By Mpho Moloi
The South African Health Products Regulatory Authority (SAHPRA) has raised alarms about the increasing presence of counterfeit Glucagon-like Peptide-1 (GLP-1) agonist products, such as Ozempic, on the local market. These products, widely used in managing type 2 diabetes and known for their weight loss benefits, are now being sold through unauthorized channels, including websites, social media, and informal vendors, posing serious health risks to unsuspecting consumers.
“These pose a health risk to the public. SAHPRA cautions the public to not purchase and/or consume such products as their safety, efficacy, and quality have not been assessed,” the authority warned in an official statement. SAHPRA’s concern underscores the dangers of unregulated medical products, which lack the rigorous testing and approval required to ensure their safety for public use.
Surge in Counterfeit Ozempic Products
SAHPRA has reported a notable increase in the availability of counterfeit versions of Ozempic, a GLP-1 receptor agonist registered in South Africa under the brand name Ozempic with two injectable pen presentations: 0.25 mg and 0.5 mg/dose pen, and a 1 mg/dose pen. Manufactured by Novo Nordisk, Ozempic is legally approved in South Africa solely for managing type 2 diabetes and reducing the risk of major cardiovascular events in adults with the condition who also have heart disease.
Despite its legitimate use in diabetes treatment, Ozempic has gained global attention for its potential to promote weight loss. However, SAHPRA clarified that it is not approved in South Africa for weight management, cautioning against off-label use due to potential risks and lack of regulatory oversight.
The Arrival of Mounjaro and Similar Concerns
Another GLP-1 agonist, Mounjaro (tirzepatide) by Eli Lilly and Company, is also gaining popularity in South Africa, though it has not yet been officially distributed by Eli Lilly within the country. Mounjaro is indicated for treating type 2 diabetes but is not authorised in South Africa for weight management. Its increasing presence on the informal market, however, suggests that it is being imported or compounded by unlicensed vendors, potentially without proper handling of its complex formulation.
The regulatory body highlighted the risks of compounded GLP-1 agonists, particularly given that these are sterile medicines requiring meticulous production processes. “The complexity of compounding GLP-1 agonists, which are sterile medicines containing complex active substances, poses a public health and safety risk,” SAHPRA stated, underscoring the dangers associated with medicines that have not undergone formal evaluation by SAHPRA.
Risks Associated with Compounded and Counterfeit GLP-1 Products
Compounded products that claim to contain semaglutide, the active ingredient in Ozempic, present a unique set of challenges. Without SAHPRA’s verification or evaluation, it is unclear whether these products contain authentic semaglutide or if they meet the necessary standards of quality and efficacy.
SAHPRA expressed concerns that these counterfeit or substandard products could pose significant health risks to individuals who consume them. Medicines containing unverified active ingredients are illegal under the Medicines and Related Substances Act, which prohibits the sale of products with ingredients that differ from those in SAHPRA-approved formulations.
Legal Ramifications and Public Safety Measures
According to Section 29 of the Medicines and Related Substances Act, anyone caught selling or distributing counterfeit medical products can be held criminally liable, with penalties applied accordingly. SAHPRA CEO Dr Boitumelo Semete-Makokotlela reiterated the authority’s commitment to public safety, stating, “SAHPRA is monitoring the supply chain as well as the online platforms for unregistered, substandard, and falsified medicines containing or claiming to contain semaglutide. We are also investigating any contraventions relating to the Medicines and Related Substances.”
The regulatory authority urged the public to report any suspicious products, particularly those falsely branded as Ozempic or Mounjaro, through SAHPRA’s 24-hour hotline or online whistle-blower platforms. Dr Semete-Makokotlela emphasized that safeguarding the health of South Africans remains SAHPRA’s top priority, urging consumers to be vigilant and avoid purchasing medicines from unauthorised sources.
Public Health Implications of Counterfeit GLP-1 Products
The proliferation of counterfeit GLP-1 products poses a dual threat to public health: it compromises the health of individuals who rely on these medications for diabetes management and undermines the efforts of legitimate pharmaceutical companies that produce approved, regulated products. Counterfeit medicines not only lack efficacy but also pose a risk of adverse side effects, which can be severe or even life-threatening.
South Africa’s rising diabetes prevalence makes the availability of authentic and effective treatments critical. SAHPRA’s warning aims to protect vulnerable individuals who may unknowingly purchase counterfeit products due to their affordability or easy accessibility through informal channels.
SAHPRA’s Efforts to Combat Counterfeit Medicine Distribution
SAHPRA’s proactive approach includes monitoring online and informal marketplaces where counterfeit products are often sold. The agency has ramped up its efforts to track and shut down illicit vendors who exploit public demand for popular medications. By collaborating with law enforcement agencies, SAHPRA is working to disrupt the distribution networks that bring unverified medicines into the country.
SAHPRA’s actions extend beyond public warnings; the regulatory body has also been working to educate the public about the dangers of unapproved medications. This includes campaigns on the risks associated with purchasing drugs through unverified platforms, as well as outreach to healthcare providers to help them recognise and report counterfeit products.
Consumer Responsibility and Preventive Measures
In light of these developments, SAHPRA has advised consumers to exercise caution and only purchase SAHPRA-registered products through licensed pharmacies and medical providers. By adhering to these guidelines, consumers can protect themselves from the risks posed by counterfeit products.
The public is urged to verify the authenticity of any GLP-1 agonist product, especially those sold outside of traditional medical settings. Healthcare providers can also play a crucial role by educating their patients on the importance of purchasing medicines from legitimate sources and discouraging the use of products obtained through informal channels.
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