Central Drug Standard Control Organization (cdsco)
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940.
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Formulated in 1940 in pursuance of recommendations of Chopra Committee (1930), the primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards.
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Under this act, while the regulations related to manufacture, sale and distribution of Drugs is primarily the concern of the State authorities, the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act.
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CDSCO functions under the Directorate General of Health Services, Ministry of Health & Family Welfare with its headquarters in New Delhi.
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Drug Controller General of India (DCGI) is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
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Recently the government of India notified Drugs and Clinical Trials Rules, 2019 for promotion of clinical trials or research in India.