NextBillion - An Initiative of the William Davidson Institute at the University of Michigan

Friday, June 21, 2013

With Indian-made generics accounting for a US market share of over 25 per cent, it is not surprising that it is gaining significant mindshare of the American drug regulator, the Food and Drug Administration (FDA).

The spate of quality issues with leading Indian pharmaceutical companies in the past couple of years, however, should not be viewed in isolation.

Big Pharma in the West, too, has been facing increasing flak from the FDA and other regulators over good manufacturing practice violations. High profile names such as J&J, Genzyme (Sanofi), GSK, Sandoz, Watson, Teva and many others have encountered their share of quality problems and have been served with ’warning letters’ from the FDA.