Federal government admits Pakistan lacks mechanism to register stents

SC asks PM’s secretary to form committee to handle the issue of registration of medical devices

Hasnaat Malik March 03, 2017

ISLAMABAD: The federal government has admitted before the Supreme Court that there is no conformity assessment body to recommend the registration of medical devices.

On Thursday, the three-judge bench of the apex court, headed by Chief Justice Mian Saqib Nisar, resumed the suo motu case related to the sale of substandard stents in the country.

The Drug Regulatory Authority of Pakistan (Drap) registers the medical devices as well as drugs. There should be a conformity assessment body under the law for recommending the registration of any medical device to the Drap board. But surprisingly there is no such body in the country.

The health secretary pointed out that the ministry has sent a summary to the Prime Minister’s Secretariat for temporarily exemption from the Drap rule, wherein a conformity assessment body’s recommendation is mandatory for the registration of medical devices. He said that the formation of the committee was delayed as the PM had not approved it.

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However, when the bench summoned the secretary to the prime minister, Fawad Hassan Fawad, to determine whether the summary had been approved, the secretary insisted that no summary had been received by the PM’s Secretariat so far.

Fawad also stated that whenever the court fixed any case, the officials concerned sent a summary to the PM for approval on the matter, adding that it is mala fide to send a summary at the 11th hour. He said that action starts on a file when it is received, adding the prime minister has directed the staff that any issue related to health should be resolved immediately. The chief justice appreciated the PM’s views.

Fawad, however, assured that the committee for registration of a cardiac stent would be established soon.

The chief justice asked him to take the PM into confidence and if need arises to change the law and approve the summary in 10 days.

The regulatory body’s chairman also informed the bench that stents had been manufactured in Pakistan and sent to Germany for testing. The chief justice observed that the Pakistani stent is of world standard and its price is also nominal.

While agreeing with the chief justice’s observation, Heart Patient Society Chairman Dr Imran said that locally manufactured stents are in a testing stage. Fawad informed that funds have been released to Nescom for manufacturing stents in Pakistan.

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The chief justice said that they would also examine the performance of Drap. He said medical devices, which are registered with Drap could be used till the final decision of this case. The chief justice remarked that life is beautiful when all facilities are available.

Justice Saqib directed the regulatory body to decide within a week the already submitted applications for the registration of stents and other medical devices. The bench asked Fawad to form a committee of the representatives of all stakeholders to sort out the issues relating to the registration of stents.

The court said that it is not the right of any doctor to insist upon implanting unregistered stents. He directed the chairman to also involve all the stakeholders in the committee for registration of stents. The hearing of the case was adjourned until March 6.

Published in The Express Tribune, March 3rd, 2017.

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