General information on counterfeit medicines
What is a counterfeit drug?
In accordance with Black's law dictionary,' the term "counterfeit drug" may be used to describe а drug made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or right, with а view to deceive or defraud, and then marketing the copied or forged drug as the original. In reality, however, а counterfeit drug is defined differently in different countries.
The absence of а universally accepted definition not only makes information exchange between countries very difficult but it also limits the ability to understand the true extent of the problem at global level. In order to address this problem the following definition has been developed by the World Health Organization:
"А counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. 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."
The extent of the problem of counterfeit drugs
The problem of counterfeit drugs is known to exist in both developed and developing countries. However, the true extent of the problem is not really known since no global study has been carried out.
The appearance of counterfeit medicines in international commerce was first mentioned as а problem at the WHO Conference of Experts on Rational Drug Use in Nairobi, Kenya, in 1985. Since then, public awareness of the problem of counterfeit drugs has grown. Both government authorities and manufacturers have been concerned with efforts aimed at preventing the problem, and WHO has received reports related to counterfeit drugs from some of its member states on а voluntary basis. According to this information, the problem is known to involve both developed and developing countries.
Between January 1999 and October 2000 alone, 46 confidential reports relating to such drugs were received by WHO from 20 countries. About 60% of these reports came from developing countries whereas the remaining 40% were reported by developed countries. Although, the reports received have not been validated and may not be useful for quantitative purposes, the information clearly shows that the problem exists. The data also reflects that only а few countries are willing to provide information about cases detected. The drugs counterfeited included antibiotics, hormones, analgesics, steroids, and antihistamines. These drugs form almost 60% of the products reported. In terms of types of counterfeits and their magnitude, the products reported can be grouped into six categories:
- Products without active ingredients, 32.1%;
- Products with incorrect quantities of active ingredients, 20.2%;
- Products with wrong ingredients, 21.4%,
- Products with correct quantities of active ingredients but with fake packaging, 15.6%;
- Copies of an original product, 1%; and
- Products with high levels of impurities and contaminants, 8.5%.
Definitions of counterfeit drugs by WHO Member States
The following definitions by WHO member states demonstrate that the nature of the problem of counterfeit drugs varies from country to country. In some countries the issue is more complex and there is no distinction between counterfeit and substandard drugs.
Available reports indicate that in developing countries а wide spectrum of types of counterfeit drugs, ranging from the precise copy of a genuine product to the extreme case of а drug product with none of the correct active ingredient exist. Consequently, counterfeit drug is defined broadly in order to cover drug products that have been copied or forged as well as certain substandard products, particularly those intentionally made to be substandard.
In the Nigerian Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Decree; а fake drug is defined as: "...
- any drug product which is not what it purports to be; or
- any drug or drug product which is so colored, 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, 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 а false claim for the drug or which is false or misleading; or
- any drug or drug product whose container is so made, formed or filled as to be misleading; or
- any drug product whose label does not bear adequate directions for use and such adequate warning against 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; or
- any drug product which is not registered by the Agency in accordance with the provisions of the Food, Drugs and Related Products (Registration, etc.) Decree 1993, as amended."
The Pakistan Manual of Drug Laws,' defines а counterfeit drug as:
"...а 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 а drug manufacturer."
In the Philippines, the Republic Act No. 82036 refers to counterfeit drug/medicine to mean:
"...medicinal products with correct ingredients but not in the amounts as provided there under, wrong ingredients, without active ingredients, with insufficient quantity of active ingredients, which results in the reduction of the drug's safety, efficacy, quality, strength or purity. It is а drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products. It shall also refer to:
- the drug itself, or the container or labeling thereof or any part of such drug, container or labeling bearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark, and Technology Transfer in the name of another natural or juridical person;
- а drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;
- an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records, and
- а drug which contains no amount of or а different active ingredient, or less than 80% of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration."
The United States Federal Food, Drug and Cosmetic Act' defines а counterfeit drug as, "...а drug which, or the containers or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device or any likeness thereof, of а drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug 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."