Vaccines development in India: advances, regulation, and challenges

Clinical and Experimental Vaccine Research · 4 authors, 1 centre

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TL;DR

This narrative review outlines the history, regulatory framework, and challenges of vaccine development in India.

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This narrative review provides an overview of vaccine development in India, focusing on its historical context, regulatory framework, and challenges. The authors describe the role of the Central Drugs Standard Control Organisation (CDSCO) as the national regulatory body overseeing clinical trials (Phase I, II, and III) and market approval. The central finding is a description of the established regulatory pathway, not an analysis of specific clinical data.

STUDY TYPE

narrative_review

SPECIALTY

infectious disease

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AI pipeline

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100% · A

ORIGINAL PAPER

PMC10435768

Vaccines development in India: advances, regulation, and challenges

Clinical and Experimental Vaccine Research

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ABSTRACT

One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body’s defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher’s knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

CITATION EXPORT

Rakshita Salalli, Jyoti Ram Dange, Sonia Dhiman et al.. Vaccines development in India: advances, regulation, and challenges. Clinical and Experimental Vaccine Research. (2023). https://doi.org/10.7774/cevr.2023.12.3.193

AUTHORS

4 · 1 CENTRES

Rakshita Salalli, Jyoti Ram Dange, Sonia Dhiman, Teenu Sharma

Chitkara College of Pharmacy, Chitkara University, Punjab, India.