Dr Reddy's Laboratories seeks DCGI nod to conduct phase III trials of Sputnik V vaccine

Indian pharmaceutical Dr Reddy's Laboratories has sought permission from Drugs Controller General of India (DCGI) to perform phase III clinical trials of Russia's COVID-19 vaccine Sputnik V in India, said a government official on Friday. Recently, Dr Reddy's laboratory joined hands with Russian Direct Investment Fund (RDIF) to conduct Sputnik V vaccine clinical trials and for its distribution. In response to application submitted by Indian Pharma giant, drugs regulator will conduct a technical evaluation of application. 

official said, "Before giving permission, drugs regulator will conduct a technical evaluation of application submitted by Dr Reddy's lab to conduct Phase III clinical trials in India of Russian COVID-19 vaccine."

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Dr Reddy's laboratories ask DCGI permission for phase III trials

As per officials, phase III clinical trials of COVID-19 vaccine Sputnik V will be multi-centre, observer-blind and randomised controlled study. CEO of RDIF Kirill Dmitriev said that Russia is in discussion with Indian government for localised production of Sputnik V in country. results of phase I-II trials of Russia's COVID-19 vaccine were published by a medical journal Lancet. On August 11, Sputnik V vaccine which was developed jointly by RDIF and Gamaleya National Research Centre of Epidemiology and Microbiology became world's first registered vaccine for Coronavirus. According to researchers, Sputnik V is a human adeviral vector vaccine which fights against COVID-19 disease. 

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COVID-19 outbreak in India

As Coronavirus cases continue to increase across globe, India has breached 63 Lakh mark. So far, India has recorded over 63,94,068 positive COVID-19 cases out of which 53,52,078 have recovered while 99,773 have died. Currently, 9,42,217 cases are active in country. MoHFW reported that in past 24 hours 81484 new cases, 1095 deaths and 78877 recoveries have been recorded. As per latest update from Indian Medical Council of India (ICMR), 7,67,17,728 successful Coronvirus tests have been conducted in India until October 1. 

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(With ANI inputs)