India To Review Approval Request For Russia's Sputnik V Vaccine On Thursday - Reports

A subject expert committee of India's Central Drugs Standard Control Organisation will consider later on Thursday the application of local pharmaceutical company Dr. Reddy's Laboratories for an emergency use approval of Russian coronavirus vaccine Sputnik V, The Hindu newspaper reported, citing company sources

NEW DELHI (UrduPoint News / Sputnik - 01st April, 2021) A subject expert committee of India's Central Drugs Standard Control Organisation will consider later on Thursday the application of local pharmaceutical company Dr. Reddy's Laboratories for an emergency use approval of Russian coronavirus vaccine Sputnik V, The Hindu newspaper reported, citing company sources.

Dr. Reddy's, the Indian manufacturer of the Russian vaccine, applied for an emergency use authorization for the drug back in February, but the Indian regulator requested additional immunogenicity and safety data of Phase 2 and 3 clinical trials held in India.

The pharmaceutical company has since submitted the additional data and expects the data analysis of Phase 3 clinical trials to be ready in early April, the newspaper reported on Wednesday.

If approved, Sputnik V will be the third vaccine registered in India, along with Covishield � an India-produced version of the AstraZeneca vaccine � and homegrown Covaxin by Bharat Biotech.

With the Sputnik V trials in India nearing completion, the Russian Direct Investment Fund, Russia's sovereign wealth fund that is behind Sputnik V exports, has concluded technology transfer agreements with four local manufacturers � Hetero Biopharma, Gland Pharma, Virchow Biotech and Stelis Biopharma. In total, the companies are set to produce more than 750 million doses of the vaccine.