ISLAMABAD: Delays in the registration and licensing of medical devices by the Drug Regulatory Authority of Pakistan (Drap) continue despite the launch of an online portal meant to speed up approvals, raising concerns among importers and health sector stakeholders about disruptions in the supply of essential medical equipment.
The issue of delays has been highlighted in a formal letter sent by Transparency International Pakistan (TI Pakistan) to Drap, stating that it had received a complaint regarding prolonged processing times in the Medical Devices and Medicated Cosmetics (MDMC) division.
The letter, addressed to Drap Chief Executive Officer Dr Obaidullah Malik, points to continued reliance on older workflows despite the introduction of a digital system for licensing and product registration.
At the same time, the Healthcare Devices Association of Pakistan (HDAP), which represents importers and suppliers of medical devices, however, said it did not lodge any complaint with TI Pakistan and was not aware of the specific reasons why the organisation wrote to Drap on the issue.
A senior HDAP office-bearer said that as an association, HDAP had not approached TI Pakistan but added that some individual stakeholders might have independently taken up the matter.
According to the complaint forwarded by TI Pakistan, the MDMC Licensing and Product Registration Portal was launched in July 2025 to digitise and streamline the approval process for medical devices and related products. The system was intended to replace manual procedures that stakeholders have long criticised for causing regulatory delays.
However, the complaint says that months after the launch of the portal, a large number of applications remain pending, with the MDMC division not fully shifting to online processing.
Importers have conveyed concerns that continued delays are affecting the timely availability of essential medical devices in the market, with potential implications for hospitals and patients who depend on uninterrupted supplies of diagnostics, consumables and equipment.
The annexure attached with the letter refers to the formal inauguration of Drap’s digital system for licensing and registration of medical devices in Islamabad last year.
TI Pakistan, while clarifying that it was not the original complainant, said it took up the matter after reviewing the information and finding sufficient grounds to seek an explanation from the regulator.
In its communication to Drap, the organisation urged the authority to examine why the MDMC division was not fully implementing the online system and to ensure timely processing of applications.
The letter also points out that regulatory delays can cast broader implications for the healthcare system, as hospitals in both the public and private sectors rely heavily on imported medical devices. Prolonged backlogs in approvals can lead to shortages, delayed procedures and higher costs for patients, it added.
Copies of the letter have been shared with high government offices, including the Prime Minister’s Secretariat and the Ministry of National Health Services, for information and necessary action.
Drap has not issued a public response to the concerns raised so far and despite repeated requests, no formal response was provided on the TI letter or complaints by the stakeholders.
