Therapy Areas: Vaccines
Dr. Reddy's and RDIF announces DCGI approval to launch clinical trial for Sputnik V vaccine in India
19 October 2020 -

Pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE:500124) (NYSE:RDY) and Russia's sovereign wealth fund Russian Direct Investment Fund (RDIF) Saturday jointly announced the receipt of 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.

The multi-centre and randomized controlled study of Sputnik V vaccine will include a safety and immunogenicity study. RDIF shall supply 100m doses of the vaccine to Dr. Reddy's upon regulatory approval in India.

On 11 August 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform.

Currently, the Sputnik V is undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week, concluded the companies.

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