Apart from supplying fraudulent data to the US Food and Drug Administration, Ranbaxy Laboratories has also been accused by the US department of justice (DoJ) of selling new drugs without getting any approvals by the US drug regulator in its plaint for permanent injunction filed on January 25, 2012, in the Maryland District Court. Ranbaxy accepted the charge when it signed the consent decree with the justice department.
Ranbaxy had signed the consent decree with DoJ in December 2011 which was filed with the Maryland district court on January 25, 2012, by the justice department. Subsequently, in May 2013, Ranbaxy agreed to pay $500 million in penalty to settle criminal and legal suits levelled against it in the US.
Two instances stated by the justice department show that between 2008 and 2009, Ranbaxy was distributing and selling certain drugs which had not been filed with the the US FDA nor had received any approvals from FDA.
Apart from issues of not following accurate drug manufacturing processes, inadequate testing of drugs and submitting false data in drug applications the DoJ also said that Ranbaxy distributed drugs ?which were not the subject of approved drug applications on file with FDA?.
An import refusal report of October 2, 2008, filed by the US FDA also states that ?the article appears to be a new drug without an approved new drug application?. That particular batch of drug was refused entry into the United States.
The Food, Drug, and Cosmetic Act authorises FDA to detain a regulated product that appears to be out of compliance with the Act. The Inspection Refusal Report (IRR) reports on those products for which a determination was to refuse admission to part or all of the product offered for importation.
