Govt rubbishes reports on approval for Covaxin due to political pressure

The Centre on Thursday refuted allegations regarding irregularities in approvals given to Bharat Biotech to make Covaxin, India’s first indigenously developed Covid vaccine. The health ministry said media reports claiming regulatory approval for Covaxin was rushed due to political pressure are “misleading” and “fallacious”.

It said the scientific approach and prescribed norms were adhered to in approving Covid-19 vaccines for emergency use authorisation. “There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous Covid-19 vaccine Covaxin, had to skip certain processes and speed up clinical trials due to political pressure. The reports further claimed that there were several irregularities in the three phases of the clinical trials conducted for the vaccine,” the ministry said.

Claiming that, these reports were “completely misleading, fallacious and ill-informed.” It said that the government of India and the national regulator, i.e. CDSCO, “followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation”.


The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2, 2021 and after due deliberations made recommendations in respect of the proposal for Restricted Emergency Approval of Covid-19 virus vaccine of Bharat Biotech, it further said. Bharat Biotech, the makers of Covaxin, said there was “no external pressure” on them to speed up its development.