By Adebayo Obajemu
Bukola initially thought that the mild fever ravaging him was about going away in a matter of minutes. That did not happen, so he took extra step and visited the nearby patent shop. The Panadol he bought would relieve his deteriorating condition, so he thought.
His condition worsened further after two days, and he was rushed to the hospital, where the doctor discovered that he had taken any medication and frowned at his visiting a local patent drug seller instead of a qualified pharmacist. The Panadol he bought was apparently fake.
For some time now Nigerians had thought that the menace of fake drugs had been conquered until last week when a report by an online media said that 70 percent of drugs in circulation is fake. This attracted a strong rebuttal from the regulatory agency.
In a statement, the National Agency for Food and Drug Administration and Control (NAFDAC) denounced newspaper report that 70 per cent of medicines in Nigeria are fake. A press statement obtained by BusinessHallmark by Moji Adeyeye, a professor and Director General of the agency, said that the report was false. Prof. Adeyeye said that a study jointly carried out by NAFDAC, the World Health Organisation (WHO) and the Department for International Development (DFID) in 2005 revealed that fake medicines stood at 16 per cent. She added that a survey conducted by NAFDAC in 2017 and 2018 on some widely used drugs showed that Nigerian medicines were 98 per cent wholesome.
Fake and counterfeit medicines have remained a public health concern. According to the World Health Organisation, WHO, one in 10 drugs sold in Africa is falsified or substandard, while two in 10 drugs sold in Nigeria are fake. These drugs include the ones that can kill or maim.
Findings show that some of these medicines contain little or no active ingredients thus prolonging illness. In Nigeria, in 2018 alone, data from the National Agency for Food and Drug Administration and Control, NAFDAC, revealed that the agency destroyed fake foods and drugs worth N4.7 billion in four exercises in Abuja; Shagamu, Ogun State; Kaduna and Gombe.
Despite these efforts, counterfeiting has continued unabated. Health watchers are worried that the country is losing the milestones widely attained in safe medicines when it achieved 40 percent reduction in counterfeit medicines in 2001 to 16.7 percent in 2005 in a survey conducted by NAFDAC and WHO.
BusinessHallmark reports that the failure of the Federal Government to implement the National Drug Distribution Policy four years after it was put in place remains a major contributor to why fake drugs still thrive in Nigeria.
“Every day, our children are killed, our pregnant women die, our elders are giving up the ghost and our hardworking men and women are dying because of lack of access to safe medicines, according to the immediate past President of the Pharmaceutical Society of Nigeria, PSN, and the Chairman, Safe Medicines Foundation, Ahmed Yakasai, in a chat with this newspaper.
Pharmacist Ifeanyi Atueyi, who is also a publisher of the industry journal’ Pharmanews’ told BusinessHallmark that “Fake and counterfeit drugs remain a serious threat to public health, and there is a need to address the challenge. Governments at all levels must work jointly with stakeholders to stem the menace through stricter regulations and monitoring.”
His words aptly describe the situation in Nigeria. Stories abound about patients inadvertently being treated with counterfeit drugs, particularly anti-malaria.
Unfortunately, in the last few years, findings show an upsurge in fake drugs which have proved to be a major contributor to high death rates.
According to experts, the problem of fake drug proliferation has affected the credibility of the healthcare system. Just recently, the social media was awash with the news of a cough syrup with alleged future manufacturing date. Experts say it is imperative to intensify efforts in fake drug eradication.
Professor Mahmud Abdullahi of the department of Pharmacy, University of Ilorin told this newspaper that “government delay in the implementation of the National Drug Distribution Policy remains a major factor in curbing the menace of fake drugs.
“A fake drug or counterfeit medicine is a medication or pharmaceutical product, which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients or none, or may be improperly processed within the body. It may contain ingredients that are not on the label which may or may not be harmful, or may be supplied with inaccurate or fake packaging and labeling.”
Experts have linked high incidences of fake drugs to the chaotic drug distribution system, porous borders allowing illegal importation of counterfeit drugs, and weak regulations amongst others. Still little or nothing is being done to implement the only strategy which could curb fake drugs.
All over the world, counterfeit medicines have remained a public health concern and this is why governments and enforcement agencies are taking tougher steps on criminal organizations and companies that are flooding the markets with the medicines.
But the reverse is the case in Nigeria as the country lacks defined drug distribution channel which has helped countries of the world block influx of fake drugs and protects the lives of their peoples. Professor Abdullahi said the challenge is enormous.
“One of the strategies the National Drug Distribution Guidelines, NDDG, which was expected to take off in July 2014, is yet to be operational. The guidelines seek to establish a well-ordered drug distribution system in the country and end the status quo where drugs are peddled by all sorts of characters. Until it is operational the challenge will continue to foster.”
