Alleged Fake Rabies Vaccines: A Test for India’s Health Governance

Why in News ?

Health authorities in Australia, followed by the United Kingdom and the United States, have advised their citizens who received rabies vaccination in India to verify whether replacement doses are required, citing concerns over the circulation of counterfeit rabies vaccines.

The episode has raised serious questions about drug supply chain integrity, regulatory oversight, and public confidence in vaccines, particularly significant for India, which carries one of the highest rabies burdens globally and is also a major vaccine producer.

Background & Context

Rabies is a nearly 100% fatal disease once symptoms appear, making vaccine efficacy and timely administration a critical public health concern.

India occupies a paradoxical position:

• It accounts for a disproportionately high share of global rabies deaths
• Simultaneously, it is a key global supplier of rabies vaccines

Against this backdrop, international advisories regarding vaccines administered in India have domestic and global implications, extending beyond health outcomes to regulatory credibility and vaccine diplomacy.

Rabies: Transmission and Prevention

Rabies is a viral zoonotic disease transmitted through the saliva of infected animals.

Transmission

• Animal bites or scratches
• Saliva contact with open wounds or mucous membranes
• Common vectors: dogs, cats, monkeys, bats

Symptoms

• Early: Fever, headache, nausea
• Advanced: Excessive salivation, hydrophobia, hallucinations, paralysis
• Once clinical symptoms appear, rabies is almost invariably fatal

Prevention

• Immediate wound washing
• Timely post-exposure prophylaxis (PEP) with vaccines and rabies immunoglobulin

India’s Rabies Burden

• As per the National Rabies Control Programme (NRCP):
  • 6,644 clinically suspected rabies cases and deaths reported between 2012–2022
  • Actual burden likely significantly under-reported
• WHO estimates:
  • 18,000–20,000 rabies deaths annually worldwide
  • One-third to two-thirds occur in children under 15
• India accounts for nearly 36% of global rabies deaths

This makes vaccine quality, availability, and trust a matter of national public health importance.

Background: Concerns Over Abhayrab Vaccine

International health advisories flagged the possibility that counterfeit rabies vaccines may have been administered in India since 2023.

• The concern centres on Abhayrab, a widely used rabies vaccine
• Manufactured by Human Biologicals Institute, a division of PSU Indian Immunologicals Limited (IIL)
• The alerts triggered global concern due to rabies’ fatal nature and India’s role as a vaccine hub

Company’s Response and Identification of Counterfeit Batch

Indian Immunologicals Limited (IIL) clarified that:

• In January 2025, it detected one counterfeit batch (KA24014)
• The batch showed tampered outer packaging
• The company immediately informed:
  • Drug regulators
  • Law enforcement agencies

IIL stated that no other counterfeit batches have been identified so far.

Nature of the Counterfeit: Packaging Diversion, Not Fake Vaccine

Investigations revealed a critical distinction:

• Counterfeit activity involved altered packaging, not fake or substandard vaccine content
• Seized samples tested at the Central Drug Testing Laboratory (CDTL), Kasauli:
  • Confirmed presence of genuine vaccine
• Suspected modus operandi:
  • Diversion of government-supplied vaccines into the private/open market using forged packaging

Locations Identified

• Delhi
• Mumbai
• Agra
• Lucknow
• Kanpur
• Patna

Raids were conducted in Delhi, Mumbai, and Agra.

Why Abhayrab Is Central to the Concern ?

• Abhayrab accounts for around 40% of India’s rabies vaccine market
• IIL is the largest rabies vaccine producer globally, with over 25 years of supply
• In many rural and semi-urban areas, Abhayrab is often the only available vaccine
• Company officials warned that international advisories could:
  • Fuel vaccine hesitancy
  • Undermine public trust in immunisation programmes

Expert Reassurance on Public Health Impact

Public health experts in India sought to calm public fears:

• Rabies PEP in India typically involves five vaccine doses
• Even if one dose were compromised, protection is usually ensured by:
  • Remaining doses
  • Administration of rabies immunoglobulin
• Hence, mass vaccine failure is unlikely

WHO-Recommended Rabies Vaccination Protocol

Unimmunised Persons

• At least three intramuscular doses
  or
• Two intradermal doses, plus:
  • Rabies immunoglobulin on Day 0

Previously Immunised Persons

• Only two booster doses required
• No immunoglobulin needed

Recent Rabies Cases and Vaccine Failure Concerns

Kerala Case Spike (2022)

• Several rabies deaths reported despite prior vaccination
• Triggered public suspicion of:
  • Vaccine failure
  • Substandard vaccines

Findings of Union Health Ministry Committee

The committee concluded:

• No evidence of vaccine failure
• Deaths linked to systemic gaps:
  • Inadequate wound washing
  • Non-administration of rabies immunoglobulin in Category-3 bites

Category-3 bites include:

• Multiple bites or deep scratches
• Broken skin licked by animals
• Highest risk of rabies transmission

The committee highlighted shortages of rabies immunoglobulin and vaccines as a critical challenge.

Governance Lessons and Way Forward

Key Governance Issues

• Drug supply chain vulnerabilities
• Weak monitoring of last-mile distribution
• Risks to India’s global vaccine credibility

Way Forward

• Strengthen end-to-end vaccine traceability
• Digitise batch-level authentication systems
• Improve availability of rabies immunoglobulin
• Enhance public communication to prevent vaccine hesitancy
• Tighten enforcement against diversion and packaging fraud