Published Sep 07, 2026 | 7:00 AM ⚊ Updated Sep 07, 2026 | 7:00 AM
The vaccine, Batch No. KE25012, was seized on 22 April from an unlicensed premises at Mukherjee Nagar
Synopsis: A batch of Abhayrab rabies vaccine failed potency testing and was declared misbranded and Not of Standard Quality by CDL Kasauli. CDSCO flagged multiple differences from the manufacturer’s retained sample, including packaging, QR code, licence number, cap colour and hologram, raising concerns of possible counterfeiting.
A batch of the rabies vaccine Abhayrab has failed a potency test and been declared “Not of Standard Quality” and “Misbranded” by the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh.
The declaration came after samples seized during a drug enforcement operation were found to differ from the manufacturer’s retained sample.
The Central Drugs Standard Control Organisation (CDSCO), in a public notice issued on Saturday, 5 September, said the case was part of intensified action against the illegal manufacture and distribution of misbranded and spurious drugs.
The vaccine, Batch No. KE25012, was seized on 22 April from an unlicensed premises at Mukherjee Nagar in North West Delhi during a joint operation by the Delhi Police Crime Branch and Drugs Control Department officials. The product was subsequently found to be misbranded and, according to CDSCO, “not manufactured by Indian Immunologicals Ltd.”
CDSCO said its officials were called to the premises for legal sampling and the samples were sent to CDL, Kasauli, for examination.
Also Read: Why are people dying of rabies in India despite vaccination?
The government laboratory’s test certificate classified the seized sample as “Not of Standard Quality and Misbranded Drug” under the Drugs and Cosmetics Act, 1940 and the Rules made under it.
The sample passed tests for physical aspects, sterility, moisture content, thiomersal and identity. However, it failed the potency test.
The laboratory also advised that further investigation could be carried out to determine whether the product meets the definition of a spurious drug under Section 17B of the Drugs and Cosmetics Act.
This means the CDSCO document establishes the product as misbranded and not of standard quality. At the same time, further investigation is required before a final statutory determination that it is a spurious drug.
Also Read: What is hurting rabies prevention?
The laboratory compared the seized sample with a retained sample of the same batch, KE25012, that had earlier been submitted by Human Biologicals Institute, a division of Indian Immunologicals Ltd, for testing and lot release.
The comparison found multiple differences in the packaging and labelling.
These included differences in the artwork, size and positioning of the registered trademark symbol, spelling of “L.Pasteur”, representation of preservative and diluent concentrations, warning-box text, company logo, artwork number and text alignment.
The laboratory also found that GS1 did not verify the QR code on the seized sample, whereas the QR code on the retained sample was verified. The diluent manufacturing licence number and fonts used for batch coding also differed.
The comparison further identified a difference in the vial cap colour. The seized sample had a blue cap, while the retained sample had a green cap. The seized vial also had a hologram pasted on the seal, which was absent on the retained sample.
The CDSCO said the laboratory findings, including the specific details of the misbranding, were communicated by the Drugs Controller General of India to States and Union Territories for regulatory vigilance and action.
Also Read: Kerala faces scrutiny over rabies vaccine quality
In a communication dated 27 August, the DCGI asked all State Drugs Controllers to alert their inspectorate staff and maintain “strict vigilance” over the movement, distribution and availability of Batch KE25012.
The States and Union Territories were also asked to take appropriate regulatory action under the Drugs and Cosmetics Act, 1940 and the Rules made under it.
CDSCO said the action was part of an ongoing mechanism to “detect unauthorised manufacturing and distribution activities and prevent the circulation of misbranded and spurious medicines.”
Also Read: Rabies is a fatal but preventable viral disease
CDSCO said the Delhi police have arrested four people in connection with the case. Further investigation and legal action are underway.
The regulator said the manufacturer had also issued a public communication about the misbranded product. It said every batch of Abhayrab is released for sale only after independent testing and batch-release certification by CDL, Kasauli.
CDSCO further said vaccines administered through hospitals, clinics and government healthcare facilities, or dispensed through licensed pharmacies, reach patients through the authorised and regulated supply chain. It also confirmed that no part of the batch concerned was exported.
The regulator said the coordinated action by CDSCO, State Drug Control authorities, the Drugs Control Department, the Delhi government and law enforcement agencies demonstrates the “continuous vigilance and integrated enforcement mechanism” to ensure medicines and vaccines meet prescribed quality and safety standards.
Indian Immunologicals Limited, the manufacturer of Abhayrab, said the vials tested by authorities “are not a product manufactured by Human Biologicals Institute”, citing 17 differences identified between the seized vial and its retained sample of the same batch.
In a statement dated 4 September, the company said the Central Drugs Laboratory (CDL) tested and released Batch KE25012 under Batch Release Certificate CDL/2025/8392 dated November 7, 2025. The company said 83,370 vials from the released batch were supplied only through its authorised distribution channel and that “No market complaint has been received in respect of the batch Number KE25012.”
The company said every batch of Abhayrab is released for sale only after independent testing and batch-release certification by CDL. It added that vaccine administered at a hospital, clinic, government healthcare facility or licensed pharmacy “reaches the patient through that released and authorised supply chain and is not affected by this matter.”
Indian Immunologicals said it had submitted its batch manufacturing, quality-control, reconciliation and distribution records to CDSCO on August 14, 2026. It said that through its representation to the DCGI dated 4 September, it had “asked the authorities to trace the source of these vials and to act against those responsible”, while extending its full cooperation to the investigation.
(Edited by Majnu Babu).
