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Editorial Advisory Board
Mr. Apurva Shah

August - September 2013

Group Managing Director
Veeda Clinical Research

Mr. Arun Sawhney
Chairman, CII National Committee on Drugs
& Pharamaceuticals and CEO & Managing
Director
Ranbaxy Laboratories Ltd

Dr. Arvind Lal
Chairman and Managing Director
Dr Lal PathLabs

Dr. Devi Shetty
Chairman
Narayana Hrudayalaya

Prof. N.K. Ganguly
President, JIPMER,
Distinguished Biotechnology Research
Professor, DBT & Former DG, ICMR

Managing Editor: Vipin Balakrishnan
Editor: Hareeni Mageswaran
Consulting Editor: Shikha Dhawan
Consulting Editor: Dr Saji Salam
Copy Editor: Gouri Athale, Shekhar B
CII-Life Sciences Division
Dr. Sengupta
(d.sengupta@cii.in)
+91 99531 30050

Mr. Hari Bhartia
Co-Chairman and Managing Director
Jubilant Life Sciences Ltd

Design & Creative: A P Madhu

Dr. Kiran Mazumdar-Shaw
Chairman and Managing Director
Biocon Limited

Dr. R.A Mashelkar

Printed and Published by
Anjan Das on behalf of Confederation of Indian Industry

National Research Professor and Former DG,
CSIR

Dr. Mrutyunjay Suar
Director, School of Biotechnology &
CEO, KIIT-Technology Business Incubator

Publishers:
Confederation of Indian Industry
India Habitat Centre, Core 4A, 4th Floor, Lodi Road,
New Delhi-110003

Dr. Naresh Trehan
Chairman
Medanta-The Medicity

Dr. Nitya Anand
Former Director, CDRI

Dr. Rajesh Jain
Joint Managing Director
Panacea Biotec Ltd

Namaste Publication Pvt Ltd
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EDITOR'S NOTE
PPP’s– The Three C’s Collaboration,
Creativity and Consistency
In an era of PPP’s, we must be prepared to innovate, collaborate and be consistent in dealing with our Public Health issues. This issue has insights into the near mirage called NCD
management, we have to understand that the only way to tackle our public health issues is by
meaningful collaboration, as multi stakeholder relationship management and disease management is a challenge in a diverse country like ours . With the rise in non communicable
diseases, lifestyle related diseases we have to innovate ways of creating awareness, while
also fi nding innovating ways of creating pools of money consistently and efficient management of the resource pools. As a solution to this interesting yet mammoth task, we should
infuse communication, marketing and social media professionals in this Endeavour. Professionals with experience in Brands, Marketing, Advocacy, Public Relations, Events and Social
media professionals will make a huge difference.
These band wagon of professionals will catalyze collaboration infuse creativity and add a
flavor of consistency. Constancy of purpose is the fi rst principle to success on such large scale
mandates like NCD, and uniting all efforts. In our country one of the greatest setbacks has
been the meeting eye to eye of policy makers and other stakeholders, and rigorous interactions between them are the road to engagement, involvement and fi nally success. The large
scale benefits can be reaped by creating credible data pools and creating a cohesive working
environment. Corporate must be endowed with this responsibility by the Government, and
set as a premise for working.
Currently, our Country’s Public Health campaigns are more for the campaign sake not for
the Health sake. This attitude shift will call for a lot more participation of Corporate. Corporate with deep pockets and business interests must become eligible partners, as it takes the
corporate to make the partnership more engaging. The Ministry of Corporate Affairs must
device a Communication framework which actually captures the demographic challenges
of such campaigns, and thus stopping PPP’s parties from reinventing the wheel. The newly
passed CSR bill will help us see more responsible Corporate divas.

Hareeni Mageswaran
hareeni.lifescienceindia@gmail.com
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CONTENTS
LSI |

August - September 2013

Cover stories on NCD
Cover Story Interviews

17 Dr Jain DC
20 Dr W.D. Bhutia
21 Prof N.K. Ganguly
33 Dr Kamlesh Jain
26 CII White paper NCD
The researchers and this white paper
clearly demonstrate the fact that each
state has its own strengths, weaknesses
and priorities which differ from other
states in many ways. Over the last
two years, Diabetes management
interventions under NPCDCS have
reached more than 17.6 million patients,
but with the incidence still going up,
it is essential to scale up the effective
interventions. The Government plans to
scale up the response to the Diabetes
epidemic by expanding the NPCDCS
from 100 districts at present to cover all
districts in the country during the 12th
National Five Year Plan is appropriate and
timely

35 HERBAL NEEM
FORMULATION

10 NOT SO SWEET - The Indian diabetes saga:
By 2030, India's diabetes burden is expected to cross the 100 million mark.
Considering the rising burden of non-communicable diseases and existing
risk factors, Government of India initiated the integrated National Program
for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases and
Stroke (NPCDCS). It is essential to have the key public health facilities well
staffed with appropriately skilled and equipped manpower to provide access
to treatment services. It is also vital to have and follow standard treatment
protocols for disease management.

Herbal formulations
which have reached
widespread
acceptability
as therapeutic
agents in India
include nootropics,
antidiabetics, hepatoprotective agents and
lipid lowering agents.
CONTENTS
Technology

Policy Watch

55

46 FDI in pharma need for a clear policy

Improving Vaccine Development
and Production Using Rapid Virus
Quantification

regime
The Government recently decided to take stock of the decade-old FDI policy for the pharma sector. This decision was
in response to the potential threat of dominance from foreign
players and a general rise in overall drug prices in the country,
arising from a spate of acquisitions of Indian companies by
MNCs starting in 2006. The most notable ones are the acquisition of Matrix Labs by Mylan, followed by Daichii Sankyo’s
acquisition of Ranbaxy, Sanofi Aventis’s acquisition of Shanta
Biotech and Abbott Labs’ takeover of Piramal Healthcare

43 Realizing the opportunity from
There are many points during the process of developing,
optimizing and producing vaccines that would benefit
from rapid enumeration of viral particles. One of the most
significant is tracking efficiency following harvest from
egg- and cell-based systems

Pharmaceutical Patents in India

60 NMR spectroscopy:

51 SPOTLIGHT

Creating waves in life sciences
Nuclear magnetic resonance or NMR spectroscopy is
a modern day tool that is used to delve deep into the
intricate machinery that operates within each cell. Initially
developed by physicists to gain insight into the magnetic
properties of atom.

48 OPINION
Future of healthcare - IT Outsourcing
The US provider IT market is set to grow drastically, with
a $19 billion investment into the sector as part of the US
recovery plan signed by the President. However the Indian
IT vendors may not be in a good position to leverage the
growth in this market as most vendors have not made the
right preparations/investments to address this market

The urgency of India’s need for access to advanced medical
interventions including innovative pharmaceutical products
cannot be overstated.

Bio pesticides
The Central Insecticide Board under the Department of
Agriculture was established by Government of India, which
is a regulatory authority for registering Insecticides. The
Insecticides were covered under Insecticides Act 1968, whose
names were included in the Insecticides Schedule from time
to time by publishing in the Gazette of India, by the Government of India. Biopesticides are also governed by the Insecticide Act 1968, included in the Schedule. For any Biopesticide
to be manufactured, which are included in the Insecticides in
Schedule, it should be mandatory to register at Central Insecticide Board (CIB), Faridabad. Only after obtaining registration
from CIB, then State Agriculture Departments of respective
States will issue license for manufacturing of Biopesticides
and Principle certificates for Marketing of Biopesticides.

Exclusive Interview

40

Dr Vijayraghavan an academic
turned policy makers shares some of his
views on the Industry

38 Academic Showcase
Dr Kumar Principal of Kumara Guru
College of Technology Coimbatore
shares their inspiring journey in
innovation.
LSI
COVER STORY

NOT SO
SWEET

The Indian diabetes saga

-Jisha Krishnan

India will be home to more than 100 million diabetics,
approximately, one-fifth of the global diabetes
population, by 2030. We need to do everything we can
and more to curb the exploding epidemic
10

LIFESCIENCE INDIA | August - September 2013
LSI
COVER STORY
“I don’t have a sweet tooth,” was the prompt response of a
30-something software engineer to the doctor’s suggestion
of getting his blood sugar levels tested.
Ask any practicing physician and he is sure to share similar experiences of patient ignorance and/indifference. And
this is the educated, urban population in India we are talking about. As we venture into the hinterlands, a majority
of medical practitioners, too, fall into this category. For a
country that is home to over 63 million diabetes patients second only to China - the ground realities are more than
shocking. According to International Diabetes Federation,
50 percent of Indians are unaware if they suffer from diabetes. And among the other half, 50 percent do not take
any treatment.
The silver lining, if any, is the latest buzz in the pharmaceutical industry: Over 15 new anti-diabetic drugs are ready to
hit the market over the next couple of years. Also, an Indian pharmaceutical company beat its global competitors
to develop the fi rst of its kind anti-diabetic medication that
holds immense promise for diabetics across the globe.
Whether these drugs will succeed in meeting the hitherto
unmet needs of diabetic patients, reduce the huge economic burden, help improve the quality and quantity of life…
these are questions only time will answer. For now, the
saga continues.

Ground zero
Estimates suggest that 9.2 percent of adults in India have
diabetes, making its prevalence second only to that in China. The country is home to over 63 million diabetes patients, an increase from 50.8 million in 2010, says the International Diabetes Federation’s ‘Diabetes Atlas 2012’.
The population with pre-diabetes (those with glucose levels higher than normal, and at increased risk to develop
diabetes) is estimated to be approximately three times the
size of the diabetic population. By 2030, India's diabetes
burden is expected to cross the 100 million mark.
“In clinical practice, a lot of patients we see today are in
their late 20s and early 30s. The patient profi le has defi nitely got younger,” says Dr Arpandev Bhattacharyya, HOD,
Department of Diabetes and Endocrinology at Manipal
Hospital, Bangalore.
Diabetes mellitus – diabetes in common parlance – is
caused either because the pancreas can’t produce insulin
(type 1 diabetes) or the insulin that is produced isn't effectively shuttling sugar into the organs (type 2 diabetes). The
latter is more common and preventable, courtesy sedentary
lifestyles and unhealthy food habits, making it the focus of
most diabetes research across the globe.
As far as the Indian scenario is concerned, we face a dual
challenge. On the one hand, we are still struggling to come
LIFESCIENCE INDIA | August - September 2013 11
LSI
COVER STORY
to terms with long-standing challenges posed by communicable diseases such as tuberculosis, malaria, cholera, diarrhea, measles and leptospirosis; add to that, the current
onslaught of non-communicable diseases (NCDs). As per
disability-adjusted life year (DALY) which is a measure of
years lost due to ill-health, disability or early death, for India the topmost NCDs are cardiovascular diseases, diabetes, cancer and chronic obstructive pulmonary disease.

Ratlam (Madhya Pradesh) and Bhilwara (Rajasthan), 1,351
(1.467%) were suspected to be diabetic.

According to the Annual Report to the People on Health
published by the Ministry of Health and Family Welfare,
Government of India in September 2010, NCDs caused
40 percent of total deaths in rural India and 42 percent in
urban India. The corresponding figures for communicable
diseases were 40 percent and 38 percent respectively.

About 70 to 75 percent of diabetes patients are treated with a
combination of two or more oral anti-diabetics (OADs) and
20 to 25 percent are treated with a single OAD, notes Dipak
Mahajan, industry analyst, pharma & biotech, healthcare
practice, Frost & Sullivan. However, due to the progressive
nature of type 2 diabetes, most diabetics require insulin for
glycemic control, making it unlikely to have a decrease in
patient numbers.

The World Health Report 2001 had indicated that NCDs
accounted for nearly 60 percent of deaths worldwide and 75
percent of these occur in developing countries. Further, a
person with NCDs is vulnerable to common infectious diseases like tuberculosis, community-acquired pneumonias
and vaccine preventable diseases leading to poorer outcome
for these diseases. “In the case of diabetes, most patients
invariably also have to cope with cardiovascular disease,
kidney disease, nerve damage and/or loss of limbs,” adds
Dr Bhattacharyya.

Clinical quest
What can’t be cured must be endured. For researchers and
clinical practitioners across the globe, the biggest challenge
is to come up with effective, affordable ways to manage the
disease.

According to Frost & Sullivan’s Competitive Intelligence research, Analysis of the Global Type 2 Diabetes Therapeutics
Market, 15 new drugs for type 2 diabetes are in late-stage
development (Phase 3 and preregistration). Metformin is
expected to remain the fi rst-line therapy, in combination
with Sulfonylureas; along with changes in diet and exercise.

Therapies with the ability to preserve or restore beta cell function,
postpone or prevent disease progression, and allow patients to remain on
a single therapy will be the game-changers in the years to come
Says Dr Subhash Kumar Wangnoo, senior consultant endocrinologist and diabetologist at the Apollo Centre for Obesity, Diabetes and Endocrinology, Indraprastha Apollo Hospital, New Delhi

As per the fi ndings of phase I of the Indian Council of
Medical Research Diabetes Study, which recently covered
the rural and urban settings in four states, the prevalence
of diabetes in Tamil Nadu was 10.4 percent, 5.3 percent in
Jharkhand, 13.6 percent in Chandigarh and 8.4 percent in
Maharashtra. The prevalence of pre-diabetes was 8.3 percent, 8.1 percent, 14.6 percent and 12.8 percent respectively.
The numbers are not small to be ignored.
Blame it on sedentary lifestyles, unhealthy dietary habits,
genetic predisposition, the increasing cases of childhood
obesity don’t make the picture any rosier. During the course
of screening school children under the national programme
for prevention and control of cancer, diabetes, cardiovascular diseases and stroke (NPCDCS), it was found that of
the 92,047 children screened in Nainital (Uttarakhand),
12

LIFESCIENCE INDIA | August - September 2013

The most significant impact on the Indian diabetes therapeutics market, according to Mahajan, is expected to be the
launch of new Incretin Mimetics, Glucagon-like Peptide-1
(GLP-1) Agonists, and Dipeptidyl Peptidase-IV (DPP-IV)
inhibitors, as well as increased use of new fi xed combinations and formulations of drug therapies in both insulin
and non-insulin segments. “These new drug classes have
better efficacy and compliance,” he says.
New therapies are starting to address different possible
roots of the condition, identifying new target areas with
the potential to reverse disease progression alongside glucose regulation. “Therapies with the ability to preserve or
restore beta cell function, postpone or prevent disease progression, and allow patients to remain on a single therapy
will be the game-changers in the years to come,” says Dr
Subhash Kumar Wangnoo, senior consultant endocrinolo-
LSI
COVER STORY
versial drug, over concerns
of the increased risk of bladder cancer, only to revoke the
suspension about a month
later, after growing pressure
from the medical fraternity.
As one of the cheapest diabetes medications, with a
good glycemic profi le and
low insulin resistance, doctors believe – with careful
patient selection – the drug
has an important role to play
in the Indian scenario.

gist and diabetologist at the
Apollo Centre for Obesity,
Diabetes and Endocrinology,
Indraprastha Apollo Hospital,
New Delhi.
Medications which help lower
blood glucose as well as manage weight - injectable therapies like exenatide (including the weekly once formulation)
and liraglutide with lixisenatide - are good news for obese
diabetic patients, especially in a country like India. “The
need of the hour”, insists Dr Wangnoo, “is to individualise the treatment, rather than offer a blanket treatment for
all”.
As far as monitoring disease progression is concerned, Dr
Bhattacharyya says that contrary to popular perception, a
very tight control is not such as good idea. “We have come
to know from three landmark trials that exercising tighter
control need not always be better; there are chances of low
sugar, which can be life-threatening. So it is best to customise the control depending on personal factors like the
patient’s age, profession, family situation and the presence
of other illnesses, among other things,” he says.
The most important unmet need of diabetes patients, experts concur, remains clinically meaningful cardiovascular
benefit. Although improvements in surrogate markers such
as lipids and inflammatory biomarkers are a step in the
right direction, clear demonstration of reduced risk of a cardiovascular event is critical for evidence-based medicine.
“We need robust evidence of not only efficacy, but also of
safety. Rosiglitazone was an excellent drug that had to be
discontinued after years in use because of its increased risk
of causing cardiovascular events. The recent controversy
surrounding pioglitazone leading to its ban and re-approval are still fresh in the mind,” says Dr Wangnoo.
In June, the Indian government had suspended the contro14 LIFESCIENCE INDIA | August - September 2013

Government efforts
It is impossible to tackle an epidemic of such gigantic proportions without government will and action. Over the last
two and half decades, though the Indian government has
been making various efforts in this endeavor, the popular
consensus is that it leaves a lot to be desired.
In 1987, the Government of India started the National Diabetes Control Programme on pilot basis in some districts of
Tamil Nadu, Jammu & Kashmir and Karnataka. The emphasis was on prevention, early diagnosis and rehabilitation of patients. According to official figures, Rs 12 lakh was
allocated for the programme during 1995-96, while an allocation of one crore rupees was made the next year. However, due to paucity of funds the programme couldn’t be
expanded to cover other regions in the subsequent years.
Later in 2005, the Ministry of Health spearheaded a national consultation to “identify action pathways and partnerships for implementing the Global Strategy in the context of
India”. To contain the increasing burden of NCDs, the pilot
phase of National Programme on Prevention and Control
of Diabetes, Cardiovascular diseases and Stroke (NPDCS)
was launched in January 2008. A total investment of about
350 million dollars is estimated to have been made to ensure that every citizen over 35 years of age in the 10 selected
districts of 10 states was tested for diabetes.
“India needs such concerted effort from the government to
tackle the ever growing burden of diabetes. It is not only
the burden which counts, but also the associated costs involved in diagnosis and treatment,” says Dr Wangnoo.
Medical expenditures for people with diabetes are 2.3 times
LSI
COVER STORY
higher than for those without diabetes, observes Kiran Mazumdar Shaw, CMD, Biocon Ltd. In the U.S, direct medical
costs are estimated to the tune of 176 billion dollars - which
includes hospital and emergency care, doctor visits and
medications – while indirect or non-medical costs come up
to about 69 billion dollars. This includes costs for absenteeism, reduced productivity and unemployment caused by
diabetes-related disability.
“In India, the poorest persons with diabetes spend an average of 25 percent of their family income on healthcare.
Though cost of diabetes treatment in India is a tenth of that
worldwide, the disease leads to severe fi nancial distress as
most patients are uneducated or incapable of managing
their disease by themselves because of diabetic complications,” she says.
The government has been making efforts to step in. “In
November 2012, the National Pharmaceutical Pricing Authority cut down the price of Glipizide from the erstwhile
Rs 26,114 to Rs 15,946 per kg”, says Mahajan, “in a measure that would ease burden on chronic patients taking the
oral rapid and short acting anti-diabetic drug”. A number
of multinational and generic companies currently manu-

peting in the fragmented market for treatment of diabetes,”
says Mahajan. Many multinational companies, such as Novartis, Eli Lilly, are engaged in setting up strategic marketing and distribution agreements with domestic players to
improve their patient base and market share.
Differential pricing, low-cost manufacturing, introduction
of innovative products, and rapid penetration into vast rural markets are some of the strategies adopted by the pharmaceutical industry in India. Mahajan gives the example of
Sanofi SA, which launched a low-cost, reusable insulin pen
called AllStar, priced at Rs 650 in October 2012.
“Used by patients to inject insulin, this device is manufactured at a facility in Gujarat, one of two such plants Sanofi
has worldwide. Similarly, Biocon’s IN105 is innovative oral
insulin, which is expected to help overcome the challenge
of invasive delivery of insulin and boost usage among both
physicians and patients,” he adds.
Typically, newer class of drugs and innovative, patented
products are relatively expensive, but companies are using
differential pricing strategies to lower the price, making it
affordable for the Indian market. In 2008, MSD launched its

India needs such concerted effort from the government to tackle
the ever growing burden of diabetes. It is not only the burden which
counts, but also the associated costs involved in diagnosis and treatment
says Dr Wangnoo.

facture and market this drug in India. Also, the National
Pharmaceutical Pricing Authority (NPPA) has imposed a
blanket ceiling on insulin prices, irrespective of the brand.
“While the move is set to bring down insulin prices, it has
left the industry upset, as it expects to lose significant margins due to the cap,” maintains Mahajan.

