Kenya Bans Parallel Medicine Imports to Tighten Drug Quality Controls
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| Health CS Aden Duale |
Health Cabinet Secretary Aden Duale announced the decision on Thursday, July 2, saying the government wants to strengthen oversight of medicines entering the country and eliminate products that fail to meet national regulatory standards.
The new policy requires all medicines and health technologies to enter Kenya only through approved import channels. Regulators will use the system to verify product quality, monitor safety standards and trace medicines throughout the supply chain.
Duale said the Ministry of Health introduced the measure after authorities identified widespread abuse of the parallel import system.
“We decided to clean up the market by stopping all parallel imports, which had become rampant and caused significant problems in our country. As we speak, we have stopped the parallel importation of medicines and other health technologies. If you were in that business, it is time to look for another one,” Duale said.
Government Halted Approvals in 2025
The Cabinet Secretary revealed that regulators stopped approving applications for parallel medicine imports on October 1, 2025.
According to Duale, the government has not cleared a single application since then and does not expect to resume approvals under the current policy.
“Since October 1, 2025, not a single parallel import has been approved for entry into the country, and I do not believe any will be approved again. We made a deliberate decision to clean up the market and end parallel imports,” he said.
The government believes the move will reduce the circulation of medicines whose quality, storage conditions and origin authorities cannot adequately verify.
Officials also expect the policy to improve patient safety by ensuring importers source medicines through regulated channels that meet Kenya's pharmaceutical standards.
Study Found Widespread Sale of Unauthorised Medicines
The announcement follows the release of a study that exposed the widespread sale of unauthorised parallel-imported medicines across Nairobi.
Researchers from Mount Kenya University (MKU) conducted the study between September 1, 2023, and October 31, 2024.
The team surveyed 2,348 pharmaceutical outlets spread across Nairobi's 85 wards.
The findings showed that about 90 per cent of the pharmacies stocked at least one unauthorised parallel-imported medicine.
Researchers also carried out an in-depth assessment in Kilimani, Parklands, Kangemi, Korogocho, Njiru and Roysambu.
The study selected the six wards because they represent different socioeconomic settings and lie at varying distances from Nairobi's Central Business District.
Researchers Flagged Multiple Safety Concerns
The researchers identified 22 different parallel-imported medicines during the assessment.
Most of the products targeted chronic illnesses, including diabetes, heart disease, urinary disorders and mental health conditions.
The study found that nearly half of the medicines already appear on Kenya's Essential Medicines List.
Researchers also established that manufacturers already supply lower-cost generic alternatives for many of the products in the local market.
Some medicines had more than ten registered generic versions available in Kenya.
Despite that availability, pharmacies continued stocking parallel-imported alternatives.
The researchers concluded that all 22 medicines failed at least one regulatory requirement.
One of the biggest concerns involved product packaging.
About 90 per cent of the medicines carried labels written entirely in foreign languages, mainly Turkish.
The researchers said patients and healthcare workers could struggle to understand dosage instructions, storage requirements, warnings and possible side effects because of the language barrier.
The study also identified concerns about storage conditions.
Researchers found that 45 per cent of the medicines carried storage instructions designed for cooler European climates instead of Kenya's tropical environment.
They warned that unsuitable storage conditions could affect medicine quality, stability and effectiveness.
In another case, researchers found a diabetes medicine carrying two conflicting storage instructions on the same package.
They said the contradiction raised fresh questions about the product's authenticity and quality assurance.
Policy Marks Shift in Drug Regulation
Kenya introduced parallel importation in 2019 to improve access to medicines and lower treatment costs by allowing importers to source patented medicines from other markets without obtaining consent from patent holders.
The government now says the system created regulatory gaps that exposed patients to medicines whose quality authorities could not consistently verify.
By restricting imports to approved channels, the Ministry of Health hopes to strengthen oversight of pharmaceutical products entering the country.
Officials also expect the new policy to improve traceability throughout the supply chain, making it easier for regulators to identify unsafe medicines and remove them from the market when necessary.
The latest reforms form part of broader government efforts to tighten regulation of Kenya's pharmaceutical sector and ensure patients receive medicines that meet approved standards for quality, safety and effectiveness.
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