Indian drug regulator tags 200 firms for inspection on poor manufacturing quality

Manufacturing
Inspection

India's drug regulator says 200 drugmakers in the country, including major local companies such as Mumbai-based Cipla and multinational Pfizer ($PFE), are being inspected for producing poor quality medicines.

The Times of India, citing a source, said the Drug Controller General of India is on the case and is methodically going down its list of serial violators in a first for such a widespread effort.

A Pfizer spokeswoman said the company had not received any relaetd inspection notices to date. Cipla told the Times of India it had not received any inspection notices so far.

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"We have already inspected 36 drug manufacturing plants over last three months. In the second phase, starting from Monday, we will conduct inspections in 20 more facilities," the Times of India said, quoting an unnamed health ministry official.

Indian drugmakers have faced a storm of notices of poor manufacturing quality from U.S. and European regulators in the past two years. Major generics manufacturers in the country were hauled up for data integrity and sanitary violations, among other issues.

The drumbeat led to India's Central Drugs Standard Control Organization announcing a multi-year effort working with industry to train workers in good manufacturing practice (GMP).

“It is high time that we put proper practices and regulation in place for the pharma industry. India has one of the biggest generic industries in the world, and we need to ensure the quality of medicines produced here,” G.N. Singh, the Drugs Controller General of India, who heads CDSCO, told the Live Mint newspaper in May.

The scope of the regulator's current work covers a category called "risk-based inspections" that analyzed regulatory data over the past 5 years from domestic as well as foreign sources and looked for serial violations, the Times of India said.

- here's the article from the Times of India

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