The Australian health department recently urged its citizens who may have received a rabies shot in India to check if they needed additional replacement doses. The UK and the US have released similar advisories.
The alert was issued over concerns that counterfeit batches of the vaccine Abhayrab — manufactured by the Human Biologicals Institute, a key division of the PSU Indian Immunologicals — were possibly circulating in India since 2023. This raised an alarm because rabies, once it develops, is nearly 100% fatal.
The viral infection is transmitted through the saliva of infected animals, leading to symptoms ranging from fever, headache, and nausea, to excessive salivation, fear of water, hallucinations, and partial paralysis. It can be prevented by a post-exposure vaccination. This is the reason people need to take rabies shots when they are bitten, scratched, or have had open wounds salivated on by dogs, cats, monkeys, and bats.
While the National Rabies Control Program reported 6,644 clinically suspected cases and deaths of human rabies between 2012 and 2022, this is likely an under-estimate. The World Health Organisation estimates that rabies causes around 18,000 to 20,000 deaths every year, of which between a third or two-thirds are in children under the age of 15. India accounts for nearly 36% of the global rabies deaths.
What is the issue around Abhayrab?
The Australian alert is the latest in a series of similar health advisories issued by the United Kingdom and the United States.
The alert from the UK issued in late October said: “The public health agencies in the four nations of the UK are conducting a look-back exercise to identify any travellers who reported receiving rabies vaccine following an animal bite in India from November 2023 onwards, to determine whether further rabies vaccination may be recommended.”
The United States Centre for Disease Control and Prevention raised an alert in November stating: “A case of rabies has been reported in the US in a traveler from India. The circulation of counterfeit Abhayrab human rabies vaccine has recently been reported in major cities in India. Counterfeit vaccines may not be effective in the prevention of rabies and could contain harmful ingredients.”
The company, meanwhile, said in a statement on Saturday: “In January 2025, IIL proactively identified in the market one specific batch (#KA24014) with a packaging different to the original. The company immediately notified the Indian regulators and law enforcement agencies…. There is no instance of any other counterfeit batch in the market.”
The counterfeit vaccines were detected in several cities, including Delhi, Mumbai, Agra, Lucknow, Kanpur, and Patna. Based on the complaints, raids were carried out in Delhi, Mumbai, and Agra.
“The counterfeit products were seized and tested, including in the government’s Central Drug Testing Laboratory in Kasauli, which tests all vaccines before they are released in the Indian market. The test report, in fact, found the vaccines to contain the genuine product. What this essentially means is that the outer package of the product was changed to divert the government supply to the open market,” said an expert in the know of the matter.
While there are several brands of rabies vaccines in India, manufactured by both national and international companies, Abhayrab is one of the most commonly available. The vaccine holds nearly 40% of the market share in the country.
“We are the largest producer of rabies vaccine in the world and have been delivering the product for the last 25 years. The challenge with such advisories is that it may lead to more vaccine hesitancy within the country. Imagine if Abhayrab is the only rabies vaccine on the shelf in a village — and someone does not take it because of this news. We want to let people know that the vaccine is safe and effective,” said a senior official from the company.
The cut-off date of November 2023 is based on the date printed on the faulty packaging. The genuine vaccines, bearing the same batch number, were actually manufactured by the company in 2024, according to the official.
Dr MK Sudarshan, founder president of the Association for Prevention and Control of Rabies in India (APCRI), sought to allay fears. “Fortunately, people in India are usually administered five doses of the vaccine following an animal bite. Now, even if one of the vaccines is of doubtful efficacy — and we still do not know what the counterfeit vaccines contained — the person will still be protected if they have received the other doses and the immunoglobulin,” he said.
Dr Sudarshan explained that the WHO vaccination schedule requires that people receive at least three doses of the intramuscular vaccine or two doses of the intradermal vaccine with an immunoglobulin given on the day of the animal bite. For those immunised previously, only two booster doses are needed.
Have there been recent cases of vaccine failure ?
A spike in rabies cases was reported in Kerala in 2022, with some suspecting ineffective vaccines to be the reason. Several of the deceased had received rabies vaccines, leading to the conclusion.
A committee set up by the Union health ministry found that the rabies cases had happened because of faulty wound washing techniques and non-administration of immunoglobulin for category 3 bites. A bite is considered to be category 3 when there are multiple bites or scratches that break the skin and the broken skin has been licked by the animal.
The committee also pointed out that the availability of immunoglobulin and vaccines was a major challenge. Dr Sudarshan explained: “In rare cases, rabies might happen despite vaccination if the wound has not been cleaned properly and on time. If the bite happens in a nerve-rich area and sends the virus directly into the nervous system, the infection may occur.”
Dog bites are a common cause for rabies. (Express photo: Praveen Khanna) 
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