Gonoshasthaya Kendra likely to hand over testing kits on April 24-25 for approval

[bluesky]

https://www.dhakatribune.com/health...over-testing-kits-on-april-24-25-for-approval

Gonoshasthaya Kendra likely to hand over testing kits on April 24-25 for approval
Mehedi Al Amin

• Published at 12:15 pm April 21st, 2020

Bigstock

They are planning to produce 100,000 kits per month once approved

The Gonoshasthaya Kendra (GK) is expecting to hand over coronavirus testing kits to the government on April 24-25.

Gonoshasthaya-RNA Biotech Limited has been developing the testing kit -- Rapid Dot Blot -- and is hopeful to get approval from the Directorate General of Drug Administration (DGDA) within a short time after the first batch of kits are handed over.

They are planning to produce 100,000 kits per month once approved.

Gonoshasthaya Kendra founder Dr Zafrullah Chowdhury told the Dhaka tribune on Monday that they are expecting to handover some kits on April 24-25.

DGDA, Institute of Epidemiology, Disease Control and Research (IEDCR), International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Combined Military Hospital (CMH), World Health Organization (WHO), and Bangabandhu Sheikh Mujib Medical University (BSMMU) will receive the kits, he continued.

"Then, they can compare our rapid test kits with Real time PCR kits."

Meanwhile, Dr Zafrullah said they obtained good results by their testing kits after analyzing five blood samples that had tested positive for Covid-19.

The IEDCR gave the samples to the GK earlier this month.

Raw materials are crucial

Gonoshasthaya Kendra is now struggling with raw materials to produce kits due to the lockdown across the world, the founder said.

"Everything is disrupted. Raw materials have to be imported as we do not produce those in the country. A lot of things are required in a manufacturing industry to produce this kit.

"Some raw materials are in Dubai and some are in China. We are trying to bring those here as soon as possible," he said.

Gonoshasthya Kendra asked for at least 3cc blood samples from 10 Covid-19 positive patients each for further testing, but they were yet to receive the samples till Monday afternoon, he said.

"We need approval from DGDA for mass production. So after the samples are provided, we are expecting to get approval from DGDA within a day or two," said Zafarullah.

He, however, said approval from WHO is not required in producing the rapid testing kits.

Gonoshasthaya-RNA Biotech earlier wanted to handover the kits to government and large medical institutions on April 11, but the attempt failed because of mechanical and electric disruptions.

On March 17, Gonoshasthaya Kendra declared that they had developed a cheap testing kit that can examine samples to detect Covid-19 in as little as 15 minutes.

A technical team of Gonoshasthaya-RNA Biotech Limited developed the testing kits and it cost about Tk2 crore.

After a two-month 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.

The team received a green signal from the government in late March 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.

 

[UKBengali]

Well looks like it is an effective testing kit but the only snag is that raw materials may be a problem.

If sufficient raw materials can be obtained then having the capacity to test 100,000 extra people a month would be very useful in the fight against coronavirus in BD.

 

[bluesky]

Well looks like it is an effective testing kit but the only snag is that raw materials may be a problem.

If sufficient raw materials can be obtained then having the capacity to test 100,000 extra people a month would be very useful in the fight against coronavirus in BD.

However, concern remains if this made in BD testing kit is up to the required world standard. I have read news whereby Turkey rejected made in China kits.

And one Chinese poster replied there are many different grades of companies in China, and foreign countries should import high quality ones. This is a typical example that there is no central authority to certify goods in China. It is the same for all other goods. You pay more and you get better products. In the case of Japan, it never allows export of goods not produced to match the standard. Domestic standard is even higher.

Most of Chinese goods are of low quality/raddi. I hope BD will follow the strict Japanese way of maintaining the standard.

 

[UKBengali]

However, concern remains if this made in BD testing kit is up to the required world standard. I have read news whereby Turkey rejected made in China kits.

And one Chinese poster replied there are many different grades of companies in China. Countries should import high quality ones. This is a typical example that there is no central authority to certify goods in China. It is the same for all other goods. You pay more and you get better products. In the case of Japan, it never allows export of goods not produced to match the standard. Domestic standard is even higher.

Most of Chinese goods are of low quality/raddi. I hope BD will follow the strict Japanese way of maintaining the standard.

Yes and that is why the kit will undergo even further trials before it is approved for mass production.

One thing that gives me hope is that the team is led by Prof Dr Bijon Kumar Sil who worked in Singapore during the SARS out break in 2003.

Please see below what calibre of scientist this man is:

https://www.aljazeera.com/news/2020...te-3-kit-detect-covid-19-200323035631025.html

"Dr Sil invented a similar kit for detecting the SARS coronavirus while working in Singapore during the outbreak of the respiratory disease in 2003. The Chinese government later bought the patent of the kit he developed as it was proven to be effective in detecting the SARS coronavirus "in most cases".

Remember that both Covid-19 and SARS are from the same coronovirus family of pathogens and so Pro Sil definitely is one of the world's top scientists in this area.

