Dr Reddy’s Laboratories Ltd has teamed up with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Russia’s Sputnik V Covid-19 vaccine in India.
The partnership will allow Hyderabad-based 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.
“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,'' Satish Reddy, Chairman, Dr Reddy’s Laboratories, said in a release on Thursday.
Commenting on the collaboration, Renu Swarup, Secretary, DBT, and Chairperson, BIRAC, said: "The government is committed to fast track clinical development of Covid 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.