By Muhammad Amaan
The National Agency for Food and Drug Administration and Control (NAFDAC), has with immediate effect classified all Pregabalin formulations as nationally controlled medicines in Nigeria.
In a directive signed by Pharm. (Mrs.) Rametu Momodu, Director of Narcotics and Controlled Substances on behalf of the Director-General of NAFDAC, said the decision follows growing evidence of dependence, misuse and abuse linked to the drug, as well as recent seizures of significant quantities of unapproved Pregabalin brands across the country.
With the new classification, all Pregabalin-containing products will be subject to the same control measures applied to other nationally controlled medicines.
It means import permit is now mandatory before any Pregabalin product can be brought into Nigeria. And permit to clear is also required before the products can be released from ports
NAFDAC added that from 1st January 2027, all Pregabalin formulations must carry traceability features on the secondary package. Manufacturers and importers will be required to include GTIN, GLN and serialization codes to enable tracking and prevent diversion.
According to the agency, Pregabalin has increasingly been linked to abuse due to its potential for dependence. The recent interception of large volumes of unregistered brands further pushed regulators to act.
“The Agency counts on the cooperation of all stakeholders in ensuring strict compliance with this directive which is aimed at strengthening regulatory control, preventing diversion and misuse of substances, and safeguarding public health,” the statement said.
Pregabalin is commonly prescribed for nerve pain, epilepsy and anxiety disorders, but it has also been flagged globally for misuse when not properly regulated.
Stakeholders in the pharmaceutical supply chain have been urged to comply immediately to avoid sanctions.
