Ranbaxy pleads guilty to felony; agrees to pay USD 500m

Ranbaxy seems to be finally coming out of its US FDA troubles. In a settlement with the US FDA at the US department of Justice, the company has pleaded guilty to felony charges relating to manufacturing at two of its plants in India, which are Paonta Sahib and Dewas.

This is a culmination of the consent degree that the company had signed in end-2011 with the US Food and Drug Administration (FDA), where they had pleaded guilty and said that they would make corrective actions and also give a fine where they were charged with criminal as well as civil charges. As part of the final settlement, which is one of the largest settlements that any generic drug manufacturer is doing with the US FDA in the US for the US market, they have agreed to pay a total fine of USD 500 million. Of this, USD 350 million will go towards settling civil claims; USD 130 million will be a fine for criminal charges as well as additional USD 20 million for forfeiture. Out of the USD 500 million, USD 48.5 million will go to the whistleblower who is Dinesh Thakur, an ex-employee of Ranbaxy who had initiated talks on some violations at Ranbaxy plants way back in 2007-2008.