COPD in India: Iceberg or volcano?
Professor Pulmonary Critical Care Sleep Medicine, B.V. Medical College, Pune 411043, India
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Review Article
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Abstract
The purpose of this article is to provide an overview of the epidemiology of COPD in India which is one of the most affected
countries in the world and contributes significantly to the mortality and morbidity of this disease; to provide insights into
the etiological determinants of COPD in India; comment on treatment aspects including drug treatment, adherence to
guidelines, treatment of exacerbations and to try to comment on whether it differs significantly from rest of the world.
The article reviews published literature on COPD in India; provides insight into comparative methodologies involved;
comments on gaps in knowledge and suggests areas of further research such as Prescription Audit. India contributes very
significantly to mortality from COPD 102.3/100,000 and 6,740,000 DALYs out of world total of 27,756,000 DALYs; thus
significantly affecting health related Quality of Life in the country. COPD is surpassing Malaria, TB even today and the gap
would get wider with time in near future. The lack of robust real time nation-wide data does plague India as well, however
multiple studies from 1994 to 2010 show increasing trends of COPD morbidity and mortality. Since most inhalational
drugs are available in the country there is no reason why mortality should not be comparable to rest of the world but there
is poor adherence to treatment guidelines, both national and international. Urban centers in India are comparable to their
global counterparts in terms of service quality and facilities and this is also work in progress. However, the rural hinterland
is poorly serviced; national GDP spending on health is remarkably low. Some innovation is emerging and that could be the
harbinger of a new future if properly nurtured. The article is an overview of COPD in India with emphasis on understanding
the multi-dimensional nature of the problem and an attempt of providing insight into possible de-bottlenecking to reduce
the pain and suffering of millions of COPD patients in India in future.
Key words
COPD; chronic bronchitis; emphysema; India; epidemiologyJ Thorac Dis 2012;4(3):298-309. DOI: 10.3978/j.issn.2072-1439.2012.03.15
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Introduction
Like everywhere else in the world and especially in the
developing world; India is changing - not only in terms of its
demographics, urbanization, economic profile, pollution but also
in terms of its health burden, disease pattern, dominant-diseasecomposition,
morbidity and mortality determinants.
Like China, India also contributes a significant and growing
percentage of COPD mortality estimated to be amongst the highest in the world; i.e. more than 64.7 estimated age
standardized death rate per 100,000 amongst both sexes as
shown in Figure 1 as mentioned in the WHO Global Infobase
Updated on 20th January 2011 (India 102.3 and China 131.5) (1).
This would translate into approximately 556,000 in case of India
(>20%) and 1,354,000 cases in China (about 50%) out of a
world total of 2,748,000 annually (2).
Figure 1. COPD Mortality Projections: Global Burden of Disease Data. Updated 20th January 2011.
However, what needs to be remembered in analyzing any
such or similar data is that the devil often lies in the details and
methodological considerations often add a different dimension
to such data figures. Common sense and wisdom dictates that
the morbidity and mortality for individual diseases - if reduced;
can help decrease the overall mortality. For example, reducing
annual chronic disease death rates by every 2% can easily avoid
36 million deaths cumulatively by year 2015 (3).
COPD is a gradually progressive disease which manifests late
and as such most methodologies are likely to under estimate
the morbidity and mortality rates of this disease, worldwide.
In developing countries resource constraints often dictate the
methodology of gathering data and inability to conduct large scale Spirometry Based surveys often compromise quality
of data gathered and estimated from questionnaire based
methodologies. However consistent patterns of trends emerging
over long periods despite different investigators addressing
the same disease; does help generalize the epidemiological
significance of the disease. COPD prevalence, morbidity and
mortality data from India perhaps falls into this category.
The prevalence of COPD has been studied extensively by
Indian investigators over the last 5 decades. These studies were
characterized by local initiatives and could not be generalized on
a national level. However, in spite of the localized nature of these
studies they did provide a trending data at major urban centers
in the country. These studies were comprehensively reviewed
by Jindal S. K. et al. subsequently (4) (Table 1). The COPD
prevalence varied from 3% to 8% amongst Indian males and
approximately 2.5% to 4.5 % among Indian females.
