Bharat Biotech has submitted a fresh request to the Brazilian regulator, Anvisa, for grant of certification of Good Manufacturing Practices (GMP) for Covaxin.
Earlier, in March, the Brazilian Regualtor refused to grant a GMP certificate to Bharat Biotech on account of some violations at the Bharat Biotech’s Covaxin manufacturing facility.
Contract with Brazil
Bharat Biotech had already signed a contract with the Brazilian government to supply 20 million doses of the vaccine. An approval for Anvisa is necessary for initiating the process.
The two requests for certification, input and production of the vaccine, cover the entire manufacturing chain of the vaccine, according to information available with Anvisa.
According to sources, Bharat Biotech is now pursuing regulatory approvals in over 60 countries, including the US and Hungary, apart from Brazil. Emergency-use authorisations have been obtained in 13 countries with more to follow, said a source in the company.
An application for Emergency Use Licence has also been submitted to WHO-Geneva. The global agency has sought additional information and the Hyderabad-based vaccine maker is expecting the approval from WHO by July-August 2021.
On the domestic front, Bharat Biotech is in the process of stepping up the supply to States. The vaccine has now reached over 30 cities in 19 States, including tier-II locations such as Warangal, Guntur, Nellore, Coimbatore and Shimoga.
After a gap of few days, the administration of second dose of Covaxin has also commenced in some States, incluidng Andhra Pradesh, Telangana and Tamil Nadu and Karnataka, according to officials.