FDA takes regulatory action against Ranbaxy's Paonta Sahib plant
The US Food and Drug Administration (FDA) has halted all drug approval applications from a facility owned by India-based Ranbaxy Laboratories, owing to evidence of falsified data and test results in approved and pending drug applications. The Paonta Sahib facility has been under an FDA Import Alert since September 2008.
The US Food and Drug Administration (FDA) has halted all drug approval applications from a facility owned by India-based Ranbaxy Laboratories, owing to evidence of falsified data and test results in approved and pending drug applications. The Paonta Sahib facility has been under an FDA Import Alert since September 2008.
The FDA said it is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with the plant in India.
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.
The affected applications are for drugs in 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.
"Companies must provide truthful and accurate information in their marketing applications," said Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research (CDER).
To address the falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility.
"The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications, and this warrants applying the Application Integrity Policy," said Deborah Autor, director of CDER's Office of Compliance.