There are growing concerns about medicines that appear to have lost their efficacy, the circulation of substandard and falsified products, compromised active pharmaceutical ingredients (APIs), and inappropriate use of medicines among patients. Experts warn that these challenges could weaken the pharmaceutical value chain, undermine treatment outcomes, fuel antimicrobial resistance, and erode public confidence in locally manufactured pharmaceutical products, IJEOMA NWANOSIKE reports.

Medicines are meant to restore health, control diseases and save lives, but their effectiveness can be undermined by misuse, poor storage and supply from unreliable sources.

The growing circulation of substandard and falsified medicines, coupled with inappropriate use and poor adherence to prescribed treatment, is raising concerns about patient safety and treatment outcomes.

Experts warn that unless stronger measures are taken to safeguard medicine quality and promote responsible use, the consequences could be costly for patients and the healthcare system.

The concerns are particularly pronounced in the treatment of malaria, with some patients reporting that previously effective and expensive brands no longer appear to produce the same results. However, questions about whether medicines have lost their efficacy point to a more complex problem involving the quality and quantity of active ingredients, how medicines are manufactured and handled, where they are obtained and how they are ultimately used.

The World Health Organisation (WHO) says substandard medicines may contain the wrong amount of the correct active ingredient, while falsified products may contain no active ingredient or an entirely different one. According to the international agency, such products can fail to treat disease and, in the case of anti-infectives, contribute to antimicrobial resistance.

Active pharmaceutical ingredients (APIs) are central to a drug’s therapeutic effect. They are the biologically active components in medicines that produce the intended therapeutic effects and are therefore critical to a drug’s efficacy. Concerns over compromised APIs are consequently not merely theoretical.

In 2025, the National Agency for Food and Drug Administration and Control (NAFDAC) issued several alerts involving medicines that failed laboratory analysis because of low API content.

In October 2025, the agency notified the public about the mop-up of batches of confirmed substandard Annmox (Batch 360M) and Jawamox (Batch 4231M and 4290M) suspensions after the products failed laboratory analysis due to low API content.

Similarly, in December 2025, NAFDAC ordered a nationwide mop-up of products manufactured by EuroPharm Laboratories after laboratory tests showed grossly low API levels in Linmoxyn suspension and Linmoxyn 500mg capsules.

More recently, the agency notified healthcare providers, importers, distributors, retailers, Patent and Proprietary Medicine Vendors (PPMVs) and the general public of the seizure of a suspected substandard and falsified antimalarial medicine, Artemether/Lumefantrine 80mg/480mg, purportedly manufactured by Bandaram Pharma Packleh Ltd (BPPL), India.

The product was intercepted by NAFDAC officials during routine post-market surveillance activities at the Coordinated Wholesale Centre (CWC) in Kano State. NAFDAC’s position, however, is that approved medicines remain effective, while misuse and substandard products can undermine treatment outcomes.

For Nigeria, where medicines move through a vast network of manufacturers, importers, wholesalers, pharmacies, patent and proprietary medicine vendors and informal markets, the question of efficacy therefore extends beyond the individual tablet, capsule or injection.

It touches the entire pharmaceutical value chain, from the sourcing and quality of APIs, formulation and manufacturing to regulation, transportation, storage, distribution and the point at which the medicine finally reaches the patient.

The issue becomes even more concerning when medicines are exposed to conditions that can compromise their potency before they reach the patient.

Experts said the efficacy, stability, quality and potency of medicines depend on appropriate storage conditions, warning that poor storage could accelerate the deterioration of APIs and shorten the effective shelf life of medicines.

Against this backdrop, the question is not simply why a drug that once worked appears to have stopped working. It is whether the medicine reaching the patient still contains the right quality and quantity of its active ingredient, has remained stable throughout the distribution chain, and is being used in the manner required to achieve the expected therapeutic outcome.

The concerns are reflected in the experiences of pharmacists who interact directly with patients. A consultant clinical pharmacist, Dr Kingsley Amibor, told The Guardian that patients frequently raise concerns about the genuineness, effectiveness and affordability of medicines.

According to him, some patients complain that medicines they previously used no longer appear to work as expected, while others are worried about the scarcity of familiar brands. He attributed some of the shortages to pharmaceutical companies exiting the Nigerian market.

Amibor said the situation could create opportunities for counterfeiters to clone or fake products whose original manufacturers had left the country, with weaknesses in the drug distribution system allowing such products to reach unsuspecting consumers.

