Right now, many of us are thinking of how we could improve ourselves during the new year. Others, such as Ranbaxy, will be forced to improve themselves in 2012. The company signed a consent decree last week, and its management must be eager to put its ugly past behind it.
Ranbaxy’s troubles stretch back at least to 2006, when FDA found significant deviations from CGMP at the company’s Dewas and Paonta Sahib, India, plants. The agency sent a Warning Letter that year and two more in 2008. In September 2008, FDA decided to deny any new drug applications or abbreviated new drug applications that listed either of the two plants as a manufacturer. It also issued an Import Alert that allowed US border officials to detain imported products manufactured at those facilities.
As if the manufacturing problems were not serious enough, federal officials, reportedly including FDA employees, searched Ranbaxy’s New Jersey offices in 2007. The US Department of Justice (DOJ) later launched an investigation into allegations of conspiracy, false statements, and healthcare fraud at the company. DOJ suspected Ranbaxy of fabricating bioequivalence and stability data to support abbreviated new drug applications, and of attempting to conceal CGMP violations.
The situation worsened in 2009, when FDA charged Ranbaxy Laboratories’s Paonta Sahib facility with falsifying data and test results in approved and pending drug applications. The agency stopped all substantive scientific review of new and pending drug-approval applications containing data generated by the facility. A few months later, Malvinder Mohan Singh stepped down as the company’s chairman, CEO, and managing director.
Last week, Ranbaxy signed the consent decree in hopes of resuming US sales of drugs manufactured at the two banned plants. In a press statement, Ranbaxy pledged to ensure the integrity of its data and to comply with CGMP. Indicating that DOJ’s suspicions had some foundation, the company also set aside $500 million to resolve civil and criminal liability arising from the department’s investigation.
Ranbaxy has taken unspecified “systematic corrective steps” to straighten itself out, according to the statement. Although we might be skeptical about these measures, the company’s new owner Daiichi Sankyo might bring the rigor and discipline that Ranbaxy seems to need. Let’s hope on behalf of patients everywhere that Ranbaxy can turn over a new leaf in 2012.