TNHA COMMENTS ON DRAFT AMENDMENTS TO THE GENERAL REGULATIONS FOR MEDICINES.

SUMMARY


The Traditional & Natural Health Alliance (TNHA) submitted comments on the draft amendments to the 2017 General Regulations for Medicine under the Medicines and Related Substances Act, 1965. TNHA, representing various stakeholders in the natural health products sector, criticizes the amendments for being ultra vires and not addressing previous court rulings that declared similar regulations unlawful. TNHA argues that the amendments fail to adequately include African Traditional Medicine, violating constitutional rights. They call for a separate regulatory framework for traditional and natural health products, distinct from pharmaceutical regulations, to ensure fair and effective governance.

The TNHA highlights that past attempts to integrate complementary medicines into the Medicines Act have failed and emphasizes the need for a new, constitutionally sound approach. They propose that traditional and natural health products be regulated similarly to food products, as seen in international practices. The TNHA stresses the importance of self-determination and representation in regulation and warns against the financial and operational burdens of the current framework. They urge the Ministry of Health to consider a new regulatory statute that respects the unique nature of traditional medicines and supplements.

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