A $500 million penalty will be paid by one of the largest largest pharmaceutical companies in the world.
Ranbaxy USA, a subsidiary of the Indian drug manufacturer Ranbaxy Laboratories Limited, pleaded guilty to charges that it knowingly created and sold adulterated drugs in the United States. The company was also charged with lying to federal regulators.
The staggering $500 million penalty against the company is said to be one of the biggest drug safety fines ever levied against a drug manufacturer. Ranbaxy agreed to paid $150 million in criminal penalties and an additional $350 million to settle civil claims in all 50 states and the District of Columbia.
The drug manufacturer said in a written statement that it had complied with the investigation by US regulators. Ranbaxy was previously ordered to stop importing 30 different drugs into the country from India. However, the company hopes to increase sales in the United States going forward.
“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,” CEO and managing director Arun Sawhney said in a statement.
Sawhney continued, “While we are 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; the conclusion of the DOJ investigation does not materially impact our current financial situation or performance.”
Ranbaxy admitted to the improper storage of drugs that were waiting to be tested, selling products that had failed purity tests, and delaying a voluntary recall. The company also made false statements to the Food and Drug Administration in 2006 and 2007 regarding test dates for several of its products.
The Pew Charitable Trusts drug safety expert Allan Coukell hopes that people will take more interest in the amount of drugs that are manufactured and imported into the country by overseas companies.
“Over the last few years, the FDA and others have been increasingly focused on the risks associated with global drug manufacturing. The agency now has new authority and new resources which should result in an increased scrutiny on the highest-risk facilities,” Coukell explained to The Associated Press.
What do you think about the $500 million penalty levied against Ranbaxy USA?
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