Updated minimum standards and rules regarding the customisation of medicines, including GLP-1 treatments for diabetes and weight loss, can be expected in South Africa next year, but local health regulators have warned pharmacies not to act as small-scale manufacturers, reports Reuters.
At a multi-stakeholder roundtable on counterfeit medicines last week, South African Pharmacy Council Registrar and CEO Vincent Tlala said the council was working with the South African Health Products Regulatory Authority (SAHPRA) on new 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 surge in popularity of GLP-1 medicines has fuelled enormous growth in compounded versions, drawing scrutiny from local as well as global regulators, and Tlala said the council was concerned pharmacies were compounding medicines in anticipation of demand rather than for specific patients.
"What we are seeing … and are against, is when pharmacies become small-scale manufacturers,” he said.
Large-scale compounding may also create openings for counterfeit medicines, and Daphney Fafudi, SAHPRA’s senior manager for market control, told Reuters on the sidelines that the country was seeing “a scourge of compounded products, especially in the area of weight-loss”.
She said SAHPRA’s updated guidelines and revised minimum standards from the pharmacy council were intended to provide greater clarity on what is and is not permissible when compounding medicines.
Reuters article – South Africa revises rules around customisation of weight-loss drug (Open access)
See more from MedicalBrief archives:
SAHPRA and drug companies flag risks of compounded weight-loss drugs
Call for action on booming fake drugs trade in SA
Novo Nordisk sues local pharmacy over alleged 'knock-off' weight-loss jabs