Lobby group lodge application to allow for use of Ivermectin

Amid coronavirus figures continuing to soar in South Africa, an MP, 11 clinicians, public health specialists,  community health workers and medical scientists – under the umbrella of the Ivermectin Interest Group (IIG) – are this week lodging a Section 21 application to the SA Health Products Regulatory Authority (Sahpra) in a bid
to pave the way for the drug to be used in fighting Covid-19.

A Section 21 application is invoked to authorise a use of a drug during an emergency.

Sahpra has criminalised the dispensing of Ivermectin, leading to police last week raiding KwaZulu-Natal’s Mayville’s Ahmed Al-Kadi Hospital after a pharmacist allegedly administered the drug to a patient.

Sahpra’s use of the Medicines and Related Substances Act to raid premises, arrest and charge pharmacists, doctors and anyone found to be distributing Ivermectin has been criticised by the IIG, with National Freedom Party MP
Ahmed Munzoor Shaik Emam mounting a campaign for the legalisation of the drug, claiming it has had up to a 100% success rate in other countries.

Shaik has decided to drop a court challenge against government on Ivermectin, after Health Minister Zweli Mkhize last Thursday told members of the parliamentary portfolio committee of Sahpra’s willingness to consider the Section 21 application and review the latest data available on the drug.

“A Section 21 application to Sahpra will be lodged within a day or two, accompanied by a comprehensive submission from experts on new evidence and research,” said Shaik.

Shaik said: “Ivermectin has been used and approved by the World Health Organisation for human consumption and it is being used extensively worldwide.”

No evidence of this could be found on the WHO’s website related to the drug being used in Covid-19 treatment. The drug is however approved for use in the treatment of several parasites in both animals and humans.

Sahpra’s reasons for denying approval

Sahpra describes Ivermectin as a widely used drug for the treatment and control of parasites in animals – used to treat several human tropical diseases not commonly seen
in South Africa.

A synthetic derivative of the antiparasitic class of compounds, in South Africa Ivermectin is registered under Act 36 of 1947 by the department of agriculture, for use in animals – making it possible for veterinarians and other trained personnel to prescribe the drug as an antiparasitic agent.

Sahpra occasionally grants Section 21 permits for the use of topical Ivermectin as an unregistered product for the treatment of patients with scabies or head lice conditions.

They explained in a statement: “Several investigators have reported that when tested in the laboratory, Ivermectin inhibits replication of the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2].

“Thus, several clinical studies have been undertaken to evaluate Ivermectin’s efficacy in treating Covid-19.”

Thus far, the results from these studies have not yet been confirmed. Sahpra has earlier noted that evidence of efficacy and safety is very uncertain, and described early phase studies as being “of very low quality” not demonstrating “any clear evidence of efficacy or safety.”

– brians@citizen.co.za

For more news your way, download The Citizen’s app for iOS and Android.