Ranbaxy probe on data forging reaches US court

By Phil Taylor

- Last updated on GMT

Related tags: Fda, Generic drug, Daiichi sankyo

The US Food and Drug Administration has resorted to a legal
challenge against India's Ranbaxy Laboratories in an ongoing
investigation into the sale of substandard drugs.

The motion, which seeks to gain access to documents the FDA believes are pertinent to its enquiry, has been filed in the district court of Maryland. According to documents filed with the court the FDA is looking into whether Ranbaxy was involved in forging data to make it seem that products were in compliance with US regulatory standards. Ranbaxy has been quick to point out that the court has not yet started any legal proceedings, and it remains to be seen if the motion seeking access to the documents will be upheld. The company stands behind the quality of its medicines and refutes the "baseless​" allegations in a press statement released July 14. "An investigation has been underway for approximately three years and no charges have been filed against the company​," it said. "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 FDA and were found to be complying with all the specifications​," it added. The allegations, reported by the Star Ledger and other newspapers in the US and India, include that Ranbaxy drugs made at a facility in Paonta Sahib, India, had too little or too much active pharmaceutical ingredient (API) and did not meet quality standards for factors such as shelf life. Ranbaxy's US headquarters in Plainsboro, New Jersey, and a manufacturing facility in New Brunswick were raided by the FDA's Office of Criminal Investigations in February 2007. Later in the same year the company initiated a recall of 73 million gabapentin tablets - an epilepsy treatment - after it was discovered that impurity levels exceeded acceptable levels. In June 2006 the FDA sent a warning letter addressed to Ramesh Parekh, vice president, manufacturing at Ranbaxy Laboratories Ltd, citing a number of deficiencies including a "failure to retain analytical raw data, undocumented stability sample test intervals​," and "inadequate staffing and resources in the stability laboratory​." The letter also cited FDA concerns with "discarded data​" in certain standard operating procedures and asked for additional stability to be provided for various generic products for which Abbreviated New Drug Applications (ANDAs) had been filed in the US. According to the court papers, the US federal agency is seeking to force Ranbaxy to turn over an internal review of its manufacturing operations in India carried out by Parexel Consulting, on the grounds that "the government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products​" into the US. Ranbaxy has said it has agreed to produce the specific documents sought by the motion, and would file a response in the court that will "strongly defend its position.​". Daiichi Sankyo deal "on track" ​ Meanwhile, the probe has prompted speculation that the ongoing sale of a majority stake in Ranbaxy to Japanese drugmaker Daiichi Sankyo, valued at $3.4bn to $4.6bn, remains unaffected by the development. That deal "is binding and final and remains on track," according to the Indian firm, a viewpoint that was corroborated by a spokesperson for Daiichi Sankyo.

Related topics: Markets & Regulations

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