2014(206)
Rs. 20,000/As Per SRO/
Form 5
17-11-2014(212)
Rs. 20,000/As Per SRO/
-doORES Sachet
Form 5
17-11-2014(213)
Rs. 20,000/As Per SRO/
FDA: Zegerid
RISEK INSTA Powder 20mg
Sachet Getz Pharma (Pvt.) Ltd
New Licensee
BNF:
Oral Rehydration Salt
(Non-proprietary)
WHO
Formulation
(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
Sandoz
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/
availability
in
Not confirmed
MOVCOL Sachet Genix Pharma
Private Limited
New Licensee
1.Availability in SRAs no
confirmed in same strength.
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
ATRENAM
Suspension
Belgium
15/90mg/5ml Dry
Areneco
Pharma
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/
New Licensee
CIPROXIN Bayer (Formulation i
different)
(Macrolide Antibiotic )
(USP Spec.s)
37.
-do-
Eryt 200mg/5ml
Dry Suspnsion
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
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
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.
Form-5
Dy No:
dated 20-10-2014
Fluoroquinolone
As per SRO/
Pack of 10s
(Tablet
General)
Manufacture
-do-
Form-5
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
20,000/-
Leflox of
Karachi.
Getz
Recommendations
by the Evaluator
43.
-do-
Form-5
Dy No:
dated 26-09-2014
Anti- Anemic
International
availability requires
1018 confirmation.
Rubifer Chewable
Tablets of AGP
(Pvt)
Limited,
Karachi.
Manufacturer
44.
-do-
Form-5
Dy No:
dated 20-10-2014
International
availability requires
1261 confirmation.
Rubifer-F Chewable
Tablet of AGP (Pvt)
Limited Karachi.
Anti- Anemic
45.
-do-
Manufacturer
CYTO Tablet 250mg
Form-5
Cipro of
Health Care
Dy No: 1019
dated 26-09-2014 Cipro
Fluoroquinolone
As per SRO
1x10s
20,000/-
Bayer
of Bayer
Health Care Karachi
BP
46.
-do-
Form-5
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-
Form-5
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
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-
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
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
Dy No: 1260
dated 20-10-2014
Antifungal
20,000/-
Manufacturer
As per SRO/
1x4s
Form-5
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
BP
55.
-do-
Source:
M/s
Vision
Pharmaceuticals, Islamabad.
GOTEC Capsules 20mg
Form-5
Dy No: 1044
dated 26-09-2014
PPI
As per SRO/
1x10s, 1x14s
Prilosec
AstraZeneca
(USFDA)
of
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
Syrup of
Pharma
As per SRO/
Pack of 60ml &
120ml bottle
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
equivalent to Ciprofloxacin..
..250mg
Fluoroquinolone
Manufacturer
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
Antibiotic
Manufacturer
Decontrolled/
50ml vial
TYLOGEN Injection
Form-5
Each ml contains:
Tylosin Tartrate.10mg
Gentamicin
as
sulphate..50mg
Antibiotic
Decontrolled/
50ml vial
Manufacturer
Remarks on the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
20,000/-
of
Recommendations
by the Evaluators
-do-
-do-
-do-
-do-
Form-5
Each ml contains:
Oxytetracycline
as
Hydrochloride.200
mg
Antibiotic
Decontrolled/
100ml vial
Manufacturer
OXY FAR Injection
20,000/-
Form-5
Each ml contains:
Oxytetracycline
as
Hydrochloride.50m
g
Antibiotic
Decontrolled/
50ml Vial
Form-5
Each ml contains:
Enrofloxacin.100mg
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
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-
Oxyfen-LA
Selmore
Pharmaceuticals,
Lahore
Bacticom of Selmore
Pharmaceuticals
Lahore
20,000/Decontrolled/,
50ml vial
Manufacturer
IVERIN Injection
Form-5
Each ml contains:
Ivermectin.10mg
Anthelmintic
20,000/-
BP
PARACTIN Injection
Decontrolled/
50ml vial
Form-5
Each ml contains:
Ivermectin.20mg
Anthelmintic
20,000/-
Actimec Injection of
Selmore
Pharmaceuticals
Lahore
BP
-do-
-do-
MELOXAM Injection
Decontrolled/
50ml vial
Form-5
Each ml contains:
Meloxicam.7.5mg
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
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
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
Vitamin
-do-
Manufacturer
HEPAFAR Injection
Form-5
Each ml contains:
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
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
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.
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
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
Form 5
13-102014 (34)
Rs.
50,000/As
Per
SRO/5gm,
15gm
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
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
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
Not confirmed
Very good, Panel recommends all the additional sections as
per approved layout plan. (24-06-14)
-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
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)
Evaluator III
S/N
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
Type of Form
Composition
Fee including
differential fee
Pharmacological
Group
Finished
Specification
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
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.
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
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
Novidat
Karachi
of
Sami
USP
-do-
LINZO Infusion
Form-5
Zyvox
USA
of
Pfizer
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
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
of
Getz
Lexotan Tablets of
Roche
(TGA
Dy. Approved)
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-
Form-5
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-
As per SRO
10x10s
Form-5
Dy No: 791
dated
23-092014
Benzodiazepine
20,000/BP
-do-
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
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
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
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
Shaiga
DM
(23-24
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
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)
Mucolytic agent
Rs. 50,000/-
Form-5D
(Manufacturers
Specs)
Corticosteroid
Rs. 50,000/-
Lafelax
Liquid
Sachet
Each 15ml sachet
contains:Lactulose67%
w/v
Form-5D
(USP Specification)
New License
CLIPPER
Gastro-resistant
prolonged release tablet
5mg
MHRA
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
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/-
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
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
Composition
Finished
Specification
Demanded
Pack size
Price
product
Me-too status
GMP status as depicted in latest
inspection report (with date) by the
Evaluator
Form-5
Anti-Infective
As per SRO
20,000/-
(Tablet General)
USP
-do-
-do-
Form-5
Anti-Infective
As per SRO
USP
Levoquin Tablet 250mg
Form-5
Anti-Infective
As per SRO
20,000/-
20,000/-
Manufacturer
-do-
Form-5
hemihydarte..500mg
20,000/-
Anti-Infective
As per SRO
Manufacturer
-doCapsule (General)
Omezole-D Capsule
Form-5
Blended
pellets
of
Omeprazole
20mg
EC.20mg
Domperidone
IR
.10mg
100,000/-
As per SRO
b
Anti-Ulcer
Emetic
and
Anti-
Manufacturer
-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
Hepa-MerzMerz
Germany
Pharmaceuticals
Hydrochloride:
135mg
Physillium
Husk..3.5gm
Antispasmodic
Laxative
M/s Elite Pharma
(Pvt) Limited, 9.5
Km
Sheikhupura
Road Lahore
-do-
and
Manufacturer
Flucolite Infusion 50ml
Form-5
Diflucan of Pfizer.
