A month ago, I posted on the Ranbaxy drug scandal – a shocking tale of systematic fraud by one of the world’s leading manufacturers of generic drugs. After the US regulator had used a whistle blower to bring the company to some kind of justice, I wondered what regulators in other countries were doing to protect themselves from medicines that were being manufactured without any proper safeguard.
Now, thanks to the Telegraph, we have an answer for the UK. And it’s a depressing one, with the regulator repeatedly ignoring emails from Dinesh Thakur, the executive who had seen at first hand that “lying to regulators and backdating and forgery were commonplace.”
In November 2005, he wrote: “The reason I am writing to you is to alert you that Ranbaxy is defrauding the UK government and the British public and hoping that [you] would be able to do something to stop this crime.”
He also urged the MHRA to contact the FDA’s chief investigator, who he said would be able to verify his claims.
In reply, he was thanked for “bringing this matter to our attention”.
A day later, he warned of “widespread and pervasive wrongdoing at Ranbaxy” and said he could put the MHRA in touch with a former executive at the company who could provide more evidence.
He hoped the MHRA would take action against the company which “has committed so many crimes to make a quick buck”. He wrote: “Given the past experience with this company, I am afraid that they are quite adept at the art of covering up their fraudulent practices and your inspections may or may not provide you with the conclusive evidence you seek.”
In the first half of 2006, Mr Thakur received a reply from an MHRA official that they were “evaluating data supplied to us from other regulators regarding recent inspections … I can assure you that appropriate action will be taken where necessary”.
Mr Thakur made a final attempt to rouse the agency in February 2007. “I wish the MHRA was as vigilant and protective of public health in the UK as the US FDA is in the USA,” he wrote.
As I suggested in my original post, someone should now follow up with the company’s British ex-CEO, Dr Brian Tempest, now chair of the advisory board of Lancaster University Management School, and too busy to speak to reporters in the superb Fortune story that first exposed this sorry tale.