Dr Reddy’s joins hands with BIRAC for Sputnik V clinical trials

HYDERABAD: Pharma major Dr Reddy’s Laboratories has entered into a partnership with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), government of India, for advisory support on clinical trials of Russian Covid-19 vaccine Sputnik V in India.

The company said the partnership will enable it 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.

The company will also have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine thanks to the tie up.

Commenting on the collaboration, Dr 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.”

Satish Reddy, Chairman, Dr Reddy’s Laboratories 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.”

It was only in mid October 2020 that 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.

The Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020, becoming the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.

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