4 web lsi_aug_sep_2013

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

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Former Director, CDRI

Dr. Rajesh Jain
Joint Managing Director
Panacea Biotec 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


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

LSI
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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


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


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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


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 ongoing 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.

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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

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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


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
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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
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E-Mail: connect@enoveo.co.in * M: +91 876 333 39 54

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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


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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)


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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


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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


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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.


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.

LSI
COVER STORY

LEARNING FROM CII NCD STATE ROUNDTABLES


LSI
COVER STORY


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.

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-


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


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 .


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.


LSI
INTERVIEW
The present clinical trials imbroglio is
an opportunity. It is an opportunity to
set our house in order. It is an opportunity to communicate to our people
that we will do so in a manner that
is exemplary from which others can
learn. It is an opportunity to communicate that we must research, discover
and innovate solutions, take them
through well-formulated and ethical
trials and when our products pass,
take them to our people and around
the world.
To absolve ourselves of this responsibility is to be a vassal state where the
rich can buy their expensive medicines and vaccines tested abroad while
the poor are denied access to these
medicines because we are gridlocked
in our processes. Such a situation is
simply immoral and unethical. Ethical, well-laid out and correct clinical
trials must be put in place and India
will have to be a major site for such
trials: our size, diversity and problems
leave us no choice.
What do you think is the future of the clinical trials industry in our country with the current policy landscape? What is
the outlook for this sector?
The future is bright. Simply because
we have to do this correctly and do
it well. The Health Ministry is going
through an extraordinarily diligent
process in putting processes in place.
This will happen soon and we must
work together to ensure that we all
participate in this process, keeping
our higher-goals of being correct and
rigorous in all what we do to further
research and application of biomedical sciences in the service of humanity. There is a great future for the sector as long as ‘industry’ and all of us
keep in mind that our shared purpose
is the service of humanity.
What are the plans of the Department to promote awareness
on the various potential sub-sectors and their prospects? Also,
could you outline the academic,

research and industry initiatives?
The applications of today come from
investigator inspired basic- research of
yesterday. If India is to be a knowledge
power, we must either defi ne worldclass basic research problems from
our contexts or excel in problems that
the West has defi ned. Being an excellent training ground for high-quality
science is necessary but not sufficient.
So, we must and will expand and
deepen our foundations. From this,
we will move to team-driven research
to solve complex problems.
We are doing both of these as well
as speeding up the collaborative environment between institutions and
industry. Check out the BIRAC website for details on the latter.
As a policy maker which country inspires you?
Strangely, right now it is India. We
have problems, we have a mess and
we are searching for solutions. Yet, we
have debates and a crisis brings out
the best in us. We have every problem
in the world and we have all the solutions within. Our solutions in affordable health, energy, and sustainable
development will have lessons for the
world. Every impediment is a challenge to us, a challenge to admit and
correct errors, a challenge to convince
detractors that we will change where
wrong but we will be fi rm where we
are right, particularly when we are
saving lives by being active and being
callous by waffl ing.
What is your vision for the industry? Where do you want India
to be ten years from now?
Ten years is too long. Here is my challenge for this industry. Many regard
the rupee as falling or fallen. Can
we make this into an opportunity to
transform India, in five years, into a
manufacturing hub for biotech by
partnering within and abroad? Our
generics and vaccine industry is world
famous. My vision is to make India a
world-class hub for innovative biotech

in the coming years.
The government is yet to take a fi nal
call on FDI in pharmaceutical companies with divergent views among
various departments. While there is
a concern of very high priced acquisition of Indian government companies
in the past, some in the government
are not sure if FDI will lead to higher
production of affordable drugs in the
country.
In the last 20 years or so, India excelled
in generics because of our strength in
reverse chemistry and favourable policies such as for `Process Patent’ rather
than a `Product Patent’. Currently, the
Indian pharmaceutical industry is one
of the world’s largest and most developed, ranking 4th in volume terms
and 13th in value terms. The country
accounts for 8% of global production and 2% of the world’s market in
pharmaceuticals. Most of the domestic pharmaceutical drug requirements
are met by the domestic industry. India has the largest number of US FDA
inspected plants (119 plants) outside
the USA. Many of these drug companies supply medicines to around
200 developing countries all over the
world at affordable price.
The policy on 100% FDI on pharma
via the automatic route was encouraged based on the premise that foreign companies would bring in newer
technologies, invest in infrastructure
and promote R & D. This would mean
they would re-orient the Indian companies from doing mainly brownfield
projects to greenfield projects.
Most M&As have taken place with
companies which were best in generics with a market share close to 40%..
Companies that were acquired have
large manufacturing capacity and
contributed tremendously in making
the country self-reliant in lower cost
and affordable public health drugs
and vaccines. Their mergers through
the automatic route those with a large
premium has led to thinking about
how to stimulate investment in green-


LSI
INTERVIEW
semination of technological invention and protection of public health
and nutrition. Internationally, the
United States of America, Canada,
UK, Italy have issued CL in many
sectors including the pharmaceutical. About 52 Developing and
Least Developed Countries issued
CL after the Doha Declaration on
the TRIPS agreement and Public
Health, in Brazil in 2007 for an
anti-AIDS drug; Thailand in 2006
and 2007 for anti-AIDS drugs;
Malaysia in 2003 for Anti-AIDS

My vision is to make India a world-class hub for
innovative biotech in the coming years
field projects over brownfield ones.
Being a signatory of the WTO, India
will be driven to develop new molecules which means spending on appropriate infrastructure for R&D and
skilled manpower. How FDI can help
here is a very important ongoing debate.
Many drug companies are
asking for Compulsory Licensing
to manufacture patented drugs.
What should be the policy?
The government’s policy as initiated
by the Commerce Ministry is clear
and I would refer you to it for details.
Compulsory licensing is an important system to produce and market a
patented product or process without
the consent of the patent owner. This
mechanism enables timely intervention by the government to achieve
equilibrium between two objectives--rewarding inventions and in an
emergency, making them available to
the public during the term of the patent.
Through such an intervention mechanism, governments balance the
rights of the patent holder with its
obligations to ensure working of patents, availability of the products at a
reasonable price, promotion and dis-

drugs; South Africa for Anti-AIDS
Drug; Kenya issued voluntary licenses
in 2004 and Ecuador in April 2010 for
an anti- AIDS drug.
Recently, some have called in favour of
Compulsory Licensing even going beyond it to obtain Obligatory License,
or OL, which is a system where royalty is paid to the patent holder. This
view refers to a system which allows
country to copy any drug as long as it
pays 4% royalty to the patent holder.
The debate continues.
Our National Pharmaceutical Policy recognizes the need to ensure an
abundant availability of good quality essential pharmaceuticals of mass
consumption at reasonable prices.
However, there are diseases where
due to high cost, the demand is low, as
people cannot afford the costs. Take
the case of cancer drugs: if we accept that there are about 20 to 25 lakh
people suffering from various cancers
in the country at any time, a conservative estimate of the average cost of
anti-cancer medicines at Rs 25,000 per
annum/patient would require drugs
worth Rs 5,000 crore. However, the
present turnover of cancer medicines
in India is only about Rs 150 crore
which reflects non-accessibility of the
medicines to a vast majority of the af-


fected population due to high cost.
No matter what our views on CL, accessibility cannot be ignored. This is
a public health access issue that we
must address while keeping our treaty
obligations.
Though the government has
announced a pricing policy for
essential drugs, it is yet to announce a pricing policy for patented drugs, which always enjoy
freedom due to the high cost of
drug development. Which factors
should the government consider
for a pricing policy for patented
drugs?
Under the WTO, India respects product patents. It is a fact that each new
drug development takes tremendous
effort, time, skill and money. The
argument is that a company which
spends on all these requirements
would like to recover costs and earn
a profit. While the greening of patents
by minor changes is not supported,
pricing for newer drugs is a complex
issue which need to address the dual
issues of affordable access and a legitimate recovery of development costs
and consequent profits.
Some recent changes made in the
clinical trials rules by the DCGI were
governed mainly by the fact that
while India has been a participant in
the global trials of most new drugs,
such drugs are either not released in
India initially or released at unaffordably high prices. In times of emergencies, governments can take recourse
to CL or OL to bring down the costs
automatically or develop technologies indigenously in a short time as
in the case of the H1N1 vaccine. Public health needs and the demand in
socially-driven health projects such
as childhood immunisation, tuberculosis-RNTCP, NACO-HIV-AIDS etc
are areas where issues are likely to be
addressed in a manner which serves
public interest and is compliant to our
treaty obligations. Pricing is not the
only way of addressing this tangled
issue!

