Dar es Salaam, Tanzania — Tanzania has officially changed the regulatory classification of ketamine and its salts, moving the medicine from the category of prescription-only medicines (POM) to a controlled drug under the narcotics classification.
The change follows the approval and gazetting of the Tanzania Medicines and Medical Devices (Scheduling of Medicines) Regulations, 2026, Government Notice No. 150 (GN No. 150). The new regulations replace the previous scheduling regulations issued under GN No. 63.
The Tanzania Medicines and Medical Devices Authority (TMDA) announced the change in August 2026, directing healthcare providers and other stakeholders handling ketamine-containing medicinal products to comply with the requirements applicable to narcotic-controlled medicines.
The decision is significant for hospitals, pharmacies, healthcare professionals, importers, distributors and other institutions that have been involved in the procurement, storage, dispensing or use of ketamine in Tanzania.
What has changed for ketamine?
Under the previous classification, ketamine was regulated as a prescription-only medicine. Its use therefore required a prescription, but it was not subject to the same regulatory controls applied to medicines classified under the narcotics category.
Under the new regulations, ketamine-containing medicinal products are now controlled as narcotic drugs. This means that healthcare facilities and other authorised stakeholders must comply with the additional controls that apply to medicines in this category.
The reclassification does not mean that ketamine has been removed from medical practice. Ketamine remains an important medicine with legitimate clinical uses. However, its handling and supply will now be subject to stricter controls intended to strengthen accountability and prevent inappropriate access, diversion and misuse.
For pharmaceutical personnel, the change is therefore more than a change in terminology. It introduces additional responsibilities around procurement, storage, documentation, reporting and supply.
Importation of ketamine to be restricted
One of the major changes concerns the importation of ketamine-containing products.
According to the TMDA notice, importation of ketamine-containing products will be limited to the Medical Stores Department (MSD), with distribution restricted to authorised premises.
This is an important development for pharmaceutical importers and healthcare institutions that previously obtained ketamine through other authorised pharmaceutical supply arrangements.
Going forward, stakeholders involved in the supply chain will need to understand how the new arrangement affects procurement and availability of ketamine-containing medicines.
The restriction also places greater emphasis on maintaining a controlled and traceable supply chain, from procurement through to the point where the medicine is used.
Stock and consumption reporting
Another important requirement introduced by the new classification is reporting of stock and consumption, in line with the requirements applicable to other narcotic drugs.
Healthcare facilities handling ketamine should therefore ensure that their records are accurate and up to date. Stock received, stock issued or consumed and the remaining balance should be properly accounted for in accordance with the applicable requirements.
For pharmacists and other healthcare professionals, this means that good documentation will become even more important.
Accurate records help facilities demonstrate that controlled medicines are being used for legitimate clinical purposes and also make it easier to identify discrepancies, losses or unexplained changes in stock.
The TMDA specifically directed facilities currently holding ketamine-containing products to submit reports on their stock levels to the TMDA headquarters or zone offices before 1 September 2026.
What should healthcare facilities do?
Healthcare facilities currently holding ketamine should not treat the reclassification as a routine administrative change.
Facilities should review their existing ketamine stock and ensure that the quantities held are properly documented. They should also review their procurement, storage, dispensing and record-keeping procedures to ensure that they are consistent with the new requirements.
Pharmacy departments should also communicate the change to relevant staff, particularly those involved in medicine procurement, stores management, dispensing, theatre services, anaesthesia and other clinical areas where ketamine may be used.
Most importantly, facilities should follow further instructions issued by TMDA regarding the handling and use of existing stocks.
TMDA has stated that, after receiving stock-level reports, it will determine the final date for the use of ketamine-containing products in private health facilities or other unauthorised parts of the supply chain.
This means facilities should not assume that existing stocks can continue to be used indefinitely without further regulatory direction.
What does this mean for pharmacists?
For pharmacists and pharmaceutical personnel, the reclassification places greater emphasis on controlled-drug management.
Pharmacists working in hospitals, health centres, pharmacies, pharmaceutical stores and other relevant facilities should familiarise themselves with the new requirements and ensure that ketamine is managed according to the controls applicable to narcotic drugs.
This includes paying attention to:
- Proper documentation of ketamine stock.
- Accurate recording of receipts and issues.
- Monitoring of stock balances.
- Appropriate storage and access controls.
- Required stock and consumption reporting.
- Procurement through authorised channels.
- Distribution only to authorised premises.
- Compliance with TMDA directives during the transition period.
The change also highlights the importance of communication between pharmacy departments and other healthcare professionals who use ketamine.
Doctors, anaesthetists, nurses and other authorised healthcare workers should be aware that the medicine is now subject to a different regulatory framework. Pharmacy departments can play an important role in ensuring that clinical teams understand the practical implications of the change.
Why the reclassification matters
Controlled medicines require a higher level of oversight because their legitimate medical use must be balanced against the risk of diversion and misuse.
Ketamine has established medical applications, including its use in anaesthesia and other clinical settings. At the same time, its controlled status means that regulators need to maintain a clear picture of where the medicine is being imported, stored, supplied and used.
The new regulatory approach is therefore expected to strengthen traceability across the ketamine supply chain.
For Tanzania’s pharmaceutical sector, the change also demonstrates the importance of keeping up with regulatory updates. A medicine’s classification can affect how it is procured, stored, supplied, recorded and reported.
Pharmaceutical professionals should therefore rely on current TMDA regulations and official notices when making decisions concerning controlled medicines.
A reminder to the pharmaceutical sector
The reclassification of ketamine is an important regulatory development that affects more than the procurement department or pharmacy store.
Healthcare facilities, pharmacists, pharmaceutical suppliers and other stakeholders involved in the handling of ketamine should review their current practices and ensure compliance with the Tanzania Medicines and Medical Devices (Scheduling of Medicines) Regulations, 2026 (GN No. 150).
Facilities holding ketamine stocks should also pay attention to TMDA’s transitional instructions, particularly those relating to stock reporting and the eventual deadline for use of existing products.
The TMDA remains the authoritative source for further regulatory instructions concerning the implementation of the new requirements.
For pharmaceutical professionals, the key message is simple: ketamine is no longer regulated merely as a prescription-only medicine. It is now controlled as a narcotic drug, and its handling must comply with the requirements applicable to that classification.
As implementation continues, healthcare institutions and pharmaceutical personnel should remain alert to additional guidance from TMDA to ensure that ketamine remains available for legitimate patient care while being managed within the required regulatory framework.
