BY VISHNU MAKHIJANI
New Delhi, American investigative journalist Katherine Eban pored over roughly 20,000 internal documents from the US FDA, including emails, memorandums, minutes of meetings and thousands of internal government records, as also replies under the Freedom of Information Act, to piece together a riveting and definitive account of how once storied Indian pharma major Ranbaxy blatantly cut corners - to improve its bottom line.
"I discovered that a cloud hovered over the company. American regulators were investigating whether Ranbaxy had fabricated quality data in order to gain approval to market its drugs. The allegations had first been made by a company whistleblower who had contacted the agency (FDA)," Eban, who travelled halfway across the globe as part of her
The whistleblower in question, says Eban, is Dinesh Thakur, then Ranbaxy's Director and Global Head of Research, Information and Portfolio Management, who, in 2004, put together a team to study a deadly secret he had come across: that the company was fudging data.
"Little by little, as the team members stitched together small bits of information, they stumbled into Ranbaxy's secret: the company
"Each member of
Noting that document forgery "was pervasive", the book says: "The company even forged its own standard operating procedures, which FDA investigators rely on to assess whether a company is following its own policies. In one instance, employees backdated documents and then artificially aged them in a steamy room overnight in an attempt to fool regulators during inspections", the book says.
Essentially, Ranbaxy's manufacturing standards "boiled down to whatever the company could get away with", the book says.
Thakur worked 14-hour days and after weeks of exhaustive research, brought his team's preliminary findings to his boss, Raj Kumar.
"Once Kumar heard from each member of
Predictably, there was no action as the findings "were not news to Ranbaxy's top executives", Eban writes in the book
"In the largest drug safety settlement to date with a generic drug manufacturer...
In this context, the book notes that the endorsement in November 2013 of Ranbaxy and other Indian pharma companies by former US President Bill Clinton for their efforts at producing low-cost generics had set the sales of the ARV drugs zooming.
In the midst of all this, Ranbaxy initially passed into the hands of Japan's Daiichi-Sankyo in November 2008 and was bought over in April 2014 by India's Sun Pharmaceutical.
In February, the Supreme Court asked the company's former owners, Malvinder Mohan Singh and his brother Shivinder to cough up the Rs 35 billion they owe to Daiichi Sankyo in compensation