Authorities are investigating ‘counterfeit’ rabies vaccine, says medicines regulator

The investigation will now have to find out who made the suspected vials of KE25012 and whether any patients received them. (Representative image) | Photo credit: Getty Images/iStochphoto

The Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has labeled a batch of Abhayrab vaccine, used against rabies, as “non-standard grade (NSG)” and “misbranded” after it failed an efficacy test, raising concerns about the circulation of fakes and prompting a probe.

Samples of the vaccine bearing batch number KE25012 were seized on April 22 during an enforcement operation by the Delhi Police and officials of the Delhi Drug Control Department from “unlicensed residential premises”. It was found to differ from the original reference samples in packaging, labeling, artwork, QR code verification, cap color and license details.

The Delhi Police have so far arrested four persons in connection with the incident and authorities are conducting further investigation and appropriate legal action, the Central Drugs Standard Control Organization (CDSCO) said on Saturday (September 5, 2026).

The investigation will now have to find out who made the suspected vials of KE25012 and whether any patients received them.

While it has yet to be confirmed whether the misbranded vaccines were released into circulation in the country, the CDCSO said no part of the affected batch was exported to any other country. The Drug Controller General of India (DCGI), in a communication dated August 27, has asked all state drug controllers to strictly monitor the movement, distribution and availability of the KE25012 batch of Abhayrab, the CDCSO said.

Drug regulatory authorities and law enforcement agencies maintain strict and continuous surveillance of the illegal manufacture, distribution and supply of misbranded and counterfeit drugs, with coordinated measures being taken to identify and disrupt illicit drug supply networks and ensure the quality and safety of medicines available to the public, the regulator said.

Indian Immunologicals Ltd. (IIL), which manufactures Abhayrab through its Human Biologicals Institute (HBI), said the affected vaccines bearing batch number KE25012 were not manufactured by the company.

In a statement issued on Friday (September 4, 2026), IIL said the original batch of KE25012 passed the required testing and was released on November 7, 2025. The company said the batch contained 83,370 vials and was distributed through its authorized network.

“Importantly, the laboratory (CDL) identified 17 differences between the vials examined and the actual retention samples of the same batch submitted by HBI for batch release,” the IIL statement said.

IIL said the seized vials did not match the original product and said a legitimate batch number may have been used for counterfeit material. Authorities are investigating the source and distribution of the suspect product and whether it is counterfeit.

The development follows an earlier episode of Abhayrab counterfeiting involving batch KA24014 in 2025. The IIL reported suspected counterfeit vials to the authorities, following which health warnings were issued in some countries over the possibility that travelers to India may have received counterfeit rabies vaccine.

The latter case is particularly important because rabies is almost always fatal once symptoms develop, making effective post-exposure vaccination critical.

For IIL, the findings will be important in determining whether the episode represents a manufacturing quality failure or a counterfeiting and supply chain issue.

IIL submitted its manufacturing, quality control, approval and distribution records to CDSCO on 14 August 2026.

Following a specific statement on Friday (September 4, 2026), the IIL noted that it had asked the authorities to trace the source of the bottles in question and take action against those responsible, affirming its full cooperation in the investigation.

Published – 05 Sep 2026 22:54 IST