NEW DELHI: Often accused of unduly favouring drug-makers, India’s drug regulatory system is under glare in the wake of Covid pandemic with three drugs getting the nod as its potential cure despite little scientific evidence of their safety and efficacy.
While two drugs got authorisation for emergency use by the Central Drugs Standards Control Organisation (CDSCO) under the Union Ministry of Health and Family Welfare, the third — an ayurvedic formulation — got the nod from the AYUSH Ministry.
For treatment of mild to moderate Covid cases, Favipiravir got the nod for Emergency Use Authorization (EUA). Favipiravir is manufactured by Fujifilm and is in use in Japan since 2014.
In India, Glenmark got the license to manufacture the drug. The evidence cited for the EUA was rather weak — an observational trial, without any comparison with a placebo arm, with 160 patients in 10 hospitals which showed that patients with mild symptoms showed some improvement.
Similarly, immuno-modulator Itolizumab, which was launched by Biocon for psoriasis in 2013, got the approval for repurposed use in moderate to severe Covid cases to manage cytokine storms.
In this case too, researchers express concern over its low-powered, small clinical trial regarding its efficacy in Covid medication.
The drug maker was also exempted from phase 3 clinical trial, considered bedrock of scientific evidence for any medical therapy, clearing the way directly for phase 4 or post-marketing assessment.
Drug Controller General V G Somani, who heads the CDSCO, did not respond to requests seeking clarification on issues related to the approvals. Even Patanjali allegedly had a similar cakewalk as it got permission to sell Coronil.
A group of doctors and researchers had written to the Medical Council of India highlighting how the purported clinical trial undertaken to assess Coronil’s efficacy grossly violated trials norms. Those who closely follow India’s drug regulation scenario say that CDSCO’s ‘chequered’ past and present is a concern.
“History informs us that CDSCO makes its decision based on every other factor except sound science and is opaque about how it arrives at its decisions,” said activist Dinesh Thakur, who blew the lid off Ranbaxy’s dubious manufacturing practices.
“It has been called out by the parliamentary standing committee on health for collusion, corruption and gross incompetence. There seems to be no accountability for its questionable function.”
Public health researcher Dr Oommen John stressed that the approvals for use of pharmaceutical agents for new indications like Covid need to be based on sound evidence.
“If the studies are not adequately powered, there is a risk of harm that can be multiplied at scale given the direction the pandemic is moving.” One major problem is a near-complete lack of transparency in the way the drug regulator functions.
The agency, for instance, does not make public the approval details or composition of the committees behind approvals.
It was only after persuasion by All India Drug Action Network that CDSCO released minutes of the meeting of the expert committee that is approving Covid drugs, but a request to reveal the name of the members remains unheeded so far.
How a drug in India is approved
- When a company in India wants to manufacture or import a new drug, it has to apply to seek permission from the licensing authority or the Drug Controller of India by filling in Form 44 also submit required data as prescribed in Schedule Y of Drugs and Cosmetics Act, 1940 and its rules.
- In order to prove its efficacy and safety in Indian population, it has to conduct clinical trials in accordance with the guidelines specified in Schedule Y and submit the report of such clinical trials in the specified format.
Stages of clinical trials in the country
Pre-clinical study - Mice, Rat, Rabbit, Monkeys .
Human pharmacology trial - estimation of safety and tolerability.
Exploratory trial - estimation of effectiveness and short-term side effects .
Confirmatory trial - Confirmation of therapeutic benefits .
Post marketing trial - Studies done after drug approval.