The South African Health Products Regulatory Authority (SAHPRA), in a decisive move to protect public health, has intensified its enforcement actions against the unlawful production and distribution of unregistered weight-loss drugs.
This crackdown primarily targets GLP-1 and GIP medications, which include Semaglutide and Tirzepatide, widely marketed for weight management.
On 11 May 2026, a joint inspection conducted by SAHPRA and the South African Pharmacy Council (SAPC) at iDexis (Pty) Ltd, trading as Sentra Pharmacy in Silverton, Pretoria, uncovered significant regulatory violations.
Officials discovered that the facility was illegally manufacturing and marketing GIP/GLP-1 injectable products under the guise of ‘compounding,’ a practice strictly limited to individual patient preparations based on valid prescriptions.
Instead of adhering to this legal framework, Sentra Pharmacy was producing these medications for broader commercial distribution.
This production oversight raises alarms regarding the safety and efficacy of such drugs, particularly given the alarming reports linking their use to adverse events, including hospitalisations.
The inspection revealed critical deficiencies in quality and safety protocols. Notably, officials identified:
Illegal importation of active pharmaceutical ingredients, semaglutide and tirzepatide.
Absence of analytical testing to verify the identity, potency, and purity of these drugs.
Inadequate sterile manufacturing conditions, posing a high risk of contamination.
Insufficient equipment for the aseptic medical products, further exacerbating safety risks.
Lack of a pharmacovigilance system to track and respond to adverse drug reactions.
As a result of these findings, SAHPRA has seized all finished products containing semaglutide, tirzepatide, and related combinations found on-site. Additionally, the company has been mandated to initiate a full recall of affected products distributed through healthcare providers and pharmacies.
Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, emphasized the authority’s commitment to safeguarding public health, stating:
‘The unlawful manufacture, importation, advertising, and distribution of unregistered medicines pose a serious risk to public health. We will not hesitate to act to protect patients and safeguard the integrity of South Africa’s regulatory system.’
The SAPC echoed these sentiments, pledging to pursue rigorous regulatory action against any pharmacy professionals involved in these illicit practices. Vincent Tlala, CEO of the SAPC, reiterated the gravity of the violations:
‘Unlawful manufacturing, promotion and distribution of unregistered GLP-1 medicines for weight loss is a direct threat to public safety. Council will not tolerate any conduct that compromises patient safety or the integrity of the pharmacy profession.’
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