In the last few months, some unscrupulous elements have intensified their illegal operations across the country, freely circulating fake and substandard drugs as well as unwholesome food and drinks. This fraudulent practice, exacerbated by the current economic downturn in the country, is putting the lives of many Nigerians on the line while the National Agency for Food and Drug Administration and Control (NAFDAC) – the agency saddled with the responsibility of regulating and controlling importation, distribution, sale and use of food, drugs and other related products – appears helpless. Assistant Features Editor, The Guardian Weekend, GBENGA AKINFENWA, captures the concerns of experts on the effects of fake drugs and food on the health of innocent consumers.
With the current economic downturn that is forcing many to seek cheaper alternatives to what they consume for survival, many innocent Nigerians now face the risk of contacting life threatening ailments as fake drugs and unwholesome foods and other consumables are flooding the markets.
Fake drugs or substandard medical products are counterfeit medications either produced at below the standard quality or sold as proxies for authentic and effective pharmaceutical brands.
According to the World Health Organisation(WHO), fake drugs are often packaged by unskilled and unauthorised individuals in unregulated facilities and mostly supplied to low-income countries with weak drug regulations.
Over the years, the counterfeit pharmaceutical industry has been thriving in Nigeria. Law enforcement agencies are battling to clamp down on foreign-linked criminal syndicates.
Holed up in small warehouses in cities across West Africa, there are people in the business of repackaging pharmaceuticals. They may also be busy tampering with expiry dates or manufacturing goods from scratch. Sometimes, these clandestine make-shift laboratories are raided by law enforcement agencies and their fake products are destroyed but it does not take long for them to pop up elsewhere.
The Guardian gathered that Nigeria has practically become a fertile ground for counterfeit and substandard medical and other edible products. This situation, though not new in the country, has become more prevalent in the last few months, especially as many Nigerians now rely on cheap products, which are often substandard or counterfeit.
Investigations revealed that while many of these items were detected and mopped up, others have found their way into shops, malls, pharmacies and homes where they have been consumed. And in the last six months, NAFDAC has continued to raise the alarm on existence of fake substances and consumables, describing them as substandard, fake and unwholesome.
For instance, on June 27, 2024, NAFDAC issued a statement announcing the circulation of fake Ginny non-dairy creamer milk in the country. The agency said the product was widely distributed and sold across the country, particularly, in the northern part, due to its high demand. NAFDAC said the genuine Ginny Creamer was imported by Satnam Investment Nigeria Ltd, whose office is at Desiree Plaza 2, Sheraton Road, Opebi, Ikeja, Lagos, while the fake was allegedly manufactured by Oki General Trading Llc, Dubai, U.A.E.
Also, on August 6, 2024, the agency informed healthcare providers and the public of a report confirming the presence of counterfeited Perjeta in Nigeria. The Marketing Authorisation Holder (MAH) Roche received a complaint from a pharmacist reporting two units of suspected counterfeit Roche products, Perjeta 420 mg/14mL.
NAFDAC declared that the chemical analysis of the product was not possible. The physical complaint sample was not available for return. “Nevertheless, the investigation of the provided pictures revealed clear evidence of counterfeit packaging material.
Perjeta 420mg Injection is used to treat breast cancer when other medicines have failed to show significant improvement. It helps to stop cancer growth and further spread and relieves the symptoms of breast cancer such as breast lumps, bloody discharge from the nipple, or changes in the shape or texture of the breast.
“All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the counterfeit product within the zones and states,” the agency said.
Also, on November 21, 2024, NAFDAC announced the circulation of counterfeit Combiart Dispersible Tablet 20/120mg in the country. The product, manufactured by India-based Strides Arcolab Limited, was discovered in the FCT, Abuja and Rivers State during surveillance activities conducted by officers of the Post Marketing Surveillance Directorate of NAFDAC. The laboratory report of the analysis carried out on the product revealed that it contained zero Active Pharmaceutical Ingredient (API). The product was also observed to have two different date markings.
The NAFDAC database of registered products confirmed that the product’s licence has expired and the NAFDAC registration number on it is wrong and not for the product.
