Ranbaxy accepts consent decree, permanent injunction

Indian drug giant Ranbaxy has accepted a consent decree filed by the U.S. Department of Justice on behalf of FDA. The decree, which must still be accepted by the U.S. District Court for the District of Maryland, requires Ranbaxy to fix long-standing manufacturing problems at plants in India as well as a plant in the United States.

The company must hire a third party to audit and approve improvements to flawed manufacturing processes before any subsequent FDA inspection of affected facilities in India and the United States. The decree also names the drug maker’s U.S. subsidiary, Ranbaxy, Inc., based in Princeton, NJ. Individuals named as defendants include Dale Adkisson, senior vice president and head of global quality, and Arun Sawhney, CEO and managing director, Ranbaxy Labs, as well as Venkatachalam Krishnam, regional director Americas, Ranbaxy, Inc.

The decree settles long-standing allegations of good manufacturing practices violations at Ranbaxy facilities at Paonta Sahib, Batamandi, and Dewas, India as well as fully-owned subsidiary Ohm Laboratories in Gloversville, NY. Products from the 3 Indian facilities have been banned from importation into the United States since 2008 and the Gloversville facility has been closed, according to FDA.

The consent decree notes that Ranbaxy made ‘adulterated, potentially unsafe' prescription medications at the facilities. Alleged violations include failure to separate penicillin and non-penicillin drugs and failure to take adequate steps to prevent the contamination of sterile products. More than 30 Ranbaxy generics have been banned from importation during the 3-year dispute. In December 2011, Ranbaxy said it had set aside $500 million to resolve potential criminal and civil liabilities associated with the FDA investigation.

“Today’s announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue,” Sawhney told Formulary in an emailed statement. “We are pleased with the progress we have made in upgrading the quality of our business and manufacturing processes.”

Recent FDA approvals of Ranbaxy’s generic atorvastatin (Lipitor, Pfizer) and atorvastatin-amlodipine besylate (Caduet, Pfizer) are not affected by the consent decree. But the Indian drug maker gave up any 180-day marketing exclusivity it might have won for 3 pending generic drug applications and forfeited exclusivity for several additional generic drug applications, according to FDA. Neither FDA nor Ranbaxy have released the names of the generic drugs affected.