The Pharmacy and Poisons Board (PPB) has warned wholesalers dealing in pharmaceutical products against selling drugs to unlicensed pharmacies.
The board has put on notice wholesalers who are supplying pharmaceutical products without proper documentation.
PPB’s Head of Good Distribution Julius Kaluai said the board is now targeting wholesalers who are supplying illegal outlets without identifying the documentation of those purchasing drugs.
“Such wholesalers will be profiled and also prosecuted. We are using our inspectors who are cracking down on the illegal chemists and will be able to get invoices of those supplying them,” he said.
The board has issued a warning to absentee superintendents who leave licensed pharmacies to be run by unqualified personnel, saying culprits will be subjected to disciplinary proceedings if they do not comply.
“Essentially you cannot use other people to commit a crime while you are comfortable somewhere,” he said.
Kaluai said despite the board’s continued wholesale audit, some people were still engaging in the unlawful practice putting the lives of Kenyans at risk.
“If these people will be denied medicines because of lack of licenses or are not registered then the problem we are dealing with will end. We have sampled some wholesalers in the country and we are dealing with them firmly,” he said.
Kaluai was speaking after leading the board on a one-week audit of hospitals and pharmaceutical wholesalers in Nakuru in a bid to enforce strict pharmaceutical regulations and protect public health.
The countrywide initiative, which began with wholesaler audits on October 13, and expanded to Level 4 hospitals on October 20, 2024, aims to ensure adherence to critical compliance standards in the distribution and handling of medicines.
Kaluai emphasised the Board’s commitment to cracking down on unlicensed practices in both hospital pharmacies and wholesale networks.
He said the efforts of the Board have got a boost after the Judiciary, through continuous sensitisation, realised the public health impact of unregistered outlets and increased fines imposed on the culprits to deter them from continuing with the businesses.
“These fines are good because this time we have not heard of any court imposing a fine of less than Sh60,000 per charge and most of them are charging more than Sh100, 000,” he said.
He said most of the quacks would find themselves parting away with more than Sh300, 000 fines when slapped with three charges of unlawful possession of Part One Poison, operating an unregistered outlet, and also doing the work of a pharmacist while not registered as one.
PPB has developed guidelines for good distribution practices, transportation of pharmaceuticals and safe management of pharmaceutical waste.
“The guidelines are available and all health practitioners are advised to familiarise themselves with the provision of the guidelines,” he said.
Kaluai emphasised the need for the public to use the health safety code 21031 displayed in registered pharmacy outlets to verify the legality of the premises they are buying medicines from.
The audits focus on key compliance areas, such as handling cold-chain medicines, adherence to pharmaceutical waste disposal guidelines, and ensuring only qualified personnel manage pharmacies.
Kaluai raised concerns over the presence of unqualified staff and unregistered medicines in hospitals, saying this increases the risks of medication errors, drug misuse, and improper handling of pharmaceuticals, endangering patient safety.
He stressed the importance of registering all pharmaceutical transport vessels with PPB and called on wholesalers to store medicines under conditions that maintain their efficacy.
PPB highlighted challenges related to wholesalers relocating without notifying the Board, making it difficult to accurately map distribution networks and conduct effective audits.
Theft of government-supplied medicines and unauthorised sales to unlicensed outlets were also flagged as serious threats to the integrity of healthcare services.
Kaluai urged private hospitals to enforce compliance by employing only licensed pharmacy staff and aligning pharmaceutical waste disposal with PPB and National Environmental Management Authority (NEMA) guidelines.
PPB said this ongoing initiative is essential to maintaining safe, effective, and high-quality healthcare standards across Kenya.
Kaluai warned against selling medicated creams in cosmetic shops.
He said the medicated creams were supposed to be sold in pharmacies and dispensed by a medical doctor and specifically a dermatologist through a prescription.
Medicated creams are regulated by the Board.
The Board called on the public to stop buying drugs from pharmacies operating without names as outlets chemists without a name are key indicators of illegality.
Kaluai said such outlets may not meet regulatory standards and could pose health risks as they could be selling unregistered medicines.
“The board strongly advises the public to exercise caution and only purchase pharmaceuticals from licensed and reputable sources,” he said.
The audits are targeting key areas to prevent risks such as medication errors, drug misuse and improper pharmaceutical handling.
The audits address unauthorised relocations of wholesalers, theft of government-supplied medicines and unlicensed sales—practices that undermine healthcare integrity.
“This ongoing initiative underscores PPB’s commitment to safe, effective, and high-quality healthcare standards across Kenya,” Kaluai said.
Pharmaceutical audits cover legal certifications, batching process, deviations in product output, history of client complaints and how they responded, corrective actions to previous infractions, and rates of return.
This comes shortly after the PPB launched its first comprehensive plan to monitor the consumption of antimicrobial drugs, including antibiotics and anti-fungals.
This was initiated as a response to the rising trend of drug resistance, which threatens the effectiveness of treatments for various infections.
For their safety and well-being, the public was urged to verify the legitimacy of pharmaceutical establishments and report any suspicious activities to the board.
The operation seeks to audit regulated pharmaceutical entities to ensure compliance with Good Distribution Practices.
Key areas of focus include auditing the distribution of narcotic and psychotropic substances to identify, monitor and establish compliance with proper dispensing practices.
Kaluai said the collaborative effort with the Interior Ministry underscores the board's commitment to curbing unlawful practices in the pharmaceutical sector, ensuring public safety, and upholding regulatory standards.
He said the success of the operation reflects the dedication of the board to maintaining the integrity of the pharmaceutical industry and safeguarding the well-being of citizens.
The board has called on all registered pharmaceutical practitioners to embrace and stay updated with regulatory provisions governing the prescription and dispensing of controlled medicines.
According to Kaluai, they should ensure the availability of records for review whenever requested by authorised officers.
Practitioners are advised to comply with labelling requirements as documented under the Pharmacy and Poisons Act (CAP 244).
