Complementary and alternative medicines are not currently
regulated by the Medicines and Related Substances Act No.101 of
1965 (the Act). This may change if the proposed amendments to the
General Regulations in terms of the Act come into force. The
Minister of Health, Dr Aaron Motsoaledi, has published draft
amendments that would bring complementary and alternative medicines
(CAMs) into the ambit of the Act, with the result that this sector
of the industry would also be regulated by the Medicine Control
Council (MCC) of South Africa. A guideline document has been
published by the MCC, indicating what would be required of
manufacturers of these products. While the guidelines cover the
requirements in some detail, they also leave some important
The potential impact of the draft amendments deserves careful
consideration and analysis. In terms of the proposed definition a
"complementary medicine" is one that is used, or intended
to be used for, or manufactured or sold for use in assisting the
innate healing power of a human being or animal, and that is used
in accordance with the practice of the professions regulated under
the Allied Health Professions Act No. 63 of 1982. 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.
The high cost of clinical trials has been taken into account by
the drafters of the guidelines, and 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.
A further consequence of the proposed legislation is that
manufacturers of CAMs will in future require a licence to
manufacture these products, as is already the case with allopathic
medicines. Current provisions relating to labelling, advertising,
package inserts, patient information leaflets and sampling will
also apply to CAMs.
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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Earlier this summer, the Health Authority – Abu Dhabi (HAAD) announced changes to two of its main health insurance programs, the 'Thiqa' plan and the Abu Dhabi Basic Plan.
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