DRUG

&
COSMETIC ACT

Under supervision
Dr Najeeb jahan Presented by
Lecturer Izhar ahmad
PG scholar
Nium Bangalore
Nium Bangalore
 HISTORY
British misrule-Providing poor healthcare system to
Indian citizens

Observations made by-Drugs Enquiry Committee, Indian

Medical Association

Reports in- Indian Medical Gazette during 1920-30

1940 – Drugs and Cosmetics Act

1945 – Rules under the Act

3
Extended to whole of India……
 OBJECTIVES
To regulate the import, manufacture, distribution and sale of
drugs and cosmetics through licensing.

Manufacture, distribution and sale of drugs and cosmetics by

qualified persons only.

To control the manufacture, import and sale of ASU drugs.

To establish Drugs Technical Advisory Board(DTAB) and

Drugs Consultative Committees(DCC).

To secure the maintenance of uniformity in standard of ASU

drugs
 INTRODUCTION:
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of
India which regulates the import, manufacture, sale and distribution of
drugs and cosmetics in India.
This act was originally known as the Drug Act and was passed in
1940.
The related Drugs Rules was passed in 1945. Since 1940, the act has
undergone several amendments and is now known as the Drugs and
Cosmetics Act, 1940.
Acts and rules are amended from time to time, the major amendment
being made on 1982.
Main object of the act is to avoid substandard of drugs in order to
maintain high standard of medical treatment.
 LIST OF AMENDING ACTS AND
ADAPTATION ORDERS--------
(CORRECT, IMPROVE)
1. The Drugs (Amendment) Act, 1955

2. The Drugs (Amendment) Act, 1960

3. The Drugs (Amendment) Act, 1962
4. The Drugs and Cosmetics (Amendment) Act, 1964
5. The Drugs and Cosmetics (Amendment) Act, 1972
6. The Drugs and Cosmetics (Amendment) Act, 1982
7. The Drugs and Cosmetics (Amendment) Act, 1995
8. The Drugs and cosmetics (Amendment) Act, 2008
 Drug and Cosmetics Rules have been divided into 19 parts
each dealing with a particular subject. There are 2
schedules to act and 26 schedules to Rules.
The Act consists of five chapters each chapter
related to particular subject
Chapter I --- Introductory/definitions (1-4)
Chapter II --- Drugs technical advisory board,
Central drugs laboratory,
Drugs consultative committee (5-7)
Chapter III ---Import of drugs and cosmetics (8-15)
Chapter IV --- Manufacture, sale and distribution
of drugs and cosmetic, (16-33A)
Chapter IVA---Provisions related to ASU drugs (33B-33O)
Chapter V ---Miscellaneous(33P-38)
In 1964, the act was amended to include ASU
drugs
ASU Medicines covered under the Act by
inserting Chapter IV A.
Came into force : 1stFebruary 1983.
GMP enforced : 7thMarch 2003.
Constitution of Central Drug Authority under
consideration.
 Drugs & cosmetics

Act Rule

Chapter
Chapter 1 IVA

Part XVI Part XVIA Part VII Part VIII Part IX

(151-160) (160A- (161- (162-167)
161B) (168-
160J) 169)
 CHAPTER 1 (SECTION-3)
Definitions-
(a) Drugs:
Ayurvedic, Siddha or Unani Drugs” includes all medicines
intended for internal or external use for or in the diagnosis,
treatment, mitigation or prevention of [disease or disorder in
human beings or animals, manufacture] exclusively in
accordance with the formulae prescribed in the authoritative
books of [ASU systems of medicine, specified in the First
Schedule].
(aa)“the Board” means:
In relation to ASU drug, the [ASU Drugs Technical Advisory
Board] constituted under section 33C.
(aaa)Cosmetics:
Any article intended to be rubbed , poured , sprinkled or sprayed
on, or introduced into, or applicated to the human body or any part
there of for cleaning, beautifying, promoting attractiveness, or
altering the appearance.
(c) Government Analyst‖ means:
In relation to ASU drug, a Government Analyst appointed by the
Central Government or a State Government under section 33-F.
(e) Inspector‖ means:
In relation to ASU drug, an Inspector appointed by the Central
Government or a State Government under section 33-G.
 (h) PATENT OR PROPRIETARY MEDICINE :
In relation to ASU systems of medicine all formulations
containing only such ingredients mentioned in the
formulae described in the authoritative books of ASU
systems of medicine specified in the First Schedule,

But does not include a medicine which is administered

by parenteral route and also a formulation included in the
authoritative books as specified in clause (a)
 CHAPTER IVA (PROVISION RELATED TO ASU
DRUGS)

