The U.S. Food and Drug Administration has increased its scrutiny of Indian pharmaceutical companies following recent events of bad practices at a handful of manufacturing facilities, according to a report in The New York Times.
Margaret Hamburg, MD, FDA commissioner, is on her first trip to India in hopes to address these issues and "recent lapses in quality at a handful of pharmaceutical firms," according to a post in the FDA Voice.
Most recently, the FDA banned Ranbaxy Laboratories from manufacturing and importing drugs to the U.S. after observations found the laboratory was not following current good manufacturing practices. In May, prior to the FDA ban, the laboratory pled guilty and agreed to pay $500 million to resolve false claims allegations of producing and distributing adulterated drugs.
In 2013, the FDA inspected 160 manufacturing facilities in India, triple the amount inspected in 2009, according to The New York Times.
The World Health Organization estimates one in five drugs produced in India are adulterated, and 40 percent of over-the-counter and generic prescription drugs consumed in the U.S. are manufactured in India, indicating "profound implications for American customers," according to the report.
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