LSI
POLICY

Realizing the opportunity from
Pharmaceutical Patents in India –
an empathetic approach is the key
pocket. Even though coverage of
government-sponsored and private
insurance is growing and is expected to cover 500 to 600mn (50% of
the population) by 2015, much of it
will be state sponsored health insurance with very limited fi nancial
resources given the volume of population that needs sponsoring.
The urgency of India’s need for access to advanced medical interventions including innovative pharmaceutical products cannot be
overstated. Given this pressing need
and the enshrined vision statements
of MNC pharma that place patients’
need at the core, addressing India’s
health needs should invariably be
high on the agenda of most MNC
pharma companies. However in reality, India has not benefitted much
from latest innovations of the pharmaceutical MNCs despite adopting
product patent regime in 2005 after signing the TRIPS agreement.
There are three major reasons cited
for this viz.

T

he skew between India’s disease burden and access to healthcare is remarkably stark. India constitutes 17% of the world’s population, but bears a
disproportionately high share (21%) of the world’s
disease burden and accounts for a grossly insufficient 1%
of the world’s healthcare expenditure. Less than 8% of India’s population have an annual household income above
$30,000 contrasting to 70% of US population (on a purchasing power parity basis). To further aggravate the affordability issue, 61% of India’s healthcare expenditure is out-of-

1. Pricing- Readiness of the market to afford the expected pricing
of patented products as defi ned by
global floor price
2. Patentability- Perceived inconsistency in the administration of patent laws according to the TRIPS agreement
leading to anxiety regarding grant of patent
3. Patent protection- Employing the provision of Compulsory Licensing in the event of emergency or market
failure.

Pricing
We believe pricing of patented products for emerging markets like India has to be very different and should not follow the philosophy and methodology followed in developed markets.

LSI
POLICY

(It is also important to note that there is an increasing scrutiny on the fairness of patented products pricing even in
developed economies driven by a belief that the current
pricing is exorbitant and untenable and is a result of inefficient R&D management and over provisioning for the cost
of risk).
A comparative analysis of prices in India vis-à-vis prices in
US, calibrated for income levels in India (per capita GNI at
PPP) demonstrates that current prices in India are higher
by 3 to 10 times for a few patented drugs.
India

ented medicine pricing
balances the multiple
and contrarian objectives of ensuring patient
access, economic sustainability for the payor
(private and public) and
the commercial interest
of innovation driven
companies. Given India’s dual challenge of
a
disproportionately
high disease burden
and scarce fi nancial resources, coupled with
the stated objective of
MNC pharma of putting “patient fi rst”, an innate sense of social solidarity and
compassionate pricing is expected from MNC pharma companies. However, their participation in the Indian market
must be value-accretive and not loss-making for MNC interest to sustain. Given this context, we suggest the following principles for defi ning a robust framework for patented
drug pricing for India –

Notes
1. GNI (Gross National Income) PPP methodology can
be followed by adjusting the international reference
US

Per capita GNI, PPP ($)

% by which price in India is higher

3,840
1

Per capita GNI PPP factor
Brand A (Cancer therapy)

50,610
13

Price in Rs.

38,781

123,567

Adjusted for per capita GNI PPP

38,781

9,376

Price in Rs.

41,039

56,705


41,039

4,302

Price in Rs.

1,638

6,518

Brand B (Immuno suppressant)
Brand C (Smoking cessa•on)


1,638

495

Price in Rs.

20,274
20,274

4,044

954%

53,295


414%

Brand D (An•-rheuma•c)

331%
501%

Source – World Bank, CIMS, RxUSA pharmacy

An interesting example is that of the most successful patented product in India which is a leader in its category and
has achieved sales in excess of Rs.200 crore in a fi fth of the
time taken by some other brands to reach similar scale, on
the back of “India friendly pricing” (i.e. India price is nearly
equivalent to the per capita GNI PPP adjusted US retail
price).
Determination of patented product pricing is complex and a
crucial aspect with far reaching implications. It is thus imperative that the framework for a robust and effective pat44 LIFESCIENCE INDIA | August - September 2013

prices of patented medicines by the ratio of per capita
income of reference countries to India and considering
the lowest of these GNI (PPP) adjusted prices as the
floor price.
2. Marginal cost to consider cost of production, variable
costs of distribution and sales/marketing. It is assumed
that expenses on R&D and overheads are a fi xed sunk
cost incurred without considering India as a market and
thus should not be reimbursed.

LSI
POLICY
‘Intensity’ of need i.e. alignment to India’s epidemiological context
‘Improvement’ i.e. effec•ve
compared to therapeu•c
equivalence

Mass market

Niche

No therapeu•c equivalent
in India i.e. substan•al
improvement

Lowest interna•onal reference price adjusted for per
capita GNI (at PPP)1 or Marginal cost2 whichever is
higher, given volume advantage offered by the high
disease burden

Lowest interna•onal reference price adjusted
for per capita GNI (at PPP)1 or Marginal cost2
+ reasonable margin whichever is higher

Therapeu•c equivalent
exists in India i.e. marginal
improvement

Cost of treatment using therapeu•c equivalent drug
in India should be used as reference with addon premium based on Compara•ve Effec•veness
Research (add-on compensa•on per addi•onal unit of
health outcome e.g. per addi•onal Quality Adjusted
Life Year or QALY saved)

‘Indigeniza•on’ of business
model (i.e. level of localiza•on
of produc•on)

Addi•onal incen•ves over and above the base price
for encouraging localized produc•on (especially for
mass market drugs)

While this framework can be used for patented drug price
fi xation for the pharmaceutical retail market, in case of public procurement of patented drugs, the Government could
use these prices as reference for further negotiations.

Patentability and Protection
In the recent past, MNC global leadership have expressed
their concerns around India's commitment for establishing
a robust and effective patent regime. Much of it is based on
the judgement where the highest judicial authority of India,
the Supreme Court, has taken a position denying patent to
a product on the basis of insufficient innovation or invoking of compulsory license on the basis of market failure by
patent appellate authority.
While we are not experts in patent laws, our discussions
with legal experts have revealed that the judgements have
been robust and well-rounded in their assessment and
completely within the limits of provisions entitled under
the TRIPS agreement.
It is pertinent to note that WTO has not been supportive
of this criticism by MNC pharma companies. WTO Director-General Pascal Lamy said the following on this subject
"Recent decisions by the courts in India have led to a lot
of protest by pharmaceutical companies. Decisions made
by an independent judiciary have to be respected as such.”
He also mentioned “TRIPs provides flexibilities that allow
countries to issue compulsory licences for patented medicines to address health urgencies.”
We do not subscribe to the view that denying a patent for
something that has been awarded patent in developed
economies is any indication of India's capability or commitment towards building a robust IP regime in India. There
are several studies that have analysed and concluded that

much of the innovations that have won patents in pharmaceutical ingredient may not stand a stringent test of significant incremental therapeutic effectiveness. Given that
we have the highest burden of diseases and substantially
less fi nancial resources both privately and at Government
level, India needs to be very judicious in matters of patentability to ensure that only true innovation is respected and
rewarded.
A robust and effective patentability and patented drug
pricing can also mitigate the apprehensions caused among
MNC pharma companies by the provision of Compulsory
Licensing. A pricing mechanism aligned to the paying propensity of India’s population would reduce the need and
frequency of invoking this provision thus promoting its judicious use. However, the provision of Compulsory Licensing must be retained so that the same can be invoked by the
Government in case of national emergency or for a specific
list of essential medicines aligned to India’s epidemiological requirements.
In conclusion, we believe there is a need to have an empathetic approach between the Government and MNC
pharma to arrive at a workable model for realising the intended benefits of TRIPS agreement. Government cannot
expect Companies to make loss in serving India market at
the same time pharmaceutical companies have to realise
that their pricing cannot be seen from the lens of global
floor price. Policy of any country should always focus on
larger interest of its population and Companies must fi nd
a way to develop business models that are relevant for the
population at large rather than expect policy that suits their
global business model.
The writers are Ajit Mahadevan and Murali Nair
Partners- Performance Improvement Ernst & Young LLP