Industry initiatives
Touted as one of the most attractive opportunities in the
pharmaceutical segment, the global market for diabetes
drugs and devices is expected to reach nearly 100 billion
dollars within the next five years. According to GBI Research’ study titled Diabetes Therapeutics Market in India
to 2018 - Rapid Uptake of DPP-IV Inhibitors, GLP-1 Agonists and Expanding Insulin Segment to Drive Growth, the
overall anti-diabetes market in India was worth 680.3 million dollars in 2011 and is projected to grow at a CAGR of
11.3 percent between 2011 and 2018 to reach 1,446 million
dollars in 2018. “India has about 126 large and small companies, including MNCs and Indian generics players, com-

patented Januvia (Sitagliptin) in India at a fi fth of its price in
US. Further, patent expiries for drugs such as Glucotrol XL,
Glyset, and Starlix (2009), Prandin/NovoNorm (2010), Actos (2011), Lantus and Humalog (2014), and Avandia (2015)
are expected to result in launch of their low-cost generic
versions. In 2009, Biocon released Basalog, the generic version of Lantus in India, increasing affordability as well as
usage of insulin. In 2010, Sanofi Aventis lowered the price
of Lantus (patent expiry 2014) by half, making it affordable
for low-income groups in Thailand and Indonesia. Reports
suggest that further price reductions in other Southeast
Asian countries are on the anvil.
Later this year, all eyes will be on Ahmedabad-based Zydus Cadila’s launch of the unique dual-action drug that is
expected to help lower blood sugar as well as cholesterol
levels (most diabetes patients tend to fight the cholesterol
battle, too). As the fi rst indigenously-developed drug, Saroglitazar, branded as Lipalyn, is the fi rst in its class of drugs
called glitazars. “These drugs may also have the potential
LIFESCIENCE INDIA | August - September 2013 15
LSI
COVER STORY
remains that not enough is being done. According to a recent study (National programme on prevention and control
of diabetes in India: Need to focus) published in the Australasian Medical Journal in June 2012, most ideas for an
integrated approach to diabetes prevention and control are
not fully implemented, partly because of insufficient funding.
“Even though India accounts for about 15 percent of the
world's diabetes burden, its spending on healthcare related
to diabetes is only 6.4 percent of worldwide spending…
Public-private partnerships are necessary at all levels of
policy,” states the study. “The Public Health Foundation of
India (PHFI), a partnership to address the limited institutional capacity for strengthening public health training, research, and policy development in India, is a good example.
Funding comes primarily from the private sector, and the
government is encouraged to match it,” it elaborates.

to modify the natural history of diabetes, thus portending
their use in pre-diabetes,” says Dr Wangnoo.

Better aware
As far as public awareness campaigns are concerned, the
industry has been proactive in partnering with government
agencies. The Sanofi Diabetes Blue Fortnight 2012, for instance, is estimated to have reached out to over 10 million
diabetics in the country.
As part of a collaborative effort by Sanofi, HEAL foundation, the Ministry of Health & Family Welfare India, International Diabetes Federation and Archaeological Survey of
India, the campaign brought together various stakeholders
in diabetes management - physicians, corporate, NGOs,
media and patients - in an effort to enhance diabetes prevention, education and management. In June this year,
Lilly India, in partnership with the Confederation of Indian
Industry (CII) and Ministry of Health, hosted the inaugural National Non-Communicable Disease Summit in New
Delhi.
It has now become common practice for pharmaceutical
companies to collaborate with hospitals to conduct diabetes
awareness camps and offer free consultations. And, as Dr
Bhattacharyya puts it, even if there is a ‘marketing agenda’,
there’s no denying the public good that comes out of such
initiatives.
Also, there are NGOs such as the Bill Gates Foundation,
Wellcome Trust, as well as local organisations that have
been playing a crucial role in advocating policy changes,
funding constant research, spreading public awareness
about prevention, early diagnosis and efficient management of the disease. Despite all these efforts, the sad truth
16

LIFESCIENCE INDIA | August - September 2013

A laudable initiative mentioned in the study is the website
www.healthy-india.org, launched in 2007, as a collaborative effort between PHFI and the Ministry of Health and
Family Welfare, Government of India. Catering to today’s
young professionals and net-savvy citizens, the online venture advocates healthy living as well as prevention of diabetes and other NCDs.

The prognosis
Studies suggest that Indians aged over 30 – comprising
about 40 percent of the population - are at risk of getting
diabetes. Further, the population aged over 50 is expected
to increase from 16 percent to 23 percent of the total population by 2030, adding significantly to the number of diabetes cases. And then, for every diagnosed case of diabetes,
there is at least one undiagnosed case of glucose intolerance, believe experts. In other words, the actual population
at risk is much greater than our current estimate.
The need of the hour is a comprehensive policy on disease
management, synergy among all healthcare stakeholders,
effective public-private partnerships and increased government spending on prevention, screening, early intervention
and new medical treatments to reduce the economic burden
of the disease, essentially by cutting down on the associated risk, morbidity and mortality. Ensuring that all doctors
in rural India are qualified to diagnose and treat diabetes,
starting diabetes clinics at all primary health centres, encouraging indigenous research and drug development,
promoting an all-encompassing insurance coverage…the
to-do list is rather exhaustive.
This is a race against time. We cannot afford ignorance. Indifference is not an option. One in five diabetes patients
across the globe will be an Indian. Whether or not one has
a sweet tooth.
LSI
COVER STORY

NCDs in India: the current status,
strategy and role of corporate sector
in their Prevention and Control
Dr. Jain, D.C.
(Former Deputy Director General (NCD), Ministry of Health & Family Welfare, Govt. of India)

Non-communicable diseases (NCDs) are becoming a major public health problem
with leading cause of adult mortality and morbidity worldwide. NCDs are rapidly
increasing globally and reached epidemic proportions in many countries, largely
due to industrialization, socio-economic development, rapid urbanization,
demographic and lifestyle changes. These diseases are posing a major challenge to
the social and economic development, and place a tremendous demand on health
systems and social welfare throughout the world especially in low/ and middle/
income countries.
NCDs are surpassing communicable
diseases as the most common causes
of morbidity and premature mortality
worldwide.
The major NCDs are cardiovascular
diseases including heart diseases and
stroke, diabetes, cancer and chronic
respiratory diseases including chronic
obstructive pulmonary disease and
asthma, mental health, and injuries.

Global Situation
An estimated 36 million deaths, or
63% of the 57 million deaths that occurred globally in 2008, were due non
communicable diseases, comprising
mainly cardiovascular diseases (48%),
cancer (21%), chronic respiratory diseases (12 %) and diabetes (3.5%) 1.
In 2008, 80% of all deaths (29 million) from NCDs occurred in low- and
middle- income countries, and with
a higher proportion (48%) of deaths
in the latter countries are premature

(under the age of 70) compared to
high-income countries (26%). As per
the projections of World Health Organization (WHO), the total number of
deaths from NCDs will increase to 55
million by 20301, if timely and appropriate interventions are not taken.

Magnitude of NCDs India

proportion of Disability Adjusted Life
Years (DALYs) than that from communicable, maternal and child health
issues, and nutrition-related causes
combined.
At present, there is no systematic reporting system of non-communicable
diseases in India; therefore it is difficult to have genuine data. However,
it is estimated that NCDs account for

India is facing a great challenge of
rising burden of Non Communicable
Diseases resulting from
rapid demographic and
Figure 1
epidemiological transiPropor•onal mortality (%of total deaths, all ages)
tions in the country. NCDs
are affecting both urban
and rural population and
all socioeconomic strata
in the country, causing
significant morbidity and
mortality with considerable loss in potentially
years (aged 35-64 years)
of life. NCDs including
accidents and injuries are
Source: WHO Non-communicable Diseases Country profile 2011
responsible for a larger

LIFESCIENCE INDIA | August - September 2013 17
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Priorities & Future Plans:

Figure 2

The available data shows that NCDs
are major contributor to high morbidity and mortality in the country with
the risk factors; tobacco, harmful use
of alcohol, lack of physical activity, unhealthy diet, obesity and stress. Most
of the NCDs like Cancer, Diabetes,
Cardiovascular Diseases (CVD), Mental Disorders and problems relating to
ageing are not only chronic in nature
but also have long pre-disease period
where efforts of adopting healthy life
style can prevent individuals from incurring these diseases.

about 53% of total deaths in 2008,
and are projected to increase to 59%
by 20152. The prevalence of diabetes
is increasing both in urban and rural population in India varying from
5-15% among urban populations, 46% in semi-urban populations and
2.5% in rural populations3, 4.In 2008,
a survey covering both urban and rural areas reported a 5.9% of diabetes
5.
High blood pressure is major risk factor for cardiovascular diseases and
is directly responsible for 57% of all
stroke deaths and 24% of all coronary heart disease deaths in India6.
Several community-based studies in
India have estimated the prevalence
of hypertension in urban as well as
rural areas. The meta-analysis of
eight studies carried out in urban areas gives a pooled prevalence rate of
164.18 per thousand and in rural areas as 157.44 per thousand6.
Chronic Respiratory Diseases including Chronic Obstructive Pulmonary
Diseases (COPD) and asthma are
affecting largely younger and aging
population. Projection of National
Commission on Macroeconomics and
Health (NCMH) report, 2005, shows
18

that asthma is expected to rise from
28.3 million in 2006 to 35.9 million by
the year 20167.
Cancers contribute about 14% of the
overall NCD mortality and 7% of the
NCD/related DALYs8. According to
National Cancer Registry Programme
of ICMR, at any point of time, there
are 28 lakh cases of cancer cases with
11 lakh new cases/ year & 5 lakh
cancer deaths / year9.The most common cancer are of oral cavity, lungs,
oesophagus and stomach among in
males, and cervix, breast and oral
cavity in females. Tobacco is the most
important identified cause of cancer
and is responsible for 30 to 50% of
cancer in men and about 10 to 50 % of
cancers in women.

NCD Risk Factors and
Social Determinants
Causative factor for non-communicable disease is something other than
a pathogen. It might result from hereditary factors, improper diet, physical inactivity, smoking, harmful use
of alcohol, stress etc. Certain factors
that increase the likelihood of getting
NCDs are modifiable whereas others
are non-modifiable risk factors. Fig-2

LIFESCIENCE INDIA | August - September 2013

The Government has already given
high priority to NCDs in the country
and has implemented vertical programmes for major non- communicable diseases with the objective of
their prevention and control. One of
these programmes is Prevention and
Control of Cancer, Diabetes, CVDs
and Stroke. Other programmes includes on Health Care of the Elderly, Mental Health, Tobacco Control,
Trauma Care, Blindness Control, Micronutrients etc. Individually each of
these programme made an effort to
enhance capacity including strengthening of physical infrastructure in a
view to reduce the gap at urban and
rural areas.
The National Programme for prevention and control of Cancer, Diabetes,
CVDs and Stroke (NPCDCS) is under implementation in 100 districts
(21 states) in the country10. The programme is being expanded to cover
all districts in a uniform and phased
manner during 12th Five Year Plan
with integration of services at district
and below level, equitable with universal coverage under overall umbrella
of National Health Mission. The main
focus of the NPCDCS11 would be on
development of data base including
health management information system, promotion of healthy life styles,
infrastructure development, early diagnosis and management of diabetes,
hypertension, cardiovascular diseases
& common cancers e.g. cervix cancer,
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breast cancer & oral cancer, and establishment of linkages with tertiary
care health facilities. To ensure long
term sustainability of interventions,
the programmes would be built within existing public health sector and
wherever feasible introduce public
private partnership models.
During 12 Five Year Pan, It is proposed
to continue on- going efforts and to
introduce following key strategies:
• Generating Awareness on behavioural and physiological risk factors for reducing exposure to life
style diseases.
• Early Diagnosis through periodic/
opportunistic screening of population and better diagnostic facilities
• Infrastructure Development and
Human Resources with capacity
for comprehensive management
of NCDs
• Population based interventions
through multi-sectoral approach
• Building evidence for action
through surveillance, monitoring
and research

Issues and challenges
The magnitude of Non Communicable Diseases demands urgent attention. Common preventable risk
factors underlie most NCDs. These
include behavioural and metabolic
risk factors. The prevalence of these
varies between income groups and
differs with gender. Till date there has
been limited focus on these issues.
With increasing burden of NCDs, the
Health Sector will face many challenges, which needs to be addressed
urgently with an integrated comprehensive framework of prevention and
control of NCDs. The major issues
and challenges related to prevention
and control of NCDs are as under.
i. Raised the priority accorded to the
prevention and control of Non
Communicable Diseases in the
national development agenda and
the National Health Policy
ii. Develop, maintain and strengthen
database and reporting system of

The Government has already given high priority to NCDs
in the country and has implemented vertical programmes
for major non- communicable diseases with the objective
of their prevention and control. One of these programmes
is Prevention and Control of Cancer, Diabetes, CVDs and
Stroke
NCDs and their risk factors.
iii. To strengthen national capacity,
leadership, governance, multisectoral action and partnerships with
stakeholders (including corporate
sector, pharma ondustries and
civil society) to accelerate country
response for the prevention and
control of NCDs
iv. Availability of cost-effective interventions including essential
primary health care packages,
and improves access to prevention
programmes, essential medicines
and affordable medical technology.
v. Budgetary allocations for high
quality research, surveillance and
monitoring systems for the prevention and control of NCDs.
vi. Development and availability of
specialized human resource for
prevention and treatment of
NCDs, and establishing referral
linkages and follow-up systems
linkages across different levels of
the health care system (primary,
secondary and tertiary) to ensure
timely treatment and follow-up
interventions for patients suffering with NCDs.
Role of Corporate Sector in Prevention and Control of NCDs
At the UN high-level meeting on
non-communicable diseases (NCDs)
in 2011, the member countries agreed
that no one factor could fully address
the burden of NCDs and called for
collaboration with “non-health actors
and key stakeholders, where appropriate, including the corporate sector and civil society, in collaborative
partnerships to promote health and
to reduce non-communicable dis-

ease risk factors — mainly tobacco,
alcohol, and ultra-processed food and
drink products
To achieve the goal of reducing the
burden of NCDs both in urban as
well as rural areas and all socioeconomic strata in the country, the corporate sector, pharma industries and
civil society can play a crucial role by
supplanting the efforts of central and
state governments through public private partnership and under corporate
sector responsibilities for the welfare
of our citizens. The central and state
governments should also involve different stakeholders including corporate sector in health promotion, early
diagnosis and treatment of common
NCD and availability of low cost diagnostics, surgical procedures and
medicines through suitable guidelines and regulations. The planning
commission also advocated for the
partnership of government with different stakeholders in the health sector in 12th Plan Document.
After consultations and discussions
at various platforms including World
Health Organization’s global ministerial conference on healthy lifestyles
(April 2011) and the Global Health
Council annual conference (June
2011), four areas where the private
sector can have a positive impact: promoting workplace wellness, improving access to diagnosis and treatment,
creating healthy community environments and strengthening education,
training and research capacity. Many
successful programs run by corporate
sector and civil society through strategic partnerships with governments
and multilateral organizations.
LIFESCIENCE INDIA | August - September 2013 19
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nanagar, Darjeeling, Jalpaiguri and
Dakshin Dinajpur. Cancer screening
guidelines have been prepared and
sent to the states.
National Institute of Health and Family Welfare (NIHFW) has trained 95
master trainers under ‘training of
trainers” in 3 programme sessions.
Additionally, 693 medical officers have
been trained by states in 32 training
sessions.
ANMs and other health workers have
been trained about diabetes, hypertension and life style related issues
that lead to such disorders.
A draft proposal for development of
Text books on Health Education for
schools from class IIIrd to Xth has
been submitted to the ministry for approval in collaboration with NCERT
amd NIHFW.

Dr. W.D. Bhutia, Deputy Director General, NCD, Government
of India in conversation with Shikha Dhawan
What all activities have the government initiated under national
program on prevention and control
of cancers, diabetes, cardiovascular
diseases and stroke (NPCDCS)?
NPCDCS is being implemented in 100
districts spread over 21 states since
2010-11 and in 2011-2012 Assam and
Sikkim were also included in the program. The districts have been selected
keeping into account their backwardness, inaccessibility and poor health
indicators.
As on 12th August 2013, State NCD
cells/ Clinics are functional at 16
sites. District NCD cell is functional
in 70 districts, district NCD clinics
are functional in 71 districts while 53
CHC clinics are functional in 8 districts. Cardiac Care Units are functional in 52 districts.
With support from private partners

(Roche and Abbott), 29,000 Glucometers, 5.8 crore Glucosestrips and
6.67 crore lancets have been supplied
to 21 states for Diabetes screening
under NPCDCS, urban health checkup and pilot phase of school health
programmes.
Total 3,53,73,528 persons have been
screened for diabetes and hypertension. Screening of all population
above 30 years of age including pregnant women and tuberculosis patients is in itself a big achievement of
the program. Out of the total population screened, 6.57% were found to be
suspects for Diabetes and 6.37% were
suspects for hypertension. The diabetes suspects need to be confi rmed
in diagnostic laboratories.
Chemotherapy services for cancer
has started in 8 districts at Jorhat,
dibrugarh, Rajkot, Jamnagar, Yamu-

20 LIFESCIENCE INDIA | August - September 2013

What challenges have the government faced in implementation
of NPCDCS?
The biggest challenge in implementation of the NPCDCS is the availability of trained skilled manpower. As it
was difficult to get cardiac specialists,
we have appointed medical specialists as in-charge of cardiac care units.
Involvement of private partners in
public health programs is also a challenge as there is lack of clarity on their
involvement.
Not much progress has been made in
public private partnership as there are
ongoing discussions on involvement
of private partners in public health issues like mental health, tobacco control and screening for diabetes.
NPCDCS was a stand-alone program
so far. From 12th plan it has come
under NRHM. With the availability
of flexipool under NRHM it will be
much easier to get things done.
We are looking forward to the advantage that NRHM umbrella will offer.
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What are the challenges to the
early detection and management of
diabetes, hypertension and stroke
and how can these challenges be
overcome?
Unlike cancer, metabolic disorders
like cardiovascular, stroke and diabetes have linked with metagenomics signature so these can be handled
together. Majority of people suffering
from these diseases which have genetic predisposition are also affected
by environment and are vulnerable from the time they are in their
mother’s womb. Major environmental
conditions being mother’s nutritional
status as well as her exposure to noxious substances like tobacco, passive
smoking and indoor pollution.
Children born with low birth weight
grow normally for few weeks but
then become obese with abnormal
growth chart. They have high insulin
and large proportion of them develop
latent autoimmune diabetes which
knocks down β cells of langerhans
(insulin producing cells in pancreas).
Recent advances in the understanding of the autoimmune process leading to diabetes have generated interest in the potential use of vaccines to
prevent type 1 diabetes.
A major challenge in diabetes is that
90% people do not know that they
have diabetes. The solution is to have
a surveillance system in place that
can detect moderate hypertension,
diabetes and cardiovascular disease.
Biomarkers are also available to identify these conditions. Use of a point
of care device for diabetes that is reliable and cost effective is very important. If random blood sugar levels are
more than 130, further investigation
is required as these may be probable
prediabetics people who should be
advised lifestyle management. Metformin or Gliptins can be prescribed
to people at risk for type 2 diabetes
while those who cannot be managed
by these drugs should be given insulin. It is also essential to get a baseline
liver function test (LFT) for diabetes

