NATIONAL DRUG

POLICY
SUBMITTED TO: MAM SUNDAS KHALID

• SUBMITTED BY: GROUP E

• 04-M-16
• 05-M-16
• 11-M-16
• 18-M-16
• 29-M-16
• 36-M-16
• 37-M-16
NATIONAL DRUG POLICY
• A national drug policy is a commitment to a goal and a guide for action. It expresses and prioritizes the
medium- to long-term goals set by the government for the pharmaceutical sector, and identifies the
main strategies for attaining them.
• It provides a framework within which the activities of the pharmaceutical sector can be coordinated.
• It covers both the public and the private sectors, and involves all the main actors in the pharmaceutical
field.
• A national drug policy, presented and printed as an official government statement, is important
because it acts as a formal record of aspirations, aims, decisions and commitment
• WHO recommends that all countries formulate and implement a comprehensive national drug policy
(NDP).
NEED OF NATIONAL DRUG POLICY
• National drug policy is needed for following reasons:
• 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
• 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
GOALS AND OBJECTIVES OF NDP

• The general objectives of a national drug policy are to ensure:

• • Access: equitable availability and affordability of essential medicines, including traditional medicine
• • Quality: the quality, safety and efficacy of all medicines;
• • Rational use: the promotion of therapeutically sound and cost-effective use of medicines by health
professionals and consumers.

• The more specific goals and objectives of a national policy will depend upon the country situation, the
national health policy and political priorities set by the government.

• In addition to health-related goals there may be others, such as economic goals. For example, an
additional objective may be to increase national pharmaceutical production capacity
MORE SPECIFIC OBJECTIVES

Improve the dispensing and presentation of medicines

• Promote the correct use of medicine by public
• Encourage correct use of health facilities
• Control or lower the cost of medicines to government and public
• Improve the manpower skis of qualified personnel
KEY COMPONENTS OF NDP

A national drug policy is a comprehensive framework in which each

component plays an important role in achieving one or more of the general
objectives of the policy (access, quality amd rational use).
Access to essential drugs:-
Essential drugs can only be achieved through rational selection, affordable
prices, sustainable financing and reliable health and supply systems.
1.SELECTION OF ESSENTIAL DRUGS

• Drug selection, preferably linked to national clinical guideline, is an important step in ensuring access
to essential drugs and in promoting rational drug use, because no public sector or health insurance
system can afford to supply or reimburse all drugs that are available on the market.
• Key policy issues are
1. The adoption of the essential drugs concept to identify priorities for government involvement in the
pharmaceutical sector and especially for drug supply in the public sector and for reimbursement
schemes.
2. Procedures to define and update the national list of essential drugs.
3. Selection mechanism for traditional and herbal medicines.
2. AFFORDABILITY

Affordability prices are an important prerequisite for ensuring access to

essential drugs in the public n private sectors.
• Key policy issues are:
1. Government commitment to ensuring access through increased affordability.
2. For all drugs, reduction of drug taxes, tariff and distribution margins, pricing
policy.
3.DRUG FINANCING

Drug financing is another essential component of policies to improve access to essential drugs.
• Key policy issues are :
1. Commitment to measure to improve efficiency and reduce waste.
2. Increased government funding for priority disease and the poor and disadvantaged.
3. Promotion of drug reimbursement as part of public and private health insurance schemes
4. Use and scope of user charges as a drug financing option
5. Use of and limits of development loans for drug financing.
6. Guidelines for drug donations.
4. SUPPLY SYSTEM

The fourth essential component pf strategies to increase access to essential drugs is

a reliable supply system.
Key policy issues:-
1. Public private mix in drug supply and distribution systems
2. Commitment to good pharmaceutical procurement practice in the public sector.
3. Disposal of unwanted or expire drugs.
REGULATION AND QUALITY ASSURANCE

The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on
pharmaceuticals, to ensure the quality, safety and efficacy of drugs, and the accuracy of product information.
• Key issues are
1. Government commitment to drug regulations including the need to ensure a sound legal basis and adequate human
and financial resources.
2. Independence and transparency of the drug regulatory agency, relations between the drug regulatory agency and the
ministry of health.
3. Stepwise approach to drug evaluation and registration, definition of current and medium term registration procedure.
4. Access to drug control facilities.
5. Internal exchange of information
RATIONAL USE

The rational. Use of drugs means that patients receive medicines appropriate for their clinical needs. In dose that meet
their individual requirements, for an adequate period of time, and at lowest cost to them. And their community.
• Key policy issues are:
1. Development of evidence based clinical guidelines the basis for training, prescribing, drug utilization review drug
supply and drug reimbursement.
2. Establishment and support of drugs and therapeutics committees.
3. The need and potential for training informal drug sellers.
4. Continuing education of health care providers and independent unbiased drug Information.
5. Consumer education and ways to deliver it.
6. Financial incentives to promote rational drug use.
RESEARCH

Operational research facilitates the implementation, monitoring and evaluation

of different aspects of drug policy.
• Key policy issues are :-
1. The need for operational research in drug access quality and rational use.
2. The need and potential for involvement in clinical drug research and
development.
HUMAN RESOURCES DEVELOPMENT

