• Wednesday, Aug 17, 2022
  • Last Update : 03:54 pm

GK kit likely to take a month to come into use if approved

  • Published at 01:55 pm May 1st, 2020
The rapid Covid-19 test kit developed by Gonoshasthya Kendra Rajib Dhar/Dhaka Tribune

Gonoshasthaya Kendra submitted a protocol to Bangladesh Medical Research Council for ethical approval of clinical test of their kits on Tuesday

The much discussed rapid test kit developed by Gonoshasthaya Kendra (GK) for detecting coronavirus in a human body, is likely to take up to a month to go for mass production if the kits pass all the standard procedures for approval.

Gonoshasthaya-RNA Biotech, a sister concern of GK, developed the GR Covid-19 Dot Blot test kit which can detect the novel coronavirus infection in 15 minutes, researchers said.

The GK has started following the formal process now to get approval for the kits.

Gonoshasthaya Kendra submitted a protocol to Bangladesh Medical Research Council (BMRC) for ethical and clinical test approval  of their test kits on Tuesday.  

After getting approval from the National Research Ethics Committee of BMRC, GK has to go to a third party contract research organization (CRO) for the clinical trials.

Gonoshasthaya has to apply to the Directorate General of Drug Administration (DGDA) for final approval of mass production with an ethical approval letter from BMRC with the results of the clinical trials. 

At this stage, the DGDA will evaluate all the documents and if it is satisfied, the authorities will give GK approval for mass production. 

After getting final approval of DGDA, Gonoshasthaya Kendra will be eligible to import the necessary raw materials for industrial production and all these steps will require at least one month to produce a large number of kits for sale and use.

Dr Mohib Ullah Khondoker, one of the co-inventors of the kit and vice principal at Gonoshasthaya Samajvittik Medical College, said: "We will need two to three weeks to start mass production after getting final approval. Import of raw materials is not possible without the approval. As many countries are using rapid test kits, the demand for reagents has increased. 

"If we received help from the very beginning, we could do it [mass production] this week," he said.

"We developed it first but we are late now. We have failed to achieve the national pride of becoming the first country to develop such a rapid test kit," he said.

Dr Mahmood-uz-Jahan, director of BMRC, told Dhaka Tribune: "Everyone should go through a proper system. There is no way of bypassing procedure when we are talking about science and especially when it will be used on human beings. 

"We will take a decision as soon as possible after completion of review [for ethical approval]. It will take no more than 5-6 days," he said.   

Who will conduct clinical trials?

After getting ethical approval from BMRC for conducting the clinical trials, Gonoshasthaya Kendra has to go to a contract research organization (CRO) for the clinical trials. But they have to go to a CRO through the DGDA to one of nine CROs in the country.

Gonoshasthaya wanted to conduct the clinical trial at Bangabandhu Sheikh Mujib Medical University (BSMMU) or icddr,b (International Centre for Diarrhoeal Disease Research, Bangladesh) as both are CROs of the country.

On Thursday, the DGDA agreed with Gonoshasthaya and wrote them that they can conduct clinical trials at BSMMU or icddr,b, wherever they choose.   

Md Salah Uddin, deputy director of DGDA, said: "Gonoshasthaya wanted to conduct clinical trials of their Covid-19 test kit invention at BSMMU or icddr,b. We wrote them, saying they can do it at any of these 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 trials," he said.

"The kits can go for clinical trials after getting ethical approval from the Bangladesh Medical Research Council [BMRC]," Salah Uddin added.

Criteria for getting ethical approval 

BMRC will send protocols to two reviewers for review. 

Reviewers will examine in detail what the method of production will be, who will sponsor it, who is investing in it and what the amount is. They will also examine how this investment will be used.

The reviewers will scrutinize the matter of whom the clinical trials will be conducted on, and whether the individuals give consent or not.

They will also examine whether there is any possibility of adverse effects on respondents or not. If so, what process of minimization of adverse effects will be followed. 

The reviewers will also see whether or not there is any clause of compensation if someone gets affected during the clinical trials. 

They will also evaluate if the kits are really needed and whether or not people will benefit if this product comes to market and so on. 

After completion of review, all members of BMRC will meet and take a decision. They may give ethical approval of clinical trials or refuse it if they are not satisfied.

BMRC Director Mahmood-uz-Jahan said: "Our main concern is human beings -- whether or not they will benefit from it and whether there is any serious adverse effect of this device on human life."

China and South Korea are taking advantage 

China is exporting rapid test kits but those have failed to maintain accuracy. India cancelled orders from China as Chinese kits have only a 5% accuracy. Some other developed countries have also rejected the Chinese kits as they were below standard. 

India, Malaysia and other countries are now importing from South Korea as South Korean kits have achieved 84% accuracy. South Korea is struggling to meet this huge demand.

On April 21, a HuffPost report said the Indian embassy in Seoul signed an agreement with a South Korean company for the supply of 500,000 rapid test kits to the Indian Council of Medical Research (ICMR).

On April 23, Livemint reported that the ICMR approved rapid test kits from South Korea, and the test kits will be used as per the protocol.

On April 16, Reuters reported that Malaysia also approved the use of antigen rapid test kits from South Korea.

On April 22, Free Malaysia Today reported the Ministry of Health said the delay in the arrival of Covid-19 rapid test kits from South Korea was due to logistical issues and the high demand for such innovations. Malaysia will import 1 million rapid test kits from South Korea. 

A recent CNN report said that so far the FDA (Food and Drug Administration) has approved five rapid test kits and these kits are not for mass use. These can be used on those individuals who have serious symptoms of Covid-19 infections.

Dr Mohib Ullah Khondoker said: "India has approved rapid test kits while USA approved earlier. The United Kingdom and other European countries will approve within a day or two according to foreign media outlets. 

"We wanted to manufacture kits in our country and we did not sell our methodology to any foreign companies. We think it is our national pride.

"The thinking that no country is using it [ rapid test kit], so we cannot use it either  has delayed the process," he added.  

Dr Mahmood-uz-Jahan said: "No country did it before does not mean that Bangladesh cannot do it either. But Gonoshasthaya has to come through a proper system and they did not do that."