Graham Hayman
CROSSFIRE
Red tape at the Medicines Control Council (MCC) is reported to be standing in the way of the registration of complementary medicines and African traditional medicine in the organisation’s databank.
Complementary medicines (CMs) form part of the rapidly expanding worldwide market for non-prescription medicines. CMs include traditional herbal medicines (both African and European) as well as functional foods, dietary supplements and so-called nutraceuticals.
Only MCC-registered drugs and products can be prescribed or sold over the counter by registered pharmacists and medical practitioners – save for the traditional herbalists who operate outside the ambit of the MCC.
Complementary practitioners claim some good medicines are being kept off the market, and they find it difficult to import the medicines necessary for their practices.
Established CM companies have been making proposals to the MCC for some time, but they always come across obstacles, said Peter Kreft, CEO of one the companies. “These companies want to be able to register products, but the pharmaceutical/medical establishment is not sensitive enough to complementary medicines. It is not simply a case of applying the same techniques of testing to complementary medicines, but in a different way.”
Precious Matsotso, the MCC’s registrar of medicines, says delays are caused firstly by the exclusion of African traditional medicine and procedures necessary to bring them into the system. Secondly, the CM group wants to scrutinise and critique the MCC’s listing system. And finally, members of the MCC have divergent views on how the new regulation system should be implemented.
As for African traditional herbalists, Matsotso says, their exclusion is partly because the “national umbrella body for African traditional herbalists is only now coming into operation, following a series of parliamentary hearings. We want to accommodate all parties.”
Registration can take about three to four years, depending on whether clinical trials are involved. However, a speedy and convenient online registration system for CMs has been devised, but this doesn’t augur well for African traditional herbalists, who have little or no access to new technologies, or training in the use of such modern equipment.
The software is linked to a database of recognised substances that are used in commercially available CMs. Online applicants must list their ingredients, and if a substance they are using is not in the database, the processing of the application is rejected. They must then apply for registration in writing.
Sources close to the MCC say the Dukes report of 1998 into a regulatory system recommended that members of all regulatory committees should declare their commercial interests. This has not been implemented yet, they say. “Some members of the CM companies have vested interests in the sale and distribution of CMs.”
Medical regulators worldwide are struggling to devise appropriate regulations for CMs in culturally diverse markets. North America, for instance, contains markets for both European traditional herbal remedies and Chinese traditional medicines.
In Britain, regulation has been strongly opposed by consumers, who want wider choice and lower costs of medicine, but has recently been the subject of debate following reports of severe side-effects.
In South Africa the chair of the Allied Health Service Professions Council, and a member of the complementary medicines committee of the MCC, Michael O’Brien, says: “Our committee is frustrated at the failure of the new MCC to get up to speed on previous work we have done on a rational regulatory framework for complementary medicines.”
The appointment of a new health minister and director general as well as new MCC members has meant that the process of devising regulations for CMs has been put back to square one, says O’Brien.
Existing legislation drawn up by former health minister Nkosazana Zuma in 1998 brought both Western prescription medicine and CMs into one regulatory regime.
However, because the proposed system lacked the essential administrative sections, control of illegal medicines became almost impossible. Mandrax smugglers, for instance, could evade prosecution.
The government therefore applied to the high court to repeal this Act. At present all medicines are regulated by the old Act 101 of 1962, the Medicines and Related Substances Control Act.
Medical journals carry many reports of unscrupulous manufacturers, particularly in the Pacific Rim. To avoid their own government regulators, some manufacturers are now targeting foreign markets. O’Brien warns that some products do not meet acceptable international standards. Some food supplements being taken particularly by young people contain heavy metals and other noxious substances, and may turn out to be harmful.
MCC inspectors are always keen to seize such products when notified. CM companies also complain that their imports are impounded arbitrarily by customs officials. “It seems to depend on who is on duty in customs on any particular day,” says Denise Maidment, speaking for a United States-based company.
Graham Hayman is a freelance journalist
ENDS