Islamabad: A significant lack of critical medical devices suffers from the health care sector across the country as customs authorities stop shipments after the expiry of a registration exemption reported the news.

Significant supplies, including diagnostic sets, surgical tools, implants and surveillance equipment, are stranded at airports and ports that aggravate an already uncertain situation for healthcare providers.

Importers and medical professionals warn that hospitals feel the load, with crucial equipment not available for urgent procedures.

Customs officials have reached the drug regulation authority in Pakistan (Drap) for guidance on whether they were released shipments or enforce the expired exemption in accordance with SRO 224 (1) 2023, which lapsed on December 31, 2024.

As a result, several shipments of Class A, B, C and D medical equipment remain blocked at different entry points due to the requirement for a certificate of enrollment and registration.

SYED OMER AHMED, President of the Healthcare Devices Association of Pakistan (HDAP), said: “The situation forced desperate importers to contact the petitions until their pending registration applications are resolved.”

Despite the court decision, customs officials remain hesitant, leading to the installation of degradation and worsening of lack of hospitals.

Ahmed emphasized that the passivity and ambiguity of Member Customs (Operations) and Drap in providing clear directives to provincial customs authorities despite IHC’s residence order had already thrown a devastating influence on the health industry.

Although Drap had recommended an extension of the exemption period and forwarded the advisory to the Prime Minister’s office through the Ministry of National Health Services, no formal notification of the government has been issued, he maintained.

“In the meantime, the customs authorities remain unclear about how to move on and have sought further clarity from drap, which is not yet to give a definitive answer,” Ahmed said.

When he expressed serious concerns about bureaucratic delays, he warned that failure to solve this regulatory bottleneck causes deterioration in the state of imported units in gates and airports, potentially leading to their complete losses.

“Medical devices are rusting away at entry points while patients suffer from lack of deficiency,” he added.

The situation is further aggravated by the absence of a permanent CEO of Drap, as the regulatory body has been without management since the retirement of Asim Rauf two weeks ago.

A senior drap official who spoke on condition of anonymity admitted that they were preparing to formally instruct the customs authorities to act in accordance with the Court’s Directive.

“Interpretation of court decisions is not drap’s responsibility. We are writing to customs officials to follow IHC’s decision. If in doubt, they must seek legal guidance,” the official said.

Pakistan is highly dependent on imported medical equipment, which is important for surgical procedures, diagnostics and emergency interventions.

In 2017, DRAP introduced the medical equipment rules that included Rule 52, enabling an exemption period for registration of medical equipment. This exception was expanded in 2021 and 2022 to give drap time to regulate thousands of previously unregistered units.

Despite repeated court decisions imposing drap to speed up the registration process, thousands of applications remain pending, leaving importers in Limbo and threatening the availability of important medical supplies.

Hospitals all over Pakistan are already facing a serious lack of diagnostic sets, implants and surgical tools, leading to canceled procedures and compromised patient care.

Reports from larger health facilities indicate that delays in getting crucial medical devices force doctors to postpone life -saving operations.

A drap insider acknowledged that the regulator lacks human resources to process pending applications effectively, resulting in repeated delays in the issuance of exceptions.