The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.
The FDA 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.
In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.
To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.
Under the AIP, the FDA has asked Ranbaxy to cooperate with the agency to resolve the questions of data integrity and reliability. This would include implementing a Corrective Action Operating Plan (CAOP) to provide assurance of the integrity and reliability of data from the Paonta Sahib facility. A CAOP includes, but is not limited to, conducting a third-party independent audit of applications associated with Paonta Sahib.
When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility.
For more information, please visit: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01962.html
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