State Tightens Noose on Over-the-Counter Blue Pills

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State Tightens Noose on Over-the-Counter Blue Pills
State Tightens Noose on Over-the-Counter Blue Pills

Africa-Press – Kenya. The government has escalated its crackdown on the illegal sale of prescription-only medicines used to treat erectile dysfunction, commonly referred to as “blue pills”, warning pharmacies, distributors and individuals that dispensing the drugs without a valid prescription is unlawful and will attract stiff sanctions.

In a statement issued on Tuesday, Health Cabinet Secretary Aden Duale said the sale or dispensing of prescription-only medicines without a valid prescription violates the law, cautioning that offenders risk regulatory and criminal action.

“Any pharmacy, wholesaler, distributor, or individual found offering or dispensing sildenafil without a prescription is liable to regulatory and legal sanctions, including seizure of products, suspension or revocation of licences and disciplinary or criminal proceedings,” Duale said.

The statement marks a significant escalation from measures announced on Monday by the State Department for Public Health and Professional Standards, which flagged the widespread over-the-counter availability of the drugs as a growing public health concern.

Principal Secretary Mary Muthoni warned that the medicines, which are also used to treat pulmonary arterial hypertension, are strictly prescription-only.

She said “dangerous interactions” when taken alongside heart and blood pressure medicines, or other medications that contain nitrates, increase the risk of life-threatening events such as heart attack and stroke.

Building on those concerns, Duale said the Ministry of Health has intensified oversight to prevent misuse of prescription medicines, including sildenafil, through tighter monitoring of the pharmaceutical supply chain.

He disclosed that the ministry has deployed an online system for declaration of batch/lot numbers for all imported, exported and locally manufactured health products.

He said that from January 1, 2026, batch and lot declaration will be “mandatory and enforceable.”

According to the Cabinet Secretary, the system is intended to strengthen the government’s ability to track the movement and sale of prescription medicines across the country.

He further noted that the ministry has finalised the Track and Authentication Standard for Health Products and Technologies, which, once formalised, will “enhance traceability, accountability and visibility across the pharmaceutical supply chain.”

Enforcement has also been stepped up through inspections targeting wholesalers, distributors and retail pharmacies.

Duale said the ministry is undertaking risk-based and targeted inspections, including systematic verification of prescription records during routine and for-cause inspections.

“As part of strengthening regulatory oversight, the ministry is currently conducting 100 per cent inspections of all licensed wholesalers within the Nairobi Region in preparation for the 2026 licensing cycle,” he added.

Practitioners found to be in breach of the regulations are being referred for disciplinary action.

Duale said non-compliant practitioners are routinely presented before the Board’s Ethics and Disciplinary Committee, where sanctions include suspension or revocation of practising licences.

“To date, over 10 practitioners have been presented before the EDC for disciplinary proceedings,” he said.

The Cabinet Secretary also pointed to institutional reforms aimed at accelerating enforcement, noting that following the appointment of new board members on November 7, the Ethics and Disciplinary Committee is expected to be fully operational from January 2026 to allow for “expeditious handling of pending cases and the referral of additional non-compliant practitioners for appropriate regulatory action.”

Beyond enforcement, the ministry is advancing public education and professional training to curb misuse of prescription-only medicines.

Duale said the government has maintained engagement with key stakeholders and rolled out public awareness initiatives to inform Kenyans of the risks associated with using prescription medicines without proper medical authorisation.

He added that more than 5,500 people have participated in ministry-facilitated continuous medical education programmes, while over 4,000 healthcare providers have been trained through in-person initiatives.

The latest measures reinforce the government’s position that prescription medicines, including drugs used to treat erectile dysfunction, must only be accessed under medical supervision to safeguard public health.

Cases of men dying in short-stay rental apartments and hotel rooms after consuming ED medication to enhance sexual performance have been previously documented by police, pointing to the severity of the situation and the need to regulate the sale of the drugs.

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