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India Hopes to Accelerate Approval of New Drugs

India Hopes to Accelerate Approval of New Drugs

The Indian government has designated the Central Drugs Standard Control Organisation (CDSCO) as the first point of registration for clinical trials of all drugs and vaccines, a move expected to cut the approval time to three months from 12 months, according to the Economic Times.
The cabinet secretary-led panel has suggested that multiple regulators and authorities dealing with approvals to revisit their approval process. The idea, the official said, is to eliminate unnecessary processes.
Following this decision, all clinical trial applications will be first registered with CDSCO, which will issue a common identification number. This number will be used to track the application at each stage. Each application will be scrutinised and sent to the respective committees for approval. The nodal coordination committee, under the Health Secretary and comprising secretaries of all committees and ministries concerned, will meet once in 15 days during the pandemic and once in a month after that to clear any logjammed proposals.

While this news is promising, The India Expert believes that the devil is often in the details. So stay tuned for more information as rules and procedures surrounding this high level decision are determined.

 

Last updated: December 26th, 2025

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