SC hints at drug regulatory authority shakeup

ISLAMABAD - The Supreme Court on Tuesday hinted at issuing order for the re-constitution of the registration board of the Drug Regulatory Authority of Pakistan (DRAP).

A three-judge Supreme Court bench headed by Chief Justice Mian Saqib Nisar took up the suo moto case regarding implantation of sub-standard stents in patients in Punjab hospitals. The judge directed the authority to file a statement detailing qualification of the DRAP registration board members.

During the proceeding, it was pointed out that Chinese stents have been registered. The chief justice observed that the Chinese stents have been registered but applications for the registration of American, Japanese and German stents were still pending with the regulatory body.

The chief justice warning the officials to mend their ways said that the court would not accept irresponsible attitude and irregularities. He said that authorities in the US were not irresponsible to approve sub-standard cardiac stents and the court would not allow implantation of smuggled stents and if anything comes in their knowledge, it would not be tolerated.

Justice Saqib said that doctors take out stents from a briefcase and imbed in the patients. He said that the patients should know what stents have been implanted. Expressing annoyance, the chief justice said that the applications for the registration of stents have been put in cold storage.

Additional Attorney General Waqar Rana told the court that a meeting of the regulatory body was held on February 6 for the registration of stents. The chief justice said that the DRAP should invite all stakeholders for a meeting for the registration of stents and submit its minutes.

At the outset, the additional attorney general submitted a joint report of secretaries of the health ministry and the DRAP. He said that the decision on the applications for the registration of stents would be made soon.

According to the report, a meeting of the registration board is scheduled for February 7 to dispose of the pending cases wherein applicants were provided with a chance for fulfilling deficiencies through letters and press advertisement.

Another meeting would be held on February 20-21 to entertain new cases of drugs (medical devices). Two cardiologists shall be taken as observer members to attend the forthcoming meetings of the registration board for the agenda of cardiac devices. These observers shall provide clinical input.

The registration process of these products shall be made speedy and the registration board shall be advised to accept original required documents at the time of issuance of registration certificate with an affidavit that the documents furnished were original and that embassy attested documents and certificate shall be provided by the firm to the DRAP within six months.

Drugs/devices including stents and allied products, if not registered/not available in Pakistan, can be imported under SRO 28(1)/2013 by any medical institution for their patients as per existing practice by several institutions in Pakistan.

The case was adjourned until the first week of March.

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