FDA under fire over Ranbaxy imbroglio

May 29, 2013 09:57 pm | Updated November 17, 2021 05:35 am IST - WASHINGTON:

The U.S. Food and Drug Administration is facing calls for reviewing its oversight of drugs produced in foreign facilities in the wake of the Ranbaxy imbroglio.

Ranbaxy pleaded guilty to criminal charges for manufacturing and distributing adulterated drugs earlier this month.

Full review

Democratic Congressman Steve Israel has demanded a full review of the FDA’s oversight of pharmaceutical drugs produced outside the U.S., arguing, “It is simply unacceptable that we should have to question whether a pharmaceutical drug or an active ingredient is safe or effective because it is produced overseas.”

Specifically, Mr. Israel has cited the “massive fraud that occurred at Ranbaxy Laboratories, which went unchecked by the FDA,” making it necessary for a thorough review into the effectiveness of oversight procedures for pharmaceutical drugs and active ingredients produced in foreign facilities. “We deserve to know that our families and these products are safe,” he adds. Meanwhile, the Indian Medical Association (IMA), which represents medical practitioners, has reportedly called upon the Drug Controller General of India (DCGI) to investigate the quality of drugs manufactured and sold by Ranbaxy.

“We will soon be writing to the DCGI asking them to check and investigate if Ranbaxy drugs are of poor quality,” Narendra Saini, Secretary General of the IMA, was quoted as saying. Ranbaxy is the sixth-largest generic drug manufacturer in the U.S. At present, over 80 per cent of active pharmaceutical ingredients for drugs and 40 per cent of finished capsules and pills sold in the U.S. are produced overseas, reports suggest. Overall, 84 per cent of U.S. drugs comprised generic medicines in 2012.

Questionable inspection

Yet, in 2009, a government watchdog, the Government Accountability Office, discovered that only 11 per cent of foreign drug manufacturing plants were inspected by regulators, compared to 40 per cent of domestic plants and the quality of foreign inspections has been described as “questionable.”

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