Ensuring global health: a comprehensive review of vaccine regulation with a focus on the Indian perspective

Abstract

The regulation of vaccines is crucial for ensuring public health and safety. A global perspective on vaccine regulation, with focus on the Indian approach in vaccine regulation, was analysed. The historical evolution of vaccine regulation, highlights significant events that shaped regulatory systems. The role of National Regulatory Authorities (NRAs) in ensuring the safety, efficacy, and quality of vaccines is discussed, along with the pivotal role of the WHO through its prequalification program. The stages of the regulatory review process, including pre-licensure review and post-licensure surveillance, are outlined. The Indian perspective is examined, with a focus on the Central Drugs Standard Control Organization (CDSCO) as the primary regulatory authority. The rigorous vaccine approval process, emergency use authorization, vaccine distribution, and administration, as well as post-marketing surveillance, are discussed. The Indian government's participation in international collaborations and emphasis on indigenous vaccine development are highlighted. This comprehensive review highlights the importance of vaccine regulation and the efforts undertaken by the Indian government to ensure the safety, efficacy, and accessibility of vaccines.