Following reports on Monday that doctors can now prescribe compounded Ivermectin in South Africa to patients, SAHPRA (SA health Products Regulatory Authority) has refuted the claims.
AfriForum announced in a press statement yesterday that it and Dr George Coetzee had successfully obtained a settlement with SAHPRA determining that a medicine containing Ivermectin as an active ingredient – Soolantra cream – had been registered by SAHPRA on 16 March 2021.
The organisation said that because of this registration, Ivermectin could now be used for other purposes than stated on the label of the registered medicine (off-label use), that includes the treatment of COVID-19.
Barend Uys, Head of Research at AfriForum, said: “The practical implication of this settlement is that doctors can prescribe ivermectin to patients if, in their judgement, it is required and patients can then take this prescription to any pharmacy where compounded ivermectin is available and buy ivermectin. No Section 21 application or reporting is required for compounded ivermectin. We are very glad as easy access to ivermectin for doctors and patients are now possible.”
SAHPRA argues: “This is grossly untrue, misleading to the public and irresponsible and could have dire consequences.”
SAHPRA said its position remains steadfast and that it has not issued a green light yet for the use of Ivermectin.
“Ivermectin may be prescribed and dispensed to patients without awaiting Section 21 authorisation, but is still subject to receiving Section 21 authorisation, informed consent and all reporting requirements normally required under Section 21,” SAHPRA explained.
SAHPRA said the unregistered Ivermectin-containing finished pharmaceutical products may only be accessed under SAHPRA’s Ivermectin Controlled Compassionate Use Programme Guideline through the authorised suppliers of such products.
Meanwhile, the entity said it has registered Soolantra cream, which is for topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea or acne-like rash in adult patients.
However, it has stressed that the Soolantra cream is not for the prevention or treatment of COVID-19.
“The effect of the registration of the Soolantra cream is that compounding is allowed in accordance with the provisions of section 14(4) of the Medicines Act such as for specific patients, on the basis of a prescription by a medical practitioner,” the entity explained.
Dr Coetzee, the first applicant in the matter, said: “We all know that COVID-19 is a dangerous disease and unfortunately there is no single wonder drug that can defeat the pandemic on its own. The most important factor in the fight against COVID-19 is every person’s immune system. Ivermectin makes a big contribution in this regard, and access to and availability thereof is, especially for the more vulnerable and needy majority of the population, indispensable for us to heal people.”
The settlement was not made an order of court and the case proceeds on Thursday.
Sources: AfriForum, SAHPRA, SA News