Intended for healthcare professionals

Feature Drug Regulation

Nigeria’s marathon struggle against counterfeit medicines

BMJ 2023; 381 doi: https://doi.org/10.1136/bmj.p1082 (Published 12 May 2023) Cite this as: BMJ 2023;381:p1082
  1. Oluwatosin Adeshokan,
  2. Christine Ro, freelance journalists
  1. Lagos
  1. christineannro{at}gmail.com

Counterfeit and substandard medicines are not unusual in Africa. A concerted enforcement effort and reworked regulation have lessened the problem in Nigeria—but the roots remain, report Oluwatosin Adeshokan and Christine Ro

In a large warehouse in the northern Nigerian city of Jos, people are repackaging medicines—including painkillers, antiretrovirals, and erectile dysfunction drugs—smuggled from South East Asia into the capital, Lagos, before being transported to Jos. The counterfeiters place the medicines in new packages labelled in English, with Nigerian registration numbers and false manufacturing dates. Often these convincingly mimic the logos of trusted brands.

Such counterfeits are on the more visible side of “fake medicine” in Nigeria. Cyril Usifoh, president of the Pharmaceutical Society of Nigeria, says that in some cases a batch of falsified drugs are mixed with a small quantity of the legitimate product. This can pass quality controls. “What we [really] struggle with is adulteration of products,” says Nelly Okpako, a pharmacist in Lagos. These are not deliberately falsified products but are substandard medicines with substantially different quantities of the active ingredients than advertised.1

Overall, there’s a consensus that in Nigeria the fake medicine problem is far less severe than it was. Data are patchy, but one estimate is that in 2001 substandard and falsified medicines made up at least two thirds of medicines in Nigeria.2 These were largely basic, quick selling medicines such as antibiotics and antimalarials. “There was a time in Nigeria when you just couldn’t buy a [real] drug,” reflects Bisi Bright, a pharmacist who leads the non-profit LiveWell Initiative.

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) claims that at least 85% of medicines sold today are legitimate, but others dispute this.3 (NAFDAC did not respond to a list of questions from The BMJ.) The actual figure is impossible to determine, but a number of experts believe that it’s substantially less than the peak.4

The ripple effects can be severe. Margaret Ilomuanya, an associate professor of pharmaceutics at the University of Lagos, says that roadside vendors are fuelling antimicrobial resistance1—for instance, by selling less effective antimalarials that contribute to malaria parasites evolving resistance. Authorities hope that further legislation and new technology will help, but poor quality medicines are so pervasive that stamping out the problem requires constant vigilance.

Decades battling bad drugs

Starting in the 1980s, economic restructuring contributed to the collapse of the brand name drug market in Nigeria. A space quickly opened up for poor quality medicines.4

One tragic landmark occurred in 2008-09, when 84 Nigerian children died after using a teething syrup contaminated with the low cost industrial solvent diethylene glycol.5 More recently Gambia, Indonesia, and Uzbekistan also connected the deaths of hundreds of children to cough syrup produced with diethylene glycol and ethylene glycol.6 And in April 2023 NAFDAC issued an alert about a cough syrup linked to the deaths of at least six young children in Nigeria’s eastern neighbour, Cameroon.7

Since the 2008-09 mass contamination, Bright believes that “drug regulation has come very far in this country.” NAFDAC has credited the dramatic fall in the proportion of counterfeit drugs partly to technological measures such as text messages and radio frequency identification tags to verify a drug’s authenticity, as well as portable analysis devices to test shipments at borders.8 These were combined with sweeping crackdowns on open drug markets and counterfeiters, public awareness campaigns, new registration requirements, and other activities enlisting broad sections of society. Still, the problem of porous borders persists, and unregulated medicines can find entry.

Healthcare experts say that drug related regulations are often ignored. While licences are required for pharmacies to distribute medicines, enormous quantities are available for anyone to buy from places such as Lagos’s sprawling Idumota Market. Truckloads of products are dispensed into a warren of shop fronts, where requests to buy prescription medicines in bulk are met with no questions. Individual vendors may have few other options for earning a living, and many parts of the country remain underserved for medicines.

