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Return illegal Covid-19 drug to Cuba or we will confiscate and destroy it – Sahpra tells SANDF

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Return illegal Covid-19 drug to Cuba or we will confiscate and destroy it – Sahpra tells SANDF

SAHPRA CEO Dr Boitumelo Semete-Makokotlela
SAHPRA CEO Dr Boitumelo Semete-Makokotlela

1st December 2021

By: News24Wire

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The South African National Defence Force's (SANDF's) R200-million deal with Cuba that has seen the importation of an unregistered Covid-19 drug appears to be in jeopardy.

Health regulators have given military bosses until Friday to provide evidence that the drug has been shipped back to Cuba, or face having it destroyed.

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On Wednesday, the South African Health Products Regulatory Authority (Sahpra) and the Auditor-General (AG) briefed Parliament's Defence Committee on the investigation into the deal for the drug Heberon Alpha R 2B.

Eyebrows were raised in April 2020 when the SANDF spent nearly R215-million on importing Heberon Alpha R 2B, manufactured by a Cuban-Chinese company. Interferons are proteins used in the body as part of its natural defence against viruses.

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Sahpra CEO Dr Boitumelo Semete-Makokotlela told the committee a letter was sent to the SANDF instructing it to return the product to Cuba by 30 November.

If not, Sahpra will confiscate and destroy the product.

She said, "This matter is reaching a conclusion from Sahpra's perspective. We will either get evidence between today (Wednesday) and Friday that this product has been sent back. If not, we will go and confiscate it and destroy the product. Communication on the return of the product to Cuba is still awaited. A letter from Sahpra asking for evidence of this process has been issued."

Interferon Alpha-2B is believed to be effective in the fight against the coronavirus. It has, however, not been approved or registered for use in South Africa.

In April, News24 reported that the Department of Defence and Military Veterans could not account for the 970 000 vials of interferon it had imported from Cuba.

The AG stepped in to investigate the department's deal to import Covid-19 drugs and found records of a R34-million payment for a consignment of the drug, which was nowhere to be found.

Semete-Makokotlela said the product had batches that expire in March 2022 and July 2022, respectively.

A clinical trial application was received on 9 May 2021 and reviewed by Sahpra's clinical trial committee.

In July, queries were sent to the SA Military Health Service (SAMHS).

"Response was only received on 26 August 2021, asking for more time to provide information. Sahpra communicated that extension was given until 30 September 2021. If the response was not received by then, the study will be rejected. [The] response of 30 September was inadequate. The study was not authorised, and the communication was issued to the SAMHS in October 2021," she said.

Overall, Semete-Makokotlela said a lack of response from the SAMHS was "very concerning".

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