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New manual warns on counterfeit drug dangers

WASHINGTON, D.C., September 12, 2002 -- A new manual published by Reconnaissance International, 'Protecting Medicines: A Manual of AntiCounterfeiting Solutions', details the threat to public health posed by counterfeit pharmaceuticals and outlines measures regulators and drug companies can take to protect the drug supply.

The manual defines a counterfeit drug as a medicine which"...may contain no active ingredient, an improperly low or high dosage, or poisonous ingredients. Such counterfeits can either fail to treat the illness or condition for which they are being taken, resulting in prolonged illness or death, or they can be the direct cause of death by containing ingredients which are injurious to human health."

The threat of counterfeit drugs appears to be increasing, in both developing and developed countries, state the authors. For example:

  • According to a recent study by a Bangkok University researcher, about a third of the antimalarial treatments on sale in Cambodia, Laos, Myanmar, Thailand and Vietnam contained no active ingredient.
  • Another study found that nearly half the drug samples analyzed from pharmacies in Nigeria were defective.
  • Between 60,000 and 80,000 children in Niger were given fake vaccines, which may have led to hundreds of fatal infections.
  • Fake Zantac, an anti-ulcer drug, has been found in UK pharmacies.
  • Counterfeit versions of Neupogen (prevention of infections in cancer patients), Serostim (AIDS wasting), Zyprexa (mental illness), Epogen (anemia), and Combvir (AIDS) have recently been found in the US.
  • Between January 1999 and October 2000 alone, 46 reports on counterfeit drugs were received by the World Health Organization (WHO) from 20 countries. About 60 percent of the reports came from developing countries, with the remaining 40 percent from developed countries.

Dr. Yasuhiro Suzuki, WHO Executive Director in charge of Health Technology and Pharmaceuticals, is cited as saying: "No country is immune from the threat of counterfeit drugs but those with weakly regulated pharmaceutical markets suffer most."

Among the factors encouraging counterfeiting, according to the manual, is "absence of or weak drug regulation". Only 20 percent of the 191 member states of WHO are considered to have well-developed drug regulation. In the other 80 percent, drug regulation is weak or lacking.

For full information on the Protecting Medicines Manual, visit

Posted: September 2002