HYDERABAD: City-based Dr. Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) on Tuesday announced that they have commenced the adaptive Phase 2/3 clinical trials in India for the Sputnik V vaccine against Covid-19, following necessary clearances from the Central Drugs Laboratory, Kasauli.
The phase 2 trial involves 100 volunteers, according to information shared by Dr. Reddy's.
These clinical trials will be a multicenter and randomized controlled study, which will include a safety and immunogenicity study and are being conducted by JSS Medical Research as the clinical research partner.
In a press release on Tuesday, Dr. Reddy's informed that it has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine.
G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.”
Dr. Reddy's and RDIF had received the clearance from the Drugs Controller General of India in October to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in India. They entered into a partnership to conduct clinical trials of the Sputnik V vaccine and its distribution in the country, as part of which the RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.