INTRODUCTION:
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 field1. Policy discussions about India’s health care system
and efforts to change it usually focus on the national level. However National
Pharmaceutical Policy in India primarily focuses on issues like import, export,
pricing, investments, R&D, industrial licensing and manufacture of drugs
and pharmaceuticals whereas various state medicines policies address key issues
like safety, efficacy and quality of medicines; promotion of accessibility,
rational prescribing, rational dispensing and rational use of medicines besides
provision of cost-effective and efficient procurement, storage and supply
management systems for medicines. This is so because healthcare is a state
subject within India and individual states manage their own healthcare delivery
including drug delivery to common masses. Therefore in recent years, there has
been increased focus at the state level and more and more states are being
provided a freer hand in designing and implementing policies that are specific
to their needs and unique circumstances. As such policy makers have to be
cognizant of state-level determinants in order to design effective policies to
improve drug accessibility and utilization2.
Therefore, more splitting of India’s medicines policy at the state level would
better address their health problems, and would open the way to innovation and
local accountability.
India’s population is also
undergoing transitions in the demographic, epidemiologic and social aspects of
health. Disparities in life expectancy, disease, access
to health care and protection from financial risks have increased. These
factors are challenging the health system to respond in new ways. The old approach to national health and
medicines policies and programmes is increasingly inappropriate. By analyzing inter and intra-state
differences in contexts and processes, it is necessary that the content of national medicines policy needs to be made more
diverse and accommodating to specific states and districts. States further along the health
transition need to develop policies to deal with the alarming issues of spurious medicines, drug addiction, unethical drug promotion
practices of pharmaceutical companies and irrational prescribing and dispensing
practices. States early in the transition would need to focus on
improving the quality and access of essential public health services, and
empowering communities to take more ownership. That sets the tone for more
splitting of medicines policy approaches in India, a major
departure from the past. More explicit and comprehensive state policies and
strategies in health and pharmaceutical sectors are needed now
more than ever3.
Further in light of the fact that drug and
pharmaceutical consumption in Indian states has touched an all time high in the
recent years, drug sale outlets have witnessed an overwhelming increase in
their number across the length and breadth of every state, morbidity rates have
shot up as never before, number of people resorting to alternative systems of
medicine has witnessed a boom, policy making officials and bodies of various
Indian states need to perceive the immediate need for a state drug policy. This
assumes importance because of the fact that most of the Indian states still do
not have their own state medicines policies and because they need to take fresh
initiatives in tune with ever-changing times and trends in drug and
pharmaceutical sector. The need for radically improving the policy framework
for this knowledge-based sector cannot be ignored any further.
National Human Rights Commission of India (NHRC)
in its recommendations for National
Action Plan to operationalize the Right to Health Care has also recommended
adoption of a state essential drug policy that ensures full availability of
essential drugs in the public health system. It also recommends that the state governments
in India should take steps to decentralize the health services by giving
control to the respective Panchayati Raj Institutions (PRIs) concerning the
government hospitals upto the district level. Enough funds from the plan and
non plan amount should be devolved to the PRIs at various levels. The local
bodies should be given the responsibility to formulate and implement health
projects within the overall framework of the health policy of the state4.
Most of the state medicines policies of
Indian states contain provisions relating to selection, procurement, storage,
distribution and rational use of medicines but there is lack of uniformity in
policy components and many state medicines policies lack vital provisions
relating to spurious drugs, drug abuse, unethical promotion and prescribing,
drug licensing, drug recall, disposal of unwanted drugs, AYUSH (comprising
Indian traditional systems of medicine and homeopathy) drugs control, drug
safety monitoring etc. Therefore this comparative policy evaluation study was
undertaken to make a comparative analysis of policy components of the state
medicines policies of six Indian states, make necessary interventions for fresh
policy initiatives in the formulation of the maiden drug policy for the state
of Jammu and Kashmir (J&K) and suggest new policy initiatives and some
novel approaches for other Indian states.
MATERIALS AND
METHODS:
This comparative policy evaluation and
interventional study was undertaken between September, 2011 to January, 2012. Drafts
of state medicines policies of six Indian states viz., Chattishgarh, Delhi,
Madhya Pradesh, Orissa, West Bengal and the draft drug policy of Jammu and
Kashmir were randomly selected and downloaded from internet for this comparative
study based on their availability on the worldwide web. Drafts were analyzed
for the presence or absence of various policy components. Subsequently, logical
interventions were made through sustained lobbying, persuasive pressure and
persistent advocacy to evolve fresh policy initiatives in the formulation and
finalization of first drug policy of J&K state and on the basis of
experiences gained from the J&K state, suggestions were proposed for new
policy initiatives and novel approaches in the formulation of medicines
policies for other Indian states that either do not have state medicines
policies as yet or their state medicines policies do not have comprehensive
provisions to cover all aspects proposed in this paper.
