KARACHI: The Healthcare Devices Association of Pakistan (HDAP) has urged the federal government to lift restrictions on medical equipment imports.

The appeal comes as the customs authorities continue to block shipments after the expiry of regulatory exemptions on Dec 31, 2024. The exemptions had allowed registered and unregistered importers to bring the medical devices from ventilators to thermometers to the country.

Talking to Dawn, HDA Chairman Syed Umer Ahmed said it is mandatory to register with the Drug Regulatory Authority of Pakistan (Drap) to import and sell medical devices and surgical equipment in the country.

Drap is supposed to either issue a certificate or reject the application of an importer seeking to registered himself with it. However, Mr Ahmed claimed that they have been facing delays at Drap.

`The problem is that although many applications have been submitted, certificates are not issued within the stipulated period. Instead, it often takes two to three years for the process to be completed,` he deplored.

Earlier, he pointed out, Drap hadallowed both the registered and unregistered importers to bring medical devices to the country till Dec 31, 2024. He added that before the expiry of deadline, they reached out to Drap and the Ministry of Health to resolve the issue, as they had extended the deadline earlier as well. After discussions, he said, Drap had recommended the matter to the health ministry to extend the deadline.

However, Mr Ahmed lamented, no decision regarding the extension or any alternative solution has been made as yet. On the other hand, he stated, owing to the expiry of the deadline, customs authorities across the country were refusing to clear their imports.

Legal recourse The HDAP chief stated that before the expiry of the deadline, they had filed a petition before the Islamabad High Court (IHC) and cited Drap, the Ministry of Health, and the customs authorities as respondents.

He claimed that the IHC had directed the authorities concerned that `no coercive action should be taken` and allowed the status quo.

Mr Ahmed said that despite the court`s orders, the customs authorities were not clearing their shipments.

He added that when they approached the customs authorities, they informed them that Drap had already been requested to clarify the matter.

However, since then the customs authorities have not responded to HDAP, he said.

Mr Ahmed regretted that the impasse had been keeping the mat-ter unresolved as the customs authorities need fresh instructions that Drap has not been issuing to them.

When contacted, a Pakistan Customs official told Dawn that in order to import any medical and surgical equipment, the importer needs to get a no-objection certificate from Drap.

`If a hospital imports something, its duty slab is different from that of an individual importing the same item,` he pointed out.

When asked whether the Islamabad High Court had restricted them from taking any action on this issue, he responded, `It is unclear whether the IHC issued directions for an individual specifically or for everyone in general. It is also possible that the direction has been challenged in the Supreme Court.

A member of the Private Hospitals and Clinics Association, Dr Muhammad Qaisar Sajjad while talking to Dawn said the government should come forward to help out the unregistered importers to resolve the issue so that they can get registered themselves with Drap as soon as possible.

He further said that the government should allow the import of medicaldevices usedfor diagnostic purposes in order to facilitate the general public. He added that shortage of any medical item has not been reported yet, but problems would obviously surface if restrictions continued.

Dawn reached out to Drap CEO Asim Rauf for comment, but no response was received until the filing of this report.