Between 2002 and 2005, a landmark and very detailed
study was undertaken in Delhi-the national capital by the
Central Pollution Control Board of India and it included all
possible components of investigation including ambient air
quality, Respiratory Health Questionnaire Survey, Spirometry
of randomized sections of Delhi population with control
population from West Bengal rural areas. It had very robust
methodology studying Sox, NOx, VOCs, RSPM, PM10, and
Hydrocarbons amongst the air pollutants and hematology, cell
cytology, molecular biology of blood cells, airway epithelial cells,
mediators of injury in sputum and buccal and airway epithelium
studied over a long period and documented extensively (5).
Space restraints won’t permit me to mention its detailed
findings here but suffice it to say that the study established the
multi-factorial links between air pollutants, smoking behavior
and respiratory and cardiovascular morbidity unequivocally
and helped pave the way for citizen activism and environmental
intervention in a unique way. The COPD prevalence in Delhi
residents was close to 4% in this study. Indoor pollution
determinants and ambient air quality parameters were also
significantly high and contributed significantly to respiratory
symptom burden in this study though a clear correlation with
Spirometry-defined-COPD was not established (5).
Around 2004-2006 Indian Council of Medical Research
commissioned a four city multi-center survey based on validated
symptom questionnaire methodology targeting 35,000 urban
and rural residents; the INSEARCH-I study. Prevalence of
COPD was documented to be around 4.1% (5% males to 3.2%
females). Smokers had 3 times more risk to develop COPD
as compared to non-smokers and Bidi smokers were at higher
risk of developing COPD (8.2%) than their Cigarette smoking
counterparts (5.9%). Cooking fuel exposure was documented
from 2% using LPG to around 5% using Kerosene and/or
biomass fuels or firewood. No statistically significant differences
could be established between different fuel types among the non
smoker populations (6). Odds of developing COPD amongst
non-smokers exposed to ETS and Fuel smoke both were higher
than for ETS exposure alone (OR 1.576).
The Global Burden of Disease study by Murray & Lopez in
1996 predicted global prevalence of COPD to be 9.34 per 1,000
for males and 7.33 per 1,000 for females of all ages (7).
The National Family Health Survey conducted nationwide
in 1998-1999 by Indian Institute for Population Sciences,
Mumbai was also published in 2000. It covered almost the entire
nation including the sub-Himalayan states with comprehensive
coverage. The prevalence of smoking in above-30-year age
group was 40.9% among males and 3.9% amongst females. For
the under 20 age group this prevalence was 4.5% and between
20 and 29 it was around 14% among males. Tobacco and Pan
Masala chewing was very widely spread among both sexes
especially in the hilly states and so was alcohol consumption in
tribal populations (8).
The National Commission on Macroeconomics and Health
was set up to study various diseases and their burden on the
health care system of the country in 2001 and the COPD burden
estimated and projected by them was an eye opener for clinicians
and policy makers alike. The commission used population
estimates starting 1996 and projected population growth till
2016 as per census of India statistics. Expected changes in
mortality figures were applied as required (Table 2). Cost of
treatment estimates were based on review of older published
studies from 1992 to 1999 and incremental cost estimates were
applied dependent on projected inflation rates. According to the
NCMH estimates; in 2006 there were around 17 million COPD
patients in India and in the next 10 years this figure is likely to
reach around 22 million (9) (Figure 2).
Figure 2. Estimated number of cases of COPD in India in the current decade.
The NCMH estimates of prevalence of COPD showed that
the burden of COPD is more in rural India and is increasing all
the time. A pilot study conducted in Hyderabad was assumed
to indicate acute exacerbation rates amongst Indian COPD
patients and a rough estimate of acute cases for the same period
was done which also showed increasing trend and additional
economic burden (Table 3) The economic burden of COPD
was estimated in Crores of Rupees (1 Crore =10 Million). As
per these estimates the current estimated burden of COPD
for India is 35,000 Crore Rs. or 350,000 Million Rs. (Rs. 350
Billion). This is likely to reach a staggering 48,000 Crore Rs.
