16 Kenyatta University students who developed a ventilator yet to get approval
Despite a public promise by the government to nurture and grow local inventions some like the ventilators have gotten stuck in the country’s approval processes.
During visit to KU in early 2020, Trade and Industrialization Cabinet Secretary Betty Maina promised the government would play its part in ensuring the ventilators and swabs reached the market.
That pronouncement made in early 2020 was like music to the ears of 16 students of Kenyatta University who were at advanced stages of developing ventilators and swabs which they displayed to Health Cabinet Secretary Mutahi Kagwe and his counterpart from the Trade and Industrialisation Ministry Betty Maina when they toured the institution.
A promise was given to support and procure these innovations from the students once their products had passed the quality and standards test.
One year on, these ventilators have been gathering dust in the labs.
“We didn’t know these were the expectations, we expected it would take a shorter time,” Maina Mambo, the Dean of students at the university said.
Simon Ndirangu, a student at Kenyatta University who was part of the project said the requisite approval from the Kenya Bureau of Standards (KEBS) was had taken unusually long.
“Imechukua muda kwa KEBS kuapprove..tulikuwa tunatarajia tutapata leseni haraka tuweze kuuza,” he told Citizen TV.
Following a call from the Govermemt for manufacturers to come up with solutions to the challenges posed by the pandemi, a collaborative team of pharmacy, engineering and medicine students developed this critical machine, which it was hoped would provide a lifeline for COVID-19 patients who develop breathing difficulties.
Ndirangu said the students were the first in Africa to develop the ventilators and the swabs. At the time, they had big hopes because the government has made the appeal to innovators.
According to Mr.Maina, the Dean of students, the first prototype was subjected to international standards that’s why they had to bring in the Kenya Bureau of Standards.
They started with getting to know the production materials
The Government through the ministries of Health and that of Trade and Industrialisation made a promise to procure the machines once the process to verify their suitability was done.
Nearly one year later that has not happened.
“We applied to pharmacy board…reviewers gave their comment..we are waiting for the feedback so that we can go for clinical trials,” Mr. Mambo said.
Bernard Karanja, a student, said they have been waiting and recently made progress after the committee convened a meeting.
In July, after the team received the certificate of calibration they embarked on the process of getting approval from the Pharmacy & Poisons board for clinical trials.
The board began the process of forming the committee which involved a lot of back and forth with the young innovators.
Currently, the team is waiting for final feedback from the board on whether they should proceed to clinical trials or not.
They had hoped that their product would enjoy some sort of emergency authorisation similar to what vaccine developers have been able to use to get the life-saving jab out and in the market.
According to CS Betty Maina, several organisations including Dedan Kimathi University and even an international car manufacturer proposed to make ventilators locally but the complexity of the device has slowed down the process.
“I am surprised at how long the process has taken, but it is all about being careful to ensure that all standards are met. Health CS Kagwe and I have been doing our best to fast-track this process. The issue is that sometimes the relevant approval agencies wait for the other to approve before they being the process and also ventilators are sensitive pieces of equipment,” she told Citizen TV.
The Cabinet Secretary however said at least two of the ventilator innovators should see their products ready for commercial use in the next 3 months joining a list of other Kenyan made products that were used to fight the pandemic.
“We are glad to see face masks, PPE’s and other devices being used and other Kenyan products. So far we have authorized numerous Kenyan companies to provide these essential goods,” CS Maina added.
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