There has been much confusion and misunderstandings about how cannabis and associated products are regulated in South Africa, with government’s own missteps adding to the uncertainty. In his last #InsideTheBox column for the year, Dr Andy Gray clearly sets out the current legal and regulatory situation and where we’re heading.

There is a fundamental assumption that underpins much of the legislation relating to pharmacologically active substances, especially those that have neuropsychiatric effects.

Some are recognised as having legitimate medicinal uses, in humans and/or animals, and so are regulated as medicines. Others are deemed to have no legitimate medicinal uses, and so their possession and use are prohibited or even criminalised. Some of these substances are obtained from natural sources, such as plants or fungi, and some have been recognised and used since antiquity, precisely for their effects, both for pleasure and ritual.

Cannabis is a prime example, which grows on all continents other than Antarctica and has been used for a wide variety of purposes, both for its pharmacological actions and for its physical attributes, as a source of fibre and nutrition.

South Africa has a long and complex history with regard to cannabis. It was the South African government which proposed to the League of Nations Dangerous Drugs Committee in 1923 that cannabis be subjected to international regulation. That status remains in place, in terms of the Single Convention on Narcotic Drugs, 1961, to which South Africa is a signatory.

Schedule I to the Convention, which is maintained by the International Narcotics Control Board, includes “the flowering or fruiting tops of the cannabis plant”, as well as “the separated resin, crude or purified, obtained from the cannabis plant”. Parties to the Convention are required to “adopt such measures as may be necessary to prevent the misuse of, and illicit traffic in, the leaves of the cannabis plant”.

Cultivation of cannabis is to be regulated in the same manner as that applied to opium poppies, but with an important caveat: “This Convention shall not apply to the cultivation of the cannabis plant exclusively for industrial purposes (fibre and seed) or horticultural purposes.”

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As a result, cannabis was for many years listed as a Schedule 7 substance in terms of South Africa’s Medicines and Related Substances Act, 1965, and also included in the “Undesirable Dependence-Producing Substances” in terms of the Drugs and Drug Trafficking Act, 1992. While exceptional access was allowed for research, analysis or use by a particular patient, substances in those categories could not ordinarily be possessed or sold.

That entire legal construct was overturned by a 2018 Constitutional Court judgment, which declared the relevant sections of both laws unconstitutional “to the extent that they criminalise the use or possession in private or cultivation in a private place of cannabis by an adult for his or her own personal consumption in private”. The court allowed legislators a period of 24 months to remedy the situation.

THC and CBD 

Although the cannabis plant contains over 100 identifiable chemical components, two are of particular importance. Tetrahydrocannabinol (THC) is the psychoactive component, whereas cannabidiol (CBD) is not psychoactive. At higher doses, cannabidiol has been shown to be effective in the management of some paediatric epilepsy syndromes.

The first change made to comply with the Constitutional Court judgment involved moving THC to Schedule 6 (alongside morphine, for example) and CBD to Schedule 4 (as a prescription medicine). The Schedule 6 inscription also included an exception to allow adult use, echoing the wording in the court judgment. The control measures applicable to a Schedule 6 substance (such as the need for a prescription) do not apply when “raw cannabis plant material is cultivated, possessed and consumed by an adult, in private for personal consumption”. The Schedule 4 inscription also allowed for low-dose CBD products (containing a maximum of 20mg per day and 600mg per pack) to be regulated as a complementary medicine, provided the labelling made only a low-risk claim (a general health enhancement or health maintenance claim or a claim of relief from minor symptoms).

The South African Health Products Regulatory Authority (Sahpra) has issued just over a hundred licences for the cultivation and export of cannabis for medicinal purposes. These licences are for the preparation of the raw material from which medicines could be made, but no THC-containing products have yet been registered in South Africa. Sahpra does not report on the number of section 21 permits issued to individual patients seeking access to THC-containing medicines, nor on the sources of unregistered medicines approved in that manner (section 21 permits allow for access to medicines not registered by Sahpra).

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Sahpra’s cannabis cultivation permits do not allow the sale of cannabis products directly to the public. Sahpra has not issued licences to any retail outlets for cannabis or cannabis-containing products. Retail outlets claiming to be licensed “dispensaries” are therefore operating illegally.

In 2024, the Schedules were again updated, with this exception inserted: “in raw cannabis plant material cultivated and possessed in accordance with a permit issued in terms of the Plant Improvement Act (Act 11 of 2018) and processed products manufactured from such material, intended for agricultural or industrial purposes, including the manufacture of consumer items or products which have no pharmacological action or medicinal purpose”.

The Plant Improvement Act, 2018, is intended to regulate the propagation and sale of particular plants, setting quality standards for economically important varieties, such as wheat. In November 2025, the Minister of Agriculture, Land Reform and Rural Development issued regulations in terms of this Act, setting a THC limit of 2% for the leaves and flowering heads of cannabis plants considered to be “hemp” (low-THC cannabis). That action provides the clarity required to interpret the Schedules to the Medicines Act and creates a process for the issuing of “hemp” permits for the cultivation and sale of low-THC cannabis for industrial applications.

‘A work in progress’ 

Bringing the Drugs and Drug Trafficking Act into alignment with the Constitutional Court judgment has been far more complex than the Medicines Act and is still a work in progress. The section of the Drugs Act which enabled the Minister of Justice to make schedules listing substances in different categories was found to be unconstitutional in 2020. Future changes to the schedules will require an Act of Parliament. Distinct from the Schedules to the Medicines Act, these lists designate which substances, for example, are considered “Undesirable Dependence-Producing Substances”, the possession of which may be a criminal offence.

Instead, the Minister of Justice and Correctional Services tabled a separate bill in 2019, which was finally passed as the Cannabis for Private Purposes Act, 2024. While that Act has been assented to by the President, it has not yet been promulgated and no regulations have been issued. The legislation is therefore not yet in operation. Regulations are needed, for example, to specify the amounts of cannabis that can be cultivated, possessed or transported. Most importantly, though enabling the possession or cultivation of cannabis in a private place, and therefore personal consumption by an adult, the Act does not enable the commercialisation of cannabis for “recreational” or “adult use”, as is the case with alcoholic beverages or tobacco products.

South Africa’s Cannabis Master Plan, which envisages three separate value chains, covering medicinal cannabis, hemp, and adult use, is now being driven by the Department of Trade, Industry and Competition (dtic). The dtic plans to submit a Hemp and Cannabis Commercialisation Policy to Cabinet by April 2026 and to table an Overarching Cannabis Bill by mid-2027.

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The 2018 Constitutional Court judgment overturned almost a century of established practice. While the evidence for the medicinal value of cannabis and specific cannabinoids is still scanty, the assumption that such products have no medicinal value at all is no longer tenable. As with all pharmaceutical products, this is a highly regulated market with high barriers to entry.

An industrial market for low-THC cannabis is already well established and the necessary steps to enable its growth are now in place. However, the ill-informed ban on the inclusion of any cannabis components in foodstuffs, which was issued and then rapidly repealed in 2025, is indicative of the lack of coherence in government policy. The challenge remains the commercialisation of an adult-use market, and whether that will enable the involvement of the small-scale rural growers who have traditionally met demand for the product.

Cannabis policy, therefore, remains in flux, and the entire legislative process has been marked by missteps, missed steps, reverses, ambivalence and confusion. Some pieces of the picture are in place, but others remain uncertain or incomplete.

- Gray is a senior lecturer at the University of KwaZulu-Natal and co-director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of #InsideTheBox columns he is writing for Spotlight.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority and previously chaired the Cannabis Working Group. 

*This column was produced by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.