SAHPRA will have more data on ivermectin by April, health committee hears
The South African Health Products Regulatory Authority (SAHPRA) says despite the continuous calls for the approval of ivermectin for use on humans, there is still not enough data to be certain of its safety.
Ivermectin is a medication used for parasitic infections in animals.
On Tuesday, the High Court in Pretoria ruled that doctors can prescribe the drug for humans for the treatment of Covid-19 on an urgent basis while waiting for approval SAPHRA.
The regulatory body has also allowed Section 21 applications as part of a controlled compassionate access programme.
SAHPRA appeared before Parliament's health committee on Wednesday.
"While there are small signals from these small studies that there might be benefit, no conclusion can be made that ivermectin is either good for treatment or that it is bad. So, you can't say it is good or bad. What will break this log jam is these bigger well-controlled studies," said Helen Rees, chairperson of the SAHPRA board.
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"We have looked into the studies and we know that these studies will come in February and March and by April we anticipate that we will have data from several different studies on an extra 10 000 people because at the movement the data is only on 2000 people."
Rees said the organisation is inviting South African researchers to apply for clinical trials on the drug, but have thus far only received three applications.
SAHPRA CEO Boitumelo Semete said they will monitor the use of the drug through the compassionate use programme.
"We will authorise manufacturers, wholesalers or disturbers that are licensed which will ensure that the available product is of the right quality. And because we want to ensure it is available at the point of treatment, we will authorise healthcare facilities to store the product.”
