CJP chides officials over shoddy stents

Hints at reconstitution of DRAP’s registration board

ISLAMABAD: Chief Justice of Pakistan Mian Saqib Nisar has warned the officials concerned to “mend their ways”, saying the court would not accept “irresponsibility” and “errors” regarding the use of stents.

“The court will not allow the use of illegal and substandard stents, and if anything [medical malpractice] comes in their (justices) knowledge, then it would not be tolerated,” the chief justice, who heads the three-judge bench, said on Tuesday.

The apex court had taken suo motu notice on reports that some public health institutions such as the cardiac ward of Mayo Hospital Lahore and some other government-run hospitals in Punjab were either implanting stents into patients even when the intrusive procedure was simply not required or if the same was needed, the patients were charged exorbitantly — up to Rs180,000 per stent.

The top court also sought statement about the qualifications and expertise of registration board members of the Drug Regulatory Authority of Pakistan (DRAP), with the chief justice hinting at reconstitution of the DRAP’s registration board.

When it was pointed out that Chinese stents were being registered, the chief justice observed that the applications for the registration of American, Japanese and German stents are pending with DRAP, saying “US authorities are not irresponsible to approve substandard stents”.

Justice Nisar said: “Patients should know what kind of stents is being infused in their hearts.”

Additional Attorney General Waqar Rana informed the court that the DRAP registration board met on the subject yesterday and added it would meet again on Wednesday (today).

The chief justice said: “DRAP should invite all stakeholders to the meeting and its minutes should be submitted in the court.” Rana also submitted the joint report of the Ministry of Health and Services and DRAP secretaries.

The AAG also informed that DRAP and provincial officials held four meetings in this regard. The case was adjourned till the first week of March.

Meanwhile, the report states that Drugs/devices -- including stems and allied products -- if not registered/not available in Pakistan, can be imported under SRO# 28(1)12013, by any medical institution for their patient use as per the existing practice by several institutions in Pakistan.

It is further stated that in order to ensure supply of all quality products, Additional Director Dr Abdul Rashid was nominated as the focal person for supervising the processing of NOCs for the import of stents and allied products not registered or not available in the country for hospitals/institutions for their patients use.

The report also stated that two cardiologists shall be taken as observer members to attend the forthcoming meetings of the registration board for the agenda of cardiac devices. The NHSR&C secretary in consultation with Maj-Gen Prof Azher Kiyani will propose the names.

“These observers shall provide clinical input. Registration process of these products shall be made speedy and the registration board be advised to accept original required documents (without the condition of embassy attestation) at the time of issuance of registration certificate with an affidavit on stamp paper that the documents furnished are original and that embassy attested documents and certificates (where applicable) shall be provided by the firm to DRAP within six months.

Published in The Express Tribune, February 8^th, 2017.