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NAFDAC’s 5+5 policy reshapes pharma industry

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By Desire Uzochukwu

Nigeria’s pharmaceutical manufacturing capacity is expanding, with the National Agency for Food and Drug Administration and Control, NAFDAC, reporting a 25 per cent increase in local manufacturing following the implementation of its 5+5 policy and Ceiling List initiative.

The regulatory measures have also reduced the importation of affected medicines by 70 per cent and helped shift Nigeria’s pharmaceutical supply mix from a 70:30 import-to-local production ratio in 2019 to 50:50 in 2025.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, disclosed this at the Lagos Chamber of Commerce and Industry, LCCI, invest in Nigeria Conference and Expo 4.0, where she urged domestic and foreign investors to take advantage of the changing regulatory environment and incentives for local healthcare manufacturing.

According to Adeyeye, the number of pharmaceutical manufacturing companies in Nigeria has risen from 174 to 190, while 176 pharmaceutical companies had undergone layout review and approval by NAFDAC as of June 2026.

Of the 176 companies, she said 70 were existing manufacturers while 106 were new companies.

Adeyeye said the 5+5 policy, introduced in 2019, was designed to gradually phase out the importation of selected medicines that Nigerian manufacturers have the capacity to produce.

She explained that companies seeking to manufacture products affected by the policy are expected to establish production facilities locally or partner with suitably qualified Nigerian manufacturers through contract manufacturing.

“Specifically, importation of drug products in these two categories decreased by 70 per cent,” she said.

The Ceiling List has also expanded the number of products restricted from importation from nine in 2020 to 36, further encouraging manufacturers and investors to develop domestic production capacity.

The policy shift has also triggered a significant increase in contract manufacturing, with the number of companies involved rising from 10 in 2019 to 87 in 2026.

“The rise in contract manufacturing reflects a strategic move toward sustainable and scalable local operations,” Adeyeye said.

She noted that the model would enable companies without manufacturing facilities to utilise available capacity in qualified local plants while reducing dependence on international pharmaceutical supply chains.

According to her, existing manufacturers are also investing in the upgrading and retrofitting of their facilities to meet current Good Manufacturing Practice, cGMP, standards.

Adeyeye disclosed that 37 existing manufacturers were undergoing construction and upgrades, while 28 had completed construction and commenced operations.

She said the pharmaceutical sector was also benefiting from the Presidential Executive Order 2024, which provides zero tariffs, excise duties and Value-Added Tax, VAT, on imported machinery, equipment and raw materials for local healthcare manufacturing.

The NAFDAC chief urged investors from the more than 43 countries represented at the LCCI conference to leverage the incentives and Nigeria’s evolving regulatory framework to establish manufacturing operations in the country.

She said foreign investment was particularly increasing in the medical devices sector, with international investors entering joint ventures with Nigerian companies to establish local production facilities.

Adeyeye also reported increased technology transfer, including the transfer of formulations for products that can be manufactured locally.

She disclosed that 16 new pharmaceutical manufacturers and six new medical devices and in-vitro diagnostics, IVDs, manufacturers had emerged.

“These emerging facilities are aligning with regulatory standards, including the installation of HVAC systems and other critical infrastructure,” she said.

Overall, Adeyeye said the 5+5 and Ceiling List initiatives had contributed to the development and retrofitting of 28 companies, alongside 16 new facilities, bringing the total to 44 facilities and representing a 25 per cent increase in local manufacturing.

She said the development was critical to strengthening Nigeria’s medicine and healthcare product security.

“NAFDAC is committed to promoting local manufacturing in Nigeria to strengthen national food and drug security through market-friendly and innovation-driven regulatory directives,” she said.

Beyond medicines and medical devices, Adeyeye said NAFDAC was extending its local manufacturing strategy to the food and cosmetics sectors through a Global Listing Re-evaluation initiative.

The initiative is aimed at identifying products that can be produced locally and encouraging manufacturers to invest in their domestic production.

She assured manufacturers that NAFDAC would continue to support the industry through regulatory handholding and Corrective Action and Preventive Action, CAPA, clinics to help companies address compliance gaps.

Adeyeye urged continued collaboration among regulators, manufacturers and investors, stressing that the emerging shift from import dependence to domestic production presented an opportunity to build a more resilient healthcare manufacturing industry in Nigeria.

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