Drug Regulatory Authority of Pakistan - DRAP

🌍 International Event Promoting Indigenous Manufacturing of APIs in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) participated in an International Event for the Encouragement of Indigenous Manufacturing of Active Pharmaceutical Ingredients (APIs), organized by the China Pakistan Medical Development Seminars Office, Islamabad, under the auspices of the Economic Affairs Division, on 30th October 2025 at Mövenpick Hotel, Islamabad.

The event aligned with the policy initiative of DRAP aimed at promoting local API manufacturing and reducing dependency on imports through facilitation, regulatory streamlining, and international collaboration.

During the event, the Dr. Noor Muhammad Shah, Director Drugs Licensing/Chairman CLB, DRAP delivered a comprehensive presentation on DRAP’s initiatives for ease of business and regulatory facilitation, including:
✅ Establishment of a dedicated API Cell at DRAP
✅ Fast-track processing of API-related applications
✅ Introduction of a Single Window Operation for efficient regulatory handling

He also apprised participants of the Government of Pakistan’s policy framework being developed to support indigenous API manufacturing and investment in the sector.

🌐 International speakers from China and the United States emphasized the strategic importance of API manufacturing for pharmaceutical security and sustainable development.
Dr. Abdul Samad from the University of New Hampshire, USA, presented a detailed design model of an API manufacturing facility, covering critical aspects such as effluent disposal, fire safety systems, classified clean areas, and compliance with international standards.

Manufacturing representatives from the People’s Republic of China shared insights on their operational models and expressed interest in joint ventures for setting up API and related manufacturing units in Pakistan across various therapeutic areas.

The event also highlighted the recently approved Pakistan Plasma Policy, introduced by DRAP officers, as a milestone toward ensuring access to safe and quality plasma-derived medicinal products.

Prominent personalities including Presidents of Chambers of Commerce, Managing Directors of leading manufacturing firms, and DRAP officers attended the session. Speakers, including Mr. Sufi Pervez (Managing Director, Pharmagen) and Mr. Hamid (Managing Director, Neutra Basic Manufacturers), appreciated DRAP’s proactive initiatives and the efforts of the China Pakistan Medical Development Seminars Office and the Economic Affairs Division in fostering such collaborations.

The event concluded on a consensus of support and resource mobilization from all participants to encourage local API manufacturing and strengthen Pakistan’s pharmaceutical self-reliance through international cooperation and investment.

DRAP Engages with Industry at RCCI on Promoting Local Pharmaceutical Manufacturing

The Director Licensing / Chairman Central Licensing Board (CLB) Drug Regulatory Authority of Pakistan (DRAP), Dr. Noor Muhammad Shah, organized an insightful session at the Rawalpindi Chamber of Commerce & Industry (RCCI) to promote Basic and Semi-Basic Manufacturing of pharmaceutical raw materials, including Active Pharmaceutical Ingredients (APIs), excipients, extracts, and primary packaging materials.

RCCI President Mr. Usman Shaukat and Vice President Mr. Fahad Barlas, provided an excellent platform to discuss the capabilities, challenges, and opportunities in expanding Pakistan’s local pharmaceutical manufacturing base.
During the session, DRAP officials highlighted the Authority’s ongoing initiatives aimed at:
✅ Facilitating indigenous manufacturing and technology transfer
✅ Streamlining licensing and regulatory processes to encourage investment
✅ Strengthening collaboration with industry and chambers for sustainable growth
✅ Advancing self-reliance in pharmaceutical raw materials and reducing import dependency

The session was well-attended by industry stakeholders, particularly those engaged or interested in local production of APIs, excipients, and related materials. Participants acknowledged DRAP’s engagement and consultative approach, recognizing it as a step toward fostering a more resilient, innovative, and self-sufficient pharmaceutical sector in Pakistan.

🇵🇰 Pakistan at Global Health Exhibition 2025, Riyadh 🇸🇦

Dr. Obaidullah, CEO of the Drug Regulatory Authority of Pakistan (DRAP), represented Pakistan as part of the national delegation at the Global Health Exhibition 2025 held in Riyadh, Kingdom of Saudi Arabia; a premier global platform bringing together policymakers, regulators, innovators, and health leaders to shape the future of healthcare.

On the sidelines of the event, Dr. Obaidullah engaged in high-level discussions with:
🔹 Dr. Christopher Elias, President, Global Development at the Bill & Melinda Gates Foundation
🔹 Dr. Hanan Balkhy, Regional Director, WHO Eastern Mediterranean Region (EMRO)
🔹 Prof. Hisham Aljadhey, President, Saudi Food and Drug Authority (SFDA)

The discussions centered around:
✅ Strengthening regulatory collaboration and convergence across the region
✅ Advancing health security and joint preparedness for public health emergencies
✅ Enhancing access to quality, safe, and affordable medicines and vaccines
✅ Promoting indigenous vaccine manufacturing to build regional self-sufficiency and resilience
✅ Exploring future partnerships in regulatory science, capacity building, and digital transformation

These interactions reaffirm Pakistan’s commitment to fostering evidence-based, transparent, and globally harmonized regulatory systems. DRAP continues to work with regional and international partners, including WHO, SFDA, and the Gates Foundation, to drive innovation, ensure equitable access to essential therapies, and strengthen health systems for a safer and healthier future.

DRAP at Health Asia 2025; Leading Pakistan’s Regulatory Transformation

The Drug Regulatory Authority of Pakistan (DRAP) showcased its reform-driven, science-based, and technology-enabled vision for healthcare regulation at the Health Asia International Exhibition & Conference 2025, held at the Karachi Expo Centre.

As Pakistan’s premier health regulator, DRAP led a series of high-impact technical sessions that brought together policymakers, industry leaders, and healthcare professionals to advance dialogue on key areas of regulatory modernization and innovation.

Key Focus Areas:
✅ Boosting Medical Devices – Promoting indigenous manufacturing of Medical Devices
✅ Bioequivalence Studies – ensuring therapeutic reliability through scientific rigor
✅ Ethical Pharmaceutical Marketing – promoting integrity and patient-centered practices
✅ PIC/S & GMP Compliance – strengthening quality standards toward global harmonization
✅ Track & Trace (2D Barcode) – introducing digital oversight for patient safety and transparency

The Honourable Federal Health Minister Syed Mustafa Kamal and Baluchistan Health Minister Bakht Muhammad Kakar graced the sessions as Chief Guests, appreciating DRAP’s leadership in transforming Pakistan’s regulatory framework and emphasizing the importance of localizing therapeutic goods manufacturing in line with international quality standards.

A large gathering of healthcare professionals, academicians, and industry representatives benefitted from these interactive sessions, which fostered collaboration, transparency, and a shared commitment to advancing quality, safety, and innovation in Pakistan’s therapeutic goods regulation.

DRAP’s strong participation reaffirmed its role as a reform-oriented, globally aligned, and patient-focused regulator, driving Pakistan’s healthcare system toward excellence and self-reliance.