(Rs. 480 Billion) in next five years. This current cost, however,
assumes that the practice of treating COPD remains what it was
when these estimates were made, 2001-2005. If, however the
medical community were to adhere to standardized national
and international treatment guidelines this cost could drastically
come down to Rs. 41 Billion today 2011-2012 and up-to Rs. 56
Billion in 2016 (9) (Figure 3).
Figure 3. Estimated economic burden of COPD in India as per current practice and savings achievable if
guidelines were implemented.
Whereas the NCMH data can be analyzed and criticized for
its approximations of cost of treatment; other studies published
around the same period corroborate the prevalence estimates.
The WHO country unit for India compiled the Morbidity
and mortality data from Non-Communicable diseases for the country from 1998 to 2002. Nongkinryh et al. published this in
Journal of Association of Physicians of India in 2004. COPD and
Asthma were second leading cause of death after Road Traffic
Accidents (Figure 4). The morbidity figures showed them to
contribute to around 55 million cases for both Asthma and
COPD combined (10) (Figure 5).
Figure 4. Estimated mortality due to non-communicable diseases in India.
Figure 5. Estimated morbidity due to non-communicable diseases in India.
A retrospective analysis of the Registrar General of India data
based on 5 years moving averages between 1966 to 1994 and further
corroborated with the census data of 2001 (excluding the hilly
regions of the country); where NFHS I & II were also available
published in the Internet Journal of Epidemiology in 2005 showed a
distinct trend of COPD overtaking Tuberculosis and Pneumonia as
leading cause of death for this period (11) (Figure 6).
Figure 6. Leading causes of mortality in rural India from 1966-1994.
That Tuberculosis and Malaria mortality has been falling and shall continue to fall has been corroborated by another
Policy paper from WHO published in 2005 (12). Tuberculosis
mortality is expected to fall from 0.4 million currently to
0.2 million by 2030. Whereas COPD mortality is expected
to increase from 0.9 million as of now to about 1.6 million in
parallel with the worldwide trends (12) (Figure 7).
Figure 7. Mortality trends of communicable diseases & COPD in SEARO region.
Any future projections can be viewed with skepticism
and hence more important than these estimates - a better
documented data available from the state of Maharashtra is
more relevant. COPD was found to be the leading cause of
death ahead of Cardiac Arrest, Stroke and Ischemic Heart
Disease combined together. The data has been compiled by the
Health Management Information System (HMIS), the Sample
Registration System (SRS), the Survey of Cause of Death (SCD),
etc. Though this is data from only one major state, it is very much
possible that other states in peninsular India are no different (13)
(Figure 8).
Figure 8. Major mortality determinants in Maharashtra State 2008.
Mortality is just one aspect of a debilitating disease like
COPD. The Health Related Quality of Life is severely affected
by the disease as well. The sub-optimal living along with
premature mortality is expressed as Disability Adjusted Life
Years or DALYs. World wide it is estimated that nearly 28,000
(Thousands) DALYs were lost due to COPD in 2002. A large
chunk of this loss came from Western Pacific Region of WHO
dominated by China (9,500,000 DALYs) and from South Asia
region of WHO dominated by India (6,740,000 DALYs). These
two nations are harboring 33% humanity; and contribute to a
50% colossal loss of life years. The disease which was ranked 12th
in 1990 in terms of DALYs lost is going to rank 5th in 2020 in the hierarchy of all diseases (14) (Figure 9).
Figure 9. Estimated DALYs lost to COPD by various regions of WHO.
A recently concluded Respiratory Questionnaire based
survey of 12 cities labeled Indian Study of Asthma, Respiratory
Symptoms and Chronic Bronchitis (INSEARCH-II) is yet
to publish its results. Some data on file has kindly been made
available to me by one of the investigating team members and
further statistical analysis is pending. Considering district as a
unit, urban and rural populations have been studied extensively
with a previously validated questionnaire survey instrument
and a fairly robust data set is likely to emerge which is likely to
substantiate the fact that close to 20% of urban Indian males
continue to smoke and less than 1% females smoke. It is also
likely to shed more light on indoor pollution and its role in
COPD prevalence. Rural residence, lower socio-economic
strata, advancing age and smoking habit are likely to be major
factors favoring COPD development if preliminary analysis is
substantiated by further analysis.
