313ghazi
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ISLAMABAD: Minister for Science and Technology Senator Shibli Faraz on Tuesday said his ministry will expedite the registration of ventilators with the Drug Regulatory Authority of Pakistan (Drap) to ensure their timely availability for induction in the healthcare system and export.
He stated this while chairing a meeting held to discuss efforts being made to counter the effects of Covid-19 pandemic.
During the meeting, an update on Pakistan-manufactured ventilators system (PMVS) and innovative products developed with facilitation and coordination of the science ministry was presented to the minister.
Mr Faraz said medical devices manufactured in Pakistan, including ventilators, should conform to the international standards and quality.
The participants were informed that out of the initial 57 ventilator designs only 16 could meet the requirements of ICU ventilators as per Acceptance Test Procedure (ATP) defined by Drap.
Currently, 2x ventilators, Pak Vent-1 (developed by Nescom) and I-live Vent (developed by PAEC) have been cleared by the Pakistan engineering Council PEC and are under clinical validation by Drap. If approved, 50 ventilators could be available in two months.
Moreover, Alnnovent developed by Alsons Group Karachi was cleared by PEC and its application for National Bioethics Committee (NBC) was under process for clinical validation study and if completed on time 10 ventilators would be available in a month.
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Who are the 41 people/companies who submitted designs for ventilators that didn't meet DRAP criteria? Did nobody on these projects think they ought to look up any legal requirements for the product they were designing? It's this sort of immaturity that really worries me about our country.
He stated this while chairing a meeting held to discuss efforts being made to counter the effects of Covid-19 pandemic.
During the meeting, an update on Pakistan-manufactured ventilators system (PMVS) and innovative products developed with facilitation and coordination of the science ministry was presented to the minister.
Mr Faraz said medical devices manufactured in Pakistan, including ventilators, should conform to the international standards and quality.
The participants were informed that out of the initial 57 ventilator designs only 16 could meet the requirements of ICU ventilators as per Acceptance Test Procedure (ATP) defined by Drap.
Currently, 2x ventilators, Pak Vent-1 (developed by Nescom) and I-live Vent (developed by PAEC) have been cleared by the Pakistan engineering Council PEC and are under clinical validation by Drap. If approved, 50 ventilators could be available in two months.
Moreover, Alnnovent developed by Alsons Group Karachi was cleared by PEC and its application for National Bioethics Committee (NBC) was under process for clinical validation study and if completed on time 10 ventilators would be available in a month.
Registration of ventilators with Drap to be expedited, says minister
Shibli Faraz says medical devices manufactured in Pakistan should conform to international standards and quality.
www.dawn.com
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Who are the 41 people/companies who submitted designs for ventilators that didn't meet DRAP criteria? Did nobody on these projects think they ought to look up any legal requirements for the product they were designing? It's this sort of immaturity that really worries me about our country.