Ranbaxy Laboratories Falsified Data

By Irene Collins
00:12, February 26th 2009
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Ranbaxy Laboratories Falsified Data

The Food and Drug Administration says India's largest drugmaker has falsified test results for some of its generic drugs. India's largest pharmaceutical maker lied about test results for more than two dozen of its generic drugs, according to U.S. regulators.

The federal agency said it is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy's Paonta Sahib site. "To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products," FDA officials said, urging patients not to disrupt their drug therapy because that could jeopardize their health.

Following the discovery of falsified data from the Paonta Sahib site in India, the FDA has halted review of applications using data from the plant until the company either withdraws the applications in question or demonstrates the integrity of the information, according to Douglas Throckmorton, M.D., deputy director of the FDA's Center for Drug Evaluation and Research.

All 25 drugs affected by the problems likely reached the U.S., regulators said, though the September import ban means it has been months since new pills reached pharmacy shelves. Ranbaxy has three other plants in India that import drugs to the U.S., such as low-cost versions of popular cholesterol drugs and antibiotics. The FDA said it has inspected Ranbaxy's plants more than 20 times in the past four years without uncovering similar problems. Officials did not specify how many drug applications Ranbaxy had pending review at the FDA.
 



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