Each ml contains:Fluconazole2mg
Antifungal
20,000/-
Manufacturer
Percemol
1gm/100ml
Infusion
Form-5
Provas of
Karachi
20,000/-
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
SAMI
Pharmaceuticals
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
Hyperosmoler complex
and infusion solution
Manufacturer
b) Routine applications
Evaluator II
S/N
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
Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(14-05-2013)
As per PAC
Form-5
15-07-2010
(N/A)
Rs.8,000/-+Rs. 12,000
(25-07-2013)
As per PAC
1.Verification of photocopies of fe
challan is required.
BNF: Xifaxanta (Norgine)
Nimixa (Getz Pharma)
Form 5
06-07-2010 Rs.8,000/
(69)
+Rs. 12000 (10-05-2013)
As Per PRC
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
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)
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
-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.
FDA: Tracleer
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.
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
submitted reference
of Me too as Poart
susp. of Neutro
pharma (62770)
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/-
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
not
Str
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)
(Manufacturers
Spec.s)
-do-
-do-
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-
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-
Form-5
30-7-2010
Itopride
Hydrochloride50
mg
Dy.No.1508
(Gastroprokinetic)
Rs.8000/-+Rs. 12000/(10-05-13)
As per PRC
(Manufacturers
Spec.s)
-do-
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
Dy.No.1506
Rs.8000/-+Rs. 12000/(10-05-13)
Centauru S (Ferozsons)
(Anti Viral)
As per PRC
(Manufacturers
Spec.s)
-do-
Good (09-06-2014)
Form-5
30-7-2010
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
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.
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.
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.
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.
Decontrolled
Each ml contains:-
30ml
Albendazole..125mg
100ml
250ml
Cobalt Sulphate0.50mg
500ml
(Anthelmentic).
1000ml
2 years
15-12-2010
Rs.8000 +
Rs. 12000 =
Rs.20,000/-
2.5 Liter
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/-
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
10s /Rs.299/-
Levofloxacin as
Hemihydrate ..........750
mg
(Quinolone group
Antibacterial)
Manufacturers
Specifications
LEVAQUIN
750mg Film
tablet
US FDA
coated
LEFLOX
750mg
Getz
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.
Rayart DS Tablet
Form 5
Tablet
8s /Rs.264/-
Artemether
.40mg
Lumefantrine.240
mg
(Anti Malarial)
ARTHEGET
40/240mg tablet
Getz
Inspection report dated
06/05/2014 good level
of GMP compliance
reported.
Remarks /
Observations
Manufacturers
Specifications
Rayart Tablet
Form 5
Tablet
4s /Rs.220/-
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.
Rayaz Tablet
Form 5
Tablet
3s /Rs.160/-
Azithromycin as
dihydrate
.
500mg
(Macrolide Antibiotic)
Manufacturers
Specifications
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
Dy No 255 R&I
dated 23-07-2010
Rs.8000/-
Rs.12,000/22-05-2013
Falgan 500mg/50ml
Form 5-D
Infusion
1,s /Rs.60/-
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
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
Form 5
Tablet
Dy. No Not
mentioned / R&I
dated not mentioned
(Covering letter dated
20/07/2010)
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
(Anti-Hyperglycemic)
Rs.8000/(22/07/2010)
Amaryl
MHRA
Amaryl
Sanofi-Aventis
GMP inspection report
dated 13/02/2013
Amaryl
MHRA
Amaryl
Sanofi-Aventis
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
Form 5
Tablet
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
Form 5
Tablet
Rs.8000/(22/07/2010)
Rs.12,000/(15/05/2013)
fee challans are
duplicate
Total Rs.20,000/20s / As per PRC
Amaryl
MHRA
Amaryl
Sanofi-Aventis
GMP inspection report
dated 13/02/2013
Evaluator II
S.N
o
Brand Name
(Proprietary
name
+
Dosage Form + Strength)
Type of Form
Composition
Fee
including
differential fee
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
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
-do-
Form 5
0572010(46)
Rs.15000/
2252013
Rs.5,000/
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
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
1.Verification
of
photocopies of fee (Rs.
15000/- + Rs. 5000/-)
paid is required.
1.Verification
of
photocopies of fee (Rs.
15000/- + Rs. 5000/-)
paid is required.
-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
1.Verification
-do-
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)
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
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.
Form 5
12-07-2010 (17)
Rs.8,000/
+Rs. 12000 (09-052013)
As Per PRC
-do-
Form 5
12-07-2010 (16)
Rs.8,000/
+Rs. 12000 (09-052013)
As Per PRC/10s
Form 5
Not confirmed
06-07-2010
Rs.8,000/ (N/A)
+Rs. 12000 (22-052013)
1.Verification
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)
3.International
availability
of
formulation in SRAs
not confirmed.
4.Formulation contains
M/s Nenza
Pharmaceuticals,
33 A Industrial
Estate Hayatabad
Peshawar
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)
Nenmether DS Tablets
Each Tablet contains:Artemether40mg
Lumefantrine240mg
(Antimalarial)
(USP Salmous Spec.s)
Form 5
16-07-2010
Rs.8,000/ (79)
+Rs. 12000 (23-052013)
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.
