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Proposal for medical devices controller

August 13, 2023

GS Paper II Indian Polity and Governance

Context:

Recently, Union Health ministry proposed a separate post for the medical devices controller.

About the News

The Union Health Ministry has presented a draft of the New Drugs, Medical Devices and Cosmetics Bill, 2023, which seeks to replace the Drugs and Cosmetics Act of 1940.

Central Drugs Standard Control Organisation (CDSCO)

DCGI heads CDSCO, which is responsible for ensuring quality drugs supply across the country.
DGCI has authority to give approval to new drugs and regulating clinical trials.

Draft proposed the creation of a separate post for a drugs and medical devices controller general in India, under whom a separate wing of officials would operate as regulators for the medical devices sector.
As of now, medical devices are treated as drugs and there is no separate definition for those.
- Currently, manufacturing activities relating to drugs and cosmetics are regulated by only the state governments through their drug control organizations.
Medical devices officers independent of drug control officers and creation of medical devices testing laboratories and the appointment of medical devices testing officers.

12 1

News Source: BS

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