The Maldives Food and Drug Authority (MFDA) has set a new global standard in health protection by identifying harmful contaminants in syrups manufactured by PHARMIX Laboratories (Pvt) Ltd., the World Health Organization (WHO) has said. WHO, in a statement, commended the MFDA’s commitment and vigilance, stating that their work sets “a paradigm for global health protection.”
The contaminants in question, ‘diethylene glycol’ and ‘ethylene glycol,’ are industrial solvents and antifreeze agents. Even small amounts of these substances can pose serious health risks, especially to children. The MFDA detected these contaminants in November 2023 using a novel screening method developed for less-resourced National Quality Control Laboratories (NQCL).
The MFDA proactively initiated a screening programme of available products after this detection. This led to the identification of numerous potentially contaminated products, prompting regulatory actions to safeguard public health.
In response to the alerts initiated by the Maldives, the Drug Regulatory Authority of Pakistan (DRAP) instructed PHARMIX Laboratories to cease the production of all oral liquid dosage medicines. On 16 November 2023, DRAP issued a recall alert for five syrup medicines that PHARMIX Laboratories manufactured. This action underscores a commitment to public safety and reinforces the effectiveness of international collaboration in safeguarding public health.
Dr Nazneen Anwar, WHO Representative to the Maldives, commended the MFDA’s efforts, stating, “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. It underscores the importance of swift action, collaboration, and stringent regulatory measures to protect vulnerable populations from the grave consequences of contaminated medicines.”
WHO emphasised the importance of sustained efforts by national regulatory and health authorities and urged these entities to persist in their vigilance and promptly report any substandard products within their jurisdictions. This success story from the Maldives, underscored by the WHO, highlights the significance of a risk-based approach to market surveillance. The Maldives’ collaborative and proactive strategy addresses immediate challenges and lays the groundwork for a safer and more resilient future in global public health.
