Dr. Reddy's partners with Department of Biotechnology - Biotechnology Industry Research Assistance Council for Sputnik V vaccine clinical trials in India
Dr. Reddy’s Laboratories (NYSE: RDY) announced a partnership with the Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology (DBT) of India for advisory support on the clinical trials of the Sputnik V vaccine. This collaboration allows access to BIRAC's clinical trial centers and Good Clinical Laboratory Practice (GCLP) labs for immunogenicity testing. The approval for conducting phase 2/3 trials in India was granted by the Drugs Controller General of India earlier this month, bolstering efforts to introduce the vaccine in the Indian market.
- Collaboration with BIRAC enhances access to clinical trial centers and GCLP labs.
- Approval received for phase 2/3 clinical trials of Sputnik V vaccine in India.
- None.
HYDERABAD, India--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine 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 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.
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.”
Commenting on the collaboration with Dr. Reddy’s, 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."
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.
About Dr. Reddy’s: Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, hereinafter “Dr. Reddy's”) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.
About RDIF: Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF’s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 tn and covering
About DBT: The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes the use and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment and industry. It is focused on attaining new heights in biotechnology research, shaping biotechnology into a premier precision tool of the future for creation of wealth and ensuring social justice – especially for the welfare of the poor. www.dbtindia.gov.in
About BIRAC: Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by Department of Biotechnology (DBT), Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.
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