LSI
POLICY

FDI in pharma in India
the need for a clear policy regime

continued to buy big domestic companies. Stringent conditions were introduced into the policy along with a mandatory FIPB nod. With complications in this policy decision
the Indian pharmaceuticals sector has attracted $11.3 billion in FDI, but the buyout of some big Indian companies
by MNC drug makers raised public healthcare concerns,
which led to one round of policy tightening.
The government had earlier this year put FDI in pharma
companies on the approval route, but had not lowered the
100% limit. Stringent conditions, such as mandatory manufacturing, and research and development, were imposed.
Over the past five years, foreigners have acquired Ranbaxy
Laboratories, Dabur Pharma, Matrix Lab, Shanta Biotech,
Orchid Chemicals and Piramal Health Care.
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’ acquisition of Piramal Healthcare.

-Hareeni Mageswaran

F

DI in pharmaceutical sector had only begun to see
activity after Prime Minister Manmohan Singh
himself endorsed policy changes to ensure that big
acquisitions of domestic drug companies by multinationals did not deny cheap drugs to Indians. Pharma
is one of the select sector that has managed to attract FDI
flows even as over all FDI into the country declined. The
DIPP's move for a review of the policy comes when the government has liberalised the FDI regime to attract dollars
into the country and Singh himself has promised a more
liberal regime to foreign investors. India had opened pharmaceutical sector to 100% FDI via the automatic approval
route in 2002, but last year was when it made a distinction
between greenfield projects and brownfield ones following
fears that Indians will be denied cheap medicines if MNCs

As a direct reaction to the takeovers, the government
through the Ministry of Commerce and Industry (Department of Industrial Policy and Promotion) amended the FDI
policy in November 2011 by permitting FDI up to 100% for
investments in existing companies in the pharma sector
through the Foreign Investment Promotion Board (FIPB)
approval route. At the same time, FDI up to 100% under the
automatic route was continued for greenfield investments
in the pharma sector.
The FIPB has laid out conditions for approving future proposals. MNC fi rm looking at buying a stake higher than
49% in an Indian pharma company will have to maintain
the same level of investment in research activities and production of NLEM drugs for next five years.

Facts to ponder
•

The government had kept decision on Mylan's takeover
of Agila Specialties, the injectables division of Banga-

LSI
POLICY

•

lore-headquartered Strides Arcolab, in abeyance till the
department of industrial policy and promotion (DIPP)
fi nalises its policy on FDI in brownfield pharma. Mylan's proposal, which would be the largest FDI induction so far this fiscal, has already received Competition
Commission of India's endorsement.
FIPB's decision on Symbiotec Pharmalab Limited's proposal has also been put on hold following DIPP's reservations.

Key Stakeholder’s Speak
Sujay Shetty –Director Leader Pharma LifeSciences
PWC
“Worldwide economies are bending backwards to attract
FDI in pharma sector, the Indian environment leaves the
investor in a no certainty climate that has set a gloomy tone.
As a result of the added regulatory oversight FIPB and CCI,
it is expected that these developments will add significant
time to the process of Mergers and acquisitions in India and
as a result will create further uncertainty in M&A ‘s. The
increasing number of stakeholders in this case like the Department of Pharma, Ministry of Health and all stakeholders further casts the gloom web. The Indian market is a very
price-sensitive market. For companies active in the area of
branded generics, this is defi nitely one particularity that
needs to be taken into account. The second aspect worth
mentioning is the labour attrition. With attrition rates as
high as the IT sector, it is very difficult for pharmaceutical
companies to keep hold of their people. A third aspect some
MNC clients have been concerned about in the past has
been the discussion of a cap on FDI. For some of the MNCs,
counterfeiting has also been a concern, although the government has recently run a study that minimized this problem. Overall, it is a highly competitive market.” He says
“having summed the industry my plea to the policy makers
is carve a unilateral pattern of working ,and work closely
with the Industry and clear the muddled negative signalled
landscape for the Investor .
Dr Vijay Raghavan – Secretary DBT
In the last 20 years or so, India had excelled in generics because of our strength in reverse chemistry and very
favourable Government policies such as for "Process Patent" rather than "Product Patent”. Currently, the Indian
pharmaceutical industry is one of the world’s largest and
most developed, ranking 4th in volume terms and 13th in
value terms. The country accounts for 8% of global production and 2% of world markets in pharmaceuticals. Most of
the domestic pharmaceutical drug requirements are met by
the domestic industry. India has the largest number of US
FDA inspected plants (119 plants), outside the USA. Many
of these drug companies supply medicines to around 200
developing countries all over the world at affordable price.
The policy on 100% FDI on pharma through automatic

route by the GOI was encouraged with the premise that
foreign companies would bring-in newer technologies, invest on infrastructure and promote R & D which means,
they would re-orient the Indian companies from doing
mainly brownfield projects to greenfield projects. Most
M & A have taken place with the companies which were
best in generics and holding close to 40 % of the market.
Companies that have been acquired have large manufacturing capacity and contributed tremendously making the
country self-reliant in public-health drugs, cheaper costs
and affordable vaccines. Their mergers through the automatic route that too with large premium has led to thinking
about how to stimulate investment in greenfield projects
over brownfield ones.
Foreign Investment Promotion Board – “The Government allows 100 per cent FDI in pharmaceuticals, but
while investments in new projects are allowed automatically, investments in brownfield or existing pharmaceutical

FDI in pharmaceutical sector had only
begun to see activity after Prime Minister
Manmohan Singh himself endorsed policy
changes to ensure that big acquisitions of
domestic drug companies by multinationals
did not deny cheap drugs to Indians
companies are required to be routed through the Foreign
Investment Promotion Board (FIPB) since late last year.
Investment up to 49% will be on the automatic route but
investment above that will be permitted only with prior
FIPB approval. Moreover, investors will have to ensure that
if foreign direct investment exceeds 49%, one-fourth of the
total investment will go towards enhancing production of
the existing facility or to set up greenfield operations. No
change is proposed in the policy with regard to foreign direct investment in greenfield facilities, where 100% investment will be allowed under the automatic route.”
DIPP- The DIPP, which is the nodal body for FDI policy,
has circulated a draft Cabinet note that seeks to bring down
the FDI limit in such companies to 49% and calls for putting foreign investment in drug facilities defi ned "critical"
on the approval route. The current policy allows up to 100%
FDI in Indian drug makers following government nod. The
DIPP spokesperson shared “The DIPP is keen on placing a
check on the acquisition of existing pharmaceutical projects,
as it is concerned that it could seriously affect the country’s
capacity to produce low-cost generic drugs. It wants to impose restrictions on at least three categories of pharmaceuticals —vaccines, injectibles and oncology medicines — in
addition to bulk drugs.”

LSI
OPINION

Future of healthcare

IT outsourcing
Dr. Saji Salam MD, MBA

G

artner forecasts that spending by global healthcare
providers for IT services
will grow by 6% to reach
$30.4 billion in 2013. Consulting, with
9% growth in 2013, will be the fastest-growing sub segment within the
global healthcare provider market for
IT services.
U.S. healthcare delivery systems face
unprecedented transformational decisions driven by the combination of
healthcare reform and regulation.
As the future of outsourcing changes,
the healthcare industry in the developing world is bound to adapt to those
changes. There are fundamental forces at work that go beyond the tradi-

tional spin on outsourcing we hear
from the IT trade bodies. Some of the
key factors that drive outsourcing in
the future would center around demographics, education, labor mobility,
and healthcare and immigration reform in developed economies. One of
the challenges that US, Europe Japan
and China face today is the changing
demographics, especially the increase
in the graying population. To maintain
an aging population these economies
need a critical mass of young educated
work force. The critical question then
becomes, where is this educated talent pool?

