Generic drug manufacturer Ranbaxy Laboratories Ltd. will have to withdraw all drug applications that contain data generated at one of its facilities in India and relinquish 180-day marketing exclusivity for three pending abbreviated New Drug Applications under a consent decree for permanent injunction filed Jan. 25 by the U.S. Department of Justice.
The decree follows a lengthy investigation by the DOJ and the U.S. Food and Drug Administration that found numerous problems at three Ranbaxy facilities in India and one facility in Gloversville, N.Y.
According to the DOJ, the problems with Ranbaxy’s drug manufacturing and testing include failure to keep records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from nonpenicillin drugs in order to prevent cross-contamination; lack of adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drug to ensure that they maintained strength and effectiveness until their expiration date.
The government also said that Ranbaxy submitted false data in drug applications, including backdating tests and submitting test data for which no test samples existed.
The consent decree is unprecedented in its scope, according to DOJ officials.
"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," Assistant Attorney General Tony West said in a statement. "Submitting false data to the FDA in drug applications will not be tolerated."
Ranbaxy said in a statement that the consent decree would not affect the company’s recently launched generic atorvastatin, because it is not manufactured in the facilities cited in the decree.
"Today’s announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue," according to Arun Sawhney, managing director of Ranbaxy Laboratories. "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."
Ranbaxy announced earlier that it had entered into the consent decree with the FDA and had set aside $500 million to settle the related DOJ investigation. The consent decree itself does not mention the size of the settlement, although it does note that "if defendants fail to comply with any provision of the law or this decree at any covered facility and/or with respect to any affected application, then [they] ... shall pay to the United States of America $15,000 in liquidated damages for each day such violation continues."
The company also agreed to relinquish the 180-day marketing exclusivity that it might have for three pending generic applications, but did not specify which drugs would be affected. The company also agreed to relinquish any 180-day marketing exclusivity that it may have for several additional generic applications if it fails to meet certain decree requirements by specified dates.
The manufacturing plants cited in the consent decree are the Paonta Sahib, Batamandi, and Dewas facilities, all in India, and the now-closed facility of Ranbaxy’s Ohm Laboratories subsidiary in Gloversville, N.Y. Import alerts for more than 30 products manufactured at the Paonta Sahib and Dewas sites have been in place since September 2008.
The consent decree also prevents Ranbaxy from manufacturing drugs for introduction to the U.S. market and for the President’s Emergency Plan for AIDS Relief Program at the four facilities.
Brenda Sandburg is a reporter for "The Pink Sheet." This news organization and "The Pink Sheet" are owned by Elsevier.