Rabies Vaccine Alert as Australia Warns of Counterfeit Doses in India

The Australian Technical Advisory Group on Immunisation, in coordination with state health departments, has cautioned that people who received the rabies vaccine Abhayrab in India from 1 November 2023 onwards may have been given falsified doses. Officials say these counterfeit vaccines could be ineffective, leaving recipients vulnerable to rabies, a disease that is almost always fatal once symptoms develop.

The advisory was issued on 22 December after investigations revealed that fake versions of Abhayrab, a vaccine not licensed for use in Australia, had entered the Indian market. Australian authorities said that because it is difficult to distinguish genuine vials from counterfeit ones, any dose of Abhayrab administered in India during the affected period should be treated as potentially invalid.

Rabies is a viral disease that attacks the central nervous system and is most commonly transmitted to humans through bites or scratches from infected animals, particularly dogs. According to the World Health Organization, once clinical symptoms appear, rabies is fatal in nearly all cases. India accounts for a significant share of the global burden, with an estimated 18,000 to 20,000 deaths each year.

The counterfeit vaccine was first identified by Indian Immunologicals Limited, the manufacturer of Abhayrab, in early 2025. The company reported that counterfeiters had copied genuine batch numbers, including Batch Number KA24014, and distributed fake products that differed in chemical composition, packaging and labelling from authentic supplies.

Indian Immunologicals Limited said it alerted Indian drug regulators immediately after detecting irregularities. “We proactively identified an issue related to a specific batch of Abhayrab in the marketplace with packaging that was different,” the company said in a statement. It added that it is working closely with regulatory authorities and law enforcement agencies and has lodged a formal complaint to support investigations.

Health authorities in Australia said reports suggest that counterfeit doses have been found in several major Indian cities, including Delhi, Mumbai, Ahmedabad and Lucknow. However, they cautioned that the full extent of distribution remains unclear.

The Australian advisory body warned that counterfeit vaccines may not contain the active antigen needed to trigger immunity or may have been stored outside the required temperature-controlled supply chain. Either scenario could result in treatment failure following exposure to the rabies virus.

As a precaution, Australian officials have advised anyone who received a rabies vaccination in India during the specified period, particularly those who were given Abhayrab or are unsure of the vaccine brand, to consult a healthcare professional without delay. Affected individuals are being offered replacement doses using rabies vaccines registered in Australia, including Rabipur and Verorab.

The warning applies both to travellers who sought treatment after animal bites and to those who received the vaccine as a preventive measure. Health authorities emphasised that timely revaccination is essential to reduce the risk of infection.

The advisory also includes guidance for people planning to travel to India or other rabies-endemic countries. Australian health officials recommend completing pre-exposure rabies vaccination before departure, as this simplifies treatment if exposure occurs. Travellers are also advised to keep detailed records of any vaccinations received abroad, including photographs of packaging and batch numbers, and to avoid contact with stray dogs, monkeys and other mammals.

This is not the first time international health agencies have carried out retrospective checks linked to rabies treatment in India. Earlier this year, the United Kingdom Health Security Agency and the United States Centers for Disease Control and Prevention conducted similar “look-back” exercises after a rabies death was associated with treatment received during travel in India.

Indian Immunologicals Limited has stressed that authorised supplies of Abhayrab remain safe. The company said every batch produced is tested and released by the Central Drugs Laboratory under the Government of India before being approved for public use. It added that Abhayrab has been manufactured since 2000, with more than 210 million doses supplied in India and over 40 countries, accounting for around 40 percent of the domestic market.

“We would like to reiterate and provide confidence to healthcare professionals and the general public that all supplies made through our authorised distributors are safe and of standard quality,” the company said, adding that it remains committed to quality, safety and transparency in the interest of public health.

Context

The warning comes amid heightened international scrutiny of medical products manufactured in India, following reports in recent years of substandard medicines linked to deaths or serious illness abroad. Health experts say the latest alert underscores the importance of robust supply chain oversight and international cooperation to prevent counterfeit medicines, particularly for life-saving vaccines used in regions where infectious diseases remain endemic.