Newsletter - Regulation has hit a wall - Natural Products - Strategic Advice
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Newsletter – Regulation has hit a wall

Newsletter – Regulation has hit a wall

With the introduction of the Medicines and Related Substances Amendment Act of 2008, enforced by parliament in June 2017, the South African Health Products Regulatory Authority (SAHPRA) have had their hands tied by the Minister of Health. Despite the consistent growth of the dietary supplement industry within South Africa, room for the growth it deserves is and has been severely stunted over the past few years – and now more so than ever. The reality faced by manufacturers and marketers within the industry is one of increased costs of product evaluation and certification for both existing and new products, as well as more stringent labelling requirements. In a nutshell, these increased measures of bringing both existing and new products to market have left the industry in a rut.

Competing with ‘big pharma’

npsa-newsletter-big-pharmaWith the changes in industry legislation throughout 2017, the dietary supplement and CAMs industry is now left to compete with the same industry requirements as the pharmaceutical industry. In short, dietary supplements and CAMs have been absorbed into the ‘big pharma’ paradigm.

The process of regulation for pharmaceuticals and supplements are worlds apart. Where the system for regulating pharmaceuticals is registered for single molecule drugs, supplements – such as a multi-vitamin – are comprised of over 25 separate ingredients. This leaves supplement manufacturers and marketers with nowhere to turn, as registration of their products is lumped within an unrelated industry.

Additionally, large pharmaceutical companies have seen the opportunity in buying into the health supplement industry, leaving little to no room for success for the smaller companies.

So what can be done, going forward in 2018?


The HPA has written and sent a four-page letter to the South African Registrar of Medicines, appealing the categorisation of dietary supplements and CAMs as medicines. The letter addressed the HPA’s concern over:

•The classification of CAMs as medicines
•New licensing requirements for exporters, importers and marketers within South Africa
•The lack of provision made for qualified, responsible pharmacists within this country
•The lack of provision for fast-track screening of new products to market.

There is no doubt that the dietary supplement and CAMs industry within South
Africa is in need of regulation. But it needs to be suitable, appropriate to ingredients, and most importantly, workable for manufacturers and marketers to succeed.
As it stands, the HPA awaits a response to their appeal from the Registrar of Medicines.


Worth a read

With the huge boom in the probiotics industry, you may want to get in on the trend! Probiotics work wonders on the gut health and help with weight management. In our first ‘Guest Blog’ from a product review company in the USA, find out three factors to consider when stocking the best probiotic supplement.

While on the popular topic of probiotics, how is one industry driving another within South Africa? Year-after-year the South African obesity rate is on the rise – how has this given rise to the growth in the probiotics industry?

You may or may not have heard of the term nutraceuticals – how is this up-and-coming industry giving ‘big pharma’ a run for its money?

Final thoughts

Despite the fact that the South African dietary and CAMs industry is faced with red tape and strict regulations, there is much hope on the horizon. We believe with the implementation of a new president and, consequently, a new manner of running government, prohibitive laws and legislation has potential to be lifted.

The burning question is: how will Cyril Ramaphosa’s new leadership of the ANC take our country forward and, as a result, open up South Africa to new business and foreign investment?

In his opening at the pre-World Economic Forum (WEF), the new ANC President outlined his plans to address the bureaucratic clutter that prevents people from investing in our country. He mentioned that opening South Africa up to foreign investment is a numberonepriority, and that a One-Stop-Shop, called ‘Invest South Africa’ is to be established – a facility where business people can go to one central place and have all their issues addressed and solved.

From an economic point of view, Invest South Africa is aimed at encouraging investment without any barriers – “Open for Business!”.

I certainly believe that we can be ‘open for business’ and have hope for the future. Watch this space for positive updates to come this 2018…


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