Dr Reddy's partners with BIRAC for Sputnik V trials in India

Pharma major Dr Reddy's on Thursday said it has entered into a partnership with Biotechnology Industry Research Assistance Council (BIRAC) set up by the Department of Biotechnology (DBT) for advisory support on clinical trials of Russian Covid-19 vaccine, Sputnik V, in India.

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 the Project  Management Unit-NBM at BIRAC.

The company will also 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 statement.

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 the Sputnik V vaccine in India.

"The government is committed to fast track clinical development of COVID vaccine  candidates and provide facilitation to accelerate market readiness of a suitable vaccine," said Renu Swarup, Secretary, DBT and Chairperson, BIRAC.

On August 11, 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.