The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York.
The consent decree requires Ranbaxy to conduct an internal review of all negligent facilities using a third-party expert audit applications containing data from the facilities in question, take steps to ensure data integrity going forward and withdraw any pending applications that use irregular data.
FDA has prevented drug products manufactured from the sites from entering in to the country since 2008, when it issued an import alert after learning of the issues.
"Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers," said Dara Corrigan, FDA associate commissioner for regulatory affairs. "The FDA continues to be committed to protecting consumers from potentially unsafe products that may be offered on the market."
Once in compliance with the FDA-mandated steps to ensure integrity, Ranbaxy will be required to conduct regular third-party audits of the facilities, set up quality assurance (QA) and quality control (QC) oversight positions responsible for all QA/QC activities, and establish an Office of Data Reliability to review pre-submission data.
"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 Justice Department's Civil Division, said in a DOJ press release.
The company has agreed to "relinquish any 180-day marketing exclusivity that it might have for three pending generic drug applications," FDA said in a statement. Reuters reported that the names of those three products were filed under seal and were not available to the public.
Ranbaxy made waves several months ago when it revealed that it had received 180-day exclusivity rights to the generic version of Lipitor. It is unclear if this exclusivity is threatened by the agreement.
Ranbaxy has agreed to pay fines for future violations, including up to $10 million per year for distributing drugs for the Indian factories with quality problems and up to $30 million per year for filing untrue statements with FDA. Additional manufacturing facilities may also be placed under the consent decree if further problems are found with those plants.
"Today's announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue," said Arun Sawhney, Ranbaxy CEO & Managing Director, in a statement released on the Ranbaxy website. "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 the high standards that patients, prescribers and the public have come to expect from Ranbaxy."
The company has put aside $500 million to cover the possibility of civil and criminal charges related to investigations over the manufacturing problems.
The consent decree's mandatory activities could mean a 12-18 month delay in abbreviated new drug approvals, said analysts that spoke to BBC News.
The consent decree is subject to court approval, at which time it will immediately go in to effect.