Prosecutors cite the high price of the drug, quick speeches and pending regulatory approvals as red flags for the contract.
Brazilian federal prosecutors have opened an investigation into a 1.6 billion reais ($ 320 million) contract for 20 million doses of a COVID-19 vaccine made by India’s Bharat Biotech, according to a document seen by Reuters.
The Attorney General’s Office (PGR) cited relatively high prices, quick speeches and pending regulatory approvals as red flags for the Bharat contract signed in February, before similar deals with Pfizer Inc and Johnson & Johnson.
Bharat did not respond to a request for comment outside of working hours in India.
The Bharat contract was also scrutinized by an investigation by the Brazilian Senate, which requested testimony Wednesday from the head of Precisa Medicamentos, Bharat’s intermediary in Brasilia.
To justify the preliminary probe, prosecutors have noted in a June 16 document that Precisa’s partners include Global Saude, a company accused of selling but failing to send medicines to the Ministry of Health in a case investigated by the cleaning.
Precisa said she was unaware of the prosecutors’ probe and was open to cooperating with Senate investigators. In a statement, the company said its negotiations with the health minister were transparent and that the price of the Bharat vaccine in Brazil was the same in more than a dozen other countries.
The health minister said in a statement Tuesday that no payment had been made to Precisa and that his legal department was analyzing the case.
Global Saude did not immediately respond to comments.
Prosecutors asked why the Ministry of Health had agreed to buy the Bharat vaccine, which had not removed regulatory barriers, for about $ 15 per dose: significantly more than it paid for the Pfizer vaccine, which had l regulatory approval.
“The history of irregularities involving partners in Precisa and the high price paid for doses under contract … require an in-depth investigation into both the civil and criminal aspects,” prosecutors wrote.
In a separate document seen by Reuters, Senate investigators cited the testimony of an unnamed public servant describing “abnormal pressure” from senior health ministry officials to reach an agreement on the Bharat vaccine, Covaxin brand.
In March, Brazilian health regulator Anvisa rejected a request by the government to import doses of Covaxin, citing concerns about Bharat’s manufacturing standards, as well as a lack of safety data and other documentation.
This month, the Anvisa council agreed to allow the import of only four million doses of Covaxin for a further study of its safety and efficacy, but the Ministry of Health must first sign an agreement with the regulator on the main conditions.