America’s $93 billion pipeline of generic pharmaceuticals often starts in places like Toansa, a village in northern India where a drug-making facility rises up beside mustard fields and manure-flecked ox-cart tracks.
Indian companies supplying a quarter of the medicines used in the U.S. must take responsibility for the quality-control necessary to export their products, the top U.S. drug regulator said as it ramps up inspections.
The head of the U.S. Food and Drug Administration said she will visit India to talk with generic- drug makers and regulators about quality concerns and plans to expand overseas inspections to address the country’s growing role in producing medicines sold in the U.S.
The Food and Drug Administration has failed to monitor the effectiveness of generics that make up 80 percent of medicines sold in the U.S., according to doctors and researchers who said new regulatory efforts aren’t enough.
The top U.S. drug regulator asked Congress for more authority over pharmacies following the deadly meningitis outbreak, a request met with resistance by lawmakers who said existing oversight hasn’t been used to the fullest.