No application submitted for OxyJet performance trial: DGDA
Directorate General of Drug Administration has said they received no application for approval of the performance trial of OxyJet CPAP, invented by a team of Biomedical Engineering Department at Bangladesh University of Engineering and Technology (Buet).
OxyJet is a low-cost medical device that can be an alternative to the costly high flow nasal cannula used for oxygen support to Covid-19 patients at hospitals.
"News has been published that the DGDA is not permitting the commercial production of the OxyJet medical device invented by Buet, and for this, the issue has been placed at the High Court for attention," said a press release issued by the DGDA last night.
DGDA said they did not receive any application for the approval of the device, the press release said.
To get DGDA's approval for supply of any medical device to the market, it needs an endorsement from the Bangladesh Medical Research Council (BMRC) and that must be produced in a factory that has ISO:13485 compliance, said the press release.
However, the DGDA recognised that Prof Toufiq Hasan, who led the OxyJet inventor team, informed them verbally and DGDA helped him discuss the issue with officials of several private companies including JMI, ANC, Get Well and Incepta Medical Device Ltd.
"DGDA made the way easier for commercial production of the device and suggested him (Toufiq Hasan) to apply to the drug administration for the approval of performance trial protocol," read the press release.
A number of media reports recently said that OxyJet is not getting the approval due to the complex procedure of DGDA and non-cooperation of the manufacturing companies.