Former Ranbaxy executive Dinesh Thakur told CBS news in a recent interview that when he asked his by his boss to uncover the possiblility of fraud at his company, he found disturbing issues relating to data that is required by the Food and Drug Administration (FDA) going as far back as 2004. The company has since changed ownership but the Ranbaxy “nightmare” still haunts Dinesh Thakur.
Over eighty percent of drugs distributed to Americans are generics and most of them are manufactured in India. Leading manufacturer Ranbaxy is among them and Thakur alleged that Ranbaxy often did not report the data required by the FDA.
In an equally disturbing revelation, Ranbaxy was banned by the FDA from selling its drugs in the United States and while banned from exporting from India to the US, Ranbaxy was still able to get its drugs sold in the US from US-based Indian Plants in 2011 according to Thakur. As far back as 2005, Thakur suggested that there was no efficacy in drugs manufactured by Ranbaxy for AIDS, heart problems and infections indeed his own son was prescribed an antibiotic for fever and Thakur insists that his son showed no improvement. He said this further led to his investigations.
Thukur told CBS News , “The data’s important because the FDA or other agencies globally look at that information to give you marketing authorization to sell the drug. We started getting the files, and, lo and behold, we find that none of that exists in the first place. … It means that we’ve gotten approvals from the FDA to sell drugs that were based on no data, or data that was fraudulent.”Thakur took the position to blow the whistle on Ranbaxy in 2005 to the FDA with the FDA finally concluding that 1600 data errors existed along with a “persistent pattern of submitting “untrue statements.” The FDA decision held that Ranbaxy’s drugs were “potentially unsafe and illegal to sell.”
According to the CBS report, in 2011 while one department of the FDA was investigating Ranbaxy for serious criminal violations, another arm of the FDA was approving the company for the exclusive rights to make the generic version of one of the most popular pharmaceuticals of all time: Lipitor , a decision by the FDA that reportedly earned the company $600 million in the first six months. The FDA maintained, however, that Lipitor did meet FDA requirements and standards.
Thakur’s whistleblowing led to Ranbaxy pleading guilty to seven felony charges and Thakur was awarded US$49 million by a US Court. The company has since been bought by a new Japanese company who have invested heavily in plant training, upgrades and full compliance.
