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Prof. Mojisola Adeyeye, Director General, National Agency for Food and Drug Administration and Control (NAFDAC), has reiterated her (and the agency’s) commitment to mitigating the prevailing high cost of medicines in Nigeria.

Speaking at a webinar organized by the Cable Newspaper with the theme ‘’Addressing Costs of Medicines’’, Prof. Mojisola asserted that the best long-term strategy to push down the high costs of medicines in the country is through enhancing local production.

She doubled down on this point, emphasizing that locally manufactured health products will be more accessible and affordable in comparison to foreign-sourced alternatives.

However, for this to happen, the economy has to improve.

The naira, for example, has been on free fall over the past few months.

Compared to the dollar, the Nigerian currency dropped 40% in value from 899/USD at the end of 2023 to 1,516/USD on February 13, 2024. And this has had a significant effect on the cost of medicines in the country.

The Director General stated that this currency devaluation, coupled with the exit of drug powerhouses such as GSK from the country, has made medicines inaccessible to Nigerians.

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So, what is NAFDAC doing to promote local production?

5 plus 5 regulatory scheme

Through the leadership of Prof. Adeyeye, NAFDAC started a program whereby companies that had been importing medicines – which the country has the capacity to manufacture locally – would only be granted a final five-year renewal on these medicines and thereafter compelled to produce the same locally.

This could be achieved by either through setting up plants in the country or partnering with existing local manufacturers.

The NAFDAC boss stated that the 5-plus-5 regulatory program has already started yielding fruit. According to her, more than 30% of new companies in Nigeria have been born as a direct result of this scheme, which is primed to have a great impact on accessibility to life-saving medicines.

 

NAFDAC ceiling 34

The agency has come up with a policy prohibiting the importation of 34 medicines that the country has the capacity to manufacture. The list includes essential drugs such as diazepam, ampicillin, and amlodipine that Nigeria has shown the ability to produce.

Promoting manufacture of active pharmaceutical ingredients

Prof. Adeyeye has emphasized the importance of manufacturing both active pharmaceutical ingredients as well as excipients.

‘’Our manufacturers import everything except water’’, she said, adding that the raw materials – Active Pharmaceutical Ingredients (APIs) and the non-active called Excipients are all imported.

‘’I told the industry operators that we need to start making some APIs locally and that has resulted in EMZOR almost completing their facilities in Shagamu. They are going to be making four anti-malaria APIs – sulfadoxime, Pyrimethamine, Artemether and Lumefantrine. The Fidson consortium is also planning manufacturing some APIs.  The DG said the initiative was aimed at reducing the cost of drugs eventually.

‘’But we cannot start manufacturing locally without strengthening the regulatory because we have never regulated local manufacturing of APIs.’’, she said.

High cost of medicines creating an avenue for substandard products

Prof. Adeyeye has acknowledged how inaccessibility to safe, quality, efficacious, and affordable medicines could be a breeding ground for substandard and falsified (SF) medicines. And how the authority will not rest in its laurels while unscrupulous businessmen thrive.

“Our work is 24/7 in terms of regulation and control of SF medicines. We do unannounced inspections of local manufacturers. Since, February 16 and 17 this year we went after the Open Drugs marketers because some of the unscrupulous manufactures or importers use the open market as haven for substandard falsified medicines.”

“We will be using Traceability technology to monitor the supply chain. NAFDAC is leading in Africa and second in the world using Track and Trace technology,” she added.

Will these initiatives be enough to boost local manufacturing of health products in Nigeria?

Time will tell.

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