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On Thursday, civil rights organisation AfriForum, released a bombshell statement regarding the legal use and distribution of ivermectin in South Africa…

The organisation had gone to court to challenge the South African Health Products Regulatory Authority (SAHPRA) to allow doctors to prescribe Ivermectin to treat patients with COVID-19.

Bombshell discovery

However, the organisation and its legal team concluded that this medicine had actually been legal all along!

 

Why?

Because SAPHRA had failed to publish a notice in the Government Gazette (as the Medicines and Related Substances Act 101 of 1965 requires)  that requires registration of Ivermectin as medicine.

Moreover, SAPHRA has so far kept this fact from the public.

“AfriForum will now amend its court application to provide for these new facts and to obtain a declaratory order that ivermectin is a legal Schedule 3 medicine and therefor does not require registration by SAPHRA.”

Ivermectin changed the course of Covid-19 pandemic in SA – Doctor

The government issued information warning against the use of Ivermectin to treat Covid-19 as it was “untested”

“It is dangerous to market Ivermectin as a treatment against COVID-19 as the drug has not been properly tested for humans,” said the statement from the government.

  • Ivermectin in the treatment for COVID-19 is still to be verified by relevant authorities.
  • We call on the South Africans and medical professionals not to distribute or take the drug until its safety and efficacy is verified.
  • The unregulated distribution of the drug can lead to sub-standard and falsified products that are harmful to human health.
  • Ivermectin is registered in South Africa for the treatment of parasites in animals under the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act.
  • There is currently no Ivermectin-containing medicines registered for human use in the country.
  • The efficacy, safety and the appropriate dosage for the use of Ivermectin remains uncertain.
  • The South African Health Regulatory Authority (SAHPRA) noted that the overall quality of clinical trials of Ivermectin in the treatment of COVID-19 patients is poor.
  • Until evidence that is more robust is available, the use of Ivermectin for COVID-19 cannot be justified.

Covid-19: What’s all the fuss about Ivermectin?

“Medicine simply does not automatically become illegal”

Willie Spies, legal representative of the interested parties, explains that the Medicine and Related Substances Act 101 of 1965 regulates the distribution of medicines and medical products. The Act also requires certain medicines to be registered before these may be sold.

“An important aspect of the restriction on unregistered medicines is that unregistered medicines are not automatically illegal.  The regulator is compelled to first publish a notice in the Government Gazette.”

“This notice gives medicine providers and pharmacies, or pharmaceutical companies who want to continue providing that medicine, six months to register the medicine. It is only when this six month period after publication of the notice in the Government Gazette expires, that the unregistered medicine becomes illegal.”

“Therefore, medicine simply does not automatically become illegal. It must first be announced as a registrable medicine, and it is only when it is recalled and not registered that it becomes illegal,” Spies explains.

However, in the 30 years that ivermectin has been available and listed as a Schedule 3 medicine, SAHPRA has failed to publish a notice in the Government Gazette to declare it illegal. Ivermectin is therefore not a registrable medicine but is listed in Schedule 3 of the Act.

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