Maturity Level of National Regulatory Authority – DDA Nepal

In the realm of public health, ensuring access to safe, effective, and quality medicines is crucial. This responsibility falls largely on the shoulders of the National Regulatory Authority (NRA) in each country. In Nepal, this vital role is carried out by the Department of Drug Administration (DDA). To assess and enhance the capacity of such regulatory bodies, the World Health Organization (WHO) utilizes a benchmarking system known as the Global Benchmarking Tool (GBT), which categorizes regulatory systems into Maturity Levels (ML) ranging from 1 to 4.

Understanding Maturity Levels

• ML-1 (Basic Level): Existence of some regulatory functions, but they may be fragmented, weak, or underdeveloped.

• ML-2 (Evolving Level): Regulatory system has elements that function and are partially implemented.

• ML-3 (Stable, Well-Functioning System): NRA is considered stable, integrated, and performs well across all regulatory functions.

• ML-4 (Advanced Level): Regulatory system operates at an advanced level with continuous improvement and innovation.

Current Status – ML-1

As of now, Nepal’s DDA is recognized to be at Maturity Level 1. While the foundational systems are in place, challenges remain in terms of infrastructure, human resources, regulatory framework implementation, and quality assurance processes. This level indicates that while efforts have been made, the regulatory system is still at an early stage and requires substantial strengthening.

ML-2 by 2025 – An Ambitious but Necessary Goal

The Government of Nepal has set a strategic goal to achieve ML-2 by the year 2025. Reaching ML-2 would signify that the DDA has developed a more functional and evolving regulatory system with improved coordination and execution of core regulatory functions, such as drug registration, market surveillance, and post-marketing monitoring.

To reach this milestone, Nepal must:

• Strengthen legal and regulatory frameworks.

• Enhance training and capacity-building for regulatory staff.

• Invest in laboratory facilities and quality control.

• Improve transparency and public access to regulatory decisions.

ML-3 by 2027 – Towards a Stable and Functional System

Achieving ML-3 by 2027 is a major step forward, aligning Nepal’s drug regulatory system with international standards. ML-3 certification would mean that the DDA operates a stable, well-integrated system capable of ensuring the safety, efficacy, and quality of medicines in Nepal. It would also open doors for international recognition, regional regulatory harmonization, and improved access to quality-assured medicines for the Nepali population.

Sustaining ML-3 through 2030 and Beyond

By 2030, Nepal aims to consolidate and sustain its ML-3 status, ensuring continuous improvement and long-term sustainability of its regulatory system. This involves:

• Institutionalizing quality management systems.

• Enhancing collaboration with international agencies and regional partners.

• Implementing digital and innovative regulatory solutions.

Conclusion

The progression from ML-1 to ML-3 within a decade is an ambitious yet achievable vision for Nepal’s Department of Drug Administration. This journey reflects the country’s commitment to strengthening its pharmaceutical regulatory system, ensuring the health and safety of its citizens, and meeting global standards in public health governance.

Nepal’s regulatory transformation will not only boost public trust in medicines and healthcare but also reinforce the nation’s capacity to respond to emerging health challenges and emergencies with resilience and confidence.

Currently, the maturity of the national regulatory authority is ML-1, and projected to achieve ML-2 by 2025, and ML-3 by 2027

• DDA Notice Regarding the Red Line on Antimicrobial Medicines
• Department of Drug Administration (DDA)