Brazil has currently banned the import of India’s indigenous vaccine ‘covaxin’. Brazil ordered 2 crore doses of covaxin. According to reports, the manufacturing facility of the vaccine does not meet the Brazilian Good Manufacturing Practice (GMP) requirement.
According to a report by The Indian Express, Brazil has refused to give GMP certificates to Covaxin. Brazilian health regulators ANVISA inspected the company’s site in Hyderabad from 1 to 5 March. During this, the regulators found flaws in the manufacturing process. According to the regulator, these issues could potentially put the vaccine quality at risk.
The company has entered into an agreement to supply 2 crore doses of covaxin to the Brazilian government through its partner Preciosa Medicamentos.
On these issues raised by Brazil, Bharat Biotech has said that these will be resolved soon. In the publication report, the company said, “The requirements stated during the inspection will be met, for this the timeline is being discussed with the Brazilian NRA and this will be resolved soon.”
Bharat Biotech has said that the agreement with the Brazilian government is still active.
According to a report published in The Indian Express, ANVISA said in its statement that some flaws were found at the manufacturing site of Bharat Biotech, which could pose a health risk for vaccine users in Brazil.
The regulator also felt that the company was not taking all necessary precautions for the sterility of the product and also lacked the necessary strategy to guarantee the accuracy of the vaccine.
Bharat Biotech, a Hyderabad-based biotechnology company, is manufacturing covaxins in association with the Indian Council for Medical Research. In January 2021, it received permission from the Government of India to use emergency.
Brazil is the second most affected country in the world due to corona virus. According to Covid Tracker of Johns Hopkins University, so far 1.21 crore cases of Covid have been reported in Brazil. So far, 3.21 lakh people have died from this virus.
Covishield and Covaxin allowed in India
In India, only two vaccines have been given the Emergency Use Authorization (EUA) – Covishield and Covaxin. The Covishield vaccine has been developed jointly by Oxford and AstraZeneca, which is being produced at the Serum Institute of India, Pune.
In many countries, including Nepal, Mauritius, covicin has been allowed to use emergency. The company has also applied for emergency use in Brazil, Philippines and Thailand.