India's drug regulator has declared a batch of the widely used rabies vaccine Abhayrab, identified as KE25012, to be substandard and potentially spurious after it failed a potency test. This development follows past concerns regarding counterfeit batches and international alerts, raising significant public health questions. The manufacturer, Indian Immunologicals Ltd, faces scrutiny as investigations into the vaccine's authenticity and quality are underway due to observed discrepancies in its packaging and labeling.

India's drug regulator has declared a batch of the widely used rabies vaccine Abhayrab, identified as KE25012, to be substandard and potentially spurious after it failed a potency test. This development follows past concerns regarding counterfeit batches and international alerts, raising significant public health questions. The manufacturer, Indian Immunologicals Ltd, faces scrutiny as investigations into the vaccine's authenticity and quality are underway due to observed discrepancies in its packaging and labeling.

India's drug regulator has declared a batch of the widely used rabies vaccine Abhayrab, identified as KE25012, to be substandard and potentially spurious after it failed a potency test. This development follows past concerns regarding counterfeit batches and international alerts, raising significant public health questions. The manufacturer, Indian Immunologicals Ltd, faces scrutiny as investigations into the vaccine's authenticity and quality are underway due to observed discrepancies in its packaging and labeling.

India’s drug regulator has deemed a batch of the rabies vaccine Abhayrab substandard and potentially spurious. Reuters found a government document that revealed that the vaccine reportedly failed a potency test, classifying it as “not of standard quality.”

Abhayrab is a widely used purified human rabies vaccine administered on the first, third, and seventh day after an infected animal bite. Manufactured by Indian Immunologicals Ltd (IIL), the vaccine holds a 40 per cent market share and costs around ₹300 to 390 per dose. According to an IIL statement in December, more than 210 million doses have been supplied in India and 43 countries.

However, the vaccine has previously faced issues with counterfeit batches. In January 2025, Abhayrab identified one of its own batches, KA24014, as misleading. The company lodged a complaint with the authorities and worked with them to remove the counterfeit batch with the same batch number from the market.

In 2025, global authorities in the United States, Britain and Australia issued alerts for travellers who may have received the vaccine in India. IIL affirmed to stakeholders that the it did not manufacture the batch in question and that the efficacy of the vaccine would remain intact, as long as it was purchased through channels authorised by the company.

The latest warning about Abhayrab comes after the government’s Central Drugs Laboratory in Kasauli found that a field sample of the vaccine’s batch (KE25012) did not meet potency requirements. While the sample passed sterility, moisture and identity tests, the laboratory found significant differences between the product and the original sample submitted by IIL for regulatory testing.

Inconsistencies were observed in the vaccine batch’s labelling, artwork, cap colour, licence details, and packing text. It also failed a QR verification.

The regulator raised concerns about the sample’s “authenticity” and warranted an investigation into whether it could be a spurious drug under India’s Drugs and Cosmetics Act. The government document did not state how many doses of the batch are being investigated or whether any of the doses from the flagged batch have been administered.