Sunday, 21 June 2020

Indian Government: Faster nod for clinical trials of all drugs and vaccines soon

The 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.

A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators.

The government may soon come out with medium and long-term measures to expedite the approval process as it looks to attract foreign capital and boost local pharma.

The cabinet secretary-led panel has suggested multiple regulators and authorities dealing with approvals to revisit their approval process. The idea is to eliminate unnecessary processes.

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Faster nod for clinical trials of all drugs and vaccines soon

A committee led by cabinet secretary Rajiv Gauba has also decided to set up a nodal coordination committee to ensure expeditious disposal of all applications with the decision binding on all regulators. "The proposal was cleared by the committee in the first week of June," a top government official told ET.

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