Generic Drug Maker Ranbaxy Settles with DOJ in Adulterated Drugs Case

The US Department of Justice reports that a plea agreement by the US branch of Indian generic drug giant Ranbaxy is the largest ever against a generic drug manufacture. Ranbaxy admitted to selling unapproved and adulterated prescription drugs in the United States.

According to the Department of Justice statement on this case, the drugs manufactured at two different plants in India, one in Dewas, and another in Paonta Sahib. The manufacturers failed to follow Current Good Manufacturing Practices (cGMPs) as mandated by the FDA. In many cases the drugs were not up to FDA standards and degraded much faster than their authentic counterparts. The Department of Justice also reports that Ranbaxy knowingly made false statements to the FDA as to the testing, content and quality of the drugs it sold in the United States.

The US Department of Justice reports that a plea agreement by the US branch of Indian generic drug giant Ranbaxy is the largest ever against a generic drug manufacture. Ranbaxy admitted to selling unapproved and adulterated prescription drugs in the United States.

According to the Department of Justice statement on this case, the drugs manufactured at two different plants in India, one in Dewas, and another in Paonta Sahib. The manufacturers failed to follow Current Good Manufacturing Practices (cGMPs) as mandated by the FDA. In many cases the drugs were not up to FDA standards and degraded much faster than their authentic counterparts. The Department of Justice also reports that Ranbaxy knowingly made false statements to the FDA as to the testing, content and quality of the drugs it sold in the United States.

The case originally came to the attention of the FDA when a former executive with Ranbaxy, Dinesh Thakur, contacted the FDA to warn them about Ranbaxy’s perfidy, reports Fortune. The department of Justice has identified Thakur as a whistleblower in the case. As such, he is entitled to approximately $49 million of the fine for his part in exposing Ranbaxy’s adulterated drugs.

John Roth director of the FDA’s Office of Criminal Investigations explains why the Department of Justice pursued Ranbaxy: “The FDA expects that companies will comply with the cGMP requirements mandated by law so that consumers can be assured that their medical products are safe and pure. The investigation that led to this settlement uncovered evidence showing that certain lots of specific drugs produced at the Paonta Sahib facility were defective, in that their strength differed from, or their purity or quality fell below, that which they purported to possess. The FDA and its law enforcement partners will continue to aggressively pursue companies and their executives who erode public confidence in the quality and safety of medical products by distributing products that do not comply with the law.”

By S. Imber