The Drug Regulatory Authority of Pakistan (DRAP) has launched a major crackdown against substandard auto-disable syringes, declaring 17 syringe batches manufactured by 11 companies as non-compliant with safety standards, it was reported on Monday.
According to DRAP, the affected 3ml to 5ml auto-disable syringes failed to meet the required auto-disable functionality standards, raising serious public health concerns.
The authority has issued medical product alerts for all 17 syringe batches and imposed an immediate ban on their sale and use in Pakistan.
DRAP stated that the syringe samples were tested by the Central Drug Laboratory (CDL) and the Drug Testing Laboratory (DTL) Karachi, where they were found to be substandard. The regulator said the syringes failed the auto-disable test, meaning they could potentially be reused due to faults in the locking mechanism.
The authority warned that repeated use of syringes poses a grave threat to public health and could contribute to the spread of infectious diseases, including hepatitis and HIV.
According to DRAP, three syringe batches manufactured by two Chinese companies were also found to be non-compliant, while other affected manufacturers are based in Punjab and Khyber Pakhtunkhwa.
Provincial authorities and regulatory field forces have been directed to conduct market surveys to identify the affected batches and ensure their removal from the market. DRAP has also ordered the seizure of all substandard syringe stocks currently available in markets.
The regulator further instructed manufacturers, importers, and distributors to immediately recall the affected syringe batches to prevent any risk to public safety.
