According to sources, the SEC accepted Dr Reddy’s utility for EUA to Sputnik V.
The resolution comes after the Drugs Controller General of India (DCGI)’s SEC met in the present day to take up Sputnik V utility for EUA in India.
Dr Reddy’s Laboratories, final week sought the federal government’s approval for the vaccine for use in India. The Russian Direct Investment Fund (RDIF) partnered with Dr Reddy’s in September 2020 to conduct medical trials of Sputnik V in India.
DCGI had then sought further information from drugmaker Dr Reddy’s Laboratories on its Sputnik V Covid-19 vaccine trial.
India is at the moment manufacturing two Covid-19 vaccines, — Serum Institute of India’s locally-made Oxford Covid-19 vaccine ‘Covishield’ and Bharat Biotech’s indigenously manufactured Covaxin.
On Sunday, authorities sources stated that by finish of the third quarter of this yr, India can be getting vaccines from 5 further producers.
“India at the moment has two Covid-19 vaccines being manufactured regionally: Covishield and Covaxin, and we are able to count on 5 extra vaccines by Q3 2021. These vaccines are Sputnik V vaccine (in collaboration with Dr. Reddy’s), Johnson & Johnson vaccine (in collaboration with Biological E), Novavax vaccine (in collaboration with Serum India), Zydus Cadila’s vaccine, and Bharat Biotech’s Intranasal Vaccine. Safety and efficacy are the Union authorities’s main issues whereas granting emergency use authorisation (EUA) to any Covid-19 vaccine in the nation,” stated the sources.
The Russian vaccine has an effectiveness of 91.6 per cent. Russia registered Sputnik V for public use in August, the primary nation to take action, although the approval got here earlier than the beginning of the large-scale trial in September.
The EUA of Sputnik V comes at a time when India is dealing with the second wave of Covid-19 pandemic with the variety of new circumstances growing every day.