Concerns Rise Over Substandard Rabies Vaccine Abhayrab in India
India's drug regulator flagged a batch of rabies vaccine Abhayrab as substandard after failing potency tests, raising counterfeit concerns once again. Indian Immunologicals Ltd clarified that the samples were from an unlicensed location and not their production. Authorities are investigating and maintaining strict surveillance over the distribution of the vaccine.
India's drug regulator has flagged a batch of the rabies vaccine Abhayrab as potentially spurious after it failed potency tests, prompting new worries over counterfeit doses. This marks the second time in recent years that concerns have been raised about fake Abhayrab doses in a country where over 6,000 rabies deaths occur annually.
Indian Immunologicals Ltd, the manufacturer of Abhayrab with a 40% market share, stated the vials under investigation were from an unlicensed Delhi location. The batch, labelled KE25012, was not produced by IIL, according to their statement. Authorities, including the federal drug regulator, have launched an investigation after four arrests related to the seized vials.
The Central Drugs Laboratory's findings revealed significant labeling and packaging discrepancies. The drug authority is urging vigilance, and while authorized distributions are unaffected, the investigation continues into potential breaches under the Drugs and Cosmetics Act.
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