Ranbaxy Laboratories

During 2004–2005, Dinesh Thakur and Rajinder Kumar, two Indian employees of Ranbaxy, blew the whistle on Ranbaxy's fabrication of drug test reports. Thakur's office computer was soon found to have been compromised. Ranbaxy then accused Thakur of visiting pornographic sites using his office computer, forcing him to resign in 2005. Thakur left India for the United States and contacted the Food and Drug Administration (FDA), which started investigating his claims.[17] As a result, on 16 September 2008, the Food and Drug Administration issued two warning letters to Ranbaxy Laboratories Ltd. and an Import Alert for generic drugs produced by two manufacturing plants in India.[18]

By 25 February 2009, the FDA said it had halted reviews of all drug applications, including data developed at Ranbaxy's Paonta Sahib plant in India, because of a practice of falsified data and test results in approved and pending drug applications.[19]

On 8 February 2012, three batches of the proton-pump inhibitor Pantoprazole were recalled in the Netherlands due to the presence of impurities.[20]

On 9 November 2012, Ranbaxy halted production and recalled 41 lots of atorvastatin due to glass particles being found in some bottles.[21][22] Also in 2012, an apparent dosage mistake was reported in which 20 mg tablets were found in a bottle of atorvastatin labeled as containing 10 mg tablets; this led in 2014 to the voluntary recall in the United States of some 64,000 bottles.[23]

In May 2013, Ranbaxy pleaded guilty and paid $500 million in fines,[24] for felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India, and misrepresenting clinical generic drug data.[25][26] Ranbaxy pleaded guilty to three felony FDCA counts, and four felony counts of knowingly making materially false statements to the FDA. Included in the adulterated products were antiretroviral (ARV) drugs destined for treatment of HIV/AIDS in Africa.[17]

In September 2013, further problems were reported, including apparent human hair in a tablet, oil spots on other tablets, toilet facilities without running water, and a failure to instruct employees to wash their hands after using the toilet.[27][28] Ranbaxy was prohibited from manufacturing FDA-regulated drugs at the Mohali facility until it complied with United States drug manufacturing requirements.[29]

In 2014, The FDA notified Ranbaxy Laboratories, Ltd., that it was prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The FDA's inspection of the Toansa facility, which concluded on 11 January 2014, identified significant CGMP violations. These included Toansa staff retesting raw materials, intermediate drug products, and finished API after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures.[30][31]

In 2019 author Katherine Eban published Bottle of Lies,[32][33] an in-depth investigation of Ranbaxy. In addition to the incidents described above, Eban describes internal struggles within the FDA as investigators who might have shut down Ranbaxy were overruled due to pressure to increase the supply of cheap generic drugs.

• The Truth Pill

• Ranbaxy: Official site (archived)