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Bharat Biotech sends a new application to the Brazilian regulator on GMP issues for covaxin

Bharat Biotech has sent a fresh request to the authorities there to obtain a certificate to supply anti-Covid-19 vaccine in Brazil. Earlier, the Brazilian health regulator refused to allow the supply of Covid vaccines if it was dissatisfied with the ‘commodity production system’ at the company’s plant. According to Brazil’s National Health Monitoring Agency ‘Envisa’, India Biotech sent the request on 25 May. A day before this, the Health Ministry gave a fresh application to get approval for the import of 20 million doses of covaxin. Earlier, Envisa officials found that the plant in which the vaccine is produced did not meet the requirements of the ‘Goods Production System (GMP)’ after which the agency refused to allow covaxine import . Bharat Biotech International Limited said on 26 February that it had entered into an agreement with the Brazilian government for the supply of 20 million doses of covaxin. He had stated that these doses would be sent in the second and third quarters of the current year. However Brazilian health regulators refused imports of vaccines due to GMP issues. The vaccine manufacturer told PTI that the points raised during the inspection would be met.