Posted 09 May 2016
This article by Tamar Kahn in Business Day Live, reports on the MCC claiming to be gearing up to seize “scores of illegal products claiming to treat diabetes, heart disease, cancer and viral illnesses”. The complementary medicines regulations, which were gazetted on November 15 2013, allowed firms to continue selling complementary medicines until they were called up for assessment by the council, starting with those deemed most risky. Only those that applied for registration as a CAM may continue to be sold until their submission has been assessed, and accepted or rejected. What is remarkable is how few complementary medicines have been submitted for registration.
The report quotes Mr Norman Fels, Chairperson of the Health Products Association (HPA), as stating that “the low response rate from the industry suggested companies were experiencing problems with the process, rather than ignoring the regulations”. However, several companies offering regulatory (including registration) services are listed as members of the HPA. Most have experience in following the “process” required. He also went on to say: “any innovation, and the importation of new products, has been blocked and the industry stifled”.
This would seem to be rather an over-exaggeration. With 155,000+ products on the market, and an estimated R7 billion annual turnover, one could hardly call this a “stifled” industry. The importing of “new products” – as we’ve seen in many cases, is the equivalent of “dumping” unproven products into South Africa. This was common practice during the 2002-2013 MCC-created hiatus.
The HPA have seemingly accepted “traditional” use of complementary medicines as a component of evidence that they work. This is antithetical to “innovation” – which must also provide de novo evidence!
The HPA should concern itself with ensuring that its member companies are able to prove to the Regulator that the products South African citizens have unscrupulously been exposed to, actually work and are safe.
Mr Fels himself is owner of the product Aminoliq, a weight-loss product with no evidence that it works, and has previously been ruled against by the Advertising Standards Authority.
Crackdown looms on complementary medicinal products
by Tamar Kahn, 28 April 2016, 05:44
MEDICINES Control Council inspectors are gearing up to seize scores of illegal products claiming to treat diabetes, heart disease, cancer and viral illnesses in a blitz aimed at enforcing tough regulations for complementary medicines.
The complementary medicines regulations, which were gazetted on November 15 2013, allowed firms to continue selling complementary medicines until they were called up for assessment by the council, starting with those deemed most risky.
The first call-up deadline, on May 15 2014, was for products claiming to be complementary medicines for [viral illnesses including] HIV, diabetes, heart conditions and cancer.
Registrar Joey Gouws said the council sent a letter to the industry, advising it that only six products submitted in terms of the call-up notice met the requirements for complementary medicines and could stay on the market, pending further scrutiny.
All other products claiming to be complementary medicines for HIV, diabetes, heart conditions and cancer are now illegal. (emphasis added)
This includes products that were not submitted for the 2014 call-up and those imported after this date that were not submitted, said Dr Gouws.
The six products that passed initial muster are Modhomco’s Cralonin oral drops, Bioforce SA’s Crataegus Oxy Liquid, Bell Lifestyle Products’ Cardio Health, the Medical Nutritional Institute’s AntaGolin, Brunel Laboratories’ Patrick Holford Cinnamon and Avid Brands’ Bioharmony Cinnabalance, according to the letter sent to the industry.
These can be sold for now, pending their registration.
Dr Gouws said the council had received only 24 applications for the call-up. The 18 that did not meet the requirements for complementary medicines for cancer, HIV, diabetes and heart disease were for other clinical conditions and would be assessed later.
Council inspectors would concentrate their enforcement efforts at the wholesaler level, as this was more effective than visiting retailers, she said.
The next announcement from the council is expected to be for the lucrative slimming and sexual hormone segment of the market. The council received 121 applications for this category.
The call-up deadline for supplements, one of the biggest market segments, is May 15 .
Health Products Association chairman Norman Fels said the low response rate from the industry suggested companies were experiencing problems with the process, rather than ignoring the regulations.
“Any innovation, and the importation of new products, has been blocked and the industry stifled,” said Mr Fels.