NATIONAL DRUG POLICY

For BPH 1st Year

Dr. Pravin Prasad

3rd Yr Resident, MD Clinical Pharmacology, Institute of Medicine

20th April, 2017 (Baishak 7, 2074), Thursday

OBJECTIVES

• Rationale for National Drug Policy

• Components of Drug/Medicine Policy

• Overview: National Drug Policy 1995,

Nepal

INTRODUCTION

• Access to essential drugs is mandatory for access to health care

• Problems with Essential Drugs:• Lack of access• Poor quality• Irrational use• Waste

• Can best be addressed within a common framework

Why still persisting?

INTRODUCTION

A commitment to a goal and guide to action

• Expresses and prioritizes

• Identifies the main strategies

• Provides a framework

• Formal record

• Involves commitment from all interested parties

Essential part of health policy

RATIONALE

• To present a formal record of values, aspirations, aims, decisions and medium-to long-term government commitments

• To define the national goals and objectives for the pharmaceutical sector, and set priorities;

RATIONALE

• To identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy

• To create a forum for national discussions on these issues.

NATIONAL DRUG POLICY (NDP)

• Similarity in NDP of various countries:• Ensure equitable access, good quality and rational use of medicines

• Why NDP needs to be tailored for each country?

NDP: OBJECTIVES

General objectives are to ensure:

AccessEquitable availability and affordability of essential drugs

QualityThe quality, safety and efficacy of all medicines

Rational Use

The promotion of therapeutically sound and cost-effective use of drugs by health professionals and

Should promote equity and sustainability of the pharmaceutical sector

NDP: SPECIFIC GOALS

Specific goals

Country Situation

National health policy

Political priorities

Economic goals

NDP: KEY COMPONENTS

Objectives→Access Quality

Rational UseComponents↓

Selection of essential drugs

X (Direct) (X) (Indirect)

X

Affordability X

Drug financing X

Supply systems X (X)

Regulation and quality assurance

X X

NDP: KEY COMPONENTS

Objectives→Access Quality

Rational UseComponents↓

Rational Use X

Research X X X

Human X X X

Monitoring and Evaluation

X X X

Each component plays an important role in achieving one or more of the general objectives

NEPAL’S NATIONAL DRUG POLICY 1995

(N-NDP)

Had positive impact on development of pharmaceutical industries and gradual

improvement in the pharmaceutical sectors of the country

N-NDP, 1995: DEFINING DRUG

• Any substance which is intended to be usedin human beings or animals

• For diagnosis, treatment, cure, mitigation andprevention of diseases, or

• For promotion of health, or

• For the destruction of micro-organisms whichhave caused disease, or

• To affect the physical structure or function ofa body.

N-NDP, 1995: MAIN POLICY

“To maintain, safeguard and promote the health of people by…..”

Further detailed in 11 different objectives

Self-reliant in Drug

Production

Availability, Affordability,

Adequateness

Manage Drug-related

activity

N-NDP, 1995: ACHIEVEMENTS

Access Related:

•National List of Essential Drugs

• Community drug programme

• 3 Brach offices of Department of DrugAdministration (DDA)

• Eight custom points for importation ofdrugs

•Human Resource Development

• Nepal Pharmacy Council Act

N-NDP, 1995:ACHIEVEMENTS

Quality Related:

• National Quality Control Laboratory

•Good Manufacturing Practices mandatory

• Pharmaceutical / Quality Standard Section established at the Ministry of Health & Population

• 40 domestic pharmaceutical houses producing 215 essential drug items

N-NDP, 1995: ACHIEVEMENTS

Quality related:

• Traditional medicines producing industries increased to 33

• Evaluation of new formulations of traditional medicines

•National Guidelines for Use of Pharmaceuticals for Clinical Trial (Nepal Health Research Council)

N-NDP, 1995: ACHIEVEMENTS

Quality related:

• One industry established in joint venture and another has technical collaboration with a foreign company.

• Three quality control laboratories were established in private sector

• Monitoring and evaluation of progress made in implementation National Drug Policy done twice.

N-NDP, 1995: ACHIEVEMENTS

Rational Use Related:

• Standard treatment schedule

• Drug Information Network of Nepal was established and made functional

• Nepalese National Formulary was published in 1997

WE WILL CONTINUE FURTHER IN NEXT CLASS…

Assignment…