South Africa’s two main medicines regulators are revising the rules that govern how pharmacies may customise, or “compound,” medicines — including copycat versions of GLP-1 drugs such as Ozempic, Wegovy and Mounjaro — after warning that some pharmacies have effectively turned themselves into unlicensed manufacturers to meet soaring demand for cheaper weight-loss injections.
What’s changing
Vincent Tlala, registrar and CEO of the South African Pharmacy Council (SAPC), said the council is working with the South African Health Products Regulatory Authority (SAHPRA) on updated minimum standards and guidelines for compounding. He made the comments at a multi-stakeholder roundtable on counterfeit medicines, framing the issue as one of scale rather than compounding itself: “What we are seeing in the market, and which we are against, is when pharmacies become small-scale manufacturers,” Tlala said, referring to pharmacies that prepare large batches of a product in anticipation of demand rather than compounding a customised dose for an individual, named patient.
Why regulators are acting now
Compounding is intended to let pharmacists prepare a tailored medicine for a specific patient who needs a variation on a commercially available product — not to mass-produce a cheaper copy of a patented drug. SAHPRA’s Daphney Fafudi told Reuters there has been “a scourge of compounded products, especially in the area of weight-loss,” and said the forthcoming guidelines are meant to spell out clearly what is, and isn’t, permitted. Regulators are concerned that large-scale compounding not only sidesteps the formal manufacturing and registration process but also creates an opening for counterfeit or substandard products to reach patients, particularly in a category — obesity treatment — where demand is outstripping the supply of registered, affordable options.
The iDexis litigation backdrop
The regulatory review follows a running legal dispute between Novo Nordisk and local compounding firm iDexis. Novo Nordisk’s semaglutide patent expired in South Africa in March 2026, but the company has argued that compounders producing semaglutide and tirzepatide copies ahead of, or alongside, that process are operating illegally. SAHPRA and SAPC inspected iDexis in May and instructed it to recall its compounded semaglutide and tirzepatide products; the Pretoria High Court granted Novo Nordisk an interim interdict against the company on 23 June, and in September the court dismissed iDexis’s application for leave to appeal. Court papers in the case disclosed that iDexis had been producing roughly 84,500 semaglutide doses a month at its peak — more than Novo Nordisk’s combined South African sales of Ozempic and Wegovy. iDexis has disputed the regulators’ findings, saying SAHPRA was aware of its compounding activity as far back as November 2023 and that it is being unfairly singled out.
Timeline for the new rules
According to SAPC, the revised compounding standards are expected to go to review in February 2027, with publication targeted for March 2027; SAHPRA is expected to release its own updated guidelines on a similar timeline. Existing regulations already cover compounding in principle, but differing interpretations of those rules are what has fuelled disputes such as the iDexis case, which is one reason regulators say clearer, updated guidance is now needed.
What this means for patients
- Compounded GLP-1 products bought from pharmacies that are stockpiling rather than preparing patient-specific doses may face tighter scrutiny, and some may be withdrawn from sale, as the new standards take effect.
- Only SAHPRA-registered GLP-1 medicines — Novo Nordisk’s liraglutide and semaglutide products, and Eli Lilly’s tirzepatide products — have been through the full safety and quality review required for the South African market.
- The new guidelines are not expected to be finalised until around March 2027, so patients currently using a compounded product should ask their prescribing pharmacist or doctor whether that specific product remains available and compliant.
- Price-sensitive patients seeking a lower-cost alternative to branded Ozempic, Wegovy or Mounjaro should ask about SAHPRA-approved generic semaglutide options now entering the market, rather than defaulting to compounded versions.
This article is for general information only and is not medical advice. GLP-1 SA does not endorse or recommend any specific product, including compounded or unregistered medicines. Always consult a registered healthcare professional before starting, stopping or changing any weight-loss or diabetes treatment.
Sources
- Demand for cheaper Ozempic options prompts compounding rule review — Bizcommunity (Reuters), 15 October 2026
- Regulators move to rein in copycat weight-loss jabs — Business Explainer, 15 October 2026
- South Africa tightens rules on weight-loss drugs — Semafor Africa, 16 October 2026