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LATEST NEWS UPDATES | Ranbaxy fined $500 m for flawed generics-Narayan Lakshman

Ranbaxy fined $500 m for flawed generics-Narayan Lakshman

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published Published on May 15, 2013   modified Modified on May 15, 2013
-The Hindu


Ranbaxy, one of India's largest pharmaceutical companies, has agreed to pay $500 million fines levied by U.S. authorities for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S.

The deal struck on Monday, said to be the largest financial penalty against a generic drug company for violations of FDA standards, came after whistleblower Dinesh Thakur, a former Ranbaxy director, wrote that eight years ago he discovered that the company "falsified drug data and systemically violated current good manufacturing practices and good laboratory practices."

Arun Sawhney, CEO and Managing Director of Ranbaxy, said in a statement that the "announcement marks the resolution of this past issue. We are pleased to continue bringing safe, effective and quality medicines to market for the benefit of consumers in the U.S. and other parts of the world."

While Ranbaxy was "disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy's stakeholders," he added.

Specifically, federal prosecutors said Ranbaxy USA Inc.'s guilty plea related to the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs. Yet, reports noted that the government's allegations against Ranbaxy made "no claims that the drugs, whose strength, purity or quality differed from the specifications, harmed anyone."

Following several years of a federal investigation into Ranbaxy's alleged "manufacturing deficiencies," the FDA, in 2008, banned the pharma giant from importing over 30 different drugs produced at Indian plants.

In 2011, the U.S. insisted that Ranbaxy faced extra oversight and third-party review to strengthen its drug-making procedures, and ensured its product data was accurate.

In bringing closure to the case, Ranbaxy was said to have admitted that it marketed adulterated medicines, including antibiotics and generic versions of drugs, to treat nerve pain, epilepsy and acne, developed at several manufacturing sites in India.


The Hindu, 15 May, 2013, http://www.thehindu.com/todays-paper/ranbaxy-fined-500-m-for-flawed-generics/article4716872.ece


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