LAHORE: Serious concerns have been raised over the alleged use of expired and mislabelled blood culture reagents at Jinnah Hospital Lahore, posing a grave risk to patient safety.
In a formal application to the Drug Regulatory Authority of Pakistan (DRAP), Noor Muhammad Mahar, Pharmacist Advocate High Court and President of the Pakistan Drug Lawyer Forum (PDLF), has called for an immediate inquiry into the matter. He alleged that expired reagents—reportedly in use since 2022—were illegally imported and re-labelled with falsified expiry dates extending to 2025.
The complaint highlights that these reagents, used for bacterial growth testing in blood transfusion patients, are classified as In-Vitro Diagnostic (IVD) Medical Devices. Under DRAP rules, they must be duly registered, have valid stability data, and carry proper import authorization. Their use, Mahar warned, could result in false-negative bacterial contamination tests, potentially leading to unsafe transfusions and life-threatening infections.
The application cites violations of Section 23 of the DRAP Act, 2012, and the Medical Devices Rules, 2017, which prohibit the manufacture, sale, or import of unregistered and mislabelled medical devices. It also refers to the Punjab Blood Transfusion Safety Act, 2016, which enforces strict liability on blood banks and hospitals to ensure safe transfusions, and relevant sections of the Pakistan Penal Code regarding negligent and harmful acts.
According to Mahar, the use of expired reagents poses severe risks:
- Contaminated or unsafe blood transfusions.
- Transmission of bacterial infections due to false-negative results.
- Increased morbidity or mortality in vulnerable patients.
- He stressed that the issue amounts to a violation of patients’ fundamental right to health under Articles 9 and 14 of the Constitution of Pakistan.
The PDLF president urged DRAP to:
- Launch a high-level inquiry into the use of expired/mislabelled blood culture reagents.
- Refer the case to the Medical Device Board, DRAP, and the Punjab Healthcare Commission for urgent inspection.
- Take strict legal action, including sealing, prosecution, and blacklisting of responsible suppliers or officials.
- Suspend use of all suspect reagent batches until proper verification is completed.
The application was accompanied by photographic evidence of expired and mislabelled blood culture bottles, batch/lot numbers, expiry proofs, and extracts of relevant laws.
Mahar concluded by urging DRAP to enforce “strict action as per law” to safeguard public health and prevent further endangerment of patients at Jinnah Hospital Lahore.
