Regulatory Framwork For Approval of Covid-19 Vaccines in India, US and Europe

Abstract

This thesis aims to examine and compare the regulatory frameworks for the approval of COVID-19 vaccines in India, the United States, and Europe. The study includes an analysis of the regulatory processes, guidelines, and requirements that are followed by the regulatory bodies like CDSCO, FDA & EMA for approving vaccines for emergency use during a pandemic. The research provides a detailed overview of the regulatory landscape and the challenges faced by regulators in these regions. Through a comparative analysis, the study highlights the similarities and differences in the regulatory approaches, including the role of clinical trial data, the criteria for efficacy and safety assessment, and the timelines for approval. The findings of the research provide insights into the strengths and weaknesses, presenting possibilities for enhancing the regulatory procedures to guarantee the safety and effectiveness of COVID-19 vaccines. This concludes that while the regulatory frameworks in each region have been effective in ensuring the safety and efficacy of COVID-19 vaccines, there is room for improvement in terms of transparency, speed, and coordination across different regulatory agencies in responding to global health crises such as COVID- 19.