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 per cent 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 realise 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.”
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 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 drugmakers. “This is a deliberate and serious campaign to malign the Indian generic industry.”
Generic drugs account for nearly 85pc of medicines prescribed in the United States and the government is relying on them to help rein in healthcare costs.
“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 US 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.” Increasingly, Lever said, he is recommending patients seek out generic drugs from specific manufacturers outside India.
India doctors hit back
Indian physicians do not share the concerns.
“Our drugs are being sold in many countries and being accepted, so we have no issues,” said Narendra Saini, Secretary General of the Indian Medical Association, a voluntary body of 215,000 doctors. “How do I know that Western drugs are better than our drugs?”
Physicians do not have a say in which generic drug a patient receives, as that depends on which products are stocked by individual pharmacies. If a patient wants to avoid a certain manufacturer, he or she may have to change pharmacies.
Hard to keep up
FDA Commissioner Margaret Hamburg, who recently returned from her first official visit to India, is urging greater collaboration between the two countries.
During her visit, the FDA and India’s Ministry of Health and Family Welfare signed a statement of intent to cooperate to prevent the distribution of unsafe drugs.
Shortly afterwards, India’s drug controller general, G.N. Singh, said in an interview that the country will follow its own quality standards.
“The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver,” he said.