Dr Reddy's OKed to conduct Phase II/III trial for Sputnik V vaccine in India

Indian generics drug major Dr Reddy’s Laboratories (BSE: 500124) and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, have received approval from the Drug Control General of India (DCGI) to conduct an adaptive Phase II/III human clinical trial for Sputnik V COVID-19 vaccine in India. This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study.

Earlier in September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.

Dr Reddy’s co-chairman and managing director G V Prasad commented: “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.”