Indian Immunologicals Denies Manufacturing Seized Substandard Rabies Vaccine Vials

Indian Immunologicals Ltd has said vials of its Abhayrab rabies vaccine, bearing batch number KE25012 and seized from an unlicensed premises in Delhi, were not manufactured by Human Biologicals Institute, a division of the company, and has asked authorities to trace their source and act against those responsible.

Abhayrab is a human rabies vaccine used for both pre- and post-exposure protection against rabies and is also supplied to government immunisation programmes in India.

The vials were drawn during an enforcement action by the Central Drugs Standard Control Organisation from an unlicensed residential premises in Mukherjee Nagar, Delhi, and sent to the Central Drugs Laboratory, Kasauli, for testing, Indian Immunologicals said in a statement.

The laboratory reported the samples as “not of standard quality” and misbranded. Its report also recorded 17 differences between the seized vial and the retention samples of the same batch held at the laboratory, which had been submitted by Human Biologicals Institute for batch release.

“On that basis, the vials examined are not a product manufactured by Human Biologicals Institute,” the company said.

Indian Immunologicals said it had, through a representation to the Drugs Controller General of India dated September 4, asked the authorities to trace the source of these vials and act against those responsible, while extending its full cooperation to the investigation.

The company said the genuine batch KE25012 had been tested and released by the Central Drugs Laboratory. The released quantity of 83,370 vials was supplied only through its authorised distribution channel, it said.

“No market complaint has been received in respect of the batch Number KE25012,” the company said.

Indian Immunologicals said it had submitted its batch manufacturing, quality control, reconciliation and distribution records to the Central Drugs Standard Control Organisation on August 14, 2026.

The company also said every batch of Abhayrab is released for sale only after independent testing and batch-release certification by the Central Drugs Laboratory. Vaccines administered at hospitals, clinics, government facilities or licensed pharmacies reach patients through the released and authorised supply chain and are not affected by this matter, it said.

The statement follows a Reuters exclusive published earlier, which reported that India's drug regulator had flagged Abhayrab batch KE25012 as substandard and was investigating whether it was spurious.

According to a government document reviewed by Reuters, the Central Drugs Laboratory found that a field sample of the vaccine did not meet potency requirements and classified it as “not of standard quality” and “misbranded”.

The sample passed sterility, moisture and identity tests, but the laboratory found significant differences between the sampled product and a retained reference sample of the same vaccine previously submitted by Indian Immunologicals for regulatory testing. These included discrepancies in labelling, artwork, QR-code verification, cap colour, licence details and packaging text, Reuters reported.

In an August 27 letter to state drug regulators, Drugs Controller General Rajeev Singh Raghuvanshi asked officials to maintain “strict vigilance” over the movement and distribution of Abhayrab batch KE25012 and take regulatory action as necessary, according to the government document cited by Reuters.

The regulator said the findings raised concerns about the sample's identity and authenticity and warranted an investigation into whether it could be a spurious drug under India's Drugs and Cosmetics Act.

The development comes less than two years after concerns were raised over another counterfeit Abhayrab batch. Indian Immunologicals had notified the drug regulator in January 2025 that counterfeit doses bearing batch number KA24014 had entered the market. Authorities in the United States, Britain and Australia subsequently issued alerts for travellers who may have received the vaccine in India.

Indian Immunologicals said at the time that it had not manufactured the counterfeit batch and that the incident was isolated.

Indian Immunologicals has supplied more than 210 million doses of Abhayrab in India and other countries over more than two decades and said in December that it held around 40% of India's domestic rabies vaccine market.