Form 5
06-07-2010, Rs.
8000/- + Rs. 12,000
(22-05-2013)
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)
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
01/07/10(Nil)
Rs.8000/+Rs.12000/(14/05/13)
Arthrotec (Pfizer)
As per
10s,20s
PRC
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
Brand Name
(Proprietary
name
+
Dosage Form + Strength)
Type of Form
Composition
Fee
including
differential fee
Pharmacological Group
Finished
Specification
product
Zetamax Tablet
Each film coated tablet
contains
Azithromycin Dihydrate eq
to Azithromycin USP
.500mg
Antibiotic
Demanded Price /
Pack size
Form 5
23-07-2010
Dy. No. 264
Rs. 8000 + 12000
Rs 340/ 6s
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
.250mg
Antibiotic
Finished product
specifications are USP
Ovulin Tablet
Each tablet contains
Clomiphene Citrate USP
50mg
Anti estrogen
Form 5
17-08-2010
Rs 20,000/As per PRC
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
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC
Specifications are
Manufacturer
M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Form 5
21-07-2010
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Rs 500
International: FDA
approved 2.5 mg/ml
has
not
M/s Macter
International (Pvt.)
Limited. F-216,
S.I.T.E., Karachi.
Form 5
Each 50 ml contains
21-07-2010
Levofloxacin 250 mg
Broad Spectrum
Antibacterial Agent
Levaquine
Finished Product
Specifications are
Manufacturer
Rs 400/ 50 ml
Form 5
21-07-2010
Levofloxacin 750 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
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.
Form 5
Each 20 ml contains
21-07-2010
Levofloxacin 500 mg
Broad Spectrum
Antibacterial Agent
Finished Product
Specifications are
Manufacturer
Rs 500/ 20 ml
Kirin Tablet
Form 5
30-08-2010
Aliskirin hemifumarate
MS150 mg
Hydrochlorothiazide USP
..12.5 mg
Local: Me
confirmation
too
Levaquine
status
needs
Finished Product
Specifications are
Manufacturer
M/s Macter
International (Pvt.)
Limited.
F-216, S.I.T.E.,
Karachi.
Form 5
30-08-2010
Rifaximin..200 mg
Non systemic Antibiotic
M/s Macter
International (Pvt.)
Finished Product
Specifications are
Manufacturer
1 10s
Mirin Capsule 50 mg
Form 5
Limited.
30-08-2010
Getz
F-216, S.I.T.E.,
Karachi.
Diacerein MS ..50 mg
Antirheumatics/ Pain
Management
As per PRC
Finished Product
Specifications are
Manufacturer
M/s Macter
International (Pvt.)
Limited.
Micam Injection 8 mg
Form 5
30-08-2010
F-216, S.I.T.E.,
Karachi.
Lornoxicam.8 mg
Finished Product
Specifications are
-do-
Form 5
20-08-2010
Dy. No. 151
Rs. 8000 + 12000
As per PRC
Specifications are
Manufacturer
M/s Pharmatec
Pakistan (Pvt.) Ltd.
D- 86/A., S.I.T.E.,
Karachi.
Form 5
31-05-2013
Rs 60,000/-
Anxiolytic
3 10
Form 5
09-06-2010
Rs 8000 + 12000
5s as per SRO
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)
-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
-do-
-do-
-do-
Form 5
04-08-2010
Rs 20,000/Pack of 20s
As fixed by Govt
Form 5
04-08-2010
Rs 20,000/Pack of 2 7s
As fixed by Govt
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
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
Form 5
04-08-2010
Rs 20,000/-
Amfax (Amson)
Grant of GMP Certificate for Export
recommended (04-09-14)
-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
Form 5
27-03-2010
Rs 8000 + 12000
Rs 178 for 20s
Rs 267 for 30s
Rs 890 for 100s
-do-
Gexin Tablets
Each film coated tablet
contains:-
Form 5
27-03-2010
Rs 8000 + 12000
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.
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)
Form 5
15-07-2010
8000 + 12000
As fixed by govt
1 10 pack
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/-
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.
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/-
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
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
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
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
(B.P Spec.s)
M/s Bloom
Pharmaceuticals (Pvt)
Ltd. Phase
I & II Industrial
Estate, Hattar
Form 5
contains:
19-07-2010
Olanzapine 10 mg
20,000
(Tranquilizers, Sedative,
Hypnotics)
USP Specifications
Rogen
Pharmaceuticals.
Olirag 5 mg Tablet
Form 5
19-07-2010
Olanzapine 5 mg
20,000
National Industrial
Zone (RCCI), Rawat,
Islamabad.
(Tranquilizers, Sedative,
Hypnotics)
Rogen
Pharmaceuticals.
Form 5
19-07-2010
20,000
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
(Quinolone)
Finished product
specifications are
Manufacturer
Rocep 500 mg Capsule
Form 5
19-07-2010
20,000
(Quinolone)
Finished product
specifications are
Manufacturer
Sulrog Tablet 25 mg
Form 5
19-07-2010
National Industrial
Zone (RCCI), Rawat,
Islamabad.
Levosulpride 25 mg
20,000
(Antidepressant/
Gastroprokinetic)
M/s Pacific
Finished product
specifications are
Manufacturer
Rogen
Pharmaceuticals.
Sulrog Tablet 50 mg
Form 5
19-07-2010
Levosulpride 50 mg
20,000
National Industrial
Zone (RCCI), Rawat,
Islamabad.
(Antidepressant/
Gastroprokinetic)
Rogen
Pharmaceuticals.
Form 5
19-07-2010
Levosulpride 100 mg
20,000
National Industrial
Zone (RCCI), Rawat,
Islamabad.
(Antidepressant/
Gastroprokinetic)
Rogen
Pharmaceuticals.
Form 5
19-07-2010
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
Evaluator II
Applications of impot checked by Evaluator IV
S.N
o
Brand Name
(Proprietary
name
+
Dosage Form + Strength)
Type of Form
Composition
Fee
including
differential fee
Pharmacological Group
Finished
Specification
product
Demanded Price /
Pack size
Form 5-A
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:
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.
