ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has declared several batches of auto-disable syringes manufactured by six companies as substandard and issued an urgent medical product alert, citing serious concerns over patient safety and public health.
According to a statement released by DRAP, multiple batches of 3ml and 5ml auto-disable syringes failed to meet the required quality standards. The decision was taken after laboratory testing conducted by the Central Drugs Laboratory in Karachi revealed that several sampled products did not comply with mandatory auto-disable functionality requirements.
Officials said the affected syringes included products manufactured by both local and international companies. Among the companies identified were Jiangxi Fenglin Medical Appliances of China, Medila Elwakia International Company of Egypt, and Shandong Care Medical of China. Several locally supplied batches from Punjab and Khyber Pakhtunkhwa were also declared substandard following the investigation.
DRAP stated that the defective syringes pose a significant public health risk because faults in the auto-disable mechanism could allow them to be reused. Auto-disable syringes are specifically designed to prevent repeated use after a single injection, reducing the risk of transmitting infectious diseases.
Health experts warn that the reuse of syringes can contribute to the spread of dangerous infections, including hepatitis B, hepatitis C, and HIV. Pakistan has long faced challenges related to unsafe injection practices, making the quality and reliability of medical devices a critical public health concern.
Following the findings, DRAP has banned the sale, distribution, and use of the affected syringe batches across the country. Provincial health departments and regulatory authorities have been directed to immediately remove the products from hospitals, clinics, pharmacies, and medical supply chains.
The Drug Regulatory Authority of Pakistan has also instructed healthcare providers to remain vigilant and ensure that only approved and compliant medical devices are used in patient care. Authorities are expected to continue monitoring the market and conducting inspections to prevent the circulation of substandard medical products.
The latest DRAP alert underscores the importance of strict quality control measures in Pakistan’s healthcare sector and highlights ongoing efforts to safeguard public health by ensuring the safety and effectiveness of medical devices used nationwide.
