In 2013, Altaf Lal was appointed head of the India outpost of the FDA. Under Lal, the FDA started conducting unannounced inspections, which were much more effective than previously scheduled inspections. Lal also started to scrutinize inspectors like Mike Gavini, who seemed to have overly close relationships with the companies they inspected. Lal noticed that some inspectors seemed to receive material benefits from the companies they were supposed to regulate.

In 2014, Lal was removed from his post. Meanwhile, Baker, who was suffering under the pressure of his investigations, was diagnosed with post-traumatic stress disorder.

Thakur tried to contact people within India’s government in an effort to reform the drug industry. He was met with silence and resistance. In his crusade, he joined forces with other advocates, such as Dr. Harry Lever and Joe Graedon. They started a group called the Safe Medicines Coalition, and together, they worked to raise awareness about the problems in the generic drug industry. Their message was not well-received, since the American public was concerned with the rising cost of branded drugs.

Thakur believed that India needed to overhaul its drug regulation laws. He decided to sue India. Throughout 2015, he built a case against the country.