Human resources and development includes the policies and strategies chosen to ensure that they are enough trained
and motivated personnel available to implement the components of the national drug policy. Lack of motivation and
appropriate expertise has been a critical factor in the failure to achieve national drug policy objectives.
• Key policy issues are :-
1. Government responsibilities for planning and overseeing the development and training of the human resources
needed for the pharmaceutical sector.
2. Definition of minimum education and training requirement for each category of staff.
3. Career planning and team building in government service.
4. The need for external assistance.
MONITORING AND EVALUATION
Monitoring and evaluation are essential components of National Drug Policy
and the necessary provision need to be included in the policy
Key policy issues are :-
1. Clear government commitment to the principles of monitoring and
evaluation.
2. Monitoring of the pharmaceutical sector through regular indicator based
3. Surveys: Independent external evaluation of the impact of the national
drug policy on all sectors of the community and the economy.
NDP INVOLVES

• A national drug policy involves a complex process of development,

implementation and monitoring. First, the policy development process results in
the formulation of the national drug policy. Second, strategies and activities aimed
at achieving policy objectives are implemented by various parties.
• Finally the effect of these activities is monitored and program adjusted if necessary.
• Throughout the process careful planning and the involvement of all parties are
needed, and the political dynamics have to be considered at all time.
1. PLANNING

Drug policy without an implementation plan remains a dead document. Careful

planning of the implementation steps and activities necessary to arrive at the
expected outcome is important throughout the process.
• There are various types of plans. The first is probably the strategic plan to
develop the policy itself, which should specify the various step in the development
process, and especially plan for the involvement of as many stakeholders as
possible. After the policy has been adopted an implementation plan, or master plan,
is needed, which typically covers a 3-5 –year period.
2. INVOLVING ALL PARTIES

Throughout the policy process (and not only in the development phase) there
should be consultation, dialogue and negotiations with all interested groups
and stakeholders.
• These include other ministries (higher education, trade, industry) doctors,
pharmacist and nurses, local and International pharmaceutical industries,
drug seller, academia, nongovernmental organizations (NGOs).
3. POLITICAL

• Formulating and implementing a national drug policy are highly

political processes. This is because such a policy usually seeks to achieve
equity of access to basic health care, primarily by making the pharmaceutical
sector more efficient, and responsive to health needs.
NDP FORMULATION PROCESS

The ministry of health is the most appropriate national authority to take the lead role in formulating a national drug
policy. There are seven steps for formulating NDP which are;
• Step 1: Organize the policy process
• The first step is to decide how to organize the development process that will identify the structure of the policy,
its major objectives and its priority components.
1. In this stage all the interested parties that need to be involved are identify the necessary resources, how these
can be obtained.
2. The need for assistance from WHO, donors or countries with relevant experience should also be assessed.
3. This stage can be carried out within the ministry of health with support from small committee of select experts.
NDP FORMULATION PROCESS

• Step 2: Identify main problems

1. In order to set a realistic objectives a through analysis and understanding of the main problems. In
pharmaceutical sector are needed. There are various ways of carring out an initial situation analysis of
which is to select team of expert with experience in policy formulation. These experts should act
independent advisers and come not only from ministry of health but also from other disciplines; they should.
2. Examine the situation systematically
3. Identify the main problems,
4. Make recommendations, these recommendations can be discusses at one or more multidisciplinary
workshops, in order to formulate Consolidated advice to the government.
NDP FORMULATION PROCESS

• Step 3: Make a detailed situation analysis

A more detailed situation analysis of the pharmaceutical sector and its
components may be needed. This should further analyze the source of the
problems, in order to identify potential solutions, choose the most appropriate
strategies, set priorities, and serve as a baseline for future systems of
monitoring and evaluation.

•
NDP FORMULATION PROCESS

• Step 4: Set goals and objectives for a national drug policy

• Once the main problems have been defined, goals can be set and priority objectives identified.
1. For example, if one of the priority problems is lack of access to essential drugs, one of the priority
objectives should be to improve the selection, affordability and distribution of essential drugs.
2. The selection of appropriate strategies to achieve the objective is more complex, since it may
involve choosing from among very different approaches. A helpful procedure is to make a
workshop involving a small number of key policy-makers. The situation analysis should justify
the choices and serve as the basis for decisions. The outlined objectives and strategies should be
discussed with all interested parties.
3.
NDP FORMULATION PROCESS

• Step 5: Draft the text of the policy

• Once the situation analysis and an outline of the main goals, objectives and approaches have
been completed, a draft text of the national drug policy should be prepared; it should set out
the general objectives of the policy. In most countries this will be to ensure that essential drugs
are accessible to the entire population; the drug are safe, efficacious and of good quality; and
are used rationally by health professionals and consumers.
• The specific objectives should also be described. Drafting of the policy can be done by a small
group of experts who have been involved in the earlier stages of the process. Examples of
national drug policy documents from other countries may be consulted.
NDP FORMULATION PROCESS