Prof. N.K. Ganguly, Advisor, Translational Health Science and
Technology Institute and President, Jawaharlal Institute of Post
Graduate Medical Education and Research in India and former
Director General of the Indian Council of Medical Research in
conversation with Shikha Dhawan
patients. For diabetic retinopathy,
proteomic signatures are used to detect retinopathy. At least 90% of these
new cases could be reduced if there
was proper and vigilant treatment
and monitoring of the eyes.
Myocardial signatures like homocysteine, high sensitive C-reactive
protein, ApoE, ApoB and triglycerides/HDL ratios can be monitored
regularly in high risk patients. In-fact
homocysteine is a common marker for
diabetes, cardiovascular disease and
stroke. If monitoring is done regularly,
appropriate interventions can be done
to control these diseases. Some major
preventative measures can be maintenance of appropriate Vitamin-D and
folate ratios in children. Cardiovascular disease can be prevented by use
of PolycapTM developed by Cadila
Pharmaceuticals Ltd. Trials conduct-

ed under the leadership of Dr. Salim
Yusuf and funded by Welcome Trust
have shown that PolycapTM reduces
the risk of coronary heart disease by
62% and stroke by 48%. The drug has
also shown to bring down the multiple risk factors for cardiovascular disease such as lowering of blood pressure, heart rate, lipids and decreasing
stickiness of platelets.
Another major breakthrough has
been the use of endoscopic procedures to avoid obese bariatric surgery
and stomach surgery. The procedures
cause significant long-term loss of
weight, recovery from diabetes, improvement in cardiovascular risk factors, and a reduction in mortality from
40% to 23%. It is also very important
to manage nutrition uptake appropriately in diabetes patients. In diabetes,
higher amounts of glycosylated heLIFESCIENCE INDIA | August - September 2013 21
LSI
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moglobin, indicates poorer control of
blood glucose levels and has been associated with cardiovascular disease,
nephropathy, and retinopathy. Monitoring HbA1c in diabetic patients may
improve their outcomes.
Another important program in the
control of diabetes is tobacco cessation. Tuberculosis prevalence is also
high in diabetes patients. Tolerance to
TB drugs can be difficult to manage in
diabetics as side effects such as nausea and loss of appetite are very challenging when trying to closely manage blood sugar. In a broader sense
due to the exacerbating effect many
non-communicable diseases are
likely to have on the existing disease
burden, an integrated public health
systems approach for management,
better screening, diagnosis, treatment
and care of communicable and noncommunicable diseases is important.
Effective health care fi nancing and
well-trained providers are essential
in our endeavors against all kinds of
infection and diseases.
Is academic research in India
aligned to the needs of our industries?
Academic research is undertaken for
publication and sometimes to fi le patents as well. Publications are the end
point for most scientists as publications are linked to their promotion.
University systems have very less interactions with industries, except in
Indian Institute of Science (IISc) in
Bangalore where industry has incubation sites. IISc has introduced many
innovative and flexible operational
modes for collaboration with industries. The aim is to provide a research
oriented environment coupled with
hi-tech facilities and the availability
of technical expertise present within
the IISc community.
Industry and academic interactions
can be seen as a mandate in many
prestigious CSIR and DBT funded research institutes. Translational Health
Science and Technology Institute
(THSTI) is part of an emerging health

biotech science cluster and has been
created for the conduct of multidisciplinary research that translates scientific and technological advancements
into medical innovations that can
fi nally be taken up by industries to
improve public health. In addition to
IISc and THSTI, many CSIR labs have
good industrial orientation. CSIR is
closely working with various indigenous industries, private and public
sector undertakings to develop and
commercialize its R&D results and
technologies.
The government initiated New Millennium Indian Technology leadership Initiative (NMITLI) operates in
public-private partnership. NMITLI
has crafted many technology projects
involving industry partners and R&D
institutions setting new global technological paradigms in the areas such
as nano material catalysts, industrial
chemicals, gene based new targets for
advanced drug delivery systems, biotechnology, bio-informatics, improved
liquid crystal devices etc. The scheme
is being implemented by CSIR.
Biotechnology Industry Research Assistance Council (BIRAC) set up as
Department of Biotechnology’s interface agency has many initiatives that
promote industrial collaborations. Its
vision is to facilitate and mentor the
generation and translation of innovative ideas into biotech products and
services by the industry, promote academia and industry collaboration and
enable creation and sustainability of
viable bio enterprises.
In your view how successful is
government’s ambitious program
on management of non-communicable diseases?
Government’s national program on
prevention and control of cancers,
diabetes, cardiovascular diseases
and stroke (NPCDCS) is focused on
health promotion and prevention,
strengthening of infrastructure including human resources, early diagnosis and management of these noncommunicable diseases. NPCDCS is
a hugely expensive program. Budget

22 LIFESCIENCE INDIA | August - September 2013

is a challenge in its implementation
so public-private partnerships (PPP)
mode can play a very important role
in all possible health care interventions at primary and tertiary health
care centers.
Integrated surveillance systems can
be set up through PPP. Diagnostic
reagents and devices are generally
costly and are in the hands of private
sector. Inclusion of private sectors as
care providers can provide cost effective interventions and also provide many health care options to care
seekers. An insurance system that is
standardized can help the marginalized population.
Community driven initiative by Abbott India Ltd with the Puducherry government has implemented a
healthcare programme for people suffering with diabetes, dyslipidaemia,
hypertension and thyroid disorders.
Abbott provided subsidized diagnostics, educational support to healthcare
providers, patient awareness material
and conducted diet guidance camps.
Random and fasting sugar levels, glycosylated hemoglobin, blood pressure
and thyroid levels were monitored
and at least 700,000 people in the
union territory after screening were
stratified as per their need and put on
interventions. Government has also
taken up these initiatives in 100 districts at different health care levels in
different states.
However, there are many grey areas in
public-private partnerships. The government can help by bringing in more
transparency and more clarity in such
collaborations. Appropriate matrixes
are required so that PPP becomes the
most preferred collaboration in the
public health arena. The government
has to make policies, processes and
modalities to streamline things. PPP
gains and spin-offs should be handled well and profit sharing between
partners should be spelled out clearly
with accountability well established
and audited routinely by impartial
parties
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www.enoveo.co.in
Enoveo Biosolutions Private Limited is a start up company, established in 2012, incubated at
KIIT Technology Business Incubator, KIIT University, Odisha. We are a team of environmental
scientists, engineers and business professionals who provide environmental bioengineering
solutions for various environmental concerns with regards to contaminated soil, waste
water bodies and effluent treatment measures.
We foster collaboration with various organizations for applied research and innovation
towards technology development for a sustainable and equitable environment.
Expertise:
v In-situ assessment and treatment : for Waste water,
Ground water and Contaminated soil
v Eco Sanitation : Implementation of key sanitary
measures for community health and hygiene
v Eco Toxicity: Toxic analysis and e- mapping for
contamination load
v Environmental Forensics: Data mining and analyses for
biological and chemical pollutants aided with structural modeling
v Green Engineering: Recycling of municipal and
industrial waste into commercial products
v Online Microbial Biosensor: Onsite detection of
chemical contamination
v Capacity Building: Training and skill development
of human resources for social awareness programmes
and sustainable livelihood generation

We provide consultancy for metagenomic analyses, technology development projects and
alternative energy. Our technical expertise comprises of professionals from France, Brazil,
USA and India.
ENOVEO Bio Solutions Private Limited
203, Second Floor, KIIT TBI, KIIT University, Bhubaneswar, Odisha, India. 751024
E-Mail: connect@enoveo.co.in * M: +91 876 333 39 54
LIFESCIENCE INDIA | August - September 2013 23
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Financial Burden from Non-Communicable
Diseases and the Road Ahead

-Shikha Dhawan

Non-communicable
diseases (NCDs) like
diabetes, cancers,
cardiovascular
diseases are no
longer a lifestyle
related disease of
rich countries. With
the emerging lifestyle
trends and sedentary
way of life, NCDs now
account for a very
large burden in terms
of both mortality
and morbidity in low
and middle income
countries (LMICs)

ommunicable and noncommunicable
diseases
(NCD) account for 60% of
all deaths worldwide, with
80% of those taking place in developing countries and in the age groups of
prime productivity. As per disabilityadjusted life year (DALY) which is a
measure of years lost due to ill-health,
disability or early death, for India the
topmost NCDs are: Cardiovascular
Diseases (CVDs), Diabetes, Cancer
and Chronic Obstructive Pulmonary
Disease (COPD) and Communicable
Diseases are: Pneumonia, HIV/AIDS,
Tuberculosis and Vaccine preventable
diseases.

C

diseases leading to poorer outcome for
these diseases. Direct cost for patients
with co-morbidities is generally 45%
higher than the direct cost for patients
without co-morbidities.
Burden of disease associated with
NCDs and injuries is higher than that
associated with the health conditions
included in the Millennium Development Goals (HIV/AIDS, tuberculosis,
malaria, and maternal, child and reproductive health), even in developing countries. The menace of NCDs
are expected to exceed communicable,
prenatal and food borne diseases as
the leading causes of death in all countries by 2020.

The major risk factors for non-communicable diseases are smoking, alcohol
abuse, a sedentary lifestyle and an unhealthy diet. The dilemma for health
care system is that a person with a
non-communicable disease is also vulnerable to common infectious diseases
like tuberculosis, community-acquired
pneumonias and vaccine preventable

NCDs pose a heavy fi nancial burden
on poor households as cost of medicines is expensive. When it is difficult
to meet day-to-day mundane expenses, the treatment of NCDs has fi nancial implications on affected households. Cost can be a major deterrent to
seek medical care. For diabetes, cost of
insulin represents an important source

24 LIFESCIENCE INDIA | August - September 2013
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of spending for patients and their
families. NCDs management is not
well covered under our health insurance systems.
There are indirect costs which also
have to be borne by individuals affected by NCDs. These costs mainly
include time and productivity loss by
patients and caregivers because of
the illness as well as income lost by
patients and family members. Complications and co-morbidities related
to the severity of illness increase the
household fi nancial burden.
Health-fi nancing systems that improve fi nancial risk protection and
help achieve universal health coverage holds great potential to manage
the fi nancial burden of NCDs.

man resources, early diagnosis and
management and integration with the
primary health care system through
NCD cells at different levels for optimal operational synergies. Under the
12th Plan, the program has come under NRHM and the country is looking
forward to the advantage the NRHM
umbrella will offer.

ment of ‘NCD clinic’ at CHCs and
District Hospitals.
Efforts are being taken to increase
awareness for promotion of healthy
lifestyle through involvement of mass
media.
Training of master trainers have been
done by National Institute of Health
and Family Welfare (NIHFW) and
Indian Nursing Counsel. Pilot project on school based diabetes screening programme have been initiated in
many districts. The health ministry,
along with Confederation of Indian
Industry (CII) and pharmaceutical
company Eli Lilly and Co., is working on policy interventions to control
diabetes.

All said and done, health promotion
and prevention of chronic NCDs are
yet to be adequately addressed in
the country’s health system. Though
many commendable targets have been
achieved since the implementation of
the NPCDCS program, a lot needs to
be done still. The achievements of the
program till date include development
of Operational Guidelines and training modules for Health Workers and
Medical Officers.

The health ministry is also exploring
the possibilities of public private partnership (PPP) initiatives and the involvement of industry to complement
the government’s programme. Health
Ministry has envisaged including curriculum on health education as part of
2014’s academic curriculum in Central
Board of Secondary Education (CBSE)
affi liated schools across India.

The need of the hour is a comprehensive policy on disease management,
Human resource has been hired for
synergy among all healthcare stakeNational NCD Cell while setting up
holders, effective public-private partof State and District NCD cells are in
nerships and increased government
process. Funds for implementation
spending on prevention, screening,
of NPCDCS in 27 districts across 19
early intervention and new medical
states were released in March 2011 for
treatments to reduce the economic
opportunistic screening, establishburden of non-communicaFramework for the analysis of economic impacts of NCDs on households.
ble diseases by reducing risk,
Ref: McIntyre D. et al (2006), Soc Sci Med
morbidity and mortality related to these diseases. Health
Loss of working time of
Intra-& inter
promotion, prevention and
person who is ill &
household labour
caregivers
substitution
early treatment would reduce
No
Indirect
some of the direct costs by
costs
Hiring other
Loss of income of
appropriate mix of prevenlabour & other
person who is ill &
strategies
tion and treatment according
caregivers
(due to absenteeism,
to their relative costs and imNon
missing business
Seek
communicable
appointments, etc.)
care
pact.
disease
Costs can be further reduced
by rational use of medications
for NCDs. Government of
India has launched the ambitious integrated National
Programme for Prevention
and Control of Cancers, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)
since 2010 with focus on
health promotion and prevention, strengthening of
infrastructure including hu-

Financial costs of health
care (consultation,
medicines, laboratory,
hospitalization, etc)

Yes

Directs
costs
Other financial costs
related to seeking care
(transportation, special
dietary regimes, etc.)

Reducing/delaying
consumption of
non-health goods &
services (food,
education, electricity,
leisure, etc)
Use of savings

Reduced well being
and increased
financial
vulnerability for
individuals &
households

Sale of assets
Borrowing
Delaying
investments
Other strategies to
cope with financial
costs (assistance
from other, etc)

LIFESCIENCE INDIA | August - September 2013 25
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CII Recommendations' based action plan
(linked to NPCDCS Strategic Framework)
Research clearly indicates that countries,
states, regions with greater means of health
education and awareness have better health
outcomes, giving the healthcare providers and
policy makers the option to choose the best
interventions leads to overall improvement in
the healthcare outcomes of the community. In
practice, however, finding the mechanism to
make this happen is difficult. Ultimately, as in
any system, the real value of choice comes from
people having the right information to select
the option that is superior. This framework
endeavors to systematically present the available
information and options for the policy makers
and program managers. The framework has been
designed to be in synchrony with the NPCDCS
strategy that aims to strengthen prevention,
diagnosis, treatment and capacity aspects of the
health system.
Issue

Recommendations

Strategy 1) Prevention through behaviour change
Very little focus
on "root cause" of
disease

Put emphasis of health education with focus on prevention activities like exercise, dietary control and stress
management in children and young adults.
Promote workplace interventions like use of stairs, no-smokingpolicies, standing desks etc should be
promoted
Deploy mass media campaigns (through print, electronic and social media) for increasing community
awareness regarding healthy dietary practices
Revisit media policies to discourage advertisements related to junk/fast food, tobacco and other harmful
commodities while promoting messages related to exercise, healthy lifestyle etc is important.
The private partners, development agencies and Government to synergize CSR and development activities to
streamline them with the NPCDCS program.
"Diabetes Education Kiosks" should be set up jointly by the government and non-governmental partners to
enable community in getting key health education messages closer to their homes.

Limited involvement
of community based
groups

PRI (Panchayati Raj Institutions), NGOs, CBOs and community forums like Ramayan Mandalis, Saas Bahu
sammelans should be involved for providing health education regarding prevention, screening, early diagnosis
and timely & appropriate treatment

26 LIFESCIENCE INDIA | August - September 2013
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Issue

Recommendations

While targeting the adolescents and children, health educators should reach out to school children through
Limited reach to
adolescents and other National Rural Health Mission's School Health Program with messages pertaining to good dietary practices.
vulnerable groups
Health education to pregnant women could be provided at the outreach sites (MCHN days).
High incidence
of LBW babies - a
contributor to insulin
resistance

Awareness campaign to promote better dietary practices, ante-natal care and rest during last-trimester of
pregnancy etc.
Have a directory of LBW babies to screen LBW babies at regular intervals for pre-diabetes

Strategy 2) Early Diagnosis (and screening)
No opportunistic
screening being
conducted at health
facilities for DM

Cross referrals from programs like RNTCP and NPCB can help identify cases early

Limited outreach of
screening facilities

Glucometers to be made available at all the sub centre level and PHCs

Non-diabetic but overweight and the high risk group people (having family history, having low birth
weight) should be given a dietary plan, exercise advice and followed-up after 6 months.

A standardized screening system to have accurate linkages between different facilities
Integration and collaboration with screening systems established in other national programs like RNTCP,
NPCB, RCH, NACP.

Issue

Recommendations
PPPs (Public Private Partnerships) with NGOs, CBOs and professional bodies (like IMA, IAP, OPPI, FOGSI
etc) for reaching out to the community with better screening
Use of IDRS (Indian Diabetic Risk score) for screening in resource limited situations
Mobile Health Units, to be equipped with screening facilities for DM
At CHC level in addition to regular screening, HbA1c (Glycosylated Haemoglobin) estimation should be
conducted and the diabetic management should be done based on
HbA1C results.

No separate cadre that
can be engaged for
screening in urban areas.

Municipal corporations in the state often function as a separate system. There is a need to collaborate
with the urban local bodies to synergize the health interventions being implemented by NPCDCS,
Ministry of Health and Family Welfare and Urban Development.
System of urban dispensaries or health centres set up by urban local bodies to be equipped with
screening tools and equipment

Strategy 3) Treatment
Filling up of medical specialist vacancies in medical colleges, district hospitals and CHCs..
Deficiency in availability
of Human resources at the
Empanelment of senior doctors through associations, corporate and individually for tertiary care
facilities
hospitals and peripheral centres for complications management
Issue

Recommendations
Building ICT platforms like telemedicine, GramSat for areas
where there is lack of any skilled manpower and limited
opportunities to hire or partner with private sector
Utilizing peripheral workforce available under ICDS (Integrated Child Development Services) Scheme Aanganwadi workers and under NRHM - ASHA workers.

Verticality in the
programs leading to
artificial shortages in
HR

Integrated approach to disease management, including integration of funding lines and reporting
mechanisms.
Realignment of roles and responsibilities of healthcare providers aimed at multi-skilling and holistic
disease management.
Continuum of care approach where a General Physician, an Ophthalmologist, an Endocrinologist,
vascular surgeon neurologist work in tandem for treatment of DM

LIFESCIENCE INDIA | August - September 2013 27
LSI
COVER STORY

Limited diagnostic
facilities

Facility survey and facility needs assessment should be conducted regularly to know the exact status of
existing equipment in various institutions, for diagnosis and treatment of DM
Glycosylated Hemoglobin tests and Microalbuminuria should also be added to the list of free
investigations
Advanced tests should be conducted at DH and Medical College levels to screen for complications
especially those related to kidney, eyes, feet and nervous system. At teaching institutions in addition to
other tests, the Insulin sensitivity test should also be performed.

Issue

Recommendations

Ambiguous Policies

Clear policy on deputation, transfer & posting, promotions etc, which also has performance linked
incentives tied to clear deliverables.
Clarity on roles and responsibilities of existing manpower, with clear delegation of funds, functions and
functionaries
Need for greater flexibility for the state to re-align funding for locally relevant NCD activities and
regional priorities, akin to NRHM flexi-pool.

No cadre of diabetes
counselors

A diabetes educators cadre to provide specialized counselling services at ter•ary level

High out of pocket
expenses due to lack
of reimbursement
mechanisms

An OPD based Insurance scheme for Non-communicable diseases like Diabetes.

Diabetes educators or counsellors should be available on a toll free helpline for increasing compliance
The exis•ng reimbursement systems like Rashtriya Swashthya Bima Yojana (RSBY) cover only the
hospitalization and not chronic illnesses like diabetes. There is a need to extend this to the out-patient
care for DM, Hypertension to prevent subsequent expenditure on treating complications.
Drugs should be available, accessible and affordable at all levels of health system - the PHCs, CHCs, DHs
and teaching centres. The free supply of medicines in the government medical college hospitals and
tertiary care general hospitals needs to be streamlined.

Issue

Recommendations

Limited compliance to
standard treatment
guidelines

Doctors need to be provided with a protocol based guide for reference, appropriate training and CMEs
to become confident and work away the fear of prescribing insulin.

Weak referral linkages

nReferral systems are weak at the peripheral level and there is a need for JSY-like referral
transportation system for emergencies arising out of NCDs

Supply chain management
issues

Glucometers, Insulin and other supplies procurement and logistics management should be adequately
budgeted and timely procurement initiated, keeping in view the lag time.
The industry stakeholders could provide better packaging for anti-diabetic drugs with clear indications,
treatment modalities and compliance printed on the packaging

Strategy 4) Capacity building of human resources (healthcare providers)
Training needs unknown

Training needs assessment during and after the recruitment of manpower, on NCDs.
Budgeting related to training to be in line with the training needs assessment of each state.

Limited integration of
training

Integration of NCDs prevention and treatment in pre-service and in-service training
The training on NCDs should be made mandatory or; linked to career development opportunities.
Annual training calendars for each state should be developed in advance in consultation with the NCD
cell and shared with all potential training institutes to ensure timely engagement.

28 LIFESCIENCE INDIA | August - September 2013
LSI
COVER STORY

Issue

Recommendations

Limited orientation
regarding NCDs

Standardized orientation programs for NCD program management team, including Simple operational
guidelines on fund utilization.
Orientation training of policymakers on various prevention, treatment and complications management
strategies for DM.
Training of nursing staff as Diabetic educators and in using innovative tools like Diabetes Conversation
Maps
Chemists and pharmacists should be trained and sensitized about the need for providing literature,
explaining the effects, side effects, importance of compliance and complications related to DM.

Few opportunities of
continuing medical
education around DM

DM should be included regularly in the CME programs for doctors and nurses
CMEs should focus on special indications like juvenile diabetes, gestational diabetes and complications
management, with involvement of both public and private healthcare providers at primary, secondary
and tertiary levels.
To avoid treatment related complications and enhance patient outcomes, have uniformity in the
treatment modalities throughout the country. This could be achieved through standard treatment
guidelines for DM.

nLimited capacity of
State/ National training
institutes

Government could source-in or source-out trainings on NCD through partnerships with multitude of
leading training institutes (public and private) like SIHFW, NIHFW, Medical Colleges, Regional institutes
and other autonomous public health bodies.

Issue

Recommendations
nVirtual (online) lectures for medical and paramedical staff for training on DM updating and enhancing
technical expertise and confidence in managing a case of DM.

nMultiple training
institutes working in
isolation – no uniformity
or accreditation of
curriculum

A nodal agency at the national level capacitated to provide accreditation to training courses for
healthcare providers to be followed uniformly by all states
Standard training modules or manuals on NCDs to be used uniformly by all training institutes
Regular up-gradation (maybe once a year) of training course curriculum across all training institutes

Strategy 5) Surveillance, Monitoring & Evaluation Recommendations
Multiple MIS formats

There are several stand-alone MIS in the health system which need to be standardized and integrated.
The MIS for NPCDCS should be mainstreamed with other cross-sectoral initiatives being carried out by
Government and other development partners (like World Bank, USAID, FAO, WFP, UNICEF, WHO etc)
Engaging PRI (Panchayati Raj Institutions) members in community-based monitoring. The Village Health
Committee (VHC) should form the link between the Healthcare providers and the community.

Limited disease
surveillance systems

A clinical registry of the people suffering from DM should be prepared. All the individuals seeking
services from NPCDCS should be given health card with unique identity number to track treatment.
Duplication of diagnostic tests leads to wastage. To avoid this medical history of the patient can be
linked to the Aadhaar card (UID) on a medical record system.

Issue

Recommendations
A program surveillance unit to conduct performance audit and allocation of funds
Ensuring quality control by conducting frequent prescription audits to help in standardizing treatment
practices and ensuring quality control towards ensuring patient satisfaction.
LIFESCIENCE INDIA | August - September 2013 29
LSI
COVER STORY

LEARNING FROM CII NCD STATE ROUNDTABLES

30 LIFESCIENCE INDIA | August - September 2013
LSI
COVER STORY

LIFESCIENCE INDIA | August - September 2013 31
LSI
COVER STORY

32 LIFESCIENCE INDIA | August - September 2013
LSI
COVER STORY

Q Chhattisgarh is implementing the NPCDS program
since when and in what all districts?
In 2010 the state received the official communication from
Government of India that 3 districts have been selected for
Government’s national program on prevention and control
of cancers, diabetes, cardiovascular diseases and stroke
(NPCDCS). These programs were initiated initially in Bilaspur (pilot district), while in and 2011 and 2012 two more
districts Raipur and Jashpur were selected. Since 2010,
not much progress had been made in the programme. In
2012-13, I was appointed as the state nodal officer for proper structuring and implementation of the program at the
state level. NCD Cell set out to increase the visibility of the
program in the field in terms of structure, proper human
resources and guidelines that could percolate down in the
districts. At present, three NCD (Non Communicable Disease) clinics have been established called the Healthy Life
Style Centre one per district in district hospitals. 15 NCD
clinics will be established in community health centers and
a total of about 38 NCD clinics will be established in the
entire three districts.

Dr. Kamlesh Jain, State Nodal officer, NCD,
Chhattisgarh in conversation with Deepti
Nirwal

The current status is that the State NCD cell has been established as per the mandate of the program. Finance and
logistics officers have been appointed. Program Associates
are working in the districts along with 14 health counselors
and 26 Data Entry Operators.
LIFESCIENCE INDIA | August - September 2013 33
LSI
COVER STORY
Q What all constraints have been
faced by the state in implementation of the program?
The mandate of the program is that
state’s share of the budget is 15% and
rest is provided by the centre. Here
comes a challenge for implementation
i.e. the funds are allocated activity
wise. This needed to be streamlined
as sometimes the available funds
can’t be utilized properly. If the funds
are provided as a complete grant for
the programme it could be utilized
as per activity. Another constraint
is that NCDs are taken as a parallel
program. The health system is more
tuned to handle communicable dis-

suspects with >140 mg/dl glucose levels. Although diabetes is an emerging problem, its visibility is lacking in
public. Even public health systems are
not inclined to screen for NCDs. We
have to break the myth that diabetes
can be treated only by private providers.
In 2012, I have carried out orientation of doctors and health providers.
Community vibrations were brought
about by healthy life style abhiyans.
Community mobilization was done
using TV, audio video systems, health
camps, counselor meetings, painting competition at schools. The fi rst

Under NCDs program, recruitment of doctors was difficult.
So we gave good remunerations and empanelled parttime doctors for 3-4 hrs to conduct camps
eases like malaria and tuberculosis.
NCDs should be made a comprehensive part of integrated health care.
Refresher training is required for the
existing human cadre as NCDs are
not a parallel program. To begin with,
already available specialist doctors
should be mobilized. Further down
the line when OPD strength increases the manpower strength can also be
increased.
A major constraint in the NCD national program that I faced was hiring of doctors and management staff.
Chhattisgarh is a tribal dominant
state so we had problem to get trained
qualified specialists. At times, qualifications were high so there was mismatch with the remuneration.

week of November is every year celebrated as Chhattisgarh establishment week “Rajyotsava”. During the
2012 celebrations, NCDs were given
prominence through exhibitions and
the message was clearly given that
the health department is interested
in managing NCDs. On 14th November 2012, World diabetes Day, we
ran a “Blue Light Campaign”. Major
government buildings of the state
were lighted with symbolic blue light
to spread awareness about Diabetes.
This innovative initiative of the state
NCD cell received a wide media coverage and lot of print. TV channels
covered the news with great importance. This helped to sensitize the
general public about World Diabetes
Day and the campaign.

Q What all initiatives have been
taken by the state for the diabetes
program and what is the way forward?
In sub-health centers at grass root
levels diabetes screening programs
have been successfully implemented.
Till date 9,70,028 people have been
screened for diabetes with glucostrips.
Amongst these 57,444 are diabetes

State NCD cell has succeeded to
reach 10 lakh population of the state
through media campaign in association with prestigious news and FM
channels. Jingles on FM on diabetes
and lifestyle diseases and awareness
messages of Honorable Chief Minister
of state resonated the message across
the state. State of Chhattisgarh’s efforts in spreading awareness on Dia-

34 LIFESCIENCE INDIA | August - September 2013

betes has become one of the unique
initiatives across the country. Nearly
700 prominent personalities across the
state were presented a symbolic blue
ring (meaning uniting for Diabetes)
and briefed about diabetes and their
support was sought for the campaign.
Campaign also made efforts to reach
to the general population and more
than 300 persons have been presented with the symbolic blue ring.
To bring more visibility, I have planned
to identify parallel support from Public Private Partners (PPP) to establish
Diabetic Day Care, Lifestyle Centre
in Raipur and Bilaspur and also for
school heath based program in PPP
mode. I have roped in funds from
European Union (European Union
State Partnership Program) as well to
establish Diabetic Clinics. At present
we are looking for NGOs or company
CSR to run these clinics for NCDs. Expression of Interest (EOI) was issued
and we have received about 35 EOIs.
Currently, I have put up a proposal to
CII to help in fi nding an implementing partner.
Under NCDs program, recruitment of
doctors was difficult. So we gave good
remunerations and empanelled parttime doctors for 3-4 hrs to conduct
camps. State’s 2013 Essential Drug
List has included the drugs for NCD
program to provide free drugs. I had
also initiated a proposal for juvenile
diabetes mellitus to track young patients and give them free insulin till
23 years of age. But due to free drug
policy, the drugs for juvenile diabetes
mellitus patients will now be given
free anyways.
New innovative devices especially
non-invasive technologies have been
added in state’s project implementation plan. Efforts have to be done to
endorse new devices within the public health system. We have even constituted a committee to judge the utility of novel devices in public health
system.
LSI
SPOTLIGHT

HERBAL NEEM FORMULATION:
Miracle cure for wound healing

-Poorva Shrivastava

Since time immemorial, herbal medicines
have been popular as remedies for diseases
worldwide. These are safe since they are
natural products. Herbal formulations which
have reached widespread acceptability
as therapeutic agents in India include
nootropics, antidiabetics, hepatoprotective
agents and lipid lowering agents. The
use of herbs is often more affordable
than purchasing expensive modern
pharmaceuticals.

I

nfected wounds in legs, foot and other parts
of the body are very common clinical problems that require intensive care in a wound
clinic. These wounds are caused by trauma
or complicated surgical operations on infected organs. Patients suffering from diabetes, arterial or
venous disease of lower limbs have a high risk of
developing infected wounds. Any wound or ulcer
that does not heal in 6 weeks is said to be a chronic
wound.
There is more than one reason why a wound does
not heal, infection being just one. Lack of blood
supply, venous or arterial insufficiency, radiation,
foreign bodies, nutritional deficiency, diabetes,
jaundice, alcoholism, toxins, cancer, steroids and
chemotherapeutic agents, hereditary healing disLIFESCIENCE INDIA | August - September 2013 35
LSI
SPOTLIGHT
NEEM SPA
Applications and benefit of making Novel Oil

Soak Neem in
water for 12 hrs

Drink Neem
decoction to
enhance immunity,
activate metabolism,
purify blood

Steam is
generated

Neem
Decoction

Boil the water

Mix in 4 oils and 17 herbs
to get Novel Oil which
would cure any kind of
wound, any kind of skin
disease and Allopecia

Take neem bath
and in-hale steam

Neem Decoction

Wash your body

order, old age etc., can be cited as other reasons. Among
these the most common reason being diabetes, where the
only solution at times is amputation. These wounds are
treated with various antiseptics and dressing materials.
Most of these are provided by multinational companies at a
very high cost. Moreover the antiseptics used are harmful
to the healing process and are expensive too.
The high cost makes these unaffordable to the common
man. These antiseptics have been actually shown to be
cytotoxic and damage the delicate granulation tissue and
epithelial cell.
By efforts of Mr. Manish Saxena, a neem based herbal formulation has shown tremendous improvements in diabetic
foot ulcers and healing in other wounds. A
staunch devotee of Lord Krishan, he calls
his oil as “Hare Krishna Oil.” The oil formulation can easily heal diabetic ulcers, bed
sores, venous ulcers, arterial ulcers, varicose
ulcers, knee replacement wounds etc.
In 1998 Mr. Manish Saxena was a research
associate in Department of Surgery, AIIMS and was associated with a clinical trial
for wound care. He saw that there is rising
number of amputations in non healing ulcer cases among diabetic wounds (one lakh
amputations per year). While trying to fi nd
out a solution to this problem he met Dr. T.
V Rao of Maharishi Ayurved Ltd who intro36 LIFESCIENCE INDIA | August - September 2013

duced the benefits of neem based formulations to him. One of the major formulation created was a novel neem oil that
was a miracle cure for healing wounds.
In 1999 his innovation was recognized
by Department of Science and Technology (DST) and they provided him with a
grant under TePP (Techno-Entrepreneur
Promotion Programme). With the available funds from DST, a multi-centric
randomised trail was conducted at the
wound care clinic, Department of Surgery, AIIMS and Central Council for Research in Ayurveda & Siddha (CCRAS)
with Principal Investigators Dr. Anurag
Shrivastava and Dr. K.D Sharma respectively. All the laboratory experiments for
pre-clinical toxicity studies were carried
out at SGS India based in New Delhi.
The oil formulation was completely safe
and had no side-effects: obviously as the
ingredients are all natural products and
we have used them in one form or another.

The standardization of the innovation was done at National Institute for Pharmaceutical Education and Research
(NIPER) with Dr. Parikshit Bansal as the principal investigator. The formulation was also tested on eye wounds in
rabbits at Rajendra Prasad eye centre at AIIMS under Professor S.C. Ghosh. The formulation has been commercialized by M/s Venus Remedies Ltd.
Among several neem based formulations that were researched and tested at various clinics and hospitals, another neem based formulation with more capabilities to heal
wounds such as venous/arterial wounds, diabetic wounds,
wounds due to MRSA (Methicillin-resistant Staphylococcus aureus causing several difficult-to-treat infections in
LSI
SPOTLIGHT
humans), traumatic wounds, gunshot
wounds, burns, wounds caused by
chemotherapy/radiotherapy and all
types of chronic skin infections like
psoriasis, alopecia (stops hair fall),
any pain or inflammation, ear /nose
infections, crack heels and aids skin
rejuvenation have been developed
by Mr. Manish Saxena. For complete
healing, he recommends a holistic approach as outlined in his neem spa.

Miracles of neem based oil
formulation
A man driver by passion, Mr. Manish
Saxena has been himself making the
neem based formulation for the last
15 years utilizing herbs and oils of the
highest quality to maintain quality
and purity of the product. As a wound
care expert, he is working with Dr.
Amar Pal Singh Suri at Diabetes FootCare and Wound-Care Clinic, New
betic wounds patients could get benefitted and the amputation rate can be decreased which is now two limbs per 30
seconds according to a WHO survey”. An NGO, Sri Ram
Seva Trust, New Delhi helps Mr. Manish Saxena to distribute the neem based oil formulation to poor and needy
patients. Extensive research on this formulation has been
taken up by Prof. Ameena Gurib Fakim at CEPHYR (Centre de Phytothérapie et de Recherche, www.cephyr-recherche.com) a limited company incorporated under Mauritian
Law to promote the formulation worldwide.
Many miraculous healings have been observed with the
oil. Orthopedic wounds caused due to knee replacement
surgery where foreign body is inserted and likewise any
surgical wound where some foreign body is put in the body
like proline mesh have healed in record time with application of this oil. Three MRSA wounds have been healed till
date while the oil has benefitted leprosy patients as well.
Several bomb blast cases of BSF, CRPF and army with
splinters wounds and even bedsores have been successfully treated and cured by Mr. Manish Saxena. His vision is
to open neem clinics in every country and every city.

Delhi where more than 1000 patients have been successfully treated for the last 15 years. According to Dr. Amar
Pal Singh Suri, “We have not observed any side effect till
date. Our success rate has been more than 95%. We wish to
spread awareness about this center so that maximum dia-

Manish Saxena can be contacted at
saxmanish@gmail.com

LIFESCIENCE INDIA | August - September 2013 37
LSI
ACADEMIC SHOWCASE

Inspiring Innovation
LSI Academic Showcase
Principal Kumaraguru College of Technology shares some of the unique Industry Academia
initiatives of the college. KCT is one of the premier institutions in the country .
Which are the institutions that
have recruited from KCT?
The Kumaraguru College of Technology has over 200 students who have
successfully passed out and pursuing
their higher studies in various countries including USA, UK, Canada,
Australia, New Zealand, Germany,
Sweden, Denmark, Belgium, Finland,
Austria, Malaysia etc. Many of our
graduates have completed their higher studies in premier Indian institutes
like IITs, IIMs, NITs, BITS, IISER and
the list is growing.
It is our privilege to share that our
graduates are working in many
MNCs- Genentech Inc., Baylor College of Medicine, and Novartis, USA,
Anglo Arabian Healthcare, Dubai,
United Arab Emirates, Indian Immunological Limited, Hyderabad, Biocon,
Bangalore, Ramky Group, India, Novartis, OTC, India, GLR Laboratories
Pte. Ltd., Chennai, Orchid Pharmaceuticals Pte, Ltd., Chennai and many
more..

What are the unique subjects
and methodologies our course offers to the Biotechnology students?
The Students of B.Tech biotechnology
at KCT study a blend of courses from
various related disciplines. These
courses are relatively unique compared to most syllabi across India. For
examples, courses related to Chemical
engineering, Biopharma,Food technology, IPR, biosafety and bioethics.
These courses are in addition to the
core biotech curriculum comprising

of fundamental biosciences, genetic
engineering, bioprocess, downstream
processing, Bioinformatics, Immunology In addition a unique blend of inhouse and inter-departmental electives is also offered to the students
interested in other related topics like
Immunotechnology, Biomedical engineering, Programming for bioinformatics, Environmental biotechnology, Nanotechnology
Medical
textiles, Bioenergy, Clinical research
and Management .

38 LIFESCIENCE INDIA | August - September 2013

Please enlist the Innovation-initiative of the Institution
The Kumaraguru College of Biotechnology Department has fi led a provisional patent registration for the selective extraction of dyes from textile
dyeing unit wastewater.
We are pursuing research on nanotechnology for the synthesis of nanoparticles for antimicrobial activity. We
are Investigating the plant resources
for valuable biomolecules as pharmaceutical for diseases such as cancer,
diabetes, arthritis etc. We are developing medical textiles with plant
based enzymes for warts.
The Confederation of Indian Industry (CII) works to create and sustain an environment conducive
to the development of India, partnering industry, Government, and civil society, through advisory
and consultative processes.
CII is a non-government, not-for-profit, industry-led and industry-managed organization, playing
a proactive role in India's development process. Founded over 118 years ago, India's premier
business association has over 7100 members, from the private as well as public sectors, including
SMEs and MNCs, and an indirect membership of over 90,000 enterprises from around 257 national
and regional sectoral industry bodies.
CII charts change by working closely with Government on policy issues, interfacing with thought
leaders, and enhancing efficiency, competitiveness and business opportunities for industry
through a range of specialized services and strategic global linkages. It also provides a platform
for consensus building and networking on key issues.
Extending its agenda beyond business, CII assists industry to identify and execute corporate
citizenship programmes. Partnerships with civil society organizations carry forward corporate
initiatives for integrated and inclusive development across diverse domains including affirmative
action, healthcare, education, livelihood, diversity management, skill development, empowerment
of women, and water, to name a few.
The CII Theme for 2013-14 is Accelerating Economic Growth through Innovation, Transformation,
Inclusion and Governance. Towards this, CII advocacy will accord top priority to stepping up the
growth trajectory of the nation, while retaining a strong focus on accountability, transparency
and measurement in the corporate and social eco-system, building a knowledge economy, and
broadbasing development to help deliver the fruits of progress to all.
With 63 offices, including 10 Centres of Excellence, in India, and 7 overseas offices in Australia,
China, France, Singapore, South Africa, UK, and USA, as well as institutional partnerships with 224
counterpart organizations in 90 countries, CII serves as a reference point for Indian industry and
the international business community.

