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Jump to Key Points JOHANNESBURG, Oct 14 (Reuters) - South Africa is revising its rules governing the customisation of medicines, including sought-after GLP-1 treatments for diabetes and weight loss, health regulators said, warning pharmacies not to act as small-scale manufacturers.
At a multi-stakeholder roundtable on counterfeit medicines on Wednesday, South African Pharmacy Council Registrar and CEO Vincent Tlala said the council was working with the South African Health Products Regulatory Authority (SAHPRA) on updated minimum standards and guidelines for compounding medicines.
The revised standards are expected to go before the council in February, with publication targeted for March. Updated SAHPRA guidelines are expected to be released at the same time, Tlala said.
The popularity of GLP-1 medicines such as Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Mounjaro and Zepbound has fuelled growth in compounded versions, drawing scrutiny from regulators globally.
- South Africa revising compounding standards for GLP-1s + other medicines.
- Regulators caution pharmacies against small-scale manufacturing.
- Concern: compounding in anticipation of demand, not patient-specific need.
- Large-scale weight-loss compounding may ↑ counterfeit medicine risk.
- New SAHPRA guidelines + pharmacy standards expected Mar; litigation ongoing.
Compounding refers to the preparation of customised medicines by pharmacists for patients needing a variation to a commercially available product. Tlala said the council was concerned pharmacies were compounding medicines in anticipation of demand rather than for specific patients.
"What we are seeing in the market, and which we are against, is when pharmacies become small-scale manufacturers," he said.
Authorities are concerned that large-scale compounding may create openings for counterfeit medicines, particularly in high-demand categories such as weight-loss drugs.
"There is a scourge of compounded products, especially in the area of weight-loss," Daphney Fafudi, SAHPRA's senior manager for market control, told Reuters on the sidelines.
Fafudi said the updated guidelines from SAHPRA and revised minimum standards from the pharmacy council were intended to provide greater clarity on what is and is not permissible when compounding medicines.
While existing regulations already contain provisions governing compounding, differing interpretations of those rules have led to disputes within the industry, including litigation involving local pharmaceutical compounding company iDexis and Novo Nordisk.
(Reporting by Nqobile Dludla; editing by Philippa Fletcher)
