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ICMR Chief Lists 6 Reasons Why We Shouldn’t Use Molnupiravir for COVID

Vinod K. Paul also indicated issues with molnupiravir pertaining to the DCGI’s approval, and a request that the Subject Expert Committee had made.

This article was originally published on The Wire Science, our website dedicated to science, health and environment reportage and analysis. Follow, read and share.

New Delhi: The director-general of the Indian Council of Medical Research (ICMR), Balram Bhargava, took a strong stand against the use of the antiviral drug molnupiravir to treat COVID-19, at the Union health ministry’s press conference in Delhi on December 12.

This isn’t Bhargava’s first public opposition to the drug – he expressed issues with using molnupiravir at the last press conference as well – but this time he was clearer with the reasons for his position.

In December 2021, the Drug Controller General of India (DCGI) had considered and approved Merck’s application for molnupiravir in India. But Bhargava spelled out six reasons the drug won’t yet find a place in India’s official COVID-19 treatment guidelines, which ICMR sets out.

Molupiravir has certain risk(s) that warrant caution.
Experts present at a meeting of the National COVID-19 Task Force are of the opinion that there is rampant and irrational use of molnupiravir (in other countries).
Both its known and unknown harms outweigh its stated benefits.
Members of the same task force also reviewed the evidence currently available for molnupiravir and concluded, unanimously, that it shouldn’t be included in the national COVID-19 treatment guidelines.
As more evidence emerges about the use of molnupiravir, experts will continue to review it.
Molnupiravir’s current clinical window of application is too narrow – i.e. it can be used only among the elderly and among unvaccinated individuals with comorbidities. Experts haven’t observed any benefits among patients with diabetes and those who have recovered from COVID-19 and have been fully vaccinated.

Now, while the drug may not find a place in the treatment guidelines, its approval by the DCGI means pharmaceutical firms are free to manufacture and distribute it in the market. The principal limitation of not being included in ICMR guidelines is that government doctors can’t prescribe it.

According to Bhargava, the US drug regulator’s decision to approve the use of molnupiravir was based on only one trial in the US, with 1,433 participants. “Another trial was prematurely terminated for business reasons.”

He added that 12 clinical trials of molnupiravir have been registered in India, all yet to begin – implying that ICMR could change its mind based on their findings.

NITI Aayog member (health) Vinod K. Paul, who was also present at the press conference, said India’s stance on molnupiravir parallels those of Australia, Canada, Denmark and the UK, whose regulators have approved the drug but whose governments have left it out of their treatment guidelines.

Paul also said – related to point no. 6 of Bhargava’s list of reasons – that the US National Institutes of Health were using molnupiravir only among patients at high risk of getting severe COVID-19 or who had already been hospitalised.

According to him, DCGI had approved molnupiravir with similar conditions last year – but that it hasn’t placed any document in the public domain to this effect.

Also read: What We Know So Far About India’s Third Wave – and Why it’s a Mistake to Dismiss it as ‘Mild’

The Subject Expert Committee (SEC), of the Central Drug Standards Control Organisation, had recommended to the DCGI that the latter approve molnupiravir. It also asked the pharmaceutical firms that had applied for licences to manufacture molnupiravir in India to submit additional information to the DCGI:

The specific category of COVID-19 patients likely to receive the greatest benefit from the drug,
Details of their risk mitigation plan,
A factsheet for the drug’s contents, terms of administration and indications, and
A proposed package insert that specifies limitations in the drug’s use in non-technical language.

We don’t know if these manufacturers provided this information. The Wire Science checked the websites of at least three firms currently manufacturing molnupiravir and found no information pertaining to the SEC’s request. (For example, see this press release by Torrent Pharmaceuticals, another release by Cipla and this page on the Dr Reddy’s website.)

The Wire Science couldn’t verify if these firms were supplying the information with the packaged drug itself.

Testing and sequencing

While Bhargava and Paul were clear – for reasons that may or may not be borne out – about their position vis-à-vis molnupiravir, they couldn’t settle a bit of confusion that has arisen around testing. ICMR had previously recommended that the asymptomatic contacts of a confirmed COVID-19 patient wouldn’t have to get themselves tested.

