HYDERABAD: Hyderabad-based Dr Reddy’s Laboratories and the Russian Direct Investment Fund announced on Tuesday that they have commenced the adaptive Phase 2/3 clinical trials for the Sputnik V vaccine in India to fight Covid-19, after receiving necessary clearances from the Central Drugs Laboratory, Kasauli. The Phase 2 trial involves 100 volunteers, stated a release by Dr Reddy’s.
This clinical trials will be a multi-centre and randomised controlled study, which will include safety and immunogenicity study and are being conducted by JSS Medical Research. In a press release on Tuesday, Dr Reddy’s said it had 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.
GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “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 Drugs Controller General of India in October to conduct adaptive Phase 2/3 human clinical trial for the Sputnik V vaccine in India. They entered into a partnership to conduct clinical trials for 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.