Policy & Regulation
Dr. Reddy's Partners On Sputnik V vaccine Clinical Trials in India
29 October 2020 - - Indian biopharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) has forged a partnership with biotechnology Industry Research Assistance Council (BIRAC), Department of biotechnology, government of India, for advisory support on clinical trials of Sputnik V vaccine in India, the company said.

The partnership will allow Dr. Reddy's to identify and use some of BIRAC's clinical trial centres for the vaccine, which are funded under the National Biopharma Mission, implemented by Project Management Unit-NBM at BIRAC.

Further, the company will have access to Good Clinical Laboratory Practice labs to conduct immunogenicity assay testing of the vaccine.

Earlier this month, Dr. Reddy's and Russia Direct Investment Fund received approval from the Drugs Controller General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.

On August 11, 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 vector platform.

Dr. Reddy's major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe.

Its major markets include USA, India, Russia and CIS countries, and Europe.

Russian Direct Investment Fund is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors.

RDIF acts as a catalyst for direct investment in the Russian economy.

RDIF's management company is based in Moscow.

Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB 1.9tn and covering 95% of the regions of the Russian Federation.

The Department of biotechnology, under the Ministry of Science and Technology, promotes the use and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment and industry.


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