Drug Controller General of India

Subject: Government organisation

Context:

The Drug Controller of India has demanded that the Serum Institute of India (SII), Pune, which is conducting Phase-3 trials on people in India involving U.K.-based AstraZeneca’s COVID-19 vaccine candidate, explain why tests have not been paused in India too until safety has been established.

Concept:

• Drug Controller General of India within CDSCO is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera
• CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) of India.
• The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
• CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
• Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice.