PHOTO: REUTERS
The Drug Regulatory Authority of Pakistan (DRAP) has issued directives to the four provinces to enforce orders in their respective hospitals performing cardiac procedures using stents.
The directives have been issued on orders of the apex court hearing a suo motu case of anomalies in stent procedures.
The Federal Investigation Agency in January this year had exposed a scam that involved selling fake stents to heart patients on exorbitant prices. The scam also exposed some healthcare staff at Lahore’s Mayo Hospital, who sold fake stents for up to Rs 200,000 that actually cost Rs 6,000. It was also revealed that at times, patients were told that a stent has been fixed in their arteries when it was not.
DRAP Chief Executive Officer Dr Mohammad Aslam had informed a parliamentary committee that substandard stents are sold in the market and doctors also use expired stents.
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The Supreme Court and a parliamentary committee on health directed the Ministry of Health Services and DRAP to devise a pricing policy for stents till April 26, 2017.
Medical devices are not capped anywhere in the world and only India has recently slashed stent prices by up to 85 per cent in February this year after similar kind of issues were highlighted.
The National Pharmaceutical Pricing Authority of India has fixed the ceiling price of drug eluting stents and bioresorbable stents at Rs 30,000 and that of bare metal stents at Rs 7,500.
Representatives of manufacturers and suppliers argue that high quality Food and Drug Administration, United States, approved stents will disappear from the market like in India if prices are fixed.
The DRAP CEO maintained that though prices of medical devices are not fixed but such unethical practices are also not found in other countries like in Pakistan and India. He said manufacturers and hospitals have been asked to clearly display the prices on the packaging of the medical instruments used for angioplasty and in hospitals for which they have been asked to provide a separate place to the companies to display the price list.
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A mechanism for pricing is under progress, he said, both from stakeholders’ suggestions and independent analysts’ evaluation, which will be reviewed to finalise the matter of stent pricing and medical devices.
The regulator will introduce a pricing formula on its own if the manufacturers or suppliers do not give their proposals, he said.
Meanwhile, the directive issued to keep a check on unethical practices states that the manufacturers or importers of coronary stents shall print maximum retail price (MRP) on the label of cardiac stents and widely disseminate the MRP of their brands and also publicise on their websites and print media.
In order to check exorbitant and irrational prices and unethical profiteering, the directive states that the establishments performing cardiac procedures and using stents will specifically and separately maintain the prices of stents along with brand name of its manufacturers.
The healthcare establishments will also ensure making video recording of the whole procedure making three copies and handing them over to the patient, Society of Interventional Cardiologists and Cath laboratory.
Published in The Express Tribune, April 3rd, 2017.
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