COUNTERFEIT RABIES VACCINES & THE PUBLIC HEALTH CHALLENGE

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Picture Courtesy: Indian Express

Context:

Health authorities in Australia, the UK, and the US have advised travellers who received rabies vaccines in India since late 2023 to review their vaccination status. The concern stems from the suspected circulation of counterfeit batches of Abhayrab, a widely used rabies vaccine manufactured by the Human Biologicals Institute (a unit of Indian Immunologicals).

Background of the story:

Foreign health agencies have issued advisories after reports of counterfeit Abhayrab vaccine packs possibly circulating since 2023. The manufacturer clarified that a single suspect batch (KA24014) with mismatched packaging was detected in January 2025, after which regulators and law-enforcement authorities were immediately informed. Subsequent testing showed that the vials actually contained the genuine product, indicating that government-supplied stock may have been diverted and repackaged for sale in the private market. Suspect vaccines were reported from multiple cities—including Delhi, Mumbai, Agra, Lucknow, Kanpur, and Patna—and raids were carried out following these reports. Despite the controversy, Abhayrab remains one of the most widely used rabies vaccines in India, accounting for nearly 40 percent of the national market.

Current status of rabies in India:

• India contributes roughly one-third of the world’s rabies fatalities, with close to 20,000 deaths every year, making it the country most severely impacted by the disease.
• The infection continues to be endemic in India and dog bites remain the dominant source of transmission.
• Children below 15 years account for nearly 40% of all rabies cases, placing them among the most at-risk groups.
• The burden of disease falls disproportionately on economically weaker and socially marginalised communities, including rural populations, daily wage labourers, waste pickers, and brick-kiln workers.
• Limited awareness, delayed care-seeking, high treatment costs, and poor healthcare access significantly increase the likelihood of death following exposure.
• India is estimated to have around 80 million free-roaming dogs, and about 20 million dog-bite incidents occur each year.
• Post-exposure care remains suboptimal: around one-fifth of exposed individuals receive no vaccine at all, and nearly 50% fail to complete the full course of vaccination.
• Rabies Immunoglobulin (RIG) is often scarce, costly, and not reliably available in government facilities, restricting its use in severe bite cases.
• Breakdowns in the health system—such as refusal or delay in treatment and improper wound cleaning—lead to many preventable deaths.
• Vaccine availability does not fully meet national demand, with India requiring approximately 60 million doses annually but producing about 50 million, part of which is also exported.
• Dog-population control strategies such as Catch–Neuter–Vaccinate–Release (CNVR) alone are insufficient, as nearly 40% of the dog population turns over every year.

What is rabies?

Rabies is a preventable viral infection that attacks the central nervous system and causes progressively worsening inflammation of the brain and spinal cord. The disease is present in more than 150 countries and territories worldwide. It spreads to humans and other animals mainly through bites or scratches from infected animals, most commonly dogs. Without prompt medical treatment after exposure, the illness is almost always fatal. Rabies is classified as a Neglected Tropical Disease (NTD) because it disproportionately affects people in poor, rural, and hard-to-reach areas. Although effective vaccines and immunoglobulins are available, many communities still do not have adequate access to them. Children between 5 and 14 years of age are frequently affected because they are more likely to come into contact with animals and may not recognise risky situations.

Types of rabies in humans:

Furious rabies

This is the more frequent form of the disease. It is marked by restlessness, agitation, excessive activity, hydrophobia (fear of water), aerophobia (fear of air or drafts), confusion, and aggressive episodes. Death usually occurs within a few days due to failure of the heart and lungs.

Paralytic rabies

This form develops slowly and quietly, which means it is often overlooked or diagnosed late. Weakness and paralysis begin near the bite site, gradually spread to the rest of the body, and eventually progress to coma and death. Because symptoms are subtle, paralytic rabies is a major contributor to under-reported cases.

Transmission:

Rabies is caused by the rabies virus, which specifically targets the brain and nervous system. The infection is transmitted mainly through:

• bites or scratches from infected animals
• saliva entering broken skin or mucous membranes

Dogs are responsible for around 99% of human infections, making dog-mediated rabies the principal public-health concern in many regions.

Symptoms of rabies:

Early symptoms are usually general and flu-like, such as:

• fever and body aches
• tingling, burning, or abnormal sensations around the bite wound

As the virus reaches the nervous system, it causes severe brain and spinal cord inflammation, which is almost invariably fatal without prior vaccination or timely post-exposure treatment. The incubation period may vary from one week to a year, depending on where the bite occurred and the amount of virus introduced.

