The Directorate General of Drug Administration (DGDA) has agreed to begin a clinical trial of Gonoshasthaya Kendra’s rapid Covid-19 testing kits at Bangabandhu Sheikh Mujib Medical University (BSMMU) or Diarrhoeal Disease Research, Bangladesh (icddr,b).
The drug administration wrote a later to Gonoshasthay Kendra in this regard on Thursday mentioning that the inventors can conduct clinical trials of their testing kits at BSMMU or icddr,b, wherever they want.
Confirming the development, DGDA Deputy Director Md Salah Uddin said: “Gonoshasthaya wanted to conduct a clinical trial of their invented Covid-19 test kits at BSMMU or icddr,b. We wrote to them that they can conduct the trials at any of two organizations. It is up to them.”
“Copies of the letter were also sent to BSMMU and icddr,b, so that they can help Gonoshasthaya to conduct the trial,” he said.
“The kits can go for clinical trial after getting ethical approval from Bangladesh Medical Research Council (BMRC),” Salah Uddin added.
Gonoshasthaya Kenra submitted the protocol of their kit before the BMRC for ethical approval on Tuesday. A decision will be taken after reviewing the protocol.
When contacted, BMRC Director Dr Mahmood-uz-Jahan said: “We will make a decision as soon as possible after the completion of the review process. After conducting clinical trial, Gonoshasthaya will have to apply to DGDA for final approval to go for commercial production.”
A team of Gonoshasthaya-RNA Biotech, a sister concern of Gonoshasthaya Kendra, has developed the rapid testing kit, which can detect novel coronavirus infection in 15 minutes. The project cost about Tk2 crore.
After two months of research, Prof Dr Bijon Kumar Sil, head of the Department of Microbiology at Gono Bishwabidyalay, and his four associates Dr Nihad Adnan, Dr Md Raed Jamiruddin, Dr Firoze Ahmed, and Dr Muhibullah Khandaker invented the kit finally.
On March 17, Gonoshasthaya Kendra declared that they had developed a cheap testing kit that can examine samples to detect Covid-19 in mere minutes.
The team received a green signal from the government over two weeks ago to import the raw materials for producing the testing kits.
Researchers say the testing kit can detect coronavirus infection in 15 minutes and is expected to cost around Tk300-350 each.