Kenya Approves New Diabetes Drug for Local Distribution After KEBS Certification

The Pharmacy and Poisons Board (PPB) has approved the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide for local distribution in Kenya, following certification by the Kenya Bureau of Standards (KEBS) and a successful review of clinical trial data. The approval, gazetted on 1 July 2026, marks Kenya as the first country in East Africa to formally approve the drug for routine clinical use, giving prescribers access to a therapy that has transformed diabetes and obesity management globally since its commercial launch.

"This is a significant addition to Kenya's therapeutic armamentarium against a disease that is growing at an alarming rate," said PPB Director-General Dr Jacinta Ondati. "Semaglutide has demonstrated efficacy in glycaemic control, weight reduction, and cardiovascular risk reduction that is unmatched by any previous oral or injectable diabetes agent."

Kenya's Diabetes Crisis

The approval comes as Kenya confronts a rapidly escalating type 2 diabetes epidemic. The International Diabetes Federation estimates that 3.1 million Kenyans currently live with diabetes, a figure that has more than doubled since 2010. The IDF projects that Kenya's diabetic population could reach 4.7 million by 2035 if lifestyle and dietary trends continue on their current trajectory. Urban adults aged 35 to 64 are the fastest-growing patient cohort, reflecting a dietary transition characterised by increased consumption of refined carbohydrates, sugary beverages, and ultra-processed foods, combined with sedentary working patterns.

The disease imposes enormous economic costs. A 2025 analysis by the African Population and Health Research Centre estimated that diabetes-related healthcare expenditure — including hospitalisation for complications such as diabetic ketoacidosis, foot ulcers, and renal failure — costs Kenya approximately Ksh 89 billion annually in direct healthcare costs and lost productivity. Fewer than 40 per cent of Kenyans with diabetes are currently well-controlled on existing medications, meaning that large numbers are progressing toward expensive complications.

Endocrinologists have argued for years that access to newer diabetes medications is constrained in Kenya by delayed regulatory approval, import duties on pharmaceuticals, and the absence of SHA reimbursement for specialist diabetes care. "Our patients have been reading about semaglutide in medical journals for four years while being unable to access it," said Dr David Githinji, President of the Endocrine Society of Kenya. "This approval removes one significant barrier."

Access, Cost, and SHA Coverage

Semaglutide will initially be distributed in Kenya by three licensed pharmaceutical importers — Cosmos Limited, Elys Chemical Industries, and Lab and Allied Limited — at a recommended retail price of between Ksh 6,500 and Ksh 8,200 per monthly dose, depending on formulation. The injectable form (Ozempic) will be available first, with the oral form (Rybelsus) expected to receive a separate import licence by October 2026.

The SHA Benefit Package Committee has initiated a health technology assessment to determine whether semaglutide should be included in the SHA reimbursement list, a process that typically takes six to twelve months. Until inclusion is confirmed, patients will need to pay out of pocket, placing the drug beyond the reach of most low-income Kenyans. Diabetes advocacy groups have urged the committee to accelerate the assessment, citing evidence that preventing diabetes complications through better glucose control would save the SHA fund significantly more than the cost of medication reimbursement.

The Thika generic drug manufacturing plant is not yet licensed to produce biological medicines of the complexity required for GLP-1 agonists, but the Ministry of Health's pharmaceutical industrial policy includes provisions for negotiating technology transfer agreements with major biologic manufacturers after 2028. In the interim, the PPB has stated it will fast-track approval for any WHO-prequalified biosimilar version of semaglutide that becomes available, which analysts expect could reduce the price by 60 to 70 per cent. For the 3.1 million Kenyans managing diabetes — many of them relying on first-generation medications that have changed little since the 1990s — the arrival of semaglutide, whatever its initial cost barriers, represents a meaningful expansion of what Kenyan medicine can offer.