Ranbaxy Laboratories on Thursday announced that it had filed a consent decree with a U.S. court as part of its settlement with the U.S. authorities regarding a ban on certain manufacturing plants operated by the company in India.
In a statement issued here, the company said the consent decree with the U.S. Food and Drug Administration that was signed on December 20, 2011, had been filed with the United States District Court for the District of Maryland. In 2008, the USFDA had banned 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib and Batamandi unit in Himachal Pradesh, citing gross violation of approved manufacturing norms.
In the same year, the U.S. Department of Justice had moved a motion against the company in a local court alleging forgery of documents and fraudulent practice.
“Under the terms of the consent decree, which is subject to approval by this court, Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices,” the statement added.
Commenting on the development, Ranbaxy Chief Executive Officer and Managing Director Arun Sawhney said: “Today's announcement is the next step in the process of finalising our agreement with the FDA to resolve this legacy issue. 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.”