Indian media called it the Biocon breakthrough. On 11 July, the biopharmaceutical company’s made-in-India drug Itolizumab had just received emergency authorisation by the Drug Controller General of India (DCGI) for the treatment of moderate to severely ill Covid patients. Originally created to treat a skin disease called psoriasis, Itolizumab was repurposed and tried on Covid patients to avoid the onset of a cytokine storm—or when the body’s immune system begins to attack the body, often fatally.
But even as Biocon’s “breakthrough” was being celebrated, its 30-patient, randomised control trial conducted over four hospital sites in India had already come under fire. The paltry size of the trial was being offset against Biocon’s tall “mortality benefits” of the drug. “As a lay person, if I read the Biocon press release, I would think this drug has a 90% chance of preventing mortality. I wouldn’t think twice about taking it off the market,” says a Bengaluru-based senior clinical trials scientist, who requested anonymity as he’s not authorised to speak with the media.
What got lost in the fine print, says the expert, was that Itolizumab was given a marketing license under a contentious, little-used regulatory fiat called “restricted emergency use” or Emergency Use Authorisation (EUA).
The rapid clip at which Covid infections and deaths have grown across the world has governments, regulators and doctors against the wall. India now has 2.2 million recorded cases, and as of 12 August, it’s adding the highest number of new cases in the world.
Yet, no single drug or therapy has been approved for treating Covid-19. “We can’t afford to wait in a pandemic. In such a situation, the regulator has the discretion to allow use of new drugs, or repurposed drugs, without going through a sequential, multi-stage trial,” says Santanu Tripathi, head of Clinical and Experimental Pharmacology at the Calcutta School of Tropical Medicine. Along with Itolizumab, drugs like Remdesivir, Favipiravir and convalescent plasma therapy convalescent plasma therapy Convalescent Plasma Therapy Dr. Joy Varghese Convalescent plasma treatment involves injecting the COVID-19 patient with convalescent sera (singular:serum) of people who recovered from the infection recently. The patient cured of the disease will have antibodies that drive coronavirus away have been given the EUA nod.
EUAs are a handy, if imperfect, tool to save lives in a life-threatening pandemic. But they’re far from being a well-tested, detailed blueprint. The science behind why an EUA is granted to a particular drug or therapy is dynamic. By their very nature, they can’t be too rigid since they only kick in during emergencies. The concept of actually granting EUAs is alien to India’s drug regulators.
“EUAs didn’t strictly exist in India before Covid. Drugs are either approved all the way or rejected.