FDA to go tough as imported Indian medicines set off safety concerns

In a bid to keep a quality check on the imported drugs from country like India, the FDA is going to set up an Office of Pharmaceutical Quality that aims at enhancing the health agency’s inspection of brand-name, generic and over-the-counter drugs.

The announcement was made by FDA’s Center for Drug Evaluation and Research director Janet Woodcock at the Bloomberg Health care summit on Friday.

FDA Commissioner Dr. Margaret Hamburg has recently visited India to discuss “recent lapses in quality at a handful of pharmaceutical firms,” say a New York Times report.

According to the NYT report, India is the second-largest exporter of over-the-counter and prescription drugs to the United States.


The New York Times report says, the agency carried inspection on 160 Indian drug plants in 2013 and penalized many for not satisfying the quality concerns. The FDA’s penalties have badly hit some of the leading Indian companies like Ranbaxy, one of the country’s largest drug manufacturers. It reportedly had to pay a $500 million fine in 2013.

Hamburg, in his recent blog on FDAVoice, said: “In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world. As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable.”


  • zookeeper216

    Are they talking about the drugs made by French companies which are just as safe as the ones made here?

  • mary

    India imports most of our generic drugs. I have refused metformin made in india in the past, because I found it to be as helpful as taking chalk tablets with no medicine in them at all. So this does not surprise me at all.

    Generics, which are supposed to be the same, are often made in India and India is our largest importer of medicines. France is way behind them. They will get around to all of them soon, I hope. Somemonths my meds work, then the next batch is lacking enough actual medicine in them to help much. Canada also makes generics, which I have found to be of better quality. BUT due to problems withthe FDA, they no longer are making my metformin.

    Sandoz is a large maker of generics, some of the factories are in the USA and some in Canada. They are the ones not currently making the metformin which I liked and found to be good. So now I have no choice but to take the ones made in India, which are iffy. My diabetes, and complications of, have been sufferring for over 3 months now, because I cant get my Sandoz brand.