Counterfeit Drugs - November 2003

Fact sheet
31 October 2003

1. Up until April 1999, of the 771 cases of counterfeit drugs reported to WHO, indications about the quality of the active ingredients contained were supplied only for 325 cases. Of these, about 59% contained no active ingredients, 7% contained the correct amount of active ingredients, 17% contained the incorrect amount of active ingredients and 16% contained different active ingredients.

* The consumption of a paracetamol syrup prepared using glycerol which was contaminated with diethylene glycol (a toxic chemical used as an anti-freeze) resulted in the death of 89 people in Haiti in 1995.
* Around 2500 people are believed to have died in Niger in 1995 after they were given a fake meningitis vaccine.

2. A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source.

3. Both branded medicines and generic medicines are subject to counterfeiting.

4. Counterfeiting of pharmaceuticals is a criminal activity often undertaken by people and organizations involved in other types of crime.

5. Trade in counterfeit drugs is widespread and affects both developing and developed countries.

6. The supply of counterfeited drugs is more pronounced in countries where the manufacture, importation, distribution, supply and sale of medicines are less regulated and enforcement weak.

7. The majority of counterfeit cases involve tablets and capsules. Antibiotics account for almost half of the reported cases of counterfeit drugs.

8. Counterfeit drugs are dangerous and can even result in death.

9. Counterfeit drugs are always a waste of public or private money.

10. Counterfeiters abuse the opportunities resulting from new global trade arrangements which may decrease traceability of pharmaceutical products and increase the chances for counterfeiting.

The terms "drug", "medicine", "pharmaceutical product" are used interchangeably in this paper.

Counterfeit Drugs: Action Sheet

  • National laws should ensue that the manufacture, trade, distribution and sale of medicines are effectively regulated.
  • Governments should establish and/or strengthen their drug regulatory authorities (DRAs) with responsibility for the registration and inspection of locally manufactured and imported medicines.
  • Drug regulatory authorities should develop standard operating procedures and guidelines for the inspection of suspected counterfeits.
  • Adequate training and powers of enforcement against counterfeits should be given to personnel from drug regulatory authorities, the judiciary, customs and police.
  • Drug regulatory authorities should initiate widespread use of screening tests for the detection of counterfeits.
  • Severe penalties should be introduced and applied for criminals caught manufacturing, supplying or selling counterfeit drugs.
  • Partnerships should be established between health professionals, importers, industry and local authorities to combat counterfeits.
  • Countries should systematically use the WHO Certificate Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
  • Countries in the same region should work towards the harmonization of their marketing authorization procedures.
  • Countries with experience in combating counterfeit drugs should provide assistance to others for training in areas related to quality control, drug detection and enforcement.

For enquiries please contact:
Quality Assurance and Safety of medicines (PSM/QSM)
World Health Organization CH-1211 Geneva 27
Tel: +41 22 791 37 43
Fax: +41 22 791 47 30