Related Experiment Video
Updated: Jul 18, 2025
07:44
Fabrication of Pulsatile Polymeric Microparticles Encapsulating Rabies Antigen
Published on: May 12, 2023
1.2K
Vaccines development in India: advances, regulation, and challenges
Rakshita Salalli1, Jyoti Ram Dange1, Sonia Dhiman1
1Chitkara College of Pharmacy, Chitkara University, Punjab, India.
Clinical and Experimental Vaccine Research
|August 21, 2023
Summary
Vaccine development, a key medical innovation, requires rigorous testing for effectiveness and safety. India
Area of Science:
- Medical Science
- Immunology
- Public Health
Background:
- Vaccine development is a significant medical advancement driven by scientific innovation.
- Vaccines are crucial biological products that bolster the body's immunity against infectious diseases.
- India has a long history of vaccine development, from smallpox to recent COVID-19 vaccines.
Purpose of the Study:
- To provide an overview of vaccine development regulations in India.
- To detail the registration and approval procedures for vaccines.
- To highlight the historical context of vaccine development in India.
Main Methods:
- Review of historical vaccine development milestones.
- Analysis of regulatory frameworks, including the Drugs and Cosmetics Rules, 1945, and New Drugs and Clinical Trials Rules, 2019.
- Examination of Chemistry, Manufacturing, and Controls (CMC) requirements for vaccine approval.
Main Results:
- Vaccine development necessitates comprehensive data on effectiveness, immunogenicity, and safety for marketing approval.
- Regulatory guidelines in India ensure the quality and safety of manufactured and imported vaccines.
- Scientific innovation and regulatory compliance are key to reducing global disease burden.
Conclusions:
- India has established a robust regulatory system for vaccine development, registration, and approval.
- Adherence to regulations like CMC is essential for vaccine market authorization.
- Continued scientific advancement in vaccinology is vital for public health protection.
More Related Videos
10:16Efficient Transfection of In vitro Transcribed mRNA in Cultured Cells Using Peptide-Poloxamine Nanoparticles
Published on: August 17, 2022
3.3K
05:15Detection of Neutralization-sensitive Epitopes in Antigens Displayed on Virus-Like Particle VLP-Based Vaccines Using a Capture Assay
Published on: February 10, 2022
3.7K
Related Concept Videos
01:51Vaccinations
44.7K
Overview
44.7K
01:29Microorganisms in Medicine and Therapeutics
54
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
54
01:11Clinical Trials: Overview
3.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.0K
01:28Preclinical Development: Overview
4.5K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.5K
01:22Development of Immunocompetence
342
The initiation of cell-mediated immunity can be observed as early as the third month of fetal growth, with active antibody-mediated immunity following approximately one month later.
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
342
01:30Cancer Vaccines
400
Cancer treatment vaccines are a rapidly evolving field that offers a promising approach to immunotherapy. Unlike traditional vaccines that prevent diseases, cancer treatment vaccines are designed to treat existing cancers by stimulating the immune system to recognize and attack cancer cells.
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
Cancer vaccines come in two categories: preventive (prophylactic) and treatment (active). Preventive vaccines, such as the Human Papillomavirus (HPV) vaccine, protect against viruses that cause certain...
400