'Misbranded' Abhayrab Rabies Vaccine Seized In Delhi, 'No Part Exported To Any Other Country': What DCGI Said

(MENAFN- Live Mint) Four people were reportedly arrested after a batch of "misbranded" Abhayrab rabies vaccine was seized during a search of an unlicensed premises in Mukherjee Nagar, Delhi, on April 22, 2026, according to a notice by the Drugs Controller General of India (DCGI).

This is the second time in less than two years that concerns were raised about counterfeit Abhayrab doses in India.

The regulator said the findings raised concerns about the sample's "identity and authenticity" and warranted investigation into whether it could be a spurious drug under India's Drugs and Cosmetics Act, Reuters reported.

A batch of Abhayrab vaccine declared 'misbranded'

The Delhi Police Crime Branch, along with the Delhi Drugs Control Department, seized a batch of the Abhayrab vaccine (batch number KE25012), which was declared misbranded and not of Standard Quality by the Central Drugs Laboratory (CDL), Kasauli.

Officials from the Central Drugs Standard Control Organisation (CDSCO) were called to the premises for legal sampling, following which the samples were sent to the Central Drugs Laboratory (CDL), Kasauli, for examination.

"The product was subsequently reported as misbranded and not of standard quality by CDL, Kasauli," read a notice shared by ANI on X.

According to news agency ANI, the manufacturer reaffirmed that genuine Abhayrab vaccines are released only after independent testing and government batch-release certification.

"Four people have been arrested in connection with the case, while further investigation and legal action are underway," the notice shared by ANI added.

Authorities confirmed that no part of the affected batch was exported to any other country, and that the seized product was not manufactured by Indian Immunologicals Ltd. Abhayrab manufacturer issues statement

The manufacturer of Abhayrab issued a public communication last week, providing information about the misbranded product.

Indian Immunologicals Ltd (IIL), which makes Abhayrab and holds a 40 percent share of the domestic rabies vaccine market, said in a statement dated September 4 that the vials carrying the label Abhayrab that were examined by the regulator were not manufactured by the company.

"The CDSCO drew vaccine samples from ​an unlicensed residential premises located at Mukherjee Nagar, Delhi", Sunil Tiwari, VP of IIL, was quoted by Reuters as saying. The vials were labelled as Abhayrab batch number KE25012, he ⁠added.

The manufacturer reaffirmed its commitment to quality and said every batch of Abhayrab is released for sale only after independent testing and batch-release certification by CDL, Kasauli.

It said the vaccines ‌supplied through ⁠authorised channels, including hospitals and licensed pharmacies, were unaffected by the issue.

The IIL said it had provided batch records to the regulator and ​asked authorities to trace the source of the vials and act against those responsible, while cooperating with the investigation.

The company added it had received queries from healthcare professionals regarding batch ​KE25012, but no market complaints. The original batch consisted of 83,370 vials distributed through authorised channels, it added.

What did thelab report reveal

Having supplied more than 210 million doses of Abhayrab in India and other countries for over two decades, IIL said the lab report identified 17 differences between the seized samples and the retention samples of the same batch held at the lab.

While the sample passed sterility, moisture and identity tests, the laboratory found significant differences between the sampled product and a retained reference sample of the same vaccine previously submitted by a division of Indian Immunologicals for regulatory testing.

These included discrepancies in labelling, artwork, QR code verification, cap colour, licence details and packaging text.

'Strict and continuous surveillance'

The DGCI said regulatory and law enforcement agencies are maintaining "strict and continuous surveillance" against illegal manufacture, distribution and supply of misbranded and spurious drugs to identify and disrupt unauthorised drug supply networks and safeguard 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.

The states were also asked to take appropriate regulatory action under the Drugs and Cosmetics Act, 1940 and the rules framed under it.

What is Abhayrab: Dosage, side-effects

Abhayrab is a human rabies vaccine used for both pre- and post-exposure protection against rabies. It is administered in multiple doses and is also supplied to government immunization programmes 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.

Dose administration:

Pre-Exposure: 0.5 mL or 1.0 mL of reconstituted vaccine (as per diluent supplied) on days 0, 7 and 21 or 28. Only people, whose occupation puts them at continual or frequent risk of exposure, should receive periodic booster doses whenever the rabies virus neutralizing antibody titre drops below 0.5 IU/mL.

Post-Exposure: For a new case: 0.5 mL or 1.0 mL of reconstituted vaccine (as per diluent supplied) on days 0, 3, 7, 14 and 28.

Rabies immunoglobulin should be administered preferably as soon as possible after initiation of post-exposure prophylaxis in case of Category III bites but not beyond 7 days from the first dose of vaccination.

For previously immunized individuals: One dose (0.5 mL or 1.0 mL, as per diluent supplied) of reconstituted vaccine intramuscularly at one site on day 0 and day 3. The administration of Rabies immunoglobulin is not required in such cases.

Adverse effects: Abhayrab may cause the following adverse effects

Mild pain, rash, and redness at the site of injection Fever Headache Muscle pain Discomfort In rare cases, abhayrab may cause high fever, arthritis, lymphadenopathy, and anaphylaxis.

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