• Section33(B) Application of chapter IVA

• Section33(C) ASU drugs technical advisory board
• Section33(D)ASU drugs consultative committee
• Section33(E)Misbranded drugs
• Section33(EE) Adulterated drugs
• Section33(EEA) Spurious drugs
• Section33(EEB)Regulations of manufacture for sale of ASU
drugs
 Drugs Technical advisory Board-DTAB
 Director General of health
 Drug Controller, India
 Principle officer of ISM
 Director of the Central drugs Laboratory
 Government Analyst
 Pharmacognocist
 Phyto-chemist
 4 person from ASU pharmacopeia committee
 1 teacher in Dravaguna
 1 teacher in Ilmul-advia
 1 teacher in Gunapadam
 3 person from ASU drugs industry
 3 practitioner of ASU medicine
 DRUGS TECHNICAL ADVISORY BOARD-DTAB

Drug Principle
Controller, officer of Phyto-
Director General ISM chemist
of health India

Government Pharmacognocist
Director of the Analyst
Central drugs
Laboratory
1 teacher in
1 teacher in Dravaguna
Ilmul-advia
1 teacher in
Gunapadam 4 person from
ASU
pharmacopeia
3 person from ASU 3 practitioner of committee
drugs industry ASU medicine
 Drugs Consultative committee-DCC
It is also an Advisory Body consist of two representative central
government to be nominated by Government .
One representative of each state Government to be nominated by the
State Government.
Function
DCC to advise the Central Government, the State Governments and
the ASU-DTAB on any matter for the purpose of securing uniformity
throughout India in the administration of this Act in so far as it
relates to ASU drugs.
It shall meet when required.
It has power to regulate its own procedure
• Misbranded Drugs:-
If it is so coloured , coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic
valve.
If it is not labelled in the prescribed manner.
If its label or container or anything accompanying the drug bears any
statement, design or device which makes any false claim for the drug
or which is false or misleading in any particular
• Adulterated Drugs:-
If it consists, in whole or in part, of any filthy, putrid or decomposed
substance.
 If it has been prepared, packed or stored under insanitary conditions
whereby it may have been contaminated with filth or whereby it may
have been rendered injurious to health
• Spurious Drugs:-

If it is sold, or offered or exhibited for sale, under

a name which belongs to another drug.
 If it is an imitation of, or is an substitute for,
another drug or resembles another drug in a
manner likely to deceive, or bears upon it or upon
its label or container the name of another drug,
unless it is plainly and conspicuously marked so
as to reveal its true character and its lack of
identity with such other drug.
• Section33(EEC)Prohibition of manufacture and
sale of certain ASU drugs
• Section33(EED)Power of central government to
prohibit manufacture, etc., of ASU drugs in public
interest.
• Section33(F)Government analysts
• Section33(G)Inspectors
• Section33(H)Application of provision of section
22,23,24,25.
• Section33(I)Penalty for manufacture, sale, et,. Of
ASU drugs in contravention of this chapter.
• Section33(J)Penalties for subsequent offences
• Section33(K)Confiscation
• Section33(I)Application of provisions to
government departments
• Section33(M)Cognizance of offences
• Section33(N)Power of central government to
make rules
• Section33(O)Power to amend first schedule
 SCHEDULES TO THE ACT
 First schedule –: Names of books under
ASU systems

 Second schedule –:Standard to be

complied with by imported drugs and by
drugs manufactured for sale, sold, stocked or
exhibited for sale or distribution
 Name of books under 1st Schedule
UNANI
 Karabadin Qadri
 Karabadin Kabir
 Karabadin Azam
 Ilaj-ul-Amraz
 Al Karabadin
 Biaz Kabir Vol. II
 Karabadin Jadid
 Kitab-ul-Taklis
 Sanat-ul-Taklis
 Mifta-ul-Khazain
 Madan-ul-Aksir
 Makhzan-ul-murabhat
 National Formulary of Unani Medicine
 Unani Pharmacopoeia of India
 GOVERNMENT ANALYST:-

• These officers are appointed by the Central or State Government and

perform the duties.
• Persons having Qualification for appointments as government as
governmental analysis for drugs;
• Must have a degree in Medicine/Ayurveda/Sidha/Unani system and not
less than 3 year post graduate experience in the analysis of drug.
Duties:
• Analysed or tested such sample or drugs and cosmetics may be sent to
him by Inspectors.
• Timely forward reports to the Government giving the results of analytics
work.
 LICENSING AUTHORITY:-

Qualification:
• All member should be Graduate in Pharmacy on Pharmaceutical Chemistry or in
Medicine with Specialization in Clinical pharmacology or microbiology.
• 5 year Experience in manufacture or testing of a drugs.

