The Ministry of Health has announced a crackdown on the illegal distribution of prescription-only medicines, underlining that selling or dispensing drugs such as sildenafil without a valid prescription is a punishable offence.
Those found in breach face regulatory and legal consequences, including confiscation of medicines, suspension or revocation of licences, and disciplinary or criminal proceedings.
Cabinet Secretary Aden Duale, in a notice on Tuesday stressed the importance of compliance, saying, “Sale or dispensing of prescription-only medicines without a valid prescription is unlawful.” He noted that the ministry has put in place a series of measures to prevent misuse and ensure public safety.
To strengthen oversight, the ministry has introduced an online system for declaring batch and lot numbers for all imported, exported, and locally manufactured health products.
This requirement, which takes effect from 1st January 2026, is expected to improve monitoring of the movement and sale of prescription drugs.
In addition, the Track and Authentication Standard for health products has been finalized and is awaiting formal adoption after stakeholder consultations, a move that will improve accountability and traceability across the pharmaceutical supply chain.
Inspections remain a key enforcement tool. The ministry is conducting comprehensive checks on all licensed wholesalers in Nairobi, while routine inspections of pharmacies and distributors continue nationwide.
Duale noted, “Practitioners found to be non-compliant are routinely referred to the Board's Ethics and Disciplinary Committee for regulatory action.” Over ten practitioners have already been brought before the committee, and the newly appointed Board, operational from January 2026, is expected to expedite pending and future cases.
The ministry is finalizing scheduling of medicines, which will guide practitioners on regulatory compliance and enforcement procedures. In addition, recruitment of extra regulatory staff is ongoing, aimed at widening inspection coverage and strengthening enforcement at retail pharmacies.
Public education and stakeholder engagement remain a priority. Campaigns to inform the public about the risks of using prescription drugs without medical oversight are ongoing.
More than 5,500 healthcare professionals have participated in ministry-led continuing education programmes, and over 4,000 others have received in-person training on patient safety, rational medicine use, and compliance with medicine scheduling regulations.
