Abhayrab rabies vaccine batch fails potency test. Regulator alerts states.
Where it stands
India's drug regulator has flagged Abhayrab batch KE25012. Delhi Police and drug inspectors seized the vials from an unlicensed flat in Mukherjee Nagar on 22 April 2026. The Central Drugs Laboratory, Kasauli, found the sample failed the potency test. The label, QR code and cap colour did not match the maker's reference sample. The laboratory called the sample 'not of standard quality' and 'misbranded'. On 27 August 2026 the regulator asked states for strict vigilance over the batch. On 4 September 2026 Indian Immunologicals said the vials were not the company's product. On 5 September 2026 CDSCO said Delhi Police have arrested four people. CDSCO said no part of the batch was exported. Who made the vials is not known.
Background
Abhayrab is a rabies vaccine made by Indian Immunologicals Limited at Ooty in Tamil Nadu. The National Dairy Development Board set up the company in 1982. India reported 54 suspected human rabies deaths in 2024 and more than 37 lakh dog bites. An ICMR survey estimated 5,726 rabies deaths a year. The Central Drugs Laboratory at Kasauli tests and releases vaccine batches before sale. The laboratory handles about 7,000 batches a year. In January 2025 the company reported a counterfeit Abhayrab batch, number KA24014, to the regulator. Australia and the United Kingdom later issued advisories for travellers vaccinated in India.
How it developed
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1982 to 13 January 2025How it started
Every vaccine batch passes through Kasauli. A fake Abhayrab batch surfaced in January 2025.
Indian Immunologicals Limited makes Abhayrab, a rabies vaccine, at Ooty in Tamil Nadu. The National Dairy Development Board set up the company in 1982. The Central Drugs Laboratory at Kasauli is India's national control laboratory for vaccines. The laboratory receives about 7,000 batches a year for testing and release. Drug inspectors also draw samples from the supply chain. Laboratories test the samples. CDSCO puts the failed batches on its website every month. A maker of a failed batch must recall the batch and stop distribution. On 13 January 2025 Indian Immunologicals reported a falsified Abhayrab batch, number KA24014, to the Drugs Controller General of India.
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23 to 27 December 2025New fact
Australia warns travellers about counterfeit Abhayrab. The maker calls the alert over-cautious.
On 23 December 2025 the health department of Victoria, Australia, published an alert on counterfeit Abhayrab batches in India. The alert asked people vaccinated with Abhayrab in India from 1 November 2023 to ask a doctor about replacement doses. On 27 December 2025 Indian Immunologicals said the alert did not reflect the current situation. The company said the counterfeit batch KA24014 was detected in January 2025 through a packaging anomaly. The company said every batch made in India is tested and released by the Central Drugs Laboratory before sale. The company said it had supplied more than 210 million doses across India and 40 countries.
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27 August 2026, reported on 5 September 2026New fact
Kasauli lab fails Abhayrab batch KE25012 on potency. DCGI writes to states.
On 27 August 2026 the Drugs Controller General of India wrote to state drug regulators about Abhayrab batch KE25012. The Central Drugs Laboratory at Kasauli had tested a field sample of the batch. The sample passed the sterility, moisture and identity tests. The sample failed the potency test. The label, artwork, QR code, cap colour, licence details and packaging text differed from the company's reference sample. The laboratory called the sample 'not of standard quality' and 'misbranded'. The letter said the findings needed investigation as a possible spurious drug. The letter asked states for strict vigilance over the batch's movement and distribution.
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4 September 2026Official response
Indian Immunologicals says the failed vials are not the company's product. The company asks the regulator to trace the source.
On 4 September 2026 Indian Immunologicals said the vials tested at Kasauli were not the company's product. The company said the laboratory found 17 differences from the batch's reference samples. The company said the genuine batch had 83,370 vials. The company said the laboratory released that batch on 7 November 2025. The company asked the regulator to trace the source of the vials. The statement does not say who made the vials.
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5 September 2026New fact
CDSCO says the vials were seized in Delhi on 22 April 2026. Four people have been arrested.
On 5 September 2026 CDSCO published a public notice on the seized vials. CDSCO said Delhi Police and drug inspectors searched an unlicensed flat in Mukherjee Nagar, Delhi, on 22 April 2026. CDSCO called the vials of batch KE25012 misbranded and 'not manufactured by Indian Immunologicals Ltd'. CDSCO said Delhi Police have arrested four people. CDSCO said no part of the batch was exported. The notice does not say who made the seized vials.
Why it matters for UPSC
For GS2, separate the two regulators. CDSCO approves new drugs and sets standards. State drug controllers license manufacture and sale. For GS3, separate 'not of standard quality' from 'spurious'. Not of standard quality means the drug failed a test. Spurious means the drug is not what the label says. The laboratory found the first. The regulator only suspects the second. A suspicion is not a finding. Also keep reported deaths (54 in 2024) apart from estimated deaths (5,726 a year). The two numbers measure different things.
Key terms
Sources (14)
- Central Drugs Standard Control Organisation · official · CDL Kasauli: National Control Laboratory for testing of immunobiologicals (vaccines and antisera) for human use5 Sep, 10:45 am
- Press Information Bureau · official · Status of Drug Quality Testing under CDSCO (Rajya Sabha reply, 1 April 2025)5 Sep, 10:45 am
- NaTHNaC · official · Falsified rabies vaccine: India (26 February 2026)5 Sep, 10:45 am
- Department of Health, Victoria · official · Health alert: Counterfeit batches of rabies vaccine (Abhayrab) reported in India (23 December 2025)5 Sep, 10:45 am
- National Herald · Australia's move 'over-cautionary', says Indian vaccine maker after blanket warning (27 December 2025)5 Sep, 10:45 am
- Akashvani News · official · Indian Immunologicals Limited refutes claims by Australian health authorities on fake Abhayrab vaccine doses (27 December 2025)5 Sep, 10:45 am
- Central Drugs Standard Control Organisation · official · NSQ Alerts portal: monthly Not of Standard Quality and Spurious lists (July 2026 list checked)5 Sep, 10:45 am
- Business Standard · Govt flags Abhayrab rabies vaccine batch as substandard after potency test (Reuters copy, 5 September 2026)5 Sep, 10:45 am
- Reuters · Exclusive-India flags Abhayrab rabies vaccine batch as substandard, probes if spurious, document shows (4 September 2026)5 Sep, 10:45 am
- Indian Immunologicals Limited · official · Statement on Abhayrab, Human Biologicals Institute (a division of Indian Immunologicals Limited), dated 4 September 2026, signed by Sunil Tiwari, VP and Head of Quality Management6 Sep, 1:20 am
- Business Standard · IIL says NSQ Abhayrab vials were not manufactured by its division (5 September 2026)6 Sep, 1:20 am
- The Hindu · Authorities probing 'counterfeit' rabies vaccine, says drug regulator (5 September 2026)6 Sep, 1:20 am
- Central Drugs Standard Control Organisation · official · Public Notice: Drug Regulatory and Law Enforcement Agencies Intensify Coordinated Action Against Illegal Manufacture and Distribution of Misbranded Drugs (New Delhi, 5 September 2026), with the CDL Kasauli test certificate (Form 13) and photo annexures6 Sep, 1:20 am
- BusinessLine · IIL stands by rabies vaccine, as CDSCO flags 'fake' vials seized from unlicensed Delhi residence (5 September 2026)6 Sep, 1:20 am