Experts believed its rationale to be that in the event of a shortage, tests shouldn’t be ‘wasted’. However, on the January 12 presser, Bhargava unfolded a detailed presentation to convince his audience that the country wasn’t at all short on tests. His words were that test kits are “hugely and easily available”. Yet he still stuck to the position that asymptomatic contacts of a confirmed COVID-19 patient wouldn’t have to get tested – except if they were elderly, pregnant and/or had comorbidities.

The confusion arose from what he said next: that all contacts – symptomatic or asymptomatic – of a confirmed COVID-19 patient would have to quarantine themselves for at least one week.

The question is: since there is a surplus of test kits, why not test all contacts of a confirmed COVID-19 patient and quarantine only those who test positive – instead of advising against tests if one doesn’t have symptoms yet still push for a week’s quarantine?

Finally, government officials at the presser said the omicron variant appears to be rapidly replacing the delta variant as the dominant strain around the country: “In metros,” according to Paul, “it seems 80% of cases are due to the omicron variant,” Paul said. But he and his colleagues continued to remain opaque about the percentage of ‘positive’ samples in which genome-sequencing facilities have detected the omicron variant.

Trust in Government? Not With This Record, We Can’t

The standard practice of this government has been to ask people to trust it and give its decisions a chance – be it the note-ban, GST or the farm laws. When it comes to Covaxin, can we follow the same logic?

Those questioning the rushed approval of Covaxin, the COVID-19 vaccine indigenously developed by the Indian Council of Medical Research and Bharat Biotech, are being shamed. They are being asked not to bring politics into matters of science. A fervent plea is being made to trust the government as it would not be so crazy as to put the lives of its people in danger.

Even if we have a pathological aversion to the current regime, at least we should show some respect towards the Indian bureaucracy, doctors and scientists!

Akhilesh Yadav has been targeted and the Congress party criticised for questioning the government’s move to grant unduly speedy approval to Covaxin. Akhilesh Yadav might have put it clumsily but the substantial part of his refusal to accept the vaccine promoted by this government is being deliberately missed.

He is a political leader and he also represents the Indian people. He has every right to examine the decisions and policies of the government. Other political parties also have the right to put to test the claims of the government.

What is Akhilesh Yadav saying? He says that this government has shown that it takes decisions without following any kind of due process or taking into account their full implication for the concerned people. Many of these decisions – political, economic, social – have damaged the lives of citizens and hurt their interests. So, he finds it difficult to go by the word of the same government, especially in a matter of health.

The standard practice of this government has been to ask people to trust it and give its decisions a chance. It is repeating the same argument in the matter of farm laws. Give them two years and then we will see. Is Akhilesh not right to say that with this vaccine we cannot follow the same logic!

Also read: All You Need to Know About Bharat Biotech and Covaxin During the Pandemic

Government’s messaging around COVID-19

Since we are being asked to trust the scientists and those involved in researching the vaccine, why not pay attention to what Dr. Gagandeep Kang, one of India’s top vaccine science researchers is saying. She is not a politician, nor is she a compulsive critic of this government. She is a respected expert. When she, in her measured and professional way, says that she is confused by the claims and the decision regarding the vaccine, we need to take her seriously and ask questions to the government.

It is possible that the vaccine may ultimately turn out to be safe but that does not make the criticism redundant. It is about the casual approach of the government while dealing with life and death issues. The government includes the bureaucrats and scientists too who serve it.

It has become a habit to say that emergency situations demand emergency decisions. It gives a blank cheque to the government and turns it into an unaccountable master of the people.

Yes, ideally we should trust our administration, police, doctors and scientists. Ideally! Because it is assumed that they are answerable to the Constitution and their peers. They should be at an arm’s length from the government. But to get that respect you have to be like Dr. Fauci, who had the courage to tell the American people, that the claims of the US President on COVID-19 were wrong and this, while the President was in attendance.

But in India we read Dr. Anil Kumar claiming in a research paper that the COVID-19 pandemic would leave India by mid-September 2020. Dr. Kumar is no small fry. He is the deputy director general (public health), directorate general of health services of the ministry of health and family welfare. Should we not have trusted his word? After all, even if he was wrong, maybe he was only expressing his wish that India becomes free of the pandemic as early as possible!

Even before him was Dr. V.K. Paul, a respected health professional, and a member of the NITI Aayog. He made an astounding claim in April last year that in India the COVID-19 curve had been flattened. He assured people through an interview in the Indian Express that “the effect of the first three weeks of the nationwide lockdown was becoming clearly visible. India has succeeded in flattening the curve.” We know he was not right. All he was trying to do was to justify the severe lockdown.

