On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.
In addition, Ranbaxy will make a provision of $500 million to resolve all potential civil and criminal liability in connection with an investigation by the US Department of Justice (DOJ). The department was evaluating allegations of conspiracy, false statements, and healthcare fraud at the company. DOJ launched the investigation after federal officials, reportedly including representatives of FDA, searched Ranbaxy’s New Jersey offices in 2007.
The consent decree follows FDA’s accusation in February 2009 that Ranbaxy’s Paonta Sahib, India, facility had falsified data and test results in approved and pending drug applications. FDA invoked its Application Integrity Policy (AIP) and stopped all substantive scientific review of new and pending drug-approval applications containing data generated by the facility.
As part of the AIP, the agency asked Ranbaxy to resolve the questions of data integrity and reliability. The company was expected to initiate a corrective action operating plan to certify the integrity and reliability of data from the Paonta Sahib facility. Malvinder Mohan Singh stepped down as chairman, CEO, and managing director of Ranbaxy about two months after FDA’s actions.
“While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes,” said Arun Sawhney, Ranbaxy CEO and managing director, in a press release. “Ranbaxy’s new management team, and its new majority shareholder, Daiichi Sankyo, are committed to the utmost levels of professionalism and integrity, and to ensuring that all Ranbaxy facilities meet the high standards that patients, prescribers, and the public expect from a leading global generic pharmaceutical company. We look forward to continuing to work cooperatively with the FDA to strengthen the public trust in our company.”