The pharma company’s response comes amid reports that Brazil is suspending its $324 million deal to procure indigenously developed Covaxin due to suspected irregularities.
Bharat Biotech also slammed allegations by a former Brazilian health ministry official that its partner Precisa Medicamentos asked for an advance payment to be made to a third party, a shell company based in Singapore called Madison Biotech Pte Ltd.
The company clarified that Madison Biotech Pte is one of the 13 companies founded or acquired by Bharat Biotech chairman and managing director Dr Krishna Ella and was set up in 2020 for the purpose of external R&D and sales and marketing of vaccines.
“We wish to dispel any notion or implication of any wrongdoing whatsoever, as all these are affiliate companies founded / acquired and operated by Dr Krishna Ella. More than 3,000 personnel are employed in 6 cities across all these organizations,” Bharat Biotech said in a statement.
Pointing out that during the past few weeks, media reports at large have been misrepresenting the procurement process of Covaxin in Brazil and other countries, the company said that it has followed a step-by-step approach in the case of Brazil.
“Since the first few meetings with the ministry of health (MOH) Brazil during Nov 2020 until June 29, 2021, a step-by-step approach has been followed towards contracts and regulatory approvals, during this nearly 8-month long process,” the company’s statement read.
The company also said that after it received emergency use authorisation (EUA) from Brazilian authorities on June 4, 2021, it has not received any advance payments nor supplied any vaccines to MOH Brazil as of June 29, 2021.
Detailing the process, the company said that once it receives a letter of intent (or MOU) for procurement, it applies for EUA in that country and post EUA the MOH of that country places an order by releasing a purchase order with the required initial quantities.
“In order to secure a firm purchase order from the country, the company proceeds to raise a proforma invoice to the MOH, towards the supply of vaccine. Based on the invoice, the MOH pays the amount in advance. Once the payment is received, the company proceeds to supply the agreed quantities and within the agreed timelines,” it said.
“Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully. In several countries, MOHs have placed orders for procurement prior to the approval of vaccines such as USA, EU, India, etc. However, procurement happens only post EUA,” it pointed out.
On the pricing issue, it said Covaxin’s pricing has been clearly established between $15-20 per dose for supplies to governments outside India. “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,” it said.
On the tie-up with Precisa Medicamentos, it said Bharat Biotech follows a partnership model in all countries, where its vaccines are supplied, as it does not have its own offices in these countries.
“Precisa Medicamentos is Bharat Biotech’s partner in Brazil which provides assistance, guidance, and support with regulatory submissions, licensure, distribution, insurance, conduct of phase III clinical trials, etc,” it explained.
Bharat Biotech said Covaxin has received EUA in 16 countries and EUA are under process in 50 countries worldwide. The company is also in discussion with the World Health Organisation (WHO) to obtain emergency use listing for Covaxin, it said.
“The product has been exported to several countries, with additional requests for supplies being received. Technology transfer activities are in progress to companies in the United States and other countries,” it said.