Authority Widens Narcotics Controls in Bid to Shut Down Diversion Networks

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Federal drug authorities have rewritten the rules on how narcotic and psychotropic medicines move through the health system, tightening control from the moment a shipment enters the country to the point a tablet is prescribed, dispensed, stored or destroyed.

A directive issued in December 2025 by the Ethiopian Food & Drug Authority (EFDA) and public for nearly two months replaced a regime built around serial-numbered prescription pads with a framework that extends accountability along the entire supply chain and sharply raises the penalties for non-compliance. Under the revised rules, the Authority's supervision explicitly covers manufacturing, import and export, and the storage and destruction of controlled medicines.

Enforcement powers are expanded, with inspectors entering facilities to audit stock levels, suspend licenses, confiscate medicines, and take cases to court. Trafficking, illegal possession and misuse of controlled medicines are treated as criminal offences. Medicines needed for legitimate treatment remain available through a special licensing system backed by prescriptions and documentation specifying dosage and quantity.

According to the Authority's officials, the tougher position is driven by continued misuse and diversion of opioids and benzodiazepines. A national list for psychotropic substances and narcotic drugs, released in 2024, already limits which facilities may dispense them, restricting narcotic drugs more tightly than psychotropic medicines. Even so, higher-grade narcotics are reported on the black market and at social gatherings.

The directive introduces structural changes for pharmacies, requiring those that handle controlled medicines to separate storage, registry systems, and accountability mechanisms from ordinary pharmaceutical services. Facilities are required to obtain specific competency certification from EFDA and comply with stricter authorisation and monitoring requirements. However, several pharmacy operators told Fortune that while paper-prescription controls have been in place, they were unaware of the expanded responsibilities introduced by the new directive.

There are reports that milder narcotics are described as relatively easy to obtain illegally, while stronger opioids remain harder to find but still circulate through contraband and unregistered supplies.

According to Tolessa Gemeda, an executive at the Authority's Narcotic & Psychotropic Medicine Control Desk, the directive is designed to close the gaps that allow legally imported medicines to slip into illicit markets.

"It aims to strengthen accountability and reduce diversion," he told Fortune.

People familiar with the sector blame weaknesses within formal health institutions, including cases in which interns have been able to prescribe controlled medicines with limited oversight. Regulators and industry sources also point to procurement-stage manipulation, alleging that some licensed importers and healthcare institutions misrepresent quantities and perform minor surgical procedures requiring narcotics.

However, the system’s most fragile point may be the supply.

According to Kerod Niku, who has worked as an anaesthetist at the Black Lion Hospital, facilities with the highest demand for controlled medicines face constraints and often depend on low-cost alternatives.

"If large public hospitals struggle to secure adequate supplies," he said, "smaller providers face even greater challenges."

Clinicians and pharmacy experts warn that a heavier compliance burden, including additional documentation, separate storage, and tighter authorisation, could slow access to essential medicines, particularly for pain management and palliative (pacifying) care.

The human consequences of this tension emerge in personal accounts.

A 25-year-old tour guide began using Tramadol in 2021 while at university to cope with anxiety. A packet once cost 25 to 30 Br and today sells for 50 to 70 Br. He recalled opioids entering the country through Moyale and the border with Somalia without prescriptions and being distributed through informal networks that use Telegram channels. He obserevd women appear more susceptible to dependency, often taking Tramadol during their monthlies and combining it with soft drinks to ease cramps without medical guidance.

The directive attempts to address such personal risks and the system-level leakages that feed them. It decentralises enforcement by assigning regional regulatory bodies responsibility for monitoring manufacturing, importation and usage in their jurisdictions, with reports consolidated at the national level and submitted to the International Narcotics Control Board.

EFDA retains the authority to audit facilities, suspend licenses, confiscate controlled medicines and take offenders to court.

For cross-border movement, the Authority allows visitors to bring controlled medicines into the country if they present prescriptions, medical history and prior approval specifying the medicine type, dosage and duration. The directive also introduces a personal-use provision allowing patients to bring up to a three-month supply of prescribed narcotic or psychotropic medicines without an EFDA permit, with medicines verified at entry points rather than automatically confiscated.

It also allows special approvals to import unregistered and emergency medicines, including cancer treatments, ICU sedatives and rare drugs, based on Ministry of Health requests and supporting quality and origin certificates.

Whether these safeguards will curb abuse without cutting off access remains an open question.

Dawit Wondimagegn (MD), an associate professor of psychiatry at Addis Abeba University’s School of Medicine, believes the directive’s impact will depend on execution. He warned that stricter documentation could unintentionally reduce access to opioid pain relief, particularly for palliative care patients.

“Management gaps and involuntary pharmaceutical assistance contribute to weaknesses in drug control implementation,” he said. "The real test will be the capacity of regional regulators to enforce the rules without disrupting supply."

Melese Alemnew, a senior pharmacy practice specialist, commends the  flexibility to cases such as clinical trials. He echoed concerns that tighter prescription controls could delay access to critical pain medications. He nonetheless supported the guideline limiting prescriptions to one controlled drug per form.

"It reduces the risk that forged prescriptions will be used to obtain multiple medicines," he told Fortune.

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