Indian regulator eyes 500 drug plants for massive inspection effort


As many as 500 drug manufacturing plants in India will be inspected head-to-toe, a source from the country's drug regulator told the Economic Times, a figure which builds on a separate report last month that said 200 units were under the scanner in a phased effort to ensure good manufacturing practice compliance and eliminate suspect products from the market.

Last month, the Times of India, citing a source, said the Drug Controller General of India (DCGI) had targeted 200 plants including ones owned by Mumbai-based Cipla and multinational Pfizer ($PFE), though the latter denied receiving any notification so far.

The Economic Times updates that information, citing a source as well, suggesting the DCGI has indeed started with 200 to 250 facilities on its list under a newly introduced "risk-based" inspection system developed by the Central Drugs Standard Control Organisation (CDSCO) with a current 19 trained teams targeting sites found to pose maximum risk based on previous regulatory histories.

"This kind of inspection has never been taken up in India before. We are planning to cleanse the system completely," an unnamed official told the Economic Times.

"We are checking for practices like hygiene and qualification of the personnel (at the plant) and whether they (the drug makers) are adopting shortcuts in procedures they have to follow when internally testing their products," the official said, adding that the government will analyze and take action on lapses found only after it completes inspections at all the manufacturing sites."

Penalties are in store for violators, the Economic Times said, including suspension of manufacturing license, though getting state regulators on board remains a challenge as the federal agency relies on them for implementation.

- here's the story from the Economic Times

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