Eliminate renewal of Drug Manufacturing License (DML)
Reform IDF344
DescriptionIt has been proposed to discontinue the periodic renewal of the Drug Manufacturing License (DML) and introduce an annual fee-based system to maintain license validity, thereby reducing administrative inefficiencies and aligning Pakistan’s regulatory framework with international best practices observed in India, the United States, and the European Union.
DepartmentDrug Regulatory Authority of Pakistan - DRAP
Jurisdiction / LocationFederal - Entire Pakistan
SectorPharmaceuticals and Healthcare
Start Date24-06-2025
Target Deadline30-06-2025
Date Enacted
Implementation StatusIn Progress
Progress 30%
CCORR DirectionSimplify
Cost Savings PKR (Mil.)17
Evidence