The World Health Organization (WHO) defined fake drugs as “medicine which is deliberately and fraudulently mislabeled with respect to identity and/or source.” Like many other countries, the distribution of fake drugs in Nigeria has made the Healthcare system questionable. Consuming such drugs has harmful effects on the consumer resulting to illness, disability and even death. Fake drugs are handled so casually, you can find them being hawked in commercial buses in all parts of the country. It’s so rampant that almost every existing drug has a counterfeit.
In response to the World Health Assembly in 1988 which requested countries to combat the menace of fake products in the market, the Nigerian government started a serious move towards establishing a drug regulatory agency. Hence the first governing board of NAFDAC was formed in December 1992. Following the promulgation of the enabling Decree No 15 in Jan 1993, the agency was formally established on 1st January 1994 as a parastatal under the Federal Ministry of Health, taking over regulatory functions from the Department of Food and Drugs.
The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian government agency empowered to regulate and control the manufacturing, importation, exportation, advertisement, distribution, sale and use of drugs, foods, cosmetics, medical devices, herbal veterinary products, chemicals and other regulated products in order to ensure that safe and quality drugs and related products are available to the public.
Determined to solve Nigeria’s persistent fake drug problem and motivated mainly by the huge profits to be made, the government restructured NAFDAC’s management and reorganized the agency in April 2001. The “New NAFDAC” in 2001 through Professor Dora Akunyili as Director General, implemented new measures causing a reduction to the problems.
NAFDAC in addition to setting the standards by which other public establishments could be judged also maintains contact with a number of national and international organizations whose activities relate to its functions. These organizations include Consumer Protection Council of Nigeria (CPC), Standard Organization of Nigeria (SON), National Drug Law Enforcement Agency (NDLEA), National Institute for Pharmaceutical Research and Development (NIPRD) to mention but a few.
NAFDAC has over the years been making continuous efforts against distribution and use of fake drugs with increasing intensity of interventions since 2001 in the following areas:
As part of the inspection processes towards checking fake drugs circulation in Nigeria, NAFDAC does the following:
- Demands for mandatory provision of pre-shipment information by all importers before their drug products arrive at the port of entry of Nigeria.
- Collaborates with all Nigerian banks to ensure that drug importers get the Agency’s clearance first before financial documents are processed for them.
- Issues guidelines to airlines that might lift drugs for importers without proper authorization from the Agency
- Ensures that importation of unregistered drug products attract penalty fine and seizure until the product is registered.
- Carries out post-marketing surveillance in accordance with WHO specifications and enables set procedures for mopping up fade drugs that are already in circulation.
- Local factories in Nigeria, besides being inspected at the time of product registration, are also inspected once in three months without prior notice. This is done to ensure that they are consistent with current GMP and have not deviated from the conditions under which the product was registered.
Products from factories with poor GMP are not allowed into the country. However, the effectiveness of these inspection activities being carried out by NAFDAC remains a big question. Moreover, if the factories of local drug manufacturers are inspected routinely to ensure that they are consistent with GMP, NAFDAC should plan on how to apply same measures to imported products because that is where the bulk of drugs come into the country.
Drug Product Registration
Before any drug product is to be registered by NAFDAC, the factory must be WHO prequalified or be GMP certified for the product to be exported to Nigeria. India is one of the major importers of drug products to Nigeria. NAFDAC appoints analysts in India that help in the certification of any drug product before it leaves the shores of India to Nigeria. NAFDAC made the importers to insist to their manufacturers abroad that the product for importation have NAFDAC registration number affixed on the outer packaging before bringing it to the shores of Nigeria. NAFDAC compiled a list of all products registered with the agency in the Gazette and “NAFDAC green page” for the public to be aware of the registered products and what to buy. NAFDAC issues a 5 years valid license on registration of a product for importation in the country.
Commendable success by NAFDAC in the fight against fake drugs was realized through increased surveillance activities by the enforcement directorate from 2001. Enforcements in any drug regulating authority acts as the intelligence group that investigates cases, brings criminal prosecution, works with information provided by people and consumers, carries out raids and surveillance activities to tackle the fake drug business. With adequate information, dealers in counterfeit medicines could be traced, apprehended and possibly brought to book. Through enforcement activities, property owners are obliged to take responsibility of their tenants who utilize such properties to engage in fake drugs business. NAFDAC initiated the plan to establish a model drug market in the six geopolitical zones of Nigeria under the control and management of pharmacists with the objective of creating a better drug distribution network that can easily be monitored. But conflicts of interest amongst the stakeholders have not permitted effective enforcement of this desire in Nigeria.
NAFDAC is empowered under section 14 of its enabling law to use the resources at her disposal in publicizing and promoting its activities. In line with this, NAFDAC has created awareness of the menace of fake drugs and thus empowered the Nigerian public more than ever before. The agency has
- extended enlightenment campaigns on fake drugs to most parts of the society including schools to educate young ones on the dangers of fake drugs;
- liaised with other relevant stakeholders such as Nigerian Drug Law Enforcement Agency (NDLEA), Nigerian Bar association (NBA), Standards Organization of Nigeria (SON), Consumer Protection Council of Nigeria, the police, customs, port authorities, etc., in the goal of fighting fake drugs as contained in the enabling decree;
- established the National Pharmacovigilance Centre (NPC) that is responsible for promoting rational and safe use of medicines;
- regularly published list of identified fake/substandard products in NAFDAC quarterly bulletin and in the newspapers for the public to know;
- paid advocacy visits to international regulatory authorities in China and India for collaboration in the fight against importation of fake drug products into Nigeria;
- published a blueprint that covers the year 2005-2010 as a guide for the campaign on fake drugs, and the “NAFDAC green page” a directory of all NAFDAC-registered products, as well as regular publishing of alert notices for public awareness of products in circulation that have problems;
- organized seminars and workshops for small, medium and high enterprises as well as other stakeholders to explain NAFDAC guidelines and expectations from them.
NAFDAC has made efforts towards closing illegal drug markets (unlicensed premises) which sells either prescribed or over the counter (OTC) drugs nationwide. This effort has not yielded any positive result till date. This is because customers with low accessibility, availability and affordability will always demand for their services. However, we have to remain hopeful that the current collaborative initiative by the Pharmacists Council of Nigeria (PCN) and stakeholders will break the system in Nigeria by closing all open drug markets and establishing an organized network in the country.
Deployment of Cutting-Edge Technologies
Other measures recently employed by NAFDAC in continuation of efforts against the menace of fake drugs include deployment of cutting-edge technologies such as
- TruScan, a hand-held instrument/device used for on-the-spot detection of counterfeit medicines. It is based on a principle called Rahrnan’s Spectroscopy. TruScan is a new invention by the US military that can quickly tell whether the product is genuine or fake.
- The “Black eye”, developed by Israel, which works like Truscan and depends on the principle of active thermography (Infra-Red technology). It is very advantageous, in that, it is a non- destructive process. The “Black Eye” has the capacity to screen multiple drug samples at the same time and in addition to detecting if it is counterfeited or not, it can further give details of the constituent ingredients in the pharmaceutical product.
- The Global Pharma Health Fund Minilab Test Kit, a reliable, simple and inexpensive method for speedy evaluation of medicines. It detects counterfeit medicines.
- The Mobile Authentication Service (MAS) using Short Message Service (SMS), a technology that has put the power of detecting counterfeit regulated products in the hands of about 140 million Nigerian cell phone users. The MAS is very simple to use. The programme involves the packaging of drugs with a scratch card placed on packets from the point of manufacture. When scratched, the hidden codes revealed on the packs could be sent free of charge via SMS to a number on any of the various networks. The sender will receive a reply confirming whether the product is genuine or not. The MAS is a quick and an effective method of identifying fake drug products.
- Radio Frequency Identification system (RFID), a device that can track and trace regulated products and also prevent the forgery of sensitive documents.
The successful deployment of the TruScan technology brought NAFDAC to increased global recognition as Nigeria was the first to deploy it for detection of quality of medicines. Following this regulatory milestone with TruScan by NAFDAC in Nigeria, the Food and Drug Administration agencies in some other countries like United States of America, Germany, Sweden, Canada, Kenya, Cameroon, Uganda, etc., started using it.
The safety of human lives remains a paramount responsibility of the government of every country. As NAFDAC continues to ensure that safe and quality pharmaceuticals are available to the public, we should not hesitate to bring any misconduct to light or report any foul play to the agency.