This article is written by our guest, Sibu Mdlalose, Director: Business Development & Client Relations, LogicTrials South Africa. Logic Trials is a strategic operations partner of DZS Clinical Services.
South Africa changes rules for complementary medicines
On Monday, 22 September 2014, the Department of Health in South Africa published draft regulations to amend the general regulations to the Medicines and Related Substances Act, 1965, with a wider definition of complementary medicines.
The draft regulations define a complementary medicine as: “Any substance or mixture of substance that – (a) originates from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substance as determined by Medicines Control Council, and (b) is used or purporting to be suitable for use or manufacture or sold for use – (i) in maintaining, complementing, or assisting in the innate healing power or physical or mental state, or (ii) to diagnose, treat, mitigate, modify, alleviate or prevent diseases or illness of or the symptoms or signs thereof or abnormal physical or mental state, of a human being or animal, and (c) is used – (i) as a health supplement, or (ii) in accordance with in accordance with those disciplines determined by the Medicines Control Council.”
Clearly, the proposed definition includes a wider scope of origin for complementary medicines, saying they may be derived from fungi, algae, seaweed, and lichen in addition to the plant, mineral or animal sources currently stipulated.
This has important consequences for those substances currently available in the South African marketplace. Some of the products currently in the market would have to be reclassified according to the directives provided by the Department of Health’s Medicines Control Council (MCC).
The new regulations also allow the council to declare a product a complementary medicine. This means that such products will be scrutinized by the Medicines Control Council for safety, efficacy, and quality.
This would mean that such products would need to comply with toxicological and clinical studies. These regulations are deemed to be in the interest of public safety.
Perhaps, the unintended consequence would result in subjecting the registration for many CAMs compounds to a needlessly tedious and protracted process.
Vitamins and Probiotics will need to be registered more or less under the stringent requirements as pharmaceutical drugs.
However, the November regulations opened an honest nest accompanied by criticism and threatened legal action from the complementary medicines industry.
Following a heavy barrage of criticism, the Department of Health succumbed to industry pressure and published amended regulations in September 2014.
In terms of draft amendment regulations published in September 2014, all interested parties have up to November 2014 to comment.