When a company builds its brand on high-minded slogans like “redefining what’s possible in healthcare” and being “driven by purpose”, the public expects cutting-edge medicine.
They do not expect a pharmacy allegedly operating outside the law.
The recent raid on iDexis, a Pretoria-based compounding pharmacy trading as Sentra Pharmacy in Silverton, Pretoria — accused by the South African Health Products Regulatory Authority (Sahpra) of illicitly manufacturing weight-loss medicines — is a big wake-up call.
It exposes the dark, unregulated underbelly of South Africa’s obsession with GLP-1 weight-loss jabs.
GLP-1 and GIP medicines contain either semaglutide, tirzepatide, or a combination product containing both semaglutide and tirzepatide promoted for weight loss.
The raid by Sahpra, in collaboration with the South African Pharmacy Council (SAPC), focused on semaglutide, tirzepatide, and combination formulations and discovered critical regulatory non-compliance. All GIP/GLP-1 injectable products found onsite were seized.
Sahpra said iDexis was found to supply medicines under the pretext of “compounding”, but outside the legal framework permitted under South African law.
It said further inspection revealed serious deficiencies in quality, safety and regulatory compliance.
We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system.
— Boitumelo Semete-Makokotlela, Sahpra CEO
These included the illegal importation of semaglutide and tirzepatide ― active pharmaceutical ingredients ― the absence of analytical testing to confirm identity, potency and purity, the inadequate sterile manufacturing conditions, the high risk of contamination and inadequate equipment for aseptic medical preparations
Sahpra vowed to roll out more action to curb illicit production and marketing of GLP-1 medication and ensure players complied with the Medicines and Related Substances Act.
Sahpra CEO Boitumelo Semete-Makokotlela warned of the risks of the production and distribution of fake products on public health.
“We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system,” said Semete-Makokotlela.
Even more encouraging is the zero-tolerance stance taken by SAPC.
By threatening to strip offending pharmacists of their licences and remove them from the register entirely, SAPC CEO Vincent Tlala sent an unmistakable message: “The SAPC will not tolerate any conduct that compromises patient safety or the integrity of the pharmacy profession.”
These are strong words from authorities and are laudable given the increasing number of people relying on GLP-1 medicines to lose weight.
By targeting the pharmacies and pharmacists that are providing a veneer of legitimacy to unregistered products, regulators are finally cutting off the supply chain at the source.
However, regulators face an uphill battle as the underground market for these weight-loss drugs continues to spiral out of control.
There have been numerous reports about how illegal jabs have been smuggled through the borders from as far as China.
These are then promoted on social platforms including Facebook to unsuspecting consumers who are desperate to manage weight loss.
The clampdown should send a strong message against the proliferation of unregistered sellers and illegal marketing.
Consumers also need to be informed of the dangers of accessing GLP-1 medication on the black market.
By injecting unknown substances into their bodies, people who are desperate for a solution to their weight problems are risking their health. They should follow the advice of Sahpra, to consult healthcare professionals for guidance relating to weight management or diabetes treatment options.
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