For more detail please contact:
Confederation of Indian Industry
The Mantosh Sondhi Centre
23, Institutional Area, Lodi Road, New Delhi - 110 003 (India)
T: 91 11 45771000 / 24629994-7 F: 91 11 24626149
E: public.health@cii.in W: www.cii.in
Reach us via our Membership Helpline: 00-91-11-435 46244 / 00-91-99104 46244
CII Helpline Toll free No: 1800-103-1244
LSI
INTERVIEW

Prof Vijayaraghavan in an exclusive interview with LifeScience India shares his views
on the Industry's key issues

Dr Vijaraghavan,
Secretary, Deparment
of Biotechnology (DBT),
government of India,
shares his insights on
the policy regulatory
issues of the industry in
conversation with
Hareeni Mageswaran

As a policy maker, what is hindering the LifeScience Industry?
In one word: Connectivity. All of us need to connect as partners for a shared
purpose. This shared purpose helps bring a meaningful transformation . Science is but one component here but it is an important one. For this connectivity
to happen we in the government must constantly keep in mind that the purpose of policy is to enable transformation through the responsible and correct
use of public resources. If we worry only about using public resources in a procedurally correct manner while forgetting our purpose, policy will be hollow.
Connectivity ensures creativity with responsibility on all sides.
What are your views on the Clinical Trials industry? What is the
fate of this industry in India?
First, the term ‘Clinical trials industry’ sends a mixed message. This is not an
industry in the sense the term is usually used. We are working with people
here, we are working in a country of nearly a billion and half people. If we are
to address our problems and fi nd solutions, clinical trials are a must. A country
our size cannot rely on altruistic Scandinavians as participants who will test
out the efficacy of the drugs we use. A country of our size cannot expect the
best research and consequent new drugs and vaccines to come from California
or Switzerland.
India has a unique opportunity not only to take the lead in world-class research
in biomedical sciences but also to lead in addressing the problems of the South.

