The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.
The FDA acted Tuesday against a plant owned by Canadian generic drugmaker Apotex, a company that previously had two plants in Canada banned from shipping to the U.S. The action on the Bangalore facility includes everything except its riluzole tablets, a drug used to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease. The company said in an emailed statement that it was working closely with the FDA to resolve the problems.
The action follows the bans on other Indian plants in the last year, including two from Ranbaxy Laboratories, two from Wockhardt and one from Sun Pharmaceuticals for a variety of mess-ups, from unsanitary conditions to faking drug test results. The publicity surrounding these steps has created the perception among some doctors that Indian-made drugs, which make up 40% of the generic and over-the-counter products used by U.S. consumers, should be avoided. Roger Bate, an economist and health policy researcher at the American Enterprise Institute, has been a particular critic and has stirred up some concerns in Washington. He wrote an op-ed piece that was published in Deseret News in Utah this week criticizing India for lax oversight.
These contentions, in turn, have elicited claims of a conspiracy from members of India's drugmaking industry. "We have heard doctors making generalized statements, without being specific on any product or company," D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, said recently. "This is a deliberate and serious campaign to malign the Indian generic industry."
As for Apotex, it has faced this kind of FDA treatment in the past, and it has complained as well about being treated unjustly by the FDA. Apotex had products from plants in Toronto and Quebec banned from 2009 to 2011 after FDA inspectors found a number of problems. Once the ban was lifted, Apotex sought payback in a North American Free Trade Agreement (NAFTA) action. In its case, it contended that its plants in Canada had being treated less fairly than some facilities in the U.S. and that the action had cost it more than $500 million in lost sales.