Dr Reddy's reapplies for DCGI nod to conduct trials of Russian vaccine Sputnik V

Dr Reddy's Laboratories has reapplied for the permission of Drugs Controller General of India (DCGI) to conduct combined phase 2 and phase 3 trials of the Russian coronavirus vaccine candidate Sputnik V in India. The pharma giant has submitted a revised protocol for carrying out clinical trials. This will be a multi-centre, observer-blind, randomised and controlled study.

Earlier this month, the Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee on COVID-19 had asked the pharma firm to re-apply stating that it cannot directly conduct phase 3 trials of the vaccine in India after due deliberations. The CDCSO SEC panel suggested that the Russian COVID-19 vaccine should be tested for safety and efficacy in a smaller trial.

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The panel added safety and immunogenicity data from overseas had a smaller number of participants and there is no data available for the effects of Sputnik V on Indians. Dr Reddy's had sought permission from the DCGI to conduct phase 3 trials of the potential vaccine against COVID-19.

Dr Reddy's has teamed up with Russian Development Investment Fund (RDIF) to conduct trials and distribute 100 million doses of Sputnik V in India. Sputnik V has been jointly developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF.

Also read: Drug regulator declines proposal for large scale trials of Russian vaccine Sputnik V in India

Meanwhile, India is the second worst affected nation due to coronavirus globally as its case tally has surpassed the 72-lakh mark today. Out of these cases, 8, 26,876 are active COVID-19 cases while 63, 01,927 people have recovered from COVID-19. According to the Health Ministry's COVID-19 dashboard, 1,10,586 people have succumbed to novel coronavirus so far.

Edited with PTI inputs

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