Ref: PXL/H.O./CIR-055/2014-15                           Date: 31.10.2014

To

Dear Sir/Madam,

Subject: Complimentary and Alternative Medicine in South Africa - Changes  - regarding.

1. It is to inform that South African Department of Health in November 2013 had announced new regulations to regulate the Complementary and Alternative Medicines (CAM) sector.  This had, obviously, led to discomfiture among various segments of the Industry including those producing food supplements, vitamins and other products. Pharmexcil has taken up the matter with Department of Commerce and in turn Consul General of India, Johannesburg represented to the South African Government, to make some relaxations to the regulations and now finally the Department of Health has responded and is proposing changes to the definition of complementary medicines it introduced last year.  The following changes are made in the legislation and issued revised CAMS regulations (copy link).

(http://www.samed.org.za/Filemanager/userfiles/37995_15-9_Health%20Act%20-%202014.pdf)

2. South Africa announced its Complementary and Alternative Medicines (CAMs) regulation on 15th November, 2013. These regulations would apply to over 55,000 products in the CAMs market in South Africa in a graduated manner up to 2019. However, high risk areas such as HIV, cardio-vascular, oncology and diabetes would be brought under regulation beginning August, 2014.

3. This had led to discomfiture among various segments of the industry including those producing food supplements, vitamins and other products.

4. There was pressure being built on the South African Government, including from the Indian side, to make some relaxations to the regulations and now finally the Department of Health, South Africa has responded and is proposing changes to the definition of complementary medicines it introduced during 2013.

5. The revision, a "broader definition" of complementary medicines, would allow a greater number of products to stay in the market. The November regulations had a narrow definition which meant that large number of products would be left out.

6. As per report however, draft regulations on definition say that "complementary medicines are those which are used as health supplement or are in accordance with those disciplines determined by the Medicines Control Council". They also allow the Council to declare a product complementary medicine. The proposed definition also includes a wider scope of origin of complementary medicines including those derived from fungi, algae, seaweed, and lichen in addition to the plants, minerals or animals sources currently stipulated.

Hence, all the members may take note of the changes and act accordingly. A copy of notification is attached.

Thanking you,

With regards,

Dr. P V Appaji

Director General

Encl:

CAMs