Sunday, September 12, 2010

Need for regional state-specific drug policies in India

India is a big country with a complex and diverse social, cultural, economic and political fabric. Constitutionally health is primarily a state responsibility. Hence although health and medicine policy are formulated and revised periodically by the Govt of India, the responsibility of its implementation lies chiefly with the state Govts. The National Pharmaceutical Policy addresses provisions relating to import, export, pricing, investment, R&D, industrial licensing and manufacture of medicines and pharmaceuticals. However by 2000, India had not achieved 13 out of the 17 goals laid down in the first National Health Policy of 1983. At regional level, each state of the Union has to address its local concerns on the basis of own requirements. These concerns pertain to effective quality control of medicines; rational prescribing and use of medicines; availability of safe and effective medicines in adequate quantities at Govt. centres; improved procurement, storage and distribution practices for medicines and other medical supplies; quality pharmaceutical and healthcare services; stringent enforcement of medicine related laws; adequate pharmacy and health education, research and training facilities at all academic and healthcare institutions; and indigenous manufacture of life-saving medicines.
Keeping with above concerns, each state frames state specific medicine policy that addresses key issues related to the availability of safe and effective medicines at affordable prices as well as to their rational prescribing, improved distribution and sale in accordance with the existing laws.

Many states like Karnataka, Kerala, West Bengal, Himachal Pradesh, Punjab, Delhi, Chattisgarh, Madhya Pradesh, Orissa etc; have their own state drug and health policy but not all states. Hence there is need to enhance the level of awareness about having such a policy and to make the decision makers realize the urgency to take notice of the need.

India’s health care delivery system is divided in four levels: rural health centres, district hospitals, tertiary care hospitals and teaching hospitals. Pharmaceutical policy in India is perceived primarily as an industrial policy rather than a health policy. Under the Constitution of India both the Central Govt and the States have concurrent duties for drug control, for safety, quality and efficacy. Public expenditure on drugs has generally remained low at about US$1 per capita. The public has to largely depend on out-of-pocket expenditure, purchasing medicines from chemists or paying private practitioners. While nearly 75% of health care, including medicines, is obtained from private sources, marginalised populations living in remote rural areas largely depend on public facilities. Considering the diverse nature of India, its population size and socio-cultural characteristics, and health care being state matter, there is need for framing drug and health policies at state level in order to cater to the local requirements and ensure proper implementation of Govt. programmes at the grass root level 1.

National Human Rights Commission (NHRC) recommends the adoption of a State essential drug policy in every state that ensures full availability of essential drugs in the public health system. This could be through adoption of a graded essential medicine list (EML), transparent medicine procurement, efficient distribution and adequate budgetary outlay. It recommends that the medicine policy should also promote rational medicine use in the private sector and the health department should prepare a “State Medicine Formulary” based on the health needs of the people of the state. The medicine formulary should be supplied free of cost to all Govt. hospitals and at subsidized rates to the private hospitals. Regular updating and revision of the formulary should be ensured. Treatment protocols for common diseases should be prepared and made available to medical professionals. State Govts should take steps to decentralize the health services by giving control to Panchayati Raj Institutions (PRIs) and Govt. hospitals up to the district level. Enough funds from the plan and non plan amount should be devolved to the PRIs. The local bodies should be given the responsibility to formulate and implement health projects within the overall frame of the health policy of the state.2

Decentralization must devolve authority and power to States and Districts but also to the local bodies. This has occurred only in Kerala. Able leadership and governance connotes the ability to properly plan, adequately budget for, timely implement, properly manage, effectively monitor, sincerely review and willingly accept responsibility for the decisions taken. The strategy of the “big bang” approach of Kerala where, in one sweep, functions, powers and responsibilities were transferred, has proved to be successful as compared to other states where devolution has been incremental, halting and sporadic.3

In the past policy discussions about health care usually focussed national level. In recent years, there has been increased focus at the state level, as it is responsible for actual delivery of health services. States are thought to have a free hand in designing and implementing policies that are specific to own needs and circumstances. Analysis shows that policy makers have to be cognizant of state level determinants in order to design effective policies to improve immunization rates in the country. Given the fact that vaccine preventable diseases loom large in terms of childhood morbidity and mortality, it is critical that financial and material resources be directed at the most appropriate level based on identified inadequacies.4

India’s health system was designed when expectations were different. India has undergone transition in demographic, epidemiologic and social health. Disparities in life expectancy, disease, access to health care and protection from financial risks have increased. The previous approach to national health policies and programmes is now out dated. By analyzing inter and intra state differences, the content of national health policy needs to be more accommodative to specificities of states and districts. ‘Splitting’ of India’s health policy at the state level would better address their health problems, and would open the way to innovation and accountability. States need to focus on improving the quality and access of essential public health services, and empowering communities to take ownership. The central Govt. needs to support and facilitate states and districts to develop critical capacities rather than manage their programmes. More explicit and comprehensive state policies and strategies in health are needed now more than ever. States that are early in the health transition need to focus more attention and resources on addressing the health transition. Much of this would need to be through strengthened public sector programmes, and soliciting greater collaboration with private sector.5

Examination of plans and policy indicates the gap between the rhetoric and reality and the framework responsible for this. The spirit of primary health care has been reduced to mere primary level. The multisectoral approach that is needed and the intersectoral linkages that are essential for a vibrant, throbbing health system have been unfortunately missing. The outline of health plan documents and implementation has been incremental rather than holistic. It is important to question whether it is only the low investment in health that is the main reason for the present status of the health system or is it also to do with the framework, design and approach within which the policies have been planned.

Technological advances, investment and good policies are of no use if the system lacks leadership, direction and integrity. Unless all stakeholders are motivated by values of humane compassion for the ailing, sense of equality and dignity; the health system will continue to reflect the cement and mortar issues of the expanding medical and medicine industry, which can, in the absence of the guiding hand of the state, degrade human suffering into an opportunity for profiteering.

It is desirable that there should be one national policy addressing regional concerns of different states in country. It remains to be seen if this will work because health is a state subject in India and it is for the individual states to decide how best they can procure, store and distribute medicines on the basis of their available distribution channels and infrastructure, their topography; how best they can enforce their medicine related laws in their region; what type of medicines they should include in their EML on the basis of ADR profile of their region; and how best they can enhance the affordability of medicines on the basis
of available manufacturing capacities. Regional variations persist and so do regional programmes, hence the need for regional, state-specific medicine policies.

REFERENCES

1. Roy Chaudhury R, Parameswar R, Gupta U, Sharma S, Tekur U, Bapna JS, Gurbani NK. Quality Medicines for the Poor: Experience of Delhi Programme on Rational Use of Drugs (1995-2000). Health Policy & Planning 2005, 20: 124-136.
2. National Human Rights Commission, New Delhi. Recommendations of National Action Plan to operationalize the right to healthcare.
3. Financing and Delivery of Healthcare Services in India”: A report by the National Commission on Macroeconomics and Health. Background Papers of the National Commission on Macroeconomics and Health. Ministry Of Health And Family Welfare Government Of India, 2005.

4. Melissa Gatchell, Amardeep Thind, Fred Hagigi. Informing state-level health policy in India: The case of childhood immunizations in Maharashtra and Bihar. Acta Pædiatrica 2008, 97, pp. 124–126

5. David H, Peters,K , Sujatha Rao and Robert Fryatt. Lumping and splitting: the health policy agenda. Health Policy and Planning 2003. 18(3): 249–260

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