Abhayrab fails potency test as manufacturer denies seized vials were genuine, triggering counterfeit vaccine investigation in India.
A rabies vaccine sold under the brand name Abhayrab has come under regulatory scrutiny after a field sample failed a potency test, with India’s drug regulator classifying it as ‘Not of Standard Quality’ (NSQ) and potentially spurious. However, the manufacturer, Indian Immunologicals Limited (IIL), says the vial tested by authorities was not manufactured by the company.
The development has raised concerns about rabies vaccine safety, counterfeit vaccines, and vaccine quality, particularly because rabies is almost invariably fatal once clinical symptoms develop. Timely and effective vaccination following a potential exposure is therefore critical.
Why has Abhayrab been flagged?
According to the regulatory findings, a sample carrying Abhayrab batch number KE25012 was seized by drug authorities from an unlicensed residential premises in Mukherjee Nagar, Delhi. The sample was sent to the Central Drugs Laboratory in Kasauli for testing.
The laboratory found that the vaccine did not meet the required potency standards and classified the sample as NSQ and misbranded. The sample reportedly passed tests for sterility, moisture and identity. However, authorities also identified several discrepancies when the seized vial was compared with the manufacturer’s reference sample.
These reportedly included differences in labelling, packaging artwork, QR-code verification, cap colour, licence details and packaging text. The findings have prompted authorities to investigate whether the seized product could be a spurious drug under India’s Drugs and Cosmetics Act.
What does the manufacturer say?
Indian Immunologicals Limited, which manufactures Abhayrab through its Human Biologicals Institute division, has disputed the identity of the seized vaccine.
The company said the laboratory report identified 17 differences between the seized vial and retention samples of the genuine KE25012 batch. Based on these differences, IIL said the tested vials were not products manufactured by its Human Biologicals Institute.
The company has also said the genuine KE25012 batch underwent independent testing and was released by the Central Drugs Laboratory under a Batch Release Certificate dated November 7, 2025. IIL reported that 83,370 genuine vials from the batch were supplied through its authorised distribution network and said it had received no market complaint concerning the batch.
Company asks authorities to trace vaccine source
Indian Immunologicals has submitted manufacturing, quality-control, reconciliation and distribution records to the Central Drugs Standard Control Organisation (CDSCO) and asked authorities to investigate where the seized vials originated. The company has said it is cooperating fully with the investigation.
The key question is how vials carrying the Abhayrab name and genuine-looking batch details were found at an unlicensed premises if, as the manufacturer maintains, they do not match its genuine product.
Previous counterfeit Abhayrab concern
The latest investigation follows an earlier counterfeit-related concern involving Abhayrab. In January 2025, Indian Immunologicals reported counterfeit Abhayrab doses carrying batch number KA24014.
That episode prompted warnings concerning people who may have received the counterfeit vaccine, highlighting the importance of ensuring that rabies post-exposure prophylaxis is obtained from legitimate healthcare providers and authorised sources.
