Drug Registration Regulation 2038
The Drug Registration Regulation, 2038 is a key legal framework of Nepal enacted under the Drugs Act, 2035 to regulate the manufacturing, import, export, sale, distribution, and registration of drugs in Nepal.
Published Date: 2038/4/19 (BS)
First Amendment: 2058 BS
Contents: 12 Rules and 14 Schedules
This regulation empowers the Department of Drug Administration (DDA) to oversee drug quality, registration, licensing, advertising, and clinical trial approvals. It provides detailed guidance for every step of drug regulation through its 14 schedules, ensuring safe, effective, and quality medicines for the public.
With this post, we provide the official PDF of the Drug Registration Regulation 2038 for students, pharmacists, and healthcare professionals preparing for Nepal Pharmacy Council licensing exams, Loksewa exams, and regulatory reference.
Drugs Registration Rules, 2038 (1981)
- Drug Investigation and Inspection Rules 2040
- Drug Act 2035
- Drug Category Rules, 2043 (1986) ; Drug Standards Regulation of Nepal
- Drug Sales Distribution Codes 2080
