Bhutan has been designated as the Regional Centre of Excellence for Regulatory Quality Management Systems in a move to combat the growing threat of substandard and poor-quality medicines across South-East Asia. The recognition, announced by the World Health Organization (WHO), places Bhutan at the forefront of efforts to strengthen medical product safety and regulatory systems in the region.
The decision follows increasing reports of contaminated liquid medicines and ineffective antibiotics circulating in several South-East Asian countries, raising alarm over patient safety. Until now, countries in the region have largely depended on WHO’s regulatory tools to oversee the manufacturing, distribution, and registration of medical products.
Bhutan’s New Role
The Bhutan Food and Drug Authority (BFDA) and the Khesar Gyalpo University of Medical Sciences of Bhutan will collaborate with WHO to receive advanced training. Bhutanese regulatory officials will then provide capacity-building support to other countries within the South-East Asia Regulatory Network.
Jigme Tenzin, Chief Regulatory Officer at BFDA’s Medical Product Division, said the move is a crucial step toward ensuring safe and effective medicines for all.
“The quality defects we encounter are mostly due to substandard manufacturing, although we have not seen much falsification,” he said. “Any unsafe products we detect are immediately withdrawn from distribution. But having patients exposed to medicines that lack quality and safety increases the risk of other diseases.”
He added that Bhutan’s new role would allow regulators to keep pace with global innovations in pharmaceutical oversight. “This recognition gives Bhutan an opportunity to further strengthen capacity building and expose our regulators to new developments in regulatory processes,” he noted.
Regional Impact
WHO officials stated that Bhutan’s leadership will enhance regional readiness by establishing systems that ensure every medical product is “trustworthy, traceable, and safe.” However, it remains unclear when Bhutan will officially begin its work as the regional hub.
For now, Bhutan’s appointment signals a significant shift in how South-East Asia tackles the persistent issue of poor-quality medical products—an effort that could save countless lives across the region.
