Bharat Biotech terminates MoU with Brazilian partners after corruption allegations

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Bharat Biotech said it will continue to work with the Brazilian drug regulator to complete the regulatory approval process for Covaxin.

Hyderabad-based vaccine maker Bharat Biotech said on Friday it had terminated the memorandum of understanding with Precisa Medicamentos and Envixia Pharmaceuticals LL.C for its COVID-19 vaccine Covaxin for the Brazilian market, with immediate effect. The termination of the MoU came after the agreement with the Brazilian government to provide 20 million doses of vaccine for $ 320 million (Rs 2,375 crore) sparked controversy and prompted an investigation by authorities of that country.

An investigation was launched in Brazil after Covaxin, which reportedly failed to clear all regulatory hurdles, was sold at higher prices than the Pfizers vaccine, which had regulatory approval. Each dose of Covaxin was sold for $ 15. Precisa Medicamentos is Bharat Biotech’s partner in Brazil, providing assistance, advice and support for regulatory submissions, licensing, distribution, insurance, and conduct of Phase III clinical trials, among others.

“The company has terminated said MoU with immediate effect. Notwithstanding this termination, Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulator to complete the regulatory approval process for Covaxin,” did he declare. Bharat Biotech is seeking approvals in various countries in accordance with the legal requirements applicable in each country, he said.

Bharat Biotech signed a memorandum of understanding with Precisa Medicamentos and Envixia Pharmaceuticals LL.C on November 20 with the aim of introducing Covaxin in the territory of Brazil. The global price of the vaccine was set at between $ 15 and $ 20, and as a result, the vaccine was offered to the Brazilian government at a rate of $ 15 per dose, Bharat Biotech said. It is further reported that the company has not received any advance payment from the Brazilian Ministry of Health and has not provided any vaccine to the Ministry of Health.

The vaccine maker stressed that all of its actions, including its global transactions, are carried out in accordance with local laws and that the company employs and follows the highest standards of ethics, integrity and compliance at all times.

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