The Maldives Food and Drug Authority (MFDA), in collaboration with World Health Organization has demonstrated exemplary commitment and vigilance in identifying contaminants ‘diethylene glycol’ and ‘ethylene glycol’, in syrups manufactured by PHARMIX Laboratories (Pvt) Ltd, setting a paradigm for global health protection. These contaminants are harmful substances utilized as industrial solvents and antifreeze agents. Ingesting even small amounts, particularly for children, can pose serious health risks.
The urgency of the matter unfolded in November 2023 when Republic of Maldives became the first country to detect such contaminants in syrups after having used a new screening method developed to support screening from less-resourced National Quality Control Laboratory (NQCL). Proactively, the MFDA initiated a screening programme of available products in the market utilizing the thin layer chromatography (TLC) test for diethylene glycol and ethylene glycol, as outlined in the International Pharmacopoeia.
The findings identified numerous potentially contaminated products, prompting regulatory actions to safeguard public health. Information was disseminated to WHO and other countries and additional investigations were initiated.
With the support of WHO, a comprehensive laboratory testing confirmed the contamination, with ethylene glycol levels ranging from 0.62 to 0.82% w/w—significantly surpassing the accepted limit of 0.10% w/w. This finding was not merely a national concern as the same products had been marketed in four other countries, thus enabling to safeguard public health at a global scale.
This success story is an extension of a broader initiative that traces back to October 2022 when WHO raised the alarm about substandard and contaminated pediatric medicines. WHO's call to action urged member states to prevent, detect, and respond to incidents of substandard and falsified medical products, emphasizing the critical need to protect children from contaminated medicines.
To address this global threat, a series of training sessions and workshops were conducted at WHO's three levels (Headquarters, Regional Offices, and Country Offices) and a strategy was developed by the South-East Asia Regulatory Network to ensure the integrity of excipients and enhance regulatory testing capacities.
In response to the alerts which was initiated by Maldives, PHARMIX Laboratories was instructed by the Drug Regulatory Authority of Pakistan (DRAP) to halt the production of all oral liquid dosage medicines. On November 16, 2023, DRAP issued a Recall Alert for five different syrup medicines manufactured by PHARMIX Laboratories, demonstrating a commitment to public safety, and reinforcing the effectiveness of international collaboration in safeguarding public health.
“The commendable work of the Maldives Food and Drug Authority, in partnership with WHO, serves as a beacon of success in addressing global health challenges, underscoring the importance of swift action, collaboration, and stringent regulatory measures to protect vulnerable populations from the grave consequences of contaminated medicines.” said Dr Nazneen Anwar, WHO Representative. “As we move forward, the importance of sustained efforts cannot be overstated. National regulatory authorities and health authorities are urged to persist in their efforts, promptly notifying WHO of any substandard products within their respective countries.”
Demonstrating the efficacy of international collaboration and translating intentions into actions, this success story underscores the importance of Maldives’s risk-based approach to market surveillance; a call reiterated by WHO. This collaborative and proactive approach, demonstrated by the Maldives, not only rectifies immediate challenges but also paves the way for a safer and more resilient future in the realm of global public health.