The Drugs and Cosmetics Act, 1940, and its Rules, 1945, were established to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The primary objectives are:
1. Ensuring Safety, Efficacy, and Quality: To ensure that drugs and cosmetics sold in India are safe, effective, and of standard quality.
2. Regulation of Manufacture and Sale: To regulate the manufacture, sale, and distribution of drugs and cosmetics to prevent substandard and spurious products.
3. Control Over Import: To control the import of drugs and cosmetics to ensure that they meet the prescribed standards.
4. Clinical Trials: To ensure the ethical and scientific conduct of clinical trials.
5. Prohibition of Misleading Claims: To prohibit misleading claims for drugs and cosmetics.
Definitions:
1. Drug: As per Section 3(b) of the Act, “drug” includes:
All medicines for internal or external use of human beings or animals.
All substances intended to be used for, or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals.
Such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.
All substances intended for use as components of a drug, including empty gelatin capsules.
2. Cosmetic: As per Section 3(aaa) of the Act, “cosmetic” means any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
Legal Definitions of Schedules to the Act and Rules:
The Act and Rules are accompanied by various schedules that lay down detailed provisions and guidelines:
1. Schedule A: Forms and applications required for licenses and registrations.
2. Schedule B: Fees for tests or analysis by the Central Drugs Laboratory or Government Analysts.
3. Schedule C: List of biological and special products.
4. Schedule C1: Special provisions relating to the manufacture and testing of large volume parenteral, sera, vaccines, and other biological products.
5. Schedule D: Exemptions provided for certain drugs and cosmetics from the provisions of the Act.
6. Schedule E1: List of poisonous substances under the Ayurvedic, Siddha, and Unani systems of medicine.
7. Schedule F: Standards for vaccines, sera, and diagnostic antigens.
8. Schedule F1: Standards for surgical dressings.
9. Schedule F2: Standards for ophthalmic preparations.
10. Schedule G: List of substances that should be used under medical supervision.
11. Schedule H: List of prescription drugs.
12. Schedule H1: List of certain antibiotics and other prescription drugs requiring special monitoring.
13. Schedule J: Diseases and ailments that a drug may not purport to prevent or cure.
14. Schedule K: Exemptions in respect of certain drugs from the provisions of the Act and Rules.
15. Schedule L1: Good laboratory practices for institutions engaged in the testing of drugs.
16. Schedule M: Good manufacturing practices for premises and materials used in the manufacture of drugs.
17. Schedule M1: Good manufacturing practices for premises and materials used in the manufacture of cosmetics.
18. Schedule M2: Specific requirements for manufacture of homeopathic medicines.
19. Schedule N: List of equipment for the efficient running of a pharmacy.
20. Schedule O: Standards for disinfectant fluids.
21. Schedule P: Life period (shelf life) of drugs.
22. Schedule P1: Pack sizes of drugs.
23. Schedule Q: List of colors permitted for use in cosmetics and soaps.
24. Schedule R: Standards for condoms and other mechanical contraceptives.
25. Schedule S: Standards for cosmetics.
26. Schedule T: Good manufacturing practices for Ayurvedic, Siddha, and Unani medicines.
27. Schedule U: Particulars to be shown in manufacturing records.
28. Schedule V: Standards for patent or proprietary medicines.
29. Schedule X: List of narcotic and psychotropic substances and requirements for their sale and distribution.
30. Schedule Y: Requirements and guidelines for clinical trials and approval of new drugs.
These schedules collectively ensure that comprehensive standards and regulations are established and maintained for the manufacture, sale, and distribution of drugs and cosmetics in India.
