LAW AND ETHICS IN PUBLIC HEALTH - THE CASE OF PHARMACEUTICAL POLICY 2002
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LAW AND ETHICS IN PUBLIC HEALTH
- THE CASE OF PHARMACEUTICAL
POLICY 2002 - extracted text
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LAW AND ETHICS IN PUBLIC HEALTH
- THE CASE OF PHARMACEUTICAL
POLICY 2002
PROJECT ASSIGNMENT
POST GRADUATE DIPLOMA IN MEDICAL LAW AND ETHICS
NAVEEN I. THOMAS
(ML&E 457/ 2002)
NOVEMBER 2003
THE INSTITUTE OF LAW AND ETHICS IN MEDICINE
NATIONAL LAW SCHOOL OF INDIA UNIVERSITY
BANGALORE
... to all those people
who have been
denied access to health care ...
ACKNOWLEDGEMENTS
To be convicted can often be demoralising, but in same cases it can be challenging and
lead the person to begin a new journey and reach new heights. I felt deeply troubled by
the fact that all my efforts in life were aimed at making a better life for myself. The
studies, the ambitions, the goal and the purpose was to have a comfortable tomorrow for
myself. But the message of Christ convicted me and made me question the path that I
was to take; and that has brought me to where I arri today. To my Convictor and
Redeemer, is my first offer of gratitude.
I am ever grateful to my parents, grandmother and sister who encouraged me to do the
Medical Law and Ethics Course and persevere in it, in spite of my laziness. Savio from
Oxfam GB was very encouraging about the course. Thanks to him too.
Dr. C.M. Francis, Dr. Thelma Narayan and Dr. Ravi Narayan took a personal interest in
this project, in spite of their busy schedules; they were always there to brainstorm,
critique, give ideas and encourage me. This project would not have been complete
without their support. Dear ma’am and sirs, I can never repay you for the valuable time
and inputs you have given me, but let me promise you that I will share whatever little
knowledge I have, with others, as freely as you have done. Thank you.
I thank the entire team at THEM, including the guest faculty who contributed to this
course and added to our learning. Mangala, the ‘visible voice and face’ of TILEM, also
deserves a word of praise for all the help given to us. Special thanks to my friends, Mita
and Anant, who did the course with me and encouraged me all through. Thanks are also
due to Santhy who kept me going through the project with her prayers and
encouragement.
For me, this course was a means to learn about how people could be helped to access
healthcare as a right. I gratefully acknowledge all those people who have been denied
access to health care for whatever reason. They have been my motivation and
inspiration to do this course, and their project report is dedicated to them.
TJaveen i. thomas
1
TABLE OF CONTENTS
3-5
Introduction
I
I a.
II
III
3
I a. i
Statement of Purpose
3
I a. ii.
Focus of Research
4
I a. iii. Research Method
4
Public Health Ethics, Law and Policy
6-9
II a.
Swaraj and Public Health
6
II b.
Swaraj - A Universal Concept
7
II c.
Pooma Swaraj and Swaraj of the Poor
7
lid.
Price of Swaraj - Truth and Ahimsa
7
II e.
Ahimsa and Public Health
8
Ilf.
Right to Life - The Indian Law and Policy
9
Health, Healthcare and Drug Situation in India
10-15
India - Demographic and Health Statistics
10
III a. i. Comparative Health Indicators (India)
10
III b.
Access to Essential Medicines
11
III c.
Indian Drug Industry Fact sheet
12
III d.
Research and Development
13
III e.
TRIPS and Intellectual Property Rights
14
III f.
Price Control
15
III a.
IV
Methodology
Pharmaceutical Policy 2002 - A Case Study
16-21
IV a.
Orientation
16
IV b.
Growth of Pharmaceutical Sector
16
IV c.
Pharmaceutical vs. Health
16
IV d.
Over-ruling Good Sense
17
IV e.
Policy in Data Vacuum
17
IV f.
TRIPS and Pharmaceuticals
17
2
IV g.
Price Control
IV g. i. Consequences of Decontrol
18
IV g. ii. Need for Price Control
19
IV g. iii. Market Mechanism & Price Stability
19
IV g. iv. Drug Price Control Order
19
IV h.
Formulations at the Cost of Bulk Drugs
20
IV i.
Policy Implementation
IV j.
IV k.
Market Forces vs. People’s Health Needs
20
Pharmaceutical Policy 2002 And Swaraj
21
IV k. i.
V
18
Medical vs. Health
20
21
IV k. ii. Self Rule and Self Restraint
21
IV k. iii. Egalitarian Concept
21
IV k. iv. Provision of Basic Amenities
21
IV k. v. Truth and Ahimsa
21
Conclusion
Bibliography
Annexure 1: Health and Related Legislation in Karnataka
23
24-26
27-40
3
INTRODUCTION
"At the door stood Death. She said 7 smelled your rooster
and I came along to help you eat it?
‘And why not', said the man.
Aren’t you one who treats everyone alike?'
‘That is so, ’ said Death. ‘I have no favourites.
the poor, the rich, the young, the old. the sick, the well - all look alike to me.
‘That is the reason you may come in and share my food’ said the man.
Death entered and the two had a grand feast."
Aurora Lucero White Lea 1
For death, all may be equal and may treat everyone alike, but the same cannot be said
for the living. The disparity in socio-economic indicators between people of different
ethnic, gender, region, religion, caste and income groups could be so marked that some
groups may not even reach up to the lowest indicators of other groups. This disparity
can be seen vividly in health indicators of people2. Some important indicators have been
included in the section on Health, Healthcare and Drug Situation in India. Martin Luther
King, Jr. once said, “of all the forms of inequality, injustice in healthcare is the most
shocking and inhumane”.3
METHODOLOGY
Statement of Purpose
Having completed my Master’s degree in Medical and Psychiatric Social Work and
working on health related issues brought me face-to-face with the interface between
health issues, law and public policy. That prompted me to take up the course on Medical
Law and Ethics. The purpose of joining the course was to learn about how people could
be helped to access ‘healthcare as a right’. This led me into the area of Ethics and
Public Policy. The purpose of this paper is to examine law and ethics involved in
formulating health related policy.
1 Quoted in M. L. Kothari and L. A. Mehta, Living, Dying (Goa: The Other Indian Press, 1992)
2 The World Health Report 2002, WHO, Switzerland
3 Quoted in Down to Earth, 15 March 2003
4
“The health policy of a state or a nation depends on its value system’.
4
What value
system does a secular state adopt - cultural, traditional, religious, a mix of all these or
that of the dominant groups? A survey of literature of Health Ethics revealed two broad
categories of influences - one, that is religious in origin and two ‘ that is ‘medical
profession’ related. While Public Health Ethics draws from both the spheres, a more
comprehensive ethics framework would extend it to include social justice and equity in
health. This is not to discount the fact that religious texts or medical ethics contain
values of social justice; the lacunae can be seen as a limitation in exposition of existing
literature on the topic. This paper attempts to fill this gap by drawing up a framework of
Public Health Ethics, which helps one to understand the process of policy formulation
better and analyse it in the given context. An example of a recent policy — The
Pharmaceutical Policy 2002 has been used as case-study for analysis, using the
framework of Public Health Ethics.
Focus of Research
The primary questions researched in this paper are:
1) To determine the basis of Public Health Law and Ethics.
2) Policy Environment: What is the healthcare and drug situation in the country - the
basis on which health related policy is formed?
3) To ascertain the link between Pharmaceutical Policy 2002, Public Health Ethics and
the existing policy environment.
Research Method
A literature survey was conducted to obtain information on the above research
questions. The list of books and articles surveyed are included in the Bibliography. The
source of data was ‘secondary1, and can be broadly classified into 4 types.
