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Why Brazil has denied permission to import Bharat Biotech’s Covaxin | India News – Times of India



NEW DELHI: Brazil has refused permission to import 20 million doses of Bharat Biotech‘s Covaxin into the country, saying that the manufacturing facility in India does not meet the Good Manufacturing Practice (GMP) requirements.
The Brazilian government had signed a contract last month to buy 20 million doses of the Indian drugmaker’s vaccine.
Bharat Biotech applied for emergency use of the vaccine in Brazil on March 8.
National Health Surveillance Agency Anvisa in its website said it received a request from the Brazilian health ministry to import 20 million doses of the India-made vaccine.
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, advocatedby 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 March 29.
Hyderabad-based Bharat Biotech said it is working towards resolving the issues cited during the inspection.
It added that the order of 20 million doses from the Brazilian government has not been cancelled.
“The requirements pointed out during inspection will be fulfilled, the timelines for fulfillment is under discussion with the Brazil NRA and will be resolved soon,” the company told PTI in an email reply.
To another query, the vaccine maker said it has submitted for EUA’s (emergency use authorisation) in more than 40 countries and several countries have already issued the authorisation and supplies are in process.
Covaxin had reported an interim efficacy of 81 per cent following Phase 3 clinical trials.
Covaxin and Covishield are the two vaccines that are currently in use in India.
(With inputs from PTI)