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The prosecution cited the high price of the drug, quick conversations and pending regulatory approvals as the red flag of the contract.

Brazilian federal prosecutors have opened an investigation into a 1.6 billion reais ($ 320 million) contract to get 20 million doses of COVID-19 vaccine from India’s Bharat Biotech, according to a document seen by Reuters.

The Attorney General’s office cited high comparative prices, quick interviews and pending regulatory approvals as a red flag in the Bharat contract signed in February, before reaching similar agreements with Pfizer Inc. and Johnson & Johnson.

Bharat did not respond to a request for comment outside of Indian business hours.

The Bharat contract also examined an investigation by the Brazilian Senate, which on Wednesday declared Precisa Medicamentos, the head of Bharat’s Brazilian mediator.

To justify the preliminary probe, the prosecutor stated in a June 16 document that Precisa’s partners were in the company Global Saude, accused of selling but not giving drugs to the Ministry of Health in a case under police investigation.

Precisa said he had no knowledge of the prosecutor’s probe and was open to cooperating with Senate investigators. In a statement, the company said talks with the health ministry were transparent and that the price of the Bharat vaccine had been charged in Brazil in more than a dozen other countries.

The Ministry of Health said in a statement on Tuesday that no payment had been made to Precisa and that its legal department was examining the case.

Global Saude did not immediately respond to requests for comment.

The prosecutor questioned why the Ministry of Health approved the Bharat vaccine, which did not clear regulatory barriers, to buy about $ 15 per dose: much more than it paid for the Pfizer vaccine that had a regulatory permit.

“Precisa partners were involved in the history of the irregularities and the high prices paid for contract doses … which call for an in-depth and civil investigation,” the prosecutor wrote.

In a separate document seen by Reuters, Senate investigators cited the testimony of an unnamed public official who described the “abnormal pressures” of senior health ministry officials to reach an agreement to get the Covaxin-branded Bharat vaccine.

In March, Brazilian health regulator Anvisa denied the government’s request 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, Anvisa’s management allowed the import of only four million doses of Covaxin to further study its safety and efficacy, but the Ministry of Health must first sign an agreement with the regulator on key requirements.