The “deluge” of unregistered weight loss medication is spiralling, with compounding versions of the drug continuing to sell like hot cakes in gyms, beauty salons and even in hairdressing salons, Pharmaceutical Task Group (PTG) chair Stavros Nicolaou told News24.
He said that despite the recent high-profile legal battle that halted a pharmacy from compounding GLP-1 drugs at scale, the practice is still “mushrooming”. It’s estimated that around 230 000 South Africans are on the medication, he added, posing risks to their health and threatening to undermine general confidence in pharmaceutical companies.
The issue is not limited to pharmacies, with retatrutide – a new, triple-action weight loss medication that is still in clinical trials – being sold by various unauthorised sellers, and being widely available through online channels at exorbitant prices.
“We’re starting to see the emergence of some very disturbing sales trends in the illicit trade,” Nicolaou said.
“I think opportunists have spotted a gap in the marketplace … I don’t think anyone, including the manufacturing industry, expected such an explosion of compounded and unregistered medicines coming into the country.”
Nicolaou said the PTG was in talks with the South African Police Service about increasing regulatory enforcement at pharmacies, hairdressers, and ports of entry. This should be co-ordinated with the South African Health Products Regulatory Authority (SAHPRA), along with the Health Professions Council of SA (HPCSA) and the South African Pharmacy Council (SAPC).
Nicolaou appealed for closer co-operation between SAHPRA, border management authorities, and the South African Revenue Service, to stop the inflow of ingredients that often come under “innocuous” labelling, such as calcium.
Some suspect the retatrutide is coming from China.
SAHPRA told News24 it works with law enforcement agencies to disrupt the supply of illegal medicines and protect public health, adding that the online sales issue is “a growing global challenge that extends beyond South Africa, with digital platforms enabling products to be marketed and distributed rapidly across different countries”.
Pretoria compounds banned
SA’s demand for GLP-1 medicines has been in the spotlight since Novo Nordisk’s legal victory against iDexis, trading as Sentra, in Pretoria in June.
The court interdicted iDexis from compounding glucagon-like peptide-1 (GLP-1) drugs, registered in SA for use in weight loss and diabetes treatment, as well as to help prevent heart attacks and strokes.
Novo Nordisk owns Ozempic and Wegovy, which use semaglutide as the active pharmaceutical ingredient, while Eli Lilly’s Mounjaro, marketed and distributed in SA by Aspen Pharmacare, uses tirzepatide, which targets an additional receptor: glucose-dependent insulinotropic polypeptide (GIP).
Retatrutide, also developed by Eli Lilly, targets a third receptor, for glucagon, and is still in clinical trials.
iDexis has repeatedly maintained that its active pharmaceutical ingredients are safe and sourced from reputable suppliers, but has refused to name them. It has said it will appeal the interdict and, in a recent statement, referred to a May raid as resulting in the “alleged seizure and recall of products”.
SAHPRA has issued a recall for iDexis GLP-1 compound products, but a credible source informed News24 that the recall does not appear to be happening as intended.
The company did not respond to requests for comment on this, but iDexis has said it is complying with the judgment and has halted sales of its semaglutide and tirzepatide compounds.
Charles Green, healthcare and pharmaceutical expert at law firm Cliffe Dekker Hofmeyr, said the iDexis appeal would be closely watched, but so far the ruling has set a clear precedent regarding compounding, and should encourage new, cheaper weight-loss drugs to come to market.
He said it was unclear whether SAHPHRA alone has the capacity to address a further influx of unlawful products, as it has indicated difficulties in managing the current volume of unlawful medicines in the market.
SAHPRA has admitted to having staff resource problems, and issues in retaining scarce skills, which it often loses to the private sector. Last year it had a staff count of 311 out of an overall ambition of 430.
Green noted that for investors, there was a dual concern.
“First, the formal market is being undercut by unlicensed competitors who may not face any meaningful consequences unless court action is taken by the formal pharmaceutical sector. Second, even where precedents are set (as in the iDexis judgment), there is uncertainty as to whether regulators will enforce them consistently across the market.”
However, he added, the joint SAHPRA/SAPC enforcement notice against iDexis and subsequent product recall, which came with a warning to health professionals, were positive steps towards broader enforcement.
News24 article – Hairdressers selling ‘Ozempic’: SA’s wild weight loss market (Restricted access)
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