Nigeria’s pharmaceutical manufacturing sector is undergoing a systemic evolution towards self-sufficiency, improving access to good quality and affordable medicines, strengthening drug security, and driving economic growth among other benefits.
Historically, the nation has grappled with a 70% dependency on imported medicines, leaving the healthcare system vulnerable to global supply chain disruptions and the influx of substandard or falsified drugs. In response to this challenge, the Agency instituted the 5+5 Policy to institutionalise, promote and encourage local manufacturing and safeguard national drug security.
The 5+5 Policy is a regulatory directive instituted in 2019 to phase out imports of some selected drug products based on the outcome of a scientific survey and analysis. The policy recommends setting up of local manufacturing facility or contract manufacturing of the affected products with a chosen suitable manufacturer.
The transparent and diligent implementation of 5+5 policy by NAFDAC, has attracted the confidence of stakeholders leading to huge, unprecedented investments in pharmaceutical manufacturing sector. Since its inception in 2019, the policy has catalysed a tremendous shift in the local pharmaceutical manufacturing industrial landscape.
Some impact of 5+5 Policy include:
- Surge in Manufacturing Infrastructure: As of March 2026, NAFDAC had approved 108 new facility layout reviews. Currently, 20 new facilities have completed construction and 88 are undergoing construction nationwide reflecting the significant impact of the policy.
- Strategic Partnerships: There is a marked rise in contract manufacturing. Also, foreign investors and multinational firms are increasingly entering joint ventures with local manufacturers, fostering technology transfer and reducing the risks associated with international logistics. Contract manufacturing is also creating increase in upgrades or retrofitting of existing facilities to meet international Good Manufacturing Practice (cGMP) standards and ensure full utilisation of the installed capacity.
- Global Competitiveness: Some locally manufactured medical products have attained WHO-Prequalification including Paediatric Zinc Sulphate tablets Sulphadoxine/Pyrimethamine tablets manufactured by Swiss Pharma Limited and 0.5ml auto disabled vaccine needle and syringe manufactured by Afrimedical Manufacturing Company. Some other local manufacturers are at different stages of obtaining the same certification. These achievements have been obtained using NAFDAC’s Handholding mechanism through targeted and more frequent inspections and testing. With this quality status, ‘Made in Nigeria’ products are now qualified for procurement by donor agencies and international trade.
- Transition from importation to local manufacturing: implementation of the policy has led to significant reduction in the volume of importation of the affected products such that over 70% of products under 5+5 policy are presently being manufactured locally.
- Facility layout applications: As of March 2026, out of 191 applications received, 97% (n=185) have received regulatory approvals. Of the 185 approved applications, 42% (n=77) are existing local manufacturers while 58% (n=108) are totally new manufacturers. A total of 53 (29%) facilities of 185 approved layouts have completed construction of their plants (i.e., 11% (n=20) new facilities and 18% (n=33) existing manufacturers have completed the erection and retrofitting of their plants.
The goal and focus of 5+5 policy are to transition from 70% imported to a target of 70% locally manufactured medicines. There has been progress of decreased importation of medicines that fall under 5+5 and Ceiling 36 from 70% to about 50%. The success of this journey relies on the continued collaboration between NAFDAC, industry stakeholders, and the government to maintain a stable, world-class manufacturing ecosystem.
