The prosecutors cite the high price of the drug, the quick discussions and the pending regulatory approvals as red flags for the contract.
The Brazilian federal prosecutor’s office has opened an investigation into a 1.6 billion real ($ 320 million) contract for 20 million doses of a COVID-19 vaccine manufactured by India’s Bharat Biotech, according to a Reuters document.
The Attorney General’s Office (PGR) named comparatively high prices, quick talks and pending regulatory approvals as red flags for the Bharat deal signed in February before similar deals were made with Pfizer Inc and Johnson & Johnson.
Bharat did not respond to a request for comment outside of business hours in India.
The Bharat treaty was also examined by an investigation by the Brazilian Senate, which on Wednesday demanded a testimony from the head of Precisa Medicamentos, Bharat’s mediator in Brasilia.
In support of the preliminary investigation, prosecutors said in a June 16 document that Precisa partners include Global Saude, a company accused of selling drugs but not delivering them to the Ministry of Health in a case investigated by police to have.
Precisa said she was unaware of the prosecution’s investigation and was open to working with Senate investigators. In a statement, the company said its talks with the Ministry of Health are transparent and that the price of Bharat’s vaccine in Brazil is the same in more than a dozen other countries.
The Ministry of Health said in a statement Tuesday that no payment had been made to Precisa and that its legal department was analyzing the case.
Global Saude did not immediately respond to requests for comment.
Prosecutors asked why the Department of Health had agreed to buy the Bharat vaccine, which had failed to clear the regulatory hurdles, for around $ 15 per dose: significantly more than what it paid for Pfizer’s vaccine, the had regulatory approval.
“The history of irregularities with partners at Precisa and the high price paid for the contracted doses … require an in-depth investigation in both civil and criminal terms,” wrote prosecutors.
In a separate document viewed by Reuters, Senate investigators cited an unnamed official’s testimony describing “abnormal pressure” from senior health officials to reach an agreement on the Covaxin-branded Bharat vaccine .
In March, Brazil’s health agency Anvisa denied a government request to import doses of Covaxin, citing concerns about Bharat’s manufacturing standards and the lack of safety data and other documentation.
This month, Anvisa’s board of directors agreed to allow imports of just four million doses of Covaxin to further study its safety and effectiveness, but the Ministry of Health must first sign an agreement with regulators on key terms.