1) General ethics and ethics related to health, medicine, science and technology.
2) Health reports and health policy related.
3) Drug-issues (including Pharmaceutical Policy 2002) and drug industry related.
4) Laws related to Health and Healthcare.
4 C. M. Francis, Medical Ethics (New Delhi: Jaypee, 1993)
5
Due to the medicalisation of health, the analysis of health related issues is often limited
to ‘cause and effect’ analysis. However health, being related to ‘development at one end
of the spectrum and to the ‘individual’ at the other end, an ethical analysis needs to be
more comprehensive. This paper uses a reflective and dialectical discourse approach,
while trying to raise questions and be non -judgemental.
The use of such approaches to ethical analysis of public health is also a step towards
taking health away from the closed confines of ‘medical profession’ into the hands of
society and the community. As Henry Sigerist, the famous medical historian said, War
against disease and for health cannot be fought by physicians alone. It is a people’s war
in which the entire population must be mobilized permanently”.’1 The use of this analysis
and the conclusions therein will also contribute to strengthen the voice of the voiceless
and that of movements like the People’s Health Movement who strive to work for equity
and justice in health.
5 .Quoted in Health Action, September 2003.
6
PUBLIC HEALTH ETHICS, LAW AND POLICY
‘If Swaraj was not meant to civilize us, and to purify and stabilize our civilization, it would
be worth nothing. The very essence of our civilization is that we give a paramount place
to morality in all our affaires, public or private'.
(Mahatma Gandhi, 23 January1930, Young India, p. 26)
6
I would like to base this paper and the analysis contained in it, on an ethical framework
presented by Mahatma Gandhi during his life and struggle for India’s freedom. The
framework is relevant as we examine public health ethics from a perspective of health,
not just begin’ absence of disease’, but as a Tight of every individual to enjoy and attain
the highest state of well being’. Thus, 'health’ transcends the realm of just being a
‘medical’ issue, and moves on to being on an ‘existential’ plane. While it would not be
wrong to call it ‘Gandhian Health Ethics’, I would avoid usage of the term, for fear of not
fully integrating the essence of his message into the analytical framework on health.
Swaraj and Public Health
Gandhi, writing in young India (19 March 1931), explained the meaning of swaraj (a
vedic word) as meaning ‘self-rule’ and ‘self restraint’, and not freedom from all restraint
which ‘independence’ often means! In the context of public health, swaraj refers to self
rule’, where the person enjoys the freedom to attain his/her highest state of well being in
the manner s/he chooses. But swaraj is not complete without ‘self restraint’, where the
person’s way of life does not impinge of the right of others or themselves to attain the
highest state of well being. Very loosely put, it can be termed as ‘rights with
responsibility’. A right, which can oe claimed with authority, arising out of the fact that
one is themselves respecting the rights of others. This is what Gandhiji called Ramaraj —
i.e. sovereignty of the people based on pure moral authority’.'
6 Young India, 23 January 1930, p. 26 quoted in M.K. Gandhi, Village Swaraj (H. M. Vyas ed„ Ahmedabad:
^January WS?, p. 374 quoted in M.K. Gandhi, Village Swaraj (H. M. Vyas ed., Ahmedabad:
Navajivan Publishing House, 1962)
7
Swaraj- A Universal Concept
Swaraj in public health as in any other sphere, is an egalitarian term, and is certainly
attainable, as it arises out of every human being need to be treated with respect. It does
not discriminate between race or religious distinction, however it is for all, ‘including the
farmer, but emphatically including the maimed, the blind, the starving toiling millions’.8 In
public health it translates into, all people everywhere, irrespective of their caste, gender,
vocation or location being able to attain the highest state of well being, and having an
environment which promotes it.
Poorna Swaraj and Swaraj of the Poor
Gandhiji said that his dream of swaraj was a ‘poor person’s swaraj, where the ordinary
amenities of life that a rich person enjoyed was available to all.9 He further added that
swaraj was not poorna (complete) swaraj until basic amenities was guaranteed to all. In
public health, the provision of accessible, affordable, and availability of quality health
services is of primary importance. If swaraj is to be attained these services need to be
given as a ‘right’ to all people, everywhere.
Price of Swaraj - Truth and Ahimsa
Swaraj comes at a price. As Gandhiji put it, 'Swaraj has got to be won, worked and
maintained through truth and Ahimsa alone’.10 Untruth, false promises and illusions in
development have become the order of the day in development; in the medical
profession it has reached menacing proportions. The practise of prescribing drugs of
select companies in return for monetary and other considerations is increasing.11 To
achieve swaraj one needs to be true to oneself as to others. Gandhiji has given the
correlation between swaraj based on ahimsa and health, while writing in Harijan, in the
8 Young India, 1 May 1930 quoted in M.K. Gandhi, Village Swaraj (H. M. Vyas ed., Ahmedabad: Navajivan
Publishing House, 1962)
9 Young India, 23 January 1930 quoted in M.K. Gandhi, Village Swaraj (YA. M. Vyas ed., Ahmedabad:
Navajivan Publishing House, 1962)
10 Harijan, 27 May 1939 quoted tn M.K. Gandhi, Village Swaraj(H. M. Vyas ed., Ahmedabad: Navajivan
Publishing House, 1962)
11A detailed study on the nexus between doctors and pharmaceutical companies is available on
www. issuesmedical. ethics orq
8
issue dated 25th March 1939, 'Under swaraj based on ahimsa, nobody is anybody s
enemy; everyone contributes his or her due quota to the common goal; their knowledge
keeps growing from day to day. Sickness and diseases are reduced to a minimum’. K
Ahimsa and Public Health
Ahimsa in healthcare is a proactive concept, where one does limit oneself to not harming
others, but actively contributes to working on a common goal so that the society is
benefited. Ahimsa values the worth of the ‘other’ as that of its own self, and strives to
work towards its upliftment. Here, the values and worth of every individual is as
important as that of the whole. Speaking of swaraj, Gandhiji said that, ‘swaraj of a
people means the sum total of swaraj of individuals’.13 Swaraj in healthcare will only be
reality, when the self-rule is based on health rights which, arises from a due performance
of one’s large duties to the self, society, environment, etc. Gandhiji was speaking about
such a swaraj when he translated an Indian song into English - the song speaks about
his vision of such a land - a land where swaraj reigns.
We are the inhabitants of a country where there is no suffering and pain
Where there is no illusion or anguish, no delusion nor desire,
Where flows the Ganges of love and the whole creation is full of joy,
Where all minds flow in one direction, and where there is no occasion of sense of time,
All have their wants satisfied;
Here all barter is just, here all are cast in the same mould
No selfishness in any shape or form, no high no low, no master, no slave;
All is light, yet no burning heat,
That country is within you — It is Swaraj, Swadeshi,
The home within you Victory ! Victory I Victory !
He realises it who longs for it.14
12 Harijan, 25 March 1939 quoted in M.K. Gandhi, Village Swaraj (H. M. Vyas ed„ Ahmedabad: Navajivan
quoted in M.K. Gandhi, Village Swaraj (H. M. Vyas ed„ Ahmedabad: Navajivan
^Mahatma^andhi -Vhe Last Phase, 1956, Vol I, pp. 190-91 quotedin M.K. Gandhi, Village Swaraj (H.
M. Vyas ed., Ahmedabad: Navajivan Publishing House, 1962)
9
Right to Life - The Indian Law and Policy
As seen in the freedom derived from the concept of swaraj, the constitution too
guarantees the Right to Life. The Supreme Court in its rulings have interpreted the
Fundamental Right to Life, as stated in Article 21 of the Indian Constitution to include
right to health, as it is essential for human existence and is, therefore an integral part of
the right to life. This judgement was given in Consumer Education and Resource Centre
vs. Union of India case,15 where the court also held that humane working conditions,
health services and medical care are an essential part of Article 21
On the issue of
providing public health rights to Indian citizens, the Supreme Court judgements are in
addition to the Directive Principles of the State Policy outlined in Constitution. Article 42
states “Provision for just and humane conditions of work and maternity relief - The
state shall make provisions for securing just and humane conditions of work and for
maternity relief, Article 47 states “Duty of the State to raise the level of nutrition and
the standard of living and to improve public health - The State shall regard the
raising of the level of nutrition and the standard of living of its people and the
improvement of public health as among its primary duties and, in particular, the State
shall endeavour to bring about prohibition of consumption, except for medicinal
purposes, of intoxicating drinks and of drugs which are injurious to health”.1'' The existing
legislations in country are another source for citizens to claim their right to life and
health. As an indicator of this fact, the legislations of Karnataka, which give right to its
people, have been compiled and included in the report (refer annexure).
15 AIR 1995 SC 636
16 PHM Position paper on Right to Healthcare' (Mumbai: PHM, 2003)
17 Part IV, Constitution of India adopted on 26th Novemember 1949 quoted in PHM, Position paper on Right
to Healthcare'(Mumbai: PHM, 2003)
10
HEALTH, HEALTHCARE AND DRUG SITUATION IN INDIA
India - Demographic and Health Statistics 18
Total population (2001 census): 1,025,095,000
Annual population growth rate (1991-2001): 1.8%
Life Expectancy at birth (both sexes) 2001: 60.6 years(Male. 60.0 and Female: 61.7)
Probability of children under dying - per 1000 (2001): Male: 89 and Female: 98
Comparative Health Indicators (India):
1961-1962
1998-1999
41.2
62.9
146/1000 live births
69/1000 live births
Death rate
22.8/ 1000
8.9/ 1000
Birth rate
41.7
26.4
Life expectancy - Both sexes
Infant mortality
Total Expenditure of health as
% of GDP
1995
1996
1997
1998
1999
2000
5
5.2
4.9
5.1
4.9
4.9
83.8
84.4
84.3
81.6
82.1
82.2
16.2
15.6
15.7
18.4
17.9
17.8
Private expenditure on health
as % of total expenditure of
total expenditure on health.
Government expenditure on
health as % of total expenditure
of total expenditure on health.
18 The World Health Report 2002 (C.Murray, et.al. eds., Geneva: WHO, 2002)
11
Access to Essential Medicines
The United Nations has categorized India as number 4, i.e. technologically developed
enough to be totally self-reliant, with research capability for the discovery of new
chemical entities. India’s march to self-reliance in drugs was the result of well thought
out policies to accord a leadership role to public sector, develop self-reliance in drug
technology, create a suitable patent environment, achieve self-sufficiency in production
of essential drugs, reduce imports, ensure reasonable price, maintain high standards of
production and promote research and development.11 The Indian Patent Act 1970, Hathi
Committee Report of 1975, The National Drug Policy, 1978 and the subsequent National
Drug policy in 1986 and the National Health Policy of 1983 aided the advances in the
people’s health and in the Indian drug scenario.
However, current policies, which are in line with international agreements and
instruments, are taking India away from the self-reliance that was painstakingly built up
over the years. The analysis of pharmaceutical policy 2002, in the next section will
highlight the case better. The worst-hit due to these policies are the poor, who directly
bear the burnt of any price hike. WHO has estimated that up to 90% of total health
spending in poor countries, most of which are on medicines, are out-of-pocket
payments. To highlight the need for Access to Essential Medicines, the WHO celebrated
the 25th anniversary of the first WHO Model List of Essential medicines with the message
that ‘Access to Essential Medicines is part of the progressive fulfilment of the
fundamental rights to health.’20 WHO’s Action Programme on Essential Drugs had given
India a score of two on a scale of five on the issue of accessibility to essential drugs.
21
19 The World Drug Situation (Geneva. WHO, 1988)
20 Essential Drugs Monitor (Geneva: WHO, 2003)
21 Comparative ~Analysis of National Drug Policies (Geneva: Action Programme on Essential Drugs (APED),
WHO, 1996)
12
Indian Drug Industry Fact sheet
22
1973
1999
Rs. 225 crores
Rs. 2500 crores
1969-1970
1999-2000
2,257
20,059
1965-1966
1999-2000
Production of bulk drugs
Rs. 18 crores
Rs. 3777 crores
Formulations
Rs. 150 crores
Rs. 16,000 crores
Exports
Rs. 3.05 crores
Rs. 6631 crores
Imports
Rs. 8.2 crores
Rs. 3441 crores
R& D
Rs. 3 crores
Rs. 320 crores
1969-70
15.47% of sales
Average profitability of
1991-92
6.1 % of sales
industry
1994-95
1% of sales
1998-99
8% of sales
Japan
$412
Annual per-capita
Germany
$222
consumption of drugs
USA
$ 191
India
$3
Investment in Indian
Pharmaceutical Industry
Pharmaceuticals units
22
Source: Drugs and Pharmaceuticals Industry Highlights: Published by National Information Centre for
Drugs and Pharmaceuticals, Central Drug Research Institute, Lucknow
13
%
Type of drugs
Sale of Pharmaceuticals in
Developing Country Markets
Anti-infectives
24
Vitamins and nutrients
15
Alimentary tract diseases
11.5
Analgesics
9
Cough and cold
7.4
Cardio-vascular
6.4
Dermatogicals
5.7
Central Nervous System drugs
4.1
Anti-TB drugs
3.2
Others
13.7
Research and Development
Global Research
and Development
1998
$73.5 billion
Developed countries public funding
$34.5 billion
Pharmaceutical Industry majors.
$30.5 billion
Private not-for-profit
$6 billion
Developing countries.
2.5%
Expenditure on
Health
Global spending on pharmaceuticals research and development in the private sector is $
34 billion of which companies in the US spend invest than 70%. The top ten Multi
national companies spent $ 16.3billion. The companies are: Astra-Zeneca, Glaxo,
Wellcome, Roche, Merck, Novartis, Bristol Myers-Squibb, Johnson and Johnson, Smith
Kline Beecham, American Home, Products and Rhone- Poulenc-Rorer. A report by the
French NGO MSF titled ‘Fatal imbalance: The crisis in Research and development for
Drugs in Neglected Diseases’ said that, in its study of the world’s top 11 pharmaceutical
companies, investment and research in diseases primarily of developing countries
occurrences was minimal. Unfortunately, even countries like India with fairly advanced
R&D capabilities do not invest much in R&D. The Organisation of Pharmaceutical
Producers of India (OPPI) Study revealed that India spent Rs. 320 crores on research
and development in the pharmaceutical sector in 1999-2000, which is 0.001% of world
pharmaceutical industry.
23 Source: Financial Express, Mumbai, 6 February 2001
14
TRIPS and Intellectual Property Rights
The new TRIPS compliant policies, which will come into effect from the year 2005 have
caused serious concerns in the industry and social sector. Since the topic is vast and
outside the scope of this paper, the concerns will not be elaborated here. However, it is
important to find the right balance between protecting Intellectual Property Rights and
the basic human and life rights of the people.