Form 5-A
30-04-2009
Rs.15000 + Rs.85000
=
Rs.100000/
Rs.36/
per
vial
(0.5ml)
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
Advantan
Fatty
Ointment of CSL
Limited
(TGA
Approved)
Advantan of Bayer
Pakistan Karachi.
Synthetic corticosteroid
Manufacturer
-do-
ADVOCORT
0.1%
Ointment
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)
Synthetic corticosteroid
Manufacturer
Recommendations by the
Evaluator
-do-
Form-5D
Each ml contains:
Methylprednisolone
aceponate.1mg
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-
Form-5
06-10-2010
Dy. No.9226
8,000/-
Antimalarial
28-02-2014
Dy. No.594
12000/-
Manufacturer
As per SRO/
Pack of 25s
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-
Form-5
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
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
Antiprotozoal
20,000/-
Manufacturer
As per PRC/
Pack of 8x7s
Form-5
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
-do-
Form-5
20-09-2010
Dy. No. 1137
H2 Blocker
As per SRO
1x10s
Ranitidine tablets
of
Aurobindo
Pharma.
Zantac of GSK
20,000/-
BP
-do-
Form-5
20-09-2010
Dy. No. 1138
Leukotriene
Antagonist
-do-
Receptor
Manufacturer
FEKAST Tablets 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.
-do-
-do-
Form-5
20-09-2010
Dy. No. 1143
Leukotriene
Antagonist
As per SRO
2x7s
Receptor
Manufacturer
FINFLEX-S Tablets 50mg
20,000/-
Form-5
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
As per SRO
2x10s
Form-5
Motelukast
of
Accord Healthcare
Diclofenac sodium
of
Sandoz
(USFDA)
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.
20-09-2010
Dy. No. 1139
Antihistamine
Manufacturer
As per SRO
Pack of 10s
20,000/-
Levocetirizine
Actavis UK
of
Alergocit of Global
Pharma Islamabad.
-do-
Form-5
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
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-
Form-5
Dated: 12-102010
8,000/-
Antihistamine
Calpol
(BNF)
Plus
Dated: 31-072013
12000/-
Manufacturer
-do-
As per SRO/
Pack of 1s
90ml bottle
Form-5
Panadol
Karachi
Analgesic
8,000/-
Manufacturer
As per PRC
GSK
-do-
FEVEREN
500mg
Extra
Tablet
Form-5
Dy. No: Not
provided
8,000/- dated
27-10-10
Analgesic
As per PRC
M/s
Linear
Pharma, Rawat
Islamabad
FACAL Tablet
Form-5
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
Biphosphonates
20,000/-
Manufacturer
As per SRO/
Pack of 10s
Form-5
DOMELATE-C Tablet
Each tablet contains:
Domperidone
meleate.15mg
Cinnarizine25mg
as
Antidopaminergic/
Antihistamine
Manufacturer
As per SRO/
Pack
of
2x10s
Not available
SRAs
in
Not available
SRAs
in
-do-
DIVAL Tablets
Form-5
Depakote of Abbive
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
Hypnotic
As per SRO/
Pack
of
3x10s
Form-5
LINQUE Tablets
of
Dequit of Shaheen
Pharma
20,000/-
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
Antihypertensive
As per SRO/
Pack of 14s
Exforge of Novartis
Karachi
20,000/-
Manufacturer
AMEASAID Tablets
Form-5
Antirheumatic
20,000/-
Manufacturer
ALDONATE Tablet
As per SRO/
Pack of 30s
Form-5
Antihypertensive
20,000/-
Manufacturer
As per SRO/
Pack of 100s
LINESTIN Tablet
Form-5
Antihistamine
20,000/-
L-FENAC Capsule
As per SRO/
Pack of 10s
Form-5
Exforge of Novartis
(USFDA)
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
Urinary antispasmodic
20,000/-
Manufacturer
OFLOX Tablet
As per SRO/
Pack of 28s
Form-5
Fluoroquinolone
20,000/-
Manufacturer
As per SRO/
Pack of 10s
Form-5
CITAL Tablet
Each
chewable
contains:
Escitalopram
oxalate10mg
tablet
as
Detrusitol Tablet of
Pfizer UK
Detrusitol Tablet of
Pfizer Karachi
Terivid of Sanofi
UK
Treivid of Sanofi
Karachi
Not available
SRAs
in
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
-do-
TAMSIN Capsule
Form-5
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
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
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.
Form-5
5HT-3 Antagonist
As per SRO
USP
GRANI Tablet
Form-5
GSK,
20,000/-
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
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
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
Manufacturer
TRIDOX-TD
Powder
20,000/Decontrolled/
100gm, 500gm
and 1kg
Antibacterial
-do-
Vety
Lincon
Powder of Leads
Pharma Karachi.
Oral
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
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
Form-5A
Dy No:
provided
Not
Disposable
Applicant
M/s Bajwa Sons,
129
Circular
Road,
Lohari
Lahore
Manufacturer
Shanghai
Transfusion
Technology Co.
Form-5A
Dy No: 29 dated
08-10-10
15000/- dated 0810-10
Rs 300/ Blood
Bag of 450ml
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
Form-5A
Dy No:
provided
Not
Disposable
Famous
Quadruple
Blood Bags
Brand
Double
Form-5A
Dy No:
provided
Not
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
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.
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
Brand Name
(Proprietary name +
Dosage form + Strength)
Type of Form
Composition
Fee
including
differential fee
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
Form-5
27-10-2014
1336 R&I
International
status
in
stringent
regulatory
agencies
GMP status as
depicted
in
inspection
report (dated)
FLOXAPEN
Injection
500mg
MHRA UK
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
27-10-2014
1337 R&I
AMPICLOX
250/250mg
Injection
MHRA
AMPICLOX
500mg
Injection
Remarks /
Observations
(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
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)
Form 5
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)
1.Me-too
status
confirmation.
