In an internal report seen by TheScoop, the National Agency for Food and Drug Administration and Control (NAFDAC) has submitted a number of policy proposals to the Health Minister, Isaac Adewole, for consideration with respect to the ban on codeine.
The policy recommendations followed a meeting convened by NAFDAC with other regulators, professional associations and pharmaceutical industry representatives.
Why It Matters:
Codeine abuse in Nigeria has become a major public health concern and witnessed a lot of activism in the past few months. A BBC documentary forced the government to take actions including a ban on the product and an embargo on import permits for the Active Pharmaceutical Ingredient of the substance.
Critics have said that the ban is not a policy and may only exacerbate the crisis by creating room for illicit trade.
The NAFDAC Director-General, Prof. Moji Adeyeye claimed that over 34 containers containing Tramadol had been illegally imported into the country “within the period of the codeine saga.”
The report was split into two parts:
- The first part outlines policy recommendations of the government and stakeholders while,
- The second contained a briefing on the recall efforts of the product as directed by the Agency.
– Development of a national program on substance abuse with social and behaviour change campaigns. Campaign is to involve traditional rulers, community leaders and parents.
– Review of target populations, indication for use of Codeine and re-scheduling of Codeine containing products as Prescription-Only-Medications in Nigeria.
– Restricted permit for “very few” qualified manufacturing companies
– Another drug (name withheld) to be used as Codeine alternative in Cough Syrup but the “information should not be made known to the public”.
– NAFDAC to establish Narcortics desk offices in six geopolitical zones as part of plans to intensify pharmacovigilance.
– Ban remains in place while administration of the drug should be used for in-patient care only
– Engage with Indian government and others to prevent smuggling of the products to Nigeria
The recall status and one BIG Issue:
- 23 companies have NAFDAC permits to manufacture cough syrups containing codeine.
- According to NAFDAC, over two million bottles of Codeine have been recalled from about 15 of those companies.
- Five of the companies recorded zero recall.
- Government is exploring two options with regards to the recalled products which constitute a major loss to the manufacturers. One: Government buys the stock from Manufacturers and pays within 30 days and Two: Reschedule it as a Prescription-only-medicine (POM) while manufacturers relabel and redistribute the recalled products but with strict supervision and monitoring by the government.
Two things we find curious about the report and don’t necessarily agree with.
– The report claimed that the elites are worst hit by the drugs and substance abuse crisis. Would be interesting to see the figures NAFDAC is relying on.
– The agency lacks access to supply data or IT platform to monitor drug distribution in Nigeria.