Policy & Regulation
Dr Reddy's seeks Emergency Use Authorization for Sputnik V in India
19 February 2021 -

Pharmaceutical company Dr Reddy's Laboratories Ltd (BSE:500124) (NSE:DRREDDY) (NYSE:RDY) has initiated the process for Emergency Use Authorization (EUA) of Russian COVID-19 vaccine Sputnik V in India, the company said on Friday.

As part of the review process, Dr Reddy's will present the Drugs Controller General of India (DCGI) with the safety profile of the phase 2 study and interim data from the phase 3 study, which is expected to be completed by 21 February 2021.

Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V and for its distribution rights in India.

The vaccine reportedly demonstrated an efficacy rate of 91.6% in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia who received both the first and second doses of the vaccine.

"The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India," said G V Prasad, co-chairman and managing director of Dr Reddy's.