In fact the TRIPS agreements itself calls for such an arrangement. Article 7 of the TRIPS
Agreement states ‘the protection and enforcement of intellectual property rights should
contribute to the promotion of technological innovation and to the transfer and
dissemination of technology to the mutual advantage of producers and in a manner
technological knowledge conductive to social and economic welfare, and to a balance of
rights and obligations’. Furthermore, article 8.2 states ‘appropriate measures provided
they are consistent with the provisions of the Agreement may be needed to prevent the
abuse of intellectual property rights by rights holders or the resort to practices which
unreasonably transfer of technology. R. A. Mashlekar, the Director General of CSIR has
said that the “Ideal intellectual property rights regime strikes a balance between private
incentives for innovators and the public interest of maximising access to the fruits of
innovation. The balance is reflected in article 27 of the 1948 Universal Declaration on
Human Rights, which recognizes that ‘Everyone has the right to protection of the moral
and material interest resulting from any scientific, literary or artistic production of which
s/he is the author5 and that ‘Everyone has the right to share in scientific advancement
and its benefits’.24
In light of evidences coming up that that the TRIPS regime could affect Indian people
and the industry, policies need to be formulated to address this concern. The
Commission on Intellectual Property Rights set up by the British Government said that
the global expansion of intellectual property rights unlikely to benefit developing nations.
On the other hand, it was most likely to impose high cost- such as highly priced
medicines and seeds making poverty reduction more difficult. The independent
International Commission comprising of commissioners from developed and developing
24 R. A. Mashlekar, Current science, 81 (8), 25 October 2001, p. 955
15
countries mostly experts in science, law, ethics, and economics also said that in
addition, it would also increase in cost of access to many products and technologies.25
The South African case of high pricing of anti-retro viral (ARV) drugs for people living
with AIDS by the patent holders, is another case in point. Most of African countries and
companies (including MNCs) have approached Indian companies for buying ARV at a
fraction of the cost offered by the big pharmaceutical companies.
Anglo, American, a South African mining giant approached Cipla foranti-AIDS drugs
cocktail, which Cipla offers at $359 patient/year - which is one-thirtieth the prices
charged by MNCs.
(The Financial Express, 20 August 2002)
The 1999 Human Development Report also states that the TRIPS agreement on IPR
was drawn up with very little analysis of its likely economic impact and should be fully
reviewed to create a system that does not exclude developing countries from knowledge
or threaten indigenous knowledge or access to healthcare.
Price Control
The Ministry of Chemicals and Petrochemicals statistics point out that 75% of medicines
(1919 out of 2557) having annual sales of more than Rs. 1 crore have seen increase in
prices. In 38 medicines, the increase is over 100%. In 2000 - 01, the prices of 49%
(1245 medicines) increased, while those of 42% (1080 medicines) remained stagnant
and 9% medicines (232) prices decreased. In case of most generic, non-scheduled
medicines, the retail trade margins range between 300% to as high as 1,000 with the
average margins prevailing at about 500%. In spite of these price rises and huge profit
margis, the number of drugs under price control has been steadily decreasing over the
years owing to industry pressures. Only 33 drugs remain under price control as against
the previous 75 drugs (with a total market share of 22% as against the previous 38%).26
25 Integrating Intellectual property Rights and Development Policy (London: Commission on Intellectual
Property Rights, 2002)
26 Economic Times Mumbai, 7 September 2002
16
PHARMACEUTICAL POLICY 2002 - A CASE STUDY
Orientation
“The drug and pharmaceutical industry in the country lodayfitces new challenges on
account of: 1) liberalization 2) globalisation 3) new obligations undertaken by India
under the WTO Agreements’’. (Pharmaceutical Policy 2002 Document)
The policy begins by acknowledging that these are issues, that need to be addressed.
People are being affected and will be further affected by these macro-economic policies.
So, how does the policy address these issues? By making the industry more viable.
There is no mention anywhere about the needs of the common people who are being
affected by these changes. The new pharmaceutical policy is basically a industry
oriented document. This admission is made in the policy document itself, which states.
“These challenges (referring to the above) require a change in emphasis in the current
pharmaceutical policy and the need for new initiatives beyond those enumerated in the
Drug Policy 1986, as modified in 1994, so that policy inputs are directed more towards 1)
promoting accelerated growth of the pharmaceutical industry and 2) towards making it
more internationally competitive”. These lines set the tone for the entire policy.
Growth of Pharmaceutical Sector
The logic for the government to indulge in a massive decontrol exercise "to promote
accelerated growth and improve competitiveness" defeats logic because pharmaceutical
stocks, even during the slowdown in rest of industry (except for the automobile sector),
were the healthiest in the last quarter of 2001 and 2002. With the announcement of the
pharma
policy, the pharmaceutical
stocks, in
particular those of multinational
corporations (MNCs), have further shot up.
Pharmaceutical vs. Health
Since medicines are an integral part of the health services package, it is expected that
the Pharmaceutical Policy would be linked to the health policy. But our Pharmaceutical
Policy preceded the
new health
policy,
which was only declared later. The
17
pharmaceutical policy comes under the Department of Chemicals and Petrochemicals.
According to a press statement issued by the Federation of Medical and Sales
Representatives' Association of India (FMRAI), the Ministry of Chemicals and
Petrochemicals (MoCF) had earlier circulated secretly a document, Pharmaceutical
Policy, 2001, which has now got the Cabinet's approval. Incidentally they have described
the new policy as a "major assault on people's access to essential drugs".
Over-ruling Good Sense
The Drugs Price Control Review Committee (DPCRC) had recommended that in the
absence of health cover for majority of the population in the country, price controls
should be continued till the government expenditure on health rises to a substantial level
and the availability of essential drugs is improved. Neither of these has been achieved,
yet the Pharmaceutical Policy 2002 has recommended that price controls should be
reduced. By reducing the span of price control, the Pharmaceutical Policy 2002
overrules the suggestion of the DPCRC of 1999.
Policy in Data Vacuum
Any Govt, policy is expected to be formulated based on information collected from
independent, and the most objective sources. However, the Pharmaceutical Policy 2002
confesses that no reliable data exist to ascertain mass consumption and the absence of
sufficient competition in respect of a particular bulk drug - the two criteria which are used
for the selection of controlled drugs. The document says that, in the absence of any
exhaustive and comprehensive information, the ORG-MARG data are the best available.
Hence the policy has been formed in a data vacuum.
TRIPS and Pharmaceuticals
Two major apprehensions of adopting the TRIPS Agreement in the pharmaceutical
sector were regarding the higher prices of the patented products and their accessibility.
By providing a blanket exemption from price control, the government is making the
access to drugs difficult.
18
Price Control
It is interesting to quote from the background note circulated by the government to the
Drug Price Control Review Committee (DPCRC)27 set up under the chairpersonship of
the Secretary, Department of Chemicals and Petrochemicals prior to its deliberations. It
said, "The Drug Price Control Order (DPCO) is used as one of the essential instruments
to achieve the objective of essential medicines of good quality, at reasonable prices, for
the required health care of the masses. It has been an evolutionary process, which has
been taking cognisance of ever-emerging new factors”.
The “ever-emerging new factors” mentioned were:
•
Inadequate machinery to administer the price control orders,
•
Industry’s demands to do away with price control. The document states: "... The
industry, keen to get rid of price controls altogether, has time and again
questioned these working principles... However the industry has not been
forthcoming in providing data to substantiate their claims."
So, there is no mechanism to administer price controls, and also there is no data to
support industry’s claims that price controls are detrimental to the consumer, to the
economy and to the industry, and that decontrol would actually help R&D.
