Last Updated on October 10, 2024 by The Health Master
On June 8, India’s Central Drugs Standard Control Organisation (CDSCO) declared a batch of Typbar typhoid vaccine “not of standard quality” after it failed standard testing.
The vaccine, produced by Bharat Biotech in northern India, has since been recalled.
Related news: Drug alert: This Typhoid Vaccine fails Quality Test – CDSCO
Health officials said the levels of a particular molecule – O-acetyl – did not comply with national specifications.
In its statement, Bharat Biotech said that there were no reports of adverse events or safety issues due to the batch.
The Typbar typhoid vaccine is the first vaccine in India to get a World Health Organization Good Manufacturing Practice (WHO-GMP) pre-qualification certificate and is currently sold in more than 50 countries, according to Bharat Biotech.
The recall of the typhoid vaccine follows previous controversies involving India’s Covid-19 vaccine, cough syrups, and even eye drops sold to the United States.
In January 2021, Bharat Biotech, with crucial backing from the Indian government, got its Covid-19 vaccine endorsed by the regulators despite discrepancies in the number of clinical trial participants and trial protocols.
The company later said there were no issues with the “veracity” of the data that had been used.
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