Then appeared on the scene the ICMR. It startled us last year by setting 15 August as the deadline for the vaccine. When this caused an uproar within the scientific community in India and world at large, the ICMR rushed to modify its position to save its face. It said that it only intended to have the vaccine developed by 15 August which did not mean that it would be ready to be used.

A healthcare takes a swab from a migrant worker in Delhi August 17, 2020. Photo: Reuters/Adnan Abidi

The ICMR is a body of scientists. But its role has not been exemplary in the times of the current pandemic. The Indian way of dealing with authorities has ensured that it did not face the kind of criticism it would have faced had it been in some other country. It cared more for the masters than the masses, one must say.

What does it really mean when one hears that at least the government would not endanger the lives of its people? It was the health secretary who emphatically asserted that the Tablighi Jamaat was responsible for spreading the COVID-19 virus in India. Lav Agarwal, joint secretary of the health ministry, told the press, “The main reason for increased number of cases is that members of the Tablighi Jamaat have travelled across the country.”

The bureaucrats of the central government and Delhi government maintained a separate count for the COVID-19 infected who belonged to the Tablighi Jamaat, implying that they were the main source of spread of the virus in India. What did this do? Across India it put all Muslims at risk. They were attacked physically, at least two died, one of them by suicide. Muslims faced social boycott, it ruined their livelihood and alienated them socially. Who was responsible for it? Were not Muslims the people of this government?

Also read: India’s Vaccine Approvals Had One Problem. It Gave Rise to the Other Two.

Functioning in a monarchical way

When the government announced a complete lockdown with just four hours’ notice, we were asked by people like P. Chidambaram to fall in line, to be the soldiers of the commander-in-chief prime minister. It was said that he was doing it to save the lives of his people. As we know now that this decision which devastated the lives of lakhs of the migrant workers, over a hundred of whom died, did not help arrest the spread of COVID-19.

The state governments were left to deal with the fallout and implications of this decision but the central government had not even cared to consult them before taking such a monumental step.

Later, people called it cruel, insensitive as lakhs walked in intense heat and the government informed the court that all was well. The government stood aloof and kept watching as people died after obeying its orders.

Even before the pandemic, two “historical” decisions were taken by this government – demonetisation and introduction of the goods and services tax (GST) system. Both moves proved to be a curse for the masses, small businesses and independent entrepreneurs, and the government relished their plight. People have not been able to recover from these blows even now.

People standing in long queues to exchange their old Rs 500 and 1000 notes and withdraw cash from the ATM in New Delhi. Credit: PTI/Subhav Shukla/Files

Demonetisation caused a cash crunch lasting for about six months. Photo: PTI/Subhav Shukla/Files

Similarly, the enactment of the Citizenship Amendment Act (CAA) and the declaration of the National Register of Citizens (NRC) has made the lives of crores of people without the required documents uncertain and has put legally Muslims in an unequal situation in their own country. Does it endanger lives or not?

By downgrading the status of Jammu and Kashmir, its bifurcation and the reading down of Article 370, this government has made it very clear that it has little regard for the lives of the Kashmiri people, again, especially Muslims.

The most recent example of the monarchical way in which the government functions is the enactment of the three farm laws. Farmers see their complete ruin in these laws but the government claims that it knows best.

The demand for trust in our bureaucrats is laughable. They have shown that they see themselves as the servants of the government and not the people. How far they can go in serving their masters was revealed when the district magistrate (DM) of Hathras acted roguishly while first burning the body of the Dalit woman who had been gang-raped and murdered and then threatened her family members, pressurising them to withdraw their complaint.

The attitude of the bureaucracy in critical moments has always remained apathetic to the people, the weak, Dalits and Muslims. It is hostile to them, even treating them as ‘non-people’.

The poor DM is a lowly officer! What about those sitting in the Election Commission and Information Commission? What happened to the souls of those adorning the chairs in the NHRC? Why are the most powerful officers in the ED and NCB doing the hatchet job for this government? After all, they are the most powerful officers of India!

Then there are scientists. Those who fudge data, remain silent when the government is lying to the people are known as objective professionals and those who speak out are blamed for politicising science.

