Ranbaxy falsified drug data for years — a $500M fine and the end of an Indian pharma giant

Ranbaxy Laboratories was India's largest pharmaceutical company, known for manufacturing affordable generic drugs for global markets. In the mid-2000s, whistleblowers inside the company revealed that Ranbaxy was systematically falsifying data in drug applications to the US FDA. The company's plants manufactured adulterated drugs, retested failed materials to produce acceptable results, and failed to investigate reports of harmful side effects.

Whistleblowers Rajinder Kumar, director of R&D, and Dinesh Thakur, director of Research Information, exposed the fraud. Kumar resigned after the board refused to recall drugs approved using fraudulent testing. Thakur resigned after the company tried to plant pornography on his computer to justify firing him. Their reports prompted the FDA to issue an Import Alert in September 2008, banning drugs from two Ranbaxy plants.

In May 2013, Ranbaxy pleaded guilty to three felony violations of the Federal Food, Drug, and Cosmetic Act and four felony counts of knowingly making false statements to the FDA. The company paid $500 million in fines. CEO Malvinder Mohan Singh was fired in May 2009.

In 2014, Sun Pharmaceutical acquired Ranbaxy for $4 billion, ending its existence as an independent company. In 2016, the Singapore International Court of Arbitration ordered former Ranbaxy shareholders to pay $525 million to Daiichi Sankyo for intentionally misleading the Japanese company during its 2008 acquisition. The scandal became a landmark case for pharmaceutical data integrity and regulatory compliance.