The Central Drugs Standard Control Organisation (CDSCO) 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, the Government said on Tuesday.
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 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 firm has been asked to provide some other information as well.
In reply to a media query here at a press briefing, Union Health Secretary Rajesh Bhushan said that the Russian vaccine has an agreement with an Indian commercial entity (Dr Reddy’s Lab) which has approached the Indian regulator (DCGI) for clinical trials and that the regulator has given some suggestions which need to be incorporated by the entity.