In a significant development, Drugs Controller General of India (DCGI) on Sunday (January 3) formally approved Serum Institute’s Covishield and Bharat Biotech’s Covaxin for restricted use in India.
“Serum Intitute and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C. After adequate examination, CDSCO 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 trial,” DCGI said in a press statement.
The DGCI granted the approval after a Subject Expert Committe of Central Drugs Standard Control Organisation (CDSCO) recommended these two vaccines for emergency use in India. It may be recalled that Covishield was recommended for emergency use on January 1, whereas Covaxin was recommended for restricted use on January 2. On Saturday, Union Health Minister Harsh Vardhan had said the vaccines would be given free of cost to priority groups in the first phase.
Prime Minister Narendra Modi has welcomed the DCGI decision and said that approval of two vaccines is a a decisive turning point to strengthen a spirited fight.”DCGI granting approval to vaccines of Serum Institute and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” he said.