Australia has banned the pharmacy compounding of weight-loss injections, deeming these products “potentially unsafe and dangerous.” Despite this, South African compounding pharmacies continue to create their own versions of popular weight-loss drugs like Ozempic and Mounjaro, and sell them to the public.
In South Africa, the practice is also illegal when pharmacies produce these copycat injections in large quantities or use unregistered ingredients. However, increasing demand has turned compounding into a lucrative business for some pharmacies. In June, the Gauteng High Court ordered iDexis, a compounding pharmacy in Tshwane, to cease production of semaglutide-containing medicines after confiscating large quantities of these weight-loss jabs.
This ruling marked a significant victory for the South African Health Products Regulatory Authority (Sahpra) and the Pharmaceutical Task Group. However, Stavros Nicolaou from the Pharmaceutical Task Group warned that this momentum could dissipate if Sahpra and the South African Pharmacy Council (SAPC) do not quickly establish clearer guidelines for compounding pharmacies.
Nicolaou stated, “You can win these court cases, but all of that can unravel because we’re just not acting swiftly enough as a country.”
During a recent panel discussion, representatives from Sahpra, SAPC, police, border control, and the pharmaceutical industry gathered to address the public on their efforts to combat the trade of counterfeit drugs. Sahpra noted it has received around 600 complaints this financial year regarding fake medicines sold through informal channels, such as gyms and local salons. Daphne Fafudi, Sahpra’s head of regulatory compliance, expressed concern that the issue is worsening, saying, “People do die, and it doesn’t even come to our attention.”
Some counterfeit drugs are sold secretly, while others are readily available. An example is retatrutide, a weight-loss injection still in research phases and not yet licensed anywhere. Despite this, it is openly sold in South Africa. Nicolaou urged law enforcement to take decisive action against those selling retatrutide as a deterrent for others.
Vincent Tlala, CEO of the SAPC, confirmed that revised guidelines for compounding pharmacies are being developed with input from Sahpra, but these are not expected to be ready until February or March next year. Nicolaou deemed this timeline too lengthy, pointing out that other countries have already implemented restrictions to curb the circulation of such products.
While compounding medicines is legal in South Africa under specific conditions, it requires a healthcare professional’s prescription. Compounding in bulk is only allowed when there is clear evidence of regular demand, yet many pharmacies are producing large quantities without such proof. Sahpra’s chief executive, Boitumelo Semete-Makokotlela, emphasised that this practice amounts to manufacturing, which necessitates a good manufacturing practice licence that most compounding pharmacies do not possess.
Another concern lies in the sourcing of ingredients. Active pharmaceutical ingredients must be registered and imported by licensed entities, but some pharmacies obtain unregistered ingredients illegally, often smuggled in by travellers.
