Pharma crusader Dinesh Thakur takes drug regulators to court
NEW DELHI: One of India’s bestknown whistleblowers, who exposed dangerous practices in the generic drug industry in 2013, is taking the country’s drugs regulators to court, accusing them of failing to enforce rules on drug safety in the $15-billion industry.
Three years ago, Dinesh Thakur exposed how India’s then largest drugmaker and his former employer, Ranbaxy Laboratories, failed to conduct proper safety and quality tests on drugs and lied to regulators about its procedures.
He made almost $48 million as a whistleblower award from the US, when American regulators fined Ranbaxy $500 million for violating federal drug safety laws and making false statements to the Food and Drug Administration.
Ranbaxy said the fine marked the resolution of past issues and it continued to make safe, effec- tive and quality medicines.
T hakur i s now CEO of Florida-based MedAssure Global Compliance, which advises drug companies on quality and safety.
Thakur’s fresh case, a Public Interest Litigation (PIL) suit, is listed on the Supreme Court website for hearing on Friday. It alleges that responses provided to him by the government show how lax regulation can lead to potentially harmful medicines being sold in India without proper approvals.
The suit, which names as respondents the health ministry, the Drugs Consultative Committee and the Central Drugs Standard Control Organisation (CDSCO), would not result in penalties but sets as objectives the creation of a framework for the recall of drugs and a commission to examine faulty drug approvals.
“We welcome whistleblowers, but their intentions should be genuine, should be nationalistic.”
The other parties did not respond to requests for comment.
Thakur, who spent much of 2015 working with lawyers to file more than 100 public information requests on how drug authorities had responded to cases where rules had been broken, said the responses he obtained show the CDSCO and the health ministry have still not adequately investigated and prosecuted those breaches, despite saying they would.