Ranbaxy subsidiary to pay $500 million in US lawsuit settlement

14 May 2013 Evaluate

In the largest drug safety settlement case of a generic drug maker in the US, pleading guilty to felony charges related to drug safety, drugmaker Ranbaxy Laboratories’ US subsidiary, Ranbaxy USA, Inc, has agreed to pay $500 million to the US Department of Justice (DOJ) for settling a criminal and civil lawsuit, which leveled charges of falsifying data from its drug facilities and shoddy manufacturing practices against it. $150 million was charged towards criminal fine and forfeiture and $350 million for civil claims.

However, there would not be any additional financial impact of the settlement, given that the company, in December 2011, had earmarked $500 million to resolve the potential criminal and civil liabilities related to the investigation by the government into its manufacturing practices and falsifying data.

Ranbaxy, in December 2011, signed a consent decree with US FDA to resolve its long pending issues over quality and regulatory issues, following the US FDA banning the import of 30 drugs from its two plants in Dewas and Paonta Sahib in 2008, and also stopped marketing approvals for new ones following quality control and data reporting issues.

The company’s US subsidiary was found guilty of three felony counts related to the manufacture of drugs at two Indian locations which failed to meet safety standards and to four counts of making material false statements.

Meanwhile, $48.6 million would be handed to Dinesh Thakur, former Ranbaxy director and global head of research information & portfolio management, who acted as the whistleblower in the case.

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