Karachi: The Prime Minister of Pakistan has finally approved the appointment of Dr. Ubaidullah Malik as the new Chief Executive Officer (CEO) of the Drug Regulatory Authority of Pakistan (DRAP).
Dr. Malik is a pharmacist by profession and holds a PhD in Pharmaceutical Sciences from the University of Peshawar. He has been serving in the drug authority since 2001 and has held various key positions, including Director Administration, Director Registration, and Director Import-Export of medicines.
Notably, DRAP was functioning without a chief for one month and three days following the end of the tenure of former CEO Asim Rauf on February 5, 2025. Asim Rauf had served two consecutive three-year terms as the head of DRAP. During his tenure, the drug registration and inspection process was expedited, and online inspection and registration systems were introduced. Additionally, an online portal was developed to facilitate medicine imports and exports, allowing patients to apply online for sending medicines abroad.
Furthermore, Pakistan aligned its drug registration process with the Common Technical Document (CTD) format, similar to the U.S. FDA and European regulations, marking a significant step toward international accreditation.
Challenges for the New CEO:
The appointment of Dr. Ubaidullah Malik has been widely welcomed, with Noor Mehr, President of the Pakistan Drug Lawyers Forum, calling it a positive step.
However, the new CEO faces significant challenges, including:
1. Uncontrolled Drug Prices: The lack of regulation over medicine prices remains a pressing issue.
2. Incomplete Online Registration System: While digital initiatives have been launched, they remain incomplete.
3. Lack of Transparency in Herbal and Neutraceutical Products Registration: DRAP’s website does not yet provide a complete list of registered herbal and neutraceutical products and their manufacturers.
4. Lack of Drug Inspectors: Punjab and Sindh each have only one federal drug inspector, making regulatory oversight difficult.
5. Regulation of Medical Devices and Medicated Cosmetics: DRAP has yet to fully implement effective regulatory measures in these sectors.
6. Rising Use of Steroids and Mercury-Based Products: The increasing use of harmful substances like steroids and mercury in medications and cosmetics requires urgent regulatory action.
Experts stress that DRAP must take immediate steps to address these challenges and ensure transparency, efficiency, and public health safety in Pakistan’s pharmaceutical sector.
