The Hyderabad-based Dr Reddy’s Laboratories, which has collaborated with Russia Direct Investment Fund (RDIF) to conduct clinical trials of COVID-19 vaccine Sputnik V, has applied to the Drugs Controller General of India (DGCI) for permission to conduct the phase-3 human trials in India, PTI reported.

RDIF will supply to drugmaker Dr Reddy’s 100 million doses of the vaccine after regulatory approval, the firm said last month.

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Sputnik V has been developed by Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF.

“The Dr Reddy’s Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against COVID-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval,” a source told PTI.

Sources said it would be multi-centre, observer-blind, randomised controlled study. The phase-3 trial of Sputnik V is underway in Russia since September 1 on around 40,000 subjects, they added.

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Currently, two vaccine candidates, the indigenously developed by Bharat Biotech in collaboration with ICMR and the one developed by Zydus Cadila Ltd, are in phase 2 of human clinical trials.

The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials in India.