During the course of this pandemic, we have seen multiple controversies over the “cures” and “treatments” touted by Indian companies, ranging from Patanjali’s “Coronil” to Glenmark’s “Fabiflu” and finally Biocon’s “Itolizumab”. The approval granted to Biocon has come under particularly withering criticism for many reasons, ranging from the waiver of crucial Phase III trials to allegations of poorly designed Phase II trials.

The fact that the national task force declined to incorporate Biocon’s Itolizumab’s drug into treatment protocols for Covid-19, despite the drug being approved by the Drugs Controller General of India (DCGI), is reason enough to question the latter’s approval of this drug. I did exactly that in an opinion piece that I wrote for the Telegraph, titled “An opaque model of drug approval in India”.

In that piece, I took aim primarily at the DCGI, questioning the lack of transparency in its grant of approval to Biocon’s drug and the fact that established norms of “evidence based medicine” were being thrown to the wind by the regulator. The DCGI has a track record of granting questionable approvals, as pointed out in a Parliamentary report and a second official report commissioned by the DCGI which identified three former DCGIs by name for granting dubious drug approvals.

Although my entire piece was targeted at the DCGI, it was Biocon’s top regulatory affairs manager who decided to respond to my piece in the Telegraph the very next day, claiming (incorrectly) that my piece had factual inaccuracies and that the DCGI had performed its job transparently. The fact that Biocon was unhappy with some of the issues I raised regarding its new drug was already evident from the ad-hominem attacks made on me by its top brass on Twitter in full public view.

While I have no complaints about mudslinging on Twitter, I do think it is problematic when national newspapers like the Telegraph publish pieces by powerful pharmaceutical companies without fact-checking them, and then refuse me an opportunity for a rebuttal.

To provide context to the problems with Biocon’s piece, let me begin with background to the controversy around Biocon’s drug.

The entire controversy over the approval granted to Biocon’s new drug stems from the fact that Phase III trials were waived by the DCGI. In the world of drug development, Phase III trials are the riskiest because this is the stage at which drugs are required to prove their efficacy and risk-benefit ratio on a large set of patients. Most drugs fail at this stage of development.

Under Indian law, it is possible to get approval for a drug without Phase III trials only if the drug demonstrates “remarkable efficacy” during Phase II trials. This is called an “accelerated approval” and can be granted only for unmet medical needs. A second route to sell a drug before the conclusion of Phase III trials is to follow the procedure laid down in Chapter XI of the New Drugs and Clinical Trial Rules, 2019. Under this regulatory pathway, a series of additional protocols have to be followed before a patient can access an unapproved drug.

From the little information available in the public domain, it is not clear as to which of these routes has been used by the DCGI to grant Biocon approval.

Now to the problem with Biocon’s rebuttal. The company’s response contains three arguments.

First, it claims that it received approval under Section 26B of the Drugs and Cosmetics Act, 1940. This claim is questionable because Section 26B requires the central government to issue a notification in the official gazette in each instance where it invokes its decision-making powers under Section 26B.

For example, on July 27, 2020, the health ministry invoked its powers under Section 26B to waive the requirement of a sales license under the Drugs and Cosmetics Act for the sale of hand sanitisers and published its decision in the Gazette of India. This order is available on the Gazette of India’s official website. However, this very website does not show any order regarding any approval granted by the Ministry of Health to Biocon. There is also the question of whether Section 26B can be used to approve new drugs; there is a strong legal argument that it cannot.

These issues beg the question: did the Telegraph fact-check the claims made by Biocon prior to publication?

Second, Biocon tries to draw an equivalence to the approvals granted to Gilead for Remdesivir and to Glenmark for Favipiravir. However unlike Biocon, both Gilead and Glenmark conducted Phase III clinical trials for their drugs. Thus there was no requirement for them to seek special exemptions under Section 26B. Further, the official gazette does not contain any notifications under Section 26B for either Remdesivir or Favipiravir. How then did the Telegraph publish these claims?

Third, Biocon claims:

Incredibly, Telegraph’s editors never asked Biocon to cite a source for this claim being made within quotation marks, as is the norm. Under American law, the United States Food and Drug Administration can grant “accelerated approvals” before the conclusion of Phase III trials. This is different from “waiving” Phase III trials because applicants are still expected to conduct properly designed and controlled Phase III trials. In January, 2017 the USFDA published 22 case studies where Phase II and Phase III trials had divergent results, concluding,“As we continue to explore alternatives to requiring phase 3 testing, it is important to keep in mind the benefits they provide to both patients and to the medical research enterprise.”

Taking on powerful drug regulators and pharmaceutical companies is never easy. It is mostly a thankless battle between unequals. In fact, there is a sordid history of the industry’s disproportionate role in framing regulations which it is governed by. That should make us question such unsolicited defense of the regulator by the industry.

And the DCGI doesn’t have a stellar history either of always acting in the interest of the people of India. While I ask for no special privileges, I do think I am entitled to ask opinion editors to conduct cursory fact-checks before renting out prime real estate in their newspapers to pharmaceutical companies.

Dinesh Thakur is a public health activist.

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