Guide to Drugs and Cosmetics Act, 1940 (Act 43 of 1940)

Along With 
Drugs and Cosmetic Rules, 1945
As Amended upto (2nd Amendment) Rules, 2018
Vide GST 277 (E).dt.23-3-2018, w.e.f.23-3-2018
The Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017
(Act No. 16 of 2017, dt.20-4-2017)
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Description
The main object of the Drugs and Cosmetics Act, 1940 is prevent sub-standards in drugs, presumably for maintaining high standards of medical treatment. That would certainly be defeated if the necessary concomitants of Medical or Surgical treatment were allowed to be diluted, the very same evil which the Act intends to eradicate would continue to subsist. The Act regulates the important into , manufacture, distribution and sale of drugs and cosmetics in the country. The problems of adulteration of drugs and also of production of spurious and sub-standard drugs are posing serious threat to the health of the community. It is, therefore, considered necessary to impose stringent penalties on anti-social elements indulging in the manufacture or sale of adulterated or spurious drugs or drugs not of standard quality, which are likely to cause death or grievous hurt to the user.
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Contents
The Drugs and Cosmetics Act, 1940
1.    Introductory
2.    The Drugs Technical Advisory Board, The Central Drugs Laboratory and
       the Drugs Consultative Committee
3.    Import of Drugs and Cosmetics
4.    Manufacture, Sale and Distribution of Drugs and Cosmetics
4A.  Provisions Relating to ayurvedic, Siddha and Unani Drugs
5.    Miscellaneous
The Drugs and Cosmetics Rules, 1945
Part I : Preliminary
Part II : The Central Drugs Laboratory
Part III : 
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 VI-A : Sale of Homoeopathic Medicines
Part VII : Manufacture for sale or for Distribution of Drugs other than Homoeopathic Medicines
Part VII-A : Manufacture for sale or for Distribution of Homoeopathic Medicines
Part VIII : Manufacture for Examination, Test for Analysis
Part IX : Labelling and Packing of Drugs other than Homoeopathic Medicines
Part IX-A : Labelling and Packing of Homoeopathic Medicines
Part X : Special Provisions Relating to Biological and other Special Products
Part X-A : Import or manufacture of new Drug for Clinical Trials or Marketing
Part X-B : Requirement for the collection, storage, processing and distribution of
                 whole human blood, human blood components by blood banks manufacture
                 of blood products and collection, processing, testing, storage banking and 
                 release of umbilical cord blood stem cells
Part XI : Exemptions
Part XII : Standards
Part XIII : Import and Registration of Cosmetics
Part XIV : Manufacture of Cosmetics for Sale or for Distribution
Part XV : Labelling, Packing and Standards 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 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 Alcohol in Ayurvedic (Including Siddha) or Unani Drugs
Part XVIII : Government Analysts and Inspectors for Ayurvedic (Including Siddha) or Unani Drugs
Part XVIII : Pharmacopoeial Laboratory for Indian Medicines to function as Central
                 Drugs laboratory for the purpose of testing or Analysis of Ayurveda,
                 Siddha and Unani Drugs
Part XIX : Standards of Ayurvedic, Siddha and Unani Drugs
Schedule A - Forms
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