 

[bluesky]

https://www.newagebd.net/article/105186/dgda-declines-to-accept-samples

Gonoshasthaya Kits
DGDA declines to accept samples
Iqbal Mahmud Rana | Published: 19:58, Apr 26,2020 | Updated: 00:24, Apr 27,2020

The Directorate General of Drug Administration has refused to accept the COVID-19 test kit developed by Gonoshasthaya Kendra, said the Kendra’s founder Zafrullah Chowdhury on Sunday.

He also said that the DGDA appeared indifferent and non-cooperative to efforts of developing the kits.

In a briefing at Gonoshasthaya Kendra Hospital at Dhanmondi in Dhaka, Zafrullah alleged that the directorate wanted to serve the business interest of some private companies, not of the people.

The briefing took place hours after DGDA allegedly declined to accept Gonoshasthaya-manufactured samples of COVID-19 testing kits for external validation.

Earlier on Saturday, the Kendra unveiled its kits named Rapid Dot Blot to test COVID-19.

Related Coverage:

• › Gonoshasthaya unveils kit
• › Gonoshasthaya gets permission for kit trial

The organisation planned to handover the samples to that the DGDA officers at a programme, but no government officers turned up there despite being invited.

Zafrullah at the briefing said that a three-member Gonoshasthaya Kendra team, including Bijon Kumar Sil, the scientist who developed the kit, went to the Drug Administration office to handover samples to get approval.

‘Drug Administration officers asked us to complete validation through a third-party Contract Research Organisation. At first they recommended ICDDR,B, but that organisation is currently under lockdown. Then they asked us to go to a CRO,’ said Zafrullah.

About the validation by a third-party CRO, he said that the Drug Administration had said that if Gonoshasthaya did not want to do the validation by a third-party CRO itself, the administration would have to prepare a budget for the work and then it would be sent to the company for validation.

He added that the process would rather delay the kit supply process during present crisis time.

DGDA is acting against public interests and prioritising private interests, said the Kendra trustee.

‘We have developed the kit and now it is up to the DGDA to approve it. Instead DGDA officers are creating hurdles in every step. They are rather focusing on third-party contract research organisation for misappropriating money,’ said Zafrullah.

He said that the DGDA should decide who to examine or validate the kits because if Gonoshasthaya was asked to do it, it might go to an organisation with which it had good relationship and which would validate its kit without proper investigation.

DGDA director general Mahbubur Rahman, however, denied the allegation saying that Zafrullah was rather misleading people.

‘A team of Gonoshasthaya Kendra came to us today (Sunday) and we had a discussion in a cordial manner. We have asked them to complete external validation tests from Bangabandhu Sheikh Mujib Medical University, Institute of Public Health and Institute of Epidemiology, Disease Control and Research. They also agreed to do that,’ Mahbubur told New Age.

‘Now, they are telling the opposite at their briefings. I smell something fishy,’ he added.

The Kendra has been complaining that unwillingness from the concerned authorities and bureaucratic complexities delayed their efforts for developing kits to detect novel coronavirus infections.

Even the prime minister’s office had to intervene for getting them permission for COVID-19 sample testing from the Directorate General of Health Services

 

[ebr77]

Looks like the corrupt bureaucrats and leaders will not allow us to be saved so easily.

https://www.facebook.com/video.php?v=2594630037422627

 

[mmr]

Looks like the corrupt bureaucrats and leaders will not allow us to be saved so easily.

https://www.facebook.com/video.php?v=2594630037422627

dont worry. corona will go away by its own. BAL ministers says so.

 

[bluesky]

dont worry. corona will go away by its own. BAL ministers says so.

No, you are wrong in this count. I believe in what minister Obaidul Quader said the other day. He said BD people's united power will hold out Covid-19. By the same logic, an all powerful BD does not need testing kits as well. This is why govt people are discouraging its inventors.

 

[mmr]

No, you are wrong in this count. I believe what minister Obaidul Quader said the other day. He said Corona is afraid of BD people's united power. By the same logic, an all powerful BD does not need testing kits.

It will just go away....one day obaidul will wake up and it will just be gone. Just like magic.

 

[ebr77]

dont worry. corona will go away by its own. BAL ministers says so.

Note that Dr Jafarullah mentioned that these people will not be swayed easily as they are profiting heavily by importing kits used in PCR from China / India .

 

[mmr]

Note that Dr Jafarullah mentioned that these people will not be swayed easily as they are profiting heavily by importing kits used in PCR from China / India .

Its true for many things in bd where we dont have local capacity as BAL listen to lobbyists who are importers. Most time these business ppl are politically connected. Even during piblic health crisis BAL and the cronises working hard to make money. And you wonder why BD is far behind in manufacturing capacity.

 

[bluesky]

Note that Dr Jafarullah mentioned that these people will not be swayed easily as they are profiting heavily by importing kits used in PCR from China / India .

You are correct. Please, also understand why locals are not building many other industries? It is because a few govt/BAL stakeholders get financial benefits from the importers of daily necessities from China and India.

This group of national traitors will lose their bribe money if local people build industries and produce goods, instead. So, this BAL group in the govt discourages local industries to grow. I am not talking here about export industries but for local consumption.