On December 23, 2024, the Directorate General of Drug Administration (DGDA), in collaboration with USAID's Promoting the Quality of Medicines Plus (PQM+) program and technical partner JBRSOFT Limited, unveiled the DGDA Digitalization Roadmap. This strategic initiative marks a significant advancement in Bangladesh's efforts to modernize its medicines regulatory system, aiming to enhance transparency, efficiency, and resilience in public health governance. The roadmap outlines a comprehensive plan to achieve the World Health Organization's Global Benchmarking Tool (GBT) Maturity Level 3 and to secure prequalification for the National Drug Control Laboratory (NDCL). By establishing a robust Management Information System (MIS) unit, the DGDA is poised to transition towards a more integrated and data-driven regulatory framework. Key components of the roadmap include a thorough assessment of existing infrastructure, a five-year strategic implementation plan, and the development of interoperable digital modules for licensing, inspection, pharmacovigilance, and clinical trials. Additionally, the roadmap emphasizes the importance of data governance, capacity building, stakeholder engagement, and adherence to international interoperability standards. This initiative reflects Bangladesh's commitment to aligning its regulatory practices with global standards, thereby strengthening the country's capacity to ensure the quality, safety, and efficacy of medicines.
Purpose & Scope of the Digitalization Roadmap: The roadmap provides a comprehensive and phased plan for developing a digitally empowered, transparent, and interoperable medicines regulatory system in Bangladesh. It lays out the strategic goals, technological requirements, and governance frameworks needed to achieve:
- WHO GBT Maturity Level 3
- Digital prequalification of the National Drug Control Laboratory (NDCL)
- A hybrid MIS infrastructure integrating regulatory workflows, data analytics, and stakeholder engagement tools
Key features of the roadmap include:
- Assessment of Existing Infrastructure: Comprehensive evaluation covering hardware, networking, cybersecurity, policy compliance, disaster recovery, and backup systems, along with insights from Key Informant Interviews (KII) across nine core functional areas.
- Five-Year Strategic Plan: Clearly defined short-, medium-, and long-term milestones to guide phased implementation.
- Integrated Regulatory Architecture: Blueprint for interoperable digital modules encompassing licensing, inspection, pharmacovigilance, clinical trials, and other critical regulatory functions.
- Data Governance Framework: Includes real-time dashboards, analytics, and decision-support systems to enhance regulatory oversight and transparency.
- Focus Areas: Emphasis on technology and reporting frameworks, capacity building and training, change management, stakeholder engagement, and realization of digital health benefits.
- Advanced Technology and Risk Management: Incorporates plans for cybersecurity, system redundancy, machine learning, artificial intelligence, and disaster recovery mechanisms.
- Interoperability Standards: Designed to enable seamless integration with DGHS, DGFP, WHO, and other international regulatory platforms.
- Implementation Strategy: Roadmap execution plan supported by detailed budgeting and financial forecasting.
Collaboration Across Institutions: The project was anchored in a multi-sectoral, consultative approach. PQM+ through its technical partner, JBRSOFT, facilitated collaborative dialogues, technical consultations, and validation workshops with stakeholders from:
- DGDA senior leadership and technical teams
- PQM+ teams
- Public health and IT experts from government and development agencies
- Policy makers, former secretaries, and WHO experts
Picture: Snaps from the dissemination event.
Leadership & Contributors
- Advisor: Major General Md. Shameem Haidar, Director General, DGDA
- Supervision: Mr. Ashraf Hossain (DGDA), Dr. Syed Khyyam (PQM+), Dr. MHM Mahmudul Hassan (PQM+), Mr. Mehedi Hasan (PQM+)
- Editor: CEO, JBRSOFT Limited
JBRSOFT Project Team
- Ms. Shanjida Rahman Sultana, Project Coordinator
- Mr. Mohammad Aftab Uddin, Technical Advisor
- Ms. Fatema Banu, Software Developer
- Mr. Md. Abul Hasnat, Operation Director
- Dr. Amany Ayub, Public Health Advisor
Picture: Final Technical Working Group Meeting at DGDA
Technical Working Group (TWG): Comprising DGDA directors, assistant directors, IT personnel, PQM+ specialists, and the CEO of JBRSOFT, the TWG played a pivotal role in ensuring that the digitalization roadmap was aligned with DGDA’s regulatory mandates, technical infrastructure, and operational needs.
Key Informant Interviews: The project integrated valuable insights from:
- Mr. Md. Humayun Kabir, Former Senior Health Secretary
- Mr. Md. Abul Kalam Azad, Former DG, DGHS
- Mr. Sukhendo Sekhor Roy, System Analyst, MIS, DGHS
Digital Roadmap Outcomes: PQM+’s technical partner, JBRSOFT, designed the roadmap using:
- Baseline Assessment and Survey, KII, IDI, Literature Review and IT Infrastructure Assessment
- SWOT Analysis
- Enterprise Architecture principles
- Health Information System (HIS) design patterns
- Agile development roadmaps
- Open standards for data security and interoperability
Some of the proposed deliverables include:
- A Regulatory Information Portal
- Online modules for Drug Registration, Inspection, Adverse Drug Reaction Reporting, Clinical Trial Oversight
- Integration with NDCL Laboratory Information System
- A centralized dashboard development
- A centralized Stakeholder Relationship Management Platform
- AI-ready backend for analytics and forecasting
Final Recommendations:
The digitalization of DGDA through the MIS unit represents a significant advancement for regulatory governance and public health in Bangladesh. By adhering to these recommendations and maintaining a forward-looking approach, DGDA can achieve its strategic goals and set a benchmark for regulatory excellence in the region.
- Strengthen Governance and Leadership
- Focus on Continuous Improvement
- Enhance Stakeholder Collaboration
- Prioritize Data Security and Privacy
- Plan for Financial Sustainability
December 2024 Dissemination: A National Milestone
At the national dissemination meeting on December 23, 2024, JBRSOFT and USAID's PQM+ Programme officially shared the printed version of the roadmap with over 40 stakeholders from MoHFW, DGDA, DGHS, PQM+, MSH, WHO, and digital health partners. The session featured:
- A formal handover of the roadmap to DGDA leadership
- Presentations on roadmap structure, implementation strategy, and global alignment
- Discussions on stakeholder roles, investment needs, and next steps
Why This Matters:
The roadmap is not just a technical document—it is a strategic tool for governance transformation. It empowers DGDA to:
- Transition to a paperless regulatory system
- Improve the efficiency, traceability, and accountability of medicine regulation
- Boost international recognition of Bangladesh’s regulatory capacity
- Enable data-driven decisions in public health and pharmaceuticals
JBRSOFT’s Role in Digital Health Transformation: This project further strengthens JBRSOFT Limited's position as one of the pioneers in digital health innovation across South Asia and LMICs. With a proven track record in designing national health platforms, pharmacy systems, AMR surveillance tools, and e-regulatory systems, JBRSOFT remains committed to shaping resilient, data-powered health futures.
“It is an honor to spearhead this national initiative. Our mission is to bridge the gap between health governance and technology by building systems that are smart, scalable, and human-centered.” — CEO, JBRSOFT Limited
JBRSOFT extends its sincere gratitude to the PQM+ team, with special appreciation to Dr. Syed Khyyam, Dr. MHM Mahmudul Hassan, and Mr. Mehedi Hasan for their invaluable guidance and support throughout the development of the roadmap.
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