Ranbaxy Laboratories "systemically violated" good manufacturing practices, says the whisteblower whose alert led to a US probe, a day after India's top drugmaker agreed to pay a hefty USD 500 million to settle charges over its adulterated drugs.
The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India and included acne drug Sotret, epilepsy and nerve pain drug gabapentin and antibiotic ciprofloxacin.
"Eight years ago, as the Director of Project and Information Management at Ranbaxy, I discovered that the company falsified drug data and systemically violated current good manufacturing practices and good laboratory practices," Dinesh Thakur, a former Ranbaxy executive who is settled in US now, said in a statement.
When Ranbaxy failed to correct problems, he alerted healthcare authorities.
The Generic drugmaker pleaded guilty yesterday to felony charges related to drug safety and will pay USD 500 million in civil and criminal fines under the settlement agreement with the US Department of Justice.
Thakur, of Belle Mead, New Jersey, will receive USD 48.6 million from the USD 500 million that Ranbaxy agreed to pay to settle allegations that the company sold adulterated drugs manufactured at its Paonta Sahib and Dewas plants.
"This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless where they are manufactured," Thakur said. "I am relieved that the government's investigation has concluded."
The settlement is its largest-ever with a generic drugmaker over drug safety, according to the US government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.
Ranbaxy USA pleaded guilty to three felony counts under the Food, Drug and Cosmetic Act -- which prohibits adulterated drugs -- and four felony counts of knowingly making material false statements to the US Food and Drug Administration.
