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The Drugs and Cosmetics Act, 1940 and Rules, 1945
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Number of Pages: 618 pages

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GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) THE DRUGS AND COSMETICS ACT AND RULES

THE DRUGS AND COSMETICS ACT, 1940 as amended by

the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960,
the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments)
Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and
Cosmetics (Amendments) Act, 1982, the Drugs and Cosmetics (Amendments)
Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995.

AND

THE DRUGS AND COSMETICS RULES, 1945

as corrected up to the 30th April, 2003 2

CONTENTS

The Drugs and Cosmetics Act, 1940,
as amended by the Drugs (Amendment) Act, 1955,
the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962,
the Drugs and Cosmetics (Amendment) Act,1964,
the Drugs andCosmetics (Amendment) Act, 1972,
the Drugs and Cosmetics (Amendment) Act, 1982,
the Drugs and Cosmetics (Amendment) Act, 1986
and the Drugs and Cosmetics (Amendment) Act,1995.. . . .

The Drugs and Cosmetics Rules, 1945 as corrected upto 30.04.2003

Notification issued under the Drugs and Cosmetics Act . . . .

3

LIST OF AMENDING ACTS AND ADAPTATION ORDER
The Repealing and Amending Act, 1949 (40 of 1949).
The Adaptation of Laws Order, 1950.
The Part B States (Laws) Act, 1951 (3 of 1951)
The Drugs (Amendment) Act, 1955 (11 of 1955)
The Drugs (Amendment) Act, 1960 (35 of 1960)
The Drugs (Amendment) Act, 1962 (21 of 1962)
The Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964)
The Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972).
The Drugs and Cosmetics (Amendment) Act, 1982 (68 of 1982)
The Drugs and Cosmetics (Amendment) Act, 1986 (71 of 1986)
The Drugs and Cosmetics (Amendment) Act, 1995 (22 of 1995)

4

LIST OF ABBREVIATIONS USED

A.O. 1950 . . . . . . . for Adaptation of Laws Order, 1950. Cl. . . . . . . Clause Ins. . . . . . . inserted
P. . . . . . . Page
Pt. . . . . . . Part
Reg. . . . . . . Regulation.
Rep. . . . . . . Repealed.
S. . . . . . . Section
Sch. . . . . . . Schedule.
Sec. . . . . . . Section
Subs. . . . . . . Substituted
w.e.f. . . . . . . with effect from.
G.O.I . . . . . . Government of India.
dt. .... . . date/dated

5

THE DRUGS AND COSMETICS ACT, 1940

________ ARRANGEMENT OF SECTIONS ________

CHAPTER I INTRODUCTORY SECTIONS
Short title, extent and commencement.
Application of other laws not barred.
Definitions

3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir.

4. Presumption as to poisonous substances.
CHAPTER II THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORTORY AND THE DRUGS CONSULTATIVE COMMITTEE
The Drugs Technical Advisory Board.
The Central Drugs Laboratory.
The Drugs Consultative Committee. 7A. Section 5 and 7 not to apply Ayurvedic, Siddha or Unani drugs.

CHAPTER III
IMPORT OF DRUGS AND COSMETICS
Standards of quality
Misbranded drugs
9A. Adulterated drugs
9B. Spurious drugs.
9C. Misbranded cosmetics.
9D. Spurious cosmetics

10 Prohibition of import of certain drugs or cosmetics. 10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.

11. Application of law relating to sea customs and powers of

Customs officers.
12 Power of Central Government to make rules.
13 Offences.
14 Confiscation

15. Jurisdiction

6

CHAPTER IV MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS

SECTIONS
Standards of quality.
Misbranded drugs.
17A. Adulterated drugs.
17B. Spurious drugs.
17C. Misbranded cosmetics.
17D. Spurious cosmetics.
Prohibition of manufacture and sale of certain drugs and
cosmetics. 18A. Disclosure of the name of the manufacturer ,etc. 18B. Maintenance of records and furnishing of information.
Pleas .
Government Analysts.
Inspectors.
Powers of Inspectors.
Procedure of Inspectors.
Persons bound to disclose place where drugs or cosmetics are manufactured or kept.
Reports of Government Analysts.
Purchaser of drug or cosmetic enabled to obtain test or analysis.
26A. Power of Central Government to prohibit manufacture etc. of drug and cosmetic in public interest.
Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter.
27A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter.
Penalty for non-disclosure of the name of the manufacturer, etc. 28A. Penalty for not keeping documents, etc., and for non-disclosure of information.
28B Penalty for manufacture, etc. of drugs or cosmetics in contravention of section 26A.
Penalty for use of Government Analyst’s report for advertising.
Penalty for subsequent offences.
Confiscation.
31A. Application of provisions to Government departments.
Cognizance of offences.
32A. Power of Court to implead the manufacturer, etc.
Power of Central Government to make rules .
33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.

7

CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC SIDDHA AND UNANI DRUGS

SECTIONS 33B. Application of Chapter IVA. 33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory

Board. 33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. 33E. Misbranded drugs. 33EE. Adulterated drugs. 33EEA. Spurious drugs. 33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and

Unani drugs. 33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs. 33EED. Power of Central Government to prohibit manufacture etc., of

Ayurvedic, Siddha or Unani drugs in public interest. 33F. Government Analysts. 33G. Inspectors . 33H. Application of provisions of sections 22, 23, 24 and 25. 33I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha

or Unani drugs in contravention of this Chapter. 33J. Penalty for subsequent offences. 33K. Confiscation . 33L. Application of provisions to Government departments. 33M. Cognizance of offences. 33N. Power of Central Government to make rules. 33O. Power to amend First Schedule.

CHAPTER V
MISCELLANEOUS
33P. Power to give directions.
Offences by companies.
34A. Offences by Government departments.
34AA. Penalty vexatious search or seizure.
Publication of sentences passed under this Act.
Magistrate’s power to impose enhanced penalties.
36A. Certain offences to be tried summarily.
Protection of action taken in good faith.
Rules to be laid before Parliament.

THE FIRST SCHEDULE

THE SECOND SCHEDULE

 

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