In 2007, whistleblower Dinesh Thakur alerted the U.S. Food and Drug Administration to serious quality-control problems at Ranbaxy Laboratories, prompting a criminal investigation. On February 25, 2009, the FDA said it had halted reviews of all drug applications from India after identifying falsification of data and test results in approved and pending applications. The case exposed failures in manufacturing oversight and the reliability of clinical information used to approve generic medicines.
In May 2013, Ranbaxy pleaded guilty to felony charges involving the manufacture and distribution of adulterated drugs and misrepresentation of clinical generic-drug data, paying $500 million in fines. Thakur and lawyer Prashant Reddy later documented the episode in the 2022 book The Truth Pill, which argued that weak Indian regulatory enforcement and limited transparency allowed dangerous practices to persist. The book also describes deaths linked to pharmaceutical malpractice, including 12 children in Jammu and Kashmir who died after consuming cough syrup containing diethylene glycol, underscoring the human cost of inadequate drug controls.