Sputnik V India rollout in emergency use authorisation mode expected in March – Times of India

HYDERABAD: The Russian Covid-19 vaccine Sputnik V is expected to be rolled out into the Indian market in March this year in EUA (emergency use authorisation) mode, a top official of Dr Reddy’s Laboratories said on Friday.
“The Phase III (trials) is currently ongoing. We are dosing patients and we expect to complete the dosing as part of Phase III by February. After that we expect to compile the data and submit (application) for EUA…to DCGI (Drugs Controller General of India), Deepak Sapra, CEO, API & Pharmaceutical Services, Dr Reddy’s Laboratories said.
“Based on the approval from DCGI we believe that we should be in a position to launch the vaccine through EUA in the month of March,” he added.
Dr Reddy’s Labs entered into a partnership with Russia’s sovereign wealth fund – Russian Direct Investment Fund (RDIF) to conduct Phase II/III trials of Sputnik V and distribute over 100 million doses of the vaccine in India.
Sapra also said that currently the company does not have any Sputnik V doses available in India and in the initial phases it will be distributing vaccines imported from Russia.
“We don’t have any doses available in India at the moment but we are in discussions with a couple of players to tie up adequate quantities so that with EUA coming in, the amount of vaccines coming into the country can be synchronised plus the amount of vaccines that will be produced within India can be synchronised to build up our overall stocks,” he said.

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