IT demand and supply: a
hard look at the numbers
In 1999, with the rise of e-commerce,
enrollments in computer science in
the US hit new highs; the average
computer science department had an
enrollment of about 400 students. But
with the dot-com crash, enrollments
started to fall and hit bottom around
2007, at 200 per department.The average enrollment per department today
is just over 300 students at PhD granting institutions. Estimates today range
from 100,000 - 125,000 computer science enrollments per year in the US.


Per NASSCOM (National Association
of Software and Services Companies)
India produces about 550,000 engineers annually. Despite debates on
quality of the education in India, and
the percentage of these engineers that
are really employable, the sheer numbers do point to the magnitude of the
talent gap.
The professional services sector in US
is expected to create 5 million jobs by
2016 a growth of 16.7 percenatge.Computer and mathematical science occupations are projected to add 822,000
jobs by 2016 —at 24.8 percent growth,
the fastest growing segment among
professional subgroups. Though IT
services in US have been hit by the recession, the impact has been lesser (so
far) compared to other sectors.

Talent war: create vs import talent?
To keep the US/European economies
aﬂoat, it is imperative to ﬁ nd employees in the productive age group
to work and contribute towards taxes
and social programs such as Social
Security and Medicare. Of course the
economy has to create jobs; however a
critical mass of educated workforce is

LSI
OPINION

One of the challenges that US, Europe
Japan and China face today is the changing
demographics, especially the increase in
the graying population
also required to take on those jobs. In the US alone, there
is a shortage of 40,000 healthcare IT professionals and a
projected shortage of 75,000 physicians and 500,000 nurses
by 2020. Making college education affordable is a basic fi rst
step towards creating this talent pool. If generating homegrown talent is not working well, then the immigration
policy has to be streamlined to facilitate smoother flow of
labor to the US.

Immigration and Healthcare reform:
To address labor shortages in the future, a comprehensive
immigration reform that addresses the talent shortage in
the country is needed. Studies by National Foundation for
American Policy state that each H1B visa provided actually
creates 5 additional jobs in the US economy. There could be
counter arguments as well in the immigration debate, especially in the wake of unemployment numbers in the US.
Europe, UK and Australia and the Middle East are attempting to attract Indian talent with various immigration programs to fast track growth in their economies. The shape
and form of immigration system in the US/Europe will
have to change dramatically to attract talent. Though the
US continues to be the destination of choice for most immigrants, several fi rst and second generation immigrants
from emerging economies are making a beeline to return
to their home countries to be part of the exciting growth
stories there.

Healthcare provider IT pie: MNCs vs
Indian Vendors
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 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
global healthcare provider IT market is cornered by IBM,
CSC, Accenture and Deloitte. In the last few years these
MNC fi rms have made very good progress in ramping up
their offshore capabilities in India.
On the other hand Indian vendors have made very little
progress moving up the value chain or cutting into the integrated service offerings that their global peers are able to
provide. Indian vendors may lose out if they do not make
the investments necessary to move to the next level. The

major challenge that Indian vendors face is the lack of investment to acquire domain knowledge. Indian vendors
have to move beyond downloading and rehashing content
of the Net and throwing in a few key phrases from the industries they service to really building deep industry knowledge. Some of the outsourcing companies present revenue
generated by business analysts as consulting revenue, and
the Indian media gobbles up the numbers. While one can
manage to impress the media with such stories, the clients
in the markets they service have more stringent criteria to
evaluate industry knowledge. Though a handful of Indian
outsourcing companies have a mild to medium presence in
the health insurance sector, it is a different story all together in the provider (hospital) market. While growth in the
health insurance sector has slowed, Indian vendors have
not been able to make a dent in the provider market, which
is growing rapidly. The established players make $ 50- 60
million from each large EMR implementations in the provider segment.

Challenges
Though the IT industry grew in India despite the political
system, India Inc has come to an inflection point, where
the political will to address a host of infrastructure, security
and social challenges is critical for the industry’s move to
the next level.Adding to the challenges is the fact that the
cost arbitrage may be impacted by the vagaries of foreign
exchange fluctuations. The risk of a falling dollar, in the
context of high inflation in the US that may follow the injection of trillions of dollars into the US economy via quantitative easing needs to be considered. Corporate governance
will continue to play a role in the future of outsourcing as
the recent scam at a top five Indian outsourcer reminds us.
The emergence of several large and small players across the
world that are able to provide cheaper labor needs to be
watched as well. Though these players may not be able to
build scale, they could develop niche skills that eat into the
total outsourcing pie.

India Inc vs the Indian professional
Irrespective of the fate of Indian IT vendors, or India as an
offshore IT destination, Indian professionals will continue
to be in demand as they continue to fi ll up the jobs vacated
by graying population across the world. Indian professionals may travel to where the jobs are, or the jobs may travel
to where the Indian professional is located. In the future
of outsourcing, demographic stars seem to be aligned in
favor of the ubiquitous Indian professional, a sort of microoutsourcing shall we say?
Dr. Saji Salam is a healthcare management consultant based out
of Minneapolis and serves as Director of Clinical Informa•cs at
a mul•na•onal informa•on services firm. He can be reached at
salamsaji@gmail.com

LSI
SPOTLIGHT

Biopesticides-

Ecofriendly Pesticides
V.VIJAYA KUMAR, Manager(Biotech),
Core Green Sugar & Fuels Pvt. Ltd., Karnataka

Biopesticides or Biological Pesticides
have been defined as a form of pesticides
based on microorganisms or natural
products. They include naturally occurring
substances that control pests (biochemical
pesticides), microorganisms that control
pests (microbial pesticides), and pesticidal
substances produced by plants containing
added genetic material (plant-incorporated
protectants) or PIPs.

LSI
SPOTLIGHT

Advantages of Biopesticides
1. They are less harmful than chemical pesticides.
2. They are often effective in small quantities.
3. Biopesticides give protection throughout the crop period.
4. They multiply easily in soil and leave no residual problem, eliminate the pathogens/pests from the site of infection.
5. Highly effective against specific diseases/ pests, can be
used in combination with Biofertilizers.
6. They do not cause toxicity to plants and are eco friendly.
They are safe to the environment and the person who
applies them.
7. Along with controlling the plant diseases and pests,
they can be used as a component in IPM (Integrated
pest Management) and greatly reduce the use of conventional pesticides, while the crop yields remain high.
They are easy to handle.
Mode of action of Biopesticides is not similar for all the Biopesticides. It differs based on the organism used as a Biopesticide and pest that is to be controlled.
The following are the categories of Biopesticides that are being
widely used:
1) Microbial Biopesticides
a) Bioinsecticides: Bacillus thuringiensis is the classical
example of microbial pesticide, which controls the Lepidopteron insects in cotton by secreting a crystal protein.
After ingestion of the crystal protein by the insect, it
stops feeding and dies. The genes from Bacillus thuringiensis are introduced through genetic engineering
technique into the cotton genome and the protection
against insects through out the life cycle of the crop
period, became a reality. Beauveria bassiana, Metarrhizium anisopliae, Verticillium lecanii are the other
commonly used bioinsecticides for controlling various
insects.

pests are called as Botanical Biopesticides. Azadirachtin
extracted from the neem seeds is a classical example of
Botanical pesticide. It acts as anti feedant and kills the
various insects. Sqamocin, extracted from the seeds of
Annona squamosa is another useful biopesticide for
control of insects.
3) Viral Biopesticides: Granulosis virus and Nuclear Polyhedrosis Virus (NPV) controls many caterpillar pests.
NPV affects alfalfa looper, corn earworm, imported
cabbageworm, cabbage looper, cotton bollworm, cotton
leafworm, tobacco budworm, armyworms, European
corn borer, almond moth, spruce budworm, Douglas
fi r tussock moth, pine sawfly and gypsy moth. The vial
biopesticides invade an insect's body via the gut. They
replicate in many tissues and can disrupt components
of an insect's physiology, interfering with feeding, egg
laying and movement.
4) Plant Incorporated Protectants: The genes from Bacillus
thuringiensis (Bt) are introduced through Genetic Engineering into the cotton genome and protects against insects throughout the life cycle of the crop. The Bt genes
are introduced successfully in potato, maize, soya bean
to kill insects pests. Research is underway to introduce
Bt genes in egg plant, okra, cabbage, cauliflower, tomato, wheat and rice in India.

b) Biofungicides: Trichoderma viride and Pseudomonas
species are the commonly used fungal & bacterial Biofungicides that controls various soil borne fungi that
causes wilt, rots, damping off etc. diseases in various
crops. They control fungal pathogens by various mechanisms such as competition, mycoparasitism, antibiosis & lysis and induced systemic resistance. When the
spores of the fungus come into contact with the body
of an insect host, they germinate, penetrate the cuticle,
and grow inside, killing the insect within a matter of
days. Afterwards, a white mold emerges from the cadaver and produces new spores.
2) Botanical Biopesticides: The natural extracts from different parts of the plant that are used to control insect


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SPOTLIGHT
Pheromones are secreted
to indicate the location
of food sources, to warn
others around about potential dangers, or locate
a potential mate for reproduction.
Female moths release a
sex pheromone into the
air to attract male moths.
Male moths detect the
pheromone "scent" and
then follow it to locate
and mate with the female.

Other Biopesticides:
1) Predators: Chrysopa carnea and Chrysopa rufi labris are
found abundantly in the fields. They lay eggs on foliage.
After hatching in a day or two they feed on aphids, larvae,
eggs, small worms, mites, thrips and immature whitefly.
2) Parasitoids: Trichogramma is an exclusive egg parasitoid. It lays eggs in the eggs of various Lepidopteron
pests (Moths, Butter fl ies etc.). After hatching the larvae
feed on the host egg and destroy it. Being an egg parasitoid, it destroys the pest population before it causes
any damage to the crops. It is used against sugarcane,
paddy, fruits and vegetable pests.
3) Entamopathogenic nematodes: Heterorhabditis is an
entomopathogenic nematode used for control of different beetle larvae in soil. It searches the host in the
soil and after active penetration into the larval body
through the cuticle, the nematode releases a symbiont
pathogenic bacterium (Photorhabdus), that multiplies
rapidly and kills the host, within 24 to 72 hours. Heterorhabditis and Photorhabdus then feed upon the insect. Spawned juvenile nematodes then search for new
hosts.
4) Pheromones: These are the Biochemical Biopesticides.
Pheromones are chemical signals that trigger a natural response in another member of the same species.
Insects release pheromones to serve many functions.

Synthetic
pheromones
can be used to disrupt
pest ecology and reduce
crop damage. Small
amounts of synthetic female pheromone is used
to attract males into
traps, by measuring trap
counts, the data can be
used to predict the insect
population and a decision on appropriate pest control measures can be initiated.

Status of Biopesticides in India
The consumption of Biopesticides in the year 2011-12
is 5170.69 Mts. Bt accounts for around 15 % of total consumption of biopesticides in India and its consumption is
increasing at a rate of about 10% per year. Neem based
pesticides, NPV and Trichoderma are the other major biopesticides produced and used in India. Central Insecticide
Board Registration Committee (CIBRC) has registered 21
Biopesiticides (18 Microbial Biopesticides and 3 Botanical
Biopesticides) for use in the country under section 9(3) and
9(3B) of Insecticide Act, 1968.
For quality control of bio-pesticides, Government of India
has notified, vide Gazette notification G.S.R. 756 (E) dated
15th December 2006, the 7 Laboratories in different States
(New Delhi, Uttaranchal, Jammu, Assam, Maharashtra,
Karnataka, Tamil Nadu) to function as Central Insecticides
Laboratory in respect of bio-pesticides. A total 834 pesticides have been included in the Schedule to the Insecticides
Act, as on 15-01-2013 by the Government of India by issuing the Gazette Notifications from time to time and listed
on the website (www.cibrc.nic.in).
Some success stories about successful utilization of biopesticides and bio-control agents in Indian agriculture include

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SPOTLIGHT
control of diamondback moths by Bacillus thuringiensis, control of mango hoppers and mealy bugs and coffee
pod borer by Beauveria, control of Helicoverpa on cotton,
pigeon-pea, and tomato by Bacillus thuringiensis, control
of white fly on cotton by neem products, control of Helicoverpa on gram by N.P.V., control of sugarcane borers by
Trichogramma, control of rots and wilts in various crops by
Trichoderma-based products and control of wilts in different crops by Pseudomonas fluorescens.

Constraints in Biopesticides production
The major constraint in Biopesticides production is their
slow activity, target specificity and limited availability.
Other constraints include limited shelf life and requirement
of skilled man power to produce good quality Biopesticides
without contamination.

Availability of Biopesticide Cultures
Good quality Biopesticides cultures (Fungal and Bacterial)
are available at
• Indian Type Culture Collection (ITCC) at IARI, New
Delhi
• Tamil Nadu Agriculture University, Coimbatore
• Microbial Type Culture collection (MTCC) at IMTECH,
Chandigarh
• National Collection of Industcial Microorganisms
(NCIM) at NCL, Pune

Regulations Governing Biopesticides
The Central Insecticide Board under 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 Sched-

ule, it should be mandatory to register at Central Insecticide
Board (CIB), Faridabad. After obtaining the registration
from CIB, then only the State Agriculture Departments of
respective states will issue the license for manufacturing
of Biopesticides and Principle certificates for Marketing of
Biopesticides.

Registration of Biopesticides at CIB:
The Biopesticides are to be registered with Central Insecticide Board, (Department of Agriculture, Govt. of India),
Faridabad, provisionally under section 9(3)b of Insecticides
Act 1968. The provisional Registration will be given for 2
years and extendable further, on yearly basis depending on
the progress of data generation and submission of the same
to CIB. During the period of provisional registration, the
products can be manufactured and marketed in accordance
with the specifications and the shelf life given in the provisional registrations.
After obtaining the provisional registration, the data pertaining to Toxicology, Bioefficacy, shelf life and container
content compatibility of product is to be submitted. After
all the conditions of provisional registration are fulfi lled,
then only the Biopesticide is allowed for permanent registration.

Role of Biopesticides in Economic Development
The Biopesticides can be used very effectively in Integrated
Pest Management Programme (IPM). By using Biopesticides reduction in chemical pesticides consumption can be
achieved. Pesticides residue problems can also be avoided,
which is a boon for Agricultural exports, where pesticidal
residues are the major problem. Biopesticides in combination with Biofertilizers play a key role in Organic farming
where the food crops, vegetables, fruits crops are grown
organically without using synthetic fertilizers/ pesticides.
The produce from these crops fetch higher income to the
farmers.

S.No

Names of Biopes•cides

Category

1

Bacillus species, Gliocladium Species, Pseudomonas spp, Agrobacterium radiobacter strain 84, Agrobactarium
tumefaciens Alcaligenes spp., Serra•a marcescens GPS 5

Bacterial

2

Trichoderma Species , Beauveria bassiana, Metarrhizium anisopliae, Ver•cillium lecanii, Nomuraea
rileyi,Hirsutella species, Streptomyces griseoviridis, Streptomyces lydicus, Candida oleophila, Fusarium
oxysporum (non pathogenic), Pythium oligandrum, Erwinia amylovora (Hairpin protein), Ampelomyces
quisqualis, Phlebia gigantean, Plaecilomyces lilacinus, Penicillium islanidicum (for groundnut), Aspergillus nigerstrain AN27, VAM , Chaetomium globosum, Piriformospora indica

Fungal

3

Grannulosis Viruses (GV), Nuclear Polyhedrosis Viruses (NPV)

Viral

4

Neem products (Neem leaves, Neem oil, Neem seed kernel, Neem cake), Squamocin

Botanical

Biopes•cides included in the Insec•cides schedule (Source: www.cibrc.nic.in)

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TECHNOLOGY

Improving Vaccine Development
and Production Using Rapid
Virus Quantification

V

irus quantification represents a rate-limiting step
at many stages of vaccine development and production, for both egg and cell culture. Currently,
one of the most widely used tools for the determination of virus concentration is the viral plaque assay,
or variations such as tissue/egg culture infectious dose
(TCID50/EID50). The viral plaque assay is a cumbersome,
subjective and traditional biological technique that was
originally applied to the quantification of animal viruses
in 1952. This assay requires significant hands-on time by a
trained technician, and has a time to result of several days
or weeks depending on the virus. Other methods for virus quantification exist, including a variety of ELISA-type
protein assays, transmission electron microscopy (TEM),
and quantitative PCR (qPCR). However, each of these approaches has its own drawbacks, perhaps the most important being that they require well-trained technicians and
have a significant time to result. The table below summarizes the primary methods of quantifying virus.

The ViroCyt Virus Counter 2100 was developed in response
to needed improvements in virus quantification. The instrument is a personal flow cytometer optimized for rapid virus
enumeration (less than 5 min analysis time) at a per sample
cost below $5. As illustrated in Figure 1, the Virus Counter
assay utilizes a dual fluorescence staining approach. Viral
genomes (and nucleic acids in general) are stained with a
dye that emits in the yellow region of the visible spectrum
and proteins in viral capsids (and other background pro-

teins) are stained with a dye that emits in the red region of
the spectrum. This “universal” approach to staining allows
for the detection of a wide variety of viruses using a simple
assay.In the instrument, stained viral particles are hydrodynamically focused through a laser probe region and subsequently detected via fluorescence on two separate optical
channels. Fluorescence bursts on each channel are counted
as a function of time. However, when fluorescence bursts
are simultaneously observed on both the nucleic acid and
protein emission channels the “simultaneous event” is
counted as an intact virus particle. The dual stain approach
provides some degree of discrimination from free protein
aggregates (counted only on the protein channel) or free
nucleic acids (counted only on the nucleic acid channel) in
solution. The number of simultaneous events counted during the analysis time is used in combination with sample

TECHNIQUE

ASSESSMENT

REPRODUCIBILITY

TIME

LABOR

COST/SAMPLE

Plaque assay

Infec!ve units

Poor

Days

High

Inexpensive

FFA

Infec!ve units

Poor

Days

High

High

TCID50

Infec!ve units

Poor

Days

High

Inexpensive

HPLC

Viral an!gen

Excellent

Days

High, experienced

High

HA

Viral an!gen

Good

Hours

Low

Inexpensive

SRID

Viral an!gen

Good

Days

Moderate

High

ELISA

Viral an!gen

Good

Hours

Moderate

Moderate-High

qPCR

Viral gene expression

Excellent

Hours

High, experienced

High

TEM

Viral par!cles

Good

Days-weeks

High, very experienced

Very High

Virus Counter

Viral par!cles

Excellent

10 minutes

Low

Inexpensive

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TECHNOLOGY
flow rate to calculate the volumetric
concentration of virus particles (Figure 2). Because the sample flow rate
is accurately and precisely measured
in real-time, there is no need for an
internal calibrant bead such as those
used in typical flow cytometric cell
counting assays.

Why Infectivity Assays
Are Increasingly Irrelevant
There are a variety of approaches for
determining viral titer, many of which
rely on measuring infectivity or the
amount of antigen, but do not enumerate viral particles. There is grow-

Comparing Infectious and Total Particle
Counts
To compare infectious titers with
total particle count, samples of influenza H1N1, Cytomegalovirus
(CMV), Respiratory Syncytial Virus
(RSV) and Rubella were measured
by TCID50 assay or plaque titer, Virus Counter 2100 instrument and
quantitative TEM. As shown in Figure 3, total particle counts determined by either TEM or the Virus
Counter were statistically identical,
while titer by TCID50 measured a
fraction of the total particles, with
counts ranging from 2-3.5 orders
of magnitude lower than TEM or
Virus Counter 2100 values. These
results highlight the relative abundance of non-infective particles as
a percentage of the total population
across multiple virus types.


ing evidence, however, that the number of non-infectious viral particles is
of significant biological importance
and can impact both in vitro and in
vivo studies. This mounting data suggests a need for rapid quantification
of the total number of viral particles
in a virus containing sample, which is
only possible using the Virus Counter
2100.

Background: The Biology and Biological Consequences of Non-Infective
Viral Particles
Although viral particles may be noninfective for a number of biological
reasons, defective viral replication
is often the cause. For example, viral capsids which lack genomes may
be produced during the packaging
phase, leading to empty particles.
Mutations or defects in viral genomes also result in the production
of viral particles which are incapable
of supporting full replicative cycles.
These include relatively minor mutations in key genes controlling the
viral life cycle or much larger-scale
defects.
In the case of so-called “defective
interfering particles” (DIPs) discov-

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TECHNOLOGY

ered in influenza, very large portions
of the viral genome are often missing.
A full replicative cycle is possible only
if the DIP particles are in the presence
of replication-competent, co-infecting
viral particles. In such a case, DIPs
may “piggyback” competent particle
replication offsetting their defects,
and as a result, DIPs compete for resources against replicative-competent
particles and have even been shown
to protect against lethal infections. In
addition to providing potential competition for critical resources, it has
been more recently documented that
DIPs affect the severity of infection
through modulation of host immune
response.
As a result of increasing amount of
research into non-infectious influenza particles, other classes of these
particles have been discovered.
Noninfectious cell-killing particles
(niCKP) found in influenza cultures,
interferon-inducing particles (IFPs),
and interferon induction-suppressing
particles (ISPs) all play significant
biological roles without causing viral
infection. The observation that these
non-infectious particle types actually make up the majority of particles
in active influenza infections, raises
the question of whether these particles should be ignored. DIPS have
also been documented in other virus
types. In Dengue viral infections, they
appear to play a role in natural biological attenuation. In HIV, genome replication errors due to the reverse tran-

scription process cause the formation
of DIPs which actively contribute to
infection through “priming” of CD4+
T lymphocytes.
In addition to their effect on biological
systems, monitoring non-infectious
particle numbers can be important
for other applications as well. During
production of the seasonal flu vaccine,
influenza is grown then purified from
chicken eggs. Following purification,
the virus particles are split apart using
a specialized reagent and the immunogenic HA proteins are harvested
from this solution. Non-infectious
particles that are known to have a protein capsid and a partial genome will
also contribute the immunogenic HA
protein after being split. It is therefore
essential during this process to have a
rapid method for accurately measuring total particle concentrations.
Other types of vaccine production
can also benefit from total particle
quantification. Attenuated vaccines
use a replication deficient version of a

virus to cause an immune response,
but with little to no viral infection.
Since these attenuated viruses do
not replicate, they will not cause the
cytopathic effect that most infectivity assays base their detection on. In
a sense, all attenuated vaccines consist of non-infectious virus particles,
and thus, the only methods to reliably
quantify them are total particle quantification methods. Virus-Like Particles or VLPs are an emerging vaccine
platform, and because of the requirement that they be devoid of genetic
material, are also non-infective. The
primary means of quantification are
currently antigen-based or depend on
analysis using electron microscopy.
Given the extensive biological role of
these non-infective particles, as well
as their impact on the development
and manufacture of viral vaccines, viral particle quantification is essential.

