Bharat Bio’s Telangana unit failed GMP test, led to Covaxin suspension:

NEW DELHI: It was non-compliance with good manufacturing practices (GMP) at Bharat Biotech‘s flagship vaccine manufacturing facility at Hyderabad‘s Genome Valley that led to the World Health Organisation (WHO) suspending Covaxin supply for UN procurement.

Confirming this, WHO told TOI that the inspection it had carried out between March 14 and 22 “found that the manufacturing site for the production of the Covid vaccine Covaxin, located in Telangana, India, is not compliant with GMP and systemic issues need to be addressed”. “Problems were detected in some parts of the manufacturing process and changes were made after the EUL (emergency use listing) was granted but were not submitted to the national drug regulator and WHO for evaluation. The inspection was part of a campaign of manufacturing sites in India,” WHO said.

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