Complementary and alternative medicines to be regulated - but definitions cause confusion
South Africa represents a multi-million rand market for complementary and alternative medicines – but currently these products are not regulated by the Medicines and Related Substances Act No.101 of 1965 (the Act). However, proposed amendments to the General Regulations in terms of the Act may alter this situation radically, with complementary and alternative medicines (CAMs) becoming subject to regulation by the Medicine Control Council (MCC) of South Africa. The MCC has in turn published guidelines outlining the consequences and requirements that will face the manufacturers of CAMs, which can be summarised as follows:
Once the amendments come into force CAMs will have to be registered with the MCC – which means that an applicant must then provide data on the safety, efficacy and quality of the medicine to be registered. In some cases applicants wishing to register CAMs will be allowed to submit literature-based evidence of the safety and efficacy of the proposed product. However, where claims made by the applicant are categorised as “high”, clinical data will be required. Manufacturers of CAMs will in future require a valid Section 22C licence to manufacture these products. The Department of Health and the MCC will scrutinise all aspects relating to the advertising and marketing of these products.
While some aspects of the draft amendments are quite clear, the proposed legislation does cause concern due to an extremely vague definition for complementary medicine. Furthermore, the guidelines refer to a “designated active ingredient, as defined”, while there is no such definition in the proposed legislation, and while the proposed vague definition of complementary medicine does not include this concept. This appears to be the result of the South African Department of Health having based its proposals on similar Regulations that are applicable in Australia. The Australian Regulations contain a clear definition for complementary medicine and lists what are regarded as “designated active ingredients”.
At present, there is no clarity as to whether or not products such as sport nutrition formulations, multi-vitamins and energy supplements would be regarded as CAMs. Interested parties were given until 22 September to provide submissions regarding the guidelines, while the deadline for submissions on the published Regulations is 22 October 2011.