US doctors concerned on Indian drug quality, after outbreak of FDA recalls

Some U.S. doctors are getting concerned about the quality of generic drugs supplied by Indian manufacturers following an outbreak of recalls and import bans by the Food and Drug Administration. With around 40 % of generic and over-the-counter drugs export, India is second largest exporters of drugs in US market after Canada.

Latterly, the FDA has banned the importation of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and, most recently, Sun Pharmaceutical Industries Ltd. mentioning the quality control problems ranging from data manipulation to sanitation.

Indian drug makers are not the only companies to recall the products or to be warned by the FDA about manufacturing problems. For instance, Johnson and Johnson have recalled dozens of products ranging from artificial hips to children’s Tylenol over the past five years due to quality control failures. And last year, Germany’s Boehringer Ingelheim said it would shut down its United States contract manufacturing unit, Ben Venue Laboratories, after it was cited for repeated manufacturing violations that led to shortages of the cancer drug Doxil.

Dr. Harry Lever, a cardiologist at the Cleveland Clinic said "We are losing control over what people are swallowing. Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it”. In response to these statements the secretary general of the Indian Pharmaceutical Alliance, a trade group representing large Indian drugmakers, D.G. Shah said that the doctors are making generalized statements, without being specific on any product or company. This is a deliberate and serious campaign to malign the Indian generic industry. If US doctors come across a medicine that does not meet quality standards, they should report it to regulators. Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the US FDA’s job.