New Delhi: Brazil’s health regulator, Anvisa, has denied permission to import Bharat Biotech’s Covid-19 vaccine Covaxin into the country after its authorities found that the plant in which the vaccine is being made did not meet Current Good Manufacturing Practice (CGMP) requirements. Covaxin is being manufactured at Bharat Biotech’s Hyderabad-based facility.
According to the Brazilian website Universo Online, one of the reasons Covaxin fell short of manufacturing standards was its reported “failure to comply with severalrules and instructions on good production practices.”
The problems related to non-adherence to demands for documentation, methods of analysis, and integrity of containers, the report said. Methods used for “sterilising, disinfecting, removing or inactivating viruses” also came under the scanner, the report also said.
“…considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines, or the non-compliance with the petition procedures submitted for analysis advocated by current legislation, resolves: Refuse the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (ies) contained in the ANNEX,” the Brazilian government said in a statement.
In response, Bharat Biotech said that it is working to resolve the issues raised during the Brazilian inspection and that the order for 20 million doses from the Brazilian government remains active.
Bharat Biotech had previously stated that it was in the process of filing regulatory documents for Covaxin’s approval in more than 40 countries.
Citing an interim vaccine efficacy of 81 per cent in Phase 3 clinical trials, Bharat Biotech said the Phase 3 clinical trials for Covaxin involved 25,800 volunteers, making it the “largest trials ever conducted in India” in collaboration with the Indian Council of Medical Research (ICMR).
With PTI inputs