SAHPRA to unveil controlled access programme to Ivermectin

The South African Health Products Regulatory Authority (SAHPRA) said it will unveil a "compassionate and controlled access programme" to Ivermectin.

THE South African Health Products Regulatory Authority (SAHPRA) has indicated that it may soon allow the use of Ivermectin pills to treat Covid-19 patients. 

In a rare media press conference on Wednesday afternoon, SAHPRA’s Chief Executive Officer Dr Boitumelo Semete-Makokotlela said the regulatory body will, in the next couple of days, unveil a “compassionate and controlled access programme” to Ivermectin.

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Semete-Makokotlela said the regulator has been in dialogue with many scientists and medical professional bodies in SA and across the world regarding the potential use of Ivermectin to treat Covid-19.

“(SAHPRA) has considered all of this and the current context we are facing as a country where we are in a second wave. We are seeing lives being lost and many medical practitioners have reached out to us as a regulator,” she said.

“We had to have very in-depth conversations about the limited options available (to treat Covid-19).”

However, Semete-Makokotlela said that SAHPRA still stands by its statement, released on 6 January 2021, in which they stated there is still insufficient scientific data available to prove that Ivermectin is an effective treatment for Covid-19.

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The official position for SAHPRA, Semete-Makokotlela said, is that more clinical trials and research still needs to be done.

“A number of these studies are saying we cannot say (if) there is risk or there is significant benefit (to using Ivermectin for the treatment of Covid-19),” she said. 

Ivermectin is not registered on SAHPRA’s database, meaning it is illegal to distribute it in SA.

Various media reports however suggest there is already a black market in Durban for the tablets. 

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Semete-Makokotlela said SAHPRA will be releasing a revolving framework over the next couple of days that will guide healthcare practitioners over the use of Ivermectin.

SA universities have also submitted requests to conduct their own clinical trials to determine if Ivermectin is an effective treatment for Covid-19, said Semete-Makokotlela.

“We will have to work very closely with the medical professionals because they will be very important in reporting any adverse affects or any positive benefits of this,” she said.    

 

 


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