There is not enough data to prove whether ivermectin is safe or harmful, says Sahpra.
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The South African Health Products Regulatory Authority (Sahpra) has warned that ivermectin is still illegal in SA for use in the treatment and prevention of Covid-19 in humans, except by approved medical practitioners.

This comes after Sahpra's approval of the drug for controlled compassionate use for Covid-19 amid a legal battle with AfriForum, a doctor and two of his patients at the North Gauteng High Court.

Addressing parliament's health portfolio committee, the regulatory body warned that there was not enough scientific evidence around the use of the drug, both for safety and efficacy, to either treat or prevent Covid-19. The authority said there were only 10 medical practitioners approved to use the drug for Covid-19, but there was not enough data to prove whether it was safe or harmful.

The drug has been around for more than 40 years but only for use in animals.

Sahpra CEO Dr Boitumelo Semete-Makokotlela said the drug was also not available to buy over the counter.

“In terms of its purported indication for its use for preventing Covid-19, I have indicated that there is completely insufficient information and that's why this compassionate-use programme will enable us to get the data. And that's why there is a very stringent reporting mechanism,” she said.

Semete-Makokotlela said the drug would be available only to the approved practitioners who will be provided with details of the licensed manufacturers, wholesalers and distributors of the drugs.

Her warnings came after questions from MPs about legality of the sales and importation of the drug in the country. Last week authorities bust six people trying to smuggle ivermectin tablets worth an estimated R6m through OR Tambo International Airport.

DA MP Evelyn Wilson had earlier expressed concern about the bust and the whereabouts of the seized tablets.

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National Freedom Party MP Ahmed Munzoor Shaik Emam, who had supported the court action to make the drug available, was also critical of the outlawing of the drug in the country.

He had asked why the drug was illegal when there was data around the world about its use.

Sahpra had explained that the drug had been registered in the country, before Covid-19, but only for animal use.

Responding to fears about the quality of vaccines after they get into the country, Semete-Makokotlela said companies contracted for distribution and storage would have to comply with their standards.

She also moved to allay fears over scammers using disposed vaccine vials to pass them off as legitimate Covid-19 vaccines through the black market.

“When it comes to the disposal of the vials, this will be included in the protocols [to be followed by contracted companies],” she said.


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