Industryweek 5295 Ranbaxy

Generic Drug Manufacturer Ranbaxy Spends $300 Million to Improve Safety

May 22, 2013
Last week, New Delhi-based Ranbaxy pleaded guilty in the United States to charges of making and distributing adulterated drugs made at its two Indian plants of Paonta Sahib and Dewas, agreeing to a $500 million settlement.

NEW DELHI - Indian generic giant Ranbaxy said Wednesday it has spent over $300 million to overhaul its operations and ensure no repeat of drug safety violations that led to a multimillion-dollar U.S. fine.

Last week, New Delhi-based Ranbaxy pleaded guilty in the United States to charges of making and distributing adulterated drugs made at its two Indian plants of Paonta Sahib and Dewas, agreeing to a $500 million settlement.

"Ranbaxy is a different company today," Ranbaxy CEO Arun Sawhney said in a statement, adding all the company products "in the global market are safe."

"We have made significant improvements in the way we conduct our business to ensure greater quality control and have made investments of over $300 million in our manufacturing facilities to install state-of-the-art technologies," he added.

The U.S. settlement ended eight years of criminal and civil investigations into the company, which is now majority-owned by Japan's Daiichi Sankyo.

Daiichi bought a controlling stake in Ranbaxy in 2008 in a $4.6 billion transaction to gain entry into the fast-expanding global copycat drugs market.

But the Japanese firm saw the value of its investment plummet because of regulatory reverses for Ranbaxy Laboratories in the United States, the world's biggest drug market.

Daiichi said in a separate statement it continued to support Ranbaxy in its efforts to "correct the conduct of the past" that led to the investigations by the U.S. Department of Justice and the U.S. Food and Drug Administration.

"These efforts include significant changes to Ranbaxy's management, culture, operations and compliance," it added.

The latest statements came amid media articles suggesting Indian drugmakers may find it tough to win new contracts in their main U.S. market with the Ranbaxy case raising questions about safety standards of Indian-made drugs.

The fraud was brought to light by ex-employee Dinesh Thakur, who wrote in a public statement that Ranbaxy had created "a complicated trail of falsified records and dangerous manufacturing practices."

Copyright Agence France-Presse, 2013

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