India's quality lapses sparking turmoil throughout the generic drug industry

India is a crucial player in the global drug supply chain. It produces 40% of the generics and over-the-counter drugs that U.S. consumers turn to, and the U.S. is the world's largest market. But there is a growing perception among doctors that Indian-made meds fall short on quality, leading some drugmakers to cry conspiracy and others to wonder how best to respond.

Among those doctors whose perception about Indian-made drugs has changed is Dr. Steven Nissen, head of cardiology at the Cleveland Clinic. "I'm just beginning to realize the gravity of the problem," he told Reuters. "It's terrible and it is starting to get a lot of traction among physicians."

Doctors really have no control over whether their patients get a drug made in India or somewhere else. That depends on what is on the pharmacy shelves. And even then, many facilities in the U.S. and Europe have also been cited by the FDA for failures.

Some defenders see a conspiracy against Indian manufacturers. "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, told Reuters. "This is a deliberate and serious campaign to malign the Indian generic industry."

There has been an effort recently by a group of U.S. researchers and others, led by American Enterprise Institute drug authority Roger Bate, to convince lawmakers that Indian-made meds are something they should be concerned about. One of the doctors working on that effort is Dr. Harry Lever, a cardiologist at the Cleveland Clinic. "We are losing control over what people are swallowing," he told Reuters. He said he often suggests that patients see if they can avoid buying generics made in India.

There has also been no lack of publicity about the failings at Indian drug plants. The issue received lots of press when FDA Commissioner Margaret Hamburg made a trip there to meet with Indian regulators and industry bigwigs. The FDA recently added a Sun Pharmaceuticals plant to the list of facilities in India that have been banned. That list includes four plants operated by India's largest generics drugmaker, Ranbaxy Laboratories, as well as two plants operated by Wockhardt.

But the FDA has also taken actions against any number of U.S. facilities, as well as plants in Europe operated by the largest of Big Pharma companies. German drugmaker Boehringer Ingelheim even shut down a sterile injectable drug plant in the U.S. last year after years of trying to fix problems pointed out by the FDA.

Some Indian drugmakers are pondering how to respond. According to Reuters, Jefferies India analyst Piyush Nahar said in a recent report that Indian drugmakers told him that they have boosted their investments in compliance. But some are also considering investing in U.S. or European facilities "to overcome challenges relating to both regulations and perceptions."

But some U.S. drugmakers say there is spillover for the entire industry when questions of quality arise. Tony Mauro, the North American president of Mylan ($MYL), recently told Bloomberg: "The industry as a whole always suffers when there's challenges from a quality perspective because this whole industry's foundation is about sameness of the brand." 

- read the Reuters story