Counterfeit Drugs: 8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard: 8.3 Counterfeit products

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

Table of Contents

	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

8.3 Counterfeit products

The following applies specifically to counterfeit products:

- When examining a possible counterfeit pharmaceutical product the inspector shall first screen the product by looking, smelling, touching and listening to the sound of me packing and its contents. The inspector shall look for anything, in particular its labelling and packing, that makes the product look different from an original reference sample. A SOP may assist in examining the product in this way.

- When the organoleptic examination does not give conclusive evidence the inspector shall have a sample tested using appropriate simple screening methods, such as the basic tests recommended by WHO or a suitable thin-layer chromatography method.

- In addition to any full analytical testing, the drug regulatory authority of the country of origin stated on the label of the product may be asked to establish whether the product is counterfeit.

- Proven cases of counterfeit pharmaceutical products shall be fully documented and communicated to all other inspectors, to increase their level of expertise. Information on counterfeit products shall also immediately be made available to drug regulatory authorities of other countries concerned and to WHO.