Bharat Biotech has submitted a fresh application seeking Certification of Good Manufacturing Practices, pertaining to Covaxin, with Brazilian health regulator ANVISA. Besides filing a new certification request, Bharat Biotech has also filed an application seeking certification of GMP for the biological input it produces, according to a translation of the notice in Portuguese posted on the Brazilian regulator’s website.
The move by the company, earlier this week, comes nearly two months after ANVISA denied its request for the certification, citing GMP issues, thus not allowing import of vaccine. The company has struck a deal, through a Brazilian partner, to supply 20 million doses of the indigenously developed Covaxin to the Latin American country.
According to ANVISA website, Brazil’s Ministry of Health had on May 24 also filed a new application for authorisation to import 20 million doses of the Covaxin, manufactured in India. It had cited in the application that vaccine had been authorised for emergency use in India.
ANVISA said Bharat Biotech’s two requests for certification — input and production of the vaccine — cover the entire manufacturing chain of the vaccine. It said GMP certification of all stages of vaccine production is a prerequisite for registration of vaccine in Brazil.
