Flies found by US FDA threaten Indian town built on generics

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.

Toansa's factory complex -- owned by Ranbaxy Laboratories, one of India's largest drugmakers - has for years produced ingredients for dozens of pharmaceuticals sold to Americans, including AstraZeneca Plc's top-selling heartburn medication Nexium, as well as its own generic copies of drugs including Pfizer Inc.'s Lipitor.

Ranbaxy and its Toansa factory are in the crosshairs of the US Food and Drug Administration, which has recently taken a tougher stance on the quality of generic drugs originating in India amid complaints by doctors and others. The agency said last month that it has begun a $20 million program to test generic drugs.

In January, FDA inspectors paid a surprise visit to the facility in Toansa, in a rural area north of New Delhi, and found broken equipment, windows stuck open and flies "too numerous to count," according to the FDA's report of its inspection. Workers ran quality tests over and over until they got the results they wanted, the FDA noted. Shortly after, the FDA banned the import of drug components made at the Toansa plant.

Ranbaxy voluntarily suspended all shipments of active pharmaceutical ingredients, or APIs, from Toansa and a second Indian plant, Dewas, after the FDA ban, Ranbaxy's parent company, Daiichi Sankyo, said in a February 25 statement. Ranbaxy is continuing to make drugs for non-US markets using API inventory from Toansa and Dewas and from external sources, Yasuki Minobe, a Daiichi spokesman, said by telephone March 4.