Drug Act 2035
Introduction to the Drug Act 2035 (औषध ऐन, २०३५): Foundation of Nepal’s Pharmaceutical Regulation
The Drug Act 2035 B.S. (1978 A.D.) marks a pivotal moment in the history of pharmaceutical legislation in Nepal. Enacted with the primary goal of safeguarding public health by regulating the production, import, export, sale, distribution, and use of drugs, this Act laid the legal foundation for ensuring the quality, safety, and efficacy of medicinal products available in the country.
Structured into 7 comprehensive chapters and 40 detailed sections, the Act outlines legal frameworks for drug classification, licensing, inspection, standards, and penalties for non-compliance. Its implementation has played a crucial role in shaping Nepal’s healthcare and pharmaceutical landscape.
Since its first publication in 2035 B.S., the Act has undergone three significant amendments to address the evolving challenges of public health and pharmaceutical practices:
- First Amendment: 2045 B.S.
- Second Amendment: 2057 B.S.
- Third Amendment: 2079 B.S.
These revisions reflect Nepal’s commitment to strengthening drug regulation in line with global standards and national needs.
Click below to read or download the full PDF version of the Drug Act 2035.
Drug Act 2035 Pharma Info Nepal PDF
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