Central Drugs Standard Control Organisation (CDSCO)

Published: 11th May, 2024

Context

The Union government has taken over the authority to issue manufacturing licenses for new drugs intended for export. This move shifts the power from state governments to the Central Drugs Standard Control Organisation (CDSCO), which is India's primary regulatory body for drugs.

Role of CDSCO

CDSCO operates as the Central Drug Authority under the Drugs and Cosmetics Act, 1940.
It operates under the Directorate General of Health Services, Ministry of Health & Family Welfare.
CDSCO is responsible for various tasks including approving drugs, conducting clinical trials, setting drug standards, regulating imported drugs' quality.
Along with state regulators, it is jointly responsible for grant of licenses of certain specialized categories of critical Drugs (blood and blood products, Fluids, Vaccine and Sera)

Fact Box: About the Drugs & Cosmetics Act, 1940

The Act, along with its associated rules, delegates regulatory responsibilities to both central and state regulators for overseeing drugs and cosmetics.
The Act aims for uniform implementation to ensure patient safety and well-being by regulating drugs and cosmetics.

CURRENT AFFAIRS FOR UPSC IAS

Central Drugs Standard Control Organisation (CDSCO)

Role of CDSCO

Fact Box: About the Drugs & Cosmetics Act, 1940

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