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Dr Reddy's asked to resubmit application for both phase 2,3 trials of Russian COVID-19 vaccine Sputnik V

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Dr Reddy's laboratories will have to submit a new application. According to the SEC, they have to conduct both phase-2 and 3 clinical trials and cannot directly hold phase-3 trial for the vaccine in India," a source said.The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V vaccine as well as for its distribution.Upon regulatory approval in India, RDIF shall supply to drug maker Dr Reddy's 100 million doses of the vaccine, the firm had said last month.According to sources, it would be multi-centre, observer-blind, randomised controlled study.Sources said, meanwhile, the phase -3 trial of Sputnik V is underway in Russia since September 1 on around 40,000.

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