By Rishika Sadam
HYDERABAD, Sept 4 – India’s drug regulator has flagged a batch of extensively used rabies vaccine Abhayrab as substandard and probably spurious after it failed a efficiency take a look at, a authorities doc seen by Reuters exhibits.
The discovering marks the second time in lower than two years that considerations have been raised about counterfeit Abhayrab doses in India, a rustic that experiences practically 6,000 rabies deaths a yr and the place the vaccine is a frontline defence towards the in any other case practically all the time deadly an infection.
Indian Immunologicals Ltd has equipped greater than 210 million doses of Abhayrab in India and different nations for over 20 years and held a 40% share of the home rabies vaccine market, it stated in December.
In an August 27 letter to state drug regulators, India’s Medicine Controller Basic Rajeev Singh Raghuvanshi requested officers to keep up “strict vigilance” over the motion and distribution of Abhayrab batch KE25012 and take regulatory motion, as crucial.
The motion got here after the federal government’s Central Medicine Laboratory in Kasauli discovered {that a} area pattern of the vaccine didn’t meet efficiency necessities and categorised it as “not of ordinary high quality” and a “misbranded” drug, in line with the doc.
Whereas the pattern handed sterility, moisture and identification assessments, the laboratory additionally discovered important variations between the sampled product and a retained reference pattern of the identical vaccine beforehand submitted by a division of Indian Immunologicals for regulatory testing.
These included discrepancies in labelling, paintings, QR code verification, cap color, licence particulars and packaging textual content.
The regulator stated the findings raised considerations in regards to the pattern’s “identification and authenticity” and warranted investigation into whether or not it may very well be a spurious drug beneath India’s Medicine and Cosmetics Act.
Indian Immunologicals and the federal regulator didn’t reply to a number of requests searching for remark.
PREVIOUS WARNINGS TO TRAVELLERS
Indian Immunologicals had beforehand notified India’s drug regulator in January 2025 that counterfeit Abhayrab doses bearing batch quantity KA24014 had entered the market. World well being authorities in the US, Britain and Australia later issued alerts for travellers who might have acquired the vaccine in India.
On the time, the corporate stated it had not manufactured the counterfeit batch, reiterated that the incident was remoted and stated it was not conscious of some other counterfeit doses in circulation.
India information an estimated 5,726 human rabies deaths yearly, in line with a 2024 examine by the Indian Council of Medical Analysis’s Nationwide Institute of Epidemiology.
Abhayrab is a human rabies vaccine used for each pre- and post-exposure safety towards rabies. It’s administered in a number of doses and can be equipped to authorities immunization programmes in India.
The federal government doc doesn’t state what number of doses of the batch now being investigated might have been distributed, nor whether or not any doses from the flagged batch had been exported or whether or not international regulators had been notified of the newest alert.
Indian Immunologicals exports Abhayrab to greater than 40 nations together with South Africa, Turkey, Vietnam, Cambodia, Zimbabwe, Thailand and the United Arab Emirates.
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