Complementary and Alternative Medicines (CAMs): Know the basics
Apr 3rd 2014, 07:56
Copy prepared by Wendy Smith
Recent amendments to the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) as outlined by the Department of Health (DoH) and Medicines Control Council (MCC) have set new boundaries for the marketing and sale of Complementary and Alternative Medicines (CAMs) in South Africa. The Health Products Association of Southern Africa (HPASA), together with consulting partner, Saige, provides a brief overview of the requirements.
The legislation, published into law on 15 November 2013, calls for certain standards to be met using a phased-in approach for implementation. These standards include, among others, the removal of banned substances and scheduled substances (by December 2013), changes to label information on pack (by 15 February 2014) and registration of certain product groups with the MCC (several dates and call-ups). This relates to products that fall within the CAMs definition as outlined by the DoH and MCC.
Furthermore, most, if not all, complementary medicines will need to be manufactured in a MCC-licensed pharmaceutical plant and all Complementary Medicine importers, retailers, wholesalers and marketers are required to obtain a licence to import and sell these products.
Janet Welham of Saige says: “There are several thousand products that are available in South Africa that can be categorised as Complementary Medicines (including Homeopathy, Aromatherapy and Herbal Medicines); Dietary Supplements (including vitamins, minerals, nutritional supplements) and Traditional Medicines (including, Chinese Traditional Medicines, Sowa Rigpa, Unani Tibb and Ayurveda Medicines).”
She continues: “The legislative requirements for these practices of medicines are different; as some of them are now classified as foods, that is, they would need to comply with the current food regulations. Others fall within the definition of Complementary Medicines and would need to comply with the recently published legislation. While others fall within the definition of Allopathic Medicines and would have to apply Allopathic standards.”
Under the CAMs legislation, on-pack labelling requirements differ to previous standards and need to include, among other elements: a disclaimer on the label (until it has been evaluated by the MCC) to the effect of: “This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease;” All label information supplied in a second language; a Package Insert (PI); a Patient Information Leaflet (PIL) as well as the following information: the category of medicine, its pharmacological classification and its discipline. Labels also need to adhere to medicine label requirements in general.
Regarding the pharmacological classification, Welham says that this information can be difficult to provide because “this is a term that is associated with Allopathic Medicines and is not a term always used with CAMs.”
Brands and manufacturers should also take note of the proof of medical claims their products make and this is divided into a low-risk and a high-risk claim. The requirements for each level of risk are based primarily on a product’s scientific formulation.
The legislation is far-reaching and does not only cover labelling and ingredient matters. It also organises products into different groups, in fitting with the legislation’s definition of CAMS and the type of medical claim made, if any.
Broadly speaking, vitamins, minerals and food supplements that fall below given levels within the schedule list and make no reference to a medical claim, would most likely be classified as a foodstuff (rather than a complementary medicine) and as such would fall within the current food regulations.
Vitamins, minerals and food supplements that contain higher levels than those stated in the schedule list and/ or make reference to a medical claim would generally be classified as an Allopathic Medicine and would need to comply with Allopathic standards too.
Medicines within the Allied Health Professions Council (http://www.ahpcsa.co.za) are defined as Complementary and Alternative Medicines by the legislation. This includes Herbal Medicines; Homeopathic Medicines, Ayurveda Medicines, Aromatherapy Medicines and Chinese Traditional Medicines.
In short, CAMs will now fall under pharmaceutical regulations under the new legislation, bringing with it an entirely new set of rules to an industry that has seen considerable growth in South Africa.
The legislation has fuelled ongoing debate and has been met several questions from the industry. However, its true nature will only be seen once the full scope of the regulations are implemented and enforced; albeit from the onset, implementation is set to be a costly and lengthy exercise.
Please note: The purpose of this article is to provide a brief overview of the said regulations and is no way intended to provide practical or legal advice in any manner or form.
For more information contact the Health Products Association of Southern Africa (HPASA) (http://www.hpasa.co.za/), on email@example.com, or +27 11 789 4464.
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