Islamabad: The Drug Regulatory Authority of Pakistan (DRAP) has rejected allegations of prolonged delays in the registration and licensing of medical devices, saying the claims raised with Transparency International Pakistan were factually incorrect and did not reflect the current operational realities of the regulator.
In a formal reply to Transparency International Pakistan regarding complaints about delays in approvals by DRAP’s Medical Devices and Medical Cosmetics Division, the authority said it had significantly improved internal workflows and digitised most of its regulatory processes to ensure faster processing of applications.
The response came after Transparency International Pakistan wrote to DRAP following a complaint alleging prolonged processing times for licensing and registration of medical devices, raising concerns among importers and healthcare stakeholders about potential disruptions in the supply of essential medical equipment.
In its reply, DRAP strongly denied the allegations and said the authority had undertaken major administrative and digital reforms over the past year to improve efficiency and transparency in regulatory processes.
According to DRAP, about 70 percent of its regulatory processes have already been fully digitised, including licensing, product registration, pricing approvals, import and export permissions for pharmaceuticals and biologicals, lot release of vaccines, allocation of controlled drugs and registration of medical devices. The remaining processes are expected to be digitised by June 2026.
TI Pakistan Reply (25.02.2026)
Officials said the move towards digital processing has improved internal monitoring, enabled tracking of applications and enhanced coordination between applicants and regulators, leading to measurable gains in efficiency and reduced approval timelines.
DRAP also pointed out that the reforms had been recognised at the highest level, noting that the Prime Minister conferred the “Reforms Champion Award” on the authority in December 2025 in acknowledgement of improvements in regulatory performance.
TI Pakistan Reply (25.02.2026)
Providing details of the new system, DRAP said that since the launch of an online portal for medical device applications in July 2025, the Medical Devices Board had decided 4,196 applications, with an average disposal time of about 21.8 business days. Previously, the approval process for such applications often took several months or even years.
TI Pakistan Reply (25.02.2026)
The authority added that older manual applications submitted before digitisation were also being processed through a systematic review process. According to DRAP, around 5,066 manual applications have been examined by the Medical Devices Board through weekly meetings and about 2,900 approval letters have already been issued.
TI Pakistan Reply (25.02.2026)
Officials said the remaining applications were found to have regulatory deficiencies requiring additional information, clarifications or compliance with statutory requirements, which had been communicated to the applicants.
DRAP maintained that the progress had been achieved through process optimisation and improved coordination within the organisation, without any increase in staff strength.
The authority said it remains committed to transparency, regulatory efficiency and compliance with international standards while ensuring timely access to quality medical devices for patients and healthcare providers.
According to the reply, DRAP is also in the process of recruiting additional technical personnel and strengthening its information technology infrastructure to further improve service delivery and institutional capacity.
The regulator said any assertion that it was not performing effectively did not reflect the improvements made in reducing backlogs and processing timelines. It also invited Transparency International Pakistan to share details of any specific complaint involving a particular company or product so that it could be addressed within the applicable regulatory framework.
Copies of the correspondence were also shared with the Prime Minister’s Secretariat, the federal minister for national health services, the health ministry and other relevant authorities for information and further action.
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