The Federal Ministry of Health has directed the National Agency for Food and Drug Administration and Control (NAFDAC) to ban with immediate effect, further issuance of permits for the importation of codeine as active pharmaceutical ingredient for cough preparations.
“It is a public knowledge that easy access to codeine, tramadol and other substances of abuse is promoted by the chaotic drug distribution system, especially in Northern Nigeria”
“The directive became necessary due to the gross abuse of Codeine in the country and in its stead syrups should be replaced with dextromethorphan which is less addictive” said Isaac Adewole, minister of Health on Tuesday in Abuja.
The minister also directed the Pharmaceutical Council of Nigeria, (PCN) and National Agency for Food and Drug Administration and Control (NAFDAC) to supervise the recall for labelling and audit trailing of all codeine containing cough syrups in the country, while he has also banned sales of Codeine containing cough syrup without prescription across the country.
According to him, NAFDAC had an emergency meeting with the Pharmaceutical Manufacturers Group (PMGMAN) to inform them that there is an embargo on all new applications for registration of codeine- containing cough syrups as well as applications for renewal has been abolished.
The Pharmacists Council of Nigeria (PCN) has been directed to continue enforcement activities on Pharmacies, Patent and Proprietary Medicine Vendor’s Shops and outlets throughout the country. According to him, NAFDAC was also directed to fully carry out its functions among others: to regulate and control the manufacturing, distribution and sale of drugs, including inspection at points of entry of drugs, drug products and food for compliance with the new directive.
Adewole further said that the FMOH shall ensure collaboration among regulatory agencies namely, NAFDAC, PCN, National Drug Law Enforcement Agency (NDLEA), Nursing and Midwifery Council of Nigeria (NMCN), for effective implementation of extant Acts, regulations, policies and guidelines on codeine control and usage.
“Furthermore, these agencies shall work together to increase pharmacovigilance around codeine, tramadol and other related substances of abuse,” he stated.
The PCN has been directed to continue enforcement activities on pharmacies, patent and proprietary medicine vendors’ shops and outlets throughout the country.
