Delhi-Seized Abhayrab Vials Were Not Manufactured by IIL, Company Clarifies
New Delhi: Indian Immunologicals Limited (IIL) has clarified that the Abhayrab vaccine vials bearing Batch No. KE25012, which were seized from an unlicensed residential premises in Delhi and subsequently declared misbranded and Not of Standard Quality, were not manufactured by its Human Biologicals Institute.
In a statement dated September 4, 2026, Human Biologicals Institute, a division of Indian Immunologicals Limited, said it had received queries from healthcare professionals regarding Abhayrab (Rabies Vaccine, Human I.P.) bearing Batch No. KE25012 and issued the clarification to explain its position.
The company stated that during an enforcement action, the Central Drugs Standard Control Organisation (CDSCO) collected vaccine vials labelled as Abhayrab, Batch No. KE25012, from an unlicensed residential premises in Mukherjee Nagar, Delhi. The samples were subsequently sent to the Central Drugs Laboratory (CDL), Kasauli, for testing and were reported as misbranded and Not of Standard Quality.
However, IIL pointed out that the same laboratory report documented 17 differences between the seized vial and the retained samples of the corresponding batch held by CDL. The retained samples had originally been submitted by the company to the laboratory as part of the mandatory batch-release process.
“On that basis, the vials examined are not a product manufactured by Human Biologicals Institute,” the company stated.
Clarifying the status of the genuine batch, IIL said Batch No. KE25012 had been tested and released by the Central Drugs Laboratory through Batch Release Certificate No. CDL/2025/8392, dated November 7, 2025.
The company disclosed that the released quantity of 83,370 vials from the genuine batch was supplied exclusively through its authorised distribution channel. It further stated that it had not received any market complaint concerning genuine products belonging to Batch No. KE25012.
The company’s clarification followed enforcement action involving vials labelled as Abhayrab, Batch No. KE25012, collected by CDSCO authorities from the Mukherjee Nagar premises. IIL maintained that the seized vials should be distinguished from the genuine batch manufactured by the company and released after the prescribed laboratory testing and certification.
Addressing concerns among patients who may have received the vaccine, IIL stated that every batch of Abhayrab is released for sale only after independent testing and batch-release certification by CDL. According to the company, vaccines administered at hospitals, clinics and government healthcare facilities or dispensed through licensed pharmacies reach patients through the released and authorised supply chain and are not affected by the matter involving the seized vials.
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IIL further informed that it had submitted its batch-manufacturing, quality-control, reconciliation and distribution records to CDSCO on August 14, 2026.
Through a specific representation submitted to the Drugs Controller General of India (DCGI) on September 4, 2026, the company requested the authorities to trace the source of the seized vials and initiate action against those responsible.
The vaccine manufacturer said it was extending full cooperation to the ongoing investigation by the regulatory and law enforcement authorities.
To view the official statement, click the link below:
