The Ministry of Health has announced a major regulatory crackdown on the illegal sale of prescription-only medicines, with a particular focus on sildenafil, commonly known as the “blue pill” used for erectile dysfunction.

In a press statement issued on December 23, 2025, the Ministry warned that pharmacies and individuals dispensing prescription drugs without proper authorisation will face tough sanctions.

“Sale or dispensing of prescription-only medicines without a valid prescription is unlawful. As such, 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,” the statement read.

The ministry said the move is aimed at protecting public health, curbing misuse of medicines, and strengthening regulatory compliance across the pharmaceutical sector, particularly in urban centres where illegal sales have been reported.

Monitoring and inspections

To strengthen oversight and prevent misuse of prescription medicines, the Ministry has rolled out enhanced supply chain monitoring systems. It has deployed an online platform for the declaration of batch and lot numbers for all imported, exported, and locally manufactured health products.

From January 1, 2026, batch and lot declaration will be mandatory and enforceable to improve tracking of prescription medicines, including sildenafil.

The Ministry has also finalised the Track and Authentication Standard for Health Products and Technologies, which has undergone stakeholder consultations and is expected to enhance traceability and accountability once formalised.

On enforcement, the Ministry is conducting risk-based and targeted inspections of wholesalers, distributors, and retail pharmacies, including verification of prescription records. It is currently undertaking 100 percent inspection of all licensed wholesalers within the Nairobi Region ahead of the 2026 licensing cycle.

More than ten practitioners have already been presented before the Board’s Ethics and Disciplinary Committee for disciplinary proceedings, with sanctions including suspension or revocation of practising licences.

Strengthening oversight and public awareness

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 handle pending and new cases.

The Ministry is also finalising the scheduling of medicines, which will be made publicly available to enhance regulatory clarity and compliance.

In addition, the Ministry has authorised the recruitment of additional regulatory staff to strengthen inspection coverage at the retail pharmacy level.

It has also intensified public education and stakeholder engagement to raise awareness on the risks of using prescription-only medicines without medical authorisation. More than 5,000 participants have attended Ministry-facilitated CMEs, while over 4,000 healthcare providers have undergone in-person compliance training.