• Step 6: Circulate and revise the draft policy

• The draft document should be widely circulated for comments, first within the ministry of
health, then in other government ministries and departments, and finally to relevant
institutions and organizations outside the government, including the private and academic
sectors.
• Endorsement by government sectors responsible for planning, finance and education is
important since the successful implementation of many elements of the policy will depend on
their support as well. Once this wide consultation is complete, the draft document should be
revised in the light of the comments received, and finalized.
NDP FORMULATION PROCESS

• Step 7: Secure formal endorsement of the policy

• In some countries the document can then go to the cabinet or parliament for endorsement
• In others it will remain an administrative document that serves as basis for implementation plans
and changes in the law and regulations. In some countries the entire national drug policy
document has become law.
• This is a powerful demonstration of political commitment but it can also cause problems, as future
adjustments to the policy may become difficult. It is therefore recommended that only certain
enabling components of the policy are incorporated into law, without too many operational details.
NDP FORMULATION PROCESS

• Step 8: Launch the national drug policy

• Introducing a national drug policy is much more than a technical task. To a large extent the policy’s
success will depend on the level of understanding of different sectors of society, and on their support
for its objectives. The implication and benefits for all interested parties should therefore be stressed.
• The policy should be promoted through a clear and well-designed information campaign. Public
endorsement by respected experts and opinion leaders can be very useful. Information should be
disseminated through a variety of channels to reach different target groups. The media can play a
major role in ensuring public understanding and support for the policy some countries have organized
high profile launches.
IMPLEMENTATION OF NDP
A policy, however carefully formulated, is worthless if it is not implemented. Every drug policy needs an overall
implementation plan or “master plan” ; each component of the policy needs a detailed strategy and specific action plans.

1. Priorities for implementation

• For each country the priorities for implementation will be different. For example, when health care coverage is broad and
access to drugs is not a problem, rational use and the cost of drugs is likely to be concern. In such a situation, implementation
of a drug policy will focus on regulating the market and control costs without decreasing sustainable access and equdrug
• In least developed countries total spending on health and pharmaceuticals may be very low. In this situation the focus of the
policy will be more on increasing access to essential drugs.
• Priorities for implementation should be based on severity of problems, and on potential for success in achieving the objective
and making an impact with available resource
• lated, is worthless if it is not implemented. Every drug policy needs an overall implementation plan or “master plan” ; each
component of the policy needs a detailed strategy and specific action plans.
2. Master Plan and Work Plan
The national drug policy leads to an implementation plan or master plan, which
may cover a 3-5 year period. If resources are insufficient without external input, a
set of priority activities should be identified that can be performed within existing
resources
Potential donor inputs should be included, and gaps in funding can be identified as
a guide for future donor support. The master plan facilities monitoring and follow
up and it is important that it is communicated to all parties involved
• The master plan should be broke down into annual action plans and work plans
which should be carefully developed with the various agencies involved in
implementations agencies involved in implementation
• 3. Responsibilities in Implementation
• As lead agency, the ministry of health should oversee and coordinate all
activities and monitor the extent of implementation and the achievement of
targets. In some countries a separate unit within the ministry, with its own
budget and personnel, acts as the coordinating body
• Apart from the coordinating body, it is recommended that a national
consultative forum is created to oversee policy implementation
• National institutions, such as the drug regulatory agency the pharmacy
department in the ministry of health, the central medical stores and district or
provisional health offices are key players in drug implementation; other
agencies dealing with finance, trade, economic planning and education
• 4. Financial resource:
• It is important to match the strategies and action plans with available
financial resources. Allocations from government funds and income from
drug registrations and fees are the usual funding sources. The responsible
agencies should have a mechanism for actively seeking funds and be able to
secure regular funding from the government.
• Contributions from international and local donors are also possible sources.
However, there should be no conflict of interest in accepting donor
contributions, for example, when donors are interested in funding activities
that are of low priority in the national drug policy
• 5. Regional cooperation:
• Regional cooperation implementing institutions drug and can be policies. Organizations
useful in Countries, can share information, expertise, skills and facilities. Exchanging
experiences helps to ensure that best practices are promoted, that mistakes are not repeated
and that limited resources are used effectively.
• Sharing information and technical expertise can be particularly effective if the policies and
strategies are mutually relevant and easy to adapt. Harmonization of drug regulatory
standards can be one outcome of successful technical and regulatory cooperation among
countries.
• Harmonization in these areas could lead to a more economical use of human, animal and
material resources, and to the development of regionally or internationally agreed standards.
During the process of harmonization each country must ensure that the areas being
harmonized can be implemented and are relevant to national interests.
6. Technical Cooperation with WHO:
• WHO can provide a forum for exchange of information, and can promote
cooperation through regional and international training courses and through
inter-country research projects. WHO collaborating centers’ and other centers
are also involved in training and research, forming professional networks and
exchanging information among cooperating countries
REFERENCE

1.Drug regulation and drug policy by Siham Abdoun (Msc &P.hd)

Published on feb 18,2014
2.National Drug policy by Ambu Vijayan published on January 07,2018