Regulatory Framework And Approval Process

Regulatory Body	Key Function And Responsibility
CDSCO (Central Drugs Standards Control Organisation)	Functions as national regulatory authority.
PVPI (Pharmacovigilance Program of India)	Review safety data.
NTAGI (National Technical Advisory Group on Immunization)	Reviews disease burden, efficacy, and cost-effectiveness. Recommends new vaccine introduction to Ministry Of Health And Family Welfare.
ITSU (Immunization technical Support Unit)	Supports advisory group technical functions.
AEFI Surveillance System	Monitors safety signals after market introduction.

India lacks vaccine-specific national regulatory authority for licensing, post marketing surveillance, GMP inspection, and clinical trial approval.

Clinical Phase	Detail And Purpose
Preclinical	Identifies target antigen and tests vaccine safety and efficacy in laboratory and animal models.
Phase One	Recruits dozens of participants to test vaccine dose level and safety.
Phase Two	Recruits hundreds of participants to evaluate immunogenicity and safety.
Phase Three	Recruits thousands of participants to establish safety and efficacy.
Phase Four	Postmarketing clinical trials to gather information regarding risks, benefits, and long-term effects. Tests product in special patient populations.

Recently Approved Newer Vaccines

Drugs Controller General Of India approved ten-valent pneumococcal conjugate vaccine (Pneumosil) by Serum Institute Of India for active immunization against invasive disease and pneumonia in infants from six weeks.
Pneumosil contains capsular polysaccharides of ten serotypes conjugated to cross-reactive material.
Subject Expert Committee recommended fourteen-valent vaccine (Biological E) demonstrating noninferiority to thirteen-valent vaccine.
Twenty-valent pneumococcal vaccine licensed since June 2023 for adults over eighteen years.
Thirteen-valent vaccine conjugated to tetanus toxoid (Pneumoguard) licensed for primary series at six, ten, and fourteen weeks.
Typbar-TCV licensed in 2013 for children aged six months and older, demonstrating eighty-one percent efficacy at one year.
Zyvac-TCV and Typhibev received marketing authorizations based on noninferiority trials.

Cervavac granted market authorization as quadrivalent HPV vaccine containing viral proteins of serotypes six, eleven, sixteen, and eighteen.
Cervavac developed by recombinant DNA technology producing noninfectious virus-like particles.
Covaxin approved for children aged six to twelve years as whole virion inactivated vaccine.
Corbevax approved for children aged five to twelve years.
Covovax approved as recombinant nanoparticle vaccine.
ZyCoV-D granted emergency use authorization as plasmid DNA vaccine expressing spike protein.
Thrabis licensed for use above eighteen years as novel three-dose recombinant nanoparticle-based rabies glycoprotein vaccine.
Monoclonal antibodies Twinrab and Rabishield available for postexposure prophylaxis.
Rotavac (live naturally attenuated) and Rotasiil (pentavalent virus) rolled out in national immunization program after successful phase three trials.

Pentavalent meningococcal conjugate vaccine (MenFive) licensed in 2023 for individuals between eighteen and eighty-five years.
MenFive targets serogroups A, C, W, Y, and X.
Quadrivalent meningococcal conjugate vaccines Menactra and Menveo licensed earlier.

Dengvaxia not licensed in India due to requirement of additional safety data and observed increased risk of severe dengue in seronegative individuals.
Qdenga phase three trial data pending in India.
WHO approved RTS,S/AS01 and R21/Matrix-M malaria vaccines globally.
Indian introduction of malaria vaccines awaiting further evaluation in highly endemic tribal and hilly areas.

VPM1002 tuberculosis vaccine currently in phase three clinical trials, engineered as recombinant live attenuated vaccine expressing listeriolysin.
M72/AS01E subunit vaccine candidate undergoing phase three trial.
H4 vaccine combines IC31 adjuvant with antigens.
Generalized modules for membrane antigen-based Shigella vaccine in early-stage clinical trials.
SF2A-TT15 conjugate vaccine targets Shigella flexneri.
ETVAX vaccine against enterotoxigenic Escherichia coli shows potential in phase two trials.

National Vaccine Policy supports Indian vaccine industry.
Department Of Biotechnology, Indian Council Of Medical Research, and Department Of Science And Technology provide liberal support.
Indian manufacturers supply approximately forty-three percent of global universal immunization program vaccines.
Serum Institute Of India leads global production.
Post-pandemic acceleration observed in development of mRNA, DNA, protein subunit, and vector-based vaccine platforms.
Clinical trial networks established for rapid testing during health emergencies.