According to him, some complaints about medicines not working could also be linked to how the medicines are administered. He explained that pharmacists counsel patients on the appropriate use of medicines and that failure to follow such guidance could contribute to treatment failure.

Addressing complaints about reduced efficacy of antimalarial medicines, particularly previously effective and expensive brands, Amibor identified inappropriate use, poor adherence to recommended dosing schedules and the circulation of falsified or adulterated medicines as possible factors.

He said many Nigerians obtain antimalarial medicines outside registered pharmacies and therefore may not receive professional counselling on their appropriate use.

He added that incorrect timing of doses could contribute to treatment failure, stressing the importance of following the recommended dosing schedule for artemisinin-based combination therapies.

Amibor further linked concerns about reduced efficacy to weaknesses in the drug distribution system, which he said could facilitate the falsification or adulteration of APIs.

He said counterfeiters could reduce the quality or quantity of an API or replace it with a different one, stressing that any reduction, replacement or other compromise of the active ingredient could have serious consequences for a medicine’s effectiveness.

Amibor also called for greater support for local pharmaceutical industries to produce APIs, including through collaboration with the Nigerian Institute of Pharmaceutical Research and Development (NIPRD), as part of efforts to strengthen local supply.

While the quality of the API is central to efficacy, a fellow of the West African Postgraduate College of Pharmacists, Dr Charles Nwako, said the conditions under which medicines are stored and handled could also determine whether they retain their intended potency.

Nwako told The Guardian that the efficacy, stability, quality and potency of medicines depended on appropriate storage conditions, warning that poor storage could accelerate the deterioration of pharmaceutical products.

He said some medicines could deteriorate before the expiry date stated on their containers if they were exposed to unsuitable storage conditions. According to him, every API, together with the other ingredients in a formulation, has specific storage requirements, and failure to maintain those conditions could shorten the effective shelf life of a medicine.

Nwako expressed particular concern about the handling of medicines in open drug markets, where he said products could be kept in environments that were not suitable for preserving their quality. He said people without professional pharmaceutical training might not understand the scientific basis for the required storage conditions and could treat medicines simply as articles of trade.

He said compromised medicine quality could have consequences beyond treatment failure, including the development of drug resistance, worsening disease conditions, economic losses and increased hospital admissions or readmissions.

According to him, patients who repeatedly receive medicines with compromised effectiveness may spend more money seeking additional treatment, while illnesses that are not adequately treated could progress into more serious conditions.

Nwako also warned that persistent concerns about medicine quality could undermine public confidence in pharmacists, healthcare professionals and health institutions. He said this could encourage self-medication or drive some members of the public towards traditional remedies that may not have been standardised.

To address the problem, Nwako called for stronger regulation of the pharmaceutical supply chain and urged that only licensed pharmacists should operate pharmacies.

He said quacks and traders should be prevented from handling medicines and called for stronger collaboration between NAFDAC and PCN to tackle quackery, counterfeit medicines and adulteration.

Nwako also advocated proper storage facilities as a requirement for pharmacies handling pharmaceutical products, while urging federal, state and local governments to strengthen NAFDAC and PCN with adequate manpower, equipment, offices and security to enable them to carry out effective regulatory functions.

He further called for stronger surveillance and enforcement, saying the continued existence of open drug markets, unregistered drug outlets and the involvement of unqualified persons in medicine distribution needed to be addressed.

The pharmacists’ concerns come against the backdrop of NAFDAC’s position that approved medicines remain effective, but that misuse, poor-quality products and inappropriate sources of medicines can undermine treatment outcomes.

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, recently maintained that approved medicines remain effective, while warning that misuse could contribute to treatment failure and antimicrobial resistance.

The NAFDAC chief said the agency conducts annual surveys across the country, collecting medicine samples from different locations to determine whether they contain the required active ingredients and have the expected potency.

She said where medicines fail to meet the required standards, NAFDAC takes action against the affected company, including shutting down a company or specific production lines until the quality of the products can be established through testing.

Adeyeye added that NAFDAC’s post-marketing surveillance activities enable the agency to investigate complaints about medicines whose efficacy is questioned.

She urged members of the public who suspect that a medicine is not working effectively to provide NAFDAC with information about the product, including its name and manufacturer, so that the agency can obtain samples and conduct laboratory tests.

Adeyeye also linked medicine quality and efficacy to the source from which medicines are purchased. She therefore advised Nigerians to avoid buying medicines from street vendors and to patronise legitimate outlets where purchases can be traced through receipts.