Gonoshasthaya: Delays in test kit approval process depriving people of treatment

Gonoshasthaya Kendra (GK) founder Dr Zafrullah Chowdhury has said that many serious patients suffering from kidney and heart disease are being deprived of treatment due to delays in the approval process for their Covid-19 testing kit.

Dr Zafrullah made the observation at a GK hospital press conference on Monday.

He said: “Kidney patients are not getting dialysis. No hospital will admit a patient without a Covid-19 test result. People are dying without treatment. They should at least have the chance to get a Covid-19 test. 

“Bangabandhu Sheikh Mujib Medical University (BSMMU) formed a committee to validate our kit. The committee is ready. The sample of our kit is ready for handover to BSMMU. However, a letter from the vice-chancellor of BSMMU is needed to hand over the samples to the committee. The committee told us that the letter is ready and on the table of the VC, but the letter is yet to come to us,” he added.

“BSMMU formed a committee but did not empower the committee. The committee has to obtain permission from the VC for every step,” Dr Zafrullah continued.

“We are not accusing anyone. We want to say that it is a delay. We wanted to give at least some help to the people, but we failed to make them understand the importance [of test kits] in a pandemic situation. We need a comprehensive approach to serve the people,” the GK founder continued. 

“It is not rocket science to test our kit. BSMMU can do it in two or three days, if they want. They only need to match the efficiency of our kit with the efficiency of the PCR machine,” he said. 

Dr Zafrullah also requested temporary approval from the government to start tests with their kit.

“We cannot test our patients without approval. If we do, some can say we are not obeying the rules. Give us temporary approval until final approval, so that we can test some patients with our kits. Many countries have issued temporary approvals for rapid test kits,” he said. 

Dr Zafrullah also said he wants 5,000 square feet of land from anyone who can provide it, in order to make a dialysis center where 100 Covid-19 positive kidney patients can get dialysis every day.

The GK founder also wants to complete their Savar campus within a month so that they can begin producing 1 million test kits a month. 

“We failed to gain pride as the first inventor of a rapid test kit in the world. We have failed to bring honour to the country,” he said. 

When contacted, BSMMU Vice Chancellor Kanak Kanti Barua said: "Dr Zafrullah Chowdhury can say anything, but the fact is there is no involvement of mine in this validation process. I formed the committee, it was my duty. Now, the committee will review Gonoshasthaya's protocol, the committee will collect the kit sample and, finally, the committee will give the validation result. The committee will let me know. I have no other involvement in the process.

"When committee reviews the protocol, it needs some time as it is a scientific issue and involved with human health" the VC added.

Gonoshasthaya Kendra first wrote a letter to the Directorate General of Drug Administration (DGDA) on March15. Almost two months have passed since, but GK has still not received approval and third party validation remains incomplete.