Generic drug maker Ranbaxy has pleaded guilty to federal drug safety violations, and it will pay $500 million in fines, the India-based company and prosecutors have announced.
The settlement – the largest in history involving a generic manufacturer and drug safety – will resolve claims that the company knowingly sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices, the
New York Times reports.
A former Ranbaxy executive was the one who alerted the federal government; he will receive nearly $49 million in compensation for being a whistle-blower, according to the New York Times.
The issue involved 26 generic pharmaceuticals manufactured between 2003 and 2010 at two of Ranbaxy’s locations in India, according to the Florida Attorney General’s Office. Florida will receive more than $3 million alone as a result of the settlement.
Ranbaxy has acknowledged that it failed to conduct proper safety and quality tests of several drugs including generic versions of many common medicines, like gabapentin, which treats epilepsy and nerve pain, the New York Times reports. With gabapentin, Ranbaxy admitted that between June and August in 2007, it knew that certain batches had tested positive for unknown impurities and had unreliable shelf lives. It had waited until October 2007 to alert the F.D.A. and announce a recall, which involved more than 73 million pills.
Ranbaxy had been operating under a consent decree with the federal government since January 2012 to “address manufacturing practices and data integrity issues in the two Indian manufacturing plants at issue,” a release from the Attorney General’s Office states.
Ranbaxy is a member of the Daiichi Sankyo Group, which is headquartered in Tokyo.
The company has not exported drugs from the two Indian factories since 2008, according to the New York Times.