The sale of illegal medicines is a significant threat to public safety. In his latest Inside The Box column, Dr Andy Gray asks whether the South African Health Products Regulatory Authority has the necessary tools at hand to provide protection in this area.
The United Kingdom's medicines regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), announced in June 2025 that it seized millions of doses of illegal medicines and removed hundreds of illegal online listings, as part of Interpol's Operation Pangea. "Illegal" medicines here refers to those not authorised for sale in the United Kingdom or being sold outside of regulated distribution channels, such as licensed pharmacies. The MHRA's Criminal Enforcement Unit (CEU) worked with "law enforcement partners" to secure arrests related to illegal medicines. The Australian medicines regulator, the Therapeutic Goods Administration (TGA), also took part in the same Interpol action.
However, the TGA has another method of dealing with non-compliance with the applicable Australian law, in the form of infringement notices imposing fines on individuals or companies. In January 2026, the TGA issued infringement notices, totalling Australian $43 560, on six individuals for "alleged importation and unlawful advertising of therapeutic goods". For example, a registered health practitioner was fined for allegedly importing unregistered cosmetic injectables. The TGA was of the opinion that these unregistered products would "pose serious safety risks due to unknown composition or contamination".
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In South Africa, the South African Health Products Regulatory Authority (SAHPRA) is seeking maturity level 3 status for medicines regulation. Whether SAHPRA achieves this status will depend, in part, on how effectively it is able to deal with non-compliance. The World Health Organization uses the WHO Global Benchmarking Tool (GBT) to assess the capacity of a national regulator. At various points in the GBT, there is mention of the need for local legislation to "specify the applicable fines, charges, penalties, or sanctions in the event of non-compliance". The GBT calls for clarity on "adequate and proportional sanctions, penalties and prosecution of violations of the applicable legislation".
The law in South Africa
Section 29 of the Medicines and Related Substances Act, 1965, includes a list of offences. For example, it is an offence to contravene or fail to comply with the provisions of section 14(1). That section prohibits the sale of an unregistered medicine that is subject to registration, unless with the specific approval of the Authority (in terms of section 21). Any person who makes any false or misleading statement in connection with any medicine, whether in an application for registration or in the process of sale, is also guilty of an offence. Section 30 then states that any person who is convicted of an offence referred to in section 29 shall be liable to "a fine, or to imprisonment for a period not exceeding 10 years". Sub-section 4 states: "Notwithstanding anything to the contrary in any law contained, a magistrate's court shall be competent to impose any penalty provided for in this section."
However, SAHPRA is unable to impose a fine on its own and has to rely on the National Prosecuting Authority to bring a charge before an appropriate court. Custodial sentences for transgressions of the Medicines Act are rare, in contrast to the many prosecutions brought in terms of the Drugs and Drug Trafficking Act, 1992. Fines are also rarely imposed.
A broad remit
SAHPRA's Inspectorate, Licencing and Compliance Unit has a broad remit in relation to pharmaceutical crime. For instance, it is tasked with the monitoring and control of border posts for imports and exports of health products, the identification of substandard and falsified medicines, and ensuring that unregistered health products are removed from the public. The Unit also has to monitor and act against illegal retail outlets selling health products and illicit manufacturing facilities.
The SAHPRA inspectorate operates in accordance with tightly regulated powers. These powers were severely trimmed by the Constitutional Court in their 1998 ruling in the Mistry case. In particular, the court objected to the power given to an inspector of the then Medicines Control Council to "enter upon any premises, place, vehicle, vessel or aircraft at or in which there is or is on reasonable grounds suspected to be any medicine or Scheduled substance", without a warrant. Justice Albie Sachs held that this meant that "inspectors are given the power to enter any home where aspirins, ointments or analgesics happen to be, and once there, may inspect not only medicine cabinets or bedside drawers, but also files which might contain a person's last will and testament, private letters and business papers." As a result, the court found the relevant section to be unconstitutional and therefore invalid.
Subsequent amendments to the legislation have altered section 28 of the Medicines Act. While SAHPRA inspectors may, at a reasonable time, enter a place that is licensed with SAHPRA or a place where medicine is ordinarily compounded, dispensed or handled, they may only enter a private dwelling with the permission of the occupier and with a warrant issued by a magistrate. There is an exception allowed when an inspector believes that a delay in obtaining a warrant "would defeat the object of the entry, search and seizure".
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South Africa's regulator has other ways to enforce the law. It can detain products at ports of entry, together with the country's Border Management Authority (BMA), it can issue warning letters, it can suspend or cancel a licence to import, export, manufacture or distribute medicines, and it can declare a medicine undesirable and force its removal from the market.
However, unlike Australia's TGA, it has limited powers in relation to advertising and marketing, cannot block a web site, and cannot issue infringement notices (and thus require payment of a fine). It can only approach a court to impose a fine or custodial sentence in the event of a conviction for a listed offence. In Australia, infringement notices are seen as an effective alternative to formal court action. However, if the recipient of an infringement notice fails to pay, further action can be taken.
Regulatory gaps
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Section 18C of the Medicines Act, which first came into effect in 2003 and was extended to cover medical devices in 2017, requires the Minister of Health to make regulations on marketing and provide for Codes of Practice, after consultation with the relevant industries and other stakeholders. No such regulations have been issued.
That is not the only gap in SAHPRA's armamentarium. It urgently needs to be enabled to impose an "adequate and proportional sanction", not only on those entities licensed in terms of section 22C(1)(b), but on individuals and other entities whose actions potentially place the public at risk of harm.
The necessary guardrails can be constructed to ensure that SAHPRA does not have excessive powers, as prosecutor, judge and jury, but enable timely, efficient and effective actions in the public interest.
The 1965 Medicines Act has passed its sell-by date and has been amended to the point of being a ragged jumble of deletions and insertions. This is an opportune moment to reconsider how it currently deals, and how it ideally should deal, with non-compliance.
*Dr 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 columns he is writing for Spotlight.
Disclosure: Dr Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
