Hyderabad-based IIL seeks review of Australian advisory on Abhayrab vaccine

Indian Immunologicals Limited has asked Australia to review its advisory on the rabies vaccine Abhayrab, saying the warning is based on a single counterfeit batch that was identified and removed from the supply chain nearly a year ago.

Hyderabad: Hyderabad-based top vaccine maker Indian Immunologicals Limited (IIL) on Saturday formally requested the Australian government to review its recent health advisory regarding the anti-rabies vaccine ‘Abhayrab,’ labeling the warning as “misplaced” and potentially harmful to public trust.

The dispute follows an advisory by the Australian Technical Advisory Group on Immunisation (ATAGI), which suggested that any Australian traveler who received Abhayrab in India after November 1, 2023, should consider their vaccination invalid.

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The IIL, the public sector vaccine manufacturer from Hyderabad, refuted the blanket warning, asserting that the issue was restricted to a single counterfeit batch identified and resolved nearly a year ago.

In a letter sent to ATAGI on Thursday, December 25, 2025, IIL clarified that the concern revolves exclusively around Batch No. KA24014 (Mfg: March 2024; Exp: February 2027). The company maintains that they proactively identified a “packaging anomaly” in this specific batch in early January 2025 and immediately alerted Indian regulators.

IIL pointed out that the Australian advisory appears to be based on a localised notification issued by the Delhi government in March 2025, which was specific only to that one batch. The manufacturer maintains that the counterfeit products were purged from the supply chain long ago and are no longer available on shelves.

The present crisis was first flagged by IIL in January 2025 after discovering sophisticated fakes in circulation. In its initial alert to the Drug Controller General of India (DCGI), IIL noted:

“We have identified that the counterfeit product has the same information as our product, ‘Rabies Vaccine, Human (Abhayrab) batch no KA24014’. This counterfeit product exhibits several differences in formulation, packaging, labelling, and manufacturing compared to our original product. It is also observed that the product is being circulated without maintaining the cold chain of 2 to 8 degrees Celsius.”

Drug regulatory authorities in Hyderabad confirmed that the fakes did not originate from the official manufacturing plant in Telangana. Instead, they were being injected into the supply chain at the wholesaler level, often through “gray market” operators who bypass standard regulatory checks.

Investigations by local authorities identified Delhi, Mumbai, Ahmedabad, and Lucknow as the primary hubs where the fake batches were circulating. Following a nationwide alert to all State Drugs Control Administrations (DCAs), local inspectors were directed to monitor the market.

New directives now mandate that all sales and purchases of rabies vaccines must be documented through proper tax invoices. Pharmacies and hospitals have been ordered to report any suspicious individuals offering vaccines at discounted prices or without proper documentation.