Central Drugs Standard Control Organisation (CDSCO)
1. What is CDSCO?
CDSCO, under the Directorate General of Health Services, Ministry of Health & Family Welfare,Government of India, is the National Regulatory Authority for pharmaceuticals and medical devices in India.
2. What are CDSCO’s primary responsibilities?
o Approving new drugs and overseeing clinical trials.
o Setting drug standards.
o Regulating the quality of imported drugs.
o Coordinating with state drug control organizations.
3. Where is CDSCO headquartered?
CDSCO’s headquarters is at FDA Bhawan, Kotla Road, New Delhi, and it operates through anetwork of zonal, sub-zonal, and port offices, as well as laboratories across the country.
4. What legislation governs CDSCO?
The Drugs & Cosmetics Act, 1940, and rules 1945, which aim for uniform implementation to ensure the safety and well-being of patients by regulating drugs and cosmetics.
5. What specialized categories of drugs does CDSCO oversee?
CDSCO, along with state regulators, is responsible for granting licenses for critical drugs such as blood and blood products, I.V. Fluids, vaccines, and sera.
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