Counterfeit Drugs

The World Health Organization (WHO) defined counterfeit drugs as “medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source.” According to WHO, counterfeiting can apply to “both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”6 According to this definition, what makes a drug or medicine counterfeit is the deliberate or intentional mislabeling of the product.
In 1992, the International Pharmaceutical Federation (FIP) jointly carried out a survey with the Commonwealth Pharmaceutical Association on the incidence and control of counterfeit drugs. To ensure that all respondents based their response on the same interpretation of counterfeit medicines, they defined counterfeit medicines as medicinal products which have been deliberately or fraudulently mislabelled with respect to identity and/or source. These included those products with the correct ingredients, wrong ingredients, no active ingredient, or fake packaging. They excluded substandard products, which were correctly labeled.
The U. S. Federal Food, Drug and Cosmetic Act defines a counterfeit drug as “a drug which, or the containers or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drugs, and which, thereby, falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.”
According to Pakistan’s Manual of Drug Laws, a counterfeit drug is “a drug, the label or outer packing of which is an imitation of, resembles or so resembles as to be calculated to deceive, the label or outer packing of a drug manufacturer.”

Substandard Drugs

Substandard drugs are genuine drug products which do not meet quality specifications set for them. The term substandard is used to describe the quality status of genuine drugs produced by legitimate manufacturers. Normally, manufacturers use specifications laid down by official Pharmacopoeias, such as British Pharmacopoeia (BP), United States Pharmacopoeia (USP), and European Pharmacopoeia (EP) for each drug that they produce. If a drug fails to meet the pharmacopoeia specifications used for its formulation, the drug is classified as substandard.
Nigerian Definition
Individual countries are left to further specify what will constitute mislabeling, misbranding, faking, adulteration or substandard, within the context of the interpretations of fake and counterfeit products in their laws and regulations. The Nigerian definition combines the provisions of two decrees: The Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Decree No. 25 of 19999 and Drugs and Related Products (Registration, etc) Decree No. 19 of 1993.

Adulterated Drugs

A drug or drug product is regarded as adulterated if:
(a) The methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current Good Manufacturing Practice (GMP) to assure that such drugs meet the requirements of the Food and Drugs Act as to the safety, and has the identity and strength, and meets the quality and purity characteristics which it purports or is represented to possess.
(b) It purports to be or is represented as a drug, the name of which is recognized in an official compendium, has its strength differing from, or its quality or purity falling below the standard set forth in such compendium.
(c) Consists in whole or in part any filthy, putrid or decomposed substance, or has been prepared, packaged or stored under unsanitary conditions where it may have been contaminated with filth or whereby it may have been rendered injurious to health, or is packed in a container which is composed in whole or in part of any injurious or deleterious substance which may render the content injurious to health, or bears or contains for the purposes of colouring any colour other than one which is prescribed, or contains any harmful or toxic substance which may render it injurious to health, or has been mixed with some other substance so as to reduce its quality or strength.

Fake Drugs

A fake drug is defined as:
(a) any drug or drug product, which is not what it purports to be.
(b) any drug or drug product, which is so coloured, coated, powdered or polished that the damage is concealed, or which is made to appear to be better or of greater therapeutic value than it really is, or which is not labeled in the prescribed manner, or which label or container or anything accompanying the drug bears any statement, design or device which makes a false claim for the drug or which is false or misleading.
(c) any drug or drug product whose container is so made, formed or filled as to be misleading.
(d) any drug or drug product whose label does not bear adequate directions for use and such adequate warning for use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of use; any drug or drug product, which is not registered by NAFDAC in accordance with the provisions of the Food, Drugs and Related Products (Registration) Decree.

Unwholesome Food

Unwholesome processed food product is any food product which consists in whole or in part of any filthy, putrid or decomposed substance or has been prepared, packaged or stored under unsanitary conditions where it may have been contaminated with filth or whereby it may have been rendered injurious to health; or is packed in a container composed in whole or in part of any injurious or deleterious substance which may render the content injurious to health. Others are food products that bear or contains for the purposes of colouring any colour other than one which is prescribed; or contains any harmful or toxic substance which may render it injurious to health or has been mixed with some other substance so as to reduce its quality or strength.

Fake Drugs and Substandard Regulated Products as Identified by NAFDAC

NAFDAC has identified various forms of fake/counterfeit drugs and other unwholesome regulated products in Nigeria. These include drugs with no active ingredient(s) or drugs containing only lactose or even chalk in tablets or olive oil in capsules. Others are drugs with insufficient active ingredients such as Chloroquine tablets containing 41mg of the active ingredient instead of 200mg, or 50mg of active ingredient in Ampicillin instead of 250mg. Others are drugs with active ingredient(s) that are different from what is stated on the package such as Paracetamol tablets packaged and labeled as Fansidar (sulphadoxine and pyrimethamine combination).

There are also cloned drugs with the same quantity of active ingredients as the original drug. Cloning is hiding behind a fast moving registered product to rake up profits without the associated liabilities and it is solely driven by financial motives. Examples include Panadol by GSK containing 500mg of Paracetamol powder cloned by some criminals to contain the same 500mg Paracetamol powder as the original. What these fraudsters fail to understand is that minimal effective blood concentration, which determines the efficacy of the drug, is not only dependent on the quantity of active ingredient, but also on the quality, excipients, and formulation techniques. The big question, however, is: who takes responsibility when there are adverse effects of a cloned drug? Fast moving cosmetics, food and drinks are also massively cloned.
Others are drugs without the full name and address of the manufacturer, expired drugs or drugs without expiry dates, toxic herbal preparations mixed with orthodox medicine, and contaminated infusions and injectables. Other forms of substandard/unwholesome products include syringes with poor calibrations or blunt to semi-blunt tips, contaminated and/or pyrogenic syringes, needles, surgical blades, blood bags and infusion sets, non-sterile gloves, sutures and condoms, expired products and those products without expiry dates or best before dates, or relabeled with the intention of extending their shelf life, and contaminated chemicals.

Still others include food and drinks contaminated with bacteria, heavy metals, trace metals, radioactive materials, and banned chemicals, or those containing unapproved sweeteners, colours, flavours and other additives, or others with poor quality or internationally unacceptable packaging. There are also cosmetics containing harmful and banned or restricted chemicals like hydroquinone (more than 2%), mercuric compounds and hexachlorophene, packets and bottles of designer perfumes imported into Nigeria, and filled locally with diluted concentrates. Other such products are alcoholic drinks without stated alcohol content, regulated product not registered by NAFDAC and products marked, "for export only." NAFDAC has used every opportunity at its disposal to inform the International community that products labeled “for export only,” for whatever reason, are totally unacceptable to Nigerians. Drugs, food, or other regulated products that cannot be used in the country of manufacture should never be imported into Nigeria.