The Hindu Business Line : Ranbaxy refutes allegations by US Govt

The bitter pill
The US Department of Justice alleged that Ranbaxy submitted false and fabricated information to the USFDA
Ranbaxy earns 25 per cent of revenues from US market

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New Delhi, July 14 Ranbaxy Laboratories Ltd on Monday refuted the allegations contained in the motion filed by the US Department of Justice (DOJ) that the company submitted false and fabricated information about its generic drugs to the US Food and Drug Administration.

“No legal proceedings in the sense of a prosecution have been initiated. The company continues to cooperate with the DOJ in regards to the investigation and has agreed to produce the specific documents sought by the Motion. Ranbaxy will be filing a response today in the US District Court for The District of Maryland and will strongly defend its position,” Ranbaxy said in a statement.

“The company would like to state that an investigation has been underway for approximately three years and no charges have been filed against the company. The FDA has also gathered over 200 random samples of various products marketed by the company in the US. These products have been independently tested by the USFDA and were found to be complying with all the specifications. Under these circumstances the company finds that the allegations are baseless,” it added.

Ranbaxy said that its business in the US continues as normal. “Ranbaxy remains committed to providing high quality generic medicines at affordable prices to its customers and patients in the United States. Ranbaxy also clarifies that the company’s deal with Daiichi Sankyo is binding and final and remains on track,” the statement said.

Earlier the US Department of Justice alleged that Ranbaxy submitted false and fabricated information to the USFDA. It said that allegations from reliable sources and supporting documents indicate a pattern of systemic fraudulent conduct by Ranbaxy. It further said the submissions contained false and fabricated information about stability and bioequivalence of drugs, failure to timely report the distribution of drugs that were out of specifications, and attempts to conceal violations of Good Manufacturing Practise (GMP) regulations. The DOJ alleged that Ranbaxy has used active pharmaceutical ingredients (API) from unapproved sources in its drugs.

If the allegations are proved right then it could be a huge blow to Ranbaxy, which earns nearly 25 per cent of its revenues from the US market. Pharmaceutical market watchers said that this could dilute India’s reputation in the generic space.

Ranbaxy ran into rough weather with the US authorities in 2006 when an inspection was conducted on the company’s drug product manufacturing facility in Poanta Sahib on February 2006. Later on February 14, 2007, federal agents executed search warrants at Ranbaxy facilities in New Jersey.

Ranbaxy’s shares closed nearly 11 per cent down on the NSE today at Rs 475.30.