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CDSCO comes under Directorate General of Health Services, Ministry of Health & Family Welfare.
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It is the National Regulatory Authority (NRA) of India for Drugs.
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The Drugs & Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
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Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials.
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Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine etc.