In the line of fire

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SummaryIt’s been seen as a double-whammy for the Indian pharmaceuticals industry. The US drug regulator, US Food and Drug Administration has shown no let up in censoring Indian pharmaceutical companies for shortcomings in their manufacturing operations—Lupin is the latest to draw the American drug regulator’s ire after Sun Pharmaceuticals and Ranbaxy.

It’s been seen as a double-whammy for the Indian pharmaceuticals industry. The US drug regulator, US Food and Drug Administration (USFDA) has shown no let up in censoring Indian pharmaceutical companies for shortcomings in their manufacturing operations—Lupin is the latest to draw the American drug regulator’s ire after Sun Pharmaceuticals and Ranbaxy. It is now the turn of our own drug regulator, Central Drugs and Standard Control Organisation, to flex its muscles. In a recent move, the drug regulatory body has withdrawn the licenses given to 17 domestic pharmaceutical companies from producing generic versions of an anti-obesity drug in India, after reports by the European drug regulatory authority—European Medicines Agency—of severe side effects.

With the safety of public health foremost in the minds, the move by Indian drug regulator to stop the manufacturing of the anti-obesity drug in the country seems to have to have gone down well in industry circles. However, it is the role donned by the American drug regulator that is causing a lot of heart-burn in the domestic pharmaceutical industry.

“Indian drug companies are deliberately being singled out and capital punishment reserved especially for them,” says an industry insider. Little wonder, their brushes with the drug regulators—in India as well as overseas—is something they would like to forget as early as possible.

India has about 75 USFDA approved plants and is one of the most dominant players in global exports of generic formulation and active pharmaceutical ingredients. In the Asian region, China comes a distant second with 22 FDA plants, followed by Taiwan with 10 plants. With various incentives given for generic prescription in the US on a significant upswing, USFDA is in an overdrive to ensure that safe medicines enter the American healthcare system. The American drug regulator is responsible for the safety of foods, drugs and other health-related products sold in the US. “Thus we need to be prepared for more USFDA inspections in the country. We could also see some more Indian drug companies being hauled up in future if they are not complying with their regulatory norms for a drug’s quality, safety and efficacy,” says Avesthagen founder Villoo Morawala-Patell.

It seems the woes of Indian drug companies are far from over. When contacted, Rita Chappelle from the office of public affairs, USFDA stressed, “FDA will continue to do its job of protecting and promoting the public’s health through inspections to ensure compliance with US

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