This government has always been cavalier in its politics and policies. It is dangerous to the people. People – if they have to be safe and alive, alive as humans – need to look at each and every move of this government with a critical if not suspicious eye.

How the Indian Government Helped Let GVK Biosciences Off the Hook

The commerce minister and the pharma industry lobby used smoke and mirrors to change the narrative

MoS for Commerce Nirmala Sitharaman with investors. Credit: PTI

Whenever a foreign regulator raises a red flag on compliance issues at an Indian pharmaceutical company, the standard response of the pharma industry, Drug Controller General of India (DCGI) GN Singh and the Ministry of Commerce has been to dismiss the findings either by questioning the competence and integrity of the foreign regulator, or by portraying them as puppets of the western pharmaceutical industry.

For example in my case, where Ranbaxy agreed to pay $500 million in fines and penalties in the US, the press release put out by the Commerce Ministry stated, “Government has strong reason to believe that some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries getting affected by the strength of Indian pharma industry.”

Such ad hominem attacks have been taken to an extreme in this latest case involving GVK Bio. Minister of State for Commerce & Industry Nirmala Sitharaman stuck her neck out to defend GVK Bio by announcing, on August 6, 2014, the suspension of the long pending talks on the Indo-EU Free Trade Agreement (FTA).

In her statement to Indian Express, she claimed that her decision was neither “unconsidered or an instant decision”. This is truly incredible because, according to a response received by my attorney under the RTI Act, the Government of India has not yet completed its investigation into GVK Bio. In his response dated October 26, 2015 — almost three months after Ms Sitharaman suspended scheduled talks on the FTA — the DCGI has stated that a copy of the investigation report into GVK Bio could not be provided since the investigation was not complete, and that under Section 8(1)(h) of the RTI Act, matters under investigation were exempt from the Act.

How then did Ms Sitharaman decide by August 6, 2014 that GVK Bio was in the right and the EU was in the wrong?

Even more surprisingly, in the same news report, the minister says: “What prompts the banning without even telling us the reason? After we decided to cancel the chief negotiators’ meeting, they sent a letter stating that this (the decision to ban) was a regulatory decision. This is not a regulatory issue; even if it were so, we deserve an explanation.”

Ms. Sitharaman’s claim is incorrect for two reasons. Firstly, the French regulator ANSM has made its detailed inspections reports of GVK Bio publicly available (I applied for and received copies of these from the agency). The preliminary inspection report dated July 18, 2014, of the investigation conducted in May 2014, is incredibly detailed and runs into 122 pages.

The specific allegation against GVK Bio was that its employees were using Electrocardiograms (ECGs) from one subject and substituting it for another. For example in one of the studies, five ECGs allegedly recorded for one subject were found to have entirely different characteristics and, on closer scrutiny, it was alleged that four of these ECGs were actually recorded from four other subjects. Similarly in another study, it was alleged that six ECGs were recorded from one subject and subsequently identified as belonging to five different subjects. The report notes that four of these ECGs were recorded within a period of 10 minutes.

The French alleged that ECGs were fabricated in all nine clinical trials that they inspected. A copy of the preliminary inspection report was given to GVK Bio, and it was given the opportunity to rebut these findings. On the basis of GVK Bio’s rebuttal, certain observations were withdrawn by ANSM in its final report dated July 21, 2014 — but the agency stood by its main findings regarding fabrication of ECGs and violation of Good Clinical Practices (GCPs).

In summary, the French agency has systematically given all necessary findings to GVK Bio before coming to its conclusions. The minister’s public comments do not square up with these facts.

The second issue with Ms Sitharaman’s stance is where she says the EU decision to revoke approvals for these drugs “is not a regulatory issue”. Unlike trade tariffs or IP agreements which are subject to bilateral or multilateral trade agreements, drug or food regulation is not considered a trade issue, and these aren’t covered by international treaties. Each country makes sovereign decisions in this regard. When Maggi was banned by India on safety grounds, would India have tolerated interference by the Swiss government because Nestle, the manufacturer, is Swiss? Ms Sitharaman’s comments raise the question of whether she was properly briefed by her own bureaucrats.

Uninformed comments, uninformed consent

Independent of the minister’s comments is the issue of inappropriate and intemperate remarks by the DCGI GN Singh and by DG Shah, the spokesperson of the Indian Pharmaceutical Alliance (IPA). In The Hindu story on the GVK Bio whistle-blower, DCGI Singh, has been quoted as saying “One must understand that there is a bigger game being played out here. I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers.”

