On Tuesday, Dr. Reddy’s Laboratories Ltd. and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India.
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.”
This will be a multicentre and randomised controlled study, which will include safety and immunogenicity study. The clinical trials are being conducted by JSS Medical Research as the clinical research partner.
In addition, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support and to use BIRAC’s clinical trial centres for the vaccine.