APPLICATION EXAMPLES
Rapid Quantification of Egg-Grown
Influenza
Embryonated chicken eggs have been
the primary means of producing influenza vaccines for many decades.
Although there has been significant
effort to move away from this system,
it will continue to provide the bulk of
the global vaccine supply during the
current decade and possibly well into
the next. Until newer cell-based approaches are validated and scaled-up,
there remains ample opportunity to

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TECHNOLOGY
improve egg-based methods. A notable bottleneck is the quantification of
virus along the entire vaccine development and manufacturing process.
Current approaches often require
days or weeks to obtain a result, limiting their utility or potentially delaying the time-critical process of getting
vaccines for seasonal and emerging
pandemic strains to the public. Consequently, there is an urgent need for
faster, more accurate methods of determining the amount of virus present during the creation of these lifesaving products.
An Overview of Influenza Virus
Growth in Eggs
Vaccination against harmful infec-

tious diseases has been one of the
most important global public health
advances of the past 100 years. Due
to surging demand for a wider range
of vaccines, the industry is facing the
challenge to updating from traditional, time-consuming methods to
new, more efficient technology. An
example of anticipated changes in the
vaccine industry is the drive to transition away from egg-based production of influenza vaccine toward more
nimble methods such as cell-culture,
recombinant protein expression and
virus-like particles. While there has
been significant progress, top global
producers of flu vaccine still rely heavily on eggs to grow the virus.

concentration within minutes, it can
have a significant impact at multiple
stages during vaccine research, development and production, such as those
indicated by a star in Figure 4 below.
These include:
• The selection of high-growth reassortants that have the appropriate antigenic properties for each
type and strain to be used in the
multivalent vaccine would significantly reduce the time to seed
stock selection.
• Faster elucidation of virus yield as
a function of various parameters
during culture would speed time
to scale up for production.
• Tracking virus concentration during subsequent purification steps

ety of viruses (Figure 5), which are
then inactivated and injected into
the individual to provide protective
immunity. Although the bulk of the
seasonal flu vaccine is still produced
in this manner, there are a number
of issues associated with egg-based
systems. Chief of these are the variability in growth characteristics of
each viral strain and batch to batch
differences between eggs. In addition,
even seemingly minor inconsistences
in incubation times can have a significant impact. Consequently, providing
as close to “real time” quantification
of total viral particle count during the
growth cycle is a primary unmet need
in the vaccine industry. Of utmost importance is the ability to take samples

is also essential in that identifying points where virus is lost will
enable process improvements and
lead to greater efficiencies in calculated in both time and money.
• The ability to track virus levels in
real-time, which is not possible
with traditional methods, will
ensure optimal harvest time with
maximal yields.
Using Eggs to Produce Flu Vaccine:
Primary Unmet Needs
Chicken eggs have been utilized since
the mid-20th century to grow a vari-

from a large representative number of
eggs, and rapidly prepare and analyze
the samples to allow for adjustments
in incubation conditions or immediately harvest.

Egg-based production has a long
timeline and requires close coordination between government agencies and vaccine producers to deliver
safe and effective vaccines before
the onset of flu season.Since the Virus Counter provides a direct, physical measurement of total intact virus

Same Day Determination of Virus
Concentration in Allantoic Fluid Now
that we’ve defi ned the unmet need for
a method that provides rapid, quantifiable and reproducible results, what
is the proof that the Virus Counter is
the solution, specifically with regards
to egg-grown influenza? The follow-

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TECHNOLOGY
ing are just a small sample of
results obtained by the Virus
Counter in this setting.

use of a given stock. It is worth
noting that the TCID50 assay
typically takes between 3-8 days
to perform, and is often subject
to significant variability.

Serial dilution curve. An essential fi rst step in validating
any quantification method is
to perform a serial dilution
analysis, whereby a concentrated sample is diluted by
known fractions and analyzed. In this example, samples of three different influenza strains were obtained
from allantoic fluid and diluted. The expected result is
to see a linear relationship
between the logarithm of the
dilution and the logarithm of
the result.

Comparison of Virus Counter
with qPCR. Quantitative PCR
(qPCR, also known as real time
PCR) utilizes primers specific to
the viral genome to amplify and
simultaneously quantify a targeted DNA molecule. The quantity
can be either an absolute number of copies or a relative amount
when normalized to DNA input
or additional normalizing genes.
Figure 8 illustrates a close correlation between the two quantification techniques. Notice the
much larger error bars for the
qPCR results relative to those for
the Virus Counter.

The results in Figure 6 show
good linearity across the
dilution series, with slopes
near 1. Data from the negative control do not show this
same pattern, as they are at
or below the stated limit of
detection of the Virus Counter of 1x106 vp/ml.

CONCLUSION
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. More often than not,
the long and complex steps of
taking crude material and transforming it into a product ready
for patients results in substantial
loss of material.

Comparison of Virus Counter with TCID50. Traditional
approaches to virus quantification fall into two categories: Those that determine
infectivity, and those that do
not. Examples of the former
include plaque titer assay
and tissue culture infectious
dose 50 (TCID50), and transmission electron microscopy (TEM) and quantitative
polymerase chain reaction
(qPCR) for the later.
Four different influenza
strains were quantified using
both the Virus Counter and
TCID50. As is typically the
case for influenza (and many other viruses), the number of intact virus particles per unit volume (vp/ml) is 1-2.5
logs higher than the number of infectious particles (Figure 7), due primar-

The ability to track essentially in
real time the quantity of virus at
beginning and end of each distinct stage will identify where
losses are occurring, and allow
improvements to be made. Even
small gains in efficiency at each
step would lead to considerable
fi nancial benefits.
ily to the abundance of the previously
discussed Defective Interfering Particles. Since DIPs are known to play
a role in immunity, these results can
provide information about subsequent

Michael Ar•nger, Michael Moeller
and Kevin Kohlmeier
The writers work at ViroCyt LLC,
Denver, CO, USA
mar•nger@virocyt.com

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TECHNOLOGY

NMR spectroscopy:
Creating waves in life sciences
-Neel Sarovar Bhavesh
ICGEB, New Delhi
http://www.neelsb.com

W

orld is visible to us through a fi ne interplay
between the matter, it is composed of, and
the light, that shines on it. Our limitations as
human beings allow us to see only a small
part of light, the visible part, which along with some of its
well-known cousins - X-rays, microwaves and radiowaves,
is part of a large family called the electromagnetic spectrum. This spectrum, similar to a rainbow, is made up of a
nearly infi nite number of ‘colors’ that cannot be perceived
directly by us. The way that matter interacts with the electromagnetic spectrum forms the underlying principle of
spectroscopy. Many of our scientific advances of the modern era, right from determining how fast the universe is
expanding to looking at the incredibly tiny atoms and molecules that make up our body, owe their success directly or
indirectly to spectroscopy. To put this in perspective, we
now know that a piece of our skin as small as the point of
a needle contains more than a thousand skin cells, each


of which contains thousands of proteins, carbohydrates,
fats, nucleic acids, and small compounds. These ‘biological
macromolecules’ and ‘metabolites’ in turn, are composed
of six basic elements – carbon, nitrogen, hydrogen, oxygen,
phosphorus and sulphur which, when arranged in an extremely ordered fashion, ultimately make us what we are.
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, NMR spectroscopy has evolved very rapidly
and become an essential tool for physicists, chemists, geologists, biologists, and clinicians. Technical advances in
NMR spectroscopy and its applications have earned twelve
Nobel prizes in the field of physics, chemistry and physiology/medicine confi rming its importance and ubiquitous
nature. In recent years, NMR has provided many significant breakthroughs, which were earlier thought to be near
impossible, like atomic-resolution structure of protein inside a living cell, functional imaging of brain, biomarker
identification using bio-fluids (urine, serum, saliva etc), oil
exploration, detection of explosives, quality control of wine
to name a few.

