Nigeria’s journey toward producing own drugs, medical consumables

President Bola Tinubu’s administration will soon begin to reflect positively on the cost of essential medical commodities, Prof. Mojisola Adeyeye, the Director-General, National Agency for Food and Drug Administration Control (NAFDAC) and Prof. Ali Pate, the Minister of Health and Social Welfare, assured during a recent function in Lagos.

The assurance followed current high cost of medications, which left many in fears that if the trend continues, many Nigerians may not be able to cope.

Stakeholders in the health sector like the Nigeria Medical Association (NMA) blame the rise in cost of medical products to the exit of pharmaceutical giants from the country, largely because of insecurity and challenging business environment.

The exit of the companies has led to drug shortages, geometric increase in prices and job losses, raising serious concerns about access to essential medicines by millions of Nigerians.

Therefore, in bringing succour to sick citizens, government is making efforts to tackle the challenge to solve accessibility and affordability of medicines and other medical supplies Nigerians required for good health.

The NAFDAC boss said government has identified rejuvenation of local pharmaceutical industry as panacea for high cost of medicines in the country.

According to her, the devaluation of the Naira also accounted for the high cost of production locally as the high exchange rate made procurement of raw materials and equipment imported for production high.

She added that the difficulty associated with procurement of dollar, cost of imported drugs also hit the roof.

Adeyeye said two multinational pharmaceutical companies left the country, which caused an increase in the cost of drugs they produce to go up.

To encourage local pharmaceutical industry to grow, she said NAFDAC started the “5 plus 5” regulatory scheme where a company importing drugs that the local pharmaceutical industry is able to produce will get a five-year licence renewal.

According to her, the importer must migrate to local manufacturing or partner local manufacturer during the five-year renewal period.

“This is the outcome of a study done in 2019 which reveals that the top five drugs imported are also the top five drugs manufactured in Nigeria,” she said.

She disclosed that more than 30 per cent of new pharmaceutical companies currently in Nigeria emanate as a results of the “5 plus 5” initiative.

Adeyeye noted that with such idea, many importers started building their own companies or partnering local manufacturers through contract “and that’s the way to make drugs available, accessible.”

The NAFDAC boss explained that the agency also implemented another policy change called NAFDAC Ceiling 34, where drugs under those ceiling cannot be imported.

According to her, the ceiling increased from nine to 34 drugs when she assumed office, so that those 34 drugs manufactured locally with good installed capacity will not be allowed into the country.

Adeyeye, who expressed concern that “Nigeria imports virtually everything except water,” added

that “the raw materials for Active Pharmaceutical Ingredients (APIs) and the non-active called Excipients are all imported.

“I, therefore, told industry operators that we need to start making some APIs locally and that resulted to EMZOR’s almost complete facility in Shagamu.

“The company will be producing four anti-malaria APIs – sulfadoxime, Pyrimethamine, Artemether and Lumefantrine.

“Fidson Consortium is also planning to manufacture some APIs, aimed at reducing the cost of drugs eventually.

“But we cannot start manufacturing locally without strengthening regulatory bodies. In preparation for the manufacturing, the intellectual capacity has to be strengthened’’, she said.

Adeyeye also said that NAFDAC introduced traceability technology to monitor the supply chain of drugs and other medical devices as part of regulation from the agency.

She added that some of the manufacturers or importers use the open market window as haven to import Substandard Falsified (SF) medicines.

She also said that NAFDAC is leading in Africa and second in the world, using Track and Trace technology — GS1 technology-driven to make the supply chain visible.

She said NAFDAC’s efforts are all about local content, which is also the thrust of President Bola Tinubu’s administration.

“Embracing this will lead to increase in the nation’s GDP, our unemployment will decrease and Nigeria will be better off for it,’’ she stressed.

The Minister of Health and Social Welfare, Prof Ali Pate, noted that the escalating costs of pharmaceuticals are part of the global phenomenon.

He said that the present administration is focused on solving the issue, explaining that “we are working hard to do so through the Presidential Initiative to Unlock the Pharmaceutical Value Chain that the President announced in October 2023.”

He said that there are two pockets of issues which are underlying the government efforts, adding that Nigerians are hurting the Forex devaluation which is on the supply side and the ability to buy materials, equipment, and the infrastructure deficit.

“Some infrastructure for manufacturing that we have are not at the level that can meet up the demand that we have,” the minister noted, stressing that healthcare financing and affordability have been long-standing issues.

Pate disclosed that the president had asked that a permanent solution be worked out and government had started work in collaboration with the private sector, saying that both entities must work closely.

He further disclosed that government has continued to engage pharmaceutical consultative forum “and we are just finalising an instrument to address the fiscal policy constraints for the raw materials and manufacturing equipment.

“That’s an instrument that signals government’s intervention to advance medical industrialisation agenda.”

He noted that massive efforts are also underway to reform the health insurance landscape.

On his part, Fidelis Ayebae, the Founder and Chief Executive Officer of a private health facility, highlighted the importance of the pharmaceutical sector in healthcare and the socioeconomic development of Nigeria.

According to him, the sector has the potential to ensure access to good medicines, improved health and wellbeing, job creation, knowledge sharing, skilled workforce capacity building.

He added that “it also has potential access to huge foreign exchange earnings and significant contributions to Nigeria’s industrial growth and development.

“This sector has been associated with some of the longest recorded value chain catalytic initiatives.

“Evidence suggests that one job created in pharma can catalyse up to 10 jobs in ancillary sectors. We therefore commend this administration for the due recognition accorded the sector.

“This administration has also prioritised collaborative activities to manufacture vaccines locally and to produce our own Active Pharmaceutical Ingredients (APIs). These and many more under the leadership of President Tinubu.

“Since the brilliant initiative of the Presidential initiative to unlock the value chain was announced, we leveraged our massive international network, and have been working night and day to align with government’s vision for health access and socioeconomic empowerment.

“We are now poised to make big announcement in vaccine manufacturing and local production of Active Pharmaceutical Ingredients (APIs),” Ayebae added.