ASSESSMENT OF THE INCIDENCE OF SUBSTANDARD DRUGS IN DEVELOPING-COUNTRIES

In a number of developing countries there is reportedly a high inciden ce of the availability of substandard drugs. The majority of these rep orts do not contain quantitative data to support these claims, nor do they describe the methodology employed for the quality assessment. Man y assume counterfeiting as the reason for the poor quality and in some cases this is not justified. We collected 96 samples of chloroquine a nd selected antibacterials from Nigeria and Thailand in a controlled a nd methodical manner and analysed them using appropriately validated m ethods based on high-performance liquid chromatography capable of dete cting drug-related impurities and quantifying active drug(s). The resu lts indicate that 36.5% of the samples were substandard with respect t o pharmacopoeial limits. Decomposition was the cause of poor quality i n a number of the samples but overall, poor manufacturing appeared to be prevalent. The analyses generated little evidence to indicate fraud ulent manufacturing. Treatment failure and drug-resistance are possibl e consequences of the use of substandard drugs.