Ensuring global health: a comprehensive review of vaccine regulation with a focus on the Indian perspective
DOI:
https://doi.org/10.18203/2394-6040.ijcmph20240295Keywords:
Vaccines, Regulation, National Regulatory Authorities, WHO, Legal framework, Safety, EfficacyAbstract
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.
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References
WHO. National regulatory authorities for vaccines, 2021. Available at: https://www.who.int/teams/regulationprequalification/regulatory-authorities. Accessed on 23 May 2023.
European Medicines Agency. How medicines are approved in Europe, 2021. Available at: https://www.ema.europa.eu/en/humanregulatory/overview/authorisation-medicines. Accessed on 23 May 2023.
WHO. Global Vaccine Action Plan, 2021. Available at: https://www.who.int/teams/immunization-vaccines-and-biologicals/strategies/global-vaccine-action-plan. Accessed on 23 May 2023.
United States Food and Drug Administration. Biologics License Applications (BLA) Process (CBER), 2021. Available at: https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber. Accessed on 23 May 2023.
WHO. Emergency use listing procedure (EUL), 2021. Available at: https://www.who.int/news-room/q-a-detail/emergency-use-listing-procedure-(eul). Accessed on 23 May 2023.
Central Drugs Standard Control Organization. About CDSCO, 2021. Available at: https://cdsco.gov.in/opencms/opencms/en/About-CDSCO/. Accessed on 23 May 2023.
The Indian Express. Fact sheet: Shortage of vaccine raw materials, SII CEO to Biden: End export embargo, 2021. Available at: https://indianexpress.com/article/india/covid-vaccine-export-raw-material-sii-adar-poonawalla-serum-institute-7277089. Accessed on 23 May 2023.
Dixon JR. The International Conference on Harmonization good clinical practice guideline. Qual Assur. 1998;6(2):65-74.
Coalition for Epidemic Preparedness Innovations. CEPI policy documentation: equitable access policy, 2017. Available at: https://msfaccess.org/sites/default/files/2018-09/CEPIoriginalPolicy_2017.pdf. Accessed on 23 May 2023.
Puyvallée A, Storeng KT. COVAX, vaccine donations and the politics of global vaccine inequity. Global Health. 2022;18(1):26.
Towse A, Chalkidou K, Firth I. How should the world pay for a coronavirus disease (COVID-19) vaccine? Value Health. 2021;24:625-31.
Bollyky TJ, Gostin LO, Hamburg MA. The equitable distribution of COVID-19 therapeutics and vaccines. JAMA. 2020;323:2462.