Introduction of Separate Regime for Non-Sterile Personal Protective Equipment (PPE) Manufacturers
|Reform Description||Requirements for Manufacturing of Non-Sterile PPEs Simplified
Before: The manufacturers of PPEs were following a pharmaceutical regime which required them to hire pharmacists and install HVAC systems etc., causing huge financial burden.
After: Under the new Regime, all such unnecessary requirements have been removed for PPE manufacturers.
|Sector||Medical Devices Manufacturing|
|Jurisdiction/Location||Federal (Entire Pakistan)|
|Department||Drug Regulatory Authority of Pakistan (DRAP)|
|Date of Implementation||29-07-2021|
|Details||Difficulty||● After the breakout of COVID-19 pandemic, the global demand for Personal Protective Equipment (masks, gowns, gloves, etc.) increased manifold. This provided an opportunity to the manufacturers of the textile industry to tap into the local and foreign demand of PPEs.
● However, the regulatory regime for this sector was similar to the stringent requirements of the pharmaceutical sector, including hiring of pharmacist and installation of HVAC systems etc. which was unwarranted in PPE manufacturing and imposed additional burden.
|Analysis||● During Public Private dialogue between the stakeholders, it was concluded that requirements such as pharmacist/ HVAC were not needed for PPE manufacturers.|
|Solution||● On the basis of recommendations of BoI and the private sector, DRAP notified a separate regime for non-sterile PPE manufacturers in line with the international standards.|
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