**1. Introduction**

Essentially pharmaceutical policy formulation can be viewed from three different perspectives viz., supply chain perspective that includes components like selection, quantification, tendering and procurement, storage and distribution, quality control and use by the patients; industrial perspective that includes components like manufacture, sale, import, export, licensing, pricing, investments, R&D including clinical research, innovation, patents and drug regulatory affairs; rational use perspective that includes components like safety, efficacy and quality of medicines; promotion of accessibility (including availability and affordability), rational prescribing, rational dispensing and rational use of medicines besides provision of cost-effective, timely and efficient centralized procurement and decentralized distribution of drugs. In spite of different perceptions and perspectives about pharmaceutical policy it goes without saying that quality pharmaceutical and healthcare services to patients can

only be ensured in presence of a strong policy framework that caters to all the needs in respect of drug delivery services and incorporates all components required to enforce and implement existing laws in respect of key issues of public importance.

Worldwide, at national levels terms like national drug policy, national medicines policy and national pharmaceutical policy are used synonymously to describe a policy framework for action in relation to import, export, pricing, investments, research and development, industrial licensing and manufacture of drugs and pharmaceuticals though at deeper regional levels these terms more often than not are used to indicate policies required to enforce and ensure effective quality control of drugs; rational prescribing and use of medicines; availability of safe and effective drugs in adequate quantities particularly at government health facilities; improved procurement, storage and distribution practices for drugs and other medical supplies; quality pharmaceutical and healthcare services at hospitals; stringent enforcement of drug related laws; adequate pharmacy and health education, research and training facilities at all academic and healthcare institutions etc.

Thus at regional and state levels focus of pharmaceutical policy development is more upon regulating safe and effective use of good quality drugs, good dispensing and prescribing practices and rational use of medicines by the patients besides their availability at affordable prices to all sections of the society irrespective of their caste, creed, color or religion within one hour walking distance from their place of inhabitation as well as their acceptability as a reliable source of relief from diseases and disorders. WHO defines national medicines policy as a commitment to a goal and a guide for action that 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 public and private sectors, and involves all the main actors in the pharmaceutical field [1].

On paper, the policy development process appears to be a linear process. It is a step-by-step process that moves from problem statement, to definition, to objectives and outcomes. Those objectives and outcomes are developed, analyzed and evaluated into optional solutions and instruments to be deliberated on. A decision is made by elected or government officials. A policy moving forward goes into program design, potential legislative drafting, implementation and planning. The program is implemented, monitored and evaluated. Finally, the process is reviewed and assessed. The problem is that policy development does not happen in a vacuum. The process looks opaque from the outside in, (given policy priorities, urgencies and timelines) the actual policy process does not always follow the theoretical process, and while stakeholder/citizen engagement can happen throughout the policy cycle, it is at the discretion of the policy makers when, how and what impact it will have on the outcome [2].

In the process of developing and implementing a pharmaceutical policy framework several stakeholders including national and multi-national drug manufacturers, state and central governments (including all ministries like health, commerce, trade, industry), regulatory authorities, patients, doctors, pharmacists, pharmaceutical traders, insurance agencies, academia, professional associations, NGOs, civil society and consumer groups assume primary importance without whose active involvement the whole process would be inadequate and sometimes even inappropriate leaving huge gaps in their comprehensiveness, inclusiveness and acceptability.

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 commitments. Without such a formal policy document there may be no general *Stakeholders in Pharmaceutical Policy Development DOI: http://dx.doi.org/10.5772/intechopen.105606*

overview of what is needed; as a result, some government measures may conflict with others, because the various goals and responsibilities are not clearly defined and understood. The policy document should be developed through a systematic process of consultation with all interested parties. In this process the objectives must be defined, priorities must be set, strategies must be developed and commitment must be built. The consultations and national discussions preceding the drug policy document are very important, as they create a mechanism to bring all parties together and achieve a sense of collective ownership of the final policy. This is crucial in view of the national effort that will later be necessary to implement the policy. The policy process is just as important as the policy document itself [1]**.**

Role, responsibilities and importance of various stakeholders in pharmaceutical policy development and implementation is described one-by-one as under:
