Islamabad: The Islamabad High Court (IHC) has directed the federal government’s law officer to submit a written response regarding the status of the Drug Regulatory Authority of Pakistan’s (DRAP) proposal to extend the exemption period for medical device registration.
The directive was issued by a single bench, led by Justice Saman Rifat Imtiaz, while hearing a petition filed by the Healthcare Devices Association of Pakistan (HDAP). The court asked the government to explain why the proposal was rejected and clarify why it was not presented before the federal cabinet.
The federal law officer was further instructed to assist the court in determining which legal provision requires federal government approval in this matter. If such a requirement exists, the officer must explain how the Ministry of National Health Services, Regulations, and Coordination (NHSRC) can refuse to place the issue before the cabinet.
Earlier, the court had directed the Ministry of Health to apprise it of DRAP’s pending proposal. In response, the federal law officer informed the court that the NHSRC had rejected DRAP’s request for an extension.
However, the written report submitted by the NHSRC did not mention the rejection or provide any reasons for it. The court observed that the report also failed to clarify the status of DRAP’s request. Additionally, verbal submissions by Sibgat Ullah, Section Officer (SO) for DRAP at NHSRC, were deemed unhelpful.
The court noted contradictions in the submissions: Sibgat Ullah initially stated that the prime minister had rejected DRAP’s request but later admitted that the matter was never placed before the cabinet. The court questioned why the proposal had not been presented before the cabinet, especially when previous exemption extensions were approved in this manner.
Petitioners, who are engaged in the import and sale of medical devices, sought a directive for DRAP to process their pending applications for registration or enlistment. They also requested an extension of the exemption deadline under the Medical Device Rules, 2017.
Their counsel, Umer Hameed Khan, argued that DRAP had been delaying decisions on pending applications. He highlighted that a notification issued on February 27, 2023, had exempted certain categories of medical devices from the rules. However, the exemption was not extended, nor was any action taken to process the pending applications.
The counsel warned that this inaction could lead to coercive measures against the petitioners. He further pointed out that previous exemptions were granted within 90 days, yet this time, despite the expiry of the period, the matter remains unresolved. This delay has caused financial losses to petitioners due to demurrage costs on shipments stuck at the port and has also contributed to shortages of essential medical devices in the market.
The federal law officer submitted that DRAP is currently working to clear its backlog and has the capacity to process more than half of the pending applications by March 1, 2025, through increased meetings of the Medical Devices Board (MDB). Deputy Director (Legal) DRAP, Hafiz Bilal Bin Akbar, confirmed that MDB meetings are now held twice a week, significantly reducing pendency.
The court emphasized the need for a written response from the NHSRC to bring clarity to the approval process for DRAP’s exemption extension proposal. The law officer was once again directed to provide a detailed report explaining the status of the proposal, reasons for rejection, and the justification for not presenting it to the cabinet.
Previously, the court had issued an interim stay order, ruling that no coercive measures should be taken against the petitioners until their pending applications are processed. However, the counsel argued that this relief was insufficient, as customs authorities were hesitant to release shipments without specific court orders.
