Whistleblower Dinesh Thakur takes pharma regulators to court

Pharma crusader Dinesh Thakur who received nearly $48 million in whistleblower award from the United States for exposing dangerous practices of generic drug maker Ranbaxy Laboratories that led to a $500 million fine by US regulators on the Indian drug major, is now taking India's drug regulators to court for failing to enforce rules on drug safety in the $15 billion industry.

Thakur has now filed a public interest litigation (PIL) in the Supreme Court, alleging that responses provided to him by government show how lax regulation can lead to potentially harmful medicines being sold in India without proper approvals.

Thakur says the responses he obtained show that the Central Drugs Standard Control Organisation (CDSCO) and the health ministry have still not adequately investigated and prosecuted those breaches, despite saying they would.

"An overwhelming number of non-standard-quality drugs are not prosecuted in criminal cases, since state drug controllers only impose minor administrative penalties on the offenders," Thakur says in the lawsuit, citing government data.

Neither the health ministry nor the has responded to Thakur's allegations on the penalty policy.

The suit is listed it for hearing on Friday.

It was Thakur's revelations in 2013 on the dangerous practices of drug manufacturing in India's generic drugs industry that led to the FDA action against Ranbaxy for violating federal drug safety laws and making false statements.

Dinesh Thakur made his name as a whistleblower three years ago when he 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.

Ranbaxy had then said the fine marked the resolution of past issues and it continued to make safe, effective and quality medicines.

Thakur's latest suit, which names the health ministry, the Drugs Consultative Committee and the Central Drugs Standard Control Organisation as respondents, would not result in penalties or rewards for the whistleblower, but is intended to help evolve a framework for the recall of drugs and improve the process of drug approvals.