The Directorate General of Drug Administration (DGDA) has not given its approval to the coronavirus testing kit developed by the Gonoshasthaya Kendra.
A spokesperson for the DGDA told Dhaka Tribune on Thursday that they have written to the Gonoshasthaya Kendra informing the decision.
“The technical sub-committee of the Drug Control Committee recommended to not approve it after reviewing the report filed by the BSMMU (Bangabandhu Sheikh Mujib Medical University) technical committee,” said DGDA Deputy Director Md Ayub Hossain.
He said the testing kit failed to meet “world-recognized criteria of having 90% accuracy, so it has not been approved."
The drug authorities official, however, said that Gonoshasthaya has the option to improve its testing kit’s accuracy and file for an approval again.
Describing the DGDA’s decision as “very unfortunate”, Gonoshasthaya Kendra said that its testing kit should have been approved in line with the recommendations made by the BSMMU amid the Covid-19 crisis.
The statement by Gonoshasthaya’s Coordinator for GR Covid-19 Rapid Dot Blot Kit Project Muhib Ullah Khandekar said that they will inform over their next course of actions “soon”.
