About Central Drugs Standard Control Organisation:
- It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs and Cosmetics Act
- Nodal Ministry: It works under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
- Headed by: The Drugs Controller General of India (DCGI) is the head of the CDSCO.
- Functions: It is responsible for overseeing the import, manufacture, sale, and distributionof medical device in the country. The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for:
- Approval of new drugs; Conduct of clinical trials; Laying down the standards for drugs; Control over the quality of imported drugs in the country; Coordination of the activities of State Drug Control Organizations.
- CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
- Headquarters: New Delhi.
