EU & Competition news

Indian pharmaceutical firm Ranbaxy celebrated the decision at Southwark Crown Court to quash the prosecution of its UK subsidiary, Ranbaxy (UK) Limited by the Serious Fraud Office but may face investigation by the US Department of Justice (DoJ) for an alleged fraud that allowed "adulterated and misbranded" medicines to be sold in the United States.

Ranbaxy claimed that in 2006 the SFO launched a prosecution of the firm following accusations of anti-competitive conduct in connection with the supply of penicillin-based anti-biotics sold to the National Health Service (NHS). It was alleged that the practice had cost the NHS an estimated £40m. Southwark Crown Court declined an application by the SFO for permission to appeal to the English Court of Appeal, although the SFO retains a right to appeal to the Court of Appeal directly.

Ranbaxy said that it is, “a responsible company committed to providing high quality generic medicines at affordable prices to its customers and patients throughout the world”.

In the DoJ papers, filed in a US District Court in Maryland, it was claimed that evidence exists to show that Ranbaxy used active pharmaceutical ingredients from unapproved sources resulting in the sale of sub-potent, super-potent and adulterated medicines. It was also alleged that test-data used to show that the medicines had met US standards had been fabricated.

In a statement Ranbaxy said that it strongly denies the allegations contained in the motion and that it continued to cooperate with the DoJ regarding the investigation and had agreed to produce the specific documents sought. Ranbaxy said that the investigation had been underway for three years and that no charges had been filed against the company. A spokesman said that the US Food and Drug Administration had gathered over 200 random samples of various products marketed by the company in the US that had been found comply with all the specifications.

Ranbaxy reacted to speculation that the company’s agreement with Daiichi Sankyo may fall through following the DoJ investigation by saying the deal “is binding and final and remains on track”.

This material first published by the LexisNexis Butterworths. All rights reserved.