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TAC submission on draft guidelines for the registration of complementary medicines

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The Treatment Action Campaign (TAC) has submitted comment to the registrar of the Medicines Control Council (MCC) on draft guidelines for the registration of complementary medicines.

We welcome the fact that steps are being taken to regulate the complementary and alternative medicines industries. Lack of regulation in these industries and failure to enforce existing laws have allowed quackery to flourish in South Africa.

However, we are concerned that the proposed guidelines do not set the bar high enough when it comes to substantiating claims of safety and efficacy. In line with the recently enacted Consumer Protection Act, these guidelines must provide patients and consumers with the maximum protection against companies making unsubstantiated claims in relation to complementary medicines.

The proposed guidelines would allow some products to be registered with the MCC without sufficient scientific evidence of safety and efficacy. The guidelines indicate that literature specific to a particular discipline of complementary medicine (e.g. homeopathic materia medica) could provide sufficient substantiation for registration.

We are opposed to the registration of any complementary medicines without reliable scientific evidence of safety and efficacy. If the MCC does decide to allow the registration of complementary medicines without such evidence, they will have a duty to ensure that the lack of scientific evidence is clearly indicated on product lables and in advertising for those products. The full submission can be downloaded here.