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Beware of ‘Made in India’ medicine

Dinesh Thakur | Updated on January 23, 2018 Published on August 12, 2015

Daunting standards: There's no escaping them

Instead of crying foul, Indian regulators should be examining the evidence and acting upon it

It’s the same old story. A foreign drug safety regulator identifies serious data integrity issues provided by an Indian company. Yet, instead of investigating the accusations in a transparent manner, the Centre predictably cries foul.

Regulators in the European Union ordered the prohibition of sale of about 700 drugs that received approval based on questionable clinical data supplied by GVK Biosciences of Hyderabad. In response, the government called off talks on a long pending free trade agreement with the EU.

Falsifying data

Undermining a treaty that could benefit millions of Indian consumers is worrying, especially when India has repeatedly turned a blind eye to the rampant problem of falsification of data. It is standard practice across the world to approve generic drugs on the basis of safety established by clinical research organisations (CROs) such as GVK Biosciences. In order to ensure that generic drugs are as effective as the innovator drug they copy, it is necessary for CROs to carry out some basic clinical tests on human subjects. Patient information like electrocardiograms (ECGs) provided by the CRO become a key criterion in the approval of such drugs. The European Medicines Agency (EMA) has said that during its inspections of GVK Biosciences, it found “systematic falsification of ECGs for an extended period of time”.

While it’s possible that the drugs which receive approvals based on these faked results are as effective as the others, how can one be sure? The Centre’s argument that no safety issues have been reported with any of the 700 drugs during post-marketing surveillance is beside the point. By this argument, no one has fallen sick after eating Maggi either, yet, the Food Safety and Standards Authority of India (FSSAI) thought fit to rightly raise concerns about the levels of lead found in their testing. Shouldn’t we apply the same standard consistently?

Here are some facts. GVK Biosciences has admitted that 2-10 per cent of the ECGs are suspect. Many of drugs on the banned list are manufactured in Europe for consumption in Europe.

In fact, Indian companies have said that the ban in Europe doesn’t have a material impact on their earnings . The Europeans have gone to great lengths to explain that their decision is based on scientific reasoning.

Isn’t it interesting that rather than respond to the European action based on scientific investigation, our commerce ministry links it with trade? How is this a trade issue if the Europeans don’t want their citizens to take medicines manufactured by European companies in Europe? Our response makes India look like a petulant child.

Safety protocols

The effectiveness of safety protocols is based on their uniform and consistent enforcement. Selective enforcement or post-facto reasoning undermine the very logic of establishing these safety protocols in the first place.

There is a tendency amongst Indian bureaucrats to address patient safety only when patients die. This is a dangerous attitude; the safety of the our drug supply is dependent upon ensuring data integrity and proper record-keeping. Together, these requirements help foster a culture of ethical business practices. It should be noted that Section 28A of the Drugs and Cosmetics Act penalises the failure to maintain proper records with a prison term and a fine. Ensuring data integrity is, therefore, not an American requirement — Indian policymakers clearly recognised the need for true and unvarnished data when they amended Indian law to include such a requirement. Why then is the Indian government so reluctant to enforce its own laws?

Perhaps the most troubling aspect is that this is not the first time India has experienced these problems. As the person responsible for prosecution of Ranbaxy for similar behaviour in a US court, I’m well aware of the rampant culture of data falsification within the Indian pharmaceutical industry. Ranbaxy accepted the allegations when it agreed to plead guilty to seven counts of criminal felony and pay $500 million in penalties. When my case became public, the then minister of health, Ghulam Nabi Azad, made a commitment to Parliament on August 23, 2013, that an investigation would be ordered into the functioning of Ranbaxy’s plants and their compliance with Indian law.

To date the Centre has not released the results of the investigation. I have not been asked to provide any input into the investigation. Was the minister’s statement in Parliament mere eye-wash or is this now a standard operating mechanism? After all, the government is yet to make public its finding into the allegations of data fraud at GVK Biosciences. It is several months now since the French and the German regulators made public their findings about GVK Biosciences, what is the Indian regulator waiting for?

Failure to crack the whip after Ranbaxy pleaded guilty meant that other manufacturers have continued with questionable manufacturing practices until caught by a foreign regulator. Isn’t it surprising that the US regulator has issued as many as 15 warning letters for data integrity since May 2013 to Indian manufacturers while India’s Central Drug Standard Control Organisation (CDSCO) hasn’t said a word? If the US and UK can test ‘Maggi’ because of health concerns raised in India by Indian regulators, why is it so difficult for Indian regulators to follow leads provided by their western counterparts especially when the same manufacturing plants supply to the Indian market?

Lobby power

Part of the problem lies in the lobbying power of the Indian pharmaceutical industry and the impotence of our drug regulators. In its 59th report, the parliamentary standing committee on health and family welfare spoke of an “invisible hand”, of questionable approvals and missing files, but little came of it. In 2013 when the ministry of health and family welfare tried introducing a new Bill in Parliament to revamp drug regulation in India, the department of commerce objected to several clauses on behalf of the drug industry. Apparently, tighter regulation would make the industry less profitable. And therein lies the crux of the problem.

The capitulation of the Indian drug regulator to the interests of the pharmaceutical industry is now complete. The parliamentary standing committee arrived at this conclusion when it noted “that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured”.

With the diminishing credibility of the Indian pharmaceutical industry, policymakers in the US and EU will and have enacted their own measures to ensure the safety of their citizens. These measures will undoubtedly reduce profits of the Indian industry and if the Centre continues to parrot the industry’s verse, the writing for the industry will be on the wall. No amount of sabre-rattling and trade threats from India will scare the West, the largest market for Indian pharmaceutical companies, into subjecting its citizens to questionable Indian medicine. Shouldn’t Indian citizens expect the same from their own government?

The writer is the executive chairman of Medassure Global Compliance Corporation and was the whistleblower against Ranbaxy Laboratories

Published on August 12, 2015
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