The Brazilian 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 the Current Good Manufacturing Practice(CGMP) requirements.
Reacting to it, the city-based vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian Health Ministry to import 20 million doses of Covaxin. However a decision on that was suspended by the regulator due to the absence of some key documents. "…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," a Brazilian government gazette said on March29.