LAHORE: A majority of the government hospitals in Punjab are using unregistered cardiac stents despite the fact that the Drug Regulatory Authority Pakistan (DRAP) has granted registration to over 55 such products all over the country.

It was revealed in a meeting chaired by Chief Minister Shahbaz Sharif here on Monday. Health minister Khawaja Salman Rafique, secretary Najam Shah, Punjab Institute of Cardiology (PIC) Chief Executive Prof Dr Nadeem Hayyat Mallick and other senior officers attended the meeting. DRAP Chief Executive Officer (CEO) Dr Aslam Afghani also participated in the meeting through video link.

The meeting was called in the backdrop of a scam involving recovery of low-quality cardiac stents by the Federal Investigation Agency (FIA), Lahore, some days back.

A stent is a small, metal-mesh tube that expands after its placement inside a coronary artery. It is often used during or immediately after angioplasty to help prevent artery blockage.

An official privy to the information shared in the meeting told Dawn the chief minister was shocked to know that a majority of the medical institutes in Punjab had been using unregistered cardiac stents.

The chief minister was also apprised that other cardiac products, including pacemakers and valves, being used in hospitals were also not registered by the DRAP, according to the official.

The PIC, Jinnah and Mayo hospitals were among the major institutes in Lahore where unregistered coronary artery stents were being used during surgical procedures, the CM was told.

Recently, the pharmacy located in the PIC Lahore procured unregistered stents at a cost of Rs12500,000.

On inquiring, the official said, the chief minister was told by senior medics that the surgeons had no other option but to use these products since there was no mechanism to get them registered with DRAP.

The medics were of the views that refusal of surgeons to use these products could lead to a cardiac health crisis.

They said the doctors at the state-run hospitals tried their best to provide latest surgical products to the patients.

“We have granted registration to nearly 55 brands, and a majority of these produce latest coronary artery stents”, DRAP CEO Dr Afghani told Dawn.

He said the DRAP had registered the products of the companies working in US, UK, Germany and Japan. It has even registered the United States Food and Drug Authority (FDA) approved products in order to ensure quality.

About the standard, he said, the DRAP only allowed registration to those companies which were already registered with the regulatory authorities in the countries of their origin.

Published in Dawn January 17th, 2017

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