- Thomas P C Dorlo, senior scientist 12,
- Raffaella M Ravinetto, senior scientist 3,
- Jos H Beijnen, professor12,
- Marleen Boelaert, professor4
- 1Department of Pharmacy and Pharmacology, Slotervaart Hospital, The Netherlands Cancer Institute, Amsterdam, Netherlands
- 2Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
- 3Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium
- 4Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium
- Correspondence to: T P C Dorlo
Attaran and colleagues propose new definitions for the quality of medicines and plead for a global treaty tackling both substandard production and falsification.1 We support this, as the international community tends to concentrate its efforts on falsified medicines, whereas substandard drugs are just as much a threat.2 Moreover, in practice the distinction can be difficult.
We recently described the case of a poor quality medicine from Bangladesh that did not contain its active ingredient, miltefosine.3 4 The medicine, authorised by the national regulatory authorities, was manufactured locally for the Bangladeshi elimination programme for visceral leishmaniasis, a neglected tropical disease. The problem surfaced only after reports of abnormally high numbers of treatment failure.
According to the proposed definitions, this medicine is substandard. Whether it is falsified remains unclear. Attaran et al argue that a criminal intent would make the manufacturing …