On 15 November 2013 the Minister of Health finally published Regulations to the Medicines Act (Medicines and Related Substances Act, 1965 (Act 101 of 1965), not for comment, but for implementation. They defined complementary medicines for the first time in South Africa. In addition the Regulations incrementally “called up” various complementary medicines over the following six years.
If a product that has been called up, and has not been registered, or an application for registration has not been received by the MCC, then according to the Medicines Act (Section 14(1)) it may no longer be sold.
The Regulations also created a new category of medicines – category D – which are complementary medicines “subdivided into such disciplines as may be determined by the Council after consultation with the Allied Health Professions Council of South Africa.”
This left “dietary supplements” out in the cold and the Health Products Association of South Africa (HPA) embarked on a lawsuit against the Minister of Health and MCC to challenge the regulations. The lawsuit was dropped after the MCC published a revised proposed definition of complementary medicines which included “health supplements.” This misleading description possibly opens the door to a host of products claiming to “assist” or “support” a human’s or animal’s “health,” when there is no evidence that they do.
Today, 15 November 2015, is exactly two years since Notice R.870 of 15 November 2013 was gazetted.
One of the groups of complementary medicines specifically referred to, was “slimming preparations” – for which applications for registration had to have beeen submitted within 24 months – i.e. 15 November 2015. A “roadmap” was published by the Medicines Control Council (MCC) in November 2013, for the benefit of the complementary medicines industry, (not consumers!).
Certain products were called up “immediately” as of the date of publication of the Regulations. These were “antiviral agents”, “oral hypoglycaemics”, “cardiac medicines”, “cytostatic agents.” It is unclear which of these have in fact been registered, or how many applications for registration have been received.
- An example of a complementary medicine claiming to be an antiviral agent, from the discipline homeopathy, would be Oscillococcinum®. There is no evidence that it has been registered or that an application for registration has been submitted.
- An example of a complementary medicine claiming to be an oral hypoglycaemic would be Antagolin, distributed by Medical Nutrition Institute (Pty) Ltd. Antagolin claims to assist your body to regulate blood sugar more efficiently, and that it is therefore suitable for prediabetics and type 2 diabetics. An application for registration of Antagolin has apparently been submitted to the MCC, but there is no evidence that it has been registered. It is unclear which Allied Health Council-regulated “discipline” it would be categorised as.
- Another example of a complementary medicine claiming to be an oral hypoglycaemic would be Solal’s “Glucose Regulating & Diabetes Formula.” There is no evidence that it has been registered or that an application for registration has been submitted. It is unclear which Allied Health Council-regulated “discipline” it would be categorised as.
- There is no evidence that complementary cardiac medicines or cytostatic agents have been registered, or that an application for registration has been submitted. It is unclear which Allied Health Council-regulated “disciplines” these would be categorised as.
Slimming products have been a favourite complementary medicine of many manufacturers / retailers / distributors for many years. Some have contained dangerous substances associated with heart attacks and other serious side effects.
By today, 15 November 2015, all such products should have been registered, if they have sufficient evidence for their claims; or applications for their registration should have been submitted.
The Registrar of the MCC is obliged to publish the details of all newly registered medicines in the Government Gazette.
The Registrar of the MCC is also obliged, in terms of S15(11) of the Act, to publish the details of all products “called up”, for which applications have been received.