Pandemic is a test of faith for Indians and faith is manifested in religion for most Indians but religion is also a set of rules. But “we are Indians” is shorthand for “we don’t like rules”! A dichotomy that faith somehow seems to be comfortable reconciling. Science too has rules and law is all about rules and both science and law struggle to deal with jugaad, the essence of short-circuiting rules for the “greater good” that is often badly articulated and therefore, allows, like religion, disparate understandings, often to suit each person’s or group’s belief.
This may well be the summary of India’s tryst with COVID.
What Is Medicine? What Works and What Is Mere Snake Oil?
The Drugs & Cosmetics Act may have a colonial past but it has been updated periodically. Sadly, the enforcement has been very “jugaad”.
As a result, Coronil, kadha, homeopathy, other “immunity boosters” which shouldn’t have been allowed to be marketed and sold without the rigour of scientific basis have had “bumper sales” last year. Sadly, the Delhi High court “stayed” the 2018 amendments to the law which introduced this scientific rigour. Ironically, this injunction was granted in a petition by Reckitt Benckiser, that very well known “ayurvedic” company!
Before we blame all ills on babajis and other well-known snake oil merchants, the drug regulator approved HCQ, plasma therapy, Remdesivir, Favipavir, Tocilizumab, Itolizumab for use on COVID patients without following the process of approvals after clinical trials as mandated by Indian drug regulations. This wasn’t unusual and the pandemic is no excuse for short-circuiting the law - the drug regulator has been censured by the Parliamentary Standing Committee for “illegal” and unscientific drug approvals in the past. Sadly, Indian Council for Medical Research (ICMR), the premier research institution encouraged the use of these drugs without any scientific data to back their therapeutic claims just so that the government is seen to be acting diligently. The government’s widespread advocacy of such treatments, including “encouraging” the prophylactic use of HCQS, undermines the credibility of the regulator and the regulatory process when global clinical trials have demonstrated these to be ineffective.
'Off-Label Use’
If the drug regulator had not approved HCQS, plasma therapy, Remdesivir, Favipavir, Tocilizumab, and Itolizumab, would doctors be prevented from using these drugs in appropriate cases?
As the effective use of dexamethasone has shown us, drug regulations permit what is widely known as “off label use”. Ironically, despite Itolizumab being “approved” by the drug regulator on the basis of its “remarkable efficacy”, ICMR didn’t include it in its COVID treatment protocol. Clearly there are limits to how much science will bend to politics!
Vaccines – Approval Before We Know That It Works
The lax enforcement of drug regulations and the short-circuiting of the approval process spills over into vaccines as well.
Both SII and BB were allowed to manufacture and stockpile vaccines even before clinical trials were completed – a clear violation of drug regulation which mandates the grant of permission to manufacture for marketing and sale only after clinical trials are completed and there is enough data to demonstrate safety and efficacy. Approval and granting permissions is a sequential process - permission to manufacture for analysis to generate laboratory data, then permission to conduct clinical trials and then to manufacture for clinical trials, and finally, once the vaccine is approved for marketing, permission to manufacture for marketing and sale – each of these is a specific “gate” before entering the next stage and the government notified this process specifically for vaccines in May 2020.
Although this permission to manufacture for marketing and sale was granted on January 03, 2021, millions of doses of vaccines were manufactured month before this permission was granted, while clinical trials were still ongoing. Circumventing these regulations gives the impression that there was no doubt that the regulator would approve the vaccine and clinical trial data were a mere formality. The subsequent “approval” for Covaxin and the approval of Covishield without a full clinical trial to demonstrate efficacy in India gives credence to this suspicion. The terms “emergency use authorization”, “restricted emergency use” and “backup vaccine for emergency use in clinical trial mode” used by the regulator while “approving” the vaccines are alien to Indian drug regulation and cause doctors and patients to be confused about the vaccines.