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TECHNOLOGY
NMR spectroscopy makes use of the fact that atomic nuclei, which usually spin randomly, sometimes tend to behave themselves in the presence of a powerful magnetic
field (about million times as powerful as that of the Earth!)
and get aligned in the same direction as this field. These
magnetized atoms can then be irradiated with a concentrated blast of radio waves (similar to those used in mobile communication) to see how they react. Their reaction
(called free induction decay) gives us vital knowledge about
how these atomic nuclei are affected by their environment
and vice. For instance, a carbon nucleus bound to hydrogen
will react differently as compared to one bound to oxygen.
Changes in atomic environments as a result of interactions
with other entities also result in unique NMR signals. Just
as each FM radio station has its own frequency band (98.3
megahertz (MHz), 93.5 MHz, to quote a few); every type
of atomic nuclei has its own unique radio frequency called
resonance frequency. In a magnetic field around 200,000
times that of the Earth, hydrogen atoms have a resonance
frequency of 500 MHz, carbon-13 (an isotope of carbon) atoms resonates the most at 125 MHz and nitrogen-15 (an
isotope of Nitrogen) resonates at 50 MHz. However, in the
presence of external influences, resonance frequencies undergo very minute changes. While the frequencies are in
the order of MHz (106 hertz), these minute changes are in
hertz (Hz) – very small, but detectable. These tiny changes
in frequency are called ‘chemical shifts’ (The phenomenon
of chemical shift was fi rst observed by Prof. S. S. Dharmatti who later initiated NMR research at TIFR, Bombay).
As long as the environment of an atom remains constant,
its chemical shift value also stays unchanged. A slight perturbation however, is sufficient to cause a perturbation in
chemical shift. Atomic nuclei give different reactions to a
radiofrequency pulse when placed in different environments and they start cross-talking with neighboring atomic
nuclei. This cross-talk with other atoms closer in space is
crucial for determining what any organic molecule, be it a

protein, nucleic acid or a small carbohydrate, looks like in
3D (The NMR technique to calculate 3D structure is called
nuclear Overhausser enhanced spectroscopy (NOESY) was
fi rst performed by Prof. Anil Kumar who currently works
at IISc, Bangalore). This development helped scientists not
only to visualize the atomic-resolution three-dimensional
structure of macromolecules in solution mimicking their
natural environment inside the cell but also study the dynamics and interactions. Though almost half a century
younger to X-ray crystallography, NMR spectroscopy has
contributed to about 40% of nucleic acid and 12% of protein
structures deposited in the protein data bank (PDB, http://
www.rcsb.org).
One might wonder what use might these have at a tangible level. NMR spectroscopy can tell you for instance, if a
particular protein can be a potential therapeutic target for
an anti-malarial or anti-tuberculosis drug, if the abnormal
level of a carbohydrate in blood marks the presence of a
potentially life-threatening tumor, or if an unexplainable
illness is caused just because one protein out of thousands
decided not to perform its intended role. NMR spectroscopy has proven to be indispensable in the design and
screening of such compounds. Moreover, the modes of action of many drugs have also been discovered using NMR
and other forms of spectroscopy. For instance, in 2010, a
group of scientists in Singapore found that a drug called
Tacrolimus or FK506, usually given to people who have had
organ transplants, also kills the malaria parasite by binding
specifically to a receptor called PfFKBP35 on its cell surface.
This discovery was possible largely by determining the molecular structure of PfFKBP35 before and after it bound to
Tacrolimus, using NMR spectroscopy.
The use of NMR in drug discovery is best highlighted in
case of the human survivin protein. This protein is an attractive target for anti-cancer therapy because survivin in
its inactive form makes immortal cancer cells to die in a
natural manner. Abbott laboratories have recently screened
a large number of peptides (small fragments of proteins) to
determine which would best fit onto the surface of the survivin protein to render it completely inactive. This was done
by fi rst determining the 3D structure of survivin protein by
NMR spectroscopy. The structure of the protein provided
clues to where possible drugs (peptide fragments) could
bind. The binding site would contain amino acids whose
atoms would undergo a large change in chemical shift
when bound tightly to a peptide and remain unperturbed if
no binding occurred, thus helping in selecting those fragments, which could potentially act as anti-cancer drugs.
This approach has been used for designing several drugs
in the recent past and comes under the banner of Fragment
Based Drug Discovery (FBDD).
The survivin case is also an interesting example of how the

LSI
TECHNOLOGY
study of biological interactions provides insight into possible modes of drug binding. The NMR derived 3D structure
of survivin protein showed that in its functional form, it
exists as a pair of two survivin molecules, together forming the shape of a bow and a tie. Under normal conditions
inside a cell, survivin binds to a peptide called Smac. The
exact amino acids of survivin that are engaged in this binding could be accurately determined using NMR, by checking the changes in chemical shifts of atoms inside survivin
after the addition of Smac. It could then be concluded that
these amino acids constituted the binding site on the survivin protein.
Just as NMR has proven to be a crucial implement for drug
discovery, it has also recently proven its mettle in the field
of metabolomics. Metabolomics involves the fast and accurate detection of small molecules that float around in bodily
fluids such as urine, blood (serum or plasma), cell or tissue
extracts. Such small molecules are usually not more than
1500 times the weight of a single hydrogen atom, the smallest atom in the universe. In contrast, the average protein is

The use of NMR in drug discovery is best
highlighted in case of the human survivin
protein. This protein is an attractive target
for anti-cancer therapy because survivin
in its inactive form makes immortal cancer
cells to die in a natural manner
more than 30,000-100,000 times heavier than hydrogen! It
can be used to quantitatively measure dynamic biochemical responses of living organisms to physiological or pathological stimuli. Metabolomics has diverse range of application areas including investigation of disease mechanisms,
diagnosis/prognosis of pathologies, nutritional interventions and drug toxicity. Profi ling of metabolites has become
increasingly important in identifying biomarkers of disease
progression and drug intervention, and can provide additional information to support or aid the interpretation of
genomic and proteomic data.
Among the techniques used for study of metabolites highresolution NMR spectroscopy has advantages over others,
as it is a quantitative nondestructive, noninvasive, nonequilibrium perturbing technique that provides detailed
information on solution-state molecular structures, based
on atom-centered nuclear interactions and properties. It
can also used to explore metabolite molecular dynamics
and mobility (such as ligand–protein binding). It is a robust and reliable technique for metabolomics applications
in which high reproducibility is paramount. It allows the
detection of a wide range of structurally diverse metabo62 LIFESCIENCE INDIA | August - September 2013

lites simultaneously, providing a metabolic ‘snapshot’ at a
particular time point. Metabolite concentrations down to
the few micromolar range are readily detectable.
A study carried out in 2006, for example, used NMR to
show that in patients with cancer of the pancreas (the organ
that makes insulin), a type of fat called phosphatidyl inositol was much lower than normal in blood. This was discovered using blood sample of patients for metabolomics.
When compared to the blood of a normal, healthy person, it
was found that the hydrogen signals that belonged to phosphatidyl inositol were of a far lower strength, though their
chemical shift values were unchanged. The significance
of this fi nding is that doctors can monitor the level of this
compound in the blood of those who have a family history
of pancreatic cancer or those who work with cancer causing
chemicals. A rapid treatment is thus, now possible before
the cancer progresses to a more dangerous state. Thanks
to NMR, phosphatidyl inositol is now an important ‘biomarker’ for pancreatic cancer.
Besides the usual biofluids, cerebrospinal fluid or CSF is
also being tested for biomarkers nowadays. CSF is the nutritious liquid in which our brain and spinal cord float. In
some cases of tuberculosis, the outer covering of the brain
(called meninges) gets swollen in a condition called meningitis. This condition is potentially fatal unless detected
early. NMR based biomarker discovery showed that a molecule called cyclopropane (consists of three carbon atoms
forming a triangle) is present in CSF when this disease
strikes. Similarly, other biomarkers have been discovered
for other diseases affecting the nervous system. These include Alzheimer’s disease, Huntington disease, bacterial
and viral meningitis. Given that 89% of known drugs are
small molecules, one can appreciate the therapeutic potential of discovering such biomarkers. These biomarkers hold
tremendous promise as weapons against many of the unbeatable diseases that exist today. Even if a small percentage of these pass through clinical trials and fi nally come
into the market as prescription drugs, it will still be a big
leap forward for medicine.
NMR spectroscopy, along with other methods, has shed
light in the last few decades on the way macromolecules
behave inside a cell and outside. The fi nely tuned harmony
that exists between the parts of a cell has been made visible to us thanks to these techniques. Advances in basic
sciences have provided a clearer picture of the role of every cellular component, be it a lowly amino acid or a huge
ribosome. This knowledge is a stepping-stone to the next
era of medicine, giving us the capability to make extremely
targeted approaches to combating illnesses. Be it miracle
drugs, diagnostic kits, vaccines or therapies, we now have
the formidable arsenal that we lacked a decade or more ago,
thus paving the way for a more secure future.

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