Pregabalin Is Now Nationally Controlled in Nigeria: What You Need to Know Beyond the Headlines

The announcement that pregabalin has been placed under national control in Nigeria has circulated widely, but the regulatory change raises an important question: what exactly does “nationally controlled” mean, and does it mean pregabalin is internationally scheduled?

A 14 September 2026 directive from the National Agency for Food and Drug Administration and Control (NAFDAC) states that all pregabalin-containing formulations are now subject to the existing control measures applicable to nationally controlled medicines in Nigeria.

The directive makes obtaining the relevant permit to import pregabalin-containing formulations and securing clearance mandatory with immediate effect.

NAFDAC said the decision was prompted by concerns about the potential for dependence, misuse and abuse associated with pregabalin, alongside recent seizures of significant quantities of unapproved pregabalin brands in the country.

Pregabalin is controlled nationally –but not internationally scheduled

This is perhaps the most important distinction in the new development.

A classification document for Nigeria separates substances controlled internationally under the 1961 Single Convention on Narcotic Drugs, 1971 Convention on Psychotropic Substances and 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances from medicines that Nigeria controls nationally.

Pregabalin does not appear in the international schedules listed in the document. It appears separately on Nigeria's “List of Drugs Nationally Controlled by Nigeria.”

In other words, Nigeria's decision to control pregabalin nationally does not mean that pregabalin has been placed under an international UN drug-control schedule.

The World Health Organization's Expert Committee on Drug Dependence (ECDD) considered pregabalin as part of its 2018 review and recommended that it not be scheduled under international control at that time. Instead, pregabalin was to remain under surveillance for potential public-health harms.

The WHO explains that countries can apply their own national controls to substances that are not under international control.

So, what has actually changed in Nigeria?

The immediate change is regulatory.

According to NAFDAC's directive, pregabalin-containing formulations are now subject to the control measures applicable to nationally controlled medicines, including mandatory permits for importation and clearance.

The measure therefore has direct implications for businesses involved in the importation and legitimate supply of pregabalin-containing medicines.

It does not, based on the directive, amount to a ban on pregabalin.

Pregabalin remains a medicine with established clinical uses, including the treatment of neuropathic pain and epilepsy. WHO's international review considered both its therapeutic use and concerns surrounding misuse and dependence.

Why has NAFDAC introduced the control?

NAFDAC points to two factors in its directive.

The first is the growing body of evidence concerning the potential for dependence, misuse and abuse associated with pregabalin.

The second is the recent seizure of significant quantities of unapproved pregabalin brands within Nigeria.

These are the reasons stated by the Agency for the regulatory decision and should be distinguished from independently established evidence about the scale of pregabalin misuse in Nigeria.

Internationally, concerns about pregabalin misuse have also been documented. WHO currently identifies pregabalin as a medicine for which information about misuse and abuse has been brought to its attention and maintains it under surveillance.

Another change is coming in 2027

The NAFDAC directive also establishes a future requirement for pregabalin formulations.

From 1 January 2027, pregabalin formulations will be required to carry specified traceability features on their secondary packaging:

• Global Trade Item Number (GTIN)

• Global Location Number (GLN)

• Serialisation

The requirement is separate from the immediate import and clearance controls and gives affected stakeholders a defined deadline to prepare for the new traceability requirements.

For manufacturers, importers and other pharmaceutical supply-chain stakeholders, this means that compliance with the new framework will extend beyond obtaining import permits.

What does this mean for pharmacies?

For pharmacies and other regulated medicine outlets, the immediate significance is the need to pay closer attention to the regulatory status and sourcing of pregabalin-containing products.

The NAFDAC directive specifically concerns nationally controlled medicines and introduces requirements around importation and clearance. Pharmacists and other stakeholders should therefore ensure that products are obtained through legitimate, authorised supply channels and that applicable regulatory documentation and requirements are observed.

The new traceability requirements will add another layer of supply-chain identification from January 2027.

What does it mean for patients?

The announcement should not be interpreted as meaning that pregabalin has been banned in Nigeria.

The regulatory change concerns control of the medicine, particularly its importation and supply within the regulated medicines system.

Patients who use pregabalin should therefore not stop or alter their treatment simply because of the announcement. Any decision to start, stop or change pregabalin treatment should be made with the appropriate healthcare professional.

The greater regulatory emphasis also reinforces the importance of obtaining medicines from legitimate sources rather than relying on unapproved products.

The bigger picture

Nigeria's decision illustrates an important feature of medicines regulation: national drug-control systems can be broader than the international scheduling system.

The international system operates through the UN drug-control conventions, with the WHO Expert Committee on Drug Dependence providing scientific and medical assessments and the United Nations Commission on Narcotic Drugs making international scheduling decisions.

Individual countries can nevertheless impose additional controls within their own jurisdictions. WHO explicitly recognises that countries may classify medicines differently on their national lists and may add medicines that are not included in the international conventions.

That is the position now reflected in Nigeria's national list: pregabalin is nationally controlled in Nigeria, while it is not currently listed in the international schedules.

What happens next?

The immediate priority for affected pharmaceutical stakeholders will be compliance with the new import and clearance requirements.

The next major regulatory milestone is 1 January 2027, when the GTIN, GLN and serialisation requirements for pregabalin formulations are scheduled to take effect.

Further implementation guidance from NAFDAC would be important, particularly on issues such as transitional arrangements for existing stock and the practical application of the new traceability requirements.

For now, the key point goes beyond the headline: Nigeria has introduced national controls for pregabalin, but this should not be confused with international scheduling or a ban on the medicine.