FG To Stop Importation Of Vital Drugs, Enforce Regulatory Scheme

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As a way of showing support for the expansion of the pharmaceutical sector, the federal government of Nigeria has once again affirmed its intention to implement the “5 plus 5“ regulatory scheme.

The “5 plus 5” regulatory scheme grants a last five-year renewal to a company that imports medications that the country’s pharmaceutical industry can actually produce.

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

This was disclosed by Prof. Mojisola Adeyeye, the director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), during a webinar lecture organised by The Cable Newspaper and themed: ‘’Addressing Costs of Medicines’’.

Adeyeye maintained that more than 30 per cent of new companies in Nigeria are the 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 and accessible,’’ she said.

Adeyeye also explained that the Agency effected another policy change called “NAFDAC Ceiling 34” wherein drugs under those ceilings cannot be imported into the country. She said the ceiling was increased from 9 to 34 drugs when she came into office so that those 34 drugs that are manufactured locally with good installed capacity will not be allowed to enter into the country.

‘’Our manufacturers import everything except water. 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.

Adeyeye said NAFDAC organised a workshop in October 2023, solely aimed at strengthening the regulation of local manufacturing of APIs. The workshop attracted 150 participants, regulators, manufacturers, professors from the universities and the future workforce -part four students.

The NAFDAC boss lamented that because of the high cost of medicines some unscrupulous people are now producing substandard falsified medicines, and warned 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, adding that NAFDAC is leading in Africa and second in the world when it comes to using Track and Trace technology.

GS1 Technology is driven for the purpose of making the supply chain visible, and 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.

In his remark, Prof Ali Pate, the coordinating minister of health and social welfare, noted that the escalating costs of pharmaceuticals is part of the global phenomenon, expressed regrets that for the past 20 years the nation has been catching up, and stressed that this 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.

Pate disclosed that the government has continued to engage with the pharmaceutical consultative forum, led by Prince Adeluyi. ‘’We are just finalising 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” he said.

He further disclosed that massive effort is underway to reform the health insurance landscape. He stated, ‘’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 noted that the absence of a third party is the reason people are feeling the pain of the rising cost of medicines, and that the National Health Insurance Agency (NHIA) and NAFDAC have been working tirelessly to develop a medical supply chain initiative that will address it.

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