40 LIFESCIENCE INDIA | August - September 2013
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  • 4. Editorial Advisory Board Mr. Apurva Shah August - September 2013 Group Managing Director Veeda Clinical Research Mr. Arun Sawhney Chairman, CII National Committee on Drugs & Pharamaceuticals and CEO & Managing Director Ranbaxy Laboratories Ltd Dr. Arvind Lal Chairman and Managing Director Dr Lal PathLabs Dr. Devi Shetty Chairman Narayana Hrudayalaya Prof. N.K. Ganguly President, JIPMER, Distinguished Biotechnology Research Professor, DBT & Former DG, ICMR Managing Editor: Vipin Balakrishnan Editor: Hareeni Mageswaran Consulting Editor: Shikha Dhawan Consulting Editor: Dr Saji Salam Copy Editor: Gouri Athale, Shekhar B CII-Life Sciences Division Dr. Sengupta (d.sengupta@cii.in) +91 99531 30050 Mr. Hari Bhartia Co-Chairman and Managing Director Jubilant Life Sciences Ltd Design & Creative: A P Madhu Dr. Kiran Mazumdar-Shaw Chairman and Managing Director Biocon Limited Dr. R.A Mashelkar Printed and Published by Anjan Das on behalf of Confederation of Indian Industry National Research Professor and Former DG, CSIR Dr. Mrutyunjay Suar Director, School of Biotechnology & CEO, KIIT-Technology Business Incubator Publishers: Confederation of Indian Industry India Habitat Centre, Core 4A, 4th Floor, Lodi Road, New Delhi-110003 Dr. Naresh Trehan Chairman Medanta-The Medicity Dr. Nitya Anand Former Director, CDRI Dr. Rajesh Jain Joint Managing Director Panacea Biotec Ltd Namaste Publication Pvt Ltd 102, Srinidhi Signature, 8th Cross, LBS Nagar, Bangalore-17
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  • 6. EDITOR'S NOTE PPP’s– The Three C’s Collaboration, Creativity and Consistency In an era of PPP’s, we must be prepared to innovate, collaborate and be consistent in dealing with our Public Health issues. This issue has insights into the near mirage called NCD management, we have to understand that the only way to tackle our public health issues is by meaningful collaboration, as multi stakeholder relationship management and disease management is a challenge in a diverse country like ours . With the rise in non communicable diseases, lifestyle related diseases we have to innovate ways of creating awareness, while also fi nding innovating ways of creating pools of money consistently and efficient management of the resource pools. As a solution to this interesting yet mammoth task, we should infuse communication, marketing and social media professionals in this Endeavour. Professionals with experience in Brands, Marketing, Advocacy, Public Relations, Events and Social media professionals will make a huge difference. These band wagon of professionals will catalyze collaboration infuse creativity and add a flavor of consistency. Constancy of purpose is the fi rst principle to success on such large scale mandates like NCD, and uniting all efforts. In our country one of the greatest setbacks has been the meeting eye to eye of policy makers and other stakeholders, and rigorous interactions between them are the road to engagement, involvement and fi nally success. The large scale benefits can be reaped by creating credible data pools and creating a cohesive working environment. Corporate must be endowed with this responsibility by the Government, and set as a premise for working. Currently, our Country’s Public Health campaigns are more for the campaign sake not for the Health sake. This attitude shift will call for a lot more participation of Corporate. Corporate with deep pockets and business interests must become eligible partners, as it takes the corporate to make the partnership more engaging. The Ministry of Corporate Affairs must device a Communication framework which actually captures the demographic challenges of such campaigns, and thus stopping PPP’s parties from reinventing the wheel. The newly passed CSR bill will help us see more responsible Corporate divas. Hareeni Mageswaran hareeni.lifescienceindia@gmail.com
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  • 8. CONTENTS LSI | August - September 2013 Cover stories on NCD Cover Story Interviews 17 Dr Jain DC 20 Dr W.D. Bhutia 21 Prof N.K. Ganguly 33 Dr Kamlesh Jain 26 CII White paper NCD The researchers and this white paper clearly demonstrate the fact that each state has its own strengths, weaknesses and priorities which differ from other states in many ways. Over the last two years, Diabetes management interventions under NPCDCS have reached more than 17.6 million patients, but with the incidence still going up, it is essential to scale up the effective interventions. The Government plans to scale up the response to the Diabetes epidemic by expanding the NPCDCS from 100 districts at present to cover all districts in the country during the 12th National Five Year Plan is appropriate and timely 35 HERBAL NEEM FORMULATION 10 NOT SO SWEET - The Indian diabetes saga: By 2030, India's diabetes burden is expected to cross the 100 million mark. Considering the rising burden of non-communicable diseases and existing risk factors, Government of India initiated the integrated National Program for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS). It is essential to have the key public health facilities well staffed with appropriately skilled and equipped manpower to provide access to treatment services. It is also vital to have and follow standard treatment protocols for disease management. Herbal formulations which have reached widespread acceptability as therapeutic agents in India include nootropics, antidiabetics, hepatoprotective agents and lipid lowering agents.
  • 9. CONTENTS Technology Policy Watch 55 46 FDI in pharma need for a clear policy Improving Vaccine Development and Production Using Rapid Virus Quantification regime The Government recently decided to take stock of the decade-old FDI policy for the pharma sector. This decision was in response to the potential threat of dominance from foreign players and a general rise in overall drug prices in the country, arising from a spate of acquisitions of Indian companies by MNCs starting in 2006. The most notable ones are the acquisition of Matrix Labs by Mylan, followed by Daichii Sankyo’s acquisition of Ranbaxy, Sanofi Aventis’s acquisition of Shanta Biotech and Abbott Labs’ takeover of Piramal Healthcare 43 Realizing the opportunity from There are many points during the process of developing, optimizing and producing vaccines that would benefit from rapid enumeration of viral particles. One of the most significant is tracking efficiency following harvest from egg- and cell-based systems Pharmaceutical Patents in India 60 NMR spectroscopy: 51 SPOTLIGHT Creating waves in life sciences Nuclear magnetic resonance or NMR spectroscopy is a modern day tool that is used to delve deep into the intricate machinery that operates within each cell. Initially developed by physicists to gain insight into the magnetic properties of atom. 48 OPINION Future of healthcare - IT Outsourcing The US provider IT market is set to grow drastically, with a $19 billion investment into the sector as part of the US recovery plan signed by the President. However the Indian IT vendors may not be in a good position to leverage the growth in this market as most vendors have not made the right preparations/investments to address this market The urgency of India’s need for access to advanced medical interventions including innovative pharmaceutical products cannot be overstated. Bio pesticides The Central Insecticide Board under the Department of Agriculture was established by Government of India, which is a regulatory authority for registering Insecticides. The Insecticides were covered under Insecticides Act 1968, whose names were included in the Insecticides Schedule from time to time by publishing in the Gazette of India, by the Government of India. Biopesticides are also governed by the Insecticide Act 1968, included in the Schedule. For any Biopesticide to be manufactured, which are included in the Insecticides in Schedule, it should be mandatory to register at Central Insecticide Board (CIB), Faridabad. Only after obtaining registration from CIB, then State Agriculture Departments of respective States will issue license for manufacturing of Biopesticides and Principle certificates for Marketing of Biopesticides. Exclusive Interview 40 Dr Vijayraghavan an academic turned policy makers shares some of his views on the Industry 38 Academic Showcase Dr Kumar Principal of Kumara Guru College of Technology Coimbatore shares their inspiring journey in innovation.
  • 10. LSI COVER STORY NOT SO SWEET The Indian diabetes saga -Jisha Krishnan India will be home to more than 100 million diabetics, approximately, one-fifth of the global diabetes population, by 2030. We need to do everything we can and more to curb the exploding epidemic 10 LIFESCIENCE INDIA | August - September 2013
  • 11. LSI COVER STORY “I don’t have a sweet tooth,” was the prompt response of a 30-something software engineer to the doctor’s suggestion of getting his blood sugar levels tested. Ask any practicing physician and he is sure to share similar experiences of patient ignorance and/indifference. And this is the educated, urban population in India we are talking about. As we venture into the hinterlands, a majority of medical practitioners, too, fall into this category. For a country that is home to over 63 million diabetes patients second only to China - the ground realities are more than shocking. According to International Diabetes Federation, 50 percent of Indians are unaware if they suffer from diabetes. And among the other half, 50 percent do not take any treatment. The silver lining, if any, is the latest buzz in the pharmaceutical industry: Over 15 new anti-diabetic drugs are ready to hit the market over the next couple of years. Also, an Indian pharmaceutical company beat its global competitors to develop the fi rst of its kind anti-diabetic medication that holds immense promise for diabetics across the globe. Whether these drugs will succeed in meeting the hitherto unmet needs of diabetic patients, reduce the huge economic burden, help improve the quality and quantity of life… these are questions only time will answer. For now, the saga continues. Ground zero Estimates suggest that 9.2 percent of adults in India have diabetes, making its prevalence second only to that in China. The country is home to over 63 million diabetes patients, an increase from 50.8 million in 2010, says the International Diabetes Federation’s ‘Diabetes Atlas 2012’. The population with pre-diabetes (those with glucose levels higher than normal, and at increased risk to develop diabetes) is estimated to be approximately three times the size of the diabetic population. By 2030, India's diabetes burden is expected to cross the 100 million mark. “In clinical practice, a lot of patients we see today are in their late 20s and early 30s. The patient profi le has defi nitely got younger,” says Dr Arpandev Bhattacharyya, HOD, Department of Diabetes and Endocrinology at Manipal Hospital, Bangalore. Diabetes mellitus – diabetes in common parlance – is caused either because the pancreas can’t produce insulin (type 1 diabetes) or the insulin that is produced isn't effectively shuttling sugar into the organs (type 2 diabetes). The latter is more common and preventable, courtesy sedentary lifestyles and unhealthy food habits, making it the focus of most diabetes research across the globe. As far as the Indian scenario is concerned, we face a dual challenge. On the one hand, we are still struggling to come LIFESCIENCE INDIA | August - September 2013 11
  • 12. LSI COVER STORY to terms with long-standing challenges posed by communicable diseases such as tuberculosis, malaria, cholera, diarrhea, measles and leptospirosis; add to that, the current onslaught of non-communicable diseases (NCDs). As per disability-adjusted life year (DALY) which is a measure of years lost due to ill-health, disability or early death, for India the topmost NCDs are cardiovascular diseases, diabetes, cancer and chronic obstructive pulmonary disease. Ratlam (Madhya Pradesh) and Bhilwara (Rajasthan), 1,351 (1.467%) were suspected to be diabetic. According to the Annual Report to the People on Health published by the Ministry of Health and Family Welfare, Government of India in September 2010, NCDs caused 40 percent of total deaths in rural India and 42 percent in urban India. The corresponding figures for communicable diseases were 40 percent and 38 percent respectively. About 70 to 75 percent of diabetes patients are treated with a combination of two or more oral anti-diabetics (OADs) and 20 to 25 percent are treated with a single OAD, notes Dipak Mahajan, industry analyst, pharma & biotech, healthcare practice, Frost & Sullivan. However, due to the progressive nature of type 2 diabetes, most diabetics require insulin for glycemic control, making it unlikely to have a decrease in patient numbers. The World Health Report 2001 had indicated that NCDs accounted for nearly 60 percent of deaths worldwide and 75 percent of these occur in developing countries. Further, a person with NCDs is vulnerable to common infectious diseases like tuberculosis, community-acquired pneumonias and vaccine preventable diseases leading to poorer outcome for these diseases. “In the case of diabetes, most patients invariably also have to cope with cardiovascular disease, kidney disease, nerve damage and/or loss of limbs,” adds Dr Bhattacharyya. Clinical quest What can’t be cured must be endured. For researchers and clinical practitioners across the globe, the biggest challenge is to come up with effective, affordable ways to manage the disease. According to Frost & Sullivan’s Competitive Intelligence research, Analysis of the Global Type 2 Diabetes Therapeutics Market, 15 new drugs for type 2 diabetes are in late-stage development (Phase 3 and preregistration). Metformin is expected to remain the fi rst-line therapy, in combination with Sulfonylureas; along with changes in diet and exercise. Therapies with the ability to preserve or restore beta cell function, postpone or prevent disease progression, and allow patients to remain on a single therapy will be the game-changers in the years to come Says Dr Subhash Kumar Wangnoo, senior consultant endocrinologist and diabetologist at the Apollo Centre for Obesity, Diabetes and Endocrinology, Indraprastha Apollo Hospital, New Delhi As per the fi ndings of phase I of the Indian Council of Medical Research Diabetes Study, which recently covered the rural and urban settings in four states, the prevalence of diabetes in Tamil Nadu was 10.4 percent, 5.3 percent in Jharkhand, 13.6 percent in Chandigarh and 8.4 percent in Maharashtra. The prevalence of pre-diabetes was 8.3 percent, 8.1 percent, 14.6 percent and 12.8 percent respectively. The numbers are not small to be ignored. Blame it on sedentary lifestyles, unhealthy dietary habits, genetic predisposition, the increasing cases of childhood obesity don’t make the picture any rosier. During the course of screening school children under the national programme for prevention and control of cancer, diabetes, cardiovascular diseases and stroke (NPCDCS), it was found that of the 92,047 children screened in Nainital (Uttarakhand), 12 LIFESCIENCE INDIA | August - September 2013 The most significant impact on the Indian diabetes therapeutics market, according to Mahajan, is expected to be the launch of new Incretin Mimetics, Glucagon-like Peptide-1 (GLP-1) Agonists, and Dipeptidyl Peptidase-IV (DPP-IV) inhibitors, as well as increased use of new fi xed combinations and formulations of drug therapies in both insulin and non-insulin segments. “These new drug classes have better efficacy and compliance,” he says. New therapies are starting to address different possible roots of the condition, identifying new target areas with the potential to reverse disease progression alongside glucose regulation. “Therapies with the ability to preserve or restore beta cell function, postpone or prevent disease progression, and allow patients to remain on a single therapy will be the game-changers in the years to come,” says Dr Subhash Kumar Wangnoo, senior consultant endocrinolo-
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  • 14. LSI COVER STORY versial drug, over concerns of the increased risk of bladder cancer, only to revoke the suspension about a month later, after growing pressure from the medical fraternity. As one of the cheapest diabetes medications, with a good glycemic profi le and low insulin resistance, doctors believe – with careful patient selection – the drug has an important role to play in the Indian scenario. gist and diabetologist at the Apollo Centre for Obesity, Diabetes and Endocrinology, Indraprastha Apollo Hospital, New Delhi. Medications which help lower blood glucose as well as manage weight - injectable therapies like exenatide (including the weekly once formulation) and liraglutide with lixisenatide - are good news for obese diabetic patients, especially in a country like India. “The need of the hour”, insists Dr Wangnoo, “is to individualise the treatment, rather than offer a blanket treatment for all”. As far as monitoring disease progression is concerned, Dr Bhattacharyya says that contrary to popular perception, a very tight control is not such as good idea. “We have come to know from three landmark trials that exercising tighter control need not always be better; there are chances of low sugar, which can be life-threatening. So it is best to customise the control depending on personal factors like the patient’s age, profession, family situation and the presence of other illnesses, among other things,” he says. The most important unmet need of diabetes patients, experts concur, remains clinically meaningful cardiovascular benefit. Although improvements in surrogate markers such as lipids and inflammatory biomarkers are a step in the right direction, clear demonstration of reduced risk of a cardiovascular event is critical for evidence-based medicine. “We need robust evidence of not only efficacy, but also of safety. Rosiglitazone was an excellent drug that had to be discontinued after years in use because of its increased risk of causing cardiovascular events. The recent controversy surrounding pioglitazone leading to its ban and re-approval are still fresh in the mind,” says Dr Wangnoo. In June, the Indian government had suspended the contro14 LIFESCIENCE INDIA | August - September 2013 Government efforts It is impossible to tackle an epidemic of such gigantic proportions without government will and action. Over the last two and half decades, though the Indian government has been making various efforts in this endeavor, the popular consensus is that it leaves a lot to be desired. In 1987, the Government of India started the National Diabetes Control Programme on pilot basis in some districts of Tamil Nadu, Jammu & Kashmir and Karnataka. The emphasis was on prevention, early diagnosis and rehabilitation of patients. According to official figures, Rs 12 lakh was allocated for the programme during 1995-96, while an allocation of one crore rupees was made the next year. However, due to paucity of funds the programme couldn’t be expanded to cover other regions in the subsequent years. Later in 2005, the Ministry of Health spearheaded a national consultation to “identify action pathways and partnerships for implementing the Global Strategy in the context of India”. To contain the increasing burden of NCDs, the pilot phase of National Programme on Prevention and Control of Diabetes, Cardiovascular diseases and Stroke (NPDCS) was launched in January 2008. A total investment of about 350 million dollars is estimated to have been made to ensure that every citizen over 35 years of age in the 10 selected districts of 10 states was tested for diabetes. “India needs such concerted effort from the government to tackle the ever growing burden of diabetes. It is not only the burden which counts, but also the associated costs involved in diagnosis and treatment,” says Dr Wangnoo. Medical expenditures for people with diabetes are 2.3 times
  • 15. LSI COVER STORY higher than for those without diabetes, observes Kiran Mazumdar Shaw, CMD, Biocon Ltd. In the U.S, direct medical costs are estimated to the tune of 176 billion dollars - which includes hospital and emergency care, doctor visits and medications – while indirect or non-medical costs come up to about 69 billion dollars. This includes costs for absenteeism, reduced productivity and unemployment caused by diabetes-related disability. “In India, the poorest persons with diabetes spend an average of 25 percent of their family income on healthcare. Though cost of diabetes treatment in India is a tenth of that worldwide, the disease leads to severe fi nancial distress as most patients are uneducated or incapable of managing their disease by themselves because of diabetic complications,” she says. The government has been making efforts to step in. “In November 2012, the National Pharmaceutical Pricing Authority cut down the price of Glipizide from the erstwhile Rs 26,114 to Rs 15,946 per kg”, says Mahajan, “in a measure that would ease burden on chronic patients taking the oral rapid and short acting anti-diabetic drug”. A number of multinational and generic companies currently manu- peting in the fragmented market for treatment of diabetes,” says Mahajan. Many multinational companies, such as Novartis, Eli Lilly, are engaged in setting up strategic marketing and distribution agreements with domestic players to improve their patient base and market share. Differential pricing, low-cost manufacturing, introduction of innovative products, and rapid penetration into vast rural markets are some of the strategies adopted by the pharmaceutical industry in India. Mahajan gives the example of Sanofi SA, which launched a low-cost, reusable insulin pen called AllStar, priced at Rs 650 in October 2012. “Used by patients to inject insulin, this device is manufactured at a facility in Gujarat, one of two such plants Sanofi has worldwide. Similarly, Biocon’s IN105 is innovative oral insulin, which is expected to help overcome the challenge of invasive delivery of insulin and boost usage among both physicians and patients,” he adds. Typically, newer class of drugs and innovative, patented products are relatively expensive, but companies are using differential pricing strategies to lower the price, making it affordable for the Indian market. In 2008, MSD launched its India needs such concerted effort from the government to tackle the ever growing burden of diabetes. It is not only the burden which counts, but also the associated costs involved in diagnosis and treatment says Dr Wangnoo. facture and market this drug in India. Also, the National Pharmaceutical Pricing Authority (NPPA) has imposed a blanket ceiling on insulin prices, irrespective of the brand. “While the move is set to bring down insulin prices, it has left the industry upset, as it expects to lose significant margins due to the cap,” maintains Mahajan. Industry initiatives Touted as one of the most attractive opportunities in the pharmaceutical segment, the global market for diabetes drugs and devices is expected to reach nearly 100 billion dollars within the next five years. According to GBI Research’ study titled Diabetes Therapeutics Market in India to 2018 - Rapid Uptake of DPP-IV Inhibitors, GLP-1 Agonists and Expanding Insulin Segment to Drive Growth, the overall anti-diabetes market in India was worth 680.3 million dollars in 2011 and is projected to grow at a CAGR of 11.3 percent between 2011 and 2018 to reach 1,446 million dollars in 2018. “India has about 126 large and small companies, including MNCs and Indian generics players, com- patented Januvia (Sitagliptin) in India at a fi fth of its price in US. Further, patent expiries for drugs such as Glucotrol XL, Glyset, and Starlix (2009), Prandin/NovoNorm (2010), Actos (2011), Lantus and Humalog (2014), and Avandia (2015) are expected to result in launch of their low-cost generic versions. In 2009, Biocon released Basalog, the generic version of Lantus in India, increasing affordability as well as usage of insulin. In 2010, Sanofi Aventis lowered the price of Lantus (patent expiry 2014) by half, making it affordable for low-income groups in Thailand and Indonesia. Reports suggest that further price reductions in other Southeast Asian countries are on the anvil. Later this year, all eyes will be on Ahmedabad-based Zydus Cadila’s launch of the unique dual-action drug that is expected to help lower blood sugar as well as cholesterol levels (most diabetes patients tend to fight the cholesterol battle, too). As the fi rst indigenously-developed drug, Saroglitazar, branded as Lipalyn, is the fi rst in its class of drugs called glitazars. “These drugs may also have the potential LIFESCIENCE INDIA | August - September 2013 15
  • 16. LSI COVER STORY remains that not enough is being done. According to a recent study (National programme on prevention and control of diabetes in India: Need to focus) published in the Australasian Medical Journal in June 2012, most ideas for an integrated approach to diabetes prevention and control are not fully implemented, partly because of insufficient funding. “Even though India accounts for about 15 percent of the world's diabetes burden, its spending on healthcare related to diabetes is only 6.4 percent of worldwide spending… Public-private partnerships are necessary at all levels of policy,” states the study. “The Public Health Foundation of India (PHFI), a partnership to address the limited institutional capacity for strengthening public health training, research, and policy development in India, is a good example. Funding comes primarily from the private sector, and the government is encouraged to match it,” it elaborates. to modify the natural history of diabetes, thus portending their use in pre-diabetes,” says Dr Wangnoo. Better aware As far as public awareness campaigns are concerned, the industry has been proactive in partnering with government agencies. The Sanofi Diabetes Blue Fortnight 2012, for instance, is estimated to have reached out to over 10 million diabetics in the country. As part of a collaborative effort by Sanofi, HEAL foundation, the Ministry of Health & Family Welfare India, International Diabetes Federation and Archaeological Survey of India, the campaign brought together various stakeholders in diabetes management - physicians, corporate, NGOs, media and patients - in an effort to enhance diabetes prevention, education and management. In June this year, Lilly India, in partnership with the Confederation of Indian Industry (CII) and Ministry of Health, hosted the inaugural National Non-Communicable Disease Summit in New Delhi. It has now become common practice for pharmaceutical companies to collaborate with hospitals to conduct diabetes awareness camps and offer free consultations. And, as Dr Bhattacharyya puts it, even if there is a ‘marketing agenda’, there’s no denying the public good that comes out of such initiatives. Also, there are NGOs such as the Bill Gates Foundation, Wellcome Trust, as well as local organisations that have been playing a crucial role in advocating policy changes, funding constant research, spreading public awareness about prevention, early diagnosis and efficient management of the disease. Despite all these efforts, the sad truth 16 LIFESCIENCE INDIA | August - September 2013 A laudable initiative mentioned in the study is the website www.healthy-india.org, launched in 2007, as a collaborative effort between PHFI and the Ministry of Health and Family Welfare, Government of India. Catering to today’s young professionals and net-savvy citizens, the online venture advocates healthy living as well as prevention of diabetes and other NCDs. The prognosis Studies suggest that Indians aged over 30 – comprising about 40 percent of the population - are at risk of getting diabetes. Further, the population aged over 50 is expected to increase from 16 percent to 23 percent of the total population by 2030, adding significantly to the number of diabetes cases. And then, for every diagnosed case of diabetes, there is at least one undiagnosed case of glucose intolerance, believe experts. In other words, the actual population at risk is much greater than our current estimate. The need of the hour is a comprehensive policy on disease management, synergy among all healthcare stakeholders, effective public-private partnerships and increased government spending on prevention, screening, early intervention and new medical treatments to reduce the economic burden of the disease, essentially by cutting down on the associated risk, morbidity and mortality. Ensuring that all doctors in rural India are qualified to diagnose and treat diabetes, starting diabetes clinics at all primary health centres, encouraging indigenous research and drug development, promoting an all-encompassing insurance coverage…the to-do list is rather exhaustive. This is a race against time. We cannot afford ignorance. Indifference is not an option. One in five diabetes patients across the globe will be an Indian. Whether or not one has a sweet tooth.
  • 17. LSI COVER STORY NCDs in India: the current status, strategy and role of corporate sector in their Prevention and Control Dr. Jain, D.C. (Former Deputy Director General (NCD), Ministry of Health & Family Welfare, Govt. of India) Non-communicable diseases (NCDs) are becoming a major public health problem with leading cause of adult mortality and morbidity worldwide. NCDs are rapidly increasing globally and reached epidemic proportions in many countries, largely due to industrialization, socio-economic development, rapid urbanization, demographic and lifestyle changes. These diseases are posing a major challenge to the social and economic development, and place a tremendous demand on health systems and social welfare throughout the world especially in low/ and middle/ income countries. NCDs are surpassing communicable diseases as the most common causes of morbidity and premature mortality worldwide. The major NCDs are cardiovascular diseases including heart diseases and stroke, diabetes, cancer and chronic respiratory diseases including chronic obstructive pulmonary disease and asthma, mental health, and injuries. Global Situation An estimated 36 million deaths, or 63% of the 57 million deaths that occurred globally in 2008, were due non communicable diseases, comprising mainly cardiovascular diseases (48%), cancer (21%), chronic respiratory diseases (12 %) and diabetes (3.5%) 1. In 2008, 80% of all deaths (29 million) from NCDs occurred in low- and middle- income countries, and with a higher proportion (48%) of deaths in the latter countries are premature (under the age of 70) compared to high-income countries (26%). As per the projections of World Health Organization (WHO), the total number of deaths from NCDs will increase to 55 million by 20301, if timely and appropriate interventions are not taken. Magnitude of NCDs India proportion of Disability Adjusted Life Years (DALYs) than that from communicable, maternal and child health issues, and nutrition-related causes combined. At present, there is no systematic reporting system of non-communicable diseases in India; therefore it is difficult to have genuine data. However, it is estimated that NCDs account for India is facing a great challenge of rising burden of Non Communicable Diseases resulting from rapid demographic and Figure 1 epidemiological transiPropor•onal mortality (%of total deaths, all ages) tions in the country. NCDs are affecting both urban and rural population and all socioeconomic strata in the country, causing significant morbidity and mortality with considerable loss in potentially years (aged 35-64 years) of life. NCDs including accidents and injuries are Source: WHO Non-communicable Diseases Country profile 2011 responsible for a larger LIFESCIENCE INDIA | August - September 2013 17
  • 18. LSI COVER STORY Priorities & Future Plans: Figure 2 The available data shows that NCDs are major contributor to high morbidity and mortality in the country with the risk factors; tobacco, harmful use of alcohol, lack of physical activity, unhealthy diet, obesity and stress. Most of the NCDs like Cancer, Diabetes, Cardiovascular Diseases (CVD), Mental Disorders and problems relating to ageing are not only chronic in nature but also have long pre-disease period where efforts of adopting healthy life style can prevent individuals from incurring these diseases. about 53% of total deaths in 2008, and are projected to increase to 59% by 20152. The prevalence of diabetes is increasing both in urban and rural population in India varying from 5-15% among urban populations, 46% in semi-urban populations and 2.5% in rural populations3, 4.In 2008, a survey covering both urban and rural areas reported a 5.9% of diabetes 5. High blood pressure is major risk factor for cardiovascular diseases and is directly responsible for 57% of all stroke deaths and 24% of all coronary heart disease deaths in India6. Several community-based studies in India have estimated the prevalence of hypertension in urban as well as rural areas. The meta-analysis of eight studies carried out in urban areas gives a pooled prevalence rate of 164.18 per thousand and in rural areas as 157.44 per thousand6. Chronic Respiratory Diseases including Chronic Obstructive Pulmonary Diseases (COPD) and asthma are affecting largely younger and aging population. Projection of National Commission on Macroeconomics and Health (NCMH) report, 2005, shows 18 that asthma is expected to rise from 28.3 million in 2006 to 35.9 million by the year 20167. Cancers contribute about 14% of the overall NCD mortality and 7% of the NCD/related DALYs8. According to National Cancer Registry Programme of ICMR, at any point of time, there are 28 lakh cases of cancer cases with 11 lakh new cases/ year & 5 lakh cancer deaths / year9.The most common cancer are of oral cavity, lungs, oesophagus and stomach among in males, and cervix, breast and oral cavity in females. Tobacco is the most important identified cause of cancer and is responsible for 30 to 50% of cancer in men and about 10 to 50 % of cancers in women. NCD Risk Factors and Social Determinants Causative factor for non-communicable disease is something other than a pathogen. It might result from hereditary factors, improper diet, physical inactivity, smoking, harmful use of alcohol, stress etc. Certain factors that increase the likelihood of getting NCDs are modifiable whereas others are non-modifiable risk factors. Fig-2 LIFESCIENCE INDIA | August - September 2013 The Government has already given high priority to NCDs in the country and has implemented vertical programmes for major non- communicable diseases with the objective of their prevention and control. One of these programmes is Prevention and Control of Cancer, Diabetes, CVDs and Stroke. Other programmes includes on Health Care of the Elderly, Mental Health, Tobacco Control, Trauma Care, Blindness Control, Micronutrients etc. Individually each of these programme made an effort to enhance capacity including strengthening of physical infrastructure in a view to reduce the gap at urban and rural areas. The National Programme for prevention and control of Cancer, Diabetes, CVDs and Stroke (NPCDCS) is under implementation in 100 districts (21 states) in the country10. The programme is being expanded to cover all districts in a uniform and phased manner during 12th Five Year Plan with integration of services at district and below level, equitable with universal coverage under overall umbrella of National Health Mission. The main focus of the NPCDCS11 would be on development of data base including health management information system, promotion of healthy life styles, infrastructure development, early diagnosis and management of diabetes, hypertension, cardiovascular diseases & common cancers e.g. cervix cancer,
  • 19. LSI COVER STORY breast cancer & oral cancer, and establishment of linkages with tertiary care health facilities. To ensure long term sustainability of interventions, the programmes would be built within existing public health sector and wherever feasible introduce public private partnership models. During 12 Five Year Pan, It is proposed to continue on- going efforts and to introduce following key strategies: • Generating Awareness on behavioural and physiological risk factors for reducing exposure to life style diseases. • Early Diagnosis through periodic/ opportunistic screening of population and better diagnostic facilities • Infrastructure Development and Human Resources with capacity for comprehensive management of NCDs • Population based interventions through multi-sectoral approach • Building evidence for action through surveillance, monitoring and research Issues and challenges The magnitude of Non Communicable Diseases demands urgent attention. Common preventable risk factors underlie most NCDs. These include behavioural and metabolic risk factors. The prevalence of these varies between income groups and differs with gender. Till date there has been limited focus on these issues. With increasing burden of NCDs, the Health Sector will face many challenges, which needs to be addressed urgently with an integrated comprehensive framework of prevention and control of NCDs. The major issues and challenges related to prevention and control of NCDs are as under. i. Raised the priority accorded to the prevention and control of Non Communicable Diseases in the national development agenda and the National Health Policy ii. Develop, maintain and strengthen database and reporting system of The Government has already given high priority to NCDs in the country and has implemented vertical programmes for major non- communicable diseases with the objective of their prevention and control. One of these programmes is Prevention and Control of Cancer, Diabetes, CVDs and Stroke NCDs and their risk factors. iii. To strengthen national capacity, leadership, governance, multisectoral action and partnerships with stakeholders (including corporate sector, pharma ondustries and civil society) to accelerate country response for the prevention and control of NCDs iv. Availability of cost-effective interventions including essential primary health care packages, and improves access to prevention programmes, essential medicines and affordable medical technology. v. Budgetary allocations for high quality research, surveillance and monitoring systems for the prevention and control of NCDs. vi. Development and availability of specialized human resource for prevention and treatment of NCDs, and establishing referral linkages and follow-up systems linkages across different levels of the health care system (primary, secondary and tertiary) to ensure timely treatment and follow-up interventions for patients suffering with NCDs. Role of Corporate Sector in Prevention and Control of NCDs At the UN high-level meeting on non-communicable diseases (NCDs) in 2011, the member countries agreed that no one factor could fully address the burden of NCDs and called for collaboration with “non-health actors and key stakeholders, where appropriate, including the corporate sector and civil society, in collaborative partnerships to promote health and to reduce non-communicable dis- ease risk factors — mainly tobacco, alcohol, and ultra-processed food and drink products To achieve the goal of reducing the burden of NCDs both in urban as well as rural areas and all socioeconomic strata in the country, the corporate sector, pharma industries and civil society can play a crucial role by supplanting the efforts of central and state governments through public private partnership and under corporate sector responsibilities for the welfare of our citizens. The central and state governments should also involve different stakeholders including corporate sector in health promotion, early diagnosis and treatment of common NCD and availability of low cost diagnostics, surgical procedures and medicines through suitable guidelines and regulations. The planning commission also advocated for the partnership of government with different stakeholders in the health sector in 12th Plan Document. After consultations and discussions at various platforms including World Health Organization’s global ministerial conference on healthy lifestyles (April 2011) and the Global Health Council annual conference (June 2011), four areas where the private sector can have a positive impact: promoting workplace wellness, improving access to diagnosis and treatment, creating healthy community environments and strengthening education, training and research capacity. Many successful programs run by corporate sector and civil society through strategic partnerships with governments and multilateral organizations. LIFESCIENCE INDIA | August - September 2013 19
  • 20. LSI COVER STORY nanagar, Darjeeling, Jalpaiguri and Dakshin Dinajpur. Cancer screening guidelines have been prepared and sent to the states. National Institute of Health and Family Welfare (NIHFW) has trained 95 master trainers under ‘training of trainers” in 3 programme sessions. Additionally, 693 medical officers have been trained by states in 32 training sessions. ANMs and other health workers have been trained about diabetes, hypertension and life style related issues that lead to such disorders. A draft proposal for development of Text books on Health Education for schools from class IIIrd to Xth has been submitted to the ministry for approval in collaboration with NCERT amd NIHFW. Dr. W.D. Bhutia, Deputy Director General, NCD, Government of India in conversation with Shikha Dhawan What all activities have the government initiated under national program on prevention and control of cancers, diabetes, cardiovascular diseases and stroke (NPCDCS)? NPCDCS is being implemented in 100 districts spread over 21 states since 2010-11 and in 2011-2012 Assam and Sikkim were also included in the program. The districts have been selected keeping into account their backwardness, inaccessibility and poor health indicators. As on 12th August 2013, State NCD cells/ Clinics are functional at 16 sites. District NCD cell is functional in 70 districts, district NCD clinics are functional in 71 districts while 53 CHC clinics are functional in 8 districts. Cardiac Care Units are functional in 52 districts. With support from private partners (Roche and Abbott), 29,000 Glucometers, 5.8 crore Glucosestrips and 6.67 crore lancets have been supplied to 21 states for Diabetes screening under NPCDCS, urban health checkup and pilot phase of school health programmes. Total 3,53,73,528 persons have been screened for diabetes and hypertension. Screening of all population above 30 years of age including pregnant women and tuberculosis patients is in itself a big achievement of the program. Out of the total population screened, 6.57% were found to be suspects for Diabetes and 6.37% were suspects for hypertension. The diabetes suspects need to be confi rmed in diagnostic laboratories. Chemotherapy services for cancer has started in 8 districts at Jorhat, dibrugarh, Rajkot, Jamnagar, Yamu- 20 LIFESCIENCE INDIA | August - September 2013 What challenges have the government faced in implementation of NPCDCS? The biggest challenge in implementation of the NPCDCS is the availability of trained skilled manpower. As it was difficult to get cardiac specialists, we have appointed medical specialists as in-charge of cardiac care units. Involvement of private partners in public health programs is also a challenge as there is lack of clarity on their involvement. Not much progress has been made in public private partnership as there are ongoing discussions on involvement of private partners in public health issues like mental health, tobacco control and screening for diabetes. NPCDCS was a stand-alone program so far. From 12th plan it has come under NRHM. With the availability of flexipool under NRHM it will be much easier to get things done. We are looking forward to the advantage that NRHM umbrella will offer.
  • 21. LSI COVER STORY What are the challenges to the early detection and management of diabetes, hypertension and stroke and how can these challenges be overcome? Unlike cancer, metabolic disorders like cardiovascular, stroke and diabetes have linked with metagenomics signature so these can be handled together. Majority of people suffering from these diseases which have genetic predisposition are also affected by environment and are vulnerable from the time they are in their mother’s womb. Major environmental conditions being mother’s nutritional status as well as her exposure to noxious substances like tobacco, passive smoking and indoor pollution. Children born with low birth weight grow normally for few weeks but then become obese with abnormal growth chart. They have high insulin and large proportion of them develop latent autoimmune diabetes which knocks down β cells of langerhans (insulin producing cells in pancreas). Recent advances in the understanding of the autoimmune process leading to diabetes have generated interest in the potential use of vaccines to prevent type 1 diabetes. A major challenge in diabetes is that 90% people do not know that they have diabetes. The solution is to have a surveillance system in place that can detect moderate hypertension, diabetes and cardiovascular disease. Biomarkers are also available to identify these conditions. Use of a point of care device for diabetes that is reliable and cost effective is very important. If random blood sugar levels are more than 130, further investigation is required as these may be probable prediabetics people who should be advised lifestyle management. Metformin or Gliptins can be prescribed to people at risk for type 2 diabetes while those who cannot be managed by these drugs should be given insulin. It is also essential to get a baseline liver function test (LFT) for diabetes Prof. N.K. Ganguly, Advisor, Translational Health Science and Technology Institute and President, Jawaharlal Institute of Post Graduate Medical Education and Research in India and former Director General of the Indian Council of Medical Research in conversation with Shikha Dhawan patients. For diabetic retinopathy, proteomic signatures are used to detect retinopathy. At least 90% of these new cases could be reduced if there was proper and vigilant treatment and monitoring of the eyes. Myocardial signatures like homocysteine, high sensitive C-reactive protein, ApoE, ApoB and triglycerides/HDL ratios can be monitored regularly in high risk patients. In-fact homocysteine is a common marker for diabetes, cardiovascular disease and stroke. If monitoring is done regularly, appropriate interventions can be done to control these diseases. Some major preventative measures can be maintenance of appropriate Vitamin-D and folate ratios in children. Cardiovascular disease can be prevented by use of PolycapTM developed by Cadila Pharmaceuticals Ltd. Trials conduct- ed under the leadership of Dr. Salim Yusuf and funded by Welcome Trust have shown that PolycapTM reduces the risk of coronary heart disease by 62% and stroke by 48%. The drug has also shown to bring down the multiple risk factors for cardiovascular disease such as lowering of blood pressure, heart rate, lipids and decreasing stickiness of platelets. Another major breakthrough has been the use of endoscopic procedures to avoid obese bariatric surgery and stomach surgery. The procedures cause significant long-term loss of weight, recovery from diabetes, improvement in cardiovascular risk factors, and a reduction in mortality from 40% to 23%. It is also very important to manage nutrition uptake appropriately in diabetes patients. In diabetes, higher amounts of glycosylated heLIFESCIENCE INDIA | August - September 2013 21
  • 22. LSI COVER STORY moglobin, indicates poorer control of blood glucose levels and has been associated with cardiovascular disease, nephropathy, and retinopathy. Monitoring HbA1c in diabetic patients may improve their outcomes. Another important program in the control of diabetes is tobacco cessation. Tuberculosis prevalence is also high in diabetes patients. Tolerance to TB drugs can be difficult to manage in diabetics as side effects such as nausea and loss of appetite are very challenging when trying to closely manage blood sugar. In a broader sense due to the exacerbating effect many non-communicable diseases are likely to have on the existing disease burden, an integrated public health systems approach for management, better screening, diagnosis, treatment and care of communicable and noncommunicable diseases is important. Effective health care fi nancing and well-trained providers are essential in our endeavors against all kinds of infection and diseases. Is academic research in India aligned to the needs of our industries? Academic research is undertaken for publication and sometimes to fi le patents as well. Publications are the end point for most scientists as publications are linked to their promotion. University systems have very less interactions with industries, except in Indian Institute of Science (IISc) in Bangalore where industry has incubation sites. IISc has introduced many innovative and flexible operational modes for collaboration with industries. The aim is to provide a research oriented environment coupled with hi-tech facilities and the availability of technical expertise present within the IISc community. Industry and academic interactions can be seen as a mandate in many prestigious CSIR and DBT funded research institutes. Translational Health Science and Technology Institute (THSTI) is part of an emerging health biotech science cluster and has been created for the conduct of multidisciplinary research that translates scientific and technological advancements into medical innovations that can fi nally be taken up by industries to improve public health. In addition to IISc and THSTI, many CSIR labs have good industrial orientation. CSIR is closely working with various indigenous industries, private and public sector undertakings to develop and commercialize its R&D results and technologies. The government initiated New Millennium Indian Technology leadership Initiative (NMITLI) operates in public-private partnership. NMITLI has crafted many technology projects involving industry partners and R&D institutions setting new global technological paradigms in the areas such as nano material catalysts, industrial chemicals, gene based new targets for advanced drug delivery systems, biotechnology, bio-informatics, improved liquid crystal devices etc. The scheme is being implemented by CSIR. Biotechnology Industry Research Assistance Council (BIRAC) set up as Department of Biotechnology’s interface agency has many initiatives that promote industrial collaborations. Its vision is to facilitate and mentor the generation and translation of innovative ideas into biotech products and services by the industry, promote academia and industry collaboration and enable creation and sustainability of viable bio enterprises. In your view how successful is government’s ambitious program on management of non-communicable diseases? Government’s national program on prevention and control of cancers, diabetes, cardiovascular diseases and stroke (NPCDCS) is focused on health promotion and prevention, strengthening of infrastructure including human resources, early diagnosis and management of these noncommunicable diseases. NPCDCS is a hugely expensive program. Budget 22 LIFESCIENCE INDIA | August - September 2013 is a challenge in its implementation so public-private partnerships (PPP) mode can play a very important role in all possible health care interventions at primary and tertiary health care centers. Integrated surveillance systems can be set up through PPP. Diagnostic reagents and devices are generally costly and are in the hands of private sector. Inclusion of private sectors as care providers can provide cost effective interventions and also provide many health care options to care seekers. An insurance system that is standardized can help the marginalized population. Community driven initiative by Abbott India Ltd with the Puducherry government has implemented a healthcare programme for people suffering with diabetes, dyslipidaemia, hypertension and thyroid disorders. Abbott provided subsidized diagnostics, educational support to healthcare providers, patient awareness material and conducted diet guidance camps. Random and fasting sugar levels, glycosylated hemoglobin, blood pressure and thyroid levels were monitored and at least 700,000 people in the union territory after screening were stratified as per their need and put on interventions. Government has also taken up these initiatives in 100 districts at different health care levels in different states. However, there are many grey areas in public-private partnerships. The government can help by bringing in more transparency and more clarity in such collaborations. Appropriate matrixes are required so that PPP becomes the most preferred collaboration in the public health arena. The government has to make policies, processes and modalities to streamline things. PPP gains and spin-offs should be handled well and profit sharing between partners should be spelled out clearly with accountability well established and audited routinely by impartial parties
  • 23. LSI COVER STORY www.enoveo.co.in Enoveo Biosolutions Private Limited is a start up company, established in 2012, incubated at KIIT Technology Business Incubator, KIIT University, Odisha. We are a team of environmental scientists, engineers and business professionals who provide environmental bioengineering solutions for various environmental concerns with regards to contaminated soil, waste water bodies and effluent treatment measures. We foster collaboration with various organizations for applied research and innovation towards technology development for a sustainable and equitable environment. Expertise: v In-situ assessment and treatment : for Waste water, Ground water and Contaminated soil v Eco Sanitation : Implementation of key sanitary measures for community health and hygiene v Eco Toxicity: Toxic analysis and e- mapping for contamination load v Environmental Forensics: Data mining and analyses for biological and chemical pollutants aided with structural modeling v Green Engineering: Recycling of municipal and industrial waste into commercial products v Online Microbial Biosensor: Onsite detection of chemical contamination v Capacity Building: Training and skill development of human resources for social awareness programmes and sustainable livelihood generation We provide consultancy for metagenomic analyses, technology development projects and alternative energy. Our technical expertise comprises of professionals from France, Brazil, USA and India. ENOVEO Bio Solutions Private Limited 203, Second Floor, KIIT TBI, KIIT University, Bhubaneswar, Odisha, India. 751024 E-Mail: connect@enoveo.co.in * M: +91 876 333 39 54 LIFESCIENCE INDIA | August - September 2013 23
  • 24. LSI COVER STORY Financial Burden from Non-Communicable Diseases and the Road Ahead -Shikha Dhawan Non-communicable diseases (NCDs) like diabetes, cancers, cardiovascular diseases are no longer a lifestyle related disease of rich countries. With the emerging lifestyle trends and sedentary way of life, NCDs now account for a very large burden in terms of both mortality and morbidity in low and middle income countries (LMICs) ommunicable and noncommunicable diseases (NCD) account for 60% of all deaths worldwide, with 80% of those taking place in developing countries and in the age groups of prime productivity. As per disabilityadjusted life year (DALY) which is a measure of years lost due to ill-health, disability or early death, for India the topmost NCDs are: Cardiovascular Diseases (CVDs), Diabetes, Cancer and Chronic Obstructive Pulmonary Disease (COPD) and Communicable Diseases are: Pneumonia, HIV/AIDS, Tuberculosis and Vaccine preventable diseases. C diseases leading to poorer outcome for these diseases. Direct cost for patients with co-morbidities is generally 45% higher than the direct cost for patients without co-morbidities. Burden of disease associated with NCDs and injuries is higher than that associated with the health conditions included in the Millennium Development Goals (HIV/AIDS, tuberculosis, malaria, and maternal, child and reproductive health), even in developing countries. The menace of NCDs are expected to exceed communicable, prenatal and food borne diseases as the leading causes of death in all countries by 2020. The major risk factors for non-communicable diseases are smoking, alcohol abuse, a sedentary lifestyle and an unhealthy diet. The dilemma for health care system is that a person with a non-communicable disease is also vulnerable to common infectious diseases like tuberculosis, community-acquired pneumonias and vaccine preventable NCDs pose a heavy fi nancial burden on poor households as cost of medicines is expensive. When it is difficult to meet day-to-day mundane expenses, the treatment of NCDs has fi nancial implications on affected households. Cost can be a major deterrent to seek medical care. For diabetes, cost of insulin represents an important source 24 LIFESCIENCE INDIA | August - September 2013
  • 25. LSI COVER STORY of spending for patients and their families. NCDs management is not well covered under our health insurance systems. There are indirect costs which also have to be borne by individuals affected by NCDs. These costs mainly include time and productivity loss by patients and caregivers because of the illness as well as income lost by patients and family members. Complications and co-morbidities related to the severity of illness increase the household fi nancial burden. Health-fi nancing systems that improve fi nancial risk protection and help achieve universal health coverage holds great potential to manage the fi nancial burden of NCDs. man resources, early diagnosis and management and integration with the primary health care system through NCD cells at different levels for optimal operational synergies. Under the 12th Plan, the program has come under NRHM and the country is looking forward to the advantage the NRHM umbrella will offer. ment of ‘NCD clinic’ at CHCs and District Hospitals. Efforts are being taken to increase awareness for promotion of healthy lifestyle through involvement of mass media. Training of master trainers have been done by National Institute of Health and Family Welfare (NIHFW) and Indian Nursing Counsel. Pilot project on school based diabetes screening programme have been initiated in many districts. The health ministry, along with Confederation of Indian Industry (CII) and pharmaceutical company Eli Lilly and Co., is working on policy interventions to control diabetes. All said and done, health promotion and prevention of chronic NCDs are yet to be adequately addressed in the country’s health system. Though many commendable targets have been achieved since the implementation of the NPCDCS program, a lot needs to be done still. The achievements of the program till date include development of Operational Guidelines and training modules for Health Workers and Medical Officers. The health ministry is also exploring the possibilities of public private partnership (PPP) initiatives and the involvement of industry to complement the government’s programme. Health Ministry has envisaged including curriculum on health education as part of 2014’s academic curriculum in Central Board of Secondary Education (CBSE) affi liated schools across India. The need of the hour is a comprehensive policy on disease management, Human resource has been hired for synergy among all healthcare stakeNational NCD Cell while setting up holders, effective public-private partof State and District NCD cells are in nerships and increased government process. Funds for implementation spending on prevention, screening, of NPCDCS in 27 districts across 19 early intervention and new medical states were released in March 2011 for treatments to reduce the economic opportunistic screening, establishburden of non-communicaFramework for the analysis of economic impacts of NCDs on households. ble diseases by reducing risk, Ref: McIntyre D. et al (2006), Soc Sci Med morbidity and mortality related to these diseases. Health Loss of working time of Intra-& inter promotion, prevention and person who is ill & household labour caregivers substitution early treatment would reduce No Indirect some of the direct costs by costs Hiring other Loss of income of appropriate mix of prevenlabour & other person who is ill & strategies tion and treatment according caregivers (due to absenteeism, to their relative costs and imNon missing business Seek communicable appointments, etc.) care pact. disease Costs can be further reduced by rational use of medications for NCDs. Government of India has launched the ambitious integrated National Programme for Prevention and Control of Cancers, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) since 2010 with focus on health promotion and prevention, strengthening of infrastructure including hu- Financial costs of health care (consultation, medicines, laboratory, hospitalization, etc) Yes Directs costs Other financial costs related to seeking care (transportation, special dietary regimes, etc.) Reducing/delaying consumption of non-health goods & services (food, education, electricity, leisure, etc) Use of savings Reduced well being and increased financial vulnerability for individuals & households Sale of assets Borrowing Delaying investments Other strategies to cope with financial costs (assistance from other, etc) LIFESCIENCE INDIA | August - September 2013 25
  • 26. LSI COVER STORY CII Recommendations' based action plan (linked to NPCDCS Strategic Framework) Research clearly indicates that countries, states, regions with greater means of health education and awareness have better health outcomes, giving the healthcare providers and policy makers the option to choose the best interventions leads to overall improvement in the healthcare outcomes of the community. In practice, however, finding the mechanism to make this happen is difficult. Ultimately, as in any system, the real value of choice comes from people having the right information to select the option that is superior. This framework endeavors to systematically present the available information and options for the policy makers and program managers. The framework has been designed to be in synchrony with the NPCDCS strategy that aims to strengthen prevention, diagnosis, treatment and capacity aspects of the health system. Issue Recommendations Strategy 1) Prevention through behaviour change Very little focus on "root cause" of disease Put emphasis of health education with focus on prevention activities like exercise, dietary control and stress management in children and young adults. Promote workplace interventions like use of stairs, no-smokingpolicies, standing desks etc should be promoted Deploy mass media campaigns (through print, electronic and social media) for increasing community awareness regarding healthy dietary practices Revisit media policies to discourage advertisements related to junk/fast food, tobacco and other harmful commodities while promoting messages related to exercise, healthy lifestyle etc is important. The private partners, development agencies and Government to synergize CSR and development activities to streamline them with the NPCDCS program. "Diabetes Education Kiosks" should be set up jointly by the government and non-governmental partners to enable community in getting key health education messages closer to their homes. Limited involvement of community based groups PRI (Panchayati Raj Institutions), NGOs, CBOs and community forums like Ramayan Mandalis, Saas Bahu sammelans should be involved for providing health education regarding prevention, screening, early diagnosis and timely & appropriate treatment 26 LIFESCIENCE INDIA | August - September 2013