Since rural poor staying in ill ventilated houses using dry
wood as fuel are likely victims of indoor air pollution; the
prevalence among non-smoking females from this subset may
throw significant light on the non-smokers’ COPD prevalent in
India (15) (Figure 10).
Figure 10. Non-smoker’s COPD - misery seeking missile?
The non-smoker’s COPD is an entity which needs to be
documented in greater detail and this task has to be done by
researchers in Asia, Africa, Latin America and other developing
regions of the world. COPD among non-smokers may turn out
to be a misery seeking missile. A study of 12,000 slum dwellers
from Pune in Maharashtra revealed a questionnaire based COPD
prevalence rate of 6.5% (8.5% in males and 4.5% in females). Of
those diagnosed with COPD, 69% were never smokers. Absence
of a separate kitchen for cooking was an independent risk factor
associated with COPD prevalence in males (OR=1.95, P=0.02)
while use of kerosene fuel for cooking increased the odds of
COPD in females by around 2.5 times (OR=2.48, P=0.01) (16)
(Figure 11).
Figure 11. COPD amongst non- smokers Is indoor pollution the culprit?
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Tuberculosis sequelae and COPD
India has remained the Tuberculosis capital of the world
for far too long. MDR Tuberculosis continues to be on the
rise. However healed tuberculosis with structural sequelae
continues to contribute to significant respiratory morbidity in
India and other developing countries of the world. COPD as
defined by post bronchodilator FEV1/FVC ratio of less than
0.7 has been defined as Post TB COPD for many years (17).
Studies from India indicate that healed Tuberculosis with or
without significant X-ray abnormality (Up-to 48% of healed
Tuberculosis) have COPD based on the spirometry criteria.
The longer the duration post completion of anti-tuberculosis
treatment, the longer is the chance of developing spirometry positive COPD. Relative risk of 26% at 5 years post Anti-TBTreatment
(ATT) increases to 41% at 10 years post ATT (18).
One could perhaps argue whether this is indeed COPD or
not especially if there is no history of smoking or exposure to
noxious gases or particulates in home or work environment.
However, with increasing awareness of non-smoker’s COPD,
the role of other aerosols becomes equally important and even
in absence of this history, post TB COPD may increasingly be
accepted as a separate phenotype. There is an urgent need for
further research in this area.
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Therapeutic aspects of COPD in India
For historical reasons, to make medicines available to its billion
plus poor population; India made certain changes in its patent
laws whereby Indian Pharmaceuticals can manufacture many
drugs by the “process patent” route rather than the “product
patent” route. This has kept the prices of drugs at affordable levels
to a large extent and also increased availability of multiplicity
of brands in the Indian market. As such there are close to a
dozen Indian pharmaceutical companies manufacturing inhaler
formulations or DPI formulations for Asthma and COPD.
Triple drug combinations - containing inhaled corticosteroids,
bronchodilators (LABA), plus anti muscarinic drugs like
Tiotropium (LAMA) - have been cleared by Indian FDA
nearly five years ago. Unique combinations such as LABA plus
LAMA or LABA + ICS combinations such as Formoterol plus
Fluticasone have also been available for a fairly long duration.
There is an urgent need to do research in therapeutic audits
in both Asthma and COPD about the various combination
therapies by inhalational route. This will not only help Indian
patients but also benefit other emerging medical markets &
economies. As of now, there seems to be a paucity of data about
these formulations, not going beyond clinical trial data submitted
to Indian FDA (19).
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Pulmonary rehabilitation aspects
Considering the fragmented nature of the healthcare delivery
industry in India, there are no big centers of excellence in
India providing protocolized rehabilitation services as in the
western world. Mostly individual physician initiatives lead to
rehabilitation in informal un-structured manner. A recent study
from Manipal demonstrated the utility of improvised unsupported
upper limb exercise (UULE) and lower limb exercise (LLE) in
COPD rehabilitation with improvement in health related QOL
parameters, 6MWD, and chronic respiratory questionnaire for
fatigue, emotion, and mastery (20) (Figure 12).
