PR No.209 CRACKDOWN AGAINST UNREGISTERED STENTS BY DRAP Islamabad: January 24, 2017

Federal inspector of Drugs conducted a raid on Shifa International Hospital Islamabad to observe the use of unregistered stents. Main pharmacy, Satellite Pharmacy, cardiac ward and Kath Lab where stents are used and inspected thoroughly for 8 hours. Stents of Abbott, Medtronic, Blur medicine’s Devices and Boston were in use approved by DRAP

An investigation team comprising of Additional Director Quality Assurance, Director Medical Devices and Deputy Director General conducted investigation on Mayo Hospital Lahore case.

Statements of Prof. Shafiq Saqib Cardiac Surgeon, Nurses, Technicians were recorded. Poor storage practices of medicine’s and stents were observed in old and tertiary care hospital of the 110 million populous province of Pakistan. Five different types of stents, Catheter, Baloon and Sutures were seized due to not meeting the regulatory requirements of registration, not meeting the packaging and labelling rules, 1986.

Federal drug inspector Lahore took serious notice about apathic storage conditions of warehouse of Government hospital.

Saving Life technology and Pak Punjab Carded supplied unregistered stents to the Mayo Hospital Lahore with the consent of Consultants were noticed. It is violation of Drug Act 1976. The case would be sent to Drug Court Lahore.

AM Systems and Ferozsons supplied registered stents approved by DRAP were in use too. Authority has approved stents imported from America, Germany, Netherland and Ireland. Two imported brands which are popular in the world are registered with Drug Regulatory Authority of Pakistan and doctors and hospitals were advised to use only registered stents.

 

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