Bharat Biotech files 2 new GMP certification requests with Brazil’s Anvisa for Covaxin | India News

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HYDERABAD: Bharat Biotech has approached the Brazilian health regulator seeking Good Manufacturing Practices (GMP) certifications for indigenously developed Covaxin’s production line as well as its biological input.
The two new applications come nearly two months after Anvisa (Agência Nacional de Vigilância Sanitária) turned down the Brazilian health ministry’s request for authorisation to import 20 million doses of Covaxin on the grounds that Bharat Biotech’s manufacturing facilities did not comply with its GMP standards.
“Regarding the fulfillment of GMP by the manufacturer Bharat Biotech, one of the main aspects that motivated the previous decision, the company filed a new certification request at Anvisa, referring to the production line of the finished product. The request is being analyzed in accordance with law,” said a loosely translated version of Anvisa’s announcement.
“…a new request for certification of GMP for the biological input produced by Bharat Biotech was filed on Tuesday (May 25). The application for certification of production of the input comes one day after the new application for certification of the vaccine production line,” Anvisa said on its website.
“The two requests for certification, input and production of the vaccine, cover the entire manufacturing chain of the immunizer. GMP certification of all stages of vaccine production is a prerequisite for the registration of the immunizer in Brazil,” it said.
“For the exceptional import order, only the minimum data of Good Production Practices are analyzed, but without the need for the certificate in question,” Anvisa added.
On May 24, Brazil’s ministry of health had filed an application with Anvisa again seeking authorisation to import 20 million doses of the `Made in India’ Covaxin.
Anvisa said that after it turned down the Brazilian health ministry’s request for importing and distributing Covaxin on March 31, 2021, Bharat Biotech’s partner Precisa Medicamentos had continued its negotiations to fix the problem areas that Anvisa had cited while rejecting the application.
“The requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil NRA (national regulatory agency) and will be resolved soon,” Bharat Biotech had then said in a statement.



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