The insinuation is that the French regulators were acting at the behest of multinational pharmaceutical companies. How does a bureaucrat representing a government body level such allegations without evidence? The revocation of approvals by the EU equally affected foreign companies like Abbot and Mylan, both US-based companies, since they too relied on GVK Bio for bioequivalence studies. How does this square with the DCGI’s intemperate assertion that the EU action was an international pharma conspiracy against Indian companies?

In similar vein, DG Shah, speaking on behalf of the IPA, has been quoted by The Hindu as saying “The banning of these 700 drugs merely on a suspicion of ‘manipulation’ of ECGs of healthy volunteers and without sufficient evidence was uncalled for. The inspector had erred, yet the Agency did not intervene, in spite of the error being brought to its notice by the government. It only leaves doubt about its intention.”

In a statement to Mint on August 6, 2015, Shah has been quoted as saying, “While the drug inspector sent by the French authorities claimed ECG (electrocardiogram) data of clinical trials were manipulated, the inspector was not competent to vet such data. It is only a cardiologist who can verify such data.”

The evidence in the ANSM reports categorically contradicts Shah’s claims. For instance, the ANSM report clearly states that cardiologists at the regulatory body were asked to confirm the findings of the inspector on the issue of fabrication of the ECGs, and that these cardiologists backed the findings of the inspector. Further, the credentials and competence of Olivier Le Blaye, the ASNM official who inspected GVK Bio, are beyond reproach. A cursory search would have shown Shah that Le Blaye was the one who first uncovered the fraud at Vimta Laboratories in 2004, as part of the WHO inspection which became the basis of my investigation into the wrongdoing at Ranbaxy.

Shocking indifference

Equally surprising is the nonchalant attitude of the establishment towards the issue of ECG fabrication. The feeling seems to be that ECGs at a CRO are not a matter of concern. The ANSM report concedes that ECGs are not pivotal to establishing bioequivalence, but the ECG data is still important to monitor the health of subjects participating in the bioequivalence study.

If anything, the ANSM observation on the ECG data was to protect Indian patients participating in these bioequivalence studies. Although such studies are relatively safe, things can go wrong, as was evidenced at GVK Bio in 2008 when a healthy 25 year old volunteer died in a Felodipine bioequivalence study. The DCGI announced an investigation into that death in 2008, but when my attorney requested a copy of their findings under the RTI Act, the Central Drug Standard Control Organisation (CDSCO) responded that the “file was not readily available”, and that the Delhi office was seeking relevant information from zonal offices of the CDSCO. We are yet to receive this report.

In addition to the ECG fabrication issue, ANSM raised a string of other issues relating to the manner in which GVK Bio was conducting these clinical studies – issues that made it difficult to detect any abnormalities. Other, more serious findings pertained to the breach of “informed consent”, since subjects recruited for these studies at GVK Bio were informed that ECGs would be recorded only at the beginning of the study. The inspection however found that ECGs were recorded four more times during the duration of the study. Aside from the question of why these repetitions were necessary, such repeat ECGs were not part of the study protocol, and violates informed consent. Although the Indian regulator may be lax about such issues, informed consent is at the core of GCPs in the rest of the world, especially the EU.

It is a sad commentary into the state of affairs that instead of examining whether GVK Bio had indeed falsified data for regulatory submissions to the CDSCO, the DCGI and the Commerce Minister prejudged the issue even before concluding their own investigation – which leads to the conclusion that it is business as usual for the Indian pharmaceutical industry.

The author is the Executive Chairman of Medassure Global Compliance Corporation.

There’s No Romance in this Story of Fudged Clinical Trials

How systemic problems at a drug testing lab, GVK Bio, morphed into the story of an illicit affair.

How systemic problems at a drug testing lab, GVK Bio, morphed into the story of an illicit affair

The headquarters of GVK Bio. Credit: gvkbio.com

In October this year, a national newspaper in India ran a front page news item with the headline “A love story that cost GVK its international reputation”.

The story spoke of a former GVK Biosciences employee turned whistle-blower, and of a chain of unintended consequences that resulted in the European Medical Agency (EMA) cancelling the marketing authorisation of 700 drugs previously approved for sale in the EU on the basis of data generated at GVK Bio. This in turn caused India to cancel scheduled talks on the Indo-EU Free Trade Agreement (FTA).

