Earlier this year, Ranbaxy Laboratories and U.S. regulators unveiled what promises to be the benchmark of consent decrees for years to come. The 55-page, 5-year agreement set a long list of do's and don'ts for the Indian genericsmaker, which was found faking quality data.
As part of the decree, Ranbaxy is now bringing in a couple of hired guns from the U.S. to tell it what improvements are left to be made. CEO Arun Sawhney says he expects the consultants' work at its manufacturing plants in India to be completed by the end of June, reports The Economic Times. The disclosure is a reminder that although the drugmaker is again shipping product to the U.S., it will continue to operate under much more stringent FDA oversight than other companies.
Ranbaxy reported a huge first quarter, in large part because its North American sales doubled during the period, to 20.93 billion rupees ($375 million). That was tied to getting an FDA sign-off to manufacture and sell in the U.S. its generic version of Lipitor, made at one of its major Indian plants.
But it still has a long way to work its way back into the good graces of the FDA. In 2008, regulators uncovered a list of issues, including faked drug quality data, and banned 30 products from the U.S. The blueprint for that journey is laid out in the 55-page consent decree. Among other things, Ranbaxy is required to hire data-integrity and manufacturing experts who will watch over its shoulder, make recommendations and take the issues up with the FDA. If anything slips by these controls, Ranbaxy must establish, and publicize, an anonymous disclosure program so employees can report "suspected violations."
- read the Economic Times story