A number of designs have been submitted to the ministry and a few are in advanced approval stages
Federal Minister of Science and Technology, Senator Shibli Faraz during a Covid-related meeting said his ministry will ensure the timely registration of ventilators with the Drug Regulatory Authority of Pakistan (DRAP) in a bid to have ventilators inducted into the healthcare system as quickly as possible. Faraz emphasized that locally manufactured medical devices must meet international standards.
The minister was updated on the Pakistan Manufactured Ventilators System (PMVS) and innovative products developed with the facilitation and coordination of the Ministry of Science and Technology/ Pakistan Engineering Council. It was discussed that out of the initial 57 ventilator designs, only 16 met the requirements of Intensive Care Unit (ICU) ventilators as per Acceptance Test Procedure (ATP) defined by DRAP and PEC.
For the moment, ventilators from NESCOM, known as Pak Vent-1 have been cleared by PEC and under clinical validation by DRAP. Post-approval, 50 ventilators can be delivered for use in 2 months’ time.
PAEC’s I-Live approved by DRAP and PEC
As per PAEC, its ventilator I-live Vent has received approval from DRAP as well after going through the testing process. “Besides passing through all internal reviews and testing, the ‘i-Live’ ventilator also successfully passed the independent reviews and testing conducted throughout the development lifecycle by the evaluation team from Pakistan Innovation and Technology Centre and the Pakistan Engineering Council (PEC),” PAEC said.
Alsons Group Karachi’s Alnnovent is cleared by PEC and its application for National Bioethics Committee (NBC) is under process for the clinical validation study. The company will be able to deliver 10 ventilators in a month if its validation comes through.