Indian generic drug quality has been questioned recently by a number of U.S. doctors. The concerns are a result of numerous recalls and import bans by the Food and Drug Administration (FDA) of generic drugs supplied by Indian manufacturers. India is the second-biggest supplier of generic drugs to the U.S. (Canada being the first) with 40 percent of generic and over-the-counter drugs.
Generic drugs from Ranbaxy Laboratories Ltd, Wockhardt Ltd, and Sun Pharmaceutical Industries Ltd. have been banned by the FDA. The FDA cited numerous quality control problems as a reason for the ban.
According to an article in Reuters, Dr. Steven Nissen, head of cardiology at the Cleveland Clinic, stated that he was “just beginning to realize the gravity of the problem. It’s terrible and it is starting to get a lot of traction among physicians.”
D.G. Shah, Secretary-General of the Indian Pharmaceutical Alliance, a trade group representing large Indian drugmakers, believes this attack “is a deliberate and serious campaign to malign the Indian generic industry.”He goes on to say that “Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the U.S. FDA’s job.”
Indian physicians like Narendra Saini, Secretary-General of the Indian Medical Association, have responded by saying “Our drugs are being sold in many countries and being accepted, so we have no issues,” and “How do I know that Western drugs are better than our drugs?”
Other U.S. doctors are concerned about the quality of generic drugs in general, not just Indian generic drugs. Doctor’s actually do not have any control over which generic drug patients receive. This depends on what drugs are in stock at your local pharmacy. Unfortunately, patients may have to change pharmacies to avoid a certain drug manufacturer.
As generic drugs become more prevalent, particularly for treating GIST, this will become an increasingly important issue for our community. We will continue to monitor this situation and report on information as it becomes available.
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Read the full article on Reuters.