Feds file 'unprecedented' consent decree involving Indian generic drugmaker

The Justice Department filed what it called an “unprecedented” consent decree for a permanent injunction (PDF) against Ranbaxy Laboratories, a Gurgaon, India-based generic drug company.

An investigation conducted by the Justice Department and the Food and Drug Administration found problems with the company's seven manufacturing and testing facilities in the U.S. and India. They include failure to keep records showing proper manufacturing of drugs; failure to establish procedures that prevent the contamination of sterile drugs; and inadequate testing of drugs until their expiration date.

The government also alleges that Ranbaxy submitted false data on drug applications.

“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,” said Tony West, assistant attorney general for the Justice Department's civil division, in a news release.

The consent decree halts the company's manufacturing of drugs for the U.S. market until its facilities meet the standards set by the FDA. In addition, it requires Ranbaxy to hire a third-party organization to audit its facilities in the U.S. and India as well as the applications containing data from those sites.

Ranbaxy announced in December that it had signed the consent decree with the FDA and that the company had set aside $500 million to resolve civil and criminal liability. The decree is subject to approval by the U.S. District of Maryland, according to the Ranbaxy news release.

“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 and managing director, in a written statement released Wednesday. “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.”