DCGI grants approval to Serum Institute, Bharat Biotech's COVID-19 vaccines

The Drugs Controller General of India (DCGI) on January 3 granted emergency use authorisation for the Serum Institute of India (SII)'s 'Covishield' and Bharat Biotech's 'COVAXIN' vaccines against COVID-19, the disease caused by the novel coronavirus. These have been approved for 'restricted emergency use' in India.

"Serum Institute 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.

Earlier on Saturday, the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of the Serum Institute of India (SII) and Bharat Biotech`s vaccines.

Prime Minister Narendra Modi has welcomed the DCGI decision and said that approval of two vaccines is 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.

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.

— Narendra Modi (@narendramodi) January 3, 2021

As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

The Subject Expert Committee recommended a grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune.

It also recommended the grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to Bharat Biotech International Ltd Hyderabad.

The recommendations were made for the consideration and final decision of the Drugs Controller General of India.

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

Union Health Minister Dr Harsh Vardhan said earlier in the day that in the first phase of COVID-19 vaccination, free vaccine shall be provided across the nation to most prioritised beneficiaries that include one crore healthcare and two crore frontline workers.