In 1978, the Government of Nepal enacted Drug Act 2035 and the following year established the Department of Drug Administration (DDA) under the Ministry of Health and Population (MOHP). The DDA’s mandate includes regulating the production, marketing, import, export, storage, supply, sale, and distribution of medicines and health technologies; enforcing Drug Act provisions on regulatory compliance; formulating policies and regulating prices to facilitate access to products; and promoting rational medicine use. MTaPS’ work focuses on supporting the MOHP and national regulatory authority to build the DDA’s institutional capacity and improve the legal provisions and tools needed to deliver on the DDA’s mandate.
MTaPS focuses on the following technical areas:
The program is supporting the DDA and MOHP to review options for reconfiguring the DDA’s organizational structure to optimize the use of human resources, position it to fulfil its functions in the decentralized model, and clarify roles and responsibilities to improve accountability. As a follow on to an MTaPS-supported review of the legislative framework, the program is helping to address gaps and weaknesses in legal provisions and regulations that target areas of greatest risk in medicines regulation.
Regulatory systems strengthening
MTaPS is working with the DDA and the World Health Organization (WHO) to complete a baseline assessment that benchmarks the performance and maturity of Nepal’s pharmaceutical regulatory system. Thereafter, the program will collaborate with WHO and other partners to help the DDA formulate an institutional development plan and implement activities that systemically address regulatory gaps and build institutional and staff capacity to sustain and build on improvements.
Quality management system
To ensure that the DDA’s operational processes are clearly defined and controlled, MTaPS is helping to develop a quality management system (QMS),f starting with marketing authorization, marketing surveillance, licensing, and inspection functions. The QMS development process incorporates review and re-engineering of existing procedures to improve alignment with best practices and international guidelines.
Regulatory information system
As a first step to assisting the DDA in modernizing its regulatory information system, enhancing visibility, and facilitating use of information for better decision making, MTaPS is working with the DDA to develop the requirements and technical specifications for an integrated electronic regulatory information system. Work will be phased and is initially focused on the marketing authorization, marketing surveillance, licensing, and inspection functions.