Union Ministry of Health and Family Welfare has launched indigenously manufactured Tetanus and Adult Diphtheria (Td) Vaccine at the Central Research Institute (CRI), Kasauli.
This launch marks a major step toward national health security, strengthening India’s public health infrastructure, and advancing the vision of Atmanirbhar Bharat in healthcare.
Key Highlights
- The Td vaccine will now be supplied under the Universal Immunization Programme (UIP).
- CRI will supply 55 lakh doses by April 2026.
- Production will progressively scale up in subsequent years.
- The initiative aligns with India’s goal of self-reliance in pharmaceuticals and vaccine manufacturing.
- CRI is the first government institute manufacturing vaccines under Good Manufacturing Practices (GMP) standards.
Regulatory & Policy Backing
In 2006, the World Health Organization (WHO) recommended replacing the Tetanus Toxoid (TT) vaccine with the Td vaccine. This recommendation was reaffirmed in:
- WHO Tetanus Vaccine Position Paper (2017)
- Strategic Advisory Group of Experts (SAGE) deliberations (2002 & 2016)
In India, the National Technical Advisory Group on Immunization (NTAGI) recommended replacing TT with Td across all age groups, including pregnant women.
The transition strengthens diphtheria protection while sustaining maternal and neonatal tetanus elimination gains.
Manufacturing & Approval Process
CRI undertook the full development cycle:
- Developmental studies completed
- Test License obtained
- Waivers secured for preclinical and Phase I–III trials
- Marketing Authorization granted
- Manufacturing license obtained
- Commercial production initiated
- Release clearance from Central Drugs Laboratory, Kasauli
This reflects the strengthening of India’s vaccine regulatory framework.
India has achieved Maturity Level 3 in WHO’s global benchmarking of regulatory systems, reinforcing global confidence in its vaccine ecosystem.
Integration with Universal Immunization Programme (UIP)
The UIP is one of the world’s largest immunization programmes:
- Covers 11 vaccines protecting against 12 diseases.
- Approximately 2–2.5 crore children are born annually.
- Similar number of women become pregnant each year.
- Total annual immunization cohort: nearly 5 crore beneficiaries (2.5 crore children + 2.5 crore pregnant women).
- Covers 27 doses up to age 16.
- National vaccine coverage: nearly 99%.
Digital tracking is enabled through the U-WIN platform, which monitors vaccination events in real time.
About Tetanus
Cause:
Clostridium tetani spores found in soil and animal feces.
Transmission:
Non-communicable; enters through contaminated wounds or umbilical stump.
Symptoms:
- Jaw cramping (“lockjaw”)
- Muscle spasms
- Difficulty swallowing
- Seizures
Maternal & Neonatal Tetanus (MNT):
Occurs due to non-sterile cord cutting practices.
Prevention:
Tetanus-Toxoid-Containing Vaccines (TTCV).
Key Facts:
- Recovery does not provide immunity.
- Neonatal tetanus deaths reduced by 97% globally (1988–2018).
- India eliminated MNT in 2015 (less than 1 case per 1,000 live births in every district).
About Diphtheria
Cause:
Corynebacterium diphtheriae (toxin-producing strains).
Transmission:
Respiratory droplets and direct contact.
Hallmark Symptom:
Grey pseudomembrane in throat causing airway obstruction.
Complications:
- Myocarditis (heart inflammation)
- Neuropathy (nerve damage)
- Fatality rate up to 30% without treatment
Treatment:
- Diphtheria Antitoxin (DAT)
- Antibiotics
Concern: Growing antimicrobial resistance (AMR).
Pandemic disruptions led to under-vaccination in many regions, increasing outbreak risks.
Why Td Vaccine is Important
- Provides dual protection against tetanus and diphtheria.
- Strengthens adult immunity.
- Protects pregnant women and newborns.
- Sustains elimination gains while expanding diphtheria coverage.
India’s Vaccine Leadership
India is widely known as the “pharmacy of the world” and among the largest vaccine manufacturers globally.
During COVID-19:
- Two indigenous vaccines developed within 9 months.
- Over 220 crore doses administered.
- Vaccination certificates delivered digitally.
- Under Vaccine Maitri, vaccines supplied to nearly 100 countries, including 48 free-of-cost.
Public institutions like CRI have played a crucial role in strengthening domestic and global vaccine capacity.
Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana
- World’s largest publicly funded health coverage scheme.
- Covers over 62 crore people.
- ₹5 lakh annual coverage for citizens above 70 years irrespective of socio-economic status.
About Universal Immunization Programme (UIP)
- Launched in 1985
- One of the world’s largest public immunization programmes
- Provides free vaccines against multiple vaccine-preventable diseases
- Implemented by Government of India
About Central Research Institute (CRI), Kasauli
- One of India’s oldest vaccine manufacturing institutes
- Located in Himachal Pradesh
- Plays key role in public sector vaccine production