Prosecutors listed the high price of the drug, rapid negotiation and waiting for regulatory approval as red flags for the contract.
According to a document seen by Reuters, Brazilian federal prosecutors have begun investigating a 1.6 billion reais (320 million U.S. dollars) contract involving 20 million doses of COVID-19 vaccine produced by India’s Bharat Biotech.
Before reaching similar deals with Pfizer and Johnson & Johnson, the Office of the Attorney General (PGR) listed relatively high prices, fast negotiations, and waiting for regulatory approval as red flags for the Bharat contract signed in February.
Bharat did not respond to a request for comment outside of working hours in India.
The Bharat contract has also been reviewed by the Brazilian Senate investigation, which requires the head of Bharat’s intermediary Precisa Medicamentos in Brasilia to testify on Wednesday.
To justify the preliminary investigation, the prosecutor pointed out in a document dated June 16 that Precisa’s partners include Global Saude, a company accused of selling drugs to the Ministry of Health but not delivering them to the Ministry of Health in a case investigated by the police. Pharmaceutical company.
Precisa stated that it has no knowledge of prosecutors’ investigations and is willing to cooperate with Senate investigators. The company said in a statement that its negotiations with the Ministry of Health are transparent and that the price of the Bharat vaccine in Brazil is the same as that in a dozen other countries.
The Ministry of Health said in a statement on Tuesday that it had not paid Precisa of any kind and its legal department is analyzing the case.
Global Saude did not immediately respond to a request for comment.
Prosecutors questioned why the Ministry of Health agreed to purchase the Bharat vaccine, which has not passed the regulatory barrier, at a price of about $15 per dose: much higher than it paid for the Pfizer vaccine that received regulatory approval.
The prosecutor wrote: “Involving the history of violations of Precisa’s partners and the high price paid for the dose prescribed in the contract… intensive investigations are required in civil and criminal aspects.
In another document seen by Reuters, Senate investigators cited the testimony of an unnamed civil servant, describing what a senior official of the Ministry of Health imposed in order to reach an agreement on the Bharat vaccine (Covaxin brand). Abnormal pressure”.
In March of this year, Anvisa, the Brazilian health regulatory agency, rejected the government’s request to import Covaxin dosages, citing concerns about Bharat’s manufacturing standards and lack of safety data and other documents.
This month, Anvisa’s board of directors agreed to allow only 4 million doses of Covaxin to be imported to further study its safety and effectiveness, but the Ministry of Health must first sign an agreement with regulatory agencies on key conditions.