South Africa is struggling to stop the sellers of illegal weight-loss injections, with some pharmacies producing these drugs in large quantities without the required licenses. Regulators say clearer rules for pharmacies that make their own medicines are on the way, but these are only expected by February or March 2027.
In June, the Gauteng High Court ordered a compounding pharmacy, iDexis, to stop producing medicines containing semaglutide, the active ingredient in Ozempic. However, experimental weight-loss drugs like retatrutide are still being sold openly in the country, despite not being approved for sale anywhere in the world.
Regulatory Challenges
The pharmaceutical industry warns that the delay gives illegal sellers more time to operate. Stavros Nicolaou, chairperson of the Pharmaceutical Task Group, said that the momentum built by the court order could be lost if regulators do not follow up quickly with clearer guidelines.
Sahpra says it has received around 600 complaints so far this financial year relating to illegitimate and fake medicines being sold through informal supply chains, reaching the public via online portals, gyms, or even local hairdressers.
Some fake or illegitimate drugs are sold covertly, while others are traded in plain sight. Retatrutide is one such drug, which is still being tested in studies and has not been licensed for sale by any drug regulatory authority in the world. Yet, it is sold “openly and brazenly” around the world, including in South Africa.
Illicit Trade
Earlier this year, a man reportedly died in the United States after taking injections sold as retatrutide on the black market – although the British Medical Journal said the evidence for the drug causing the fatality was “less clear cut” than media reporting suggested. Nicolaou urged the police service and the Hawks to make an example of those who sell retatrutide in South Africa, as a deterrent to others.
Revised guidelines for compounding pharmacies were underway, a process Sahpra is leading, with input from the SAPC. However, these were not expected to be ready until February or March next year. According to Nicolaou, this is too late. Regulators in other countries have introduced bans and restrictions on compounding pharmacies specifically for weight-loss jabs, to prevent the kind of products that have flooded South Africa.
Vincent Tlala, CEO of the SAPC, said that the lack of coordination between enforcement agencies is a major problem, and that police detectives and prosecutors are often ill-equipped to handle specialized pharmaceutical cases. For consumers, the advice from regulators is to use authorized channels and check that medicines are registered, and to be wary of unusual or blank packaging, or products with no printed expiry date.
The South African Revenue Service official Gene Ravele noted that the lack of coordination between enforcement agencies is being exploited by organized crime, and that this is also true for counterfeit and illegitimate drugs. Nakampe Masiapato, head of the Border Management Authority, added that police detectives and prosecutors need to be trained to handle specialized pharmaceutical cases, as they currently have no idea what these cases are about.
Public Awareness and Safety
Boitumelo Semete-Makokotlela noted that peptides, such as BPC-157, are being sold as healthcare products without evidence of their safety or effectiveness in treating humans. She emphasized the need to close loopholes that allow the sale of experimental drugs and medicinal products directly to the public.