Best elements of
all the state policies were pooled and proposed for the formulation of maiden
drug policy of Jammu and Kashmir state. While proposing new policy initiatives,
due consideration was given to the reports and recommendations of various
expert committees like Hathi Committee (1975), National Human Rights Commission
(1999), Parliamentary Standing Committee for Petroleum and Chemicals (2001),
Mashelkar Committe (2003) and National Commission for Macroeconomics and Health
(2005). For inclusion of the proposed provisions in the draft drug policy of
J&K state, sustained lobbying was initiated through a Civil Society Forum (CSF)
comprising of eminent people from all shades of life including health,
judiciary, law, police, mass media, politics and industry. Members of the Forum
met Governor, Chief Minister, Health and other cabinet ministers of the Jammu
and Kashmir state and impressed upon revising the draft drug policy of J&K
framed in 2009 and placed over website of the J&K health department for
public review. This political lobbying was supplemented with persistent
advocacy with senior bureaucracy of the health ministry and finally a four hour
long marathon meeting of the Civil Society Forum members led by this author was
held with senior officials of the health ministry of J&K state with a view
to incorporate the necessary changes in the draft drug policy of the state.
CSF members through continued motivation and
sound explanations pressed for the inclusion of some of the provisions aimed at
curbing the menace of spurious medicines, drug abuse, unethical prescribing and
promotion of drugs and the provisions relating to drug licensing, cosmetics and
AYUSH drugs control, rational blood bank and blood transfusion practices, recall,
withdrawal and disposal of unwanted/expired drugs, enforcement of pharmacy
education regulations, revamping the activities, composition and functioning of
defunct J&K Pharmacy Council, provision of hospital and clinical pharmacy
services in govt. hospitals etc. Awareness was raised among common masses as
well as among professionals in the field regarding these gross deficiencies in
the draft drug policy of J&K state through a series of articles5-10 in professional
journals and local newspapers. After hectic deliberations, some of the
suggestions put forth by the CSF members were incorporated in the draft and
some were rejected. Subsequently revised draft of the drug policy was accorded
approval by the cabinet of ministers of the Jammu and Kashmir state.
RESULTS:
Lack of uniformity
in policy components of state medicines policies of five Indian states was
conspicuous and most of them were found to lack vital provisions relating to
spurious drugs, drug abuse, unethical promotion and prescribing, drug licensing,
drug recall, AYUSH (comprising Indian traditional systems of medicine and
homeopathy) drugs control, drug safety monitoring etc. After comparative analysis
of the draft drug policies of six Indian states and subsequent interventions
made in the formulation of maiden drug policy of J&K state, qualitatively,
a better policy could be evolved for the state of Jammu and Kashmir through sustained
lobbying, persistent advocacy and logical interventions by the Civil Society
Forum even though many suggestions of the Forum were dropped by the state
government that could have made the draft even more robust and comprehensive.
Based on the
success achieved in the interventions made in respect of J&K draft drug
policy, new initiatives and novel approaches are suggested in Table-2 for
inclusion in the existing state drug policies of those Indian states who
already have their own state drug policies but do not cover all these aspects and
also for consideration of those Indian states who have not formulated their own
state drug policies as yet.
DISCUSSION:
In India, 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, their topography and available
infrastructure; how best they can enforce their drug related laws in their
region depending upon the type of drug related crimes most often reported from
their area; what type of drugs they should include in their essential drugs
list on the basis of adverse drug reaction profile of their region that has
been scientifically proved to vary from country to country and from state to
state; how best they can enhance the affordability of medicines on the basis of
their available manufacturing and other facilities that again vary greatly from
state to state, so on and so forth. In nutshell regional variations persist in
every state and so do their regional programmes, hence the need for separate
regional policies. This paper does not suggest scrapping of a national medicines
policy in India, rather it suggests need for a state drug policy in every
Indian state in addition to the one at national level, alternatively the need
to make the national pharmaceutical policy focus on all areas of regional
interests and priorities. Some of the Indian states have framed their own state
drug policies but a majority of them lack such robust and comprehensive policy
framework to guide their drug delivery services.
