The Drug Controller General of India (DCGI) has declined the proposal of pharma company Dr Reddy’s Laboratories to conduct Phase 3 trials for Sputnik V. Instead of jumping straight to a large-scale trial, Dr Reddy’s has been advised to consider a small trial first.
Russia has held Phase 3 trials for the vaccine since 1 September on around 40,000 subjects. However, according to the Subject Expert Committee which looked into Dr Reddy’s proposal, “the safety and immunogenicity data in overseas Phase I/II studies is small and there is no data available on Indian subjects”. “After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct Phase II/ III clinical trial in the country with proper monitoring for humoral & cell-mediated immune response,” it further said. The committee has also said that the firm should submit the protocol for the consideration of the committee.
