New Delhi: There are growing concerns among several nations regarding the genuineness of anti-rabies vaccines administered to victims – in this case their citizens – of animal bites in India.
After the US and UK, the Australian health department has now urged its citizens, who may have received anti-rabies shots in India – if they require additional replacement doses.
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 alerts were issued over concerns that counterfeit batches of the vaccine Abhayrab – manufactured by the Human Biologicals Institute, a key division of the PSU Indian Immunologicals – may have possibly been circulating in India since 2023, as reported by The Indian Express.
Rabies, once it develops, is nearly 100% fatal. It 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. The only remedy is post-exposure vaccination.
This is the reason people need to take anti-rabies shots when they are bitten, scratched, or have had open wounds salivated upon by dogs, cats, monkeys, and bats.
The National Rabies Control Program reported 6,644 clinically suspected cases and deaths of human rabies between 2012 and 2022 in India. Experts, however, believe this is an under-estimate.
The World Health Organisation (WHO) 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.
Several companies manufacture anti-rabies shots in India. Abhayrab is the market leader with a 40% share.
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 government supply to the open market,” an expert told the newspaper.
“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,” a senior official from the company has been quoted as saying.
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, the official said.
Dr M K 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.
Not all rabies cases can be attributed to fake vaccines. 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.
“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,” Dr Sudarshan explained.
