The Subject Expert Committee under India’s drug regulatory authority recommended the Russian Covid-19 vaccine Sputnik V for Emergency Use Authorization (EUA) in a review meeting convened on Monday. Its approval is now pending with the Drug Controller General of India, who is likely to give a green signal to make Sputnik V the third Covid-19 vaccine in India.
Dr Reddy’s Laboratories, the Hyderabad-based pharmaceutical company had sought the EUA for the Sputnik V. The firm is in partnership with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V in India. The pact was signed in September last year and the third phase trial of the vaccine is underway in the country.
The Russian vaccine has an efficacy of 91.6% and is conducting its Phase III clinical trials in the UAE, India, Venezuela and Belarus, according to the Sputnik-V’s website.
Apart from Dr Reddy, the RDIF has tied up with a host of Indian pharmaceutical players for home production of the Sputnik V. It has signed the pact with Virchow Biotech Private Limited in March to produce up to 200 million doses per year of the Covid-19 vaccine in India.
The RDIF has also partnered with Stelis Biopharma Pvt Ltd and Panacea Biotec earlier this month to produce 200 million and 100 million doses per year of Sputnik V in the country.