The Drug Regulatory Authority (DRA) celebrated its first foundation day coinciding with the World Blood Donor Day yesterday. Coinciding with the day, DRA launched quality manual and technical guideline for manufacturing medicines and other information materials related to medicines.
DRA deals with all matters related to medicine and medicinal products. Apart from regulating medicines, the DRA is also the regulatory body for blood safety in the country.
“The DRA plays a very important role in ensuring the safety of the blood. Under the blood and blood products regulation 2016, the authority has been regulating areas related to blood because blood is also like medicine and we have to ensure there are reporting systems in case of reactions due to transfusion of blood. We also look at various aspects like processing, the way things are documented and the capacity of the people. Therefore DRA plays a very important role in ensuring the quality of the blood,” said Kinga Jamphel, Head of DRA.
Blood and blood products regulation of Bhutan 2016 came into force from June 2016 and since then DRA has been monitoring the blood products in collaboration with the Ministry of Health.
This regulation applies to all the blood centres and blood storage centres involved in the collection, preparation, storage and quality assurance of blood and blood products.
“Actually the regulations came into force from 2016, since then we have working side by side within the Ministry of health especially in putting systems into place. We also do inspections of various health centres and make sure that the hygiene, sanitation, and the processes carried out by the people in the process of blood transfusion. Since 2016 we have been gradually enforcing the regulations and of course taking note of the availability of resources in the local situation,” he added.
The day was also celebrated to create awareness among the public on the mandates of the Authority and the important role played in assuring the quality of medicinal products in the country. The day was also to acknowledge the contributions of various stakeholders and celebrate past achievement together.
The DRA was established as a unit under the Ministry of Health in 2004. Later in 2008, the Authority was delinked from the ministry of health as an autonomous agency.
