The long wait for India’s 1.3 billion people is over as the country’s drug regulator has given emergency approval to two ‘made in India’ Covid-19 vaccines. Two vaccines for coronavirus, Pune-based Serum Institute’s Covishield and Bharat Biotech’s Covaxin, received emergency approval from the Drug Controller General of India (DCGI).
“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of Serum and Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to Cadila Healthcare for conduct of the Phase-3 clinical trial,” said VG Somani, DCGI, during a media briefing today.
“We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe,” Somani said.
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).
PM Modi: Made in India Covid-19 vaccines make us proud
Minutes after the country’s drug regulator announced the approval for two coronavirus vaccines today, Prime Minister Narendra Modi said it would make every Indian proud that the two were “made in India”.
“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,” the Prime Minister tweeted.
New Year gift India has been waiting for
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.”
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).
India, the world’s second most-infected nation with 1,03,23,965 cases and almost 1,50,000 deaths, is gearing to rollout the vaccines at a time when a new strain of UK coronaviru has led to a fresh wave of restrictions worldwide. The government has already been holding nationwide dry runs ahead of the mass inoculation drive.