NEW YORK: The Indian drug manufacturers have come under scrutiny by the US Drug regulatory agency upon reports of falsified drug tests and selling of fake medicines, a report in the New York Times revealed on Saturday.
The newspaper said 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 the recent lapses in quality at 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 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.
