No matter how keen the Russian Direct Investment Fund (RDIF) is on bringing its Sputnik V to the Indian soil, the sovereign wealth fund’s distribution partner in India — Dr Reddy’s Laboratories (DRL) — is yet to file a formal application to start Phase 3 clinical trials (part of a multi-centre bridge trial of Sputnik V over 1,000 volunteers) here, said sources at the Central Drugs and Standards Control Organisation.
Sources further added that there were no plans for any emergency-use authorisation of the Sputnik V without relevant and convincing local data.
An email sent to DRL remained unanswered till the time of going to press.
Speaking at a webinar, Tagir Sitdekov, first deputy chief executive officer of RDIF, said they planned to start clinical trials here soon and that there have been no adverse side-effects so far. Five-thousand volunteers have received the jab.
Russia has started production of the vaccine at two facilities owned by the RDIF. The Gamaleya Research Institute of Epidemiology and Microbiology, too, has started production.
Sitdekov said RDIF is already in talks with Indian players for contract manufacturing the Sputnik V. No deal has been signed yet. Russia is also scouting for partners in China, Korea, and Brazil, apart from India.