Health

Pharmaceutical industry: ‘5+5’ policy, a transformer

Photo caption: Third from Left, Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, next to her is the President of LCCI, Engr. Leye Kupoluyi and members of the team of investors from Cameroon at the end of the Conference in Lagos.

 

*As NAFDAC implements executive order 2024

 

By Charles Okonji

In furtherance of its efforts in achieving achieving the renewed hope agenda of the President Tinubu’s led administration, the Director General of the National Agency for Food and Drug Administration and Control NAFDAC, Prof Mojisola Adeyeye, has stated that the Agency’s ‘5 Plus 5’ policy and Ceiling List initiatives has improved local production of medicines and medical devices.

Prof. Adeyeye who dropped this hint during the just concluded Lagos Chamber of Commerce and Industry (LCCI) organised ‘Invest in Nigeria Conference and Expo 4.0’, pointed out that the policy has led to an increase in the number of pharmaceutical manufacturing companies in the country from 174 to 190.

She urged foreign investors from over 43 countries at the event to leverage on the transformation of the food and drug regulatory framework in the country to establish their presence in Nigeria.

The NAFDAC DG emphasized that the 5+5 Policy is a regulatory initiative by NAFDAC, designed in 2019 to phase out the importation of some medicines selected through scientific survey and critical analysis.

According to her, the selected products, which are those for which local manufacturers have the capacity to produce, are prohibited from entering Nigeria and can only be manufactured locally.

She said that stakeholders are required to set up facility locally or collaborate with  existing suitably qualified local manufacturers.

The Ceiling List, an additional regulatory directive to facilitate local manufacturing, she said, increased the number of certain products that were restricted from being imported into Nigeria to 36 from nine in 2020.

The DG further elucidated that the policies have jointly facilitated a notable increase in facility layouts submissions for both Pharmaceutical and Medical Devices Companies.

“The Executive Order of President Bola Ahmed Tinubu, GCFR, that provided zero tariffs, excise duties, and Value-Added Tax (VAT) on imported machinery, equipment, and raw materials for local healthcare manufacturing has added a boost to the pharmaceutical industry.

“As at June 2026, the DG a total of 176 pharmaceutical companies underwent layout reviews (Existing and new companies) and approval by the Agency. (Existing companies – 70 and new companies – 106)

“This trend indicated a shift from importation to local production, reflecting growing industry confidence and investment. Specifically, importation of drug products in these two categories decreased by 70%.

“As a result of these initiatives, the ratio of imports: locally manufactured pharmaceutical products has shifted – from 70:30 (2019) to 50:50 (2025).

“The policy initiative has led to an expansion of contract manufacturing partnerships. More companies are actively seeking partnerships with GMP-compliant local manufacturers. The number of companies doing contract manufacturing jumped from 10 in 2019 to 87 in 2026, so this approach reduces reliance on international supply chains and supports the development of domestic production capacity.” She averred.

The rise in contract manufacturing reflects a strategic move toward sustainable and scalable local operations,’ she said, adding that existing facilities are undergoing retrofitting and upgrades to meet international current Good Manufacturing Practice (cGMP) standards.

To qualify as a contract manufacturer, she said that companies must meet stringent requirements and have idle capacity to manufacture for contract givers.

The DG assured that NAFDAC would continue to provide regulatory support to strengthen the local manufacturing sector- through handholding and CAPA (Corrective Action and Preventive Action) clinics.

She noted that 37 existing manufacturers are under construction upgrading, while 28 of the existing manufacturers have completed construction and are operational.

According to her; “There has been a marked increase in foreign investment, particularly in the medical devices sector. International investors are entering joint ventures with Nigerian firms to establish local manufacturing facilities, which further boosts industrial growth. There has also been an increase in technology transfer of formulations for which there is local capacity.

“The number of new pharmaceutical and medical device manufacturers is steadily increasing with 16 new pharmaceutical manufacturers and six new medical devices & In-vitro diagnostics (IVDs) manufacturers.

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

She outlined a breakdown of the ‘overall impact of the 5+5/ ceiling list on local manufacturing as follows: 28 newly developed and retrofitted companies and 16 new facilities, making a total of 44, and resulting in a 25% increase in local manufacturing.

“As part of stimulating local manufacturing of the items, NAFDAC is implementing Another strategy that the Agency is embarking on in the food and cosmetics sectors is the Global Listing Re-evaluation. The goal is to critically identify products that can be manufactured locally and encourage local manufacturing of such products.

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

“The implementation of local manufacturing policies has attracted huge investments into the economy. Stakeholders are therefore engaged to continue to collaborate and cooperate with NAFDAC in the implementation of policies and regulatory directives on local manufacturing.

“The increase in local manufacturing is in tandem with the Executive Order of the Federal Government. We should embrace it,” she stressed.

 

 

 

 

 

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