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🇦🇪 United Arab Emirates /Health & Science

Indian company clarifies after Abhayrab rabies vaccine is deemed substandard

From Khaleej Times · () English

Translated from English and summarized by DistantNews. Read the original for the full story.

At a glance

News Official statement Under investigation
  • India Immunologicals said vials from Abhayrab rabies vaccine batch KE25012 were flagged as substandard and misbranded after authorities sampled them at an unlicensed residential premises in Delhi.
  • The company said laboratory testing found 17 differences between the examined vial and retention samples from the same batch.
  • India Immunologicals said people vaccinated with the questioned vials are not affected by the matter and that it is cooperating with an investigation into their source.

India Immunologicals has issued a clarification after the country’s drug authority flagged vials of its Abhayrab rabies vaccine as Not of Standard Quality and misbranded. The company said healthcare professionals had asked questions about batch KE25012.

queries from healthcare professionals

· India ImmunologicalsThe company said questions from medical professionals prompted its clarification about batch KE25012.

According to the statement, the Central Drugs Standard Control Organisation drew the vials from an unlicensed residential premises in Mukherjee Nagar, Delhi. India Immunologicals said the laboratory report recorded “17 differences” between the examined vial and retention samples from the same batch held by the company and submitted for batch release.

17 differences

· India ImmunologicalsThe company cited the laboratory report’s comparison between the examined vial and its retention samples.

The firm said the tested vials were therefore not manufactured by Human Biologicals Institute, its subsidiary. It also said people vaccinated with the vials were not affected by the matter because every vaccine batch is released for sale only after independent testing and certification by the Central Drugs Laboratory.

are not a product manufactured by Human Biologicals Institute

· India ImmunologicalsThe firm disputed that the examined vials came from its subsidiary’s manufacturing process.

India Immunologicals said it had submitted its manufacturing, quality-control, reconciliation and distribution records to the national drug regulator. It has also asked authorities to identify the source of the vials and said it is fully cooperating with the investigation.

not affected by this matter

· India ImmunologicalsThe company said people vaccinated with the questioned vials were not affected.
About this summary

Originally published by Khaleej Times in English. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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