Public Health Principal Secretary Mary Muthoni has announced new regulatory measures to tighten control over the sale of Viagra following an exposé that raised concerns over its abuse.
In a statement on Sunday, December 21, Muthoni explained that sildenafil is not an over-the-counter drug and is legally restricted to prescription use.
"The 'blue pill' commonly refers to sildenafil, which is strictly a prescription-only medicine and not an over-the-counter product. It is primarily used to treat two conditions: (1) erectile dysfunction (ED) and (2) pulmonary arterial hypertension (PAH)," she said.
Muthoni further cautioned that using sildenafil without medical supervision can be extremely dangerous, especially for individuals with underlying heart conditions or those taking other medications that may interact negatively with the drug.
"When taken with other medicines, especially nitrates or certain blood pressure and heart medicines, it can cause dangerous interactions and increase the risk of life-threatening events such as heart attack and stroke; patients should consult a doctor or pharmacist before use," she added.
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Muthoni also outlined concrete steps the ministry has already taken to curb illegal sales and improve accountability across the pharmaceutical supply chain, emphasizing enforcement, monitoring, and public awareness as key pillars of the strategy.
"What the Ministry is doing (regulatory actions): implemented a monitoring system requiring wholesalers to document and report sales of prescription medicines to retailers; conducting audits and inspections of pharmacies by reviewing prescription records for controlled dispensing; and educating consumers on the risks and consequences of using prescription-only medicines without a valid prescription," she further said.
This comes days after the Pharmacy and Poisons Board (PPB) issued a public notice warning manufacturers, importers, distributors, wholesalers, retailers and supermarkets against the sale and distribution of unregistered, falsified and counterfeit health products in Kenya.
In the notice dated Tuesday, December 9, the regulator also cautioned supermarkets, cosmetic shops, household goods stores, online sellers and other general retail outlets against stocking or selling prescription-only medicines, saying such practices violate the law and will attract regulatory action.
PPB warned that the importation, possession, distribution, sale or use of unregistered, falsified, counterfeit or recalled health products is illegal within the Republic of Kenya and will lead to serious consequences for those involved.
According to the regulator, individuals and entities found handling such products risk prosecution and criminal liability, including action against superintendent pharmacists or pharmaceutical technologists, persons acting under their direction, managers or persons in charge of premises, as well as directors and owners of the establishments.
The board further said enforcement measures may include suspension or revocation of operating licences and the closure of premises found to be in violation of the law.
On the sale of medicines in retail outlets, PPB reiterated that supermarkets, cosmetic shops, household goods stores, online sellers and other general retailers are not authorised to stock, sell or supply prescription-only medicines.
The regulator warned that any outlet found contravening this requirement will be subject to regulatory sanctions, including prosecution of owners, managers and directors, and advised businesses unsure of which health products they may lawfully sell to seek guidance directly from the Board.
The board also encouraged members of the public to remain vigilant and report any suspected illegal medicines or adverse drug reactions, urging them to act even where they are not fully certain.
“You need not be certain, just be suspicious. Report any suspected unregistered, falsified, counterfeit medicine, or adverse drug reaction to the Board," the notice read.
PPB said reports can be submitted through its online portal, via the *271# USSD code, through the mPvERS mobile application on Android and iOS, or by contacting the Board through its official email addresses and telephone line.