Consequences of Decontrol
An analysis carried out by the Delhi Science Forum (DSF) on the impact of the 1995
decontrol throws up some interesting facts about the "market behaviour. The price
movement of 28 essential drugs - eight under price control and 20 outside it - showed
that out of the eight controlled drugs there was a decrease in six of them. On the other
hand, the prices of the 20 drugs showed an increase in excess of 10 per cent and in
some cases in excess of 20 per cent. More interestingly, the DSF analysis showed that
in all segments there were wide variations in the prices of different brands of a given
formulation and the top-selling brand in any formulation is not the cheapest one,
sometimes twice as expensive. This is proof enough that the market mechanism does
not stabilise drug prices and the market share of a brand is not dependent on its price. In
27Background Note on Pharmaceutical paper 2002: Government of India, 2001
19
fact, the very reason for putting in place a price control mechanism was this atypical
market behavior in the case of pharmaceuticals. '
Need for Price Control
Analysis in the increase in prices of 50 top-selling drugs between February 1996 and
October 1998.29 It showed that the average increase in the case of brands under price
control was 0.1 per cent whereas that in the case of brands outside price control was 15
per cent. It was also found that the price rise was not a one-time increase owing to an
escalation in raw material costs but was indicative of a trend of continual increase in the
prices of decontrolled drugs.
Market Mechanism & Price Stability
There are wide variations in the prices of different brands of a given formulation. The
top-selling brand in any formulation is not the cheapest one, and is sometimes twice as
expensive. This is proof enough that the market mechanism does not stabilise drug
prices and the market share of a brand is not dependent on its price. In fact, the very
reason for putting in place a price control mechanism was this atypical market behaviour
in the case of pharmaceuticals.
Drug Price Control Order
When it was argued that the change in the Patents Act would result in an increase in
prices, the government said that it would use the mechanism of Drug Price Control
Order to keep the prices in check. Now that the Patents Act has been amended, the
TRIPS argument is being used to dismantle the DPCO. So, ultimately the industry,
supported by the Govt., wins at the cost of the poor.
28 A. S. Gupta, Analysis of Pharmaceutical Policy 2002 quoted in FMRAI, Access to Essential Medicine
(Kolkata: FMRAI, 1986)
29 ibid
20
Formulations at the Cost of Bulk Drugs
In addition to making higher profit margins for the manufacturer possible, the policy has
done away with the ceiling on profitability on formulations that existed until now
(through the Third Schedule of DPCO 1995). In case of bulk drugs, the manufacturer
has been allowed a 4 per cent higher rate of return over the existing 14 per cent on net
worth or 22 per cent on the capital employed.
•
Considering that more and more manufacturers are moving away from bulk drug
manufacture to formulations, this provides an additional windfall.
.
With no restriction on imports, pharmaceutical imports (which is largely of bulk
drugs) have been rising at the rate of 29.3 per cent while exports (which are
mainly of formulations) have been increasing at the rate of 18 percent, according
to the data of the Centre for Monitoring of Indian Economy (CMIE).
30
Policy Implementation
The Policy uses the Moving Annual Total (MAT) value and market share to determine
whether a drug should come under price control. However the companies are known to
break up production figures through various means.
Market Forces vs. People’s Health Needs
The selection of drugs for price control should be based on health need - namely, the list
of essential drugs - and not on market behaviour, which, in the case of drugs, does not
follow the norms of other consumables. But this has been the problem with the Indian
drug policy over the past four decades, in which the inputs of the health sector are never
reflected in the policy articulated by the Department of Chemicals and Petrochemicals,
which in turn is influenced by the industry lobby. The policy does not offer any
justification as to the final set of criteria that has the effect of keeping three-fourths of the
drugs in the market out of price control.
30 CMIE: Pharmaceutical Industry data 2001
21
Pharmaceutical Policy 2002 And Swaraj
Medical vs. Health
When examined from an ethical framework of 'swaraj', as presented in this paper, the
policy falters on the first premise itself when it views drugs as a pharmaceutical industry
and medical issue and not as ‘health and well being’ concern. The very fact that the
Ministry of chemical and Petrochemicals formulates the pharmaceuticals policy is a grim
reminder to this fact.
Self Rule and Self Restraint
The second premise of self rule and self restraint in swaraj also contradicts with the
Policy where ‘accelerated growth' and ‘competitiveness’ are the key words. Through the
two sets of values are not inherently contradictory, the purpose behind each of these
concepts places them at loggerheads with each other. While the former is intended to
control oneself and benefit others, the latter is intended to benefit oneself and control
others.
Egalitarian Concept
The third premise of swaraj is an ‘egalitarian society’, with positive discrimination
towards the marginalised. A policy, which does not address the issue of access of
essential drugs and services for all, goes against the basic tenets of swaraj.
Provision of Basic Amenities
The fourth premise of swaraj is the provision of basic amenities, which in pharmaceutical
and healthcare terms would translate into availability of accessible, affordable and
quality health service. However the policy does not address any of these three key
issues.
Truth and Ahimsa
The fifth premise of swaraj, which is also the means of achieving it, is that of truth and
ahimsa. A policy, which bases its assumptions on reports, which are produced and
funded by vested interests and players who have a stake in the policy, is far away from
the truth. The concept of ahimsa calls for pro-active contribution to the well-being of
Hp' '1-0
08205
22
society and its upliftment. A policy which is explicitly for the well heeded and formed to
comply with international norms and industry demands, while totally neglecting the
needs of majority of the population is actively against ahimsa. The points in the policy
which imposes TRIPS compliant conditions while reducing the medicines in the price
control list is a case in point.
23
CONCLUSION
As seen above, the Pharmaceutical Policy 2002, which was created in a data vacuum,
contradicts with the existing ground requirements, as seen in the section on health and
drug situation, and fails to address the need of providing access to essential drugs for
the entire population. As the policy document admits the policy inputs were directed
towards: 1) promoting accelerated growth of pharmaceutical industry and 2) towards
making it more internationally competitive.
As globalisation increases, and market forces overtake every system of life, it is
essential that existing social safety nets be strengthened and new ones be put in place
to hold those falling out of the mainstream due to the adverse impacts of globalisation.
This is to be done, not as a favour to those who get pushed out of the race, but because
they have been wronged and providing safety nets are only ways to prevent further
harm. However, new policies like the Pharmaceutical Policy 2002, are taking away even
the little self reliance and self sufficiency that was built up over the years. Fifty-five years
after India attained political freedom, it is on its way to losing its ‘swaraf, by playing into
the hands of few vested, powerful interests. As the value base erodes, so does our
‘ swara/.
The need of the hour is not narrowly defined nationalism, but an all-inclusive value base,
which will provide the basis for governance and citizenship. Health of the citizens would
be at the centre of such a value base. All policies would be directed towards achieving
‘Health for AH’. This is the goal and means of achieving swaraj. The dream of achieving
‘Health for AH’ through swaraj will become a reality only when every, citizen takes it on
as his/her responsibility achieve it and says in the words of Lokamanya Baiagangadhar
Tilak, that ‘Swaraj is my birth right, and I shall have it’.
