What is Central Drugs Standard Control Organisation (CDSCO)?

About Central Drugs Standard Control Organisation (CDSCO):

• It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs & Cosmetics Rules.
• It works under the Ministry of Health & Family Welfare.
• 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.