ISLAMABAD: In response to mounting concerns over the use of substandard diagnostic chemicals, the Drug Regulatory Authority of Pakistan (DRAP) has initiated a nationwide crackdown aimed at curbing illegal imports, unlicensed manufacturing, and unethical practices in the diagnostic reagent sector.
Issued on January 31, 2025, the directive calls for DRAP’s field force to carry out extensive inspections across markets, importers, and wholesale distributors dealing with diagnostic reagents to ensure regulatory compliance.
The Deputy Director of DRAP’s QA/LT Division has directed provincial drug authorities to enforce strict actions against violators. This includes the authorities in Punjab, Sindh, Khyber Pakhtunkhwa, Balochistan, Gilgit-Baltistan, Azad Jammu & Kashmir, as well as Senior Drug Inspectors in Islamabad and officials from the Pakistan Pharmacists Association (PPA) and the Health Care Commission.
The directive urges these authorities to conduct thorough inspections, ensuring that diagnostic chemicals comply with legal standards and to take necessary enforcement measures where violations are found. A detailed report of the actions taken is required within three days.
This decision follows a warning from the PPA in its letter dated January 29, 2025, which highlighted the alarming issue of counterfeit and substandard diagnostic reagents being sold in the market. These subpar products, often relabeled as branded items, have been misleading medical professionals, leading to misdiagnoses and improper treatments, which can have fatal consequences.
The PPA stressed that such violations not only put patient safety at risk but also undermine the healthcare system and economy, making regulatory intervention essential for the protection of public health.
