Clinical and Experimental Vaccine Research

  • 제12권3호
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  • Pages.193-208
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  • 2023
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  • 2287-3651(pISSN)
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  • 2287-366X(eISSN)
대한백신학회 (The Korean Vaccine Society)
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Vaccines development in India: advances, regulation, and challenges

  • Rakshita Salalli (Chitkara College of Pharmacy, Chitkara University) ;
  • Jyoti Ram Dange (Chitkara College of Pharmacy, Chitkara University) ;
  • Sonia Dhiman (Chitkara College of Pharmacy, Chitkara University) ;
  • Teenu Sharma (Chitkara College of Pharmacy, Chitkara University)
  • 투고 : 2023.01.02
  • 심사 : 2023.05.05
  • 발행 : 2023.07.31
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초록

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.

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