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.
The Minister of Health, Professor Isaac Adewole made this known in his office in Abuja on Tuesday, May 1, 2018.
He said that the directive became necessary due to the gross abuse Codeine usage has been subjected to in the country.
In its stead, the Minister said Codeine containing cough syrups should be replaced with dextromethorphan which is less addictive.
He also directed the Pharmaceutical Council of Nigeria, (PCN) and 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.
He noted that the National Agency for Food and Drug administration and Control 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.
The National Agency for Food and Drug Administration and Control [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.
The Minister stated 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,’ Adewole stated.
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