Why in news?

Health authorities in Australia have advised citizens vaccinated for rabies in India to check whether they require replacement doses, following concerns about counterfeit rabies vaccines.

Similar advisories have been issued by the United Kingdom and the United States.

This episode highlights critical issues of drug supply chain integrity, regulatory enforcement, and public confidence in vaccines—especially significant for India, which bears a high rabies burden and plays a key role in global vaccine supply.

What’s in Today’s Article?

• Rabies: Transmission and Prevention
• Background: Concerns Over Abhayrab Vaccine
• Company’s Response and Identification of Counterfeit Batch
• Why Abhayrab Is Central to the Concern?
• Expert Reassurance on Public Health Impact
• Recent Rabies Cases and Vaccine Failure Concerns

Rabies: Transmission and Prevention

• Rabies is a viral infection transmitted through the saliva of infected animals.
• Human infection can occur through bites, scratches, or saliva contact with open wounds, commonly involving dogs, cats, monkeys, and bats.
• Symptoms range from fever, headache, and nausea to excessive salivation, hydrophobia (fear of water), hallucinations, and partial paralysis.
• Importantly, rabies is preventable through timely post-exposure vaccination, which is why prompt medical treatment after animal exposure is essential.
• India’s Rabies Burden
  • According to India’s National Rabies Control Programme, 6,644 clinically suspected human rabies cases and deaths were reported between 2012 and 2022, though this is believed to be an under-estimate.
  • The World Health Organisation estimates 18,000–20,000 rabies deaths annually worldwide, with one-third to two-thirds occurring in children under 15 years.
  • India alone accounts for nearly 36% of global rabies deaths, highlighting the public health significance of vaccine safety and regulatory oversight.

Background: Concerns Over Abhayrab Vaccine

• Health authorities in Australia, the UK, and the US have issued advisories urging citizens who received rabies vaccinations in India to verify whether they require replacement doses.
• The alerts point to possible circulation of counterfeit rabies vaccines in India since 2023.
• The advisories stem from concerns that fake batches of Abhayrab, a rabies vaccine manufactured by the Human Biologicals Institute (a key division of PSU Indian Immunologicals), may be in circulation.
• The issue has triggered international alarm because rabies is almost 100% fatal once symptoms appear, making vaccine efficacy critical.

Company’s Response and Identification of Counterfeit Batch

• Indian Immunologicals Limited (IIL) stated that in January 2025, it detected one counterfeit batch (#KA24014) with altered packaging.
• The company informed Indian regulators and law enforcement immediately.
• It maintains that no other counterfeit batches have been found.
• Nature of the Counterfeit: Packaging Diversion, Not Fake Vaccine
  • Investigations revealed that:
    • Counterfeit products were detected in Delhi, Mumbai, Agra, Lucknow, Kanpur, and Patna.
    • Raids were conducted in Delhi, Mumbai, and Agra.
    • Tests conducted at the Central Drug Testing Laboratory, Kasauli, found the seized vaccines to contain the genuine product.
  • Experts clarified that the issue involved tampered outer packaging, allegedly used to divert government-supplied vaccines into the open market, rather than fake or substandard vaccine contents.

Why Abhayrab Is Central to the Concern?

• Abhayrab is among the most widely used rabies vaccines in India, holding around 40% market share.
• IIL is the largest rabies vaccine producer globally, supplying vaccines for over 25 years.
• Company officials warned that international advisories could fuel vaccine hesitancy, particularly in rural areas where Abhayrab may be the only available option.

Expert Reassurance on Public Health Impact

• Experts in India sought to allay fears:
  • In India, patients usually receive five doses of rabies vaccine after an animal bite.
  • Even if one dose were ineffective, protection is likely ensured through remaining doses and rabies immunoglobulin.
• WHO-Recommended Vaccination Protocol
  • As per World Health Organisation guidelines:
  • Unimmunised persons: At least three intramuscular doses or Two intradermal doses, plus immunoglobulin on day zero.
  • Previously immunised persons: Only two booster doses are required.

Recent Rabies Cases and Vaccine Failure Concerns

• In Kerala, a spike in rabies deaths was reported in 2022, raising public concern as several deceased individuals had reportedly received rabies vaccines.
• This led to suspicions of vaccine failure or ineffective vaccines.
• Findings of the Union Health Ministry Committee
  • A committee constituted by the Union Health Ministry investigated the cases and ruled out vaccine failure as the primary cause.
  • It concluded that deaths occurred due to:
    • Improper wound washing after animal bites
    • Non-administration of rabies immunoglobulin in Category 3 bites
      • Category 3 bites include multiple bites or scratches breaking the skin, or situations where broken skin is licked by an animal, which carry the highest risk of infection.
  • The committee highlighted limited availability of rabies immunoglobulin and vaccines as a major systemic challenge, which compromised timely and complete post-exposure prophylaxis.