Guwahati: India’s drug regulatory body on Sunday announced that the COVID-19 virus vaccines developed by Serum Institute and Bharat Biotech have been approved for restricted use in an emergency situation.
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) had recommended the ‘Restricted Emergency Approval’ of the COVID-19 virus vaccines of Serum Institute of India (SII) as well as Bharat Biotech.
The vaccines developed by SII and Bharat Biotech both have to be taken in two doses, the Drugs Controller General of India (DCGI) stated.
“After detailed deliberations CDSO has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue,” an order form DCGI stated.
It further said that, “After adequate examination, CDSO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical.”
Prime Minister Narendra Modi took twitter to congratulate the two firms and the scientists who worked on the two vaccines. He wrote, “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators.”
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