FDA Clamps Down on Indian Drug Makers

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While visiting India from February 10 to 18, 2014, FDA Commissioner Margaret Hamburg, MD, announced plans to increase regulation of pharmaceutical manufacturers in the country amid concerns about the safety of medications they produce. The number of FDA inspectors stationed in India, which is the second-largest supplier of generic medications to the United States, will increase from 12 to 19.

“We need the same level of oversight whether it is within our borders or outside,” Dr. Hamburg said, according to the Wall Street Journal.

In the last few years, the FDA has banned the sale of drugs in the United States produced by some plants in India run by Ranbaxy Laboratories Ltd and Wockhardt Ltd due to shortcomings in manufacturing standards. A Ranbaxy plant was accused of faking test results and found to have laboratories in disrepair and a sample-preparation room overrun with flies. Ranbaxy pleaded guilty to a felony and paid a $500-million fine, the largest ever imposed on a generic drug maker.

Inspections of Indian facilities are being financed with some of the approximately $300 million in annual fees being collected from generic drug manufacturers based on the 2012 Generic Drug User Fee Act. According to Dr. Hamburg, the additional inspectors will speed up the approval of Indian pharmaceutical plants.