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

Fake Rabies Vaccine Latest 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.

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.

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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.

Source: IE | NDTV | FP