Every time a patient swallows a medicine, it is expected to be safe, effective, and properly tested. But across South-East Asia, that assumption is increasingly under strain. Now, to ensure quality and safety of medicines and equipment, the South-East Asia Regulatory Network has identified Bhutan as the regional centre. Bhutanese officials will receive training and, in turn, provide capacity building support to other countries within the network.
From contaminated oral liquid medicines to substandard antibiotics, the rise in reports of poor-quality medical products has triggered new regional reforms. This was shared by the officials from the World Health Organization (WHO).
Until now, the South-East Asia Regulatory Network countries have relied on the WHO tools to assess and improve the regulation of manufacturing, distribution and registration of medicines.
Jigme Tenzin, the chief regulatory officer of Medical Product Division in BFDA said, “The quality defect or problems encountered mostly are with regard to substandard, although we have not seen much falsification. But issues arise during the manufacturing process, which we could recognise at the stage of post-market surveillance. However, if we identify any unsafe products, they are immediately withheld from distribution.”
He added that having patients exposed to medicines without quality, safety, and effectiveness will increase the burden of getting other diseases.
During the recent meeting, as Bhutan has been identified as the Regional Centre of Excellence for Regulatory Quality Management Systems, the Bhutan Food and Drug Authority and the Khesar Gyalpo University of Medical Sciences of Bhutan will collaborate with WHO to get training on improving regulations on quality and safety of medicines.
Jigme Tenzin added that, “Identifying Bhutan as the regional excellence for regulatory quality management system gives an opportunity for Bhutan to further engage in capacity building as well as to get the regulators exposed to any new development and innovations in terms of regulatory processes.”
However, officials said it is not known when the service will officially begin.
According to WHO, Bhutan will not only improve its local capacity building, but strengthen regional readiness, one that ensures every medical product reaching the public is trustworthy, traceable, and safe.
Namgay Dema
Edited by Tshering Zam
