ISLAMABAD: Princ–ipal Secretary to the Prime Minister Fawad Hassan Fawad spilled the beans when he contradicted before the Supreme Court on Thursday a claim that the Prime Minister Secretariat had received a summary seeking to exempt a rule that is creating impediment in the early registration of ancillary cardiac medical devices that help implanting stents.

The principal secretary was specially called by a three-judge Supreme Court bench headed by Chief Justice Mian Saqib Nisar to explain why the summary was still awaiting approval despite of the fact that it concerns the health issues of the people.

Health Secretary Ayub Sheikh has told the Supreme Court bench that his ministry had furnished a summary to the Prime Minister Secretariat with a request to allow invoking Rule 128 of the Medical Devices Rules, 2015.

The rule asks for relaxing the accreditation process of ancillary medical devices like catheters, cardiac cannulas, balloons, etc — used in implanting stents — by a conformity assessment body (cab) which approves these devices for final registration by the Medical Devices Board.

The court had taken up a suo motu notice on reports that a few public health institutions like the Cardiac Ward of Mayo Hospital Lahore and other government hospitals of Punjab were either putting stents in heart patients even when the intrusive procedure to implant therapeutic medicine was not required or if the same was needed, the patients were charged exorbitantly up to Rs180,000 for each stent.

On Thursday Mr Fawad took a categorical stance before the court that the Prime Minister Secretariat had not received any summary till morning also deploring that the government departments usually create an impression as if their files got stuck at the PM Office.

The secretariat, he assured the court, immediately commence necessary action the moment it received any file for approval, adding that the prime minister had issued standing instructions not to unnecessarily delay rather accord priority to matters that relates to health.

Mr Fawad told the court that the government had already sanctioned necessary funds to the National Engineering and Scientific Commission (NESCOM) to develop stents locally. During the proceedings the chief justice suggested for the locally manufactured stents.

The Supreme Court ordered the health ministry as well as the Drug Regulatory Authority of Pakistan (DRAP) to devise a solution regarding early registration of medical devices and stents by setting up a high-level committee in which stakeholders should be involved for easy availability of quality stents at affordable prices to patients after taking the prime minister into confidence.

The court also required the authorities concerned to approve the summary sent by the health ministry to the PM Secretariat within next 10 days with an observation that life become beautiful when facilities were available on earth.

“We know the snail pace movement of the summary from one department to another which sometimes takes months to travel a distance of 400 yards,” the chief justice regretted.

The authorities concerned were asked by the court not to show hesitation or resistance to amend any law if needed and ordered the DRAP to complete finalisation of pending cases relating to the registration of stents.

Till the time all brands of stents are not registered, the hospitals can implant available stents, but only of good quality. The court said the issue should be resolved early so that panic or fear among patients and doctors could be done away with.

The court adjourned the hearing till March 16.

Published in Dawn, March 3rd, 2017

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