Indian Court Tosses Criminal Suit for Ranbaxy Labs

Indian Court Tosses Criminal Suit for Ranbaxy Labs

June 25th, 2013 // 2:22 pm @

Latest FDA and cGMP Compliance News

Ranbaxy Laboratories is finally enjoying some good news this week. The Supreme Court in India is tossing out a very publicized lawsuit that was aiming to criminally prosecute all current and former executives of the generic drug company. It also was aiming for restricted marketing of products and the cancellation of production licenses for two of its plants that were heavily criticized by FDA for cGMP violations.

This lawsuit garnered a lot of attention in India and was filed not long after Ranbaxy agreed to pay out $500 million in fines to FDA and to settle the civil and criminal charges for a huge manufacturing scandal that included the use of unapproved raw chemicals, faking test data to meet cGMP standards and hiding these activities from inspectors.

The uproar over the large fine and the great extent of deceit and fraud that occurred has made some concerned that the substandard drugs were distributed in India. So, an attorney filed a public lawsuit, arguing that the company sold and marketed adulterated drugs and this made it a heinous crime and is similar to committing murder.

The Supreme Court ruled that the lawyer did not have enough evidence to go forward and that he was basing his charges on documents that referred to low quality pharmaceuticals that were marketed inside the US. FDA did issue an import alert for 20 Ranbaxy products at one point, which means that these drugs were not allowed to enter the US.

The court stated that the whole argument was based upon occurrences in the US, and the courts in India do not have jurisdiction in these matters. The court also said that the lawyer needs to show what happened in India that affected people adversely. As the lawyer could not do so, the suit was dismissed.

The decision on the suit came a few days after the media in India was focusing on another problem with Ranbaxy – a new 483 report for another facility.  Such reports are common, but Ranbaxy has been under a microscope for its cGMP flaws of late.


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