US regulator charges Ranbaxy of falsifying data, test results

26 Feb 2009

According to the US health regulator FDA, Ranbaxy has falsified data and test results in its drug applications, prompting it to take necessary actions. The US Food and Drug Administration (FDA) said in a statement that it has taken 'new regulatory action against Ranbaxy’s Paonta Sahib Plant in India' and has halted review of drug applications from plant due to evidence of falsified data.

FDA said that the affected applications from Ranbaxy are for drugs that fall into three categories: Approved drugs made at the Paonta Sahib site for the US market; Drugs pending approval at the FDA that are not yet marketed; and Certain drugs manufactured in the US that relied on data from the Paonta Sahib facility.

 

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. The AIP covers applications that rely on data generated by the Paonta Sahib facility only.

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