The publicity generated by quality problems uncovered by the FDA at some Indian generic med plants is making a growing number of U.S. doctors uneasy about their patients getting drugs that are manufactured there. While they really have no say over the source of the generic meds their patients get, the issue has at least a few Indian drugmakers weighing the need to open plants in the U.S. or Europe to fight those perceptions.
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."
Among those with a perception that Indian drugs are inferior 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."
The thing is, doctors can only prescribe branded or generic medications. Whether a patient gets a drug made by an Indian company whose operations the FDA has criticized or one made by someone else depends on what is on the pharmacy shelves.
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 industry officials see the dust-up as 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."
- read the Reuters story