About Central Drugs Standard Control Organisation (CDSCO):
- It is the National Regulatory Authority (NRA) of India for pharmaceuticals, medical devices, and cosmetics.
- It is responsible for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act 1940 and Rules 1945.
- Its primary responsibility is to ensure the safety, efficacy, and quality of drugs, medical devices, and diagnostic kits.
- The organization plays a pivotal role in the regulation and supervision of drug development, manufacturing, distribution, and marketing in India.
- 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.
- Headquarters: New Delhi
- 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.
- It is also responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country.
- The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
