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’.
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.
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.