In the year 2009,
Ministry of Health, government of Jammu and Kashmir state made its draft drug
policy public on its official website for the purpose of receiving feedback and
suggestions for review from public quarters. Drug Policy had been drafted with
broad objectives to promote availability and affordability of medicines; to
ensure their safety, quality and efficacy; to promote good prescribing and
dispensing practices and rational use of drugs in public and private sectors
and to provide a cost-effective, efficient, procurement and supply management
system for govt. hospitals. However, draft of the drug policy was found to have
specified no policy for curbing the menace of spurious drugs, drug addiction, unethical
promotion practices of drugs adopted by pharmaceutical companies, irrational
drug prescribing practices of doctors and dispensing practices of pharmacists.
Further draft had specified no policy framework for drug licensing, for drug recall
and unwanted drug disposal, for drug pricing, clinical pharmacy services and in-house
Quality Control testing at govt. run hospitals, cosmetics and AYUSH drugs
control etc.
Draft drug policy of
2009 was downloaded alongwith five other drug policies that were in force in
five Indian states of Chattishgarh, Delhi, Madhya Pradesh, Orissa
and West Bengal. Comparative study of the six drug policies revealed a
number of discrepancies and non-uniformity in their components. Apart from the
draft drug policy of J&K state, drug policies of five other Indian states
too were found lacking in provisions regarding key public concerns enumerated
above. Most of the policies studied laid their focus upon drug procurement,
storage and distribution management and had completely sidelined above
mentioned components. Among the six drug policies, only the drug policies of
Jammu and Kashmir, Orissa and West Bengal had emphasized upon the initiation of
pharmacovigilance and drug safety monitoring activities in govt. health
facilities. None of the drafts under study had specified any Narcotic Drugs and
Substance Abuse Control Policy, Drug Licensing Policy, Drug Prices Control
Policy or any Cosmetics Control Policy in spite of the fact that Drugs and
Cosmetics Act of 1940 which is currently in vogue in all these states deals
with Drugs as well as Cosmetics and consequently quality control of cosmetics goes
unchecked in all the states. Drug Policy of only West Bengal had sparingly
devised a Spurious Drugs Control Policy and no other state drug policy under
study had outlined any policy framework with respect to this burning issue. Similarly
drug policy of only West Bengal and Orissa had specified a policy for the
control of drugs belonging to Indian Systems of Medicine and Homeopath,
collectively known as AYUSH (Ayurvedic, Unani, Siddha and Homeopathy). Among
six states under study, only two states had specified a policy framework with
respect to drug donations and rational blood banking and transfusion practices
whereas only one state each had specified drug prosecution policy and unwanted
drugs disposal policy. Three states each had policy components regarding
ethical drug promotion, industrial drug manufacturing and research and
development in pharmaceuticals sector and only one state regarding promotion of
human resource in pharmaceutical sciences.
Only three state drug
policies had envisaged to set up drugs and therapeutics committees in govt.
hospitals whereas only one state had outlined drug quantification policy. Two
of the states had not laid out any policy framework for distribution of drugs
to district level facilities whereas three states had not devised any discrete
drug tendering policy. One state each had specified no rational drug use and
drug information policies in their drafts. Policy regarding preparation of a
drug formulary was not specified by two states whereas only two out of the six
study states had elaborated upon payment modalities during procurement of drugs.
State drug policies of Madhya Pradesh and Orissa were primarily and
predominantly drug procurement policies giving elaborate procedures for drug
selection, tendering, payments and distribution and laying little emphasis upon
other aspects of rational use of quality medicines. However some aspects
related to rational use have been covered under Orissa state integrated health
policy of 2002. State drug policy of West Bengal was found to be most
comprehensive followed by that of Orissa out of all the six drafts studied.
Given these
discrepancies, this paper calls for uniformity of policy components in the
medicines policies of various Indian states and introduction of new policy
initiatives based on novel approaches (outlined in Table-2) to cover the
ignored areas of public importance like spurious drugs and drug abuse. This
will pave way for improved quality, safety and efficacy of medicines made
available to patients at govt. health facilities as well as community
pharmacies and to rational drug prescribing and dispensing practices. Standard
guidelines can also be made available in this regard by the central government
on the pattern of WHO guidelines for national medicine policies.
SUMMARY:
This paper demonstrates that there is need for adoption
of fresh policy initiatives and novel approaches in the formulation process of medicines
policies for various Indian states and the initiatives need to be incorporated
in government drug policies of various states through sustained lobbying,
persistent advocacy and logical interventions. Fresh policy initiatives need to
be adopted in respect of curbing the menace of spurious medicines, drug abuse,
unethical promotion practices of medicines, irrational prescribing and
dispensing practices, unwanted drug withdrawal and disposal practices, rational
drug licensing policy, rational blood banking and transfusion policy, AYUSH
drugs control policy, Cosmetics Control Policy, Drug Prosecution Policy,
Pharmacy Education Regulations Policy, Drug Safety Monitoring Policy,
Pharmaceutical Care Service Policy etc. There is need for a paradigm shift in
the focus from drug procurement to rational use and effective regulations.
