Drug Act 2035

The Drug Act 2035 B.S. (1978 A.D.) is a landmark legislation in Nepal’s pharmaceutical and healthcare sector. Enacted to protect public health, this law regulates the production, import, export, sale, distribution, and use of drugs across the country. It set a strong legal foundation for ensuring drug quality, safety, and efficacy—a crucial step in improving Nepal’s healthcare system.

Key Features of the Drug Act 2035:

• Structured into 7 chapters and 40 sections for comprehensive drug regulation.

• Establishes legal frameworks for drug classification, licensing, inspection, and standards.

• Imposes penalties and legal actions for non-compliance.

• Ensures that all drugs in Nepal meet quality, safety, and therapeutic standards.

Amendment History:
The Drug Act has been updated over time to meet modern pharmaceutical and public health needs:

1. First Amendment: 2045 B.S.

2. Second Amendment: 2057 B.S.

3. Third Amendment: 2079 B.S.

4. Fourth Amendment: 2082 B.S.

These revisions reflect Nepal’s commitment to global standards in drug regulation and healthcare.

Read or Download the Full PDF of the Drug Act 2035 to get complete details of the law, its provisions, and updates.

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Related Acts & Guidelines:

• Drug Category Rules, 2043 (1986) – Drug Standards Regulation of Nepal
• National Drug Policy -1995