Technology for combating counterfeit medicine

A technological solution for combating counterfeit drugs

A white paper from PANalytical

Abstract

This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray powder diffraction (XRPD).

Introduction

Compared to other forms of counterfeiting, the production of fake medicines almost certainly has the greater potential for harming human health. The scale of the problem is immense with, for example, an estimated 2 - 300,000 people die in China each year as a result of counterfeit medicines¹. The impact is most severe in poor countries, where replicated drugs are used to treat large numbers of people against the most serious illnesses, such as malaria and HIV infection. However, the phenomenon is not limited by national boundaries; counterfeit drugs have been detected on numerous occasions in the highly regulated pharmaceutical supply chains of the world's most developed countries.

This white paper examines the issue of counterfeit drugs, reviewing the various types produced and the nature and range of the damage they cause. The report then focuses on analytical methods for tackling the problem, in particular the use of X-ray power diffraction (XRPD).

Defining the problem

Before discussing other aspects of the issue, the term 'counterfeit drug' should be defined. The World Health Organization (WHO) has developed the following definition:

'A 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.'

In this article the term counterfeit drug is used synonymously with 'counterfeit medicine', 'fake drug' and 'fake medicine'.