Breaking Update: Here’s a clear explanation of the latest developments related to Breaking News:Counterfeit batches of rabies vaccine circulating in India, warns Australia– What Just Happened and why it matters right now.
Australia has issued an advisory warning that counterfeit batches of a rabies vaccine have been circulating in India since November 1, 2023.
The Australian Technical Advisory Group on Immunisation issued the alert about counterfeit batches of the vaccine Abhayrab on December 22. It stated that while the vaccine is not available in Australia, those who received it while in India may still be affected.
Rabies is a viral zoonotic disease that affects the central nervous system. Infected dogs are responsible for transmitting the virus in the vast majority of rabies cases among humans.
According to the World Health Organization, the disease is fatal in 100% cases once it infects the central nervous system and clinical symptoms appear.
Abhayrub is manufactured by the Human Biologicals Institute, a division of Hyderabad-based Indian Immunologicals Limited.
Indian Immunologicals Limited told Scroll that in January, it “proactively identified an issue related to a specific batch of Abhayrab (Batch # KA 24014) in the market place with a packaging that was different”.
It added that it immediately notified Indian regulators. “We are working closely with regulatory authorities and law-enforcement agencies to swiftly curb this batch specific issue, and a formal complaint has been lodged to facilitate investigation,” stated the company.
In its advisory, the Australian advisory body said that those “who have received the counterfeit vaccine may not be fully protected against rabies and are recommended to receive replacement doses with a rabies vaccine registered in Australia”.
As it would be difficult to confirm whether an individual received a genuine or fake vaccine, anyone who received a dose of Abhayrab in India from November 1, 2023, onwards should be considered to have potentially been administered the counterfeit vaccine, it added.
The advisory body said that such persons should be offered replacement doses of a vaccine in Australia.
The World Health Organization says that as per available information, rabies causes 18,000 to 20,000 deaths every year in India. The country accounts for 36% of the total deaths due to rabies in the world.
In recent years, there have been several concerns about medical products manufactured in India being found to be substandard in foreign countries. Deaths allegedly linked to India-made cough syrups have been reported from the Gambia and Uzbekistan, while Indian-made eye drops were suspected to have been linked to infections in Sri Lanka.
‘Supplies made through authorised distributors safe’
The company told Scroll that every batch of vaccine made at Indian Immunologicals Limited is tested and released by the Central Drugs Laboratory under the Government of India prior to release for public use.
Abhayrab has been manufactured by Indian Immunologicals Limited since 2000, with over 210 million doses supplied in India and across 40 countries, the vaccine-maker said, adding that the vaccine holds about 40% of the market share.
“We would like to reiterate and provide adequate confidence to health care professionals and the general public that all supplies of Abhayrab made by IIL to the various government institutions and all supplies made through our authorised distributors are safe and of standard quality,” it added.
Indian Immunologicals Limited is committed to the highest standards of quality, safety, and transparency in the interest of public health, the statement added.