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 the Russian Direct Investment Fund (RDIF) to conduct Sputnik V vaccine clinical trials and for its distribution. In response to the application submitted by the Indian Pharma giant, the drugs regulator will conduct a technical evaluation of the application. 

The official said, "Before giving permission, the drugs regulator will conduct a technical evaluation of the 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 the officials, the 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 the Indian government for the localised production of Sputnik V in the country. The results of phase I-II trials of Russia's COVID-19 vaccine were published by a medical journal The Lancet. On August 11, the Sputnik V vaccine which was developed jointly by RDIF and the Gamaleya National Research Centre of Epidemiology and Microbiology became the world's first registered vaccine for Coronavirus. According to the researchers, Sputnik V is a human adenoviral vector vaccine which fights against the COVID-19 disease. 

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COVID-19 outbreak in India

As the Coronavirus cases continue to increase across the 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 the country. MoHFW reported that in the past 24 hours 81484 new cases, 1095 deaths and 78877 recoveries have been recorded. As per the latest update from the 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)