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Nutraceuticals

Critical supplement for building a healthy India

Contents
Foreword................................................................................................... 04 Introduction............................................................................................. 06 Executive summary................................................................................ 07 An insight into the nutraceuticals market of India
Section I: Nutritional status of the population of india....................................10 Section II: Nutraceuticals market: global and India.........................................24 Section III: Way forward............................................................................... 48

Annexure.................................................................................................. 66 Acknowledgements................................................................................ 76 Glossary....................................................................................................77 About FICCI..............................................................................................80

Foreword

Ajit Singh Chairman- FICCI Task Force on Nutraceuticals Chairman- ACG Worldwide (formerly Associated Capsules Group) President- Health Foods and Dietary Supplements Association (HADSA) Dear reader, Nutraceuticals as they are called in industry parlance cover a basket of products from dietary supplements to probiotic and energy drinks to cholesterol and fat free foods among others. Increased discretionary spending, changing lifestyles and growing awareness among Indians about healthy living are accelerating the growth of this Industry. Despite the huge potential, Indias share, with reference to the global Nutraceuticals market is still minimal. FICCI is one of the apex chambers of commerce of India, which has empowered Indian businesses in the ever changing and challenging times, to step up their competitiveness and enhance their global reach. FICCI acts an effective change agent and has been working diligently towards influencing the government to bring about necessary policy changes to give impetus to this sector. FICCI has played a catalytic role in many sectors where India commands a leadership position today. HADSA is a non-profit trade association which not only represents the interests of manufacturers, suppliers and health-care products, but also supports science-based environment for responsible marketing of nutritional supplements. FICCI and HADSA have come together to provide a platform to the industry to share their concerns, flag issues, and discuss strategies to compete globally in the field of Nutraceuticals, Functional Foods and Dietary Supplements. Our vision is to accelerate Indias share of 0.9% of the worlds US$117 billion nutraceuticals, functional foods and dietary supplements market to a sizeable number in the next few years. Considering the huge growth potential of the Indian nutraceuticals industry, I envision India to be ranked among the top players such as USA, Europe and Japan which are the current market leaders. This FICCI - Ernst & Young knowledge paper has synergized the available body of knowledge with the current business realities and suggested strategies to increase Indias share of the global Nutraceuticals market.

Nutraceuticals Critical supplement for building a healthy India

Hitesh Sharma Partner Ernst & Young

M Muralidharan Nair Partner Ernst & Young

Dear reader, Nutrition related risk factors contribute to more than 40% deaths in developing countries and India is no exception. Nutrition related disorders force back its GDP by at least one percentage point. India is reeling under the burden of nutrition deficiencies with one-fifth of the Indian population lacking the purchasing power to even consume a diet sufficient in calories, let alone nutrients; and an astounding 570 million consuming sufficient or excess calories, but lacking adequate intake of nutrients. In fact, 60% of this section consumes higher than normal calories, with a disproportionately high fat intake and this could make India the future cardiovascular and diabetes capital of the world. The key factor responsible for these severe inadequacies in nutrient intake has been a significant change in lifestyle caused by rapid urbanization and growing modernization in methods of food processing and cooking. As these changes are irreversible in nature, any agenda to foster "quality healthcare for all" is incomplete without supplementing it through nutritional interventions. Unless such interventions are introduced, the gap in nutrient intake will continue to widen. Thus, it should be a part of the nations critical agenda to ensure that every citizen has access to Nutraceuticals - products which supplement the diet to provide nutrition over and above regular food. It is a non-negotiable imperative that nutraceuticals cease being just a luxury and emerge as a necessity for the Indian populace. However there are some impediments in the path to achieving this aspiration: The prices of most nutraceutical products are high, severely limiting growth in demand, especially since India is a price sensitive market There is a lack of credibility of the benefits of nutraceutical products in the consumers minds, further aggravated by unsubstantiated claims The lack of regulations to govern nutraceuticals acts as a deterrent for committed nutraceuticals players, both Indian and international, to enter the Indian market "Nutraceuticals Critical supplement for building a healthy India", a FICCI Ernst & Young initiative is a comprehensive study assessing the current and latent potential of the nutraceuticals market in India, the critical impediments to convert latent opportunity into a market and the future imperatives for the government and private sectors. The report suggests concerted and implementable strategies to the government and private sectors which, if implemented, would assist in achieving the latent potential of nutraceuticals in India and at the same time addressing the diverse nutritional needs of the population. We encourage you to explore, invest and partner in the Indian nutraceuticals market which truly stands at an inflexion point, poised to grow.

Nutraceuticals Critical supplement for building a healthy India

Introduction
Quality healthcare is the foundation of any prosperous nation. Nutrition care, which forms an integral part of preventive healthcare, is undergoing a transformation in India. Today, food alone is unable to fully service the nutrition needs of the body. Thus, supplementing it with lifestyle interventions has become a non-negotiable imperative not only to enhance health but also to reduce dependency on curative measures. While lifestyle interventions can be manifold, this report is focused on those formulations or foods that can supplement normal diet (called " Nutraceuticals ") and does not cover services that can be offered in this regard. Also this report covers the domestic nutraceuticals market and not the export market potential of Indian nutraceuticals. This document aims to present: The nutritional status of Indians, their dietary patterns and underlying drivers An assessment of the current and latent potential of the nutraceuticals market in India Critical impediments in achieving latent potential, and Way forward for the government and private sector The viewpoints and conclusions presented in this report are an outcome of discussions with various stakeholders, regulators, key opinion leaders, subject experts, data available in the public/propriety domain and our industry understanding. An attempt has been made to provide a reference document for existing private Indian and global nutraceutical players, new entrants, potential investors and regulators to explore and assess the nutraceuticals opportunity that India presents.

Nutraceuticals Critical supplement for building a healthy India

Executive summary
Nutrition is a fundamental need. Various risk factors related to health result from an imbalance in nutrition. Together, these factors contribute to more than 40% of deaths and 30% of the overall disease burden in developing countries. In India, nearly 20% of the total population and 44% of young children (below 5 years of age) are undernourished, numbers which are significantly higher than even the poorer subSaharan African countries. Iron deficiency anemia during pregnancy accounts for one-fifth of maternal deaths in India and the prevalence of this deficiency in women has alarmingly increased from 52% in 1998 to 56% in 2006. Iodine and Vitamin A deficiencies in India are still above the WHO specified desired levels. Annually as many as 0.3 million children succumb to Vitamin A deficiency related diseases. The impact of these deficiencies is a productivity loss of around one percentage point of Indias GDP. The nature of Indias nutrition concerns are three fold On one hand is the undernourished population (380million) with majority having inadequate purchasing power to even consume a diet sufficient in calories, let alone take sufficient nutrients. Their challenge is to meet foundation needs to maintain normalcy of being. These needs would have to be addressed by government programs with the private sector playing a supportive role. On the other hand is the huge population (570 million) that is nourished in calorie intake but not in terms of nutrient intake. This segment would typically include lower middle to upper class population with sufficient purchasing power but probably low awareness about their nutrient requirements, leading to unmet condition specific needs in addition to foundation needs. In fact, there are 340 million in our population (30% in urban and 34% in rural areas) who consume more than the recommended number of calories with higher than recommended levels of dietary fats and could be the largest contributor in making India the future cardiovascular and diabetes capital of the world. While there are several factors that have contributed to these severe inadequacies, the key ones are increased urbanization, larger working class population and growing affluence. These factors have resulted in a shift of dietary habits from consuming micronutrient rich foods such as fruits and vegetables to consuming more of fat-rich calorie foods. The third population segment (80 million) is one which consumes nutrients and calories more than the norm due to their enhanced physical requirements because of their chosen lifestyles and interest areas such as professional sports, heavy exercises and extensive outdoor field work. This would lead to a greater need for nutrition, in addition to some condition specific and foundational needs. Many of the factors affecting nutrition related concerns are irreversible that have led to natural sources of nutrients being consumed in insufficient quantities. Hence, the requirement of external intervention, that can supplement diet to help prevent nutrition-related disorders and promote wellness over treatment of illness, has become critical. Such products are collectively called as nutraceuticals. As a concept, nutraceuticals is in its stage of infancy with several developed countries having defined it only in last 15 years. India has already defined it in the Food Safety and Standards Act of 2006 but is yet to implement it as the rules are not completely framed. Of the global nutraceuticals market of USD117 billion (INR5148 billion), India has less than 1% share and is estimated to be around INR44 billion in size. The three broad categories within nutraceuticals are - functional foods, functional beverages and dietary supplements. While the global market is expected to grow at a CAGR of 7%, the Indian industry has been growing much faster at a CAGR of 18% for the last three years, driven by functional food and beverages categories that are growing faster than the dietary supplements category due to wider distribution across FMCG channels as well as aggressive mass marketing. There are four key drivers to this growth an increased affluence of the ever-growing working population, a reduced affordability of sick care that in turn drives consumers towards wellness, an increased physician awareness and media penetration and finally, an increased accessibility to newer distribution channels. However, the latent market in India is two to four times the existing market size (between INR89 billion and INR172 billion) with nearly 148 million potential customers. The market is latent because there some major impediments to effectively tap this market. These are High prices of nutraceuticals when compared to conventional foods especially since India is a price sensitive market.

