Unease grows among US doctors over quality of Indian medicines

Washington/New York:  Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration (FDA).

India supplies about 40 percent of generic and over-the-counter drugs used in the United States, making it the second-biggest supplier after Canada.

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

“I’m just beginning to realize the gravity of the problem,” said Dr Steven Nissen, head of cardiology at the Cleveland Clinic. “It’s terrible and it is starting to get a lot of traction among physicians.”

Indian drugmakers are by no means the only companies to recall products or be warned by the FDA about manufacturing problems. For instance, quality control failures at Johnson & Johnson forced the company to recall dozens of products over the past five years, ranging from artificial hips to children’s Tylenol.

And last year, Germany’s Boehringer Ingelheim said it would shut down its US contract manufacturing unit, Ben Venue Laboratories, after it was cited for repeated manufacturing violations that led to shortages of the cancer drug Doxil.

India’s drugmakers, a $14 billion industry, reject any criticism that their products are inferior to drugs made in other countries.