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 labeling 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 at 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.
The cough syrup was legal, but it was against the law to sell it to people without a doctor’s prescription or those who did not have a pharmaceutical license.
The Nigerian Senate estimates that as many as three million bottles of codeine syrup are drunk every single day in just two states, Kano and Jigawa.
The BBC’s undercover team caught one executive for Emzor Pharmaceuticalsboasting he could sell “one million cartons” in a week on the black market.
But Emzor told the BBC its representative only had access to a very limited amount of its brand of syrup, Emzolyn with codeine, and could not sell large quantities illegally.
Emzor released a statement on Facebook emphasizing its commitment to the proper “handling, production, storing and distribution of products containing codeine”.
It has suspended all distribution pending a “full and thorough investigation” and has fired the employee involved.
“We hope the findings of the documentary will shed further light on the extent and impact of the illicit trade and consumption of codeine,” the statement said. “We hope that full stakeholder engagement will result in impactful action against the abuse, smuggling and faking of drugs on the continent.”