India’s drugs regulator on Sunday approved Oxford University’s Covid-19 vaccine ‘Covishield’ manufactured by the Serum Institute and the indigenously produced ‘Covaxin’ developed by Bharat Biotech for restricted emergency use in the country, paving way for a massive inoculation drive.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a Covid-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
“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,” DCGI Dr V G Somani told reporters.
Responding to the developments, Prime Minister Narendra Modi tweeted, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”
This paves the way for the roll out of at least two vaccines in India in the coming days. The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Serum Institute of India’s CEO Adar Poonawalla tweeted, “Happy new year, everyone! All the risks Serum Institute of India took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.”
Also, the authority granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said.