Diethylene glycol (DEG) and ethylene glycol (EG) are commonly used in the manufacture of industrial products such as antifreeze and glues and are never to be ingested by humans.
Unfortunately, DEG/EG have found their way in pharmaceutical products such as paediatric cough and paracetamol syrups, with such outbreaks dating back to 1937 in the USA and more recent reports in 2022 from The Gambia, Uzbekistan, Indonesia, Pakistan, Cameroon, Nigeria, Lao PDR, the Maldives and the Marshall Islands & Micronesia.
DEG & EG cause multiorgan failure, especially acute renal failure and neurological dysfunction, and have resulted in hundreds of deaths, especially of children. The presence of DEG & EG may have been caused by errors in manufacturing processes due to mislabelled glycols or substitution of the recommended pharmaceutical grade glycol excipients, glycerine, and propylene glycol (PG), that are used in good quality cough and paracetamol syrups.
The usual reference assay for detecting DEG & EG is gas chromatography with flame ionisation detection (GC-FID) but this is expensive, complicated and not commonly available in low- and middle-income countries (LMICs) where contaminated syrups are mostly reported. There are currently no widely available, inexpensive, easy to use or portable devices for inspectors to screen for DEG & EG.
Thus, the aim of this target product profile (TPP) is to provide guidance for the development of new screening devices that will enable the identification of substandard or falsified pharmaceutical products contaminated with DEG/EG.
The World Health Organization is now seeking feedback on this draft TPP from experts in industry, product developers, the scientific community, implementers and health programme personnel currently involved in the management and control of contaminated pharmaceutical products.
Comments may be submitted by individuals or organizations and will be accepted until Friday 8 August 2025, using the following feedback form:
Please submit your completed feedback form to: rapidalert@who.int
Proposed revisions arising from this public consultation will be considered by the TPP Development Group before the TPP is finalized.