What Is Counterfeit Medicines?

Introduction

Counterfeit medicines are found everywhere in the world ranging from random mixtures of harmful toxic substances to inactive and ineffective preparations. Some contain a declared, active ingredient and look so similar to the genuine product that they deceive health professionals as well as patients. But in every case, the source of a counterfeit medicine is unknown and its content unreliable. Counterfeit medicines are illegal in Malaysia. They can result in treatment failure or even death. Eliminating them is a considerable public health challenge.

Definition

The World Health Organization (WHO) defines counterfeits medicines as:

"medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source. Both branded and generic products are subject to counterfeiting. Counterfeit medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging".

As for Malaysia, there is no specific definitions on counterfeits medicines, however the legislation for counterfeit products are well covered under The Trade Act. According to The Sales and Drug Act 1952: Regulation 7(1)(a), 7(1A)(a-g) of the Control of Drugs and Cosmetic Regulation (CDCR) states that all medicinal products must be registered with National Pharmaceutical Control Bureau (NPCB) Ministry of Health before being marketed. All registered medicinal products will be given a unique registration numbers.

Products with the following criteria are considered unregistered medicinal products which include the counterfeit medicinal products:-

(i) if they bear

• No registration number
• False registration number
• Registration number belonging to other products
• Registration number which has been cancelled
• No safety label hologram Meditag ^TM
• False hologram Meditag ^TM
• Ingredient which differ from the original formula during registration
• A mixture of 2 registered products
• Information on the packaging which differ from the approved version

(ii) if they contain Adulterants

Source: MyHealth Ministry of Health Malaysia

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