A growing number of doctors in the United States have been voicing a growing concern over the quality of generic medications imported from India, according to a recent in-depth report from Reuters.

The concerns weighing on the minds of these doctors come from an increasing trend of recalls and import bans put in place recently by the Food & Drug Administration (FDA) on medications made in India.

"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's starting to get a lot of traction among physicians."

Several specific Indian manufacturers of generic meds have been accused by the FDA of being responsible for quality control problems, including sanitation issues, data manipulation and more. Making headlines most recently after having had products banned from the U.S. market are Ranbaxy Laboratories, Ltd., Sun Pharmaceutical Industry, Ltd., and Wockhardt Ltd., among others.

In terms of the specific problems that have spurred the banning of a numerous quantity of Indian-made medications, there are many.

For example, the FDA issued a recall of over 58,000 bottles of a heartburn medication imported from Dr. Reddy's Laboratories, Ltd., due to a "microbial contamination." Dr. Reddy's is based in Andhra Pradesh, India.

Other instances include the recall of approximately 64,000 bottles of a generic cholesterol drug after dosages were mixed up in the bottles. Sun Pharmaceuticals also recently recalled over 2,500 bottles of generic diabetes medication when it was discovered that it contained epilepsy medication instead.

"It's hard to be sure on a day-to-day basis with the array of medications that you have to be potentially aware of that there's a specific problem with a specific medication from a specific generic manufacturer," Dr. Elliott Antman, a cardiologist from the Boston area told Reuters.

Antman added that doctors are dependent upon agencies like the FDA to ensure their patient's well-being. He also noted that the medical community has a responsibility to make sure that resources are sufficient for those at the FDA to maintain stringent safety and control measures, especially in light of these recent issues.

Dr. Richard Kovacs, a big name in the world of cardiology who heads several American College of Cardiology committees and is among its board of trustees, agrees with Antman. Kovacs says that doctors may have to begin shouldering a newly created responsibility when it comes to their patient's medications.

"The average U.S. cardiologist has been able to assume that the drugs were safe and effective," Kovacs told Reuters."It now appears we need to be more vigilant as a profession, and assist the FDA by reporting cases where we are concerned about irregularities in the drugs supplied to our patients."

However, according to the Reuters report, the $14 billion drug manufacturing industry in India denies that its medications are in any way inferior to those made anywhere else in the world.

"We have heard doctors making generalized statements, without being specific on any product or company," said D.G. Shah, the Secretary General of the Indian Pharmaceutical Alliance, which represents the bigger drug manufacturers in India. "This is a deliberate and serious campaign to malign the Indian generic industry."


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