  • 27. LSI COVER STORY Issue Recommendations While targeting the adolescents and children, health educators should reach out to school children through Limited reach to adolescents and other National Rural Health Mission's School Health Program with messages pertaining to good dietary practices. vulnerable groups Health education to pregnant women could be provided at the outreach sites (MCHN days). High incidence of LBW babies - a contributor to insulin resistance Awareness campaign to promote better dietary practices, ante-natal care and rest during last-trimester of pregnancy etc. Have a directory of LBW babies to screen LBW babies at regular intervals for pre-diabetes Strategy 2) Early Diagnosis (and screening) No opportunistic screening being conducted at health facilities for DM Cross referrals from programs like RNTCP and NPCB can help identify cases early Limited outreach of screening facilities Glucometers to be made available at all the sub centre level and PHCs Non-diabetic but overweight and the high risk group people (having family history, having low birth weight) should be given a dietary plan, exercise advice and followed-up after 6 months. A standardized screening system to have accurate linkages between different facilities Integration and collaboration with screening systems established in other national programs like RNTCP, NPCB, RCH, NACP. Issue Recommendations PPPs (Public Private Partnerships) with NGOs, CBOs and professional bodies (like IMA, IAP, OPPI, FOGSI etc) for reaching out to the community with better screening Use of IDRS (Indian Diabetic Risk score) for screening in resource limited situations Mobile Health Units, to be equipped with screening facilities for DM At CHC level in addition to regular screening, HbA1c (Glycosylated Haemoglobin) estimation should be conducted and the diabetic management should be done based on HbA1C results. No separate cadre that can be engaged for screening in urban areas. Municipal corporations in the state often function as a separate system. There is a need to collaborate with the urban local bodies to synergize the health interventions being implemented by NPCDCS, Ministry of Health and Family Welfare and Urban Development. System of urban dispensaries or health centres set up by urban local bodies to be equipped with screening tools and equipment Strategy 3) Treatment Filling up of medical specialist vacancies in medical colleges, district hospitals and CHCs.. Deficiency in availability of Human resources at the Empanelment of senior doctors through associations, corporate and individually for tertiary care facilities hospitals and peripheral centres for complications management Issue Recommendations Building ICT platforms like telemedicine, GramSat for areas where there is lack of any skilled manpower and limited opportunities to hire or partner with private sector Utilizing peripheral workforce available under ICDS (Integrated Child Development Services) Scheme Aanganwadi workers and under NRHM - ASHA workers. Verticality in the programs leading to artificial shortages in HR Integrated approach to disease management, including integration of funding lines and reporting mechanisms. Realignment of roles and responsibilities of healthcare providers aimed at multi-skilling and holistic disease management. Continuum of care approach where a General Physician, an Ophthalmologist, an Endocrinologist, vascular surgeon neurologist work in tandem for treatment of DM LIFESCIENCE INDIA | August - September 2013 27
  • 28. LSI COVER STORY Limited diagnostic facilities Facility survey and facility needs assessment should be conducted regularly to know the exact status of existing equipment in various institutions, for diagnosis and treatment of DM Glycosylated Hemoglobin tests and Microalbuminuria should also be added to the list of free investigations Advanced tests should be conducted at DH and Medical College levels to screen for complications especially those related to kidney, eyes, feet and nervous system. At teaching institutions in addition to other tests, the Insulin sensitivity test should also be performed. Issue Recommendations Ambiguous Policies Clear policy on deputation, transfer & posting, promotions etc, which also has performance linked incentives tied to clear deliverables. Clarity on roles and responsibilities of existing manpower, with clear delegation of funds, functions and functionaries Need for greater flexibility for the state to re-align funding for locally relevant NCD activities and regional priorities, akin to NRHM flexi-pool. No cadre of diabetes counselors A diabetes educators cadre to provide specialized counselling services at ter•ary level High out of pocket expenses due to lack of reimbursement mechanisms An OPD based Insurance scheme for Non-communicable diseases like Diabetes. Diabetes educators or counsellors should be available on a toll free helpline for increasing compliance The exis•ng reimbursement systems like Rashtriya Swashthya Bima Yojana (RSBY) cover only the hospitalization and not chronic illnesses like diabetes. There is a need to extend this to the out-patient care for DM, Hypertension to prevent subsequent expenditure on treating complications. Drugs should be available, accessible and affordable at all levels of health system - the PHCs, CHCs, DHs and teaching centres. The free supply of medicines in the government medical college hospitals and tertiary care general hospitals needs to be streamlined. Issue Recommendations Limited compliance to standard treatment guidelines Doctors need to be provided with a protocol based guide for reference, appropriate training and CMEs to become confident and work away the fear of prescribing insulin. Weak referral linkages nReferral systems are weak at the peripheral level and there is a need for JSY-like referral transportation system for emergencies arising out of NCDs Supply chain management issues Glucometers, Insulin and other supplies procurement and logistics management should be adequately budgeted and timely procurement initiated, keeping in view the lag time. The industry stakeholders could provide better packaging for anti-diabetic drugs with clear indications, treatment modalities and compliance printed on the packaging Strategy 4) Capacity building of human resources (healthcare providers) Training needs unknown Training needs assessment during and after the recruitment of manpower, on NCDs. Budgeting related to training to be in line with the training needs assessment of each state. Limited integration of training Integration of NCDs prevention and treatment in pre-service and in-service training The training on NCDs should be made mandatory or; linked to career development opportunities. Annual training calendars for each state should be developed in advance in consultation with the NCD cell and shared with all potential training institutes to ensure timely engagement. 28 LIFESCIENCE INDIA | August - September 2013
  • 29. LSI COVER STORY Issue Recommendations Limited orientation regarding NCDs Standardized orientation programs for NCD program management team, including Simple operational guidelines on fund utilization. Orientation training of policymakers on various prevention, treatment and complications management strategies for DM. Training of nursing staff as Diabetic educators and in using innovative tools like Diabetes Conversation Maps Chemists and pharmacists should be trained and sensitized about the need for providing literature, explaining the effects, side effects, importance of compliance and complications related to DM. Few opportunities of continuing medical education around DM DM should be included regularly in the CME programs for doctors and nurses CMEs should focus on special indications like juvenile diabetes, gestational diabetes and complications management, with involvement of both public and private healthcare providers at primary, secondary and tertiary levels. To avoid treatment related complications and enhance patient outcomes, have uniformity in the treatment modalities throughout the country. This could be achieved through standard treatment guidelines for DM. nLimited capacity of State/ National training institutes Government could source-in or source-out trainings on NCD through partnerships with multitude of leading training institutes (public and private) like SIHFW, NIHFW, Medical Colleges, Regional institutes and other autonomous public health bodies. Issue Recommendations nVirtual (online) lectures for medical and paramedical staff for training on DM updating and enhancing technical expertise and confidence in managing a case of DM. nMultiple training institutes working in isolation – no uniformity or accreditation of curriculum A nodal agency at the national level capacitated to provide accreditation to training courses for healthcare providers to be followed uniformly by all states Standard training modules or manuals on NCDs to be used uniformly by all training institutes Regular up-gradation (maybe once a year) of training course curriculum across all training institutes Strategy 5) Surveillance, Monitoring & Evaluation Recommendations Multiple MIS formats There are several stand-alone MIS in the health system which need to be standardized and integrated. The MIS for NPCDCS should be mainstreamed with other cross-sectoral initiatives being carried out by Government and other development partners (like World Bank, USAID, FAO, WFP, UNICEF, WHO etc) Engaging PRI (Panchayati Raj Institutions) members in community-based monitoring. The Village Health Committee (VHC) should form the link between the Healthcare providers and the community. Limited disease surveillance systems A clinical registry of the people suffering from DM should be prepared. All the individuals seeking services from NPCDCS should be given health card with unique identity number to track treatment. Duplication of diagnostic tests leads to wastage. To avoid this medical history of the patient can be linked to the Aadhaar card (UID) on a medical record system. Issue Recommendations A program surveillance unit to conduct performance audit and allocation of funds Ensuring quality control by conducting frequent prescription audits to help in standardizing treatment practices and ensuring quality control towards ensuring patient satisfaction. LIFESCIENCE INDIA | August - September 2013 29
  • 30. LSI COVER STORY LEARNING FROM CII NCD STATE ROUNDTABLES 30 LIFESCIENCE INDIA | August - September 2013
  • 31. LSI COVER STORY LIFESCIENCE INDIA | August - September 2013 31
  • 32. LSI COVER STORY 32 LIFESCIENCE INDIA | August - September 2013
  • 33. LSI COVER STORY Q Chhattisgarh is implementing the NPCDS program since when and in what all districts? In 2010 the state received the official communication from Government of India that 3 districts have been selected for Government’s national program on prevention and control of cancers, diabetes, cardiovascular diseases and stroke (NPCDCS). These programs were initiated initially in Bilaspur (pilot district), while in and 2011 and 2012 two more districts Raipur and Jashpur were selected. Since 2010, not much progress had been made in the programme. In 2012-13, I was appointed as the state nodal officer for proper structuring and implementation of the program at the state level. NCD Cell set out to increase the visibility of the program in the field in terms of structure, proper human resources and guidelines that could percolate down in the districts. At present, three NCD (Non Communicable Disease) clinics have been established called the Healthy Life Style Centre one per district in district hospitals. 15 NCD clinics will be established in community health centers and a total of about 38 NCD clinics will be established in the entire three districts. Dr. Kamlesh Jain, State Nodal officer, NCD, Chhattisgarh in conversation with Deepti Nirwal The current status is that the State NCD cell has been established as per the mandate of the program. Finance and logistics officers have been appointed. Program Associates are working in the districts along with 14 health counselors and 26 Data Entry Operators. LIFESCIENCE INDIA | August - September 2013 33
  • 34. LSI COVER STORY Q What all constraints have been faced by the state in implementation of the program? The mandate of the program is that state’s share of the budget is 15% and rest is provided by the centre. Here comes a challenge for implementation i.e. the funds are allocated activity wise. This needed to be streamlined as sometimes the available funds can’t be utilized properly. If the funds are provided as a complete grant for the programme it could be utilized as per activity. Another constraint is that NCDs are taken as a parallel program. The health system is more tuned to handle communicable dis- suspects with >140 mg/dl glucose levels. Although diabetes is an emerging problem, its visibility is lacking in public. Even public health systems are not inclined to screen for NCDs. We have to break the myth that diabetes can be treated only by private providers. In 2012, I have carried out orientation of doctors and health providers. Community vibrations were brought about by healthy life style abhiyans. Community mobilization was done using TV, audio video systems, health camps, counselor meetings, painting competition at schools. The fi rst Under NCDs program, recruitment of doctors was difficult. So we gave good remunerations and empanelled parttime doctors for 3-4 hrs to conduct camps eases like malaria and tuberculosis. NCDs should be made a comprehensive part of integrated health care. Refresher training is required for the existing human cadre as NCDs are not a parallel program. To begin with, already available specialist doctors should be mobilized. Further down the line when OPD strength increases the manpower strength can also be increased. A major constraint in the NCD national program that I faced was hiring of doctors and management staff. Chhattisgarh is a tribal dominant state so we had problem to get trained qualified specialists. At times, qualifications were high so there was mismatch with the remuneration. week of November is every year celebrated as Chhattisgarh establishment week “Rajyotsava”. During the 2012 celebrations, NCDs were given prominence through exhibitions and the message was clearly given that the health department is interested in managing NCDs. On 14th November 2012, World diabetes Day, we ran a “Blue Light Campaign”. Major government buildings of the state were lighted with symbolic blue light to spread awareness about Diabetes. This innovative initiative of the state NCD cell received a wide media coverage and lot of print. TV channels covered the news with great importance. This helped to sensitize the general public about World Diabetes Day and the campaign. Q What all initiatives have been taken by the state for the diabetes program and what is the way forward? In sub-health centers at grass root levels diabetes screening programs have been successfully implemented. Till date 9,70,028 people have been screened for diabetes with glucostrips. Amongst these 57,444 are diabetes State NCD cell has succeeded to reach 10 lakh population of the state through media campaign in association with prestigious news and FM channels. Jingles on FM on diabetes and lifestyle diseases and awareness messages of Honorable Chief Minister of state resonated the message across the state. State of Chhattisgarh’s efforts in spreading awareness on Dia- 34 LIFESCIENCE INDIA | August - September 2013 betes has become one of the unique initiatives across the country. Nearly 700 prominent personalities across the state were presented a symbolic blue ring (meaning uniting for Diabetes) and briefed about diabetes and their support was sought for the campaign. Campaign also made efforts to reach to the general population and more than 300 persons have been presented with the symbolic blue ring. To bring more visibility, I have planned to identify parallel support from Public Private Partners (PPP) to establish Diabetic Day Care, Lifestyle Centre in Raipur and Bilaspur and also for school heath based program in PPP mode. I have roped in funds from European Union (European Union State Partnership Program) as well to establish Diabetic Clinics. At present we are looking for NGOs or company CSR to run these clinics for NCDs. Expression of Interest (EOI) was issued and we have received about 35 EOIs. Currently, I have put up a proposal to CII to help in fi nding an implementing partner. Under NCDs program, recruitment of doctors was difficult. So we gave good remunerations and empanelled parttime doctors for 3-4 hrs to conduct camps. State’s 2013 Essential Drug List has included the drugs for NCD program to provide free drugs. I had also initiated a proposal for juvenile diabetes mellitus to track young patients and give them free insulin till 23 years of age. But due to free drug policy, the drugs for juvenile diabetes mellitus patients will now be given free anyways. New innovative devices especially non-invasive technologies have been added in state’s project implementation plan. Efforts have to be done to endorse new devices within the public health system. We have even constituted a committee to judge the utility of novel devices in public health system.
  • 35. LSI SPOTLIGHT HERBAL NEEM FORMULATION: Miracle cure for wound healing -Poorva Shrivastava Since time immemorial, herbal medicines have been popular as remedies for diseases worldwide. These are safe since they are natural products. Herbal formulations which have reached widespread acceptability as therapeutic agents in India include nootropics, antidiabetics, hepatoprotective agents and lipid lowering agents. The use of herbs is often more affordable than purchasing expensive modern pharmaceuticals. I nfected wounds in legs, foot and other parts of the body are very common clinical problems that require intensive care in a wound clinic. These wounds are caused by trauma or complicated surgical operations on infected organs. Patients suffering from diabetes, arterial or venous disease of lower limbs have a high risk of developing infected wounds. Any wound or ulcer that does not heal in 6 weeks is said to be a chronic wound. There is more than one reason why a wound does not heal, infection being just one. Lack of blood supply, venous or arterial insufficiency, radiation, foreign bodies, nutritional deficiency, diabetes, jaundice, alcoholism, toxins, cancer, steroids and chemotherapeutic agents, hereditary healing disLIFESCIENCE INDIA | August - September 2013 35
  • 36. LSI SPOTLIGHT NEEM SPA Applications and benefit of making Novel Oil Soak Neem in water for 12 hrs Drink Neem decoction to enhance immunity, activate metabolism, purify blood Steam is generated Neem Decoction Boil the water Mix in 4 oils and 17 herbs to get Novel Oil which would cure any kind of wound, any kind of skin disease and Allopecia Take neem bath and in-hale steam Neem Decoction Wash your body order, old age etc., can be cited as other reasons. Among these the most common reason being diabetes, where the only solution at times is amputation. These wounds are treated with various antiseptics and dressing materials. Most of these are provided by multinational companies at a very high cost. Moreover the antiseptics used are harmful to the healing process and are expensive too. The high cost makes these unaffordable to the common man. These antiseptics have been actually shown to be cytotoxic and damage the delicate granulation tissue and epithelial cell. By efforts of Mr. Manish Saxena, a neem based herbal formulation has shown tremendous improvements in diabetic foot ulcers and healing in other wounds. A staunch devotee of Lord Krishan, he calls his oil as “Hare Krishna Oil.” The oil formulation can easily heal diabetic ulcers, bed sores, venous ulcers, arterial ulcers, varicose ulcers, knee replacement wounds etc. In 1998 Mr. Manish Saxena was a research associate in Department of Surgery, AIIMS and was associated with a clinical trial for wound care. He saw that there is rising number of amputations in non healing ulcer cases among diabetic wounds (one lakh amputations per year). While trying to fi nd out a solution to this problem he met Dr. T. V Rao of Maharishi Ayurved Ltd who intro36 LIFESCIENCE INDIA | August - September 2013 duced the benefits of neem based formulations to him. One of the major formulation created was a novel neem oil that was a miracle cure for healing wounds. In 1999 his innovation was recognized by Department of Science and Technology (DST) and they provided him with a grant under TePP (Techno-Entrepreneur Promotion Programme). With the available funds from DST, a multi-centric randomised trail was conducted at the wound care clinic, Department of Surgery, AIIMS and Central Council for Research in Ayurveda & Siddha (CCRAS) with Principal Investigators Dr. Anurag Shrivastava and Dr. K.D Sharma respectively. All the laboratory experiments for pre-clinical toxicity studies were carried out at SGS India based in New Delhi. The oil formulation was completely safe and had no side-effects: obviously as the ingredients are all natural products and we have used them in one form or another. The standardization of the innovation was done at National Institute for Pharmaceutical Education and Research (NIPER) with Dr. Parikshit Bansal as the principal investigator. The formulation was also tested on eye wounds in rabbits at Rajendra Prasad eye centre at AIIMS under Professor S.C. Ghosh. The formulation has been commercialized by M/s Venus Remedies Ltd. Among several neem based formulations that were researched and tested at various clinics and hospitals, another neem based formulation with more capabilities to heal wounds such as venous/arterial wounds, diabetic wounds, wounds due to MRSA (Methicillin-resistant Staphylococcus aureus causing several difficult-to-treat infections in
  • 37. LSI SPOTLIGHT humans), traumatic wounds, gunshot wounds, burns, wounds caused by chemotherapy/radiotherapy and all types of chronic skin infections like psoriasis, alopecia (stops hair fall), any pain or inflammation, ear /nose infections, crack heels and aids skin rejuvenation have been developed by Mr. Manish Saxena. For complete healing, he recommends a holistic approach as outlined in his neem spa. Miracles of neem based oil formulation A man driver by passion, Mr. Manish Saxena has been himself making the neem based formulation for the last 15 years utilizing herbs and oils of the highest quality to maintain quality and purity of the product. As a wound care expert, he is working with Dr. Amar Pal Singh Suri at Diabetes FootCare and Wound-Care Clinic, New betic wounds patients could get benefitted and the amputation rate can be decreased which is now two limbs per 30 seconds according to a WHO survey”. An NGO, Sri Ram Seva Trust, New Delhi helps Mr. Manish Saxena to distribute the neem based oil formulation to poor and needy patients. Extensive research on this formulation has been taken up by Prof. Ameena Gurib Fakim at CEPHYR (Centre de Phytothérapie et de Recherche, www.cephyr-recherche.com) a limited company incorporated under Mauritian Law to promote the formulation worldwide. Many miraculous healings have been observed with the oil. Orthopedic wounds caused due to knee replacement surgery where foreign body is inserted and likewise any surgical wound where some foreign body is put in the body like proline mesh have healed in record time with application of this oil. Three MRSA wounds have been healed till date while the oil has benefitted leprosy patients as well. Several bomb blast cases of BSF, CRPF and army with splinters wounds and even bedsores have been successfully treated and cured by Mr. Manish Saxena. His vision is to open neem clinics in every country and every city. Delhi where more than 1000 patients have been successfully treated for the last 15 years. According to Dr. Amar Pal Singh Suri, “We have not observed any side effect till date. Our success rate has been more than 95%. We wish to spread awareness about this center so that maximum dia- Manish Saxena can be contacted at saxmanish@gmail.com LIFESCIENCE INDIA | August - September 2013 37
  • 38. LSI ACADEMIC SHOWCASE Inspiring Innovation LSI Academic Showcase Principal Kumaraguru College of Technology shares some of the unique Industry Academia initiatives of the college. KCT is one of the premier institutions in the country . Which are the institutions that have recruited from KCT? The Kumaraguru College of Technology has over 200 students who have successfully passed out and pursuing their higher studies in various countries including USA, UK, Canada, Australia, New Zealand, Germany, Sweden, Denmark, Belgium, Finland, Austria, Malaysia etc. Many of our graduates have completed their higher studies in premier Indian institutes like IITs, IIMs, NITs, BITS, IISER and the list is growing. It is our privilege to share that our graduates are working in many MNCs- Genentech Inc., Baylor College of Medicine, and Novartis, USA, Anglo Arabian Healthcare, Dubai, United Arab Emirates, Indian Immunological Limited, Hyderabad, Biocon, Bangalore, Ramky Group, India, Novartis, OTC, India, GLR Laboratories Pte. Ltd., Chennai, Orchid Pharmaceuticals Pte, Ltd., Chennai and many more.. What are the unique subjects and methodologies our course offers to the Biotechnology students? The Students of B.Tech biotechnology at KCT study a blend of courses from various related disciplines. These courses are relatively unique compared to most syllabi across India. For examples, courses related to Chemical engineering, Biopharma,Food technology, IPR, biosafety and bioethics. These courses are in addition to the core biotech curriculum comprising of fundamental biosciences, genetic engineering, bioprocess, downstream processing, Bioinformatics, Immunology In addition a unique blend of inhouse and inter-departmental electives is also offered to the students interested in other related topics like Immunotechnology, Biomedical engineering, Programming for bioinformatics, Environmental biotechnology, Nanotechnology Medical textiles, Bioenergy, Clinical research and Management . 38 LIFESCIENCE INDIA | August - September 2013 Please enlist the Innovation-initiative of the Institution The Kumaraguru College of Biotechnology Department has fi led a provisional patent registration for the selective extraction of dyes from textile dyeing unit wastewater. We are pursuing research on nanotechnology for the synthesis of nanoparticles for antimicrobial activity. We are Investigating the plant resources for valuable biomolecules as pharmaceutical for diseases such as cancer, diabetes, arthritis etc. We are developing medical textiles with plant based enzymes for warts.
  • 39. The Confederation of Indian Industry (CII) works to create and sustain an environment conducive to the development of India, partnering industry, Government, and civil society, through advisory and consultative processes. CII is a non-government, not-for-profit, industry-led and industry-managed organization, playing a proactive role in India's development process. Founded over 118 years ago, India's premier business association has over 7100 members, from the private as well as public sectors, including SMEs and MNCs, and an indirect membership of over 90,000 enterprises from around 257 national and regional sectoral industry bodies. CII charts change by working closely with Government on policy issues, interfacing with thought leaders, and enhancing efficiency, competitiveness and business opportunities for industry through a range of specialized services and strategic global linkages. It also provides a platform for consensus building and networking on key issues. Extending its agenda beyond business, CII assists industry to identify and execute corporate citizenship programmes. Partnerships with civil society organizations carry forward corporate initiatives for integrated and inclusive development across diverse domains including affirmative action, healthcare, education, livelihood, diversity management, skill development, empowerment of women, and water, to name a few. The CII Theme for 2013-14 is Accelerating Economic Growth through Innovation, Transformation, Inclusion and Governance. Towards this, CII advocacy will accord top priority to stepping up the growth trajectory of the nation, while retaining a strong focus on accountability, transparency and measurement in the corporate and social eco-system, building a knowledge economy, and broadbasing development to help deliver the fruits of progress to all. With 63 offices, including 10 Centres of Excellence, in India, and 7 overseas offices in Australia, China, France, Singapore, South Africa, UK, and USA, as well as institutional partnerships with 224 counterpart organizations in 90 countries, CII serves as a reference point for Indian industry and the international business community. For more detail please contact: Confederation of Indian Industry The Mantosh Sondhi Centre 23, Institutional Area, Lodi Road, New Delhi - 110 003 (India) T: 91 11 45771000 / 24629994-7 F: 91 11 24626149 E: public.health@cii.in W: www.cii.in Reach us via our Membership Helpline: 00-91-11-435 46244 / 00-91-99104 46244 CII Helpline Toll free No: 1800-103-1244
  • 40. LSI INTERVIEW Prof Vijayaraghavan in an exclusive interview with LifeScience India shares his views on the Industry's key issues Dr Vijaraghavan, Secretary, Deparment of Biotechnology (DBT), government of India, shares his insights on the policy regulatory issues of the industry in conversation with Hareeni Mageswaran As a policy maker, what is hindering the LifeScience Industry? In one word: Connectivity. All of us need to connect as partners for a shared purpose. This shared purpose helps bring a meaningful transformation . Science is but one component here but it is an important one. For this connectivity to happen we in the government must constantly keep in mind that the purpose of policy is to enable transformation through the responsible and correct use of public resources. If we worry only about using public resources in a procedurally correct manner while forgetting our purpose, policy will be hollow. Connectivity ensures creativity with responsibility on all sides. What are your views on the Clinical Trials industry? What is the fate of this industry in India? First, the term ‘Clinical trials industry’ sends a mixed message. This is not an industry in the sense the term is usually used. We are working with people here, we are working in a country of nearly a billion and half people. If we are to address our problems and fi nd solutions, clinical trials are a must. A country our size cannot rely on altruistic Scandinavians as participants who will test out the efficacy of the drugs we use. A country of our size cannot expect the best research and consequent new drugs and vaccines to come from California or Switzerland. India has a unique opportunity not only to take the lead in world-class research in biomedical sciences but also to lead in addressing the problems of the South. 40 LIFESCIENCE INDIA | August - September 2013