There is no universal definition of counterfeit drugs, and legal definitions vary from country to country. Six different definitions are set out below.

Black’s law dictionary⁶ defines counterfeiting as “to copy or imitate, without authority or right, and with a view to deceive or defraud, by passing the copy or thing forged for that which is original or genuine”.

The American Society of Testing and Materials (ASTM)⁷ has produced a classification system that describes the various ways in which intellectual property rights contained in a product and/or its presentation, including packaging and labelling, may be hijacked. According to the classification, counterfeiting is the reproduction of a document, article or security feature with the intent to deceive close scrutiny by a qualified examiner.

The United States Federal Food, Drug and Cosmetic Act⁸ defines a counterfeit drug as “a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device 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 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”.

According to the Pakistan manual of drug laws,⁹ 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”.

The Republic Act No. 8203 of the Philippines¹⁰ defines counterfeit drugs/medicines as:

medicinal products with correct ingredients but not in the amounts as provided thereunder, 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 a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packing, and can apply to both branded and generic products. It also refers to:

a) 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 identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Terminology Transfer (BPTTT) in the name of another natural or juridical person;

b) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;

c) an unregistered imported drug product, except drugs brought into the country for personal use as confirmed and justified by accompanying medical records; and

d) a drug which contains no amount of, or a different active ingredient, or less than eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due to expiration.

WHO¹¹ defines a counterfeit pharmaceutical product as a product that is deliberately and fraudulently mislabelled with respect to identity and/or source. The definition applies to both branded and generic products. According to the WHO definition, counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with the incorrect quantity of active ingredient or with fake packaging.^* The following are a few examples of counterfeit pharmaceutical products according to the WHO definition: