India's Drug Regulator Flags Counterfeit Abhayrab Rabies Vaccine Batch After Failed Potency Test
核心洞察
India's Central Drugs Laboratory flagged Abhayrab rabies (搜索) vaccine batch KE25012 as "not of standard quality" and "misbranded" after it failed a potency test, prompting a counterfeit investigation.
The suspect vials were seized on April 22 from an unlicensed residential premises in Delhi, with four arrests made and 17 packaging differences identified versus genuine samples.
Manufacturer Indian Immunologicals Ltd. (搜索) confirmed the seized vials were not produced by the company, stating the genuine KE25012 batch of 83,370 vials was released on November 7, 2025.
India's Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh, has flagged a batch of the rabies (搜索) vaccine Abhayrab as "not of standard quality (NSG)" and "misbranded" after it failed a potency test, raising concerns about the circulation of counterfeit doses and prompting a formal probe by the Central Drugs Standard Control Organisation (搜索) (CDSCO).
The vaccine samples, bearing batch number KE25012, were seized on April 22 during an enforcement action by the Delhi Police and officials of Delhi's Drugs Control Department from an "unlicensed residential premises." The seized vials were found to differ from genuine reference samples in packaging, labelling, artwork, QR-code verification, cap colour, and licence details. Four persons have been arrested by the Delhi Police in connection with the incident so far, with further investigation and appropriate legal action being undertaken by competent authorities, the CDSCO said in a statement on Saturday (September 5, 2026).
Manufacturer Disputes Authenticity of Seized Vials
Indian Immunologicals Ltd. (搜索) (IIL), which manufactures Abhayrab through its Human Biologicals Institute (HBI), has stated that the concerned vaccines bearing batch number KE25012 were not produced by the company. In a statement issued on Friday (September 4, 2026), IIL said the genuine KE25012 batch had undergone the required testing and was released on November 7, 2025. The company said the batch comprised 83,370 vials and was distributed through its authorised network.
"Importantly, the laboratory [CDL] identified 17 differences between the questioned vials and the genuine retention samples of the same batch that HBI had submitted for batch release," the IIL statement said. IIL indicated that the legitimate batch number may have been used on counterfeit material, and authorities are investigating the source and distribution of the suspect product and whether it is spurious.
Regulatory Response and Ongoing Investigation
The investigation will now have to establish who manufactured the suspect KE25012 vials and whether any patients received them. While it is yet to be confirmed whether the misbranded vaccines entered circulation in the country, the CDSCO said that no part of the batch concerned was exported to any other country. The Drugs Controller General of India (DCGI), in a communication dated August 27, has requested all State Drugs Controllers to maintain strict vigilance over the movement, distribution, and availability of batch KE25012 of Abhayrab.
Drug regulatory and law enforcement agencies are maintaining strict and continuous surveillance against illegal manufacture, distribution and supply of misbranded and spurious drugs, with coordinated action being undertaken to identify and disrupt unauthorised drug supply networks and safeguard the quality and safety of medicines available to the public, the regulator said.
A Recurring Counterfeit Threat
The development follows an earlier counterfeit Abhayrab episode involving batch KA24014 in 2025. IIL had reported suspected counterfeit vials to authorities, following which health warnings were issued in some countries over the possibility that travellers to India could have received counterfeit rabies (搜索) vaccine. This marks the second time in recent years that concerns have been raised about fake Abhayrab doses in a country where over 6,000 rabies deaths occur annually.
The latest case is particularly important because rabies (搜索) is almost invariably fatal once symptoms develop, making effective post-exposure vaccination critical. For IIL, which holds a 40% market share for Abhayrab, the findings will be important in determining whether the episode represents a manufacturing-quality failure or a counterfeit and supply-chain problem.
IIL has submitted its manufacturing, quality-control, reconciliation and distribution records to CDSCO on 14 August 2026. Following a specific representation on Friday (September 4, 2026), IIL noted it has requested authorities to trace the source of the questioned vials and take action against those responsible, while confirming its full cooperation with the investigation. The drug authority is urging vigilance, and while authorised distributions are unaffected, the investigation continues into potential breaches under the Drugs and Cosmetics Act.