Ranbaxy and Parexel Charged with Data Fraud

PharmaManufacturing.com
07/14/2008

The US government has filed suit in the District Court of Maryland against India’s largest drug manufacturer, Ranbaxy Laboratories, and its US-based consultant Parexel Consulting, alleging that the two systematically hid and falsified data related to an investigation of what the government has deemed “substandard” drugs sold in the US. The investigation stems from a 2006 FDA probe, which held that Ranbaxy had failed to maintain adequate quality control systems and records in its Paonta Sahib plant in the Indian state of Himachal Pradesh.

The action comes at a time when Japanese drug-maker Daiichi Sankyo has expressed its desire to acquire a majority stake in Ranbaxy. Daiichi has said publicly that the US investigation will not affect the proposed deal.

The suit follows government requests for the company to provide full data related to its record-keeping practices at the plant, and a Valentine’s Day 2007 raid of Ranbaxy’s Plainsboro, New Jersey headquarters and New Brunswick, New Jersey manufacturing facility by US officials.

The US Department of Justice is investigating whether Ranbaxy committed “contract fraud and submitted false claims to Federal health benefit programmes, fabricated bio-equivalence and stability data (necessary to prove efficacy of a drug) to support marketing applications filed with the US drug regulator for selling generic drugs in the US and for supply of generic HIV/AIDS drugs under the US President’s Emergency Plan for AIDS Relief (PEPFAR).” Ranbaxy has denied all wrongdoing and its preparing an official response to the suit.

The trouble for Ranbaxy follows news in June that the company had settled ongoing patent disputes with Pfizer, Inc. related to the introduction of a generic version of Lipitor (atorvastatin) into the US market.