US drug regulators have sought a "groundbreaking" injunction against Ranbaxy Laboratories
to force the Indian drug major to correct long-standing violations
at four of its manufacturing facilities.
The court-sanctioned agreement affects three of Ranbaxy's factories in India and its wholly owned subsidiary Ohm Laboratories in Gloversville, New York. The Department of Justice filed the decree on behalf of the Food and Drug Administration.
"This action against Ranbaxy is groundbreaking
in its international reach," Tony West, assistant attorney general for the Justice Department's Civil Division, said in a statement.
"It requires the company to make fundamental changes to its plants in both the United States and India," he added.
The decree imposes a number of requirements on Ranbaxy, including implementing procedures to ensure data integrity and once the facilities are brought into compliance, hiring a third-party expert to conduct audits
of the facilities to confirm that it is being maintained.
While it is under the consent decree, Ranbaxy relinquishes any 180-day marketing exclusivity it has for pending generic drug applications.
The decree also prevents the company from manufacturing drugs at any of the facilities for introduction to the US market or for making any HIV medicines for the President's Emergency Plan for AIDS relief.
Citing manufacturing and data integrity shortcomings, the Justice Department said US food safety authorities want to block the company from doing business here because its actions made "many of Ranbaxy's drugs adulterated, potentially unsafe and illegal to sell in the United States."
The consent decree will address outstanding current good manufacturing practice (CGMP) and data integrity issues at Ranbaxy's Paonta Sahib, Batamandi and Dewas, India facilities as well as at the Gloversville facility.
The consent decree requires that Ranbaxy comply with detailed data integrity provisions before FDA will resume reviewing drug applications containing data or other information from the three Indian facilities, which have been on FDA import alert since 2008.
The FDA gave the Indian firm the go-ahead last November to make a generic version of Lipitor, which was the best-selling drug of all time and earned US pharma giant Pfizer $100 billion after coming on the market in 1997.