What are the Drug & Cosmetic Act and Rules 1940?
The Drug & Cosmetic Act and Rules 1940 was enacted by the Department of Health under the Ministry of Health and Family Welfare after receiving the consent of the Governor General on April 10, 1940, and came into force on April 1, 1947. This Act regulates the manufacture, distribution and sale of drugs, biosimilars, medical devices and importers in India. The first and foremost objective of the Act is to ensure that the drugs, biosimilars and medical devices sold in India are safe, effective and conform to state quality standards. The original version of the Act has 5 Chapters, 38 Sections and 2 schedules.
Health is a Fundamental Right granted by the Constitution of India. The Drugs Control Administration aims to assure the availability of drugs & Cosmetics of proven quality, efficacy and safety at prices as announced. In addition, it also guards the public against the exploitation of misleading advertisements.
The government of India establishes the Rules through the Drugs and Cosmetics Act of 1940. The Rules have also been amended from time to time to meet the needs of the time and to rectify any deficiencies noticed during the implementation:
- The Drugs and Cosmetics Rules, 1945
- The New Drugs and Cosmetics Rules, 2019
- To regulate the import, manufacture, distribution and sale of drugs & cosmetics through licensing.
- Manufacture, distribution and sale of drugs and cosmetics by qualified persons only.
- To avoid substandard drugs, presumably to maintain high standards of medical treatment.
- To regulate the manufacture and sale of Ayurvedic, Siddha and Unani medicines.
- To establish the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for Allopathic and allied drugs and cosmetics.