Alternative medicines to be regulated

by Tamar Kahn CAPE TOWN – The health department has published a fresh set of draft regulations for complementary medicines, a move intended to give consumers assurance that the products they purchase are safe, effective and of good quality. Currently, the complementary medicines market is unregulated and consumers have no guarantees that a medicine can do what it claims. Consumers spent R2,1bn on these products in 2003 and the market has since grown hugely as more people self-medicate in a bid to take control of their own health. The department’s first draft guidelines, published in 2004, ran into fierce opposition from the complementary medicines industry for being too stringent. Two years later the department asked the industry to provide details of the products they sold, but no further moves to control these remedies have followed until now. The new draft regulations, published in the Government Gazette on Friday, appear to draw heavily on the regulatory regime used to control western medicines. They propose that products belonging to the various classes of complementary medicines – such as aromatherapy oils, herbs, and homeopathic preparations – should be categorised into different schedules depending on their potency. Just like western medicines, consumers will be able to purchase schedule 0 to 2 products without a prescription, and manufacturers and distributors will be allowed to advertise such products directly to consumers. The regulations propose that complementary medicines of higher schedules will be more tightly controlled, and may only be advertised to the trade and health professionals. Sixteen classes of complementary medicines are defined in the regulations, including Ayurvedic and Chinese medicines. African traditional medicines have been specifically excluded as they will be covered by separate regulations, according to the registrar of medicines, Mandisa Hela. The draft regulations were given a cautious welcome by the Health Products Association (HPA), which represents complementary medicine makers. These regulations are a huge step forward, said HPA chairman Alan Tomlinson. For the time being the status quo remains unchanged, but we have a document we hope will regulate the industry, he said. The HPA has striven to distance itself from what it says are a minority of rogue players who give the complementary medicines industry a bad name. Although the draft regulations are silent on the process for registering complementary medicines, Tomlinson said it was widely expected that the authorities would issue call up notices once the regulations came into effect, instructing manufacturers and distributors to apply to register their products. The process was likely to be done one category at a time, starting with the potentially most dangerous products.