Regulatory Gap Analysis and Challenges in the Development of a Novel Candidate Vaccine in India

Abstract: Background: The vaccine is a means to control and eradicate infectious diseases and also to strengthen health systems. There should be a complete ecosystem in a well-defined, transparent, and predictable regulatory system for the development of novel candidate vaccines. There is no specified regulatory pathway provided under the law for the approval of the novel candidate vaccine in the country leading to delays or long developmental timelines. Materials and Methods: A survey was conducted among the experts in the vaccine Industry to identify the gaps and challenges faced by them during development. In this study, a questionnaire has been formulated consisting of questions on the gaps in the regulatory system which came to the fore during the COVID-19 pandemic such as the availability of detailed guidelines for the development, rolling reviews, Immune correlates of protection, animal rule, adaptive clinical study pathway, algorithm/alternate development pathway. They were also requested to choose the areas among the given list requiring a detailed guidance document and also to state three challenges faced for expediting the development of a novel vaccine. Results and Discussion: The results were collated and presented in the form of pie and bar charts and the challenges were summarised in tabular format. The results would provide a roadmap to the Policymakers on the future course of action. Keywords: Novel Candidate Vaccine, Rolling review, Emergency Use authorization (EUA), National Regulatory Authority (NRA), Central Drugs Standard Control Organization (CDSCO).