24
BIBLIOGRAPHY
A. lyerand A. Jesani, Medical Ethics (New Delhi: VHA, 2000)
A.K. Tharien, Ethical Issues in the progress of Medical Science and Technology (New
Delhi: UHAI 1995)
A.S. Gupta, Drug industry and the Indian people (New Delhi: DSF and FMRAI, 1986)
C. M. Francis, Medical Ethics (New Delhi: Jaypee, 1993)
CHAI, Seeking the signs of the Times (Secunderabad: CHAI, 1992)
F.M. Podimattam, Medical Ethics (Volume-1) (Secunderbad: HAFA, 2003)
FMRAI, Access to Essential Medicine (Kolkata: FMRAl, 1986)
G. Thomas, et.al., AIDS, Social Work and Law (Jaipur: Rawat,1997)
G.V. Lobo, Current problems in Medical Ethics ( Allahabad: St. Paul’s publications,
1974)
K.Bluestone, et.al., Beyond Philanthropy (London: Oxfam, VSO and SCF 2002)
M.K. Gandhi, Village Swaraj (H. M. Vyas ed., Ahmedabad: Navajivan Publishing House,
1962)
M.L. Kothari and L.A. Mehta, Living, Dying (Goa: The other Indian press, 1992)
Mira Siva, “ Pharmaceutical Policy-2002”, Health For The Millions, Vol. 28 No.1, April-
May 2002
N. I. Thomas, A study of charitable Giving for the Extension of Health Services
(Mumbai: TISS, 2000)
25
NPPA India, “Pharmaceutical policy 2002” http://nppaindia.nic.i_n (February 15,2002)
OPC, Law Relating to Protection of Human Rights (New Delhi: OPC, 2000)
P. T. J. Datta “ DPCO courting controversy over saving drugs”, Business Line, August 21
2002
P. T. J. Datta “ Ministry to take DPCO ruling to apex court”, Business Line, September 3
2002
R. Venkataraman, “Medical Ethics”, The Hindu, October 21, 2003 (magazine)
RGUHS, Teaching Medical Ethics in Undergraduate Education (Bangalore: RGUHS,
1999)
UN and Other Organisation Reports
Comparative Analysis of National Drug Policies (Geneva: Action Programme on
Essential Drugs (APED), WHO, 1996)
Essential Drugs Monitor (Geneva-. WHO, 2003)
Health and Equity- Effecting change (S. Raghuram ed., Bangalore: Hivos, 2000)
Integrating Intellectual property Rights and Development Policy (London: Commission
on intellectual property rights, 2002)
PHM, Position paper on Right to Healthcare’ (Mumbai: PHM, 2003)
The World Drug Situation (Geneva: WHO, 1988)
The World Health Report 2002 (C. Murray, et. al. eds., Geneva: WHO, 2002)
26
Journals
c. M. Francis and T. Narayan, “The Right to Health”3(V) Integral Liberation March 1999
Drugs and Pharmaceuticals Industry Highlights: Published by National Information
Centre for Drugs and Pharmaceuticals, Central Drug Research Institute, Lucknow.
(Several volumes:
Volume 22, No. 7, November-December
Volume 24, No. 2, February2001
Volume 24, No. 3, March 2001
Volume 24, No. 4, April 2001
Volume 24, No. 5, May 2001
Volume 24, No. 7, July 2001
Volume 24, No.11, November 2001
Volume 25, No.1, January2002
Volume 25, No. 3, March 2002
Volume 25, No. 5, May 2002
Volume 25, No. 7, July 2002
Volume 25, No. 6, June 2002
Volume 25, No 8, Aug 2002
Volume 25, No. 9, September 2002
Volume 25, No 12, Dec 2002)
27
Annexure 1
HEALTH AND RELATED
LEGISLATION IN KARNATKA
NAVEEN I. TFIOMAS
November 2003
COMMUNITY HEALTH CELL
Society for Community Health Awareness, Research & Action
(SOCHARA)
Bangalore, India
28
Introduction
If the number of laws a land possessed were an inoicator of a law-abiding society, India
would have been highly ranked among the nations of the world. However, the mere
possession of laws and other legal instruments do not ensure a law-abiding society,
instead it just adds to the notion of lawlessness (more the laws, more will be the
incidents of violations). However, legislations and legal instruments provide an avenue,
which could be harnessed by an aware and vigilant civil society to ensure order and
social justice.
The need for a vigilant and pro-active civil society has become all the more necessary in
view of legislations and decisions increasingly being taken at a global level, way beyond
the reach of local communities and very often, even national governments. The World
Trade Organisation (WTO) negotiations is a case in point, where nations and continents
are subdued into agreeing to norms and agendas that are very often set by powerful
Trans-National Corporations (TNCs). However, WTO is not the only mechanisms for
remote access and control of national resources and economies. Aid and loan given by
industrialized nations and multi-lateral organisations like the World Bank to less-
industrialized nations, are often means of coercing them to budge to the machination of
powerful vested interests. The governments of the less-industrialized nations have
repeatedly failed to stand up to such devices. In such a scenario, it is important for the
civil society to be pro-active and work towards strengthening the existing spaces
available for people to have access and control over their resources.
Much has been written about the impact of globalization on health. Even the National
Health Policy 2001 makes a note of the threats faced by people due to globalization.
However sadly, the Government action has been to reduce it’s spending on health, even
while taking the LPG (liberalization, privatization and globalization) route. More than 80%
of health spending is already in the private sector. The opening up of the health sector
under the General Agreement of Trade in Services (GATS) could see further changes in
the health care scenario in the country.
There is a dire need to explore different ways in which health of the people can be
secured.
Prioritization
of
health
spending,
increasing
the
health
budget and
29
strengthening the policy and legal environment are a few of the ways, in which this can
be achieved. Strengthening the policy and legal environment helps people to stake a
claim to health and health care as a right, if it is accompanied with proper enforcing,
monitoring, redressing and mass-awareness creating mechanisms. The role of civil
society in supporting the process cannot be over-emphasized here
The knowledge of existing legislation is the first step in enforcing or improving the policy
and legal environment. This document attempts to put together the legislations in
Karnataka which form a major part of the existing policy environment in the state.
However this has to be seen in the context of other policies and practices including the
functioning of the Taskforce on Health which was set up the state Government, role of
judiciary, rules framed under various Acts and regulations of local bodies like
corporations, municipalities, panchayats, etc. and Government Orders (G.O.).
This purpose of this document is to serve a handbook for NGOs, health activists,
academicians, Government functionaries, media persons and anybody who wishes to
know the existing Acts as provided by the Karnataka state. It has been updated up to
December 2002. A few important Acts passed in 2003 have also been included. The
website of the Department of Parliamentary Affairs and Legislation, Government of
Karnataka (http://dpal.kar.nic.in/) came in handy for preparing the handbook.
This handbook is only a preliminary document and needs to be expanded further to
include laws and policies applicable at different levels. A critique of the contents of these
laws and policies are also needed for an informed debate and policy refinement. That
would be the next step in this journey!
Naveen I. Thomas
September 2003
30
Note: The following section lists the various Acts of Karnataka state, which have a link
with health. The Acts of Karnataka state have been divided into seven sections:
D
Health related Acts
2)
Agriculture/ Veterinary/ Animal related Acts
3)
Urban related Acts
4)
Rural related Acts
5)
6)
Tobacco/ Alcohol related Acts (including industrial use)
General Acts
1
Health related Acts
Amendment(s) / Remarks
Act
SI.
Anatomy Act, 1957 (23 of 1957)
Amended by Act 15 of 1999
1.
Ayurvedic, Naturopathy, Siddha, Unani and
Medical
1966, 3 of 1968, 8 of 1969, 13 of
Practitioners) Miscellaneous Provisions Act,
1972, 7 of 1977, 46 of 1981, 38 of
1961 (9 of 1962)
1991 and 11 of 1992
Yoga
2.
Amended by Act 9 of 1966, 32 of
(Registration
and
Amended by Acts 19 of 1968, 33 of
3.
Health Cess Act, 1962 (28 of 1962)
1976
Medical Registration Act, 1961 (34 of 1961)
4.
Nurses, Midwives and Health Visitors Act,
5.
1961 (4 of 1962)
Private Nursing Homes (Regulation) Act,
6.
8.
9.
Amended by Act 9 of 1977
1976 (75 of 1976)
Rajeev Gandhi Health Sciences University
7.
Amended by Act 27 of 1981
Amended by Act 11 of 1998
Act, 1994 (44 of 1994)
District Vaccination Acf1892 (Bombay Act I
Act which is in force in Belgaum
of 1892)
area
Drugs (ControlTAct, 1952, (Bombay Act
Act which is in force in Belgaum
XXIX of 1952)
area
31
10.
11.
Female Infanticide Prevention (Amendment) i
.
- ■ £
m .
