India has approved two COVID-19 vaccines for restricted emergency use, but the decision to greenlight Bharat Biotech's Covaxin while Phase-3 trials are still underway has drawn sharp criticism from health experts and political figures.
India's drug regulator has granted restricted emergency use approval to two COVID-19 vaccines: the Oxford-AstraZeneca candidate marketed locally as Covishield, and Bharat Biotech's homegrown Covaxin. The move positions the country of 1.4 billion people to begin one of the largest vaccination campaigns anywhere in the world. Drug Controller General of India VG Somani announced the decision on Sunday, asserting that both vaccines are "110 percent safe" and that the approval process followed rigorous scientific evaluation. The Serum Institute of India, which manufactures Covishield under license from AstraZeneca, has already stockpiled tens of millions of doses in anticipation of the rollout.
Yet the approval of Covaxin has attracted scrutiny that refuses to quiet down. Unlike Covishield, which has published Phase-3 efficacy data from international trials, Covaxin remains in the middle of its own Phase-3 clinical study in India. That gap has fed unease among scientists and public health advocates who argue that granting emergency authorization without peer-reviewed efficacy numbers undermines public trust at a moment when trust matters most. Opposition leaders, including Congress MP Shashi Tharoor, have publicly called the decision premature and questioned whether political considerations outweighed scientific evidence. Several epidemiologists have echoed those concerns, warning that distributing a vaccine without transparent efficacy data could fuel hesitancy in a country where vaccine skepticism already poses a real hurdle.
Bharat Biotech's chairman and managing director Krishna Ella has pushed back hard against the criticism, and his frustration was palpable during a recent press briefing. He insisted that Covaxin is "200 percent safe" compared with other COVID-19 vaccines globally, and pushed back on what he sees as an unfair double standard applied to Indian companies. "We have not done anything wrong and we would not put anyone at risk," Ella said. "We are far better than others but sadly we do not get the recognition deserved. Why are MP Shashi Tharoor and others not questioning the UK firms?"
His defense rested on the immunogenicity data submitted to the regulator, which measures the immune response triggered by the vaccine rather than real-world effectiveness against infection. Ella pointed to animal studies where hamsters and monkeys showed complete protection against the virus, calling it the strongest preclinical dataset among any COVID-19 vaccine candidate to date. He also cited safety records from roughly 25,000 volunteers across earlier trial phases, noting that adverse reactions remained below 10 percent, a figure he described as well within acceptable limits.
The criticism has clearly struck a nerve. Ella argued that Bharat Biotech's adherence to testing protocols matches or exceeds that of globally recognized pharmaceutical companies, and he questioned why Indian innovation faces suspicion while foreign-made candidates receive the benefit of the doubt. The sentiment resonates in a country where domestic scientific achievement has often struggled for recognition on the world stage.
From a logistics standpoint, Bharat Biotech appears ready. The Hyderabad-based firm holds an inventory of approximately 20 million Covaxin doses and plans to scale annual production capacity to 700 million doses in the coming months. Pricing has not been finalized, as the cost per dose will depend on order volumes, though early expectations suggest it may start higher and come down as manufacturing ramps up. The Indian government has indicated that healthcare workers and front-line personnel will receive the first batches, with broader distribution to follow in stages.
The real test now lies ahead. India's vaccination drive will be judged not just by how quickly doses reach arms, but by whether the regulatory process that authorized them holds up under public examination. The controversy around Covaxin's early approval may fade if the ongoing Phase-3 trial confirms strong efficacy numbers, which could silence critics and validate the regulator's gamble. But if those results disappoint, the decision to authorize before data arrived will invite a far more difficult reckoning.
