STRINGENT NORMS FOR MEDICAL DEVICES
14, Apr 2019
Prelims level : International Mains level : GS-II (Polity, Governance, IR)
Why in News:
- India’s top drug advisory body, has recommended that the Health Ministry should notify all medical devices under the drug laws.
- DTAB is highest statutory decision-making body on technical matters related to drugs in the country. It is constituted as per the Drugs and Cosmetics Act, 1940.
- It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
Drugs and Cosmetics Act, 1940:
- The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards. The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
Section 3(b) (iv) in the Drugs and Cosmetics Act, 1940:
- such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.