On December 18, 2024, NAFDAC alerted the public to the sale and distribution of counterfeit Paludex tablets and suspensions across Nigeria. In a statement on its X handle, NAFDAC said the PaludexArtemether/Lumefantrine tablets (80mg/480mg) were manufactured by Impact Pharmaceutical Ltd at No. 33A/33B, Standard Industrial Layout, Emene – Enugu State and were being marketed by MD Life Sciences Ltd, Emene Industrial Layout also in Enugu State.
The statement disclosed that NAFDAC also found a Paludex (Artemether/Lumefantrine) dry powder for oral suspension (180mg/1080mg) for paediatric use in circulation. According to the statement, the oral suspension is manufactured by Impact Pharmaceutical Ltd at No. 33A/33B Standard Industrial Layout in Enugu and EcomedPharma Limited in Ogun State and marketed by MD Life Sciences Ltd.
NAFDAC said that the results of laboratory analysis on both products by a WHO-prequalified laboratory in Germany indicated zero percent ‘Active Pharmaceutical Ingredient (API’s) in the products. The agency also sampled the same products and the reports of analysis confirmed zero percent of API content.
In the statement, the products were said to be non-existent on NAFDAC registered product database and all NAFDAC registration numbers stated on the products are false.
The agency noted that genuine Artemether/Lumefantrine tablets or suspension is a combination of the two medications Artemether and Lumefantrine used to treat acute, uncomplicated malaria in adults and children.
The latest alarm was raised on January 5, 2025 when NAFDAC announced a counterfeit cancer treatment drug, Phesgo 600mg/600mg/10ml, labelled with batch number C5290S20. NAFDAC said that the drug was reportedly brought into the country by a patient for administration. At the time of the report, the product had not been administered, but it matched the characteristics of a previously reported counterfeit batch C3809C51.
“Although no physical sample was returned to Roche for investigation, images of parts of the product, specificallya Phesgo 600mg/600mg vial and a 10ml folding box, were examined….”
As a confirmation of the rising spate of this development, the agency announced last December that seized counterfeit products worth N120billion have been destroyed by its enforcement team in the last six months.
The Director General of the agency, Prof Mojisola Adeyeye, in her Christmas and New Year message, disclosed that on Wednesday, December 11, 2024, NAFDAC destroyed expired, unregistered drugs worth N11billion in Ibadan, Oyo State.
“In November, the agency seized N300million worth of fake medicines during a raid of Tyre Village and the Trade Fair Complex, Lagos State. Officers of the agency also bust counterfeit alcohol packaging centres and seized items worth N2billion in Lagos. This followed reports of illegal revalidation of expired alcoholic beverages at the Trade Fair Complex in Lagos,” she said.
Adeyeye added that in Nasarawa State, Karu Market, to be precise, bags of repackaged expired rice worth over N5billion were seized during a raid. “Also, in Nasarawa State, the agency sealed a factory and eight shops for packaging and distributing counterfeit rice, valued at approximately N5billion.”
At Wuse and Garki markets in Abuja, the agency said it confiscated over 1,600 bags of counterfeit rice worth about N5billion. Simultaneously, a total of 150 shops at Eziukwu Market in Aba, Abia State, were shut down following an operation by the agency.
As the mop-up operation was going on in the FCT and Nasarawa State, NAFDAC was carrying out a two-day operation in the Aba Market on December 16 and 17, 2024. During the operation, the agency said it uncovered large-scale production and distribution of fake and expired goods, including beverages, carbonated drinks, wines, spirits, vegetable oils, and revalidated food items such as noodles, powdered milk, and yoghurt with a market value of N5billion.
Health experts warn that consumption of fake drugs and food products is dangerous to human health, and do lead to sudden death. They claim that up to 70 per cent of drugs distributed in the country are substandard and counterfeit, and that the untoward development has been causing increased hospital admission, cases of food poisoning, organ damage and death, among others.
Health professionals are worried over the influx of fake and substandard drugs into the country. They said fake drugs are responsible for the growing cases of hypertension, heart failure, stroke, and other illnesses in Nigeria. When people take fake or substandard anti-hypertension drugs, their blood pressure will continue to rise—because what they are taking is rubbish—until they go down with stroke or even die.
Two pharmaceutical giants —GlaxoSmithKline (GSK) and Sanofi— ended operations in the country in 2022 as a result of the growing rate of fake and counterfeit drugs.
