Tuesday, 02 January 2024 12:17 GMT

India Immunologicals Issues Clarification After Abhayrab Rabies Vaccine Found Substandard


(MENAFN- Khaleej Times) India Immunologicals (IIL) has issued a statement on the Abhayrab Rabies Vaccine that was earlier flagged as substandard by the nation's drug authority.

The company said that it had received "queries from healthcare professionals" regarding the vaccine and its batch number KE25012.

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Detailing the incident, the firm first said that the Central Drugs Standard Control Organisation drew vials from "an unlicensed residential premises" in Mukherjee Nagar, Delhi.

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These vials, IIL said, were reported as Not of Standard Quality (NSQ) and misbranded. "The same laboratory report records (17) seventeen differences between that vial and the retention samples of the same batch held at the Laboratory, which we had submitted for batch release," the firm added.

Hence, it says that those vials that had undergone the examination "are not a product manufactured by Human Biologicals Institute", which is a subsidiary of India Immunologicals.

It also confirmed that people that have been vaccinated with this are "not affected by this matter" as each batch of the vaccine is released for sale only after independent testing and batch release certification by the Central Drugs Laboratory.

India Immunologicals said that it taken action by submitting its batch manufacturing, quality control, reconciliation and distribution records to the Central Drugs Standard Control Organisation.

The firm also said that it has asked authorities to find the source of these vials, while adding that it is extending its full cooperation to the investigation.

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