Government Requested to Remove Import Restrictions on Medical Devices in Pakistan
Karachi: The Healthcare Devices Association of Pakistan (HDAP) is appealing to the federal government to remove curbs on the importation of medical devices. This is after customs officials persisted in blocking imports following the lapse of regulatory waivers on December 31, 2024. Such waivers enabled registered and unregistered importers to import medical devices such as ventilators, thermometers, and other surgical instruments.
As per Syed Umer Ahmed, HDAP Chairman, importers must register with the Drug Regulatory Authority of Pakistan (Drap) to import and market medical equipment in the country. However, processing delays in registration applications have become a serious problem.
Ahmed pointed out that while numerous applications have been filed, Drap has not provided the requisite certificates promptly. It takes two to three years to register, which creates a backlog and holds imports back from clearance.
Earlier, Drap had permitted registered as well as unregistered importers to import medical devices up to December 31, 2024. Before the deadline, HDAP approached Drap and the Ministry of Health to sort out the issue and asked for an extension since the deadline had already been extended earlier. Drap had suggested the deadline be extended, but a decision is yet to be taken. Therefore, customs authorities are not clearing shipments.
Legal Action and Customs Dispute
HDAP responded by filing a petition in the Islamabad High Court (IHC) before the expiry of the deadline against Drap, the Ministry of Health, and customs authorities as respondents. The IHC ordered that no coercive steps be taken, and the status quo should continue to exist. Nevertheless, customs officials have persisted in holding up shipments, asserting that they require additional clarification from Drap.
A customs officer confirmed that importers require a no-objection certificate from Drap to import medical equipment. He also added that duty rates for hospitals are different from those for individuals importing the same products. The officer was not sure if the IHC’s instructions were for individuals or companies and said the decision could be challenged in the Supreme Court.
Request for Government Intervention
Private Hospitals and Clinics Association member Dr. Muhammad Qaisar Sajjad appealed to the government to assist unregistered importers in becoming registered with Drap. He further added that the government should make allowance for importing diagnostic medical devices to serve the demand of the masses. Although no shortage of medical goods has been reported yet, the current restriction could result in difficulties if left unresolved.
Dawn approached Drap CEO Asim Rauf for comment but was unable to receive one at the time of going to press.