Official sources on Saturday said that India’s central drug authority’s expert panel has recommended the permission for conducting phase-3 clinical trial of single-dose COVID-19 vaccine ‘Sputnik Light’ as a booster dose. For the final approval, these recommendations have sent to the Drugs Controller General of India (DCGI).
Emergency Use Permission Granted
Subject to certain regulatory provisions, On February 4, the Drugs Controller General of India granted emergency use permission to Sputnik Light vaccine in India
For conducting the phase-3 trial of Sputnik Light vaccine as booster dose, Hyderabad-based Dr. Reddy’s Laboratories had presented its proposal to DCGI. Sputnik Light is the same as component-1 of Sputnik V.
SEC Granted Conditional Permission
An official source said that “The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the phase-3 clinical trial with condition to initiate the trial with Sputnik Light vaccine for which the firm is holding emergency use authorisation permission in the country subject to certain regulatory provisions”. Sputnik Light vaccine is approved in 29 countries, including Argentina and Russia.