I saw stark similarities with the Ranbaxy case of 2004, where I was the whistle-blower. I had informed the US FDA about how Ranbaxy falsified data to seek approval of their drugs. My effort to hold Ranbaxy accountable had a positive outcome; however in the GVK Bio case, the reported facts didn’t seem to add up.

The story suggested that the Europeans had cancelled the drug approvals based on a complaint by a former employee who had cheated on his wife with a younger woman – in other words, the story fixes the problem on a disgruntled employee and an illicit affair gone wrong.

Given the international interest in the disproportionate reaction of the Indian government, my acquaintances and others in foreign media outlets attempted to establish the veracity of the claims made in the report of the newspaper, The Hindu. They however failed to get a response from the whistle-blower, who had sent 12 extensive emails to regulators and others in Europe and the US between September 5, 2014 and July 31, 2015 and then gone silent.

I was one of the recipients, and I have based my own limited investigation on the information in those messages, and on the inspection reports I procured from the French regulator. I now am in a position to establish that parts of The Hindu story, and comments by industry spokespersons, the Drug Controller General of India (DCGI) and the concerned minister in the Indian government accusing the French Regulator ANSM of bias are unfair and in some cases, blatantly false.

I have turned over the results of my investigations to three national media outlets in India, none of whom wished to pursue this story for reasons best known to them.

The GVK Bio scandal

It is necessary, first, to understand that GVK Bio does not manufacture medicines sold in Europe. It is a clinical research organisation (CRO), which conducts bioequivalence studies – tests on patients intended to establish that generic drugs work as well as their branded counterparts. The results of such studies, carried out by GVK Bio in its clinic, are used by manufacturers to secure marketing approvals in Europe, the US and presumably even in India.

The whistle-blower, a former employee at GVK Bio, sent an anonymous email on May 6, 2012 to international regulators at USFDA, ANSM (France), MHRA (UK), WHO, Inspectie voor de Gezondheidszorg (Holland), and Saglik (Turkey) alleging large scale violation of good clinical practices (GCP) at GVK Bio during its conduct of bioequivalence studies.

The email contained specific allegations of data manipulation and fabrication by GVK Bio to ensure the successful outcome of a bioequivalence study, and detailed how such fabrication was carried out. For instance, the message pointed out how concentration profiles of 14 patients had been replaced with other patients in a trial sponsored by a major Indian company seeking approval for a generic version of Felodipine, a drug used to treat hypertension.

A concentration profile is the rate at which a drug dissolves in the bloodstream – one of the key measures to prove bio-equivalence. According to the whistle-blower, the concentration profiles of these 14 patients, as recorded, would mean that the bioequivalence trial for the sponsoring Indian company would fail, and the failure would in turn delay its entry for this product into the American market.

On May 16, 2012, ten days after the original email, the whistle-blower sent a copy of the same mail to GVK Bio’s management.

The original email triggered a joint inspection of GVK Bio, and set in motion events that led to the cancellation of 700 drug approvals in Europe.

Inaccuracies in the ‘love affair’ story

Contrary to what The Hindu reported, the whistle-blower’s identity and his emails were not discovered by the Hyderabad police when they seized his computer during an investigation based on a complaint by the parents of the girl with whom he had allegedly eloped.

I applied for and received copies of the inspection reports by French regulator ANSM, which along with other regulators conducted an inspection of GVK Bio’s facilities. ANSM’s preliminary report, dated April 30, 2013, details how the identity of the whistleblower was established.

GVK Bio representatives told ANSM that when they received the anonymous email from the whistle-blower, they found his name in the ‘properties’ of a PDF file that was attached to the mail as attachment. GVK Bio then filed police complaints against the whistle-blower, and traced the cyber-café from which the email was sent.

GVK Bio then traced the IP address of the anonymous email account through Google. The company managed to triangulate the position of the whistle-blower’s mobile phone to the general location of the cyber-café. As an aside, it is disturbing that a private entity could access such sensitive personal information, and it is worth investigating how GVK Bio actually accessed these details.