I Act which is in force in Belgaum
Act, 1897 (Bombay Act III of 1897)
j
I area
Indian Lunacy (Bombay Amendment) Act,
Act which is in force in Belgaum
1938 (Bombay Act XV of 1938)
area
Nursing
12.
Homes
Registration
Act,
1949
Act which is in force in Belgaum
area
(Bombay Act XV of 1949)
Act which is in force in Belgaum
Vaccination Act, 1877 (Bombay Act I of
13.
Indian Medical Degrees (Coorg Amendment)
14.
area
1877)
Act which is in force in Coorg area
Act, 1949 (Coorg Act IV of 1949)
Act which is in force in Coorg area
15.
Public Health Act, 1943 (Coorg Act I of 1943)
16.
Vaccination Act, 1950 (Coorg Act IV of 1950)
Act which is in force in Coorg area
17.
18.
19.
20.
21.
Infections Diseases Act, 1950 (Hyderabad
Act which is in force in Gulbarga
Act XII of 1950)
area
Vaccination Act, 1951 (Hyderabad Act XXIV
Act which is in force in Gulbarga
of 1951)
area
Dangerous Drugs (Madras Amendment) Act,
Act which is in force in Mangalore -
1950 (Madras Act XVI of 1950)
Kollegal area
Drugs (Control) Act, 1949 (Madras Act XXX
Act which is in force in Mangalore -
of 1949)
Kollegal area
Medical Degrees (Madras Amendment) Act,
Act which is in force in Mangalore -
1940 (Madras Act XX of 1940)
Kollegal area
Opium
22.
and
Dangerous
Drugs
(Madras
Amendment) Act, 1947 (Madras Act XXXIV
Act which is in force in Mangalore -
Kollegal area
of 1947)
23.
24.
Opium
(Madras Amendment) Act,
1951
Act which is in force in Mangalore -
(Madras Act XXXII of 1951)
Kollegal area
Public Health Act, 1939 (Madras Act III of
Act which is in force in Mangalore -
1939)- Amended by Karnataka Act 13 of
Kollegal area
HEALTH
■
H p- 11-0
08205
I'C
*
f8(
32
1965, 83 of 1976.
Tuberculosis
25.
Sanetoria
(Regulation
of
Buildings) Act, 1947 (Madras Act XVI of
Act which is in force in Mangalore Kollegal area
1947)
Act which is in force in Mysore
Drugs Control Act 1950 (Mysore Act V of
26.
area
1950)
- Act which is in force in Mysore
area
27.
Lepers Act, 1925 (Mysore Act IV of 1925)
- Amended by Karnataka Act 13 of
1965
- Act which is in force in T/lysore
28.
Public Health Act, 1944 (Mysore Act 10 of
area
1944)
- Amended by Karnataka Act 13 of
1965
29.
Vaccination Act, 1906, (Mysore Act I of
- Act which is in force in Mysore
1906)
area
33
Agriculture/ Veterinary/ Animal related
Amendment(s) / Remarks
Act
SI.
Agricultural Pests and Diseases Act, 1968 (1
1.
of 1969)
Animal Diseases (Control) Act, 1961 (18 of
2.
1961)
Live-Stock Improvement Act, 1961 (30 of
3.
1961)
Amended by Acts 22 of
Sheep and Sheep Products Development
4.
Proposed for Repeal
Prevention of Cruelty to Animals (Bombay
5.
1978 and 20 of 1980
Act, 1973, (12 of 1974)
Amendment) Act, 1953 (Bombay Act
Act which is in force in Belgaum
area
XXII of 1953)
Prevention
of
Cruelty
to
Animals,
the
Act which is in force in Belgaum
Bombay District Police and the City of
6.
Bombay
Police
(Amendment) Act,
1946
area
(Bombay Act XXVIII of 1946)
7.
Improved Seeds and Seedling Act, 1951
Act which is in force in Gulbarga
(Hyderabad Act XXVIII of 1951)
area
Restriction
8.
of
Cash
Crops
Cultivation
Regulation (Repealing) Act, 1953
Act which is in force in Gulbarga
area
(Hyderabad Act XIV of 1953)
9.
Slaughter of Animals Act, 1950 (Hyderabad
Act which is in force in Gulbarga
Act VII of 1950)
area
34
Urban
Act
Amendment(s) / Remarks
Bangalore Water Supply and Sewerage Act,
Amended by Acts 6 of 1966, 10 of
1964 (36 of 1964)
1966 and 18 of 1984
Prohibition of Beggary Act, 1975 (27 of
Amended by Acts 7 of 1982 and 12
SI.
1.
2.
3.
of 1988
1975)
Karnataka Slum Areas (Improvement ancT
Clearance) Act, 1973 and Karnataka Public
Amended by Acts 19 of 1981,34 of
Premises (Eviction of
1984, 26 of 1986, 7 of 1988 and 21
Unauthorized Occupants) Act, 1974 (33 of
of 2002
1974)
4.
5.
UrbarTWater Supply and Drainage Board
Amended by Acts 7 of 1976, 20 of
Act, 1973 (25 of 1974)
1977, 45 of 1981 and 19 of 1993
Urban Development Authorities Act, 1987
Amended by Acts 17 of
(34 of 1987)
1991, 14 of 1992 and 12 of 1996
The Karnataka Slum Areas (Improvement
6.
and Clearance) and Certain Other Law
(Amendment) Act, 2002 (21 of 2002)
Rural
Act
SI.
Amendment(s) / Remarks
Amended by 10 of 1995, 9 of 1996, 17 of
1.
Panchayat Raj Act 1993 (14 of
1996, 1 of 1997, 10 of 1997, 29 of 1997,
1993)
29 of 1998, 10 of 1999, 21 of 1999, 8 of
2000, 11 of 2000 and 30 of 2001
Village Defence Parties Act, 1964
2.
3.
Amended by Act 22 of 2000
(34 of 1964)
Village Offices Abolition Act, 1961
Amended by Acts 8 of 1968, 13 of 1978,
(14 of 1961)
27 of 1984, 47 of 1986 and 22 of 2000
35
Tobacco/ Alcohol Related
Amendment(s) / Remarks
Act
SI.
Amended by Acts 1 of 1970, 1 of 1971,61
! of 1976, 32 of 1982 28 of 1987, 36 of
1.
; 1987, 1 of 1994, 2 of 1995. 7 of 1997, 21
Excise Act, 1965 (21 of 1966)
I of 98, 12 of 1999. 21 of 2000 and 15 of
2001
Amended by Act 10 of 1967
Prohibition Act, 1961 (1 of 1962)
2.
Prohibition of Smoking in Show
3.
Houses and Public Halls Act, 1963
(30 of 1963)
Toddy Worker’s Welfare Fund Act,
4.
1981 (31 of 1994)
The
5.
of
Prohibition
Karnataka
Smoking and Protection of Health of
Non-Smokers Act, 2001 (2 of 2003)
(District)
6.
Act,
Tobacco
1933
Opium Smoking Act, 1936 (Bombay
7.
Act which is in force in Belgaum area
Act XX of 1936)
1912
Act,
Smoke-nuisances
8.
Act which is in force in Belgaum area
(Bombay Act II of 1933)
Act which is in force in Belgaum area
(Bombay Act VII of 1912)
Tobacco Duty (Town of Bombay)
Act, 1857 and the Bombay (District)
9.
Acts which are in force in Belgaum area
Tobacco Act, 1933 (Suspension)
Act, 1945 (Bombay Act XI of 1945)
Power
10.
Alcohol
Act,
12.
F
Act which is in force in Belgaum area
(Hyderabad Act XI of 1350 F)
Cigarette- Tobacco
11.
