India approves Covishield and Covaxin for restricted ‘emergency use’
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India approves Covishield and Covaxin for restricted ‘emergency use’

The Drugs Controller General of India (DCGI) granted the approval based on recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

NEW DELHI

India’s drugs regulator on January 3 approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive.

The Drugs Controller General of India (DCGI) granted the approval based on recommendations 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 situations,” DCGI Dr V G Somani told the media here.

This paves the way for the rollout of at least two vaccines in India in the coming days.

“Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8 C,” he said.

Prime Minister Narendra Modi termed the approval a decisive turning point in India’s fight against coronavirus.

“DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” he 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,” he said in another tweet.

He also saluted the frontline workers who have been leading the country’s fight against the virus.

Serum Institute of India’s CEO Adar Poonawalla tweeted, “COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.” (PTI)

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