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US drug regulator rejects accusations that it unfairly targets Indian generic firms

BMJ 2014; 348 doi: (Published 03 March 2014) Cite this as: BMJ 2014;348:g1845
  1. Sanjeet Bagcchi
  1. 1Kolkata

The US drugs regulator has defended its actions against Indian generic drug manufacturers who flout safety and quality standards. The regulator said that product safety was its top priority and that it would take any action deemed necessary to protect consumers.

Margaret Hamburg, the US Food and Drug Administration’s commissioner, was in India for a 10 day visit from 10 February. She angered some Indian officials, who claimed that the FDA was unduly targeting Indian companies for substandard practices.

India supplies about 40% of the generic and over-the-counter drugs consumed in the United States, making it the second largest supplier (after Canada). But Indian drug manufacturers accounted for half of the warning letters issued by the FDA in 2013.

In January the FDA banned the import of drugs made at two further facilities run by the Indian generics manufacturer Ranbaxy Laboratories after finding problems with the manufacturing …

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