Pharma crusader takes India's drug regulators to court

Dinesh Thakur's fresh case, a Public Interest Litigation (PIL) suit, is listed on the Supreme Court website for hearing on Friday.

New Delhi: One of India’s best-known 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 USD 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 his name, and almost USD 48 million as a whistleblower award from the United States, when US regulators fined Ranbaxy USD 500 million for violating federal drug safety laws and making false statements to the Food and Drug Administration (FDA).

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

The head of the CDSCO, GN Singh, said: “We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic... I don`t have any comment on this guy."

The other named parties did not respond to requests for comment.

Thakur, who said there was no financial motive for the suit, spent much of 2015 working with lawyers to file more than 100 public information requests on how state and central drug authorities had responded to cases where rules had been broken, some of which first came to light five years ago.

Thakur says the responses he obtained show 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.

The health ministry and CDSCO did not respond to requests for comment on its penalty policy.

NO INQUIRY

Thakur, who worked for Ranbaxy for two years from 2003 before turning whistleblower, is now chief executive of Florida-based MedAssure Global Compliance, which advises drug companies on quality and safety.

After the Ranbaxy settlement in the US in 2013, Thakur said the authorities in India did not contact him about it or probe the reasons for the fine, nor did they respond when he approached them through 2014.

The ministry and CDSCO did not respond to requests for comment on their response.

The Ranbaxy case prompted the FDA to increase inspections of Indian pharmaceutical plants. Products from 44 such plants are now banned for sale by overseas authorities but still sell in India.

Thakur`s suit refers to the case of Buclizine, a drug made by Belgian firm UCB but since sold to Mankind Pharma for marketing in India.

The CDSCO allowed UCB to sell Buclizine as an appetite stimulant in 2006, though it was not approved for that purpose in Belgium and banned in several other countries.

UCB was not asked for clinical studies, the parliamentary committee found.

UCB said it couldn`t answer current questions related to Buclizine but that it observed all regulatory, legal, quality and safety regulations.

The CDSCO website says its expert advisory committee found “no convincing literature to support the drug’s use as an appetite stimulant” in 2013 but agreed to give Mankind Pharma time to make a case for the drug.

Since then, Mankind Pharma Managing Director Sheetal Arora told Reuters it had received no official request for data to prove the safety and efficacy of the drug, which it was still selling.

The parliamentary committee demanded an investigation and the drugs regulator committed to one in 2013. Thakur received a statement from the health ministry last year, seen by Reuters, showing no inquiry had begun.

The regulator did not respond to requests for comment.