Figure 12. Unsupported Upper Limb Exercise (UULE).
In the rapidly evolving corporate hospitals in major urban
centers of India, the physiotherapy, respiratory therapy,
occupational therapy departments are helping clinicians
shoulder the burden of COPD rehabilitation programs.
Traditional medicine practitioners and Yoga and physical
medicine practitioners are other important contributors to
the rehabilitation effort at some centers. Data about efficacy of
some of these techniques is however rather sketchy and not well
publicized and peer reviewed.
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Treatment of exacerbations of COPD
Acute exacerbations of COPD are more or less treated as per
standard international norms. Non invasive positive pressure
Ventilation (NIPPV) has become common place in most
secondary and tertiary hospitals in India and the ever growing
numbers of Intensive Care Units are making ventilatory care
available to more and more patients with every passing day (21).
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Long term oxygen treatment and home ventilation
Last two decades have seen opening of the Indian economy with
removal of restrictions on imports of life saving equipments and
as such home oxygen therapy and home ventilation in selected
patients of Severe and Very Severe COPD is no longer a novelty
in most urban centers in India. However the country is very
diverse and generally speaking, rural areas are not adequately
serviced. Western and Southern parts of the country - along with
urban centers of northern & eastern India - usually have easy
accessibility to these facilities whereas the eastern parts of the
country including the Hilly States of Sub - Himalayan ranges and
the North Eastern States are somewhat lagging behind.
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Surgical and non surgical lung volume reduction treatment modalities
This is an area of COPD treatment that has not yet developed in
India to its full potential. Lung Volume Reduction Surgery is an
important modality in severe COPD patients and the requisite
surgical team work is often not available even in many urban
centers in the country. Neither Spiration nor Zephyr Endo-
Bronchial Valve is as yet approved by Indian FDA and as such
not available to physicians or patients yet.
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Smoking cessation, primary prevention
Legal ban on smoking in public places is in place but often
not adequately implemented. Bidi industry which is as much
a problem as the cigarette industry in furthering the COPD
epidemic is not necessarily targeted by social and political
activists on health promotion grounds as it employs a huge
mass of marginalized vote bank sections of the society.
Smoking cessation initiatives as CSR activities (Corporate
Social Responsibility) are however taking good routes in urban industrialized centers in the country. This area of primary
prevention; though the most cost effective is very poorly
documented.
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National Urban Health Mission and National Rural Health Mission
Healthcare is on the concurrent list as per the Indian constitution
which means both Central and State Governments have a joint
responsibility of providing healthcare to the people. The multi
party system of democracy with a politically alert opposition
and civil society and more demanding middle class has made
the Central Government launch the National Urban and Rural
Health Mission program in the last 6 years. India has a lack luster
record of Government Spending on health as percentage of
per capita income or national GDP. The government is trying
to correct this anomaly through these programs. However
over-politicization, corruption, federal structure and lack of
political consensus are some of the bottlenecks in its orderly
implementation. As always it is the marginalized and the poor
who suffer the most. COPD has been included in the Non Communicable Diseases list of priority health problems in both
the Urban and Rural health missions. Effective implementation
of the stated program objectives will decide whether India wins
this battle against COPD or not.
China and India are bearing a disproportionate burden
of COPD morbidity and mortality. Since both countries
together constitute one third of humanity, there is potential for
cooperation between academia and researchers from the two
countries for evolving unique Asian strategies which will not
only benefit their citizens but also other neighboring nations as
well.
Whether the current epidemic of COPD in India is just a tip
of an iceberg or a volcano waiting to erupt will largely depend on
these societal responses.
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Acknowledgements
Disclosure: The author declares no conflict of interest.
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References
Cite this article as: Bhome AB. COPD in India: Iceberg or volcano? J
Thorac Dis 2012;4(3):298-309. doi: 10.3978/j.issn.2072-1439.2012.03.15
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