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. A good number of these novel
approaches have already been incorporated in the first state drug policy
approved by J&K cabinet of ministers. Similar fresh initiatives need to be
adopted in the formulation of medicines policies of various other Indian states
that do not have their own state drug policies as yet. In respect of states
that already have their own state drug policies, appropriate revisions need to
be made to incorporate all these initiatives through sustained advocacy and
logical interventions by rational drug use activists and civil society groups.
CONCLUSIONS:
Ø
Various Indian state governments need to move beyond
drug selection, quantification, procurement, distribution, storage and use
issues while formulating their medicines policies and incorporate fresh policy
initiatives as enumerated in Table-2.
Ø
Adequate and appropriate policy framework needs to be outlined in
respect of each policy initiative enlisted in Table-2 (Please visit www.drishaqgeer.blogspot.com for more details11).
Ø
While formulating medicines policies, state governments need to address
various socio-economic, legal, administrative and political factors that act as
barriers in the equitable access and rational use of quality medicines (Please
visit www.drishaqgeer.blogspot.com for more details12).
Ø
Civil society groups must take like minded people from various sections
of the society on board & launch sustained campaign for rational use of
quality medicines & make necessary interventions through persistent
advocacy & persuasive lobbying in the formulation of robust &
comprehensive state medicines policies.
Ø
There is need for more splitting of India’s medicines policy at the
state level and providing various states a freer hand in designing and
implementing policies that are specific to their needs and unique
circumstances. Policy makers have to be cognizant of state-level determinants
in order to design effective policies to improve drug accessibility and
utilization adopting fresh initiatives and novel approaches outlined here.
REFERENCES:
1.
WHO. How to develop and implement a national drug policy. Second
edition. World Health Organization 2001.p4.
2.
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;
97:124–126.
3.
David H Peters, K Sujatha Rao, Robert Fryatt. Lumping and
splitting: the health policy agenda in India. Health Policy and Planning; 18(3): 249–260.
4.
National Human Rights Commission - Recommendations of
National Action Plan to Operationalize the Right to Health Care. (http://nhrc.nic.in/disparchive.asp?fno=874
Accessed on March 6th, 2012.
5.
Geer M. I., Shah M. Y.
Guiding Principles for the formulation of a Drug Policy in the state of
J&K. Journal of Pharmacovigilance and Drug Safety 2009;6(1):22-26.
6.
Geer, M. I. Mushrooming of
medical stores in J&K state – reasons and solutions. Physicians Academy
2010; 4(7); 75-76.
7.
Geer, M. I. Deficiencies in
the draft Drug Policy of J&K government. Physicians Academy 2011; 5(2):
16-19.
8.
Geer M.I. Magnitude of
spurious drug trade in J&K – Mountain or a molehill? Physicians Academy
2012; 6(1):2-9.
9.
Geer M.I. Approved drug
policy of J&K government – A Review. Physicians Academy 2012; 6(2): 27-37.
10.
Geer M.I. Generic Drug Prescribing
in J&K - Boone or bane? Physicians Academy 2012; 6(5): 82-87.
Fresh initiatives
proposed in the formulation of medicines policies for various Indian states
Ø Rational Medicine Promotion Policy
Ø Drug Licensing Policy
Ø Rational Blood Banking and Transfusion
Policy
Ø Drug Prosecution Policy
Ø Drug Recall Policy
Ø Policy against Spurious Medicines
Ø Control of Narcotic Drugs/Substance
Abuse/Drug Addiction
Ø Drug Price Control Policy
Ø Control of AYUSH Systems of Medicines
Ø Disposal of Expired/Unwanted Medicines
Ø Hospital Drug Management Policy
Ø Cosmetics Control Policy
Ø Drug Safety Monitoring Policy
Ø Pharmaceutical Care/Clinical Pharmacy
Services Policy
Ø Pharmacy Education Policy
Ø Drug and Pharmacy Regulation Policy
Ø Medical Financing/Insurance Policy
Ø Drug Advertisement Policy
Ø Orphan Drugs Policy
Ø Clinical and Contract Research Policy
Ø Pharmaceutical Research Promotion Policy
Ø Pharmaceutical Manufacturing Policy
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