US crackdown on Indian medicines

India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators, says the New York Times. The concerns range from safety lapses, falsified drug tests and sale of fake medicines. Dr. Margaret A Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality of drugs produced by a handful of pharmaceutical firms.” India’s pharmaceutical industry supplies 40 per cent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers. FDA investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants, the New York Times report said. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers. The Indian producers are shocked by recent FDA export bans of generic versions of popular medicines — such as the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro — that the FDA. determined were adulterated. The FDA's increased enforcement has already cost Indian companies dearly — Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company, according to a news agency.