The Directorate General of Drug Administration finally has permitted Gonoshasthaya Kendra for their COVID-19 detecting kits’ performance trial after much controversies and delay.
‘The kendra can now test its kits at Bangabandhu Sheikh Mujib Medical University or International Centre for Diarrhoeal Disease Research, Bangladesh and handover the result to us,’ said director general of DGDA Mahbubur Rahman.
He told New Age that they would take necessary steps for registration after getting the result.
Earlier, GK founder Zafrullah Chowdhury complained that Drug Administration had declined to accept the kits.
DGDA director general said that they had sent a letter to the Gonoshasthaya Kendra confirming permission for the external validation of the kit.
Gonoshasthaya-RNA Biotech Limited, a concern of Gonoshasthaya Kendra in Bangladesh, had developed a method named Rapid Dot Blot to test COVID-19.
The kits were unveiled in a programme on Saturday where the GK officials were supposed to hand over the kit to the DGDA officials for validation.
The concerned government and health ministry officials, however, did not attend the programme and later they said that they had no plan to permit Rapid Testing Kits.
Zafrullah on Thursday told New Age that they had received a letter that confirms permission from the DGDA.
GK will complete its performance trial at BSMMU and the DGDA had already informed BSMMU about it, Zafrullah said.
‘We express our gratitude to the government and the drug administration for their support and requested BSMMU for quick and swift test,’ he added.
Zafrullah said that BSMMU can simultaneously test COVID-19 infected patients in their regular PCR machine and the GKdeveloped Rapid Dot Blot kits.
Thus they can easily judge effectiveness of newly developed kits, he added.
Meanwhile, earlier on Wednesday, GK officials handed over the kit developing protocols to Bangladesh Medical Research Council for its reviews.
BMRC director Mahmood-uz-Jahan told New Age that they sent the protocol to a review committee who would examine the kits’ development procedure.
‘We will send the review committee’s recommendation to the Gonoshasthaya Kendra. After their modification, we will place the protocol to National Research Ethics Committee and then they might get approval,’ he added.
Zafrullah earlier complained that the Drug Administration and other government health agencies were indifferent and non-cooperative in their efforts of providing COVID-19 testing kits and the prime minister’s office had to intervene in this process.
He said that US Centres’ country director Michael S Friedman wrote to him that they were willing to evaluate the kit.
‘We are hopeful of providing them with the kits on Sunday,’ he said.
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