Counterfeit Drugs
(1999; 61 pages) [French] [Spanish]

Table des matières

	Executive Summary
	1. Introduction
		1.1 Background
		1.2 DMP-DAP joint project on counterfeit drugs
		1.3 Structure of the guidelines
	2. Overview of the problem
	3. Impact on public health
	4. Factors facilitating counterfeiting
	5. Developing national strategies
		5.1 General considerations
		5.2 Plan of action
		5.3 Monitoring and evaluation
	6. Specific measures
		6.1 Strengthening political will and commitment
		6.2 Promulgating appropriate legislation
		6.3 Establishing a national drug regulatory authority
		6.4 Developing standard operating procedures and guidelines for drug inspectors
		6.5 Enforcing drug control laws
		6.6 Empowering the judiciary
		6.7 Fostering partnerships
		6.8 Sharing responsibilities
	7. Assessment of the problem at the national level
		7.1 Approaches
		7.2 Sampling procedures
		7.3 Limitations
	8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
		8.1 Broad objective
		8.2 Standard operating procedures (SOP)
		8.3 Counterfeit products
	9. Test methods
		9.1 Methods based on thin-layer chromatography
		9.2 Other simple methods
		9.3 Analytical techniques
		9.4 Visual inspection
		9.5 Successful implementation of simple tests
	10. Developing training programmes: inspection and examination of counterfeit pharmaceuticals
		10.1 General remarks
		10.2 Training programme on inspection
		10.3 Training programme on examination
		10.4 The practical issues of organizing and implementing the programme (35)
	11. Conclusion
	References
	Selected further reading
	Acknowledgements
	Glossary

Counterfeit Drugs

Guidelines for the development
of measures to combat
counterfeit drugs

Department of Essential Drugs and
Other Medicines
World Health Organization
Geneva, Switzerland

ORGANISATION MONDIALE DE LA SANTE

WHO/EDM/QSM/99.1
DISTR: GENERAL
ORIGINAL: ENGLISH

This document has been prepared under the auspices of the DMP-DAP Joint Project on Counterfeit Drugs which was administered by the World Health Organization Division of Drug Management and Policies (DMP) and the Action Programme on Essential Drugs (DAP) from 1995 to 1997. With effect from January 1999, the Department of Essential Drugs and Other Medicines Department (EDM) includes the former DAP and most components of DMP.

This document is not a formal publication of the World Health Organization (WHO) and all rights are reserved by the Organization. The document may, however, be freely reviewed, abstracted, reproduced, translated, in part or in whole, but not for sale nor for use in conjunction with commercial purposes.

The view expressed in documents by named authors are solely the responsibility of those authors.