Report: Ranbaxy faked documents to get FDA approvals

November 8, 2013

A former Ranbaxy executive told CBS News that the company often skipped the required steps for approval of its generic drugs, and in some cases presented fake data to get its products in U.S. pharmacies.

A former Ranbaxy executive told CBS News that the company often skipped the required steps for approval of its generic drugs, and in some cases presented fake data to get its products in U.S. pharmacies.

Earlier this year, FDA issued an import alert to detain drugs produced at Ranbaxy’s facility in Mohali, India, because the company has not complied with U.S. manufacturing requirements. Since 2008, similar seizure orders were in place for drugs from Ranbaxy’s Paonta Sahib and Dewas facilities.

"The data [for its abbreviated new drug applications (ANDAs] are  important because the FDA or other agencies globally look at that information to give you marketing authorization to sell the drug," said Dinesh Thakur, a former Ranbaxy executive who eventually became a whistleblower. "We started getting the files, and, lo and behold, we find that none of that exists in the first place. ... It means that we've gotten approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent."

Thakur told CBS that Ranbaxy's drugs for AIDS, heart problems, and infections had no proof that they were effective. He said he took his findings to Ranbaxy in 2005 but nothing was done. Then, he took his evidence to the U.S. officials. "I was dumbfounded," Thakur said. "I've worked in this industry for 11 years at that point and never seen such callous behavior."

FDA’s investigation of Ranbaxy found the company had a "persistent ... pattern" of submitting "untrue statements." Investigators found more than 1,600 data errors for 15 generic ANDAs from Ranbaxy. Eventually, FDA deemed Ranbaxy’s drugs potentially unsafe and illegal to sell.

Thakur's allegations led Ranbaxy to plead guilty to seven felonies. In 2008, Japanese firm Daiichi Sankyo bought the company. FDA says the company’s products are safe to take.