The DCGI’s approval was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)
The DCGI chief addressing the media on Sunday. ANI
India’s drugs regulator on Sunday approved Oxford’s COVID-19 vaccine Covishield, manufactured by the Serum Institute of India, and the indigenously-developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the 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 a press conference.
This paves the way for the roll out of at least two vaccines in India in the coming days.
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Prime Minister Narendra Modi termed the approvals as a ‘decisive turning point’ in the fight against the novel coronavirus and said, “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.”
We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives.
— Narendra Modi (@narendramodi) January 3, 2021
Serum Institute of India’s CEO Adar Poonawalla tweeted —
Thank you Hon. Sri @narendramodi Ji, Hon. Sri @drharshvardhan Ji, @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia Region, said, “WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region. The use of vaccine in prioritized populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19 .”
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).
Also, the authority granted Cadila Healthcare the permission to conduct the Phase III clinical trial of its vaccine candidate in India, Somani said.
With inputs from PTI
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