Local manufacturing of stents could begin by end of this year

Updated April 21, 2019

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Top quality stents cost Rs100,000, and after including balloons, medicines and fees each procedure costs Rs200,000. If local production starts, stents can be purchased for around Rs40,000, head of RIC retired Maj Gen Dr Azhar Mahmood Kayani says. — Photos by the writer
Top quality stents cost Rs100,000, and after including balloons, medicines and fees each procedure costs Rs200,000. If local production starts, stents can be purchased for around Rs40,000, head of RIC retired Maj Gen Dr Azhar Mahmood Kayani says. — Photos by the writer

After years of media criticism and the intervention of the Supreme Court, health institutions are hoping that the cost of stents and angioplasty procedures will be lowered now that the production of local stents is expected to start by the end of this year.

Local production would address the requirement for stents and make the devices more affordable. No singular international company is able to meet Pakistan’s requirements, because of which three to four companies are currently exporting stents into the country.

“We get a top quality stent for Rs100,000, and after including balloons, medicines and fees each procedure costs Rs200,000, compared to Rs250,000 in private hospitals. If local production starts we will buy stents for around Rs40,000,” the head of the Rawalpindi Institute of Cardiology (RIC), retired Maj Gen Dr Azhar Mahmood Kayani, told Dawn.

He said that last year the cost was around Rs160,000, but “now because of the devaluation of the rupee the cost has increased by around Rs30,000.”

Dr Kayani said that approximately 40,000 documented angioplasties take place in Pakistan every year. One international company cannot therefore meet Pakistan’s needs, as they manufacture stents for other countries as well.

“The National University of Sciences and Technology (Nust) has been working on manufacturing stents. Although the stents have been prepared they are in the testing process, and hopefully production will be started by the end of the year. The stents have been tested in a Polish lab,” he said.

When asked, Dr Kayani said Punjab Chief Minister Sardar Usman Buzdar recently visited the RIC and was informed that the hospital was Pakistan’s first and only cardiac centre to perform acute brain stroke interventions, reversing paralysis in stroke patients.

He said that it was proposed that all vascular diseases should be treated under one roof, and the chief minister had agreed and begun the process to allocate funding. The RIC is going to be renamed the Pakistan Cardiac and Vascular Institute.

Stents are small expandable tubes that are used to treat narrowed arteries. In people with coronary heart disease caused by the build-up of plaque, stents can open narrowed arteries and reduce symptoms such as chest pain, and help to prevent cardiac arrest.

Unregistered cardiac stents worth Rs250 million were recovered from the Mayo Hospital in Lahore in January 2017, and it was revealed that there had been cases were patients were told they had received stents even when the devices were not placed in their arteries.

The Supreme Court on suo motu had pushed the Drug Regulatory Authority of Pakistan (Drap) and other stakeholders to ensure high quality stents are available at affordable prices.

It was also then revealed that there was no mechanism for selling stents. In the absence of which, rather than selling stents through medical stores companies’ representatives at cardiac centres sold stents to patients without giving them authentic receipts. This left people in the dark about the kind and quality of stents that were used in their procedures.

The matter was also investigated by the Federal Investigation Agency, which suggested reforms. In response, the court directed Drap and the Pakistan Society of Interventional Cardiology (PSIC) to address the issue.

Established in 2005, the PSIC aims to improve interventional practices in Pakistan to meet international standards and maintain an adequate level of training for young interventionists across the country. One of its priorities is national database and registry systems, and it aims to promote cardiac health through education, advanced interventional methods and improved preventive strategies.

University of Health Sciences (UHS) Vice Chancellor Dr Javed Akram told Dawn that UHS has also been working on manufacturing stents.

“We have not only manufactured stents but have also experimented by placing them in animals, as they cannot be placed in human beings without a detailed research report. We have also contacted a lab in Germany to test our stents. I believe we will be able to start commercial manufacturing by 2020,” he said.

There are two types of stents mostly used in Pakistan, explained medical devices director at Drap Ghazanfer Ali Khan. One is a bare metal stent that lacks a medicine coating and the second are drug-eluting stents, which are coated with immunosuppressant medicine to lower the body’s ability to reject a transplanted organ or medical device. Drug-eluting stents are also divided into three generations, the third made from chromium cobalt.

The third kind, bioresorbable stents, are absorbed into the body or become part of the body, he added. These are registered in Pakistan but rarely used.

Mr Khan said that when the stents issue was raised in the SC, the PSIC recommended that bare metal stents be sold for Rs20,000 and third generation drug-eluting stents for Rs90,000. When the rupee was devalued in June 2018, the PSIC contacted the SC and it was decided that prices would be increased by 11pc.

The prices were increased to Rs22,000 (from Rs20,000) and Rs100,000 (from Rs90,000) and were to be revised fortnightly, he said.

“However, in one case [Drap] asked the court to allow us to revise the process every six months as it was not easy to do the exercise fortnightly. We suggested revising prices every six month, but the court ordered to revise the prices every three months and a committee was also established to look into the prices.

“The PSIC went to court again in January 2019 and said the committee was not complete so it should be allowed to increase prices. Although the court allowed [this], in the written order it said that the prices of stents should be Rs20,000 for bare metal stents and Rs60,000 for third generation stents,” he said.

Mr Khan said that while the PSIC has said the price of third generation drug-eluting stents should be increased to Rs115,000, “we cannot do it because the court order said the price should be Rs60,000.”

When asked about locally manufactured stents, Mr Khan said the PSIC has to inform the court that some institutions are willing to make stents and will do so by 2017. He said they had yet to contact Drap for licences.

“We will issue the licence but all the requirements have to be met for that. The PSIC has taken a number of steps, due to which I hope that they can manufacture stents by the end of the year.

“Nust did not have a purpose-built building, but they have been establishing it now as it is necessary for a quality management system. Another plus point is that the PSIC invited a Turkish company, which issued a certificate [that allows] Pakistan to export stents,” he said.

Mr Khan said Drap has been verbally informed that the stents were tested abroad and cleared 70 different tests, but has not been told this in writing.

“Nust has trained people and some faculty members are also doing PhDs on stents. So I hope that there is a bright future for Pakistan in terms of manufacturing stents,” he said.

Published in Dawn, April 21st, 2019