Consequences of Vaccination as Currently “Approved”
From from the government’s PR campaign, it would be impossible to even imagine that clinical trials for Covaxin are ongoing and efficacy data will not be available before March 2021 at the earliest and it would be prudent to wait until the trial is completed later in 2021. Similarly, a full clinical trial for efficacy of Covishield in India hasn’t been conducted and leading scientists like Dr. Kang are of the opinion that it would be premature to have mass vaccination based on available data.
A question that deserves an answer is “Why is a full CT necessary and why can’t we dispense with it during a pandemic?” Clinical trials to demonstrate efficacy are necessary so that we get scientific data on how the vaccine works in a diverse population and informs us about the risks to certain groups. Such groups would be identified by screening and require greater monitoring after vaccination or even have to be excluded from vaccination. Without the clinical trial, when vaccination is widespread, these benefits of the clinical trial experience are lost on mass population. As a result, many avoidable consequences will now present themselves, and at a scale that we cannot anticipate and manage. Even if some of these adverse events are unavoidable, we would have been better prepared for them had a proper clinical trial been conducted.
The current vaccination drive doesn’t mandate testing and screening before injection. As a result, many who are vulnerable will be injured and those may well have been avoidable had we conducted a full clinical trial and developed a screening protocol. This is, in the law, plain recklessness.
Informed consent is the foundation of clinical trials. The informed consent form used for Covaxin ignores “essential elements” listed in New CT Rules, 2019. These include information on risks to the person (which is illusory without screening), alternative therapies, details of actual compensation in case of injury, monitoring and access to medical facilities. Every doctor participating in the clinical trial has, under the law, undertaken personal responsibility for the volunteer’s health but it is inconceivable that doctors administering the vaccine to lakhs of people will even know the names of the patients and any details to be able to discharge this duty. It is almost like a factory production line – in flagrant violation of the CT Rules.
The Vaccination Program Is Discriminatory
Since there are two vaccines but those being vaccinated have no choice, one group will get the “approved” Covishield vaccine while another group will be given Covaxin which is in “clinical trial mode”. There is no justification for this discrimination, especially when there are enough stocks of Covishield available. The government is banking on people not caring about equality, liberty and other constitutional rights and if at all there is a murmur of protest, the government can easily counter it with branding all those as “anti-national”.
Those who suffer injury or death as a result of these two vaccines will be treated differently and this means that consequences are different. Those getting Covaxin will be CT “volunteers” and should benefit from the New CT Rules, 2019 including a formula based compensation for injury and death which ranges from Rs 32 lakhs to Rs 66 lakhs.
Those getting the CoviShield vaccine will however, have to go to a civil court and prove a tortious injury and actual loss to be able to claim compensation, but only after torturous few decades of judicial process.
Given the terrible record of compensation for medical injury in India, it is likely that neither group will actually get any compensation. All the adverse events that have been reported have been swiftly dismissed as having no causal link to the vaccine. While that may be true, the New CT Rules, have a different standard and volunteers getting Covaxin are entitled to compensation if the death or injury is related to the trial and that includes failure to adhere to the trial protocol, lack of informed consent, etc. The government and the vaccine manufacturers are relying on the ignorance of this to evade all liability and experience tells us that they are confident that they will succeed.
Regulator, Government & Snake Oil Merchants
The flagrant violation of drug regulation is not new to India but during a pandemic, this will lead to disastrous consequences at a pandemic scale. It is not just the pandemic that is testing our broken public healthcare system, the manner of handling it is adding to the strain.
Scientific credibility is undermined by poor policy and political PR and this is evident from the number of people entitled to the free vaccine declining it. And worst of it all is that the common man will think of vaccines in the same way as snake oil and that may well be the worst outcome of the pandemic – the drug regulator and the government being mentioned in the same sentence as babajis and snake oil merchants!
(Murali Neelakantan, is a lawyer specializing in healthcare issues. He was formerly global general counsel at Cipla and Executive Director and Global General Counsel at Glenmark.)
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