India-based drug manufacturer Ranbaxy has responded to whistleblower comments aired on U.S. television news channels, and said that the issues raised regarding substandard drug manufacturing processes and fraudulent data in reports given to the U.S. Food and Drug Administration were “historical in nature’’, and there have been “no incidents of any patients… adversely harmed.”
A week ago CBS news aired a series of reports regarding Ranbaxy, including comments by whistleblower and former Ranbaxy director Dinesh Thakur and former Ranbaxy advisor Kathy Spreen.
While Mr. Thakur, who is set to receive a payout from the $500 million fine that Ranbaxy agreed to cough up to U.S. authorities in a settlement, said that he was “dumbfounded’’ at the company’s “callous behaviour” in faking drug testing data, Dr. Spreen said that her attempts to bring the fraud to the attention of erstwhile Ranbaxy head and owner Malvinder Singh led nowhere.
The latter’s spokesperson declined to comment to The Hindu.
However, Ranbaxy has since posted its reaction to the CBS report arguing that, “comments were made about Ranbaxy’s current regulatory situation that [were] misinformed and misleading.”
Addressing some of the issues raised, Ranbaxy said that it “recognises and regrets that there may have been certain shortcomings in the past and appropriate measures have been taken to ensure they do not recur.” The company noted that an entirely new management team was in place.
Although Ranbaxy pled guilty to seven felony charges brought by the U.S. Department of Justice in May, and despite its manufacturing plants in Paonta Sahib and Dewas being subject to import restrictions or alerts, even as late as September yet another Ranbaxy facility, in Mohali, was found by the FDA to have made drugs with human hair or rubber particles in tablets and subjected to a similar import alert.