Form 5
Not confirmed
Not confirmed
As per SRO/110s
nee
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
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
1.Me-too
status
confirmation.
-do-
Ostrolife Sachet
Each Sachet contains:Cholecalciferol (USP)
60,000IU
(Vitamin)
(Manufacturers Spec.s)
Form 5
Not confirmed
Not confirmed
As per SRO/110s
nee
1.International availability
formulation in SRAs n
confirmed.
2.Me-too
status
nee
confirmation.
-do-
-do-
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
Ganaton OD (Abbott)
Satisfactory level of GMP
compliance(18-03-14)
(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
-do-
-do-
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
1.Certificate
of
Analys
stability studies accordi
to zone of Pakistan
Pellets are required.
Evaluator III
S/N
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
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
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
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
Dy No: 1276
dated 24-10-2014
Antidepressant
-do-
-do-
Manufacturer
GABANOV Capsules
Form-5
Dy No: 1274
dated 24-10-2014
Anticonvulsant
20,000/-
USP
GABANOV Capsules
As per policy of
MOH
1x10s
Form-5
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
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
Manufacturer
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
Remarks
Evaluator
by
the
-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
.
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
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
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.
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.
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
/
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/-
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.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 /
(Anticonvulsant)
Manufacturers
Specifications
M/S
Linz
Pharmaceuticals (Pvt)
Ltd., 31-G/H, Sector
15 Korangi Industrial
Area,
KarachiPakistan.
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.
Form 5
Covering letter
not attached.
Rs.8000/- Jul,
2008
(Anticonvulsant Agent)
Manufacturers
specifications
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.
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/-
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
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.
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.
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.
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.
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
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/-
(Anti-Epileptic)
Manufacturers
specifications
duplicate
dossier
M/S AGP (Private)
Limited,
B-23,
S.I.T.E., Karachi
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.1225/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.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
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.
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.735/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.270/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.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
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
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
F.B.
Area,
Form 5
Rs.8000/30-06-2008
Dy. No. Not
mentioned
(Anti-Epileptic.)
Manufacturers
specifications
F.B.
Area,
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
F.B.
Area,
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
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,
Rs.8000/30-06-2008
Dy. No. Not
mentioned
(Anti-Epileptic.)
Manufacturers
specifications
M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.
M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.
Rs.12000/Dated.20-032014
Dy. No. not
mentioned
Rs.8000/15-07-2008
Dy. No. 186
Rs.12000/Dated.08-072014
Dy. No. 1244
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Rs.8000/15-07-2008
Dy. No.176
Rs.12000/Dated.08-072014
Dy. No. 1244
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
14s/Rs.20.85/
Capsule
14s/Rs.2600/(duplicate
dossier)
Form 5
Form 5
M/S
Scotmann
Pharmaceuticals, 5D, I-10/3, Industrial
Area Islamabad.
Pregalin Capsule
Capsule
Each Capsule Contains:
Pregabalin150mg
(Antiepileptics)
Manufacturers
specifications
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
Rs.12000/Dated.29-072013 duplicate
dossier
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Rs.8000/18-10-2008
Not mentioned
Rs.12000/Dated.29-072013 duplicate
dossier
GABICA
Capsules (50, 75, 100,
150 and 300mg)
Getz
Form 5
Form 5
Pregalin Capsule
Capsule
Each Capsule Contains:
Pregabalin75mg
(Antiepileptics)
Manufacturers
specifications
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
Form 5
Rs.8000/31-12-2008
Dy. No.561
Rs.12000/Dated.08-072014
Dy. No. 1239
10x2=20s /As
Per SRO
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
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
P-Gab 50
Tablet
Each tablet Contains:
Pregabalin50mg
(Antiepileptics)
Manufacturers
specifications
Form 5
Rs.8000/31-12-2008
Dy. No. 560
Rs.12000/Dated.08-072014
Dy. No. 1233
10x2=20s /As
Per SRO
Form 5
Rs.8000/31-12-2008
Dy. No.563
Rs.12000/Dated.08-072014
Dy. No. 1234
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
specifications
10x2=20s/As
Per SRO
P-Gab 100
Capsule
Form 5
P-Gab 75
Capsule
Each capsule Contains:
Pregabalin75mg
(Antiepileptics)
Manufacturers
specifications
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
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
Rs.8000/31-12-2008
Dy. No.556
(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
10x2=20s &
14s/As Per
SRO
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
Rs.8000/09-08-2008
Dy. No.287
(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
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
Rs.8000/09-08-2008
Dy. No.286
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)
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
Gabatil-150mg
Capsule
Each Capsule Contains:
Pregabalin 150mg
Form 5
Rs.8000/22-07-2008
Dy. No. not
mentioned
(Anti epileptic)
Manufacturers
specifications
Gabatil-300mg
Capsule
Each Capsule Contains:
Pregabalin 300mg
(Anti epileptic)
Rs.12000/19-06-2014
1609 R&I
10s, 14s /
15% less then
brand leader
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
10s, 14s /
15% less then
brand leader
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
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
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
Form 5
Rs.8000/-
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.
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
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,
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.
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
(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.
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
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
As per SRO
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
P-Gablin 150Capsule
Oral Capsule
Each Capsule Contains:
Pregabalin150mg
(Gaba Analogue,
Anticonvulsant.Analgasic)
Manufacturers
specifications
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
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.
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
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 Amarant
Pharmaceuticals (Pvt)
LTD 158-D, Toro
Gadap Road, Super
highway, Karachi.
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
Form 5
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.
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.
Form 5
Rs.8000/22-11-2010
Dy. No. not
mentioned
Rs.52,000/(fast track)
19-11-2012
specifications
Brand Name
(Proprietary name +
Dosage Form + Strength)
Type of Form
Composition
Fee
including
differential fee
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
Demanded Price /
Pack size
Form 5
Not mentioned
Rs 150,000
1 ml 10s
-do-
Form 5
Not mentioned
Rs 150,000
As per PAC
-do-
Form 5
Not mentioned
Rs 150,000
As per PAC
-do-
-do-
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
Form 5
Not mentioned
Rs 150,000
As per PAC
Finished product
specifications are USP
Evaluator III
S/N
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
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
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
Recommendations by
the Evaluator
Demanded
Price / Pack Me-too status
size
GMP status as
depicted in latest
inspection
report
(with date) by the
Evaluator
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
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
USP
M-XIME Capsule 400mg
Form-5
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
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
Form-5
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
Form-5
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
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
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.
