After flurry of FDA recalls, US docs skeptical on 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.
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 and 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 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.
India’s drugmakers, a $14 billion industry, reject any criticism that their products are inferior to drugs made in other countries.
“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.”
If US doctors come across a medicine that does not meet quality standards, they should report it to regulators, he said. “Doctors are not in a position to judge whether manufacturing processes are correct or not. That is the US FDA’s job.” Generic drugs account for nearly 85 percent of medicines prescribed in the US and the government is relying on them to help rein in healthcare costs.
