U.S. voices concern over safety of Indian pharmaceuticals

Feb. 15, 2014 at 1:40 PM
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NEW DELHI, Feb. 15 (UPI) -- A top U.S. health official said concern is growing that India's pharmaceutical industry is affected by lapses in quality and safety.

Food and Drug Administration Commissioner Margaret Hamburg arrived in India this week to meet with officials and executives to talk about the safety of Indian over-the-counter and prescription drugs, The New York Times reported.

About 40 percent of over-the-counter and generic prescription drugs consumed in the United States come from India, where FDA investigators have been carrying out more inspections of pharmaceutical plants.

Ranbaxy, one of India's top drug manufacturers, pleaded guilty to felony charges regarding safety at its plants and was ordered to pay a $500 million fine last year.

G.N. Singh, India's top drug regulator, said adhering to U.S. standards would be too big a challenge for Indian companies.

"If I have to follow U.S. standards in inspecting facilities supplying to the Indian market," he said in a recent interview with an Indian newspaper, "we will have to shut almost all of those."

Other experts say although stricter standards are needed, Indian companies are not as bad as the FDA makes them out to be.

"More rigorous enforcement is needed, for sure, but this impression that India is overrun with counterfeits is unjustified," said Satish Reddy, president of the Indian Pharmaceutical Alliance.

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