**2. Governments**

Governments include state and central/federal governments and all its ministries concerned with the manufacture, import, export, investment, licensing, pricing, R&D and quality control of drugs. They are the key stakeholders and in fact pioneer in pharmaceutical policy development, planning, implementation and monitoring. For any new pharmaceutical policy development, initiatives must come from the governments and it is mainly their duty to take all other stakeholders on board for consultation before promulgation of any policy framework. Political will of the government can be the real game-changer in any country for development of effective policies on quality control, procurement, distribution, safe and effective use of medicines alongwith their equitable access, affordability and financial risk protection. Political will of the federal and state governments alone can ensure full transparency and accountability in drug selection, quantification, procurement, tendering, distribution and rational use and for such a will to take shape strong and effective leadership and governance structure is a pre-requisite. Some of the most robust policy documents have eventually turned to be a failure in absence of political will, support and effective leadership of central and state governments. Supportive governments and willing political establishments alone can earmark sufficient budgetary allocations towards healthcare in order to sufficiently meet drug demands and bear all administrative costs besides giving full autonomy to the procurement agencies to follow norms and well-established standards in drug quality and procurement without any kind of government or political interference.

India presents a peculiar example of how different federal ministries govern different aspects of pharmaceuticals and therefore how they need to be consulted and integrated not only for developing an effective policy framework but also for its effective implementation and constant monitoring. In India Ministry of Chemicals and Petrochemicals oversees policy, planning, development and regulatory activities pertaining to the chemicals, petrochemicals and pharmaceuticals sector whereas Ministry of Health and Family Welfare examines pharmaceutical issues within the larger context of public health and the focus of the Ministry of Chemicals and Fertilizers is on the industrial policy. Other ministries that also play a role in the drug regulation process include the Ministry of Environment and Forests, Ministry of Finance, Ministry of Commerce and Industry and the Ministry of Science and Technology. Issues related to industrial policy such as the regulation of patents, drug exports and government support to the industry are governed by the Department

of Industrial Policy and Promotion and Directorate General of Foreign Trade, both under the aegis of Ministry of Commerce and Industry and the Ministry of Chemicals and Fertilizers [3].
