After India-based pharmaceutical giant Ranbaxy pled guilty to seven felonies and agreed to cough up $500 million to U.S. authorities in May this year, information on wrongdoing within the company has continued to trickle out, including most recently compelling evidence that erstwhile CEO and billionaire owner Malvinder Singh was alerted to the fraud years ago.
In a recent series of news reports by CBS News here, the whistleblower in the case and former Ranbaxy Director Dinesh Thakur said that when his suspicions were initially raised and he set out to look for more data, he was met with resistance and “It was a lot of trying, like pulling teeth.”
In the case of at least 15 new generic drug applications, auditors were said to have found more than 1,600 data errors, implying that these drugs were “potentially unsafe and illegal to sell.”
The CBS reports also carried statements by Kathy Spreen, who was hired by Ranbaxy in 2004 to help the company comply with FDA regulations, who said that she became alarmed when inspecting bio-equivalence data for a Ranbaxy diabetes drug, because “The data from the generic and the brand were identical,” and “Any time you see perfect data, you’re probably looking at false data or inaccurate data or made-up data. I started asking, ‘I need the data. I need the initial raw data”.
However, Dr. Spreen said she could not get it, and went right to the top, to Malvinder Singh and when she did that, “He held my hand and he told me to just be patient and everything would be taken care of.” Yet nothing came of that promise.
Despite Ranbaxy’s felony charges earlier this year, a potential indicator of continuing malpractice came as recently as September when the FDA again issued an import alert against the company, this time on drugs made at its Mohali plant.