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 $15 billion (nearly Rs 1.01 lakh crore) 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 $48 million (nearly Rs 322.72 crore) as a whistleblower award from the United States when the US regulators fined Ranbaxy $500 million (nearly Rs 3,361.63 crore) 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 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.
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 has 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.
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 it is sold 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.
Case for whistleblowing law in India
The term `whistle-blowing' is a relatively recent entry into the vocabulary of public and corporate affairs, although the phenomenon itself is not new. It refers to the process by which insiders go public with their claims of malpractices by, or within, organisations - usually after failing to remedy the matters from the inside, and often at great personal risk to themselves. Sometimes the cost of such valiant efforts is just too high to pay.
Satyendra Dubey, was one of those rare young men who was completely and uncomplicatedly honest. He didn't know he was a hero. An engineer from Indian Institute of Technology, Kanpur and working for National Highway Authority of India probably never knew the word but died for simply doing the right thing. Gunned down by the mafia in Gaya on early November 27 morning, nearly a year after he had complained of corruption on the Golden Quadilateral project to the Prime Minister's office. Knowing the dangers that surround honest people bucking the whole corrupt system, in his letter, Dubey had requested that his name be kept secret, a request that wasn't honoured-the letter was sent from the PMO to the Ministry of Road, Transport and Highways and then to the National Highway Authority of India, with which Dubey was working as Deputy General Manager. His death speaks volumes about the growing nexus between politicians and mafia and also highlights the illegal procedures/ways involved in awarding contracts and also the allegedly fraudulent pre-qualification bids in connection to big development projects.
India has recently passed a federal Freedom of Information Bill in 2003 however it does not have a Whistleblowers Act recommended by the Constitution Review Commission in 2002. Moreover a draft bill on public disclosures recommended by the Law Commission lies in cold storage. Satyendra Dubey's death merits attention and a subsequent Public Interest Litigation urges the Supreme Court to direct the Centre to evolve a system to ensure protection to anybody who complains to the Government against corruption.
Corruption exists all over the world and thrives at all layers of government. Officers who refuse to enter the bandwagon are victimized. In India, the Tehelka expose involving defense deals had not only victimized the reporters involved in the undercover operation but also harassed virtually anybody associated with the portal. In this case, the owner of the Global capital who owned a share in the portal was imprisoned without any concrete charges framed against him. All this was due to the fact that the expose had caught some of the high ups in the ruling coalition taking bribes on camera! More recently, the Labour Government in England had found a scapegoat in Dr David Kelly who was considered a 'mole' in the Ministry of Defence inorder to draw public attention away from the Iraq war. He was named as the source of a disputed BBC report claiming the Downing Street had "sexed up" evidence of Iraqi weapons of mass destruction so as to drive the country into the war with Iraq.
The need and urgency of a whistleblowing act cannot be overemphasized even as Satyendra Dubey's death sparked off widespread public protest. Both in unlettered societies with meager resources as also in the developed world, there is an urgent need both for access to information by the public along with an act that would provide protection to all those who blew the whistle. It is time that the authorities took cognizance of the fact that money associated with development works that usually comes from the tax payers pocket lands up in corrupt hands. In the process development takes the back seat. India cannot afford to lose its money nor its resources. The real heroes of today's world are honest people. They are few and far between. They are the ones society is longing to follow. But everywhere it sees them fail. Yet the world, and developing countries especially cannot afford to loseits honest officers who stand up against all odds and risk their lives. It is time the government thinks about cleaning its system by providing protection to all those ordinary people who dares to bare open facts and has a stake at country's future. Mere assurance from the Prime Minister that the guilty wouldn't be spared is not enough---either to the citizens or to Dubey's family. If the government really means business it has to go about demonstrating that there are systems in place for good people to rely on. We need a fast and efficient judiciary to handover judgments in fair and impartial manner with or without political and social pressure, and a clean and unbiased police that will come to the aid of those working on the right side of the law; we also need public knowledge about the constitution and rule of law; and laws that will encourage people in both urban and rural areas to come forward without any fear to usher in an era of transparency, accountability and participation in the governance of the country. We need a system, a society where a person can do its duty without fear and the head held high. If the government really intends to deliver such a nation, then it is time the government pulled up its sleeves and makes concrete efforts to pass a whistleblowers act. It follows that no measure to curb government and corporate transgressions in India or elsewhere will bear fruit unless legal immunity and protection against retaliation is given to responsible and conscientious whistleblowing.
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