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
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.
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
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.
Evaluator - I
S/
N
Brand Name
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,
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
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
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
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
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
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
Registration
Board
referred Panadol sinus
Caplets
to
Pharmaceutical
Evaluation Cell for
scrutinization in light of
check list approved by
Registration Board.
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
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
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)
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
Rs.20,000
Form 5
3.Confirmation of testin
facility by DDG DRA
and FID.
BNF 61: (Singulair (MSD)
Deferred for
correction in
master
formulation and
confirmation of
international
availability
Not confirmed
Aerokast (Barrett hodgson)
(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
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
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)
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)
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
Composition
Fee
including
differential fee
Pharmacological
Group
Demanded Price /
Pack size
Finished
Specification
Type of Form
Decision in 245th
of
Registration
Board.
Me-too status
product
GMP
status
as
depicted in latest
inspection
report
(with date) by the
Evaluator
Form-5
Dated 30/04/14 Dy
No: 602
Remarks
on
the
formulation (if any)
including
International status
in stringent drug
regulatory agencies /
authorities
Deferred
for
submission
of
finished product
specifications
Deferred
rectification
following
observations:
20,000/-
Anti-Rheumatic
Manufacturer
-do-
Form-5
Dated 30/04/14 Dy
No: 605
Antibacterial
Manufacturer
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.
Form 5
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
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
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
Disinfectant
BP
Decision in 242nd
of
Registration
Board.
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
Brand Name
(Proprietary name +
Dosage
Form
+
Strength)
Composition
Fee
including
differential fee
Pharmacological
Group
Demanded Price /
Pack size
Finished
Specification
M/s
Jfrin
Pharmaceuticals,
Lasbella Balochistan
Type of Form
Oral
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
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.
Acebro syrup
(Acebrophylline
5ml)
50mg/
Decision in M-243
Fungisaf Capsule
(Fluconazole 150mg)
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
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
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
Form-5
Dy. No: 2067
dated:16-12-2013
20,000/As per PRC
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
Following drugs deferred for expert opinion. Accordingly product was referred to expert
for views. Comments are as under:S. No.
Name of Indenter/
Manufacturer
1.
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.
Awaited.
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
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. /
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 =
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/-
Awaited
Name of
Indenter/
Manufacturer
Demanded
Price/Pack
Shelf
Life
1.
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/-
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-
As per PRC
05
years
26-03-2012
Rs.100,000/-
5.
-do-
Pedesente Synthetic
As per PRC
05
26-03-2012
6.
-do-
As per PRC
years
Rs.100,000/-
05
years
26-03-2012
Rs.100,000/-
Surgical sutures
Nishat Surgical
Sindh
Pakistan
unsatisfactory
specially size of
dispropertmat with
(dia).
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
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.
Rs.1400/
5ml Eye
Drops
packs
24
month
s
Date of
application
receiving &
fee.
02-03-2010
Rs.50, 000/-
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.
Name of Indenter/
Manufacturer
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
Rs.1046.30/Pe
r 16 Sachets
24
month
s
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).
Rs.654/
Per 10
Capsules
24
month
s
29-04-2013
Rs.100,000/-
Brig.Amjad Salamat,
Military Hospital,
Rawalpindi.
Awaited.
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.
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.
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.
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.
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
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.
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 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.
Fee
deposited.
Rs.100,000
Rs.430.00/Per vial.
Rs.100,000
Rs.1716.00/Per vial.
3.
Rs.100,000
Rs.670.00Per vial.
4.
Rs.100,000
Rs.2500.00/Per vial.
5.
Rs.100,000
Rs.8330.00/Per vial.
6.
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.
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.#
Fee deposited.
1.
Rs.100000
Prices approved by
the Price
Recommendatory
Committee
Rs.600/Per vial
2.
Rs.100000
Rs.1100/Per vial.
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.
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.
Reg. No.
1.
015532
Name of Drugs.
Name of Manufacturer.
2.
059025
3.
011081
4.
027374
M/s.
Getz
Pharma
(Pvt)
Limited,
Karachi
have
deposited
required
fee
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-
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.
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
Reg. No.
1.
015557
2.
015556
Current Name of
Manufacturer.
Rocaltrol Capsules M/s. R.P Scherer GmbH,
0.25mcg.
Germany.
Rocaltrol Capsules
0.5mcg.
-do-
The firm have deposited required fee Rs.100000x2=200000/- and submitted following
supporting documents:i)
ii)
iii)
iv)
v)
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
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
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)
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)
iii)
iv)
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
Sciences, Lahore.
3.
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.
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
S. No.
Name of Importer/
Manufacturer.
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.
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.
Recommended
3.
Recommended
4.
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.
8.
9.
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
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.
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)
Recommended
(Mnf. In France
then packaging
in Belgium;
COPP of
France)
Ubroloxin Intramammary
Suspension
Each 1 injector with 10g
(12ml) contains:Cefalexin
monohydrate...................200mg
Kanamycin
monosulfate133mg
Recommended
Recommended
Recommended
Recommended
Recommended
Recommended
Recommended
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.
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.
More chances of
their misuse, drug
interaction
and
development of
resistance. It is
better to have
separate products
for
specific
purpose.
Recommended
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.
Recommended
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
Recommended
problem so should
not be used in
these
combinations.
38. M/s. Bio-Labs (Pvt)
Ltd., Islamabad.
Recommended
Contains
Amantadine
which is antiviral
drug for flu and
may have drug
interaction and
resistance
problem so should
not be used in
these
combinations.
