Bharat Biotech said the price of Covaxin had been "clearly established" for countries other than India.
Bharat Biotech today emphatically denied any wrongdoing amid a huge controversy in Brazil over a $324 million contract for Covaxin shots, now suspended over allegations of irregularities that have singed the country's top leadership including President Jair Bolsanaro.
In a statement, Bharat Biotech said it had followed a "step-by-step" approach towards contracts and regulatory approvals with Brazil.
"In the specific case of procurement of Covaxin by the Ministry of Health, Brazil, since the first meetings during Nov 2020 until June 29, a step-by-step approach has been followed towards contracts, and regulatory approvals, during this eight-month-long process," Bharat Biotech said.
"EUA (Emergency Use Approval) received on June 4. As of June 29, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil. Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully," said the Hyderabad-based vaccine maker.
President Bolsonaro is engulfed in allegations linked to the deal for 20 million Covaxin doses, which came under scrutiny as a parliamentary commission of inquiry investigated the government's handling of Covid. "I am incorruptible," Mr Bolsonaro declared when the row erupted.
Brazilian federal prosecutors are investigating whether the deal was sealed in February at comparatively high prices, quick talks and pending regulatory approvals.
Last week, a health ministry official, Ricardo Miranda, testified at the senate that he and his brother, federal deputy Luis Miranda, had informed the President about serious problems in an invoice of $45 million sent by Madison Biotech, an offshore company from Singapore.
Bharat Biotech said Madison Biotech was set up by its founder Krishna Ella last year for research and development, sales and marketing of vaccines.
According to the company, reports in the media over the past few weeks had "misrepresented" the procurement process of Covaxin in Brazil and other countries.
"The procurement process for COVID-19 vaccines and several vaccines for routine immunization follow a common process which is widely accepted, and established in Industry," said Bharat Biotech.
The price of Covaxin had been "clearly established" between $15-20 per dose for countries other than India, the company said, tackling criticism over the high prices. "The pricing for Brazil has also been indicated at $15 per dose. Bharat Biotech has received advance payments from several other countries at the above price points, with supplies in process, pending approvals," said the statement.
The company said it had partnered with Precisa Medicamentos for regulatory submissions, distribution, insurance and to carry out Phase 3 clinical trials.
Among the allegations being investigated is that the contract was assigned when Covaxin had not been approved by Brazil's National Health Surveillance Agency. Despite this status, however, Covaxin's price was agreed at $15 a dose, the highest paid by this country for any of the six vaccines contracted so far. Covaxin was rejected by the Brazil health body on March 31 and then approved for limited imports with strict conditions on June 4.