The DCGI’s approval was given on the premise of suggestions submitted by a COVID-19 topic skilled committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO)
The DCGI chief addressing the media on Sunday. ANI
India’s medication regulator on Sunday accepted 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 within the nation, paving the best way for a massive inoculation drive.
The approval by the Drugs Controller General of India (DCGI) was given on the premise of suggestions submitted by a COVID-19 topic skilled committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
“After enough examination, CDSCO has determined to simply accept the suggestions of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being accepted for restricted use in emergency state of affairs,” 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.
Prime Minister Narendra Modi termed the approvals as a ‘decisive turning level’ within the battle towards the novel coronavirus and stated, “It would make each Indian proud that the 2 vaccines which have been given emergency use approval are made in India! This reveals the eagerness of our scientific group to fulfil the dream of an Aatmanirbhar Bharat, on 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 on your assist
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia Region, said, “WHO welcomes the primary emergency use authorization given to COVID-19 vaccine within the WHO South-East Asia Region. This choice taken right now by India will assist intensify and strengthen the battle towards COVID-19 pandemic within the Region. The use of vaccine in prioritized populations, together with continued implementation of different public well being measures and group participation can be essential in decreasing the impression 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