Fe-Zole SC 5% Oral
Suspension
Each ml contains:Fenbendazole...50mg
Elemental Selenium....1.6mg
Elemental Cobalt.............10mg
(Anthelmintic).
Recommended
ENTRO-5 Powder
Each 1000gm contains:Tylosin Tartrate BP..10%
Doxycycline Hyclate USP20%
Colistin Sulphate...450 MIU
Bromhexine HCI0.5%
Neomycin SO43.6%
(Antibacterial).
Centrum Liquid
Each 100ml contains:Enrofloxacin HCI...7500mg
Sulphamethoxypyridazine
7500mg
Sulphamethazine5000mg
Trimethoprim2500mg
(Antibiotic).
43. M/s. Intervac (Pvt) Ltd,
Sheikhupura Road,
Sheikhpura.
Tilmodox Liquid
Each 100ml contains:Tilmicosin Phosphate.15gm
Doxycycline HCI15gm
(Antibiotic).
Tissue resistance.
Amprobit Liquid
Each liter contains:Amprolium HCI250gm
Ethopabate..16gm
(Anticoccidial).
Recommended
Tylothrodox Powder
Each 1000gm contains:Doxycycline HCl..100g
Tylosin tartrate ..50g
Amantadine HCl ...40g
Erythromycin thiocyanate..60g
(Antibacterial, Antiviral).
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
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).
Doxytylodine Powder
Each 1000gm contains:Tylosin Tartrate BP..200gm
Doxycycline HCI BP100gm
Amantadine HCI.40gm
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
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
Recommended
Recommended
Recommended
Recommended
Nicotinamide....0.3g
Caffeine.1.0g
Boric acid..1.0g
(Analgesic, Antipyretic)
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.
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.
Case No.14
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#
1.
2.
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
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.
Decontrolled /
Pack Size.
Shelf Life.
1.
Neomycinsulfat Powder.
Each gm powder contains:Neomycin Sulphate..1000mg.
2.
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.
3.
Director,
Department of Pharmacy,
University of Veterinary & Animal
Sciences,
Lahore.
Revised composition.
Neurozoc Injection.
Each ml contains:Novaminsulfon .. .100mg.
Etilefrin. 0.50mg.
Calcium gluconate 250mg.
Magnesium gluconate 25mg.
M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/and submitted following supporting documents:i)
ii)
iii)
iv)
Reg. No.
035001
2.
035002
3.
035003
4.
035004
5.
035005
6.
035006
7.
035127
8.
043166
9.
043167
10.
043168
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)
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.
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
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
Psychiatrist,
Rawalpindi
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
its
ii.
various firms for expert opinion. Accordingly products were referred to expert for views. Comments are
as under.
S.
No
Name of firm(s)
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
10s
As per PRC
( M-243 )
Brig. Dr. Aslam Khan,
Consultant Pulmonologist,
Military Hospital,
Rawalpindi
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.
S.
No
Proposed
Pack size
Demand
ed Price
10s
As per
PRC
Decision
Approved subject to
confirmation
of
Bilayered
tablet
manufacturing facility
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,
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.
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:
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
14s
Demanded
MRP
Rs.840.00
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-
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
Pack
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.
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.
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
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.
Pack
60ml
Per tablet
Demanded
MRP
Rs.100.00
Rs.5.33
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)
2.
3.
4.
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
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
Case No.20
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.
021801
-do-
3.
021802
-do-
4.
021803
-do-
5.
021804
-do-
6.
014346
-do-
Case No.21
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.
Packing
MRP
076280
076281
076282
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
Reg. No.
010172
2.
023317
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:-
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
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
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.
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
02
004298
03
000497
Genticyn
0.1% w/w
04
000483
Genticyn HC Cream
05
010186
Genticyn B Cream
06
007701
Multigesic Cream
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
-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
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
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.
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
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
03-06-2014
539
Form-5
Rs.50,000/-
Import to
local
contract
-do-
-do-
053856
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
Name of product(s)
Reg. No.
1.
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
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
Case No.26
Contract
manufacturer
Case No.27
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/-
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)
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.
Case No.29
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
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:
Correct Composition
Amprexa-F Capsule 12/25mg
Each capsule contains:Olanzapine ..12mg
Fluoxetine HCl ..25mg
Case No.31
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
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.
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
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.
From
Fassgen
Hattar
To
Mediate
Karachi
054069
2.
Fassgen
Mediate
054077
3.
Fassgen
Mediate
054073
4.
Fassgen
Mediate
054067
5.
Fassgen
Mediate
054065
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
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-
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)
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-
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
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
-do-
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-
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
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
-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
30s
As
Per
SRO
60s
As
Per
-do-
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. 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. 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
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.
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.
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.
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
Case No.43
Registration Board in 243rd meeting approved the registration of following drug of M/s. Wnsfeild
Pharmaceutical Hattar.
S.N
o
1.
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. (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
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-
5s
As Per
SRO
-do-
-do-
5.
-do-
30ml
As Per
SRO
-do-
-do-
6.
-do-
30ml
As Per
SRO
-do-
-do-
7.
-do-
Per
vial
As Per
SRO
-do-
-do-
8.
-do-
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
Pack size
Demanded
Price
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
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.
030449
030450
030451
029883
Levofloxacin.250 mg
(Quinolone)
5.
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.
060248
2.
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
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.
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.
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
Per
vial
As
per
SRO
16-0811
Deferred
for
clarification
weather
Lyophilization
procedure
is
mandatory/require
d
for
such
formulation
or
not.
2.
-do-
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.
2x15s
Rs.2.70
per tablet
Approved
3.
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.
3x10s
Rs.7.50
per tablet
Approved
6.
3x10s
Rs.4.00
per tablet
Approved
7.
3x10s
Rs.10.00
per tablet
Approved
3x10s
Rs.10.00
per tablet
Approved
9.
2x10s
Rs.16.00
Approved
10.
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.
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.
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
Pack
size
30s
Demande
d price
Rs.72.52/
Tablet
30s
Rs.36.26/
Tablet
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
Comments
Bethanechol chloride is indicated for the treatment of acute
PIMS, Islamabad
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
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
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-
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)
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
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.
