South Africa’s medicines regulator is under mounting pressure from pharmaceutical manufacturers. This comes after it signalled it may phase out oral phenylephrine in over-the-counter (OTC) cold and flu medicines. The South African Health Products Regulatory Authority (SAHPRA) says the concern is simple: the ingredient may not work as a nasal decongestant when taken by mouth. Phenylephrine still appears in long-standing multi-ingredient brands sold widely without prescription.
Sahpra’s CEO, Boitumelo Semete-Makokotlela, has framed the issue as an ethics and public value question. If the programme fails to show efficacy, the public pays for what is effectively a placebo. The regulator’s focus is on oral products, not phenylephrine nasal sprays or eye drops.
Why Oral Phenylephrine Phase-Out is on the Table
Developments heavily influenced the debate in the United States. In November 2024, the US Food and Drug Administration (FDA) proposed removing oral phenylephrine as an active ingredient for temporary relief of nasal congestion in OTC monograph products. This followed an agency review concluding it is not effective at recommended doses. The FDA’s proposal is not yet final. However, it has sharpened scrutiny globally.
One scientific issue raised in the wider discussion is bioavailability. If only a very small amount of oral phenylephrine reaches the bloodstream, the clinical effect on congestion may be limited.
Industry Argues Combination Products Need Separate Evidence
South Africa’s umbrella body for drug manufacturer associations, the Pharmaceutical Task Group (PTG), is opposing a phase-out. Its central argument is that the evidence assessed internationally often relates to single-ingredient phenylephrine products.
At the same time, many South African cold and flu remedies combine phenylephrine with paracetamol, antihistamines, caffeine, and other ingredients. PTG suggests that combinations could plausibly perform differently due to interactions and cites claims that paracetamol may increase phenylephrine bioavailability.
Major manufacturers have echoed the caution. Adcock Ingram, for example, has indicated it does not support a blanket or immediate withdrawal of phenylephrine-containing fixed-dose combinations. It says it is engaging with Sahpra.
Pharmacies Back Evidence, but Want a Managed Transition
Pharmacy groups are signalling conditional support for evidence-led regulation, paired with practical transition planning. The Independent Community Pharmacy Association (ICPA) has backed scientific intervention but urged a conservative approach. This would give the industry time to produce studies for multi-ingredient formulations. The Pharmaceutical Society of South Africa (PSSA) has stressed the need for clear communication to pharmacists and the public. Furthermore, it supports a gradual phase-out to allow stock to run down if withdrawals occur.
What Happens Next for Patients and the Market
SAHPRA has scheduled a stakeholder engagement for 24 April 2026 to discuss implications, timelines, and potential further studies. Official SAHPRA communications in 2026 indicate ongoing requests for submissions from holders of registrations for orally administered phenylephrine products.
A key access concern is what replaces phenylephrine for people who should avoid pseudoephedrine. Pseudoephedrine is commonly cautioned or contraindicated in patients with hypertension. Industry groups argue that restricting products could narrow options. This could also raise costs and increase pressure on primary care, including avoidable consultations.
For healthcare businesses, the immediate watchpoints are regulatory timelines, reformulation plans, pharmacy messaging, and shifts in demand across the OTC respiratory category. The oral phenylephrine phase-out question is now less about one ingredient. Rather, it is more about how evidence standards are applied to legacy OTC medicines.
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