Drugs Act, 2035 (1978)
औषधि ऐन, २०३५
Issued by Parliament of Nepal · 1978
In short: The founding law for medicines regulation in Nepal. It created the Department of Drug Administration and controls how drugs are produced, imported, sold and used.
Overview
The Drugs Act protects the public from unsafe, ineffective or misused medicines. The Department of Drug Administration (DDA) enforces it by registering medicines, licensing manufacturers and pharmacies, and taking samples for quality testing.
Key provisions
- Medicines must be registered before they are manufactured, imported or sold.
- Pharmacies, wholesalers and manufacturers must hold licences.
- Medicines are classified, and some may be sold only on prescription.
- Misleading drug advertising, and the sale of substandard or falsified medicines, are banned.
Why it matters
Medicine quality and rational use are central to patient safety and to fighting antimicrobial resistance.
What it means for practitioners
- Prescribe by generic name where you can and follow the national essential medicines list.
- Report suspected substandard medicines and adverse drug reactions to the DDA.
Frequently asked questions
Who regulates medicines in Nepal?
The Department of Drug Administration (DDA) regulates medicines under the Drugs Act 2035.
Related guides
Editorial summary by PHC-Nepal for education only. It is not legal advice. Laws may be amended, so always check the official text.