Pharmaceutical manufacturers resist Sahpra proposal to remove phenylephrine from cold remedies

The regulator cited US findings questioning the ingredient's effectiveness in oral decongestants.

The South African Health Products Regulatory Authority faced resistance from pharmaceutical manufacturers after proposing to phase out phenylephrine in oral cold and flu remedies over concerns about the ingredient's effectiveness.¹²

Phenylephrine is present in more than two dozen cold and flu products registered by Sahpra, including Adcock Ingram's Corenza-C, Aspen Pharmacare's Flutex, and iNova Pharmaceuticals' Demazin.¹² All are over-the-counter medications that do not require prescriptions.¹²

Sahpra requested evidence from local companies that phenylephrine-containing oral decongestants work after an advisory committee to the United States Food and Drug Administration unanimously concluded the products are ineffective.¹² The FDA review examined oral phenylephrine as a decongestant but did not consider phenylephrine nasal sprays or eye drops.¹²

"Our mandate is safety, quality and efficacy. We cannot have a product on the market that may not be effective because, in essence, you're giving the public a placebo," Sahpra chief executive Boitumelo Semete-Makokotlela said.¹² She added that asking the public to pay for a placebo was not ethical.¹²

The medicines have been available for decades and were never subjected to the rigorous evaluation required for products launched after the implementation of the Medicines and Related Substances Act in 1966.¹²