The Hindu Business Line : We’re committed to high quality generics: Ranbaxy

New Delhi, July 15 Ranbaxy Laboratories Ltd has told the United States Department of Justice that it was committed to developing and marketing high quality generic drug products and it will demonstrate that no data manipulation or dishonest method were adopted by the company. The response is in the wake of an investigation by the US DOJ against Ranbaxy for allegedly following submitting wrong information with the US Food and Drugs Administration.

In an eight-page response filed in the US district court for the district of Maryland, Ranbaxy said, “Ranbaxy is in the process of producing requested supporting documentation for its ANDA applications to DOJ and believes that the requested documentation will demonstrate that no data manipulation fraud, or dishonesty occurred in those applications.”

Ranbaxy also said the US Government’s requests for voluntary audits conducted at the request of counsel were bad policy. “Ranbaxy’s counsel explained to DOJ that, if drug manufacturers learned that the government would force them to disclose the results of voluntary audits to help build civil or criminal cases, companies would stop doing audits, or would stop hiring tough auditors like PAREXEL and instead hire auditors who would be less likely to be tough and thorough.” PAREXEL is Ranbaxy’s auditors.

In its submission, the pharmaceutical company said that it had repeatedly requested that the government share the details of its concerns, so that Ranbaxy can assist the government in determining whether any problem exists. “In the absence of such details from DOJ, Ranbaxy is not aware of any previously unreported problems with respect to any of the allegations in the government’s motion papers. Ranbaxy knows that FDA collected over 200 samples of Ranbaxy products and believes that FDA’s testing these samples did not uncover any product failures,” Ranbaxy 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. FDA.

The DOJ alleged that Ranbaxy has used active pharmaceutical ingredients (API) from unapproved sources in its drugs.

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Ranbaxy: Uncertainty about USFDA investigation

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