Sputnik V to enter the Indian market for emergency usage

Hyderabad: Sputnik V, the Russian Covid – 19 vaccine, is likely to enter India in emergency use authorization (EUA) mode in the next month, according to a statement given by a top official from Dr. Reddy’s Laboratories on Friday.

Deepak Sapra, CEO, API & Pharmaceutical Services, Dr. Reddy’s Laboratories has commented, “The Phase 3 (trials) is currently ongoing. We have completed 70% of the subject dosing for Phase 3 and expect to complete the dosing by February. After that, we expect to compile the data and submit (application) for EUA…to DCGI (Drugs Controller General of India) in March. Based on the approval from DCGI we believe that we should be in a position to launch the vaccine through EUA in March”.

Sapra has stated that the company signed a contract of 12 months with a local player to vaccinate 125 million people, which constitutes only 9% of the total Indian population as there is no Sputnik V doses available in India.

He further added that in the initial position imported vaccines from Russia would be distributed by the company. He also said, “We are in discussion with a couple of players to tie up adequate quantities (for manufacturing) so that with EUA coming in, the amount of vaccines coming into the country…plus the amount of vaccines that will be produced within India can be synchronized to build up our overall stocks”.

In Sapra’s opinion, the company has not yet decided the price of the vaccine in India but is expecting to work closely with the Indian government for the supply. The Indian private markets are also been taken into consideration.

In order to conduct the phase 2 and 3 trials of the Sputnik V vaccine and to distribute over 100 million doses in India, Dr Reddy’s Labs has entered into a partnership with the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund.

As a part of bridging Phase 2 and 3 study for the assessment of the safety and immunogenicity of the Russian vaccine, the Phase 3 trials are currently being conducted with 1,500 Indian volunteers. In the Phase 2 trials, the vaccine was tested on 100 Indian volunteers.