ʹֽ Our pharma regulator must wake up - The Hindu BusinessLine

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          Opinion

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          Dinesh Thakur | Updated on January 30, 2020 Published on January 30, 2020

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          It has been reported recently in the Indian press that the Drug Controller General of India (DCGI) has termed Katherine Eban’s recent exposé of the Indian pharmaceutical industry in her book Bottle of Lies as a ‘fiction filled’ account of the Indian industry.

          For the record, Eban’s book has made it to the prestigious best-seller list of the The New York Times and is based on reams of government documents and industry accounts, including my testimony as a whistle-blower in the Ranbaxy case. None of the companies named in the book has denied any of the allegations. Like any good author, Eban’s book is tediously referenced and each allegation and statement can be verified by anybody who bothers to trace the sources cited by her.

          To term such a book as a ‘fiction filled’ account is disingenuous at best, especially by a regulator who in 2014 was described by the present Health Minister as a “snake-pit of vested interests”. A few years earlier in 2012, the Parliamentary Standing Committee on Health accused the Central Drug Standards Control Organisation (CDSCO), which is headed by the DCGI, of “insolent” conduct and categorically stated that there was a “collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts”.

          The same report also concluded that “it is difficult to believe that these irregularities on the part of CDSCO were merely due to oversight or unintentional. Hence all the cases listed above and cases similar to these should be investigated and responsibility fixed and action taken against erring officials whether currently in service or retired.”

          The report of the inquiry committee set up under Dr Mohapatra to investigate some particularly suspicious drug approvals (whose files went missing) have never been published and the Health Ministry is doing all it can do to not disclose the report of the committee in a lawsuit that I have filed before the Delhi High Court.

          There have been other inquiries ordered by the DCGI almost a decade ago into deaths and malpractices at clinical research organisations (CROs). Once again, this report never saw the light of day.

          To be fair, the DCGI has learnt its lessons from the best. In the immediate aftermath of the extensive news coverage about the guilty plea entered into by Ranbaxy with the US Department of Justice which resulted in a penalty of $500 million on the company, the Commerce Ministry of India actually put out a statement blaming “vested interests” for “raking up isolated issues” while the Health Ministry had actually ordered a probe into Ranbaxy (characteristically, this report too has not been published till date).

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          Many prominent public health activists toed the government line, blaming the Indian industry’s foreign competitors for undermining the faith in the quality of medicine produced by the Indian pharmaceutical industry. If this was a response to a guilty plea by Ranbaxy, one can only imagine what it would have been if Ranbaxy lost the case after a fight in the court.

          It is of no surprise that economic nationalism won the day and that nobody in government or civil society was ever serious about a transparent investigation into the fraud against patients at Ranbaxy. After all, public health in India has always been a secondary concern whenever the fortunes of pharmaceutical companies are involved.

          This ‘head in the sand’ behaviour by policymakers in India has hurt the Indian industry. An estimated 44 per cent of manufacturing facilities in India that export to the US have been cited for what are called “data integrity violations “ and approximately 24 per cent of Indian manufacturing plants were cited for data manipulation by the USFDA post the Ranbaxy case until now. Many of them were prohibited from exporting to the US. Let that sink in.

          These figures are for compliance with the regulations which are considered the most stringent in the world. And then ask yourself what confidence do we have that these companies do not indulge in such behaviour when making medicine for the Indian market whose regulator has been so colourfully described by the Parliamentary Standing Committee?

          Given that the US is still the most lucrative market for Indian pharmaceutical companies, the prohibition on exports pinched these companies in a significant manner. More significant than the financial losses was the gradual erosion of ‘trust’ that should concern anyone who speaks for the industry.

          In 2014, Vietnamese regulators prohibited 45 Indian companies from exporting to Vietnam because of quality concerns. In the same year, European regulators prohibited 700 drugs manufactured by several different companies, because of irregularities at a CRO in Hyderabad which was clearly fabricating safety data.

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          Trust lost is difficult to regain especially with Americans and Europeans who represent the most lucrative market for Indian pharmaceutical exports. While the Americans love a story of redemption, the Indian government has done little to improve the regulation of its own industry. As a result, post the guilty plea by Ranbaxy, the USFDA ramped up overseas inspections in India.

          In the coming months, the American Congress is going to be holding hearings on the findings of the Government Accountability Office’s (the equivalent of India’s Comptroller and Auditor General) investigation into the workings of the USFDA. Rest assured, American legislators are going to take steps to better regulate overseas manufacturing in India even if it adversely affects the competitiveness of Indian pharmaceutical companies. This debate in America is being fuelled in large part by Bottle of Lies. There are still several in power who recognise rigorous investigative journalism in that country.

          The fact that the Indian regulator is apparently in denial will be used by American critics of the Indian industry to bolster their demand for reducing the extent to which medicine consumed in America can be imported from developing countries like India with dysfunctional regulators. International trade rules would likely allow for such a law to protect public health and there is little India can do to prohibit such an outcome. This, will be the outcome of erosion of trust in the Indian regulator.

          A good first step to improve trust in the regulatory framework would be to announce an official study to suggest comprehensive reform of the DCGI and CDSCO and hope that the study report is made public unlike many such previous studies.

          The writer is a public health activist, and was whistleblower in the Ranbaxy case

          Published on January 30, 2020
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