Human
Erythropoietin
4000iu
Reg No. 62219
Tropin 6000iu Inj
Each vial contains:
-Recombinant
Human
Erythropoietin
6000iu
Reg No.066152
Ltd. China
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
4.
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. China
5.
M/s Harbin
Pharmaceutical Group
of Bioengineering Co.
Ltd. 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
M/s F. Hoffmann- La
Roche Ltd., Basel,
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)
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
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.
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
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
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
MRP
Shelf life
Remarks
As per latest
decision
taken by
PAC
24 months
Approved
As per latest
decision
taken by
PAC
24 months
Approved
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.
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)
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
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
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
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)
02mg/vial
(1000KIU/vial
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
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.
Triptorelin Acetate
Corresponding to
3.75mg/Single Dose
3.
Menogon Injection
Menotrophin 75IU
4.
1mg Terlipressin
Acetate Pentahydrate
In 11mg Dry Substance
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.
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 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
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.
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.
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
Remarks:-
The
Detail / Decision
63/2013)
sample
is
of
substandard quality
under the Drugs Act
1976.
Test
report
852/2013
No.
i.
iii. Mirza
Saleemullah,
Production Manager, M/s
Kohs
Pharmaceuticals
(Pvt) Ltd
As per responsibility
fixed by the FID, show
cause notices dated 05-052014 were issued to the
Dozabitol
(Paracetamol
Syrup.
M/s Kohs
Pharmaceuticals
(Pvt) Ltd
Hyderabad
Batch No. DB
110
Mfg-Jul -13
Exp. Jun-15
(F.No. 0312/2014)-QC
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
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.
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
Limit:105%
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.
about
the
the case is as
Injection Batch
No. H110112
Lahore
under:-
i. pH
Determined 5.94
Mfg:-01-12
Exp:-01-14
(F.No.0325/2013 QC)
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)
Case No. 02
Sr.
No
1.
Name of Drugs
Rehumetic 50
Tablets (Diclofenac
Potassium)
New Cases.
Firm
CDL Report
Appellate Testing
M/s Rehmat
Pharma
Lahore.
No Challenged
Mfg Date:-03-14
Stated
50mg
Percentage:- 96.88%
(F.No.03-42/2014QC)
amount/tablet:-
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
Mr.
Muhammad
75.0%
Does not comply with
USP 37
Test
Report
LHR.136/2014
No.
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
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
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
=400mg
Percentage:- 78.29%
Percentage:- 12.378%
No.
Conclusion:The sample is of
substandard quality
on the basis of tests
performed.
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.
Substandard with
regard to Assay for
Ibuprofen (BP)
Substandard with regard to
:-
Stated:200mg/tab
Found:- 153.38mg/tab.
Determined amount/Tablet
=24.756mg
Percentage:- 76.69%
Stated
=200mg
amount/tablet
(Blister packing)
v. Tablet Rumin
(Ibuprofen) 200mg
Batch No. 640
(Jar Packing)
Mfg Date:- 2-13
Exp Date:- 01-16
-Do -
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.
Stated:400mg/tab
Stated
=400mg
Found:- 319.24mg/tab.
amount/tablet
-Do-
-Do-
Percentage:- 79.81%
Percentage:- 87.6775%
The
Inspector
Federal
of Drugs,
Test
Report
RKQ.215/2014
No.
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%
-do.
Test
Report
RKQ.206/2014
No.
for
Determined amount/Tablet
=101.328 mg
Stated
=800mg
amount/tablet
Percentage:- 12.666%
FID
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.
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.
for
Determined amount/Tablet
=101.328 mg
Stated
=800mg
-do-
amount/tablet
Percentage:- 12.666%
Does not comply
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.
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.
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.
i.
ii. Akbar
Ali
Production Incharge.
iii. Safdar Alam,
No.
Quality Control
Incharge.
viii. Biprim DS
(Co-Trimoxazole)
Tablets
-Do-
declared of Standard
Quality of the basis of
tests performed
(Jar packing)
Mfg Date:- 11-13
ix. Biprim
-do-
(Co-Trimoxazole)
Tablets
Batch No. 524
-Do-
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
(Blister packing)
Mfg Date:- 01-13
Ali
Abbass,
Managing Director
of the firm.
The
Federal
Inspector of Drug,
Karachi-III vide his
claimed/suspected
of Tablets- Rumin
(Ibuprofen) 200mg
-Do-
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
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
Conclusion:The sample is of
substandard quality
on the basis of tests
performed.
i.
M/s Alkemy
Pharmaceutical
Laboratories (Pvt.)
Ltd Hyderabad,
ii. Mr.Fraz Ahmed
Sheikh,
Managing Director,
iii. Mr. Asif Najeeb
Laghari,
QC Manager,
iv.
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.
5.
Empoir 500mg
M/s Alkemy
Sub-Standard:-
Substandard with
(Ciprofloxacin)
Tablets.
Pharmaceutical
Laboratories
Hyderabad.
57.71% (repeated)
The sample is of
substandard quality
on the basis of tests
performed.
No.
Determined:- 59.9%
(F.No. 0333/2014)-QC
regard to Dissolution
test
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
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.
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.
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
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
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.
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.
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.
Director/C.E.O
Production Incharge.
Quality Control Inchage
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
Case No.01.
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
1.
2.
Name of Medical
Device
JRZ Intravenous
Canula without
Wings without
Injection Port
(Pencil Type).
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
4.
5.
Nipro Safelet
Cath (I.V Cannula
Pen Type)
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
Name of Medical
Device
Nipro Infusion
Set
Karachi.
Manufactured by:
(with needle)
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
1.
Price
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
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.
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.
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.
Name of Medical
Device (s)
1.
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
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.
Decontrolled till
24
policy decision months
by the Policy
Board/ Federal
Government.
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.
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.
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.
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
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.
Decontrolled
19
months
1s
Decontrolled
1s
24
months
4.
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.