Executive Summary
India’s pharmaceutical industry plays a major role in global access to affordable medicines and generates significant economic returns. While it is currently ranked 3rd globally by volume alongside its domestic market valued at USD 60 billion, frequent concerns about the circulation of counterfeit medicines expose gaps in quality control and supply-chain traceability. When vaccine hesitancy is already a healthcare battle to overcome, circulation of spurious vaccines exacerbates erosion of trust in public health systems, and suboptimal public health outcomes.
Key Points
- A sample purporting to be from a batch of Abhayrab®, a widely used anti-rabies vaccine in India, was classified as “Not of Standard Quality” by the Central Drugs Standard Control Organisation (CDSCO).
- Indian Immunologicals Limited (IIL), the manufacturer of Abhayrab®, has disputed the authenticity of the seized vial, citing 17 discrepancies between the seized vial and samples from the genuine batch.
- It is reportedly the second counterfeit-Abhayrab episode in two years. The earlier one, involving batch KA24014, prompted warnings from health authorities in Australia and the US (CDC) about possibly inadequate protection.
Analysis
Given India reports 5726 human rabies deaths annually, Abhayrab is one of India’s most widely used anti-rabies vaccines owing to its usage in both pre-exposure and post-exposure protection, while also being supplied to government immunisation programmes. Particularly when much is at stake, since rabies is 100% fatal once it reaches the symptomatic stage, earlier detections of such incidents remain essential. This case illustrates the limitations of relying on detection and recall after a counterfeit has entered the supply chain.
Secondly, the suspected counterfeit vial contained the same batch number, KE25012, as the genuine one. This compounds the issue of enforcing the appropriate traceability mechanism, as the vulnerability is now shifted from the manufacturer to the supply chain. The existing traceability framework applies QR-code-based identification to the top 300 pharmaceutical brands. The 2026 amendments to the Drugs Rules, 1945 will expand QR-code requirements to all vaccines, anti-cancer medicines and narcotic and psychotropic drugs from 1 July 2027, with antimicrobials following from 1 July 2028.
The key data elements to be included in the QR include: the unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, date of expiry, manufacturing licence number, and details of excipients. The problem here is that most of these data elements are static, so a counterfeiter who copies them can reproduce a superficially valid code. While these are useful entry points, individual unit authentication using a unique serial number, linked to a central database would serve as a robust alternative.
Counterfeit packs replicating genuine serial numbers could also pass initial verification and subsequently cause the genuine pack to be flagged. To prevent this, the system should enable end-to-end tracking of each serial number, for example decommissioning the serial when the pack is dispensed, as the EU system does. While seeking to prevent a counterfeit from being scanned first would be a long-term aim, a stronger, immediate approach would be to make a first scan insufficient to prove authenticity. Upon suspicion of a duplicate product entry (in the event of a second-time scan of the same serial number), the approach would be to alert the relevant public health authorities, to quarantine both products and scrutinize their legitimacy.
Policy implications
- Strengthening recall and alert systems so that patients are evaluated and revaccinated where counterfeit exposure cannot be ruled out, as Australia did in early 2026 in response to the earlier counterfeit batch.
- India’s traceability system should use interoperable international serialisation standards, allowing exported products to be authenticated overseas.
- Establish the technical feasibility of vial-level QR/barcoding and mandate primary-pack coding accordingly, reducing reliance on secondary packaging and strengthening unit-level traceability. Closing the existing secondary-packaging exception would strengthen traceability at the vial level and reduce the risk of duplication or misidentification, reinforcing India’s credibility as a major producer of vaccines and generics.
References
Union Health Ministry expands QR Code-Based Drug Traceability Framework to vaccines, Antimicrobials and Anti-Cancer medicines. (n.d.). https://www.pib.gov.in/PressReleaseDetail.aspx?PRID=2277691®=1&lang=1
ThePrint. (2026, September 4). How counterfeit vials seized in Delhi raid put Abhayrab rabies vaccine on regulators’ radar. ThePrint
Mathur, B. (2026, September 7). Misbranded rabies vaccines seized in Delhi: What was found, why it matters. http://www.business-standard.com. https://www.business-standard.com/health/misbranded-rabies-vaccines-seized-in-delhi-what-was-found-why-it-matters-126090700769_1.html
Hindu. (2026, January 10). Watch: U.S. and Australia issue alert on fake anti-rabies vaccine in India: what you need to know [Video]. The Hindu. https://www.thehindu.com/videos/us-and-australia-issue-alert-on-fake-anti-rabies-vaccine-in-india-what-you-need-to-know/article70491713.ece