#InsideTheBox is a column by Dr Andy Grey, a pharmaceutical sciences professional on the College of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Coverage and Proof Based mostly Follow. (Picture: Provided)Remark & Evaluation
thirty first March 2026 | Andy Grey
The sale of unlawful medicines is a major risk to public security. In his newest Inside The Field column, Dr Andy Grey asks whether or not the South African Well being Merchandise Regulatory Authority has the mandatory instruments at hand to offer safety on this space.
The UK’s medicines regulator, the Medicines and Healthcare merchandise Regulatory Authority (MHRA), introduced in June 2025 that it seized tens of millions of doses of unlawful medicines and eliminated tons of of unlawful on-line listings, as a part of Interpol’s Operation Pangea. “Unlawful” medicines right here refers to these not authorised on the market in the UK or being offered outdoors of regulated distribution channels, comparable to licensed pharmacies. The MHRA’s Felony Enforcement Unit (CEU) labored with “legislation enforcement companions” to safe arrests associated to unlawful medicines. The Australian medicines regulator, the Therapeutic Items Administration (TGA), additionally took half in the identical Interpol motion.
Nonetheless, the TGA has one other methodology of coping with non-compliance with the relevant Australian legislation, within the type of infringement notices imposing fines on people or firms. In January 2026, the TGA issued infringement notices, totalling Australian $43 560, on six people for “alleged importation and illegal promoting of therapeutic items”. For instance, a registered well being practitioner was fined for allegedly importing unregistered beauty injectables. The TGA was of the opinion that these unregistered merchandise would “pose critical security dangers resulting from unknown composition or contamination”.
In South Africa, the South African Well being Merchandise Regulatory Authority (SAHPRA) is looking for maturity stage 3 standing for medicines regulation. Whether or not SAHPRA achieves this standing will rely, partially, on how successfully it is ready to take care of non-compliance. The World Well being Group makes use of the WHO World Benchmarking Instrument (GBT) to evaluate the capability of a nationwide regulator. At numerous factors within the GBT, there may be point out of the necessity for native laws to “specify the relevant fines, fees, penalties, or sanctions within the occasion of non-compliance”. The GBT requires readability on “ample and proportional sanctions, penalties and prosecution of violations of the relevant laws”.
The legislation in South Africa
Part 29 of the Medicines and Associated Substances Act, 1965, features a record of offences. For instance, it’s an offence to contravene or fail to adjust to the provisions of part 14(1). That part prohibits the sale of an unregistered medication that’s topic to registration, until with the precise approval of the Authority (by way of part 21). Any one that makes any false or deceptive assertion in reference to any medication, whether or not in an software for registration or within the strategy of sale, can also be responsible of an offence. Part 30 then states that any one that is convicted of an offence referred to in part 29 shall be liable to “a advantageous, or to imprisonment for a interval not exceeding 10 years”. Sub-section 4 states: “However something on the contrary in any legislation contained, a Justice of the Peace’s court docket shall be competent to impose any penalty supplied for on this part.”
Nonetheless, SAHPRA is unable to impose a advantageous by itself and has to depend on the Nationwide Prosecuting Authority to convey a cost earlier than an acceptable court docket. Custodial sentences for transgressions of the Medicines Act are uncommon, in distinction to the various prosecutions introduced by way of the Medicine and Drug Trafficking Act, 1992. Fines are additionally not often imposed.
A broad remit
SAHPRA’s Inspectorate, Licencing and Compliance Unit has a broad remit in relation to pharmaceutical crime. As an example, it’s tasked with the monitoring and management of border posts for imports and exports of well being merchandise, the identification of substandard and falsified medicines, and guaranteeing that unregistered well being merchandise are faraway from the general public. The Unit additionally has to observe and act in opposition to unlawful shops promoting well being merchandise and illicit manufacturing amenities.
The SAHPRA inspectorate operates in accordance with tightly regulated powers. These powers have been severely trimmed by the Constitutional Courtroom of their 1998 ruling within the Mistry case. Specifically, the court docket objected to the ability given to an inspector of the then Medicines Management Council to “enter upon any premises, place, automobile, vessel or plane at or in which there’s or is on cheap grounds suspected to be any medication or Scheduled substance”, with out a warrant. Justice Albie Sachs held that this meant that “inspectors are given the ability to enter any house the place aspirins, ointments or analgesics occur to be, and as soon as there, could examine not solely medication cupboards or bedside drawers, but in addition recordsdata which could comprise an individual’s final will and testomony, personal letters and enterprise papers.” Because of this, the court docket discovered the related part to be unconstitutional and due to this fact invalid.
Subsequent amendments to the laws have altered part 28 of the Medicines Act. Whereas SAHPRA inspectors could, at an inexpensive time, enter a spot that’s licensed with SAHPRA or a spot the place medication is ordinarily compounded, allotted or dealt with, they might solely enter a personal dwelling with the permission of the occupier and with a warrant issued by a Justice of the Peace. There may be an exception allowed when an inspector believes {that a} delay in acquiring a warrant “would defeat the thing of the entry, search and seizure”.
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South Africa’s regulator has different methods to implement the legislation. It may possibly detain merchandise at ports of entry, along with the nation’s Border Administration Authority (BMA), it may well challenge warning letters, it may well droop or cancel a licence to import, export, manufacture or distribute medicines, and it may well declare a medication undesirable and pressure its removing from the market.
Nonetheless, not like Australia’s TGA, it has restricted powers in relation to promoting and advertising and marketing, can not block a website, and can’t challenge infringement notices (and thus require cost of a advantageous). It may possibly solely method a court docket to impose a advantageous or custodial sentence within the occasion of a conviction for a listed offence. In Australia, infringement notices are seen as an efficient different to formal court docket motion. Nonetheless, if the recipient of an infringement discover fails to pay, additional motion will be taken.
Regulatory gaps
Part 18C of the Medicines Act, which first got here into impact in 2003 and was prolonged to cowl medical gadgets in 2017, requires the Minister of Well being to make laws on advertising and marketing and supply for Codes of Follow, after session with the related industries and different stakeholders. No such laws have been issued.
That isn’t the one hole in SAHPRA’s armamentarium. It urgently must be enabled to impose an “ample and proportional sanction”, not solely on these entities licensed by way of part 22C(1)(b), however on people and different entities whose actions doubtlessly place the general public vulnerable to hurt.
The required guardrails will be constructed to make sure that SAHPRA doesn’t have extreme powers, as prosecutor, decide and jury, however allow well timed, environment friendly and efficient actions within the public curiosity.
The 1965 Medicines Act has handed its sell-by date and has been amended to the purpose of being a ragged jumble of deletions and insertions. That is an opportune second to rethink the way it at present offers, and the way it ideally ought to deal, with non-compliance.
*Dr Grey is a Senior Lecturer on the College of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Coverage and Proof Based mostly Follow. That is a part of a collection of columns he’s writing for Highlight.
Disclosure: Dr Grey serves on three technical advisory committees on the South African Well being Merchandise Regulatory Authority.
Notice: Highlight goals to deepen public understanding of essential well being points by publishing a wide range of views on its opinion pages. The views expressed on this article are usually not essentially shared by the Highlight editors.
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