Abhayrab Rabies Vaccine Batch Flagged as Substandard in Delhi; Maker Denies Authenticity
Vials of the Abhayrab rabies vaccine from batch KE25012, seized in Delhi, have been declared substandard by the Central Drugs Laboratory after failing potency tests. The manufacturer stated the items were counterfeit and not its product, prompting nationwide regulatory alerts and ongoing investigations into illicit distribution networks.
Vials of the widely used rabies vaccine Abhayrab, bearing batch number KE25012 and recovered from an unlicensed residential premises in Delhi, have been classified as "Not of Standard Quality" and misbranded by the Central Drugs Laboratory in Kasauli. The development has triggered a wider regulatory investigation into potential counterfeit distribution, given that an effective post-exposure course is critical for preventing fatal outcomes after an animal bite.
As per a report by The Times of India, the Central Drugs Standard Control Organisation collected legal samples during an enforcement action at a location in Mukherjee Nagar. Subsequent laboratory evaluations determined that the seized sample failed mandatory potency requirements while passing tests for sterility, moisture, and identity. Delhi Pharmacies Banned From Adopting 80% Medicine Discounts; Here's Why.
Abhayrab Rabies Vaccine Batch Flagged Substandard
As per a report by The Economic Times, the tests revealed 17 distinct discrepancies between the seized vials and genuine retention samples submitted earlier by the manufacturer. These variations included differences in packaging artwork, labelling typography, logos, QR code verification, and cap colours, prompting authorities to examine whether the items violate Section 17B of the Drugs and Cosmetics Act.
Manufacturer Clarification And Regulatory Response
Indian Immunologicals Ltd, which manufactures the vaccine through its Human Biologicals Institute division, asserted that the examined vials were not produced by the company. The enterprise stated that 83,370 genuine units from batch KE25012 had previously passed all standard quality checks, received certification from the Central Drugs Laboratory on November 7, 2025, and were distributed strictly through authorised channels.
The Drugs Controller General of India subsequently issued directives to state drug controllers across the country. Authorities have been instructed to maintain strict vigilance over the movement and distribution of batch KE25012 and to execute necessary regulatory enforcement actions where required.
Background On Counterfeit Drug Concerns
This regulatory action highlights ongoing challenges concerning illicit drug manufacturing networks operating within urban residential zones. Four individuals were previously arrested by the Delhi Police Crime Branch following the recovery of nearly a thousand medicine vials during earlier raids in the same neighbourhood, though investigators are still verifying direct links to the current batch. India’s Free HPV Vaccination Drive 2026: Who Is Eligible and What Is It For?
The incident follows a prior counterfeit alert in January 2025 involving another batch of the same vaccine, which led to international health advisories. Because rabies is virtually 100% fatal once clinical symptoms manifest, health bodies continue to emphasize stringent supply chain tracking to protect patients relying on post-exposure prophylaxis.
(The above story first appeared on LatestLY on Sep 05, 2026 10:15 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).
