FDA under fire over Ranbaxy imbroglio

Updated - November 17, 2021 05:35 am IST

Published - May 29, 2013 09:57 pm 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.”

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in


Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.