New Delhi: Australia last week issued an advisory on counterfeit rabies vaccine manufactured by Indian Immunologicals Limited (IIL) under the brand name Abhayrab, available in Indian markets since November 2023.
The Indian vaccine-maker Saturday in a statement said the advisory was “over-cautious” and “misplaced”, highlighting that a specific batch manufactured earlier this year was identified and is no longer available for sale.
“The pharmaceutical manufacturer Indian Immunologicals Limited has reported that counterfeit (fake) batches of the rabies vaccine Abhayrab have been circulating in India since 2023. The fake vaccine differs from the registered vaccine in formulation, packaging, labelling, and manufacturing,” the Australian Technical Advisory Group on Immunisation (ATAGI) said in a statement released 19 December.
ATAGI added: “People who received the fake vaccine may not be fully protected against rabies and are advised to get replacement doses to ensure they are adequately protected. While infection with rabies is fatal, it is important to note that rabies disease after a potential exposure remains very rare among travellers.”
Days after the Australian advisory, IIL issued its own statement highlighting that the problem revolved around a single batch (No. KA24014) manufactured in March 2024 and expiring in February 2027. The problematic batch was identified in January 2025 and the appropriate authorities and enforcement agencies were informed, IIL added in its statement, according to media reports. IIL further urged the Australian government to reconsider its advisory.
“We humbly request your good office to urgently consider reviewing the advisory notification, in the interest of preventing potential complications in interpretations by healthcare practitioners and mitigating any negative impact on public trust in vaccines, particularly given the general public’s limited awareness of technical details,” IIL said in its statement according to media reports.
On 23 March 2025, the Drugs Control Department in Delhi had issued an advisory against the specific batch of the rabies vaccine produced by IIL, highlighting that this batch is counterfeit and being sold in the markets of New Delhi, Mumbai, Ahmedabad and Lucknow.
IIL in a letter dated 13 January had informed the Drug Controller General of India of the counterfeit batch of Abhayrab, including a number of differences between the original vaccine and the fake ones. Amongst the differences noted, IIL informed the authorities that original batches of the vaccine have a pink flip-off seal, while the counterfeit batches have a blue seal. Furthermore, the prices on the boxes are different, with the counterfeit batch carrying the 2022 MRP rather than current prices.
A second product pack of the counterfeit vaccines carries a different manufacturing date (November 2023), while keeping the same batch number, according to the letter IIL sent to the authorities. Furthermore, the expiry date is also different while variations are seen in the printing on the packs.
IIL is a wholly-owned subsidiary of the National Dairy Development Board (NDDB) and established in 1982 with the objective of making cost-effective veterinary vaccines for farmers across India. The company is the largest manufacturer of both human and animal rabies vaccines in the country. Around 40 percent of all human rabies vaccines in the country are manufactured by IIL, while it maintains around 70 percent market share for all animal rabies vaccines.
Abhayrab has been manufactured by IIL since 2000, with over 210 million doses supplied across the country, according to media reports.
(Edited by Viny Mishra)
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