Some fake drugs being destroyed
A recent study by the UN Office on Drugs and Crime revealed that up to 500,000 people die yearly from counterfeit drugs in sub-Saharan Africa. The same report showed as many as 267,000 deaths each year from substandard malaria drugs and up to 169,000 deaths each year from fake antibiotics used to treat pneumonia in children. Between $12 million and $44.7 million is spent each year treating people who have used counterfeit or substandard malaria drugs.
This has not only created anxiety among Nigerians, it has further raised a major concern over the efficiency of NAFDAC – the agency saddled with the responsibility of regulating and controlling importation, distribution, sale and use of food, drugs and other related products.
Established in 1983 as replacement for the former Federal Ministry of Health’s Department of Food and Drugs, the public health responsibilities of NAFDAC are to ensure that all food products sold in the country are safe for consumption; ensure that all drugs sold in the country are safe, effective, and of good quality; and ensure that all cosmetic products sold in the country are safe for use.
Among some rhetorical questions from the lips of worried Nigerians are: How did these goods escape the eagle eyes of the NAFDAC officials at the sea ports and airports? Who approved them? Did they bypass NAFDAC?
A consultant pharmacist, who is the Director of Programmes, Nigeria Academy of Pharmacy, Dr. Lolu Ojo, said the development had heightened risks of treatment failures, adverse drug reactions, food poisoning, long-term health effects, and death, among others.
“Fake drugs may contain little to no active ingredients, or worse, harmful substances like mercury, arsenic, rat poison, or cement. A drug is prescribed at a particular dose, frequency and duration to exert a therapeutic effect. When any of these parameters is missing, it could result in treatment failure. A fake drug contains inadequate amount of the active ingredients or none at all. Treatment failure could result in prolonged morbidity or could be fatal.
“A fake drug containing overdose of a drug or a molecule completely different from the prescribed could lead to adverse reactions some of which may be fatal. It can also result to death. For instance, uncontrolled hypertension or diabetes could lead to death.
‘The dangers of consumption of unwholesome food and drinks should not be underestimated too. It could lead to food poisoning. Materials contaminated by bacterial, viral, or parasitic particles can cause food poisoning, leading to symptoms like nausea, vomiting, diarrhea, and stomach cramps. Repeated consumption of unwholesome food and drinks can lead to chronic health issues such as liver or kidney damage, and increased risk of certain cancers,” he explained.
Ojo, who is the Managing Director/CEO, Merit Healthcare limited, disclosed that the proliferation of fake drugs is a ticking time bomb, threatening the health and well-being of millions of people.
Lamenting that the situation is alarming, he said NAFDAC and other regulatory agencies should be held accountable for their role in ensuring the safety of drugs and food products in the country.
“If we fail to do something drastic on the influx of fake dugs and unwholesome food items, the consequences are many and are all deleterious and unpleasant. There will be loss of lives as the most significant risk and the economic burden will be substantial, with the cost of treatment, lost productivity, and strained healthcare resources. There will be erosion of trust in government’s ability to protect the citizens and healthcare professionals and systems.”
According to Ojo, NAFDAC is doing its best to control the menace, the task is enormous and it will require the input, support, and cooperation of other government agencies, corporate bodies, professional and trade associations, religious bodies as well as leaders and individuals to win the war against fake drugs and foods.
“First, let me state that NAFDAC is not folding its arms and doing nothing. I am aware of the many efforts exerted in the past and ongoing to tackle this menace. I have had a one-on-one discussion with the Director General on this subject, she’s very passionate and committed to her job and so is her team.”
To stop the untoward development, Ojo advised NAFDAC to strengthen its regulatory frameworks\ to ensure they are aligned with international best practices and address emerging challenges. He urged the agency to increase its inspections and enforcement activities at the ports, borders, and markets. There should be strict enforcement of regulations that can help deter influx of fake drugs and unwholesome food.
“NAFDAC should establish a robust intelligence gathering system to track and trace fake drugs and unwholesome food. They need to leverage technology, such as track-and-trace systems, to monitor the movement of drugs and food products.
“There is need for collaboration with other agencies, such as Customs, Immigration, and the Police, to share intelligence and coordinate efforts. There is need to collaborate with international bodies, including the World Health Organisation (WHO), to share best practices and receive technical assistance.
