Bharat Biotech submits new request to Brazilian regulator on GMP issues for Covaxin


Hyderabad, May 27 : Bharat Biotech which faced ared flag from Brazils health regulator for supply of COVID-19vaccine Covaxin to that country over the issues of GoodManufacturing Practices in its plant, has filed a new requestto the Brazilian authorities for certification.

According to the National Health Surveillance Agencyof Brazil Anvisa, Bharat Biotech made the request on May 25and a day before the Ministry of Health of the South Americancountry filed a new application for authorisation to import20 million doses of the Covaxin.

Earlier, Anvisa denied permission to import Covaxinafter its authorities found that the plant in which the jab isbeing made did not meet the Good Manufacturing Practice (GMP)requirements.

“Regarding the fulfillment of Good ManufacturingPractices by the manufacturer Bharat Biotech, one of the mainaspects that motivated the previous decision, the companyfiled a new certification request at Anvisa, referring to theproduction line of the finished product…Complementing theprevious information, a new request for certification of GoodManufacturing Practices for the biological input produced byBharat Biotech was filed on Tuesday,” Anvisa said in a roughlytranslated Portuguese.


BharatBiotechInternational Limited on February 26said it has signed an agreement with theBraziliangovernmentfor supply of 20 million doses of Covaxin during the secondand third quarters of the current year.

However, the Brazilian health regulator refused toimport the vaccine into the country citing GMP issues.

The vaccine maker had earlier told P T I that therequirements pointed out during inspection will be fulfilled,the timelines for fulfillment “is under discussion withtheBrazilNRA and will be resolved soon.” GMP certification of all stages of vaccine productionis a prerequisite for the registration of the immunizer inBrazil.

For the exceptional import order, only the minimumdata of Good Production Practices are analyzed, but withoutthe need for the certificate in question, Anvisa further said.

Anvisa recently authorised the conduct of clinicaltrials of Covaxin in Brazil.

Approval for tests on the immuniser developed in Indiawill serve to assess the efficacy, safety and consistencybetween vaccine batches, it said.

The study which was requested by Precis Farmacutica,representative in Brazil for Bharat Biotech involves theapplication of two doses, 28 days apart, in 4,500 volunteers,in the states of So Paulo, Rio de Janeiro, Bahia and MatoGrosso in Brazil.PTI GDK SSPTI PTI

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