According to Akande Abimbola, a pharmacist in a recent article, the consequences of the current system are weighty and destructive for the health care delivery system as well as the economy. To him, the guidelines are designed to erect pillars and clearly delineated channels of distribution with roles and responsibilities.
In the guidelines, manufacturers and importers are at the apex of the ladder and their role is to make drugs available and sell only to Mega Drug Distribution Centres (MDDC), State Drug Distribution Centres (SDDC) and National Health Programmes while the next layer is occupied by the MDDC and the SDDC. The MDDC is private sector-driven; the SDDC is for the public sector at the state level. Sadly, four years after, Nigeria is yet to implement the programme.
Speaking to BusinessHallmark the Deputy President, Healthcare Providers of Nigeria, HCPAN, Mr. Madehin Gafar Lanre, said the implementation of NDDG policy will reduce fake drugs and save lives.
“What the guidelines are talking about is that we should streamline the channel of distribution from manufacturers down to the consumer level, so that if a fake drug is noticed in the system, it can easily be traced to where it is coming from and withdrawn. But since three years ago, government has continued to promise to implement it and then we were told, last year, that it will take off on January 1, 2019. Now we are in August, 2019 and nothing has been done about it and we are talking about health for all”, he said.
Lanre, who lamented the effect of fake drugs on patients and the health system, explained that patients may get the attention of the best medical practitioners who have experience and diagnosed correctly, but a single dose of fake drugs can ruin the efforts of all professionals involved in the treatment of the patients. He insisted that only pharmacists should handle drugs in the country as it is done in other countries.
According to epertss most people indulge in the production of counterfeit drugs because the penalty for manufacturing or distributing counterfeit drugs is very lenient. In Nigeria, such an offence attracts a punishment of three months to five years imprisonment or a fine of N500, 000 or alternatively a fine ranging from 70 – 3600 US dollars.
Drug counterfeiters have taken advantage of the growing access and sophistication in printing technology and now manufacture fake drugs affixed with fake NAFDAC registration numbers. Cloning of fast moving drugs is so perfect that even the brand owners find it difficult to differentiate between fake and original drugs.
Also NAFDAC has not been able to phase out completely the already existing counterfeit drugs in the market. Almost all drug manufacturers and importers supply to the same drug market where health professional and drug sellers buy their drugs as well as patent medicine sellers that sell on streets and in commercial buses. In addition, it is a common scene to see petty traders who sell kola nuts, cigarettes, oranges, among other items, in market kiosks, motor parks, and road sides, hawking drugs that range from over the counter items to antibiotics (popularly called “capsules “).
The World Health Organization (WHO) defines counterfeit drugs as those “that had been deliberately or fraudulently mislabeled with respect to identity and/or source”. The products can include incorrect ingredients, may misstate the amount of active ingredients, or can be manufactured under circumstances that lack quality control. Counterfeit drugs in Nigeria include preparations without active ingredients, toxic preparations, expired drugs that are relabeled, drugs issued without complete manufacturing information and drugs that are not registered with the National Agency for Food and Drug Administration and Control (NAFDAC).
In the past two decades Nigeria has struggled to reduce the production and trafficking of counterfeit drugs without an adequate infrastructure or the political will to properly enforce legislation and standards. Growing numbers of deaths prompted the public and the Pharmaceutical Society of Nigeria to pressure the government to take positive steps towards controlling the prevalence of counterfeit and substandard drugs in Nigeria. The government responded by enacting Decree No. 21 of 1998 on counterfeit and fake drugs, which prohibited the sale and distribution of counterfeit, adulterated, banned, and fake drugs or poisons in open markets and without a licence of registration.
NAFDAC was created in 1993 and given the responsibility to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devises, bottled water and chemicals. In 2001 under the leadership of Dora Akunyili as the director general, the agency underwent intense restructuring and reforms with the aim of revitalising NAFDAC’s mandate to “safeguard the health of the nation”.
As a result, drug failure rates fell to roughly 16% in 2006 from 2002 and the circulation of counterfeit drugs was reported to have been reduced by more than 80% of the level in 2001.
Before these reforms, counterfeit drugs had a prominent and destructive impact on those who used them unknowingly. In 1990, 109 children died after being administered fake Paracetamol tablets. In 1995, the Nigerian supply of 88,000 Pasteur Merieux and SmithKline Beecham meningitis vaccines to Niger during an epidemic resulted in about 2,500 deaths after vaccination.
Despite NAFDAC’s reported successes, counterfeit pharmaceuticals remain prevalent. In 2004, three Nigerian hospitals reported cases of adverse reactions from the use of contaminated infusions produced by four Nigerian companies. It was established that the infusions were heavily contaminated with microorganisms and 147 of the 149 brands of screened water used for injection were found to be non-sterile.
