Indian Immunologicals Addresses Counterfeit Rabies Vaccine Concerns

Indian Immunologicals Limited (IIL) has issued a statement refuting recent warnings regarding counterfeit antirabies vaccines in India. The company responded to an alert from the Australian Technical Advisory Group on Immunisation, which suggested that fake versions of the Abhayrab vaccine had been circulating since November 2023. IIL emphasised that these claims do not accurately reflect the current situation in India.

The alert from Australian health authorities raised concerns that individuals who received counterfeit doses may not be adequately protected against rabies, a potentially fatal viral disease. In a statement, Sunil Tiwari, Vice President and Head of Quality Management at IIL, reassured stakeholders of the company's rigorous quality control and pharmacovigilance systems. "The alert does not reflect the current situation," Tiwari stated, underscoring the reliability of vaccines supplied directly by IIL and its authorised distribution channels.

IIL has been manufacturing the Abhayrab vaccine since 2000 and has supplied over 210 million doses to both the Indian market and 40 other countries. The vaccine maintains a significant market share, accounting for 40% of rabies vaccinations in India. The company stressed that all its vaccines undergo stringent testing and quality assurance by the Central Drugs Laboratory, a government agency, before being released for public use.

In January 2025, IIL proactively identified a packaging issue in one specific batch of the vaccine (Batch # KA 24014) and quickly informed Indian regulatory authorities and law enforcement agencies. IIL described this incident as isolated and confirmed that the counterfeit batch is no longer available in the market. The company continues to assure healthcare professionals and the public of the safety and efficacy of its products.

Rabies is a viral zoonotic disease that adversely affects the central nervous system. Most human cases of rabies are transmitted by infected dogs. The disease is nearly always fatal once clinical symptoms develop. According to the World Health Organization, India experiences an estimated 18,000 to 20,000 deaths from rabies annually, primarily due to dog bites.

In light of the counterfeit vaccine concerns, the Australian authorities have advised individuals who received Abhayrab from November 1, 2023, onwards to consult their healthcare providers. Replacement doses using registered rabies vaccines may be necessary to ensure adequate protection against the disease. As rabies remains a significant public health issue in India, the focus on vaccine integrity is paramount to safeguard public health.