Posted 23 September 2019
Warning – Illicit and dangerous erectile dysfunction medicines
Pretoria, 28 June 2019 – The South African Health Products Regulatory Authority (SAHPRA) warns consumers not to buy illicit and dangerous medicines containing sildenafil, a substance used in the treatment of erectile dysfunction. Medicines such as Viagra, Dynafll and Avigra are approved by SAHPRA and must be prescribed by a doctor.
Any person who wishes to acquire these products needs diagnosis, prescription, management and close monitoring by authorised medical professional/s. Viagra contains sildenafil, which is a substance listed in Schedule 4 of the Medicines Schedules, as treatment for erectile dysfunction. Substances listed in this schedule require registration with SAHPRA together with the licensing of the facility that either manufactures, distributes or sells these.
Most of the illegal products are imported into the country illegally. There are few manufacturing facilities in the country, like the one that was recently found in Hammanskraal a few months ago. These products are mostly sold on online store platforms, social media platforms, health shops, retail pharmacy outlets and other falsified medicines are detected and seized at the ports of entry. SAHPRA therefore uses relevant measures as per the provisions of the Medicines Act to work with other law enforcement agencies in terms of Section 29 of the Medicines Act to curb these dangerous and illegal practices.
Within SAHPRA, there is a Post-Marketing Surveillance Unit, whose main function is to investigate complaints on medicines received from the Public or the Pharmaceutical industry. SAHPRA works with stakeholders in addressing pharmaceutical crime. Together with the South African Police Service, SAHPRA will investigate the complaint. In case of imported products, SARS will join the above entities in the investigation.
Acting CEO of SAHPRA, Portia Nkambule says, “All kinds of medicines, both branded and generic can be made fraudulently, including the so called ‘lifestyle’ medicines, such as those taken for weight loss and sexual dysfunction. SAHPRA receives tip offs from the public and encourages such tip offs. These illicit drugs are dangerous and the public is warned not to consume them.”
SAHPRA’s advice to the public is that:
Products sold in other places other than pharmacies, hospitals, clinics and at dispensing doctors must be avoided and be reported to SAHPRA:
- they present particular dangers such as the wrong dose of active ingredients, no active ingredient at all, or they may have a completely different ingredient included.
- some were found to contain highly toxic substances such as rat poison.
- they deprive sick people of treatment, leaving them vulnerable to the disease they are meant to be fighting.
- make some of the world’s most dangerous diseases difficult to treat by contributing to the development of drug-resistant strains.
- Avoid buying medicines online unless you have verified that facility and personnel providing the product/s are registered and recorded with the South African Pharmacy Council, Health Professional Council of South Africa, NDoH and/ SAHPRA.
“The activities of clandestine production establishments pose a serious risk to consumer health and safety. Consumers are at risk from unsafe and ineffective products and faulty counterfeit goods which can lead to harm and, in some cases, death. SAHPRA is committed to work with law enforcement agencies to eradicate such illicit activity, thereby ensuring that the South African public is safe and not exploited by such unscrupulous individuals and organisations,” indicates Nkambule.
Ms Portia Nkambule
012 842 7582/7583
Mr Yuven Gounden
012 842 7628
083 297 1214
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics (IVDs). Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAHPRA has three pillars to ensure that medicines, medical devices and IVDs meet the requisite standards to protect the health and well-being of South Africans:
It is these three pillars that defines the ethos of SAHPRA.
SAHPRA received an enquiry relating the illicit sale of products for sexual enhancement. The enquiry indicated that these products are being manufactured and widely distributed within the country, with reference to the raid conducted by the Hawks in Brakenhurst where the clandestine drug laboratory was discovered.