BHEKISISA: SA’s regulators are struggling to keep up with black market weight-loss jabs

Australia has banned pharmacy compounding of weight-loss jabs, labelling such drugs as “potentially unsafe and dangerous”. So why are South African so-called compounding pharmacies still making their own versions of blockbuster weight-loss drugs such as Ozempic and Mounjaro, and selling them to the public?

The reality is that such activity is illegal in South Africa as well, at least in instances where the pharmacies make up copycat weight-loss jabs in large quantities, or use unregistered or illegally imported ingredients to make them.

But as demand has soared for weight-loss jabs, which dampen appetite and make people feel full for longer, some pharmacies have turned the niche practice of compounding into a lucrative business. In June, the Gauteng High Court ordered iDexis, a compounding pharmacy in Tshwane, to stop producing medicine containing semaglutide – the active ingredient of Ozempic – after large quantities of compounded weight-loss jabs had been confiscated on its premises. 

The court order was an important legal victory for the country’s regulators, including the South African Health Products Regulatory Authority (Sahpra), Stavros Nicolaou, chairperson of the Pharmaceutical Task Group, an umbrella organisation for the pharmaceutical industry in South Africa, said during a panel discussion held in Sandton on 14 October. 

But he said the momentum built by the court order could be lost if Sahpra and the South African Pharmacy Council (SAPC) don’t follow up on it quickly with clearer guidelines for compounding pharmacies about what they can and cannot legally do. “You can go and win these court cases, and have people on the back foot, but all of that can unravel because we’re just not acting swiftly enough as a country,” he said. 

Illegal weight-loss jabs in plain sight

The panel gathered representatives from Sahpra and the SAPC, as well as the police service, border control, revenue service and the pharmaceutical industry, to explain to the public how they are working together to stop the trade in fake drugs. 

Sahpra says it has received about 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. 

“We are worried that the scourge is getting out of control,” said Daphne Fafudi, the body’s head of regulatory compliance. And it’s the public that can pay the ultimate price, she added. “People do die, and it doesn’t even come to our attention,” she said. 

Some fake or illegitimate drugs are sold covertly. Others are traded in plain sight. One of them is retatrutide, a weight-loss injection that is still being tested in studies and therefore hasn’t been licensed for sale by a drug regulatory anywhere in the world. Yet, it is sold “openly and brazenly” around the world, including in South Africa, said Nicolaou.

In the July episode of Bhekisisa’s TV programme, Health Beat, we reported how a Johannesburg woman’s doctor sold her retatrutide, telling her it’s safe because he “had it tested”, while making her sign a waiver to release him of any responsibility for what might go wrong. 

Earlier this year, a man reportedly died in the US 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. “The public needs to know that our enforcement agencies are actually enforcing the law,” he told the meeting.

Vincent Tlala, CEO of the SAPC, said revised guidelines for compounding pharmacies were under way, a process Sahpra is leading, with input from the SAPC. However, Tlala said, these were not expected to be ready until February or March next year. 

According to Nicolaou, this is too late. “The regulations are taking too long,” he says. 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. “Why are we not doing the same thing?” 

What South African law says about compounding 

Compounding medicines is lawful in South Africa, but only under specific conditions. Compounding requires a healthcare professional’s prescription, generally for a formulation that is not available as a registered medicine – for instance, if a patient requires a medication as an oral liquid that is only normally sold as a pill. 

As for compounding in bulk, the law says that a pharmacy may prepare stock in advance if it can show that patients regularly need the medicine – such as repeat prescriptions for the same person.

But some pharmacies produce large quantities without that evidence, Sahpra chief executive Boitumelo Semete-Makokotlela told Bhekisisa. This means “you’re not compounding, you are manufacturing”, which requires a good manufacturing practice licence that compounding pharmacies do not hold.

A good manufacturing practice licence shows that a company has met the safety and quality standards required to manufacture medicines.

A second concern is where ingredients come from. Active pharmaceutical ingredients — the substances in medicines that make them work — must be registered in South Africa and imported by a licensed entity, says Semete-Makokotlela. A pharmacy’s operational licence does not authorise it to import unregistered ingredients, she says, yet some have arrived in travellers’ luggage.

Another loophole that needs to be closed, Semete-Makokotlela notes, is people selling directly to the public experimental drugs that are still being studied or medicinal products that are authorised for “research purposes” only. This includes some peptide products that are neither registered medicines nor experimental drugs in formal trials (like retatrutide), yet are still widely bought and sold as lifestyle or wellness drugs to do things like lower inflammation and boost energy. 

Peptides are short chains of amino acids – small building blocks that the body uses to make proteins. Insulin is a peptide, as is semaglutide, the active ingredient in Ozempic. Both are registered medicines in South Africa. 

However, there are other peptides, such as BPC-157, which are being sold online and in gyms as solutions to specific health problems, such as tissue repair. These peptides aren’t technically medicines, nor are they actively being studied in drug trials. Yet, they are sold as healthcare products, without evidence that they are safe or effective at treating humans. 

Then there is the battle for public opinion, which is proving to be another hurdle. Semete-Makokotlela admits regulators are “on the back foot” when consumers see people losing weight while official warnings struggle to compete. 

The answer, she believes, includes offering people registered alternatives at different prices – including cheaper generics – and working with healthcare professionals to steer patients towards safe, registered medicines.

Read more: The first generic weight loss drug has hit SA — will it be enough to kill the black market?

South Africa’s first generic weight-loss drug, containing semaglutide, hit the shelves in August. 

How the public can keep safe

During the panel discussion, South African Revenue Service official Gene Ravele called the lack of coordination between enforcement agencies “the number one problem that organised crime is taking advantage of”, and that this is also true for counterfeit and illegitimate drugs. 

Border Management Authority head Nakampe Masiapato added that police detectives and prosecutors are often generalists, ill-equipped for specialised pharmaceutical cases. “They have no idea what this is about,” he said. 

For consumers, the advice from regulators is to use authorised channels and check that medicines are registered. 

Common signs that a drug is not legitimate is that it has unusual or blank packaging, no printed expiry date on the box or container, or that it doesn’t have a normal insert detailing how to take it and the common side effects. Broken or dented packaging is another big “tell”, the Sandton meeting heard. 

The bottom line is 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, said Fafudi. “If you cannot trust the source, do not trust the medicine.” DM

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.