Duties:
• To inspect all establishments licensed for the sale of drugs within the area
assigned to him.
• To send for test or analysis.
• To investigate any complaint.
• To maintain a record of all inspections made by him.
• To maintain a record of action taking by him in the performance of his duties.
 DRUG INSPECTOR:
Qualification:
 Has degree in Ayurvedic or Siddha or Unani system or a
degree in Ayurveda Pharmacy, as the case may be, conferred by
a University or a State Government or a Statutory Faculty,
Council or Board of Indian Systems of Medicine recognized by
the Central Government or the State Government.
Has a diploma in Ayurveda, Siddha or Unani System, as the
case may be, granted by a State Government or an Institution
recognized by the Central Government or a State Government
for this purpose).
Who have not less than 18 months’ experience in testing of at
least one of the substances in Schedule C in a laboratory
approved for this purpose by the licensing authority.
Who have gained experience of not less than three years in the
inspection of firm manufacturing any of the substances
specified in Schedule C
Function:
1. Inspection of all area where the drug and
cosmetics are being manufactured/sold/stocked.
2. Take sample of any drug and cosmetic are being
manufactured/sold/stocked
 MANUFACTURE FOR SALE OF ASU DRUGS-
PART XVI
• 151-Manufacutre on more than one set of premises
• 152-Licensing Authorities state govt appoint such
authorities
• 153-Application for license to manufacture ASU drugs
FORM 24-D(100Rs)
• 153A-Loan license FORM 25-E(600)
• 154-Form of license to manufacture ASU drugs
• FORM 25-D
• 154A-Form of loan license to manufacture of ASU drugs
FORM 25-E
 [FORM 25D (See rule 154)

Licence to manufacture for sale of Ayurvedic (including Siddha) or

Unani drugs
No. of Licence……………………………………………………………
1. …. ..................................... is / are hereby licensed to manufacture the following
Ayurvedic (including Siddha) or Unani drugs on the premises
situated at.................................................................................................. under the
direction and supervision of the following technical staff: —
(a) Technical staff (Names)
(b) Names of drugs (each item to be separately specified).
2. The licence shall be in force from .............................................. to ...................
3. The licence is subject to the conditions stated below and to such other conditions as
may be specified in the Rules for the time being in force under the Drugs and Cosmetics
Act, 1940.
Date of issue: ……………. Signature ...............
Designation ............
155-Certificate of renewal FORM 26-D
155A-Certificate of renewal of a loan license
FORM 26-E
155B-Certificate of award of GMP of ASU drugs
SHEDULE-T
156-Duration of license-original FORM 25-D 5yr
renewal FORM 26-D 5yr
156A-Duration of loan license 31s December of
the year
• 157-Conditions for the grant or renewal of a
licence in Form 25-D, Form 26-D.
• 157A-Maintaining of records of raw material used
by licensed manufacturing unit of Ayurveda,
Siddha and Unani drugs in the preceding financial
year
• 158-Conditions of licence
• 158A-Condition of loan licence
• 158B-Guidelines for issue of license with respect
to Ayurveda, Siddha or Unani drugs
S.no Category Ingredien Indicatio Safety Evidence/Experience of
t n study effectiveness

1 2 3 4 5 6
Published Proof of
literature effectivenes
s
1 ASU Drugs, As per text As per Not Required Not required
given in text required
158B
Any change As per text As per Not Required Not required
in dosage text required
from of ASU
2 drugs
described
in section
3a
ASU drugs As per text New Not If required Required
referred in required
3a to be
3 used for
new
indication
S.no Category Ingredien Indicatio Safety Evidence/Experience of
t n study effectiveness

1 2 3 4 5 6

Published Proof of
literature effectiveness

1 Patent or As per text Textual Not Of Pilot study as

proprietary rotational required ingredients per relevant
medicine protocol for
ASU drugs

ASU drugs As per text Existing Required Required Required

with any of
the
2 ingredients
of Schedule
E(1) of the
Drugs and
Cosmetics
Act, 1940
• 158C-Form of Free Sale Certificate and
Non-Conviction Certificate

