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On Sunday, 3 January, the Drugs Controller General of India (DCGI) granted permission to Bharat Biotech’s indigenous COVID vaccine ‘Covaxin’ and Oxford-AstraZeneca’s Covishield vaccine for restricted use in emergency situation.
“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare for conduct of the Phase III clinical trial,” DCGI said in a press briefing.
It further said that the vaccine of Serum Institute and Bharat Biotech have to be administered in two doses. Further, all the vaccines have to be stored at a temperature of 2-8 degree celsius.
AIIMS Director Dr Randeep Guleria said that both the vaccines are cost-effective and easy to administer.
"It's a great day for our country and it's a very good way to start the new year. Both the vaccines are made in India. They are cost-effective and easy to administer. We should, in a very short period, start rolling out vaccine,” ANI quoted him as saying.
Further, Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia Region, said that the organisation welcomed the approval.
On Saturday, the Central Drugs Standard Control Organisation (CDSCO) panel had recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine ‘Covaxin’ in India.
This is the second vaccine to have got approval from experts. The Subject Expert Committee (SEC) set up by the Drugs Controller General of India (DCGI) has reportedly been reviewing Covaxin’s application for emergency use.
A government press note said that the CDSCO recommended for granting permission to Bharat Biotech for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in context of mutant strain infection.”
The Oxford-AstraZeneca COVID-19 vaccine, which is called Covishield in India, had also received recommendation for emergency use “subject to multiple regulatory conditions” in the country.
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