According to sources, the SEC approved Dr Reddy’s application for EUA to Sputnik V. The decision comes after the Drugs Controller General of India (DCGI)’s SEC met today to take up Sputnik V application for EUA in India.
Dr Reddy’s Laboratories, last week sought the government’s approval for the vaccine to be used in India. The Russian Direct Investment Fund (RDIF) partnered with Dr Reddy’s in September 2020 to conduct clinical trials of Sputnik V in India.
DCGI had then sought additional data from drugmaker Dr Reddy’s Laboratories on its Sputnik V C-19 vaccine trial.
On Sunday, government sources said that by end of the third quarter of this year, India will be getting vaccines from five additional manufacturers.
“India currently has two C-19 vaccines being manufactured locally: Covishield and Covaxin, and we can expect five more 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 government’s primary concerns while granting emergency use authorisation (EUA) to any C-19 vaccine in the country,” said the sources.
The Russian vaccine has an effectiveness of 91.6 per cent. Russia registered Sputnik V for public use in August, the first country to do so, though the approval came before the start of the large-scale trial in September.
The EUA of Sputnik V comes at a time when India is facing the second wave of C-19 pandemic with the number of new cases increasing each day.
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