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SANDF and SAHPRA brief Parliament on application to use Heberon for COVID-19 treatment

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Parliament has heard that the South African National Defence Force (SANDF) imported Cuban drug Heberon into the country four months before applying for permission.

The South African Health Products Regulatory Authority ( SAHPRA) has told Parliament that SANDF imported the drugs in April 2020 and only applied in August.

SAHPRA CEO, Boitumelo Semete, says the application was rejected twice in August and October for use for the treatment of COVID-19.

SAHPRA together with SANDF were presenting before the Portfolio Committee on Defence.

Semete says that despite meetings with the Defence Force, including an undertaking to expedite an application for the use of the drugs for clinical trials, they still have not received the relevant information.

“Until to date, we hadn’t received any information on that. So according to us the bulk stock request remains rejected by the authority on the basis of insufficient information being provided but also on the basis that this is a drug that has not been authorised for use for the treatment of  COVID-19. We will only consider it for use in a clinical trial study. ”

Concern over the procurement of Heberon:

Meanwhile, earlier this month, the Committee on Defence and Military Veterans expressed concern over the procurement of the drug Heberon by the Department of Defence.

The drugs were reportedly procured for around R260 million.

The committee also received a special audit report on the financial management of COVID-19 funds by the department which highlighted the inadequate planning for the procurement of Heberon.

The reports also highlighted that the department failed to provide clarity on required quantities, lack of evidence of prior approval by SAHPRA for the importation of Heberon, and no post-importation testing which resulted in approximately 40% of the vials’ integrity possibly being compromised.

 

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