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Expert panel recommends granting approval to Sputnik V for emergency use in India

Expert panel recommends granting approval to Sputnik V for emergency use in India
Expert panel recommends granting approval to Sputnik V for emergency use in India
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Published : Apr 12, 2021, 3:38 PM IST

Updated : Apr 12, 2021, 4:10 PM IST

15:32 April 12

Expert panel recommends granting approval to Sputnik V for emergency use in India

New Delhi: An expert panel of India's central drug authority has recommended approving the Russian COVID-19 vaccine Sputnik V for emergency use in the country with certain conditions, sources said.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Monday took up the application of Dr Reddy's Laboratories seeking emergency use authorisation for Sputnik V.

Read:| COVID-19: India to decide emergency use authorisation of Sputnik V vaccine today

The Drugs Controller General of India (DCGI) will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.

The vaccine would be imported from Russia for emergency use in the country, they said.

In September last year, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India.

Read:| Indian Pharma giant to produce 200 million doses of Sputnik V every year

The Drugs Controller General of India (DCGI) has already given the emergency use authorisation for two COVID-19 vaccines -- Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

PTI

Read:| Dr Reddy's plans to launch Sputnik V in India in March

15:32 April 12

Expert panel recommends granting approval to Sputnik V for emergency use in India

New Delhi: An expert panel of India's central drug authority has recommended approving the Russian COVID-19 vaccine Sputnik V for emergency use in the country with certain conditions, sources said.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Monday took up the application of Dr Reddy's Laboratories seeking emergency use authorisation for Sputnik V.

Read:| COVID-19: India to decide emergency use authorisation of Sputnik V vaccine today

The Drugs Controller General of India (DCGI) will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.

The vaccine would be imported from Russia for emergency use in the country, they said.

In September last year, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India.

Read:| Indian Pharma giant to produce 200 million doses of Sputnik V every year

The Drugs Controller General of India (DCGI) has already given the emergency use authorisation for two COVID-19 vaccines -- Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune.

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

PTI

Read:| Dr Reddy's plans to launch Sputnik V in India in March

Last Updated : Apr 12, 2021, 4:10 PM IST
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