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.”
