Concerns regarding a growing illicit and largely unregulated medicine market in South Africa are increasing among pharmaceutical associations and healthcare organisations across the country.

According to Mossel Bay Advertiser, the concerns were emphasised following the recent seizure of 26 000 painkillers in Great Brak River over a single month.

The tablets, believed to be Stilpane and Salterpyn, are both Schedule 5 medications available strictly on a valid prescription from an authorised prescriber.

Police seized the painkillers in two separate incidents, confiscating just over 6 000 tablets on August 15 and a further 20 000 on September 14. Three suspects were arrested on charges relating to Section 22 of the Medicines and Related Substances Act 101 of 1965 and were subsequently released from custody pending laboratory test results.

Supply-chain regulations and risks

Addressing queries regarding the origin of the medication, Independent Community Pharmacy Association CEO Jackie Maimin noted that while it would be inappropriate to speculate on pending investigations, a quantity of 20 000 tablets is not consistent with normal supply to an individual patient.

Maimin explained that Schedule 5 and Schedule 6 medications must move through a strictly regulated supply chain involving licensed manufacturers, wholesalers, and authorised healthcare facilities.

“Establishing where the tablets recovered in these particular cases originated would require examination of the packaging, batch numbers, and relevant procurement and supply-chain records, and it should not automatically be assumed that they originated from a pharmacy or any particular healthcare facility,” Maimin said.

“We are seeing counterfeit and substandard medicines entering the market, as well as scheduled and prescription-only medicines being offered for sale outside legitimate healthcare channels — including online, through social media, and, in some instances, at informal outlets such as spaza shops and flea markets.”

She added that illicit importation or smuggling of medicines remains another potential source that cannot be excluded without investigation.

Substandard drugs and illegal diversion

Pharmaceutical Society of South Africa President Prof Renier Coetzee explained that substandard medications are legally manufactured and approved but fail to meet required quality standards.

“When a quality problem is identified, the medicine may be recalled from the market. For example, there may be a problem with the amount of active ingredient, the way the medicine was manufactured, or its stability. This is not necessarily intentional,” Coetzee said.

Coetzee noted that acquiring large quantities of painkillers like Stilpane could occur through falsified prescriptions or a diversion of medicines from the legitimate supply chain. Stilpane tablets contain paracetamol, codeine, caffeine, and meprobamate, with both codeine and meprobamate carrying a risk of dependence and misuse.

Health risks and medical council concerns

The South African Medical Association (Sama) warned that Stilpane carries significant potential for dependence and addiction, particularly when used regularly, in higher-than-prescribed doses, or for prolonged periods.

Sama cautioned that an overdose can cause severe sedation, confusion, and breathing difficulties, while the paracetamol component can cause serious liver damage. Large overdoses may result in coma or death. The association stated that dependence is a medical condition that should be treated without stigma.

Sama also emphasised the need for stringent controls to prevent misuse and illegal distribution while ensuring patients who legitimately require pain medication maintain access to treatment.

South African Pharmacy Council registrar Vincent Tlala said the council receives numerous complaints regarding individuals accessing Stilpane without a prescription. However, most complaints lack supporting evidence, and complainants are encouraged to submit documentation so matters can be investigated promptly.

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