Pharmaceutical regulations in Nigeria

Abstract

Nigeria's pharmaceutical sector is governed by several regulatory bodies, including the Pharmacists Council of Nigeria (PCN), the National Agency for Food and Drug Administration and Control (NAFDAC), the National Institute for Pharmaceutical Research and Development (NIPRD), and the Institute of Chartered Chemists of Nigeria (ICCON). These institutions are responsible for ensuring the safety, quality, and effectiveness of medicines available in the country. This thesis explores the current state of pharmaceutical regulation processes in Nigeria, evaluating the performance of these regulatory bodies and assessing the barriers that hinder effective oversight. A systematic review of relevant literature was conducted using academic databases such as PubMed, Scopus, Google Scholar, African Journals Online, and Research Gateway, along with regulatory websites. Out of 254 initially identified articles, 155 remained after duplicate removal. After screening for relevance and full-text eligibility, 49 studies met the inclusion criteria, following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) process. The findings reveal persistent regulatory challenges such as overlapping legal mandates, poor coordination among agencies, inadequate funding, limited digital infrastructure, corruption, and a shortage of trained personnel. These issues weaken enforcement, reduce supply chain transparency, and increase the circulation of substandard or falsified medicines. For instance, some imported vaccines have entered the supply chain without proper serial tracking, and unregulated herbal products are frequently sold in open markets without safety evaluation. To address these issues, the study recommends practical interventions such as hiring more inspectors and deploying them to rural and border areas where drug smuggling is common. Expanding medicine traceability systems like barcoding and QR code tracking on drug packages can enable real-time monitoring from port entry to pharmacy shelves. Supporting local manufacturers through tax waivers and access to low-interest loans can boost domestic drug production and reduce dependence on imports. The use of mobile apps for reporting adverse drug reactions can also enhance pharmacovigilance. In addition, digitizing regulatory processes with technologies such as block chain for secure data storage and artificial intelligence for risk prediction can improve compliance and enforcement efficiency.