Dr Reddys, RDIF get DCGI nod for Russian Covid vaccine trial
Hyderabad: Dr. Reddy's Laboratories Ltd. and Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has recently announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.
This will be a multicenter 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.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy's Laboratories, said "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."
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