NEW DELHI: The Centre on Thursday refuted reports claiming regulatory approval for the manufacture of Covaxin, India’s first indigenously developed anti-Covid vaccine manufactured by Hyderabad-based Bharat Biotech, was rushed due to “political pressure” as “misleading,” “fallacious” and “ill-informed.”
The Union Health Ministry said the government and the national regulator - Central Drugs Standard Control Organisation (CDSCO) - have followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation.
In a statement, the health ministry said that there had been media reports claiming that Bharat Biotech “had to skip certain processes” and “speed” up clinical trials due to political pressure. “The reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine. These media reports are completely misleading, fallacious and ill-informed,” the statement said.
Bharat Biotech also issued a statement condemning the “targeted narrative” against Covaxin, whose supply to UN agencies was suspended by the World Health Organisation (WHO) in April, citing deficiencies in good manufacturing practices.