‘Misbranded’ Abhayrab rabies vaccine seized in Delhi, ‘no part exported to any other country’: What DCGI said | Today’s news
Four people were reportedly arrested after a batch of ‘misbranded’ Abhayrab rabies vaccine was seized during a raid on unlicensed premises in Delhi’s Mukherjee Nagar on April 22, 2026, according to a notification by the Drug Controller General of India (DCGI).
This is the second time in less than two years that concerns have been raised in India about adulterated doses of Abhayrab.
The regulator said the findings raised concerns about the “identity and authenticity” of the sample and warranted an investigation into whether it could be a fake drug under India’s Drugs and Cosmetics Act, Reuters reported.
Batch of Abhayrab vaccine labeled ‘mislabelled’
The Delhi Police Crime Branch along with the Delhi Drug Control Branch seized a batch of Abhayrab vaccine (batch number KE25012) which was declared misbranded and substandard by the Central Drug Laboratory (CDL) Kasauli.
Officials from the Central Drugs Standard Control Organization (CDSCO) were called to the premises for legal sampling, after which the samples were sent to the Central Drugs Laboratory (CDL) Kasauli for examination.
“The product was subsequently marked as mislabeled and not of standard quality by CDL, Kasauli,” read a notice shared by ANI on X.
According to news agency ANI, the manufacturer has reaffirmed that genuine Abhayrab vaccines are released only after independent testing and government batch certification.
“Four people have been arrested in connection with the case, pending further investigation and legal action,” added the announcement shared by ANI.
The authorities confirmed that no part of the batch in question was exported to any other country and that the seized product was not manufactured by Indian Immunologicals Ltd.
Producer Abhayrab issues a statement
Manufacturer Abhayrab issued a public statement last week providing information about the misbranded product.
Indian Immunologicals Ltd (IIL), which makes Abhayrab and has a 40 percent share of the domestic rabies vaccine market, said in a September 4 statement that the Abhayrab-branded vials inspected by the regulator were not manufactured by the company.
“CDSCO has been collecting vaccine samples from unlicensed residential premises in Mukherjee Nagar, Delhi,” Sunil Tiwari, vice president of IIL, was quoted as saying by Reuters. The vials were identified as Abhayrab batch number KE25012, he added.
Reaffirming its commitment to quality, the manufacturer said that each batch of Abhayrabu is released for sale only after independent batch testing and certification by CDL, Kasauli.
It said vaccines supplied through authorized channels, including hospitals and licensed pharmacies, were not affected by the issue.
IIL said it has provided batch records to the regulator and asked authorities to trace the source of the vials and take action against those responsible while cooperating with the investigation.
The company added that it has received inquiries from healthcare professionals about the KE25012 lot, but no complaints in the market. The original batch consisted of 83,370 bottles distributed through authorized channels, he added.
What the lab report revealed
After supplying more than 210 million doses of Abhayrab in India and other countries for more than two decades, the IIL said a laboratory report identified 17 differences between hold samples and retention samples of the same batch kept in the laboratory.
While the sample passed sterility, moisture and identity tests, the laboratory found significant differences between the product in the sample and a retained reference sample of the same vaccine previously submitted by the Indian Immunologicals division for regulatory testing.
These included discrepancies in labelling, artwork, QR code verification, cap colour, license details and packaging text.
“Strict and round-the-clock supervision”
The DGCI said regulators and law enforcement agencies maintain “strict and continuous surveillance” against the illegal manufacture, distribution and supply of misbranded and counterfeit drugs to identify and disrupt illicit drug supply networks and ensure the quality and safety of medicines available to the public.
In a communication dated August 27, the DCGI asked all state drug controllers to alert their inspectorate staff and maintain strict vigilance over the movement, distribution and availability of the affected batch.
States have also been asked to take appropriate regulatory measures under the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
What is Abhayrab: Dosage, Side Effects
Abhayrab is a human rabies vaccine used for both pre- and post-exposure protection against rabies. It is given in multiple doses and is also supplied to government immunization programs in India.
It is widely used to prevent and treat rabies.
Indian Immunologicals exports Abhayrab to more than 40 countries including South Africa, Turkey, Vietnam, Cambodia, Zimbabwe, Thailand and the United Arab Emirates.
Preexposure: 0.5 ml or 1.0 ml of reconstituted vaccine (depending on the diluent supplied) on days 0, 7 and 21 or 28. Only people whose occupation puts them at constant or frequent risk of exposure should receive regular booster doses whenever the neutralizing antibody titer against rabies virus falls below 0.5 IU/ml.
After exposure: For a new case: 0.5 ml or 1.0 ml of reconstituted vaccine (according to the diluent supplied) on days 0, 3, 7, 14 and 28.
Rabies immune globulin should be administered as soon as possible after the initiation of post-exposure prophylaxis for category III bites, but no later than 7 days after the first dose of vaccination.
For previously immunized individuals: One dose (0.5 mL or 1.0 mL, depending on the diluent supplied) of reconstituted vaccine intramuscularly at one site on day 0 and day 3. Administration of rabies immunoglobulin is not required in such cases.
Adverse effects: Abhayrab may cause the following side effects
- Mild pain, rash and redness at the injection site
- Fever
- Headache
- Muscle pain
- Discomfort
- In rare cases, abhayrab may cause high fever, arthritis, lymphadenopathy, and anaphylaxis.
