DRAP Orders Nationwide Crackdown Against Substandard Diagnostic Chemicals

The Drug Regulatory Authority of Pakistan (DRAP) has directed a nationwide crackdown on illegal importation, unlicensed manufacturing, and unethical practices in diagnostic reagents following alarming reports of non-compliance with regulatory standards. In a directive issued on January 31, 2025, DRAP has instructed its field force to conduct extensive inspections of markets, importers, and wholesale distributors dealing in diagnostic reagents. As part of this initiative, the Deputy Director of DRAP’s QA/LT Division has directed all provincial drug authorities to conduct inspections and take strict enforcement actions against any violations. Authorities in Punjab, Sindh, Khyber Pakhtunkhwa, Balochistan, Gilgit-Baltistan, and Azad Jammu & Kashmir, Senior Drug Inspector ICT, Vice President Pakistan Pharmacist’s Association, and Health Care Commission have been instructed to check the illegal practices, ensure compliance with legal standards and submit a detailed report within three days. “It is requested to direct the field force under your administrative control to conduct thorough inspections of markets, importers, and wholesale distributors dealing in diagnostic reagents within their respective areas of jurisdiction. The purpose of these inspections is to verify compliance with regulatory requirements and take necessary enforcement actions against any violations,” DRAP said. This decision follows concerns highlighted by the Pakistan Pharmacist’s Association (PPA) in its letter dated January 29, 2025, addressing illegal practices and unregulated imports in the medical diagnostics sector. PPA said counterfeit and substandard diagnostic reagents (often relabeled as branded products) are misleading medical professionals and causing misdiagnoses and improper treatments that could be fatal. It warned that such violations not only compromise patient safety but also impact the overall healthcare system and economy.