Doctors can now prescribe ivermectin to Covid-19 patients, thanks to an order handed down by the Pretoria High Court on 6 April 2021.
The order read that: "Registered medical practitioners who are entitled to prescribe medicines in Schedule 3 of the Act, may, in their professional discretion, prescribe ivermectin to be compounded into a medicine that contains ivermectin as an active ingredient for the treatment of their patients, on condition that the medicine is compounded by the holder of a licence."
Essentially this means that a pharmacist, medical practitioner and any other person registered under the Health Professions Act may sell a medicine that contains ivermectin to a patient on prescription.
Ivermectin, an anti-parasitic veterinary drug, has been used by many doctors to prevent and treat Covid-19, however it was not registered with the South African Health Products Regulatory Authority (Sahpra) for human use.
The authority released a statement in January warning of “lack of adequate evidence to support its use”, that its quality could not be guaranteed because of “widespread unregulated use”, and the lack of any clinical trial. At the same time Sahpra set up the Ivermectin Controlled Compassionate Use Programme Guideline for access to unregistered ivermectin for human use under Section 21 of the Medicines and Related Substances Act.
The South African Health Products Regulatory Authority (Sahpra) has given the green light for the controlled use of Ivermectin, a veterinary parasitic drug, for Covid-19 infection management in humans...
28 Jan 2021
Sahpra registered a product containing ivermectin to treat the skin condition, rosacea on 16 March. This opened the door for the court application, as the Medicines and Related Substances Act requires that only registered medicines can be compounded, this meant the drug could be compounded with other registered medicines, and made accessible in accordance with the act, for the treatment of Covid-19.
As a result, four applications were made to the High Court to compel Saphra to make ivermectin accessible
Judge Cassim Sardiwalla also said in the order that:
- Unregistered ivermectin-containing finished pharmaceutical products remain accessible under the present programme” through authorised suppliers.
- A medical practitioner may initiate treatment with ivermectin at the same time as submitting an application for the individual to the South African Health Products Regulatory Authority (Sahpra).
Sahpra and the health minister, Zweli Mkhize were cited as the respondents in all the applications. The director-general of the Department of Health and the member of the Executive Council for Health in Gauteng were added in another application, Sahpra CEO Boitumelo Semete-Makokotla and President Cyril Ramaphosa in a third and the Department of Health in the fourth.
The respondents (without admission of any liability) were ordered to pay a total of R1.8m to the applicants.