Bottle of Lies: The Inside Story of the Generic Drug Boom

As the FDA prepared to serve a search warrant on Ranbaxy’s headquarters in New Jersey, Thakur provided the agency with detailed schematics and descriptions of the office.

On October 11, 2006, Debbie Robertson and two FDA colleagues met in person with Thakur for the first time. Thakur was nervous and said he feared for his family, given the way that whistleblowers were dealt with in India. Thakur knew that the Singh family had “hired thugs in previous disputes” (162).

In November 2006, Singh and other Ranbaxy executives met with FDA regulators. The FDA had frozen reviews of drug applications from Ranbaxy’s new plant, Paonta Sahib. Ranbaxy tried to convince the FDA that they should lift the freeze, and that the company wanted to be compliant.

Hernandez visited Paonta Sahib for an inspection a couple of months later. Though he found some evidence that the plant was still not compliant, he didn’t find anything that was definite proof of data manipulation or fraud.

On Valentine’s Day in 2007, the FDA raided Ranbaxy’s headquarters in Princeton, New Jersey. They seized about five terabytes of data, equivalent to “half the contents of the print collection of the Library of Congress”; among the documents was one marked “Do Not Give to FDA” (170).