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Tuesday April 08, 2025

DRAP without CEO for two weeks, regulatory affairs in limbo

Lack of leadership at country’s top drug regulatory body has raised concerns over delays

February 16, 2025
A representational image showing different medicines. — APP/File
A representational image showing different medicines. — APP/File

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has been operating without a Chief Executive Officer (CEO) for the past two weeks, as the government has yet to extend the tenure of Asim Rauf or appoint a successor.

The lack of leadership at the country’s top drug regulatory body has raised concerns over delays in crucial pharmaceutical and medical regulatory affairs.

“At present, DRAP is functioning without a CEO following the completion of Asim Rauf’s tenure. The Ministry of National Health Services, Regulations and Coordination (NHS, R&C) has forwarded a summary to the Prime Minister’s office,” a senior official of the health ministry told The News. The official added formal directives are awaited for an extension or the appointment of a new CEO.

The official further revealed that after Asim Rauf’s departure, an interview committee led by Dr Azhar Mahmood Kayani and comprising seven other members interviewed four shortlisted candidates for the CEO.

“In the meantime, DRAP’s Policy Board has recommended a three-month extension for Asim Rauf, allowing continuity in leadership until a permanent CEO is appointed,” the official added.

Despite the uncertainty, senior officials at the health ministry remain hopeful that a decision on the issue will be made by Monday, as ministry leadership is actively engaging with higher authorities to expedite the appointment process.

DRAP officials have expressed growing concerns over the adverse impact of the leadership vacuum on the authority’s day-to-day operations.

They noted that several critical regulatory functions have stalled, particularly for approval and imports of Active Pharmaceutical Ingredients (APIs), finished therapeutic products, and other essential medicines.

“Without a CEO in place, there is no authorised signatory to process regulatory approvals, leading to a pile-up of pending files related to pharmaceutical imports and other regulatory matters,” a DRAP official stated.

Further, a potential crisis looms over the availability of imported medical devices, as customs officials have reportedly begun halting shipments of essential medical equipment, including diagnostic kits and life-saving medical devices.

Industry stakeholders and healthcare professionals have urged the government to urgently resolve the issue, stressing that further delays could lead to supply chain disruptions and hinder patient care across the country.