Dr Reddy’s asked to resubmit application for both phase 2,3 trials of Russian COVID-19 vaccine Sputnik V
4 years, 2 months ago

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

Live Mint  

New Delhi: An expert panel at the Central Drugs Standard Control Organisation has asked Dr Reddy's Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against COVID-19, Sputnik V, in India, sources said Monday. The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine. The Subject Expert Committee on COVID-19 at the CDSCO, which held its meeting on Monday, deliberated on the application and asked the firm to submit a revised protocol stating it will have to conduct combined phase 2 and 3 clinical trials, sources told PTI. Currently two indigenously developed vaccine candidates, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila Ltd, are in the phase 2 of the human clinical trials.

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