Prevention of rabies:

Rabies is fully preventable with the right public-health actions. Key measures include:

• mass vaccination of dogs, which is the most cost-effective strategy to stop human rabies
• public awareness and responsible pet ownership to reduce dog bites
• pre-exposure or post-exposure vaccination for people at risk or after animal bites

Vaccinating dogs breaks the transmission cycle in animals, reduces human infections, and lowers the overall need for post-exposure treatment in people.

How Rabies can occur despite vaccination?

The Union Health Ministry investigation highlighted that rabies infection, though rare after vaccination, can still occur in certain situations:

• when the bite wound is not cleaned adequately or promptly
• when the bite occurs in highly innervated regions such as the face, fingers, or genitals, allowing the virus faster access to the nervous system
• when the virus reaches the central nervous system rapidly, before antibodies develop
• when immunoglobulin is omitted in severe exposures

These factors can compromise the effectiveness of an otherwise appropriate vaccination schedule.

Government initiatives for prevention and control of rabies in India:

• National Rabies Control Programme (NRCP): The programme supports states and union territories by ensuring the availability of vaccines and rabies immunoglobulin, strengthening surveillance systems, training healthcare staff, and creating community awareness on wound washing and timely post-exposure treatment.
• National Action Plan for Rabies Elimination (NAPRE) 2030: India has set a target of eliminating human deaths due to dog-mediated rabies by 2030. The plan follows a One Health framework, integrating human health, animal health, and environmental sectors. It emphasizes mass vaccination of dogs, dog-population management, access to post-exposure prophylaxis for all, and intersectoral coordination.
• Animal Birth Control (ABC) with Anti-Rabies Vaccination: Municipal bodies and state animal husbandry departments implement programmes to sterilise and vaccinate free-roaming dogs, which helps reduce uncontrolled breeding, decrease aggressive dog behaviour, and lower transmission of rabies while maintaining humane practices.
• Provision of free or low-cost PEP in government hospitals: Public healthcare facilities across many states provide free or subsidised anti-rabies vaccines and immunoglobulins, reducing catastrophic out-of-pocket expenditure for dog-bite victims and improving treatment completion rates.
• Integrated Disease Surveillance Programme (IDSP): Rabies cases and dog-bite incidents are systematically recorded and monitored, enabling early detection of outbreaks, rapid response, and evidence-based policy planning.
• One Health Committees at national and state levels: Coordinated committees involving health, veterinary, municipal, rural development, and education departments work together on rabies control through joint campaigns and data sharing.
• National Livestock Mission and Veterinary Public Health Services: These programmes support dog vaccination drives, animal health infrastructure, and laboratory capacity to diagnose rabies in animals.
• School-based awareness and community IEC activities: Government campaigns promote safe behaviour around animals, early wound washing, and immediate medical consultation through school curricula, mass media, and community health workers such as ASHAs and ANMs.
• Training of medical and veterinary professionals: Continuous training modules are conducted on intradermal vaccination techniques, PEP protocols, wound management, and rational RIG use, improving the quality of case management.

Global initiatives for rabies elimination:

United Against Rabies Forum (UAR Forum): A global platform that brings together governments, NGOs, academia, animal welfare groups, and donors to support countries with technical guidance, coordination, tools, and funding pathways.

WHO Prequalification and Normative Guidance: WHO supports countries by prequalifying rabies vaccines, issuing evidence-based vaccination protocols, and guiding adoption of intradermal regimens to reduce costs and improve access.

World Rabies Day (28 September): Coordinated by Global Alliance for Rabies Control (GARC), this annual campaign promotes public awareness, vaccination drives, and education across countries.

Mass Dog Vaccination Campaigns in Endemic Countries
Supported by WHO, GARC, and donors such as the Bill & Melinda Gates Foundation, pilot projects in Tanzania, Philippines, Bangladesh, Rwanda, and Latin America have demonstrated large reductions in human rabies deaths.

Conclusion:

The crisis of counterfeit rabies vaccines highlights weaknesses in supply-chain security, regulation, and monitoring rather than a failure of the vaccine itself. While most seized vials contained genuine product with altered packaging, the incident has created fear and the risk of vaccine hesitancy in a disease that is almost 100% fatal. Strengthening traceability, enforcement against diversion, transparent communication, and assured availability of genuine vaccines and immunoglobulin are essential to restore public confidence and prevent avoidable deaths.

Source: Indian Express