Indian Immunologicals Limited (IIL) has clarified that the Abhayrab vaccine samples recently found to be Not of Standard Quality (NSQ) and misbranded were not manufactured by its vaccine division, Human Biologicals Institute (HBI).

The clarification follows an enforcement action by the Central Drugs Standard Control Organisation (CDSCO), during which vials labelled as Abhayrab, Batch KE25012, were collected from an unlicensed residential premises in Mukherjee Nagar, Delhi.

According to IIL, the samples were subsequently sent to the Central Drugs Laboratory (CDL), Kasauli, which reported them as NSQ and misbranded.

IIL said a comparison of the questioned vials with genuine retention samples of the same batch submitted by HBI for batch release revealed 17 differences. 

Based on these findings, the company has stated that the vials examined by the authorities were not manufactured by HBI.

The company said it has submitted its manufacturing, quality-control, reconciliation and distribution records to CDSCO on 14 August 2026 to support the investigation and establish the traceability of the genuine product.

Following a specific representation submitted on 4 September 2026, IIL has also requested the authorities to trace the source of the questioned vials and take appropriate action against those responsible.

IIL reiterated that it is fully cooperating with the ongoing investigation and has sought to assist authorities in establishing how the questioned vials came to be present at the unlicensed premises.

The clarification comes amid reports concerning the quality and authenticity of Abhayrab, with IIL maintaining that the samples in question should not be attributed to its manufacturing operations.

The company’s position is that the differences identified between the questioned vials and HBI’s genuine retention samples indicate that the product tested by the authorities did not originate from HBI.