Filing of the consent decree marks the next phase in the long-running Ranbaxy manufacturing quality saga. Now the US Food and Drug Administration (FDA) and Ranbaxy will work to fix outstanding data integrity and cGMP (current good manufacturing practice) issues at three production plants in India.
“This action against Ranbaxy is groundbreaking in its international reach – it requires the company to make fundamental changes to its plants in both the United States and India”, Tony West, assistant attorney general for the US Department of Justice’s (DoJ) civil division, said.
Before the FDA will consider reviewing applications containing data from the three sites, in Paonta Sahib, Batamandi, and Dewas, Ranbaxy must meet certain provisions outlined in the consent decree.
Ranbaxy must hire a third-party expert to review the plants and applications using their information, adopt policies to ensure data integrity, and withdraw applications containing untrue statements.
Failure to meet requirements by specified dates could result in Ranbaxy losing the 180-day marketing exclusivity for several generic drug applications. Ranbaxy has already agreed to relinquish exclusivity it may have for three pending generic drug applications.
Further penalties are written into the consent decree. Distributing drugs from facilities covered by the decree or submitting untrue statements to the FDA trigger fines. The FDA can also make other Ranbaxy plants part of the consent decree if they fail to meet cGMP or have serious data issues.
The focus on integrity follows allegations Ranbaxy submitted false data to the FDA. “Because this company continued to violate cGMP regulations and falsify information on drug applications, the FDA took these actions”, Dara Corrigan, FDA associate commissioner for regulatory affairs, said.
Specific allegations centre on backdating of tests and the submitting of results for which no test samples existed. The DoJ said these actions made ‘many of Ranbaxy’s drugs adulterated, potentially unsafe and illegal to sell in the US’.
Arun Sawhney, CEO of Ranbaxy, said: “We are pleased with the progress we have made in upgrading and enhancing the quality of our business and manufacturing processes and remain committed to ensuring that all of our facilities and products meet [high standards].”
Ranbaxy first discussed the consent decree in December, weeks after it formed a pact with Teva to introduce its generic Lipitor (atorvastatin) in the US. At the time Ranbaxy said it had allocated $500m (€380m) to settle the DoJ investigation into alleged forgery of documents.