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CDSCO asks Biological E, Dr Reddy’s to review covid-19 vaccine trial protocols

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NEW DELHI : An expert panel of the Central Drugs Standards Control Organization (CDSCO) on Thursday asked Dr Reddy’s Laboratories Ltd and Biological E Ltd to review the clinical trial protocols they had submitted for their respective covid-19 vaccine candidates.While Dr Reddy’s Laboratories plans to conduct phase 3 clinical trials for the Sputnik V vaccine candidate, jointly developed by Russian Direct Investment Fund (RDIF) and Gamaleya Research Institute of Epidemiology and Microbiology, Biological E is conducting a trial of the recombinant protein vaccine developed by US’ Baylor College of Medicine.The subject expert committee (SEC) of the CDSCO in a meeting on Monday had said that Dr Reddy’s should follow the regulatory requirements and.

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