Dr Reddy's Laboratories Ltd on Thursday announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), for advisory support on clinical trials of Sputnik V vaccine in India.
According to a press release from the city-based drug maker, 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 (NBM), implemented by Project Management Unit-NBM at BIRAC.
Further, the company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine. Immunogenecity refers to the ability of an antigen to induce an immune response.
Chairman of Dr Reddy's Laboratories, Satish Reddy said, "We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India."
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, "The government is committed to fast track clinical development of COVID-19 vaccine candidates and provide facilitation to accelerate market readiness of a suitable vaccine. We at DBT look forward to this partnership with Dr Reddy' s for this Indo Russian Collaboration for Vaccine Development."
Earlier this month, Dr Reddy's and Russia Direct Investment Fund (RDIF) received approval from the Drugs Controller General of India (DCGI) 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.