Generic drugs from India - doctors wonder if they're safe

Indian-made generic drugs have some doctors worried following various drug recalls and import bands by the Food and Drug Administration.

India is the second biggest generic drug supplier to the United States after Canada, supplying about 40 percent of generic and over-the-counter drugs - and doctors are worried about the quality of the products they're receiving.

Recently the FDA has voiced quality control problems, and has banned the importation of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd.

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

The issue is especially disconcerting given that generic drugs make up 85 percent of medicines prescribed in the United States.

India's drug makers don't feel there is any specific evidence to support the accusations, however.

"We have heard doctors making generalized statements, without being specific on any product or company," said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, a trade group representing large Indian drugmakers. "This is a deliberate and serious campaign to malign the Indian generic industry."

He continued: "Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the U.S. FDA's job."

Indian drugmakers are not the only companies that have issued drug recalls or received FDA warnings about manufacturing issues. Last year, Ben Venue Laboratories - a U.S. contract-manufacturing unit - was in jeopardy of being shut down after repeated manufacturing violations that led to a shortage of the cancer drug Doxil. What's more, Johnson & Johnson has had a difficult time over the past five years as quality control failures have forced the company to recall dozens of products.

"We are losing control over what people are swallowing," said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who is trying raise awareness of the matter among U.S. lawmakers. "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."