Vaccines development in India: advances, regulation, and challenges
Open accessAbstract
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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Regulatory bodies have been cautious in approving AI-driven technologies due to concerns about data privacy, ethical implications, and patient safety.
“These bodies have been cautious in approving AI-driven technologies due to concerns about data privacy, ethical implications, and patient safety (Salalli et al., 2023).”
From Exploring the antecedents of AI adoption for effective HRM practices in the Indian pharmaceutical sector (2023) · cites this paper as Salalli et al., 2023
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References 54 · Cited by 20
Research works printed but not linked: 3
- [43]Milstien JB Batson A Wertheimer AI Vaccines and drugs: characteristics of their use to meet public health goals [Internet] Washington (DC) World Bank 2005 cited 2022 Sep 20 Available from: https://www.researchgate.net/publication/228615171_Vaccines_and_Drugs_Characteristics_of_Their_Use_to_Meet_Public_Health_Goals
- [49]Clark EM Pippin MM Safe and effective administration of vaccines and epinephrine autoinjection Treasure Island (FL) StatPearls Publishing 2023 33620849
- [57]Bharat Biotech Bharat Biotech’s iNCOVACC world’s first intra nasal vaccine receives approval for emergency use in India [Internet] Hyderabad Bharat Biotech 2022 cited 2022 Oct 5 Available from: https://www.bharatbiotech.com/images/press/Bharat-Biotech-iNCOVACC-Worlds-First-Intra-Nasal-Vaccine-Receives-Approval.pdf
- Authors
- Salalli, R., Dange, J. R., Dhiman, S., & Sharma, T.
- Affiliations
- Chitkara University (IN)
- Corresponding author
- Sharma, Teenu
- Venue
- Clinical and Experimental Vaccine Research
- Publisher
- XMLink
- Published
- 2023
- Volume
- 12
- Issue
- 3
- Pages
- 193
- ISSN
- 2287-3651 (ISSN-L)
- 2287-366X
- PMC
- PMC10435768
- OpenAlex
- W4385832451
- Cited by
- 20
- References
- 54
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 6 · 2023: 1
- FWCI
- 0.78
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Clinical and Experimental Vaccine Research (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Biotechnology and Related Fields
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Keywords
- vaccine development, vaccine regulation, vaccine registration, marketing approval, chemistry, manufacturing and controls, vaccine safety and immunogenicity, COVID-19 vaccines, history of vaccination, India
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