Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal

BirSingh November 2, 2022 2 min read

Overview Government of Nepal has established Department of Drug Administration (DDA) in 1979 to implement and fulfill the aim of […]

Overview

Government of Nepal has established Department of Drug Administration (DDA) in 1979 to implement and fulfill the aim of Drug Act 1978 and various regulations under it. The National Drug Policy 1995 focuses on establishing co-ordination among government, non-government and private organizations involved in the activities related to medicine production, import, export, storage, supply, sales, distribution, quality assessment, regulatory control, rational use and information flow. Here are the list of major Drug and Medicine Related Plan, Policies & Directives endirsed by Government of Nepal.

List of Drug and Medicine Related Plan, Policies & Directives in Nepal

S.No	Documents
1	Codes on Sales and Distribution of Drugs, 2071 (English)
2	Codes on Sales and Distribution of Drugs, 2071 (Nepali)
3	Drug Act 2035 (English)
4	Drug Act 2035 (Nepali)
5	Drug Consultative Council and Drug Advisory Committee Regulation 2037
6	Drug Investigation and Inspection Rules 2040
7	Drug Registration Guidance 2073 (Medicine registration guidance)
8	Drug Registration Regulation 2038
9	Drug Registration Regulation Revision
10	Drug Standard Regulation 2043
11	Drugs Registration Rules, 2038 (1981)
12	Emergency Use of Medicines or Vaccines Code, 2078
13	Essential Medicine List
14	Emergency Use of Medicines or Vaccines Code, 2078 Revision
15	Guidelines for Drug Donation to Nepal
16	Health Technology Product a Medical Device Directive 2074
17	Health Technology Product a Medical Device Regulation
18	Hospital Pharmacy Guideline 2072 (English)
19	Hospital Pharmacy Guideline 2072 (Nepali)
20	Hospital Pharmacy Guideline 2078 (New)
21	Narcotic Drugs Control Act 2033
22	National Drug Policy 1995
23	National GMP Code 2072
24	National GMP Code 2072 (Updated National GMP Codes)
25	Nepalese National Formulary (NNF)- 3rd edition
26	Nepalese National Formulary NNF 2nd Edition
27	Special Permission Guidance (1st revision) 2021
28	Special Permission Guidance 2074
29	Special Permission Guidance 2074 (2017)_Translated Final
30	SOP for Product Recalls

Drug and Medicine Related Act, Rules, Regulations, Policies, Guidelines & Directives in Nepal

Related readings

Department of Drug Administration Drug Act Drug and Medicine Drug Registration Regulation Hospital Pharmacy Guideline National Drug Policy Policy & Guidelines Publications

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