A new regime : On the Emergency Use Authorisation regime in India and clinical trials
India must keep an eye on adverse reactions from new drugs and vaccines
Last week, the Drug Controller General of India cleared, under the provisions of ‘emergency use authorisation’, a new mRNA vaccine for COVID-19 developed by Pune-based Gennova Biopharmaceuticals, a pioneer in India in developing mRNA vaccines. The vaccine is meant to be particularly effective against the dominant Omicron variant. With the World Health Organization having officially declared the end of the COVID-19 pandemic, there is no longer the obsessive public interest in new variants. Even less so in newer vaccines. Data suggest that the uptake of booster, or ‘precautionary doses’ of the array of COVID vaccines available in India has been declining for several months. Therefore, the significance of the new vaccine, GEMCOVAC-OM, is that it shows that an Indian company has the capability to make an mRNA vaccine, believed to be amenable to rapid production and scale-up, that could be useful against any future virus.
Normally, vaccines must go through progressive stages of testing, from petri dishes, to animals and expanding cohorts of human test subjects. Doing greater harm than good, or being unable to be better than the alternative in any of these stages is a ground for disqualification. Which is why vaccine development and approvals are a decades-long enterprise. During COVID-19, this risk-averse strategy was deemed unsuitable for the crisis at hand because of which drug regulators globally allowed vaccine makers to combine multiple stages while evaluating efficacy, thus giving greater leeway to experimental formulations. This underlines the basic framework of ‘emergency use authorizations (EUA)’ adopted by regulators globally. Unlike the U.S. Food and Drug Administration (FDA) that has for many years been evaluating novel drug and vaccine candidates, India’s regulatory system has largely been geared toward evaluating formulations that have been approved abroad and in assessing their suitability to India. Mistrust, arbitrary decree and lax regulations have historically plagued clinical trials in India. More than evidence-based assessment, it was a technicality in India’s ‘New Drugs and Clinical Trials Rules, 2019’ that allowed EUA in India for COVID-19 vaccines. A credible regime of phased, clinical trials and independent regulation for new drugs is still in its infancy in India. The FDA still authorises updated COVID-19 vaccines under emergency use provisions because while the pandemic is over, COVID-19 is not and thousands continue to die globally. This alone, however, cannot be the basis for continuing with the EUA regime in India. While the flexibility to accelerate should always be present, India must specify a streamlined regulatory process that weeds out non-essential steps but is hawk-eyed on safety and adverse reactions from new drugs and vaccines.