Establishing and Leveraging Clinical Trial Networks and Health Surveillance Systems: Crucial Strategies During the COVID Pandemic
摘要
Department of Biotechnology (DBT), Ministry of Science and Technology, launched the National Biopharma Mission (NBM) or Innovate in India for Inclusiveness (i3) in 2017. The program was co-funded by a World Bank loan and the Government of India and was implemented through Biotechnology Industry Research Assistance Council (BIRAC). The focus of the program was to bolster national product development capabilities in vaccines, biotherapeutics (including monoclonal antibodies), and medical devices to a globally competitive level over the next decades. Additionally, the imperative of strengthening the ecosystem to enhance clinical research capabilities, particularly competence, to undertake nonregulatory and regulatory compliant trials was also considered as a priority investment domain. The impact of the National Biopharma Mission led to the establishment of a strong clinical trial sites network with access to over 8,00,00 healthy population and establishment of disease registeries at hospital sites.