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

FDA investigator Peter Baker relocated to India to work for the FDA’s offices there. In 2012, he and another agent were tasked with inspecting one of Ranbaxy’s plants after the company recalled some of its drugs due to an incident that left shards of glass in the pills.

During the investigation, Baker and his colleague were diligent, but he feared that the company would go on to resell the products that were contaminated with glass. This experience made him resolve to be even stricter during his next inspections.

In 2013, Baker inspected a German-owned plant in India. He combed through data in computers in the quality control laboratory and found that the company was illegally conducting offline tests. He had “uncovered the outlines of a secondary manufacturing operation hidden beneath the surface of the first” (300-01). The parent company had not realized that this was happening. Baker learned to look for non-networked computers to uncover similar fraudulent activities at other companies.

The Ranbaxy case strained the lives of those who worked on it, including Debbie Robertson, Andrew Beato, and Thakur. In 2011, Robertson decided to retire.

In 2013, a judge approved the Ranbaxy settlement. The company settled for $500 million and none of Ranbaxy’s executives were held criminally responsible.