India flags Abhayrab rabies vaccine batch as substandard, probes if spurious, document shows

India's drug regulator has raised concerns over a batch of the widely used rabies vaccine, Abhayrab, flagging it as potentially substandard and spurious after it failed a potency test. This marks the second time in less than two years that issues have been raised regarding counterfeit Abhayrab doses in India, a country that sees nearly 6,000 rabies deaths annually.

Indian Immunologicals Ltd, which has supplied over 210 million doses of the vaccine, holds a 40% share of the domestic market. The Central Drugs Laboratory in Kasauli discovered discrepancies between the sampled vaccine and a reference sample, including labelling, artwork, and packaging differences, leading to concerns about its identity and authenticity.

The regulator has requested strict vigilance over the distribution of the affected batch, KE25012, and is investigating whether it could be a spurious drug under India's Drugs and Cosmetics Act.

Brief written by urgent.news from Hindustan Times's own syndicated text. Machine-written — may contain errors; check the original before relying on it.