The Drugs & Cosmetics Act, 1940 & Rule 1945 is an Act & Rules to regulate import, manufacture, distribution and sale of drugs and cosmetics. It extends to the whole of India. It also covers Ayurvedic, Unani and Sidha system of Medicines, Homeopathic medicines, medical devices, blood bank etc along with timely added things. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements.
Drug and Cosmetic Act, 1940 is divided into Chapters, Chapters further divided into sections. Act also contains First and Second Schedule.
1. Short title, extent and commencement.
2. Application of other laws not barred.
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
The drug 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
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
12. Power of Central Government to make rules.
Manufacture, sale and distribution of drugs and cosmetics
16. Standards of quality.
17. Misbranded drugs.
17A. Adulterated drugs.
17B. Spurious drugs.
17C. Misbranded cosmetics.
17D. Spurious cosmetics.
18. Prohibition of manufacture and sale of certain drugs
18A. Disclosure of the name of the manufacturer, etc.
18B. Maintenance of records and furnishing of information.
20. Government Analysts.
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. Power of Central Government to prohibit manufacture, etc.,
of drug and cosmetic 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.
31A. Application of provisions to Government departments.
32. Cognizance of offences.
32A. Power of Court to implead the manufacturer, etc.
33. Power of Central Government to make rules.
33A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs.
Chapter IV A
Provisions relating to Ayurvedic Siddha and Unani drugs
33B. Application of Chapter IV A
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.
33H. Application of provisions of sections 22, 23, 24 and 25.
33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drugs in contravention of this Chapter.
33J. Penalty for subsequent offences.
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.
33P. Power to give directions.
34. Offences by companies.
34A. Offences by Government departments.
34AA. Penalty 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.
37. Protection of action taken in good faith.
38. Rules to be laid before Parliament.
First Schedule: Authoritative books for Ayurvedic, Sidha and Unani Tibb System of Medicines
Second Schedule: Standard to be compiled with by imported drugs and by drugs manufactured for Sale, Sold, Stocked or Exhibited for Sale or Distributed.
Drug and Cosmetic Rules, 1945
Rules are divided into parts. Each part contains a set of rules related to particular subject.
Part I: Preliminary
Part II: The Central Drugs Laboratory
Part III: Rules Omitted
Part-IV: Import and Registration
Part-V: Government Analysts, Inspectors, Licensing Authorities and Controlling Authorities
Part VI: Sale of drugs other than Homoeopathic Medicines
Part VII: Manufacture for sale or for distribution of drugs other than Homoeopathic Medicines
Part VIIA: Manufacture for sale or for distribution of Homoeopathic Medicines
Part VIII: Manufacture for examination, Test or Analysis
Part IX: Labelling and Packing of Drugs other than Homoeopathic Medicines
Part IXA: Labelling and Packing of Homoeopathic Medicines
Part X: Special provisions relating to biological and other special products
Part XA: Import of manufacture of new drug for clinical trials or marketing
Part XB: Requirement for the collection, storage, processing and distribution of whole human blood, human blood components by blood banks and manufacture of blood products
Part XI: Exemption
Part XII: Standards
Part XIII: Import and Registration of Cosmetics
Part XIV: Manufacture of cosmetic for sale or for distribution
Part XV: Labelling, Packing and Standard of Cosmetics
Part XV(A): Approval of institutions for carrying out tests on drugs, cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics
Part XVI: Manufacture for sale of Ayurvedic (Including Siddha) Or Unani drugs
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 ayurvedic, siddha and unani drugs
Part XVII: Labelling, packing and limit of alcohal in Ayurvedic(Including Siddha) or unani drugs
Part XVIII: Government analysts and inspectors for Ayurvedic (including Siddha) or Unani drugs
Part XIX: Standards of Ayurvedic, Siddha and Unani drugs
List of Schedules of Drug and Cosmetic Act: