New Delhi: Drug firm Ranbaxy Laboratories on Thursday said it has filed a consent decree with a US court as part of its settlement with the American authorities regarding a ban on certain manufacturing plants operated by the company in India.
The Gurgaon-based company today announced that the consent decree with the US Food and Drug Administration that was signed on December 20, 2011, has 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 US 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," it added.
Commenting on the development, Ranbaxy CEO 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," Sawhney added.
Last year, Ranbaxy signed a consent decree with the USFDA to lift the ban on import of drugs from certain manufacturing plants operated by the firm. It had also announced that it has set aside a provision of USD 500 million to settle its case with the US Department of Justice.
A consent decree is a settlement of a lawsuit or criminal case in which a person or company agrees to take specific actions without admitting fault or guilt for the situation that led to the lawsuit.
First Published: Thursday, January 26, 2012, 15:36