First regulatory science project targets toxic medicine contaminants
Monash University has joined the Therapeutic Goods Administration’s Academic Outreach programme, with the first regulatory science research to focus on detecting toxic contaminants in oral liquid medicines such as cough and cold syrups.
The partnership was formalised through a Memorandum of Understanding signed by Professor Anthony Lawler, Deputy Secretary of the Health Products Regulation Group and Head of the TGA, and Professor Chris Porter, Director of the Monash Institute of Pharmaceutical Sciences and Academic Director of Therapeutics.
Through the programme, Monash and the TGA will collaborate across research, knowledge exchange and education. Possible education work at Monash includes curriculum enrichment and collaborative teaching activities connecting students with regulatory science and public health practice.
Professor Chris Porter said the partnership would align academic research with regulatory practice. “By combining Monash’s research expertise with the TGA’s regulatory leadership, we can advance innovation while also creating meaningful opportunities for student engagement and exposure to real-world regulatory challenges,” Porter said.
Detecting toxic contaminants
The first research activity will involve the Monash Quality of Medicines Initiative working with the TGA’s Indo-Pacific Regulatory Strengthening programme to evaluate existing methods, and identify new approaches, for detecting ethylene glycol and diethylene glycol in oral liquid medicines.
Monash will continue to work with the TGA’s Indo-Pacific Regulatory Strengthening programme through the Monash Quality of Medicines Initiative, which shares objectives around improving regulatory capacity and addressing substandard medicines in the region.
Ethylene glycol and diethylene glycol are described as highly toxic industrial solvents that are chemically and physically similar to pharmaceutical ingredients including propylene glycol and glycerine. Their accidental or fraudulent addition to medicinal products has led to thousands of child fatalities over the past century, particularly in low and middle-income countries where regulatory oversight and testing capacity may be limited.
Since 2022, more than 400 children have died in Uzbekistan, The Gambia, Indonesia and India after falsified ingredients entered the supply chain, leading to global alerts from the World Health Organisation.
The research will assess and optimise analytical methods for detecting the contaminants in low-resource settings with limited laboratory infrastructure. A Monash Quality of Medicines Initiative PhD project will also explore a new low-cost and rapid screening test for contamination in pharmaceutical products.
Associate Professor Pete Lambert, Director of the Monash Quality of Medicines Initiative, said the work would focus on practical tools for lower-resource environments. “Advanced analytical technologies are not always accessible in many settings, particularly in low and middle-income countries, so our focus is on optimising lower-cost, practical detection methods suited to these environments, while also exploring new approaches for rapid and scalable screening,” Lambert said.
