The Queensland firm has been linked to a series of collapsed deals to supply large quantities of rapid Covid-19 test kits
Health authorities have fined a Queensland company run by a convicted rapist $63,000 for making false claims that its coronavirus test kits had been approved or endorsed by Australian and US authorities.
Promedical Equipment Pty Ltd has been linked to a series of collapsed deals to supply large quantities of its rapid Covid-19 test kits – including to the governments of Australia and Puerto Rico.
The company obtained approvals as a supplier of a Chinese-made Covid-19 antibody test, but no others.
When that deal collapsed, the Brisbane company, which has no diagnostic experience, said it began manufacturing its own test kits, which were unsanctioned and unproven. It then continued to falsely claim in marketing material that its tests had approvals from the Therapeutic Goods Administration and the US Food and Drug Administration.
The TGA on Thursday announced it had issued five fines totalling $63,000 for advertising breaches.
“It is alleged that the company claimed or implied on its website and via social media that the TGA and the FDA had endorsed or approved a Covid-19 rapid test kit,” a statement by the TGA said.
“Advertisements for therapeutic goods must not make any statement that implies the goods have been recommended or approved by government, except in very limited circumstances. This includes statements that therapeutic goods have been approved by the TGA or international regulators such as the FDA.
“Promedical Equipment does not have a Covid-19 Rapid Test kit, or any other Class 3 in-vitro diagnostic medical device, included on the Australian Register of Therapeutic Goods (ARTG) for supply in Australia.
“The TGA has informed Promedical Equipment that it must immediately remove all advertising it is responsible for in relation to Covid-19 rapid test kits from the Promedical website and social media platforms.”
Promedical’s chief executive, Neran De Silva, was convicted of rape in 2018 and was a one-time business associate of the government services minister, Stuart Robert, through a cryotherapy treatment business.
Promedical’s two shares were purchased for $2 by De Silva’s partner.
Before the pandemic, it sold cryogenic, massage therapy and erectile dysfunction machines.
In March, the company made headlines when it claimed to be able to supply hospitals and clinics with five million tests each week.
It entered into a contract, which was never fulfilled, to sell 500,000 test kits to the Australian government.
It had been involved in negotiations with – and sent invoices to – a US logistics company and intermediaries working for the government of Puerto Rico for deals involving the supply of a large number of devices. Both deals collapsed and no money or devices ever changed hands.
In Puerto Rico, which has the lowest testing rate of any US state or territory, the deal to buy rapid antibody tests was a key component of its coronavirus response, at a critical point.
“The TGA regulates all medicines, medical devices and biologicals used in Australia and implements a range of compliance and enforcement tools. Where appropriate this may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
“Any person, including businesses, must comply with the requirements for advertising.”
Promedical confirmed it had received fines “as a result of advertising rules the company had breached”.
“Promedical has made the necessary changes to follow the advertising rules set out by the TGA,” a company spokeswoman said.
“Promedical continues to work closely with the TGA to prevent this happening in the future.”
Source: The Guardian