Introduction:
The Drug and Cosmetic Act was passed on 10th April 1940 by the Indian Legislature ( lok sabha and Rajya sabha)
* This act has 11 Amendment As Follow
* First Amendment in 1955 by the Indian Parliament
* Subsequently amended in 1960, 1962, 1964, 1972, 1982, 1986, 1995, 2008, 2011 and 2018
Objectives and Definitions:
This is an Act to uniform regulate the import , manufacture, distribution and sales of drugs all over the Country
The Primary objective of this act is to ensure that the drugs and cosmetics sold in India are safe and effective for use and confirm to quality standards.
Schedule & Rules
Drug and cosmetic rules have been divided into 18 parts each dealing with particular subjects.
* There are
a) 2 Schedule to the Act
b) 23 Schedule to the Rules
Schedule to Act
First Schedule : It prescribed the list of books specified in Ayurvedic, Siddha or Unani Systems of medicine.
CHAPTER I
INTRODUCTORY
SECTIONS
1. Short title, extent and commencement.
2. Application of other laws not barred.
3. 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 LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE
5. The Drugs Technical Advisory Board.
6. The Central Drugs Laboratory.
7. The Drugs Consultative Committee.
7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.
CHAPTER III
IMPORT OF DRUGS AND COSMETICS
8. Standards of quality.
9. 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.
CHAPTER IV
MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICS
SECTIONS
16. Standards of quality.
17. Misbranded drugs.
17A. Adulterated drugs.
17B. Spurious drugs.
17C. Misbranded cosmetics.
17D. Spurious cosmetics.
17E. Adulterated cosmetics.
18. 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.
19. Pleas.
20. Government Analysts.
21. Inspectors.
22. Powers of Inspectors.
23. Procedure of Inspectors.
24. Persons bound to disclose place where drugs or cosmetics are manufactured or kept.
25. Reports of Government Analysts.
26. Purchaser of drug or cosmetic enabled to obtain test or analysis.
26A. Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of drug and cosmetic in public interest.
26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in public interest.
27. 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.
28. 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.
29. Penalty for use of Government Analyst’s report for advertising.
30. Penalty for subsequent offences.
31. Confiscation.
31A. Application of provisions to Government departments.
32. Cognizance of offences.
32A. Power of Court to implead the manufacturer, etc.
32B. Compounding of certain offences.
33. Power of Central Government to make rules.
33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.
CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS
SECTIONS
33B. Application of Chapter IVA.
33C. Ayurvedic 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.
33-I. Penalty for manufacture, sale, etc., of Ayurvedic. Siddha or Unani drug in
contravention of this Chapter.
33J. Penalty for subsequent offences.
33K. Confiscation.
33KA. Disclosure of name of manufacturer, etc.
33KB. Maintenance of records and furnishing of information.
33L. Application of provisions to Government departments.
33M. Cognizance of offences.
33N. Power of Central Government to make rules.
33-O. Power to amend First Schedule.
CHAPTER V
MISCELLANEOUS
33P. Power to give directions.
34. Offences by companies.
34A. Offences by Government departments.
34AA. Penalty for vexatious search or seizure.
35. Publication of sentences passed under this Act.
36. Magistrate’s power to impose enhanced penalties.
36A. Certain offences to be tried summarily.
36AB. Special Courts.
36AC. Offences to be cognizable and non-bailable in certain cases.
36AD. Application of Code of Criminal Procedure, 1973 to
proceedings before special Court.
36AE. Appeal and revision
37. Protection of action taken in good faith.
38. Rules to be laid before Parliament.
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