Concerns Raised Over Indian Rabies Vaccine Amid Safety Alerts

Australia’s leading vaccine advisory group, the Australian Technical Advisory Group on Immunisation (ATAGI), has issued warnings regarding the Abhayrab rabies vaccine, which is commonly administered in India. This notice has prompted health authorities from Australia, the United Kingdom, and the United States to alert individuals who may have received this vaccine while travelling in India.

The primary issue at hand involves counterfeit batches of the Abhayrab vaccine, produced by the Human Biologicals Institute, a division of Indian Immunologicals Ltd. These fake vaccines are believed to have circulated in India since 2023, raising significant concerns about their efficacy and safety.

Investigation and Findings

In January 2025, Indian Immunologicals Ltd determined that a specific batch of the vaccine, identified by the number KA24014, had altered packaging and was potentially compromised. The company promptly notified regulatory bodies and law enforcement, leading to several raids in major cities, including Delhi, Mumbai, and Agra. During these operations, authorities seized suspicious products, and subsequent tests at the Central Drug Testing Laboratory in Kasauli confirmed that the genuine vaccines had been mislabelled. Experts indicate that only this particular batch was involved in the counterfeit issue, with no evidence suggesting a widespread distribution of fake vaccines.

Kumar, an official from Indian Immunologicals, emphasised the company's adherence to proper notification procedures, stating that they acted responsibly by informing relevant regulators as soon as the counterfeit issue was identified.

Understanding Rabies and Its Symptoms

Rabies is a viral disease transmitted primarily through the saliva of infected animals, such as dogs, cats, monkeys, and bats. The infection is nearly always fatal once symptoms manifest, making prevention critical. Post-exposure prophylaxis, including vaccination and rabies immunoglobulin for severe bites, is essential for survival.

Rabies in India

India is responsible for approximately 36% of global rabies fatalities, with estimates from the World Health Organization indicating that between 18,000 and 20,000 people die from rabies annually in the country. A significant proportion of these fatalities occurs in children, with one death recorded approximately every 30 minutes. The National Rabies Control Program reported over 6,600 suspected cases between 2012 and 2022, although the actual figures are likely higher due to under-reporting.

Abhayrab Vaccine Overview

Abhayrab ranks among the most widely used rabies vaccines in India, commanding around 40% of the market. Produced by Indian Immunologicals Ltd for over 25 years, it is readily accessible to the public. Health experts maintain that despite the counterfeit concerns regarding packaging, the vaccine itself remains safe and effective. They stress the importance of timely vaccination, as delays can significantly increase the risk of rabies.

Recent Vaccine Efficacy Concerns

In 2022, Kerala experienced a rise in rabies cases, including instances where individuals who had been vaccinated died from the virus. An investigation by a committee formed by the Union Health Ministry concluded that rabies could occur in rare instances even after vaccination, particularly if the bite is not treated promptly or if it occurs in areas rich in nerves, allowing the virus to bypass the immune response.

Counterfeit Vaccine Implications

Experts agree that the genuine Abhayrab vaccine is effective and safe. The focus now should be on public awareness, timely vaccinations, and proper wound care. Currently, India lacks a robust system for recalling counterfeit medicines or informing the public about such issues. The Central Drugs Standard Control Organisation's (CDSCO) 2024 Drug Recall Rules stipulate that companies and marketing agencies bear the responsibility for recalls. However, these guidelines are not enforceable laws and do not adequately explain how recall information reaches the public.

Guidance for Vaccinated Individuals

ATAGI advises individuals to maintain accurate records of their rabies vaccinations. Those who received the Abhayrab vaccine after November 2023 or who are uncertain about the brand should seek advice from a healthcare professional. In such cases, doctors may recommend replacement doses with a verified rabies vaccine. Vaccinated individuals who have documentation of recognised vaccines received outside India are not affected by this alert.