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.
Already, NAFDAC has developed IEC materials that will be used in an already planned national campaign against drug abuse, an awareness programme that includes Young Pharmacists Group of the Pharmaceutical Society of Nigeria. This will soon be flagged off in Kano and Lagos.
As a way of discouraging youths to shun the drugs, the Federal Government through Federal Ministry of Health shall partner with National Orientation Agency (NOA), Nigeria Football Federation (NFF), Football celebrities, members of the Actors Guild of Nigeria, Performing Musicians of Nigeria and other celebrities to drive national campaign against drug abuse.
‘The FMOH shall ensure that Drug treatment intervention for victims of substances abuse shall be undertaken across the spectrum of health care delivery system in the country,” Adewole stated.
He stated that Civil Society Organizations shall be strengthened to deliver effective sensitization, prevention, treatment and rehabilitation services.
Recalled that in view of the serious public health concerns drugs abuse poses to Nigerians , a working group which comprised of experts from various Ministries, Agencies of Government (including regulatory agencies), Development Partners and Associations was constituted in January and tagged Codeine Control and other Related Matters Working Group (CCRWG).
The CCRWG was formally inaugurated on January 23, 2018 with clear Terms of Reference of developing key recommendations and strategies to address the menace of codeine, tramadol and other related substances in Nigeria.
The CCRWG submitted its interim report on April 12, 2018 and recommended short-, medium- and long-term measures for implementation in a memorandum submitted to the Minister, today, 1st of May 2018.
WHAT IS CODEINE?

It is a substance used in treating pain and cough. It is imported into Nigeria. Syrups containing it are said to be produced by at least 20 companies in the country.
The BBC had reported “codeine addiction epidemic” in some parts of the country and how young Nigerians are using the substance to get high.

In the report, the broadcast service had also indicted Emzor Pharmaceuticals of its alleged role in the sale of the substance — leading to the company announcing a suspension of its distribution.

EMZOR BANS DISTRIBUTION OF COUGH SYRUPS CONTAINING CODEINE

After the BBC reported that its executive was discovered to have been involved in the sale of syrups containing codeine in the ‘black market’, Emzor Pharmaceuticals announced a suspension on the distribution of such syrups.

In a statement issued on Tuesday, the company said the distribution had been suspended pending the outcome of a “full and thorough internal investigation” on the issue.

It, however, denied that it is involved in its direct sales to members of the public.

BELOW IS THE FULL STATEMENT FROM EMZOR:

Emzor Pharmaceuticals is a responsible and ethical company with over 120 lines including Emzolyn with Codeine under licence from NAFDAC. Emzor is treating the findings of the BBC documentary with the upmost seriousness and has launched a full and through investigation. Emzor adheres fully to the documentation guidelines for the handling, production, storing and distribution of products containing codeine.

Our staff are trained on the controlled status of codeine and codeine products and supply guidelines. Emzor is not involved in the direct sales to individual members of the public. Emzor does not sanction the supply of Emzolyn with Codeine in any way that breaches the Dangerous Drugs Act or NAFDAC guidelines. Emzor’s daily production is below 0.5% of the reported estimated daily amounts of codeine reportedly consumed in Kano and Jigawa States. The Sales Rep depicted in the BBC video was initially placed on suspension and has now been summarily dismissed following an investigation. Any representations made by the Sales Rep are in breach of company policy and ethics and were undertaken independently by him.

The distribution of Emzolyn with Codeine has been suspended pending the results of a full and thorough internal investigation. We hope the findings of the documentary will shed further light on the extent and impact of the illicit trade and consumption of codeine. We hope that full stakeholder engagement will result in impactful action against the abuse, smuggling and faking of drugs on the continent. Thank you.