The Bhutanese Leading the way.
In the wake of recent global concerns regarding the safety of medicines (cough syrup), Bhutan’s commitment to ensuring the safety of imported pharmaceuticals has come to the forefront. The Bhutan Food and Drug Authority (BFDA) assured that the medicines imported are done through thorough regulations including the importers to furnish the test report for the cough syrups.
The World Health Organization (WHO) issued a global alert over cough syrups, manufactured by the Delhi-based Maiden Pharmaceuticals, which were suspected to be associated with acute kidney injuries and the tragic deaths of 66 children in The Gambia.
WHO said that laboratory analysis of samples of the products “confirms that they contain unacceptable amounts of diethylene glycol (DG) and ethylene glycol (EG) as contaminants”, these substances can lead to symptoms such as abdominal pain, vomiting, diarrhea, altered mental state, and even acute kidney injuries, which may result in death.
Responding to these concerns, an official from BFDA stated, “Bhutan Food and Drug Authority is a party to the Global Surveillance and Monitoring System of WHO. Any defect or issues related to the quality of medicines are reported and shared with BFDA.”
The official emphasized that the BFDA has been closely monitoring the situation since 2022, particularly focusing on the presence of DG and EG in cough syrups. These contaminants were reported in countries, like Gambia, Indonesia, and Uzbekistan.
The official explained that all cough syrups imported into Bhutan must undergo rigorous testing for DG and EG, this process is conducted at the Royal Centre for Disease Control (RCDC). Furthermore, any pharmaceuticals entering the country must be registered with the BFDA, accompanied by a Certificate of Analysis (COA) detailing the absence of these harmful substances.
The BFDA official assured that Bhutan does not import medicines from Maiden Pharmaceuticals, the manufacturer linked to the concerning syrups. Instead, the majority of medicines are sourced from companies registered with BFDA, with thorough testing and authorization procedures in place. Bhutan’s pharmaceutical imports predominantly originate from India, followed by Bangladesh.
As part of their concern for public safety, the BFDA discourages citizens from obtaining medicines from cross-border outlets that may not adhere to the stringent regulations in place. They have urged the public to report any adverse effects or concerns related to cough syrups or other medicines to the BFDA.
In recent tests conducted on cough syrups available in the Bhutanese market, no traces of DG and EG were found, reaffirming the effectiveness of the regulatory processes and the safety of medicines available to the public.
Amidst growing international concerns over medicine safety, with the proper regulatory framework, stringent testing procedures, and vigilant monitoring, Bhutan continues to ensure the safety of medicines imported.
