India's Covaxin has been denied a 'good manufacturing practices' certificate by Brazil's health regulator ANVISA.

ANVISA has denied a certificate for good manufacturing practices to Bharat Biotech as it did not meet its manufacturing standards.

ANVISA has denied a certificate for good manufacturing practices to Bharat Biotech as it did not meet its manufacturing standards.Bharat Biotech had applied for authorization for emergency use of its COVID-19 vaccine in Brazil and to supply 20 million doses of Covaxin. The process involves getting authorization from Anvisa, the regulatory body in Brazil, for emergency use. Anvisa has certified four vaccine makers after verifying the inspection reports prepared by regulatory authorities.

A team of five inspectors had visited the production facility in India to inspect and verify the technical details of the vaccine to be supplied. The team raised some issues related to the manufacturing plant and mentioned in the report that the Bharat Biotech laboratory did not meet Current Good Manufacturing Practice (CGMP) requirements and also cited a lack of safety data and documentation. The certification request was rejected as the company did not produce all the required documents, and different non-conformities were found.

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