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October 14, 2018

Sale of stents being regularised on SC directions


October 14, 2018

ISLAMABAD: A Federal Investigation Agency (FIA) official was sent to a state-run Lahore hospital as dummy heart patient. He was advised to implant two stents.

But when the same assistant director got himself examined from another hospital he was declared fit.

This was revealed in a report--a copy of which is available with The News--that the FIA has submitted to the Supreme Court about its investigations into illegal sale and purchase of stents in the Cath Lab of the Mayo Hospital in Lahore.

The report said that after the preliminary probe, the FIA raided the lab and found that different companies have established their stalls for sale/purchase of stents. A regular enquiry was conducted by the FIA, Lahore, during which it transpired that the stents were being imported at very low price from Europe and the United States even at the rate of 20 to 30 Euros per piece.

The FIA report highlighted all the deficiencies of different departments. The apex court directed the Drug Regulatory of Pakistan (DRAP) to speed up the matter of registration of stents and also make strategy to fix their prices.

The report said that before the action of FIA, unregistered stents were being used by the private and even government hospitals. Now the high-ups have strictly instructed the hospitals to not use unregistered and substandard stents. The action has safeguarded the interests of heart patients.

Under an SRO, only European (CE Mark) and American (FDA approved) stents will be used in the Pakistan. It has been decided that the DRAP will develop an IT-based national registry for cardiac stents and provide a mechanism for manufacturers, importers and cath lab to compulsorily enter the data of manufacturing and import and utilisation of cardiac stents in national registry. All laboratories will be required to be registered with the Society of Interventional Cardiologists.

The report said that to improve the quality of registered stents, high-level experts were included in the Drug Registration Board of DRAP to analyze and examine their quality before registration in Pakistan. This is meant to ensure availability of high quality stents in Pakistan.

It said that the registered importers were not following packaging and labeling rules as mentioned in the drug act but after the FIA action, they are now following them.

The report said that the illegal business of stents was at full swing, but after the FIA proceedings all the concerned quarters/departments are now well aware and vigilant to eliminate the illegal business of throughout the country.

It identified that the Mayo Hospital administration purchased unregistered stents on fake drug registration letter of DRAP from a company.

The report said that pricing is the most important factor, and no price was fixed by the DRAP. Importers were charging very high prices from the poor patients. It was identified that the importers were earning very high profit. This fact was also communicated to the Supreme Court.

A letter was sent to the DRAP chief suggesting that a maximum retail price should be fixed to safeguard the interests of poor patients. Resultantly, the SRO has been issued regarding prices of stents.

The report said that as a result of the official notification, the manufacture and importers of stents will print maximum retail price (MRP) on the label of cardiac stents and will widely disseminate the MRP of their brands of cardiac stents and also publicize the same on their website and in the print media with updating on quarterly basis.

All the manufacturers and importers of cardiac stents will display a price list on a conspicuous part of the premises of the healthcare establishments, which will facilitate showing the same so that it is known to all concerned including doctors performing the procedure and the patients or their representatives who wish to consult for the same.

The report said that the healthcare establishments performing cardiac procedures using cardiac stents will specifically and separately maintain the price of stents along with brand names of its manufacturers and importers, batch number, serial number, expiry date and other details, if any, in their billing to the patient or their representatives.

These healthcare establishments will ensure making video recording of the whole procedure, making copies and hand over one to the patient or his or her nominee, one copy to Society of Interventional Cardiologists while one of record of the Cath Lab, the report said.

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