Bharat Biotech said it will continue working with the Brazillian regulator on Covaxin approval.
Drugmaker Bharat Biotech on Friday said it has scrapped agreements with two Brazilian companies amid controversy over a $324 million deal between the South American country and Bharat Biotech for the import of 20 million doses of the made-in-India COVID-19 vaccine Covaxin.
The termination of the agreements with Precisa Medicamentos and Envixia Pharmaceuticals came after the deal set off a major political row in Brazil and spawned an investigation by authorities in the country.
"The company has terminated the said MoU with immediate effect. Notwithstanding such termination, Bharat Biotech will continue to work diligently with ANVISA, the Brazilian drug regulatory body to complete the regulatory approval process for Covaxin," it said.
Bharat Biotech is pursuing approvals in various countries as per legal requirements applicable in each country, it said.
Last month, Bharat Biotech had emphatically denied any wrongdoing on its part amid the growing controversy; the Hyderabad-based company said it had followed a "step-by-step" approach, and that: "EUA (was) received on June 4".
However, after Brazilian authorities contradicted the claim, the company replaced "EUA received on June 4" in its statement with 'On 4th June, ANVISA authorized exceptional import of Covaxin vaccine by Ministry of Health for distribution and Use Under Controlled Conditions".
The controversy erupted after a Brazilian health ministry official, Ricardo Miranda, red-flagged potential illegalities in the acquisition process of the vaccines, saying he had been pressured to clear the doubtful invoice.
Brazilian federal prosecutors and a Senate panel are investigating the deal, citing high prices, quick talks and pending regulatory approvals as points of concern in the February contract. President Jair Bolsonaro, cornered by political opponents, has denied any wrongdoing on his part.
Bharat Biotech signed an agreement with Precisa Medicamentos and Envixia Pharmaceuticals on November 20 to introducing Covaxin in Brazil.
Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of Phase III clinical trials, among others.
The global pricing of the vaccine has been set between $15-20 and accordingly, the jab was offered to the Government of Brazil at the rate of $15 per dose, Bharat Biotech said.
It also said that the company has not received any advance payments, nor has it supplied any vaccines to the Ministry of Health in Brazil, the company said.
The vaccine maker stressed that all its actions, including its global dealings, are done in accordance with local laws and the company employs and follows the highest standards of ethics, integrity and compliance at all times.
(With inputs from PTI)