The government has been trying to convert unregulated drug markets into coordinated wholesale sites that can be better monitored. But the first such attempt led to a legal challenge from patent and proprietary medicine vendors (PPMVs) facing forceful relocation.9

PPMVs outnumber pharmacists in Nigeria, and most are unregistered. Of around 25 000 illegal medicine dispensing premises shut down in the past five years, most have been PPMVs, says Ibrahim Babashehu Ahmed, registrar of the Pharmacy Council of Nigeria. The council is aiming to bring PPMVs within the scope of regulation, partly by recognising their skills. A pilot scheme is under way to register PPMVs according to three tiers: people with high education but not health training; people with health training, including nurses; and pharmacy technicians. That last tier would be able to assist community pharmacists, for instance. A different solution, proposed by the Pharmaceutical Society of Nigeria, would be to have one pharmacist supervising several non-pharmacists.

Poverty and greed

In a medicine desert in Ogun State, a corner shop owner who asks to be named only as Mr Nnamdi has become an informal dispenser of medicines. He also diagnoses community members’ conditions despite having no medical training. He sees this work as a public service, and he’s popular locally for filling a gap.

Usifoh, a professor of pharmaceutical chemistry at the University of Benin, points to three general factors driving the persistence of poor quality medicines in Nigeria: population increase, poverty, and greed. Even in areas with abundant official pharmacies, it’s cheaper and often more convenient to buy dubious medicines off the street. And there are longstanding traditions of plucking herbal medicines free of charge or buying them cheaply from informal vendors.

Poverty means that “people would rather buy a drug that is cheap, even if they don’t get any pharmacological outcome,” Usifoh tells The BMJ. Not every vendor is as seemingly well intentioned as Nnamdi, either: “Some people don’t care who dies,” says Usifoh. “They just want to make money.”

Technological promise, but is it practical?

Nigeria was one of the two pilot countries testing a new traceability technology that involves geolocation and GPS data. This Traceability and Verification System was initially funded by Gavi, the Vaccine Alliance.10 However, parts of the supply chain have reported technological challenges with moving towards full traceability of medicines. Traceability is especially difficult to ensure in complex supply chains that stretch overseas. About 70% of Nigeria’s medicines are imported11—largely from India, where regulatory oversight remains very fragmented,6 particularly for medicines destined for low and middle income countries.

Manufacturing of medicines in Nigeria has picked up since the covid-19 pandemic, but NAFDAC’s goal of achieving 70% self-sufficiency in medicines by 2025 seems very ambitious.12 Nigeria’s insecurity and unreliable electricity supply have hampered the expansion of domestic production. Another issue is that many Nigerians obtain medicines one sachet or a few tablets a time: a verification label attached to a package of medicine wouldn’t necessarily be helpful for this kind of use.

NAFDAC recently acknowledged that the supply chain of medicines is often broken, including poor handling, sometimes chaotic distribution, and substandard and falsified medicines.13 And observers agree that it’s difficult for the authorities to keep pace with Nigeria’s sophisticated counterfeiters. Clearly, the country can’t afford to be complacent about past successes in combating poor quality medicines. Otherwise, Usifoh warns, “it’s like a time bomb waiting to happen.”

Expired medicines—a hard problem to stamp out

Expiry is the biggest medicine related problem for Christianah Adeyemi, a chief in the informal waterfront settlement of Isale Ajoke. This flood prone neighbourhood in Lagos doesn’t appear on official maps.

Adeyemi reports that many well meaning non-governmental organisations or companies focusing on corporate social responsibility have swooped into the area for short periods, dumping medicines that were either expired or on the verge of expiry. “Fake drugs are many,” she says. These are of limited help when dealing with the community’s main health issues of malaria and typhoid. “We don’t want people to die like fowls,” says Adeyemi.

In other cases, expired drugs are left over when long transit and waiting times for customs clearance mean that some products are nearly or already expired when they enter Nigeria. Reluctant to waste these shipments, certain importers and distributors go ahead with sales. This practice has been known about for over two decades: one former staff member of a food and drink company told The BMJ under anonymity that this was an “open secret” in both the pharmaceutical and the food and drink industries. The staff member said that they had resigned eight years ago after seeing the company falsify expiry dates, as well as hiding certain parts of the company premises when NAFDAC’s inspectors visited.

Footnotes

  • Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following interests. This project was funded by the European Journalism Centre through the Global Health Security Call. This programme is supported by the Bill & Melinda Gates Foundation.

  • Provenance and peer review: Commissioned, not externally peer reviewed.

References