Regulators struggle with black market weight loss drugs
South African regulators are struggling to keep up with the sellers of illegal weight-loss injections, with some pharmacies producing these drugs in large quantities without the required licenses. The Gauteng High Court recently ordered a compounding pharmacy, iDexis, to stop producing medicines containing semaglutide, the active ingredient in Ozempic, after large quantities of the drug were confiscated on its premises.
This court order was seen as a significant victory for the country’s regulators, including the South African Health Products Regulatory Authority. However, the pharmaceutical industry warns that the delay in introducing clearer rules for pharmacies that make their own medicines gives illegal sellers more time to operate.
Illicit Weight-Loss Drugs
Experimental weight-loss drugs, such as retatrutide, which are still being studied and have not been approved for sale anywhere in the world, are being sold openly in South Africa. 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.
These drugs are often sold online, in gyms, or even through local hairdressers, and can be dangerous to consumers. The head of regulatory compliance at the South African Health Products Regulatory Authority, Daphne Fafudi, expressed concern that the problem is getting out of control, and that people do die, and it doesn’t even come to our attention.
The South African Health Products Regulatory Authority and the South African Pharmacy Council are working together to stop the trade in fake drugs, but the lack of coordination between enforcement agencies is a significant challenge. The CEO of the South African Pharmacy Council, Vincent Tlala, said that revised guidelines for compounding pharmacies are underway, but these are not expected to be ready until February or March next year.
Regulatory Challenges
Compounding medicines is lawful in South Africa, but only under specific conditions. Pharmacies are allowed to prepare stock in advance if they can show that patients regularly need the medicine, but some pharmacies produce large quantities without this evidence. This means that they are effectively manufacturing medicines without the required good manufacturing practice license.
Another concern is the source of the ingredients used in these medicines. Active pharmaceutical ingredients must be registered in South Africa and imported by a licensed entity, but some pharmacies have been found to be using unregistered ingredients.
The sale of experimental drugs, such as retatrutide, is also a concern. The pharmaceutical industry is calling for clearer rules and stricter enforcement to prevent the sale of these drugs.
Stavros Nicolaou, chairperson of the Pharmaceutical Task Group, urged the police service and the Hawks to make an example of those who sell retatrutide in South Africa, as a deterrent to others. He stated that the regulations are taking too long, and the delay is giving illegal sellers more time to operate.
Gene Ravele, a South African Revenue Service official, called the lack of coordination between enforcement agencies “the number one problem that organised crime is taking advantage of”. Nakampe Masiapato, head of the Border Management Authority, added 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. Common signs that a drug is not legitimate include unusual or blank packaging, no printed expiry date, or no insert detailing how to take it and the common side effects. Regulators warn that a product’s online availability or a seller’s claim that it is equivalent to a registered medicine is not proof that it has been assessed or approved.
In the case of retatrutide, it is still being tested in studies and has not been licensed for sale by any drug regulatory authority in the world.
