NAFDAC: FG To End Vital Drug Importation, Enforce Regulatory Scheme

The federal government has reaffirmed its intention to implement a regulatory scheme called “5 plus 5” to support the expansion of the pharmaceutical sector, which provides a last five-year renewal to companies that import pharmaceuticals that the country’s pharmaceutical industry can produce.

During the five-year renewal period, the importer must migrate to local manufacturing or partner with local manufacturers. This is an outcome of a study that was done in 2019 that revealed that the top 5 drugs that are imported are also the top five drugs that are manufactured in Nigeria.

The director-general, National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, disclosed this at the webinar lecture organised by The Cable Newspaper to celebrate its tenth anniversary with the theme: ‘’Addressing Costs of Medicines’’.

With this initiative, Adeyeye averred that more than 30 per cent of new companies in Nigeria are results of “5 plus 5” because many importers started building their own companies or partnering with local manufacturers through contract manufacturing. „That is access. That’s the way to make drugs available, accessible,’’ she said.

The NAFDAC boss explained that the Agency also did another policy change called NAFDAC Ceiling 34 wherein drugs under those ceilings cannot be imported. According to her, the ceiling was increased from nine to 34 drugs when she assumed office so that those 34 drugs that are manufactured locally with good installed capacity would not be allowed into the country.

‘’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 to manufacture some APIs. This initiative was aimed at reducing the cost of drugs eventually,“ she stated.

To strengthen the regulation of local manufacturing of APIs, Adeyeye said NAFDAC organised a workshop in October 2023 that attracted 150 participants – regulators, manufacturers, professors from the universities and the future workforce -part four students.

Adeyeye lamented that because of the high cost of medicines some unscrupulous people will start making substandard falsified medicines, warning that NAFDAC is not asleep. ‘’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 manufacturers or importers use the open market as a haven for substandard falsified medicines. We will be using traceability technology to monitor the supply chain,“ she vowed.

She added that NAFDAC is leading in Africa and second in the world using Track and Trace technology. GS1 Technology is driven to make the supply chain visible, adding that NAFDAC’s efforts are all about local content which is also the thrust of President Bola Tinubu administration. „Embracing this will lead to an increase in the nation’s GDP, our unemployment will decrease and Nigeria will be better off for it,“ she added.

The coordinating minister of health and social welfare, Prof Ali Pate, noted that the escalating costs of pharmaceuticals is part of the global phenomenon, expressing regrets that for the past 20 years the nation has been catching up, stressing that the present administration is focused on solving the issue.

‘’We are working hard to do so through the Presidential Initiative to Unlock the Pharmaceutical Value Chain that the President announced in October 2023. But two pockets of issues underlying what we are observing now. Nigerians are hurting. There’s Forex devaluation which is on the supply side. The ability to buy materials, equipment, the infrastructure deficit. Some infrastructure for manufacturing that we have is not at the level that could meet up the demand that we have’’, he said.

The minister noted that financing of healthcare in Nigeria, the affordability has been a long-standing issue for more than 40 years, adding that less than 10 percent of Nigerians have health Insurance or any issuance to speak of which means the cost of our financing healthcare is out of pocket, hence when prices go up the medically related reimbursement for medical care also goes up.

Pate said this has thrown many Nigerians into poverty because if they have ailments like cancer or kidney failure it’s easy if they have a viable insurance platform. He disclosed that the president has asked them to find a solution as government in collaboration with the private sector, adding that both must work closely hand in hand.

He disclosed that the government has continued to engage with the pharmaceutical consultative forum, ably led by Prince Adeluyi, stressing that ‘’we are just finalizing an instrument from the government to address the fiscal policy constraints for the raw materials and manufacturing equipment. That’s an instrument that signals the government intervention that we will do in addition to advancing medical industrialization agenda.’’

The minister also said that massive effort is underway to reform the health insurance landscape, adding that ‘’we believe that if we can expand the national health insurance scheme and have millions of Nigerians covered the ability of the system to pay for those costs of medicines, diagnostics and medicare will not be borne by individuals and households but by a third party.’’

He said that the absence of a third party is the reason people are feeling the pain of the rising cost of medicines, adding that the National Health Insurance Agency (NHIA) and NAFDAC have been developing a medical supply chain initiative which is trying to address that.