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The DCGI did well to seek more data before clearing emergency use of vaccines
With a stroke of a pen, the Drugs Controller General of India has put to rest any doubts and concerns that it would rush to grant emergency use approval to COVID-19 vaccines tested and manufactured in India or elsewhere in the absence of sufficient data. The greatly reassuring decision to seek additional safety and immunogenicity data from the Pune-based Serum Institute of India and Hyderabad’s Bharat Biotech underlines the regulator’s priorities even for emergency use approval rather than an early roll-out of vaccines that have not been sufficiently studied. The decision to seek more evidence would mean a slight delay in locally manufactured vaccines becoming available. But it clearly demonstrates that the committee did not misread the announcement by Prime Minister Narendra Modi that a vaccine will be available in the next few weeks as a signal to grant approval in haste. By keeping the approval on