National Immunization Programmes and Vaccine Policy Frameworks in India

India runs one of the largest public health immunization operations in the world, targeting millions of newborns, infants, and pregnant women every year. The national policy framework provides free vaccines against preventable life-threatening diseases through a structured schedule. The program relies on domestic vaccine manufacturing, an expansive cold chain logistics network, and digital beneficiary tracking across both urban and rural areas.

Evolution of Immunization Policy

The formal immunization drive in India began as a basic child survival strategy and expanded into a comprehensive universal framework.

• Expanded Programme on Immunization (1978): Launched by the Ministry of Health and Family Welfare following the global eradication of smallpox, introducing basic childhood vaccines like BCG, DPT, and Typhoid.
• Universal Immunization Programme (1985): EPI was restructured as the Universal Immunization Programme (UIP) to protect infants against six major diseases and cover pregnant women with Tetanus Toxoid.
• National Technology Mission on Immunization (1986): Integrated into the Prime Minister’s Technology Missions to achieve self-reliance in vaccine production and cold chain infrastructure.
• Child Survival and Safe Motherhood (1992): Merged UIP into broader maternal and child health interventions, which later transitioned into the Reproductive and Child Health (RCH) program.
• National Health Mission Integration: UIP currently functions as an integral vertical under the National Health Mission (NHM).

Diseases Covered Under the Universal Immunization Programme

The Universal Immunization Programme protects children and pregnant women against twelve vaccine-preventable diseases.

Nationally Administered Vaccines

• Diphtheria: Caused by Corynebacterium diphtheriae; protected via Pentavalent and DPT vaccines.
• Pertussis (Whooping Cough): Caused by Bordetella pertussis; administered through Pentavalent and DPT boosters.
• Tetanus: Caused by Clostridium tetani; prevented via Td (Tetanus and adult Diphtheria) in pregnant women and adolescents.
• Polio: Administered via Bivalent Oral Polio Vaccine (bOPV) and Fractional Inactivated Polio Vaccine (fIPV).
• Tuberculosis: Prevented by Bacillus Calmette-Guérin (BCG) given at birth.
• Measles and Rubella: Prevented via the combined MR vaccine.
• Hepatitis B: Administered as a birth dose within 24 hours, followed by three doses via the Pentavalent vaccine.
• Meningitis and Pneumonia caused by Hib: Prevented via the Haemophilus influenzae type b component in the Pentavalent vaccine.

Regionally and Nationally Expanded Vaccines

• Rotavirus Diarrhoea: Rotavirus vaccine (RVV) is provided nationwide in oral liquid/drop form.
• Pneumococcal Disease: Pneumococcal Conjugate Vaccine (PCV) protects against Streptococcus pneumoniae pneumonia and meningitis across all states.
• Japanese Encephalitis: JE vaccine is provided in endemic districts across targeted states, primarily in the river basins of Uttar Pradesh, Bihar, Assam, and West Bengal.

Mission Indradhanush and Catch-Up Strategies

The Ministry of Health and Family Welfare launched Mission Indradhanush in December 2014 to cover unvaccinated and partially vaccinated children and pregnant women in low-coverage pockets.

Phases of Intensification

• Intensified Mission Indradhanush (IMI 1.0, 2017): Focused on low-performing districts and urban slums to achieve more than 90% full immunization coverage.
• IMI 2.0 (2019–2020): Targeted hard-to-reach tribal blocks and celebrated 25 years of Pulse Polio.
• IMI 3.0 (2021): Focused on reaching children who missed routine vaccination doses during the COVID-19 pandemic disruptions.
• IMI 4.0 (2022): Expanded routine immunization systematically across 416 districts in three rounds.
• IMI 5.0 (2023): Conducted across all districts in India, focusing on expanding Measles and Rubella elimination campaigns for children up to 5 years.

Digital Tracking and Cold Chain Infrastructure

A national network preserves vaccine potency from the manufacturing plant to the beneficiary.

Cold Chain Network

• Temperature Regimes: Vaccines are stored between +2°C and +8°C in Ice-Lined Refrigerators (ILRs), while OPV is stored at -15°C to -25°C in Deep Freezers at regional depots.
• Equipment: Cold chain points utilize walk-in coolers (WIC), walk-in freezers (WIF), ILRs, deep freezers, cold boxes, and vaccine carriers lined with conditioned ice packs.
• Electronic Vaccine Intelligence Network (eVIN): A digitized system that provides real-time visibility into vaccine stock levels and storage temperatures across all cold chain points in the country.

U-WIN Portal

• Adapted from the Co-WIN digital platform used during the COVID-19 pandemic.
• Acts as a single national registry for tracking vaccination status of every pregnant woman and newborn child.
• Generates automated SMS alerts for upcoming doses and issues verifiable digital immunization certificates with QR codes.

National Vaccine Regulatory Framework

India operates a multi-tier regulatory architecture to ensure vaccine safety, batch testing, and post-licensure monitoring.

• National Regulatory Authority (NRA): Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), grants market authorization and clinical trial permissions.
• Central Drugs Laboratory (CDL), Kasauli: The statutory national control laboratory responsible for testing and batch release of all immunobiologicals before public distribution.
• National Technical Advisory Group on Immunization (NTAGI): Apex technical body that reviews epidemiological data, cost-effectiveness, and disease burden before recommending new vaccines for the UIP.
• National AEFI Committee: Investigates Adverse Events Following Immunization to track clinical safety signals and monitor causality assessment.

Facts on Immunization in India

• India was declared polio-free by the World Health Organization on March 27, 2014, along with the South-East Asia Region.
• The last wild poliovirus case in India was reported from Howrah, West Bengal, on January 13, 2011.
• India validated the elimination of Maternal and Neonatal Tetanus (MNT) in May 2015, ahead of the global target date.
• Pulse Polio Immunization Programme was started in India in 1995 following the WHO Global Polio Eradication Initiative.
• National Immunization Day (NID), popularly called Polio Ravivar, is conducted annually to provide oral polio drops to all children under five years of age.
• The Td vaccine replaced the traditional Tetanus Toxoid (TT) vaccine in the UIP schedule to provide booster immunity against diphtheria in older age groups.
• Shake Test is a field test used by cold chain handlers to check if freeze-sensitive vaccines (such as DPT, Hepatitis B, and TT) have suffered irreversible damage from freezing temperatures.
• The BCG vaccine was developed by French scientists Albert Calmette and Camille Guérin and was first used on humans in 1921.
• India is the largest supplier of DPT, BCG, and Measles vaccines to United Nations agencies like UNICEF and PAHO.
• Pasteur Institute of India (Coonoor) and BCG Vaccine Laboratory (Guindy, Chennai) are historical public-sector vaccine manufacturing institutions in India.