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Home / News / India /  India’s framework has a specific provision for granting EUA: Official on Covid vaccines

India’s regulatory framework has a specific provision for grant of emergency use authorisation, said Rajesh Bhushan, Secretary, Union Health Ministry said on Covid-19 vaccines.

Bhushan's statement on Tuesday comes at a time when after Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech had on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow.

The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.

Bhushan also said that Drugs Controller General of India could grant a license to some developers of Covid-19 vaccines in the next few weeks.

Six vaccines, including AstraZeneca's Covidshield and Bharat Biotech's Covaxin, are in trial stages, Bhushan said at a press conference.

Current cold chain capable of storing first lot of 3 crore Covid-19 vaccines for healthcare, frontline workers, the official further said.

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