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Why Brazil has denied permission to import Covaxin from Bharat Biotech | India News


NEW DELHI: Brazil has rejected permission to import 20 million doses of Covaxin from Bharat Biotech into the country, saying that the manufacturing plant in India does not meet Good Manufacturing Practice (GMP) requirements.
The Brazilian government had signed a contract last month to buy 20 million doses of the vaccine from the Indian pharmaceutical company.
Bharat Biotech requested the emergency use of the vaccine in Brazil on March 8.
The National Sanitary Surveillance Agency Anvisa on its website said it received a request from the Brazilian Ministry of Health to import 20 million doses of the vaccine made in India.
However, the regulator suspended a decision on the matter due to the absence of some key documents.
“… considering non-compliance with the requirements of Good Manufacturing Practices for Medicines, or non-compliance with the request procedures submitted for analysis, advocated by current legislation, resolves: Reject the Request (s) for Certification of Good Manufacturing Practices for Medicines of the company (s) contained in the ANNEX, “said a Brazilian government bulletin on March 29.
Hyderabad-based Bharat Biotech said it is working to resolve the problems cited during the inspection.
He added that the Brazilian government’s request for 20 million doses has not been canceled.
“The requirements outlined during the inspection will be met, the deadlines for compliance are under discussion with the Brazilian NRA and will be resolved soon,” the company told PTI in an email response.
To another query, the vaccine manufacturer said that it has been submitted for the US (emergency use authorization) in more than 40 countries and several countries have already issued the authorization and supplies are in process.
Covaxin had reported an interim efficacy of 81 percent after phase 3 clinical trials.
Covaxin and Covishield are the two vaccines currently used in India.
(With PTI inputs)

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