In November 2008, 34 Nigerian children aged between four months and three years died and more than 50 were hospitalised with severe kidney damage after taking My Pikin, a teething mixture containing Paracetamol. The injuries were due to the use of diethylene glycol (DEG) as a solvent for the Paracetamol. DEG was present because of inadvertent or deliberate substitution of propylene glycol, a less toxic compound than DEG which is widely used in the pharmaceutical industry.
Loss of confidence
The prevalence of counterfeit drugs in the Nigerian market has long been a source of embarrassment to Nigerian healthcare providers and resulted in a loss in confidence among the public in the nation’s healthcare delivery system. Fake drug proliferation has led to treatment failures, organ dysfunction or damage, worsening of chronic disease conditions and the death of many Nigerians. In some cases, even when patients are treated with genuine drugs, no response is seen due to resistance caused by previous intake of fake drugs.
Counterfeit drugs pose great threats to the reduction in infant mortality, improved maternal health and the combating of HIV/AIDS, malaria and other diseases, all aims of the WHO. They deny the Nigerian people the right to safe, effective and quality medicines and rob the country of valued manpower resources and economic benefits.
The loose control system in the Nigerian economy has contributed to the circulation of counterfeit drugs in the country. A major function of NAFDAC is the regulation and control of imported products. This is done by having inspectors at various airports and seaports. Registration of pharmaceuticals is a criterion that must be passed before any drug is released into the Nigerian market. A condition for registration is the analysis and testing of the drug to ensure quality and safety.
Unfortunately, the forensic laboratory, which is the major public laboratory for the purpose of quality control analysis, is not adequately equipped to cope with the volume of requests, particularly for analysis of imported drugs. These inadequate control systems are exploited by counterfeiters to manufacture, import and distribute fake and adulterated products.
Different laws regulate and control the manufacture, sale and distribution of drugs in Nigeria. Sadly, empirical data show that the situation is far from adequate. The weakest point in Nigeria’s drug regulation is in the area of implementation and enforcement. Some Nigerian drug laws are in conflict with each other, aiming more at deterrence and resulting in difficulty in bringing offenders to trial.
A review of the law is therefore essential to help ensure stability in the legislation and regulations governing drugs in Nigeria. An important short-term strategy for fighting counterfeit drugs is that pharmaceutical companies focus more on developing better technologies for protecting the identity of their genuine products. Pharmaceutical companies should develop complex labels and holograms which are difficult for counterfeiters to imitate.
Additionally, the penalties for drug offenders are not commensurate with the severity of the crime. Currently, the maximum punishment for contravening the decree on fake drugs in Nigeria is ₦500,000 ($2,500) or three months to five years in prison upon conviction. Stiffer penalties would help sharpen the attitudes of fake drug dealers. It would make the practice harder and less lucrative for drug counterfeiters.
They can educate themselves and patients on ways of identifying fake drugs using visual security tools which may include the size and shape of tablets, the quality of the print and the examination of holograms. It is clear that good practices and initiatives are being implemented to combat this issue in Nigeria, but we have a long way to go.
However, the National Agency for Food and Drug Administration and Control (NAFDAC) has denounced a recent newspaper report that 70 per cent of medicines in Nigeria are fake. A press statement obtained by BusinessHallmark by Moji Adeyeye, a professor and Director General of the agency, said that the report was false.
Prof. Adeyeye said that a study jointly carried out by NAFDAC, the World Health Organisation (WHO) and the Department for International Development (DFID) in 2005 revealed that fake medicines stood at 16 per cent. She added that a survey conducted by NAFDAC in 2017 and 2018 on some widely used drugs showed that Nigerian medicines were 98 per cent wholesome.
She described the report as “categorically untrue and grossly inaccurate.’’
“NAFDAC wishes to inform members of the public, especially health care providers, policy makers and development partners to disregard an online publication at that 70 per cent of all drugs in Nigerian markets is fake.
“NAFDAC in collaboration with WHO, DFID and United States Pharmacopeia conducted series of studies on quality of medicines in Nigeria and the report runs contrary to what Vanguard reported.
“A study of Counterfeit and Substandard Medicines in Nigeria conducted by NAFDAC in collaboration with WHO and DFID in 2005 revealed that counterfeit medicines stood at 16.7 per cent in 2005. This was as against 40 per cent in 2001,” she said.
She added that subsequent tests carried out between 2010 and 2012 revealed that the situation was even better than in 2005.
“The National Survey on Quality of medicines using Truscan® device was conducted by NAFDAC across 29 States including FCT, Abuja from January 2010 to April 2012.
“The medicines involved in the survey included antibiotics, anti-malarial and anti-diabetics. A total of 5,790 samples of medicines were tested. “5,419 samples of medicines out of 5,790 (93.6 per cent) tested during the survey passed quality tests while 371 samples (6.4 per cent) failed.