DoP proposes to oversee drug regulator

FDA Regulators DCO
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New Delhi: The Department of Pharmaceuticals (DoP) has proposed that the oversight of the Central Drugs Standard Control Organisation (CDSCO) be transferred to it, as the government plans a major overhaul of the country’s drug authority. According to media reports, concerns had been raised at the highest levels of the government over the ability of the regulatory framework to keep up with the demands of industry and scientists, triggering the move to revamp the drug authority.

The Cabinet secretary had constituted a committee tasked with reforming the drug regulatory system under the chairmanship of Rajesh Bhushan, who will take over as health secretary from the present health secretary Preeti Sudan after three months. The committee will meet on Friday, according to the order accessed by ET.

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The Department of Pharmaceuticals proposes to oversee drug regulator

The DoP is of the view that since it deals with the pharma industry the CSDCO should come under its ambit. According to the DoP this will cut down unnecessary time delay in giving approval to a drug or a vaccine. “There are multiple agencies involved in the regulatory framework for a drug/vaccine approval. The DoP also has the National Pharmaceutical Pricing Authority under it,” said a government official, who did not wish to be identified. “It makes all the more sense for the pharma department to take over drug regulation. The DoP has suggested that CDSCO be shifted under its charge.”

Fridays’ meeting will be attended by health ministry officials, joint secretary in the DoP, officials from the department of biotechnology, CDSCO and the ICMR, and pharma executives.

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