The second inconsistency in The Hindu story is the whistle-blower’s reported motive. The story suggests that the whistle-blower was dismissed by GVK Bio after his affair with a colleague was discovered. GVK Bio however has denied this claim in a subsequent clarification to The Hindu. The whistle-blower had attached a copy of his resignation letter, along with a letter from GVK Bio accepting his resignation, in one of the emails in the series. Further, the ANSM preliminary inspection report states that GVK Bio informed them, during the inspection on June 25, 2012, that the whistle-blower had left on cordial terms, after which he allegedly eloped with the former employee.

There are many versions for why the whistle-blower approached the regulators. The Hindu gives one version, the ANSM preliminary inspection report gives a different version and GVK Bio’s police complaint gives yet another reason. All relevant documents are being made available here for anyone to examine and draw their own conclusions.

The third problem with The Hindu report is that it fails to expressly mention that the French regulator ANSM, in its final inspection report dated July 11, 2013, found the allegations regarding falsification of data in the Felodipine trial to be highly credible.

Additionally, ANSM discovered other serious compliance failures at GVK Bio, some of them based on leads provided by the whistle-blower. The bioequivalence study for Felodopine was for the US market, not for Europe. Therefore, there was little that ANSM could do, despite validating the whistle-blower’s allegations.

The final inspection report by ANSM ends with a recommendation to all regulators to “systematically check” data from GVK Bio with “the utmost vigilance for possible suspicious trends, patterns or similarities”.

The missing link and doubtful sources

The Hindu story traces a direct link between the whistle-blower’s emails and the suspension of EMA approvals for 700 drugs. However, the ANSM report, which was a result of the whistle-blower’s complaint, did not lead to the suspension of the approvals.

The EMA action happened three years later, in 2015. The suspension came about because ANSM, in a second inspection of GVK Bio, discovered more instances of data falsifications and violations of GCPs.

This second ANSM inspection was conducted on May 19, 2014 at GVK Bio’s facilities, and found systematic fabrication of ECGs in 9 clinical trials. This second inspection report is the most vital link in the story on GVK Bio, since it establishes that the extreme action taken by the European Union was based on not one, but two inspections of this contract research organisation (CRO) where they detected similar compliance violations.

Also, clearly, the two inspection reports document that GVK Bio’s international reputation was not hurt because of an illicit love affair, as The Hindu story suggests, but because of documented evidence of systematic falsification of data and other irregularities.

Speaking from personal experience as one who routinely audits compliance at pharmaceutical companies, when the integrity of clinical data, which is sacrosanct to establish the safety and clinical efficacy of drugs, is compromised on two successive occasions, it calls into question all the data that the CRO has supplied for marketing approval.

The intent here is not to question the integrity of the reporter who worked on The Hindu story. However, as I have established above, all the facts of the case could have been determined by securing inspection reports from relevant regulators – as I did.

This leads to the conclusion that the report was based on selective leaks by interested parties – leaks that appear to have led the Indian media astray.

These selective leaks have led to a false impression: that there was nothing behind the EMA’s ‘harsh’ action other than the anonymous emails of a disgruntled employee. From that basis flows the perception that Commerce Minister Nirmala Sitharaman’s decision to suspend the Indo-EU Free Trade Agreement (FTA) was valid.

Interestingly, Sitharaman has recently reversed the decision to suspend the FTA, and has said talks with the EU will resume shortly.

Why this matters

The reason I felt the need to tell this story is because it shows how little has changed in India after more than a decade since that first WHO inspection at Vimta Labs, which was the starting point of the Ranbaxy scandal.

Regulatory oversight over CROs has not been strengthened in the interim; the country still lacks a robust whistleblower protection law for uncovering fraud in the pharmaceutical industry. The Whistleblowers Protection Act, 2014 is meant primarily for exposing corruption in the government. The whistle-blower scheme announced by the DCGI several years ago inspires little faith, as the institutional response of the Indian establishment has been to deny any allegations against the pharmaceutical industry.

“In a worrying trend,” reads a newspaper report dated February 11, 2013, “there has been an increase in cases of fake drugs in last three years, and efforts by authorities to encourage whistleblowers to report such illegal activity too have failed to elicit the desired response.” This report appeared, incidentally, in The Hindu.

Postscript: In a follow-up piece, I will explain how the Indian Pharmaceutical Alliance, the DCGI and the Commerce Ministry unfairly questioned the competence, integrity and motives of the French inspector and, in the process, compromised public health in India and among those patients who consume India-sourced medicines abroad.

The author is the Executive Chairman of Medassure Global Compliance Corporation