New Delhi: The Drugs Controller General of India on Sunday gave final approval to Oxford vaccine in India, named Covishield, and Bharat Biotech's Covaxin, making them first approved vaccines in the country.
Vaccines of Serum Institue of India and Bharat Biotech are granted permission for restricted use in emergency situation, the DCGI said.
This comes as an expert panel of India's central drug authority on Saturday recommended to the Drugs Controller General of India to grant permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains.
The recommendation for Bharat Biotech's vaccine came a day after the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation cleared the Serum Institute of India's emergency use athorisation application for the Oxford-AstraZeneca vaccine Covishield.
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.
Restricted use in emergency situation
It recommended "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to Bharat Biotech," the health ministry stated.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.
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).
While granting the restricted emergency use approval for the Oxford COVID-19 vaccine on Friday, the panel had imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest.
Also, the Pune-based firm should submit the safety data including the data on adverse events following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country, according to the recommendations.