The term ‘cannabis’ refers to plants in the genus Cannabis. The three most recognised species are Cannabis sativa, Cannabis indica and Cannabis ruderalis.
This flowering herb generates a group of chemicals (cannabinoids) which produce mental and physical effects when consumed. There are approximately 113 known cannabinoids in the cannabis plant and more than 6 000 different strains.
The most commonly discussed, grown and traded cannabinoids are cannabidiol (CBD), which is non-psychoactive, and delta-9-tetrahydrocannabinol (THC), which causes the ‘high’ associated with recreational drug use.
CBD provides a powerful analgesic for arthritis pain, inflammatory pain, muscle-spasticity in multiple sclerosis, nerve-related pain, nausea and vomiting associated with cancer, sleep disorders, acne, anxiety, depression and many more.
THC is a psychoactive substance, typically smoked recreationally to produce a ‘high’, but also consumed orally to reduce anxiety. Chronic use may however lead to an amotivational syndrome characterised by apathy and lack of drive.
The South African market
According to the South African Medical Journal, cannabis contains varying amounts of THC and CBD, depending on various cultivation factors. No commercial plant-derived cannabis products are currently registered for medical use by the South African Health Products Regulatory Authority (SAHPRA). Although freely available, such products are therefore unregulated and of unverified composition, and not guaranteed to be safe or effective.
In May 2019, South African minister of health, Zweli Mkhize, removed CBD from the list of schedule 7 drugs and classified all CBD-containing products as schedule 4 substances. Many CBD products are available without a prescription, provided the product contains a maximum daily dose of 20mg CBD and a tetrahydrocannabinol percentage of less than 0,001%.
“We found that about three quarters of the capsules, oils, dry material, etcetera were not what they claimed to be, while some products were also toxic – not because of the cannabis-containing ingredients, but because of pesticides, heavy metals and solvents added during cultivation and processing by illegal and unregulated operators.”
Most of South Africa’s cannabis seed is still in their unhybridised, pure form, known as African landrace strains (ALS) and containing more tetrahydrocannabivarin (THCV) than anywhere else in the world. It is therefore important that pricing is regulated, and care is taken to avoid exploitation by foreign corporations.
THCV is an antioxidant, a potent anti-inflammatory agent, an appetite suppressant and also conveys anticonvulsant properties and various medicinal uses with potential value for patients suffering from seizure-related disorders, anxiety and panic attacks, neurodegenerative conditions, posttraumatic stress and other disorders.
“Different profiles have different effects on the body. Consumers should be more aware of this and self-educate by, for example, contacting the manufacturer for more information,” says Marianne Brown, director at CanAgri Global (Pty) Ltd in KwaZulu-Natal.
“At the moment we are seeing a bunch of cannabis, mostly CBD products, on the shelves in pharmacies across South Africa. I would like to predict that it will increase substantially in the future, while the actual variety of the source of the cannabis will not be included on the label.”
At this stage, legislation does not allow retailers and manufacturers to make any claims on the healing qualities of these plant extracts.
Authorising medical cannabis
Only CBD products have been legalised in South Africa and may be sold at pharmacies and certain health shops without a doctor’s prescription. Cannabis and its components are largely treated as scheduled substances, which means that sales in South Africa are subject to strict controls in terms of section 22A of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and that these substances must be registered with SAHPRA prior to being sold.
In 2017, SAHPRA published guidelines on the cultivation of cannabis and manufacture of cannabis-related pharmaceutical products for medicinal and research purposes. It consists of the standards and controls required for the cultivation and processing of cannabis as herbal material, also identifying the necessary production steps to ensure a product of reliable and reproducible quality.
These guidelines and regulations allow South Africans to trade in CBD once a permit has been issued to do so and, according to Wandile Sihlobo, chief economist of the Agricultural Business Chamber of South Africa (Agbiz), the guidelines anticipate legislative measures that not only decriminalise cannabis, but pave the way to commercialisation.
The Cannabis Guideline provides information regarding the processes to be followed and requirements to be adhered to in applying for the necessary licence in terms of section 22C(1)(b) of the Medicines Act, allowing them to cultivate, produce, extract and test, manufacture, import, export and distribute cannabis and cannabis-containing medicine.
Applicants must fulfil a number of requirements, including personnel requirements, security measures, site and equipment maintenance policies, standard operating procedures for production, storage and distribution, and adherence to special provisions for processing cannabis into a standardised herbal medicine.
Legality and product choice
Afriplex is a South African company rooted in the development and manufacturing of botanical extracts, complementary medicines and food and beverage products. It is currently the only company in South Africa with a legal licence to process cannabis for medicinal use, but it is expected that there will be more processors in future.
“Apart from licenses which will allow the legal cultivation and processing of the plants, the processor also needs a Good Manufacturing Pharmaceutical (GMP) license,” says Danie Nel, chief executive officer of Afriplex. “In South Africa, only five places have been licensed to legally cultivate cannabis, from which we receive material.”
“We find that there is a huge amount of confusion and disinformation, both worldwide and locally, about the legality and choice of cannabis products. Consumers should be less concerned about the selection of cultivars and dosages in the pharmaceutical applications, than what it is they actually need and whether the products are legal and safe to use.”
While only CBD products have been legalised for selling without a prescription, material containing THC may be processed and exported under very strict regulations. Local use of THC-containing products is limited to regulated cases prescribed by a general practitioner and issued under special approval by relevant authorities. “We are hoping that the regulations will be amended so that all ingredients from the cannabis plant will eventually be available for medicinal use,” says Nel.
By working in close cooperation with the Department of Health, he believes that the department is being extremely careful about the manner in which the regulations are amended. “They are approaching it step-by-step and being highly responsible in a market riddled with illegal and unsafe products. We therefore need to support and trust the processes followed by the Department of Health.”
In 2019, Afriplex conducted an extensive analysis on approximately 200 cannabis products available informally in South Africa. “We found that about three quarters of the capsules, oils, dry material, etcetera were not what they claimed to be, while some products were also toxic – not because of the cannabis-containing ingredients, but because of pesticides, heavy metals and solvents added during cultivation and processing by illegal and unregulated operators.
“It wasn’t properly analysed or manufactured in a pharmaceutical facility. That is why the law protects both the consumer and companies like us, ensuring that the products sold at pharmacies are in fact what they claim to be, and that they are safe to use and meeting all the specified requirements.”
Cannabis research in Africa
The South African Cannabis Research Institute (SACRI) is the first centre of excellence in the field of cannabis and cannabinoid therapy management in Africa. The institute incorporates multidisciplinary approaches to further advance medicinal, veterinary and complementary cannabis drug development.
SACRI has partnered with other South African and international research organisations and work with universities, high-tech companies and other innovative corporations to provide research-based, proven approaches to cannabis and cannabinoid therapy management. In addition to pain management, many other specific applications for cannabis, such as inflammation, substance abuse, mental disorders and autoimmune diseases, are also being explored.
The combined services and capabilities of SACRI sets the standard for Southern African industries with regards to best practice and good governance in cannabis producing facilities. The coalition between investors, producers, innovators, manufacturers, regulators and distribution centres maintains the centre’s focus on reliable, standardised, safe and regulated cannabis products for use by patients in need.