US Docs Worried Over Indian Drug Quality

In the wake of recent series of recalls of Indian manufactured drugs and bans by the Food and Drug Administration, US doctors are concerned about the quality of generic drugs imported from India. Recently, the FDA has banned the import of products from Ranbaxy Laboratories Ltd, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd. Reason: Quality control problems ranging from data manipulation to sanitation.

About 40 percent of generic and over-the-counter drugs used in the United States are supplied by India supplies. India is the second-biggest supplier of drugs only after Canada.

“We are losing control over what people are swallowing,” Dr. Harry Lever, a cardiologist at the Cleveland Clinic, told Reuters. “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.”

But Indian drug makers are not the only ones facing recalls and bans by the FDA. Johnson and Johnson had to recall dozens of products over the past five years, ranging from artificial hips to children’s Tylenol due to quality control failures.

But India’s drug makers do not accept that their drugs are inferior to those drugs manufactured in other countries.

“We have heard doctors making generalised 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 drug makers. He added, “This is a deliberate and serious campaign to malign the Indian generic industry.”

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Looking at the FDA bans and recalls, many Indian drug manufacturers said they might consider opening plants in the US or Europe.

Source-Medindia