“They must expand public awareness campaigns to educate citizens on the dangers of fake drugs and unwholesome food and educate consumers on how to identify them. Regular training of personnel to enhance their skills and knowledge in detecting and combating fake drugs and unwholesome foods is also necessary,” he said.
Ojo also mentioned the need to strengthen NAFDAC’s laboratory capacity for effective testing and analysis of drugs and food products.
“To be honest, some of these measures are not new to NAFDAC and they are working on many if not all of them. For the agency to function efficiently there is need for adequate funding by government. NAFDAC should not be a revenue generating agency, rather, it should be adequately funded to fulfill its mandate. Resources must be allocated for maximum impact. The office of the National Security Adviser must step in to assist NAFDAC.
“We need an office of the Special Adviser on Pharmaceutical Affairs that will be able to relate to the President directly to resolve issues on research, manufacturing, distribution and consumption for the nation.”
Another Pharmacist based in Lagos, Joseph Abiola, who lamented this development, said consumption of substandard drugs had been causing more harm to Nigerians.
“It’s unfortunate that Nigeria experiences this from time to time. And of course, we know the impact wholesome drugs or food items can have on our health.
“For example, a drug is a potential poison if it is not used the way it’s supposed to be used, even if it is original, let alone when it is substandard. Definitely, substandard drugs will cause even more harm than mere poison.
“Of course, controlling this is the role of NAFDAC and other regulatory agencies and that is why they do everything to make sure that all we consume are wholesome, overall, maintaining good health among the populace. But, of course, the regulations are having some challenges.”
Abiola noted that owing to the size of the country, in terms of land mass and borders with other countries, which not only affects the movement of goods, but also movement of people, it is easy for fake goods to easily have their way into the country.
“This is a national challenge that we’ve always been grappling with, even affecting our security system and all of those things. So, the normal process, if I want to import or bring a product into the country, for example, I need to get a permit from NAFDAC and then the product will come either through the airport or the seaports. There are NAFDAC officials stationed in all these official ports. So, any product that comes in that is either a drug or food that is within the purview of what NAFDAC regulates passes through them.
“So they look at the papers, the originality, and all of that. If it is genuine, then they release the goods to whoever does the importation. And if it is not, they will impound it at that point in time. If they need to prosecute anybody, they will do it,” Abiola said.
He, however, noted that due to the porous borders, Nigeria has become a fertile ground for fake products, as importers are avoiding the necessary authorities. Some of these drugs and food items that are unwholesome come through this, unguarded in terms of that process.
“Fake products are detected when they do their routine checks, random sampling from pharmacies and supermarkets. The fact remains that some of these items may not necessarily pass through the NAFDAC officials.”
According to him, making sure that these fake products doesn’t come into the country will not be 100 per cent realizable because there is no country in the world that can boast to be 100 per cent fake drug-free, but can only be kept at the barest minimum.
“I think it is not just a responsibility of NAFDAC, but a bigger responsibility for the government of Nigeria as a whole, especially with respect to our borders that are not well guarded. So, if this is taken care of, it will do a great deal in reducing the entry of these products into the country in the first place.
“NAFDAC can also step up their efforts. If they need more personnel, then, we know the challenges we have in the country. Sometimes the only trick is that NAFDAC does not even have enough personnel to go around doing all these spot checks, but they try their best.
In her reaction, the Director General of NAFDAC, Prof Adeyeye, identified dearth of manpower as part of the challenges facing the agency in manning the land borders, seaports and airports.
“The most important thing is to make sure that that business doesn’t thrive, to serve as a deterrent to others. If there’s no deterrent, they will continue to do it. But there is another angle that we’re using or we’re trying to use now, which is to actually train them, because they can be categorised as micro, small, or medium sized enterprises.
“To train them first, on how not to fake products, the consequences of faking products, and how to make products in such a way that they can still do good business. We may not have high success, but relative success is better than no success or no attempt.”
She noted that some of the fake products do not pass through the ports, as they are produced within the country.
“In terms of airports, land ports and borders, we have our staff there working. But generally speaking; we do not have enough staff to man all the borders. So, there are still some unmanned borders where there are no NAFDAC officials.
“That is part of why we need people that we have screened before for job placement. There are those on the waitlist until we get statutory approval.”
Guardian