New Delhi: The Union government’s expert panel has rejected the proposal by Dr Reddy’s Laboratories to evaluate Russia’s Covid-19 vaccine in a Phase III clinical trial. It has instead recommended a Phase II trial, which is held among a smaller number of participants.
Dr Reddy’s had proposed to test Sputnik V vaccine, which has been found to produce an immune response with no serious adverse effects, in Phase III clinical trial.
The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.
The Subject Expert Committee (SEC) 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, the sources told news agency Press Trust of India.
The SEC advises the apex drug regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials.