Introduction of Separate Regime for Non-Sterile Personal Protective Equipment (PPE) Manufacturers

Reform ID F005
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
Beneficiaries PPE Manufacturers
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.
Reference Document

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