• 159-Cancellation and suspension of

licences

• 160-Identification of raw materials

• PART XVI (A)
• APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS
ON AYURVEDIC, SIDDHA AND UNANI DRUGS AND RAW
MATERIALS USED IN THEIR MANUFACTURE ON BEHALF
OF LICENSEES FOR MANUFACTURE FOR SALE OF ASU
DRUGS
• 160A-Application for grant of approval for testing ASU
drugs
• 160B. Form in which approval to be granted for carrying
out tests on Ayurvedic, Siddha and Unani drugs on behalf
of licensees for manufacture of ASU drugs and conditions
for grant or renewal of such approval
• 160C-Duration of approval
• 160D-Conditions of approval
• 160E-Inspection before grant of approval
• 160F-Report of inspection
• 160G-Procedure of approving authority
• 160H-Application after rejection
• 160I-Renewal
• 160J-Withdrawal and suspension of approvals
 PART XVII
LABELLING, PACKING AND LIMIT OF ALCOHOL IN ASU
DRUGS
161-Labelling, packing and limit of alcohol
161A-Exemption in labelling and packing,
provisions for export of ASU drugs

161B-Shef life or date of expiry for ASU

drugs
 PART XVIII
GOVERNMENT ANALYTS AND INSPECTORS FOR ASU
DRUGS
162- Duties of inspectors specially authorised to inspect the
manufacture ASU drugs
162-A. Qualifications for State Drug Licensing Authority for
licensing of ASU drugs
163- Procedure for despatch of sample to Government
Analyst and its Analyst and its receipt by the
Government Analyst
• Pharmacopoeial Laboratory for Indian Medicine to function as Central
Drugs Laboratory for the purposes of testing or analysis of ASU drugs
163-A. Functions
163-B.
163-C. Despatch of samples for test or analysis
163-D. Recording of condition seals
163-E. Report of result of test or analysis
163-F. Fees schedule B1
163-G. Signature on certificates
164. Method of test or analysis to be employed in relation to ASU drugs
165. Qualifications of Government Analyst
166. Duties of Government Analyst
167. Qualifications of Inspector
 PART XIX
Standard of ASU drugs
168. Standards to be complied with in manufacture
for sale or for distribution of ASU drugs
169. Permitted Excipients
 SCHEDULES TO THE
RULES
TYPE CONTENT

“A” Performa for forms( Application, issue, renewal, etc.)

“B” Rates of fee for test or analysis by CDL or Govt. analysts

“C” List of Biological and special products (Injectable) applicable to

special provisions.
“C1” List of Biological and special products (nonparenteral)
applicable to special provisions.

“D” List of drugs that are exempted from provisions of import

“E1” List of poisonous substances under the Ayurvedic , Siddha and

SJTPC
Unani systems 42

“F” Provisions applicable to blood bank

TYPE CONTENT

“F1” Special provision applicable to biological and special products,

eg. Bacterial and viral vaccines, sera from living animals,
bacterial origin diagnostic agents

“F2” Standards for surgical dressings

“F3” Standards for umbilical tapes

“FF” Standards for ophthalmic preparations

“G” List of substances required to be used under medical supervision

and labelled accordingly

“H” List of substances (prescription) that should be sold by retail

43 only
on prescriptions of R.M.P.
TYPE CONTENT

“J” List of diseases and ailments that drug should not claim to cure

“K” List of drugs that are exempted from certain provisions

regarding manufacture
“M” Requirements of manufacturing premises, GMP requirements of factory
premises, plants and equipments

“M1” Requirements of factory premises for manufacture of Homeopathic

medicines

“M2” Requirements of factory premises for manufacture of cosmetics

“M3” Requirements of factory premises for manufacture of medical devices

“N” List of equipment to run a Pharmacy

44
“O” Standards for disinfectant fluids
TYPE CONTENT

“P” Life period(expiry) of drugs

“Q” Coal tar colors permitted to be used in cosmetics

“R” Standards for mechanical contraceptives

“R1” Standards for medical devices

“S” Standards for cosmetics

“T” Requirements (GMP) of factory premises for Ayurvedic,

Siddha, Unani drugs

“U” Manufacturing and analytical records of drugs 45

TYPE CONTENT

“U1” Manufacturing and analytical records of cosmetics

“V” Standards for patent or proprietary medicines

“W” List of drugs marketed under generic names-

Omitted

“X” List of narcotic drugs and psychotropic substances

“Y” Requirement and guidelines on clinical trials for import and

manufacture of new drugs
 ADMINISTRATION OF THE ACT
AND RULES
• Advisory:
1. Drugs Technical advisory Board-DTAB
2. Drugs Consultative committee-DCC
• Analytical:
1. Central Drugs laboratory-CDL
2. Drug Control Laboratory
3. Government Analysts
• Executives:
1. Drug Inspector
2. Licensing Authorities
3. Controlling authorities