1985
1. Early - Homeopathic medicine off the market due to lack of efficacy.
2. End - Off market due to toxicity
1986
1. Peter Kreft went overseas to evaluate and understand the control of CAMS
1987
1. A Homeopathic committee was formed within the MCC
1990
Homeopathic committee proposed the regulation of Homeopathic medicine and all other CAMS by Criteria, Rationale and Reproducibility - Complementary Medicine Committee (CMC).
1996/97
1. All stakeholders in the CAMS industry were called in by the MoH to form a working group.
2. Broad Based Reference Groups (BBRG): Practitioners, Industry, Retailers and Academia
3. Aim: Determine safety, quality and efficacy of CAMS
4. !6 CAMS disciplines were condensed into 9.
5. BBRG listed substances, levels and indications of CAMS per discipline.
6. Technical subcommittees were formed to review the work of the BBRG.
1998
1. BBRG lists with levels, indications and substances were approved by the MCC.
2. SAMMDRA which included the CAMS disciplines
3. The Act was rescinded due to lack of regulations.
4. The BBRG approved lists were implemented.
5. Change in key staff at MoH late 1998. Led to restructuring at MCC including CAMS regulation with new proposals, e.g. CAMS regulated by Ministry and not MCC!
6. All work done by the BBRG was reworked.
1999/2000
1. CMC was disbanded due to various hurdles.
2. Working group formed at MCC.
3. Regulations were drafted to include grading e.g. C0, C1.
2002
1. SADC consultation programme with P. Kreft as DoH consultant.
2. Reviewed all work from 1985 to 2002.
3. Drafted new CAMS regulations.
4. Intention to publish the draft regulations.
5. Feb 2002, Call up notice for audit of CAMS. Listing process with submission of labelling information, formulation and foreign registrations/ markets.
2003
1. Draft CAMS regulations were published.
2. Different to those drafted in 2002 - thus unacceptable.
2004
1. Formation of the Complementary Medicine Stakeholder Committee (CMSC) to address the challenges irt draft regulations from 2003.
2. All stakeholders as represented in the BBRG.
2005 -2008
Review and rework draft regulations and any other relevant information to publish the current regulations.
2007
1. The HPA formed the Self Monitoring Technical Committee (SMTC)
2. Pro and Reactive surveillance of advertising of CAMS in the market place for HPA and non-HPA members.
3. Monitoring of misleading advertisements based on Appendices A & F of the Advertising Standards Authority (ASA) Code.
4. And positive lists from the BBRGs.
5. Thus SMTC works closely with ASA.
6. The company concerned is made aware of the complaint.
7. Complainant is anonymous.
8. The company will give a response.
9. The SMTC will review the response and make a decision.
10. If the respondent continues with the advertising then they are reported to the ASA.
11. N.B. The SMTC will not review a matter that is already being handled by the ASA because the ASA is a higher authority that SMTC.
2008
1. Publication of draft CAMS regulations.
2. Category D is a positive step.
3. In general the regulations are workable.
4. Concern that this is leaning more to Allopathic Medicine as opposed to the recommendations made over the years e.g. grading.
5. As opposed to: ATM's the differentiation between allopathic medicine is clearly outlined in the African Traditional Medicine Policy published in July.
6. Responsible person - criteria (cannabis roots in Ayurveda v/s leaf in Pharm world).
7. Lists: Inconsistent: Levels, Claims. No definition of use.
8. Schedules: Glucosamine S3
9. GMP - required, but concern with requirements. - 3 Generic Ptys
RECOMMENDATIONS/ WISH LIST
1. Separate and appropriate regulations and guidelines for complementary and traditional medicines
2. A separate marketing code (Direct Selling is 26% of distribution method.
3. A separate directorate with CAMS qualified key personnel and structure - MCC, DOH & MRA
4. And in the interim -
a. appropriate representation within the MCC
b. appropriate representation within the MCC committees
c. Reestablish CMC
d. Mandate & appropriate representation within the Complementary Medicines Committee (CMC)
e. Appropriately staffed CAMS task team
Prepared by: Mathabo Mashiane
Executive Director
Health Products Association of Southern Africa
Mobile: 082 377 6170
Email: excodirector@hpasa.co.za
"The HPA: Promoting and protecting the Health Products Industry"