1350
Safeguarding
Act which is in force in Mysore area
Act, 1939 (Mysore Act VI of 1939)
Power Alcohol Act, 1939, (Mysore
Act VIII of 1939)
Act which is in force in Mysore area
i
36
General
Civil
1.
Services
(Prevention
of
Amended by Act 6 of 1967
Strikes), Act, 1966 (30 of 1966)
Civil
2.
Amendment(s) / Remarks
Act
SI.
Services
Promotion,
(Reg u I atio n
of
Pay & Pension) Act,
Amended by Acts 40 of 1976 and 25 of
1982
1973 (11 of 1974)
Amended by Acts 40 of 1964, 27 of 1966,
16 of 1967, Presidents Act 1 of 1972,
Karnataka Acts 14 of 1973, 2 of 1975, 39
3.
Co-operative Societies Act, 1959
of 1975, 19 of 1976, 70 of 1976, 71 of
(11 of 1959)-
1976, 14 of 1978, 16 of 1979, 3 of 1980, 4 ;
of 1980, 5 of 1984, 34 of 1985, 34 of 1991,
25 of 1998, 2 of 2000, 13 of 2000, 6 of
2001 and 24 of 2001
Debt Relief Act, 1976 (25 of 1976)
Amended by Act 63 of 1976
4.
Departmental
Inquiries
of
attendance
of
Amended by Acts 43 of 1981 and 28 of
and
Production
of
1986
(Enforcement
5.
Witnesses
Documents) Act, 1981 (29 of 1981)
Devadasis
6.
Dedication) Act, 1982 (1 of 1984;
Evacuee
7.
of
(Prohibition
Interest
Supplementary
Act,
(separation)
(3
of
(Construction
of
1961
1961)
Existing
8.
Laws
References to Values) Act, 1957 (12
of 1957)
Essential Services Maintenance Act,
1994 (21 of 1994) (for a period of 10
9.
years
from
the
date
commencement i.e., 16-4-1994)
of
37
Famine Relief Fund Act, 1963 (32 of
10.
1963)
Amended by Act 15 of 1986, 31 of 1986, 1
11.
of
Lokayukta Act, 1984 (4 of 1985)
1988 and 30 of 1991
Prohibition of Admission of Students
to the Un- recognised and Un
12.
affiliated
Educational
Institutions
Act, 1992 (7 of 1993)
Resettlement of Project Displaced
13.
Persons Act, 1987 (24 of 1994)
Repealing and Amending Act, 2000
14.
(22 of 2000)
Right to information Act, 2000 (28 of
15.
2000)
Amended by Acts 1965, 20 of 1975, 65 of
Societies Registration Act, 1960, (17
16.
17.
of 1960)
1976, 7 of 1978, 48 of 1986, 11 of 1990, 9
of 1999, 7 of 2000 and 6 of 2002
State Aid to Industries Act, 1959 (9
Amended by Acts 3 of 1964 and 20 of
of 1960)
1978
State Commission for Women Act,
18.
1995 (17 of 1995)
State Universities Act, 2000 (29 of
19.
2001)
Transparency in Public Procurement
20.
Act 1999 (29 of 2000) and 21 of
2001
21.
The Karnataka Fiscal Responsibility
Act, 2002 (16 of 2002)
22.
Charitable Endowments Act, 1890.
This is a Central Act which has been
(Central Act 6 of 1890)
amended by the Karnataka Act 19 of 1973
Famine
23.
Relief
Fund
Act,
(Bombay Act XIX of 1936)
1936
Act which is in force in Belgaum area
38
Fodder and Grain Control Act, 1939
24.
Growth of Foodcrops Act,
25.
Act which is in force in Belgaum area
(Bombay Act XXVI of 1939)
1944
Act which is in force in Belgaum area
(Bombay Act VIII of 1944)
Hindu Women's Rights to Property
26.
(Extension to Agricultural Lands)
Act which is in force in Belgaum area
Act, 1947 (Bombay Act XIX of 1947)
(Control)
Molasses
27.
Act,
1956
Refugees Act, 1948 (Bombay Act
28.
Guarantees
1954
Act,
Industries
1953
Act,
Act which is in force in Gulbarga area
(Hyderabad Act XXXVI of 1956)
Children Protection Act,
33.
Act which is in force in Belgaum area
1947 (Bombay Act XXVII of 1947)
Abolition of Whipping Act, 1956
32.
Act which is in force in Belgaum area
(Bombay Act XLI of 1954)
(Emergency Powers) Whipping Act,
31.
Act which is in force in Belgaum area
(Bombay Act XXII of 1954)
Village
30.
Act which is in force in Belgaum area
XXII of 1948)
State
29.
Act which is in force in Belgaum area
(Bombay Act XXXXVIII of 1956)
1343 F
Act which is in force in Gulbarga area
(Hyderabad Act IX of 1343 F)
-Famine (Stricken Pettadars Property
34.
Protection Act, 1931 F (Hyderabad
Act which is in force in Gulbarga area
Act III c.1381 F)
Labour
35.
Act,
1952
Settlements
Act,
1956
Act which is in force in Gulbarga area
(Hyderabad Act XLIV of 1956)
Poisons Act 1322 F (Hyderabad Act
37.
Act which is in force in Gulbarga area
(Hyderabad Act XXXVI of 1952)
Mining
36.
Housing
Act which is in force in Gulbarga area
IV of 1322 F)
Protection of Flood Stricken Debtors
38.
Property Act, 1318F (Hyderabad Act
I of 1318 F)
Act which is in force in Gulbarga area
39
of
Protection
39.
Houses
from
the
Floods of Mossi River Act, 1318 F
Act which is in force in Gulbarga area
(Hyderabad Act II of 1318 F)
Sati
40.
1830
Regulation,
(Madras
Kollegal area
Regulation I of 1830)
Essential
Articles
Control
and
Requisitioning (Temporary Powers)
41.
Act,
Act which is in force in Mangalore -
1949 (Madras Act XXIX of
Act which is in force in Mangalore -
Kollegal area
1949)
42.
Control
Articles
Essential
and
Requisitioning (Temporary Powers
Act which is in force in Mangalore
Re-enacting) Act, 1956 (Madras Act
Kollegal area
VI of 1956)
Relief
Famine
43.
44.
Act,
Act which is in force in Mangalore -
Kollegal area
Prevention of Couching Act, 1945
Act which is in force in Mangalore -
(Madras Act XXI of 1945)
Kollegal area
Conservancy
Act,
1884 Act which is in force in Mangalore Kollegal area
(Madras Act VI of 1884)
Abolition of Whipping Act,
46.
1936
(Madras Act XVI of 1936)
Rivers
45.
Fund
1949
Act which is in force in Mysore area
(Mysore Act XII of 1949)
- Act which is in force in Mysore area
- Amended by Karnataka Acts 11 of 1958,
Betting Tax Act, 1932 (Mysore Act
47.
IX of 1932)
7 of 1974, 22 of 1980, 20 of 1981, 21 of
1989, 18 of 1994, 6 of 1995, of 1997, 3 of
1998, 5 of 2000
48.
(Maintenance)
Essential
Service
Act,
1942
(Mysore Act XXIII of
Limitation
(War Conditions) Act,
Act which is in force in Mysore area
1942)
49.
1947 (Mysore Act I of 1947)
Act which is in force in Mysore area
40
50.
Lotteries and Prize Competitions
- Act which is in force in Mysore area
Control and Tax Act, 1951 (Mysore
- Amended by Karnataka Acts 26 of 1957,
Act XXVII of 1951)
13 of 1965)
Pension Act, 1871 (Mysore Act XXII
51.
Poisons Act, 1910 (Mysore Act 10 of
52.
Act which is in force in Mysore area
of 1871)
1910)
Act which is in force in Mysore area
- Media
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