CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO)

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Context:

The Central Drugs Standard Control Organisation (CDSCO) received recognition from the World Health Organization (WHO) for maintaining a functional vaccine regulatory system. 

Details

A group of international experts from WHO conducted a comprehensive review of India’s vaccine regulations and concluded that it meets WHO's standards for vaccine safety, efficacy, and quality.

The WHO established certain guidelines to ensure that vaccines are of high quality, they reviewed to assess how well India's regulatory system matches these global standards, especially with the updated WHO Global Benchmarking Tool (GBT). India previously received a benchmark in 2017, but now it has been re-evaluated and maintains a maturity level of 3, scoring high in various areas.

India is a main vaccine producer and supplies vaccines to around 150 countries. The WHO Prequalification Programme will help to ensure that these vaccines meet global standards, making it easier for countries to access them.

About The Central Drugs Standard Control Organisation (CDSCO) 

1. It is India's main authority for regulating cosmetics, pharmaceuticals, and medical devices. 
2. The Drug Controller General of India (DCGI) heads the CDSCO and plays a key role in drug regulation. It approves specific drug categories like blood products and vaccines. It resolves disputes related to drug quality. In India, companies need DCGI approval to sell new prescription drugs. 
3. It operates under the Ministry of Health and Family Welfare and follows rules laid down in the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019.
4. To support its work, the DCGI gets advice from two important groups: the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
5. The CDSCO has several zonal offices across India. These offices conduct inspections before and after licensing, keep an eye on products in the market, and manage drug recalls when necessary. Manufacturers must appoint an Authorized Indian Representative (AIR) to handle all communications with the CDSCO.

Function

• CDSCO approves new drugs and oversees clinical trials in India.
• It sets the quality standards for imported drugs.
• If a drug is found harmful, CDSCO has the power to ban it under Section 26A of the Act.
• It grants licenses to government hospitals to import specific drugs for their patients.
• It registers foreign drug and medical device manufacturers that wish to sell their products in India.

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Source: 

New Indian Express

Wikipedia