Nutraceuticals Critical supplement for building a healthy India

Lack of credibility of the benefits of nutraceuticals in the minds of consumers, further aggravated by the unsubstantiated claims made by certain products. Regulatory framework not yet implemented despite the act being in place for over three years plus inadequate resources available for implementation. This lack of regulations to govern nutraceuticals acts as a deterrent for large foreign players planning to enter the Indian market.

Measures should be taken to ensure availability of adequate resources for efficient implementation of laid out rules. These measures could include gearing-up of staff strength, specialized training and increasing the number of food testing laboratories from an estimated 250 laboratories currently to a required number of 500 laboratories. Encourage research and development in the field of nutrition and deploy Public Private Partnership (PPP) models to serve needs of the undernourished segment of population The government should establish a dedicated fund for focused nutraceuticals research and support nutraceutical players by providing them with research infrastructure Ensure that a larger population gets the benefit of nutraceuticals For this, the government should explore PPP to deliver the benefits of nutrients to the undernourished section of the population.

What needs to be done?


To overcome the above mentioned impediments and to pave the way for nutraceuticals to supplement Indias quality healthcare agenda, the following initiatives need to be undertaken:

Agenda for the government


Lay down rules to govern quality and claims of nutraceutical products While the Food Safety and Standards Authority created as per the Food Safety and Standards Act 2006 have plans to lay down rules for governing standards of articles of food and to regulate their manufacture, storage and distribution by end of 2009 based on panel recommendations, it is of critical importance that these rules be made exhaustive to govern quality and claims of nutraceutical products. The rules should: Clearly specify revised RDA levels (the RDA norms of 1989 are outdated and do not reflect lifestyle changes as well as the considerable nutritional research accumulated in this period) Recognize proven nutrients and labeling requirements. Define permitted health claims and the product approval process. Identify standards/monographs, and Provide guidelines on good manufacturing practices for nutraceutical products. Leading international practices highlighted in the report can be used as reference while framing the rules.

Agenda for the private sector


Product development: develop customer focused products that address specific needs of different consumer segments The private sector should invest in research to develop products that meet specific consumer needs, preferences and taste. One potential area can be converting the nutritional properties of herbs and botanicals from the rich pool of traditional Indian sources into nutraceutical products. Product differentiation: differentiate products by focusing on credibility building and/or lowering prices of products In the cluttered market with me-too products and inadequate intellectual property protection, the private sector can focus on product differentiation by building credibility of their brands and making products more affordable. Focusing on cost reduction initiatives could be one of the levers to lower prices. Product promotion: increase awareness of the benefits of nutraceuticals through advertising and physician education This is easier said than done. Concrete and sincere effort needs to be put in by the stakeholders to enable nutraceuticals to supplement Indias quality health agenda, ushering a shift in the mindset from illness to wellness, from curing to preventing.

Nutraceuticals Critical supplement for building a healthy India

Section

Nutritional status of the population of india

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Nutraceuticals Critical supplement for building a healthy India

Summary
Various risk factors related to health result from an imbalance in nutrition. Such imbalances in India are widely prevalent leading to adverse outcomes. The impact of these outcomes is a productivity loss of around 1% point of Indias GDP Analysis of our dietary intake reveals nutritional imbalances across most segments of population : Majority of the undernourished population (380 million) faces a challenge to meet foundation needs to maintain normalcy of being. There is a huge population (570 million) that is nourished in calorie intake but not in terms of nutrient intake. They face the challenge of meeting condition specific needs in addition to foundation needs and could be the largest contributor in making India the future cardiovascular and diabetes capital of the world. There is another population segment (80 million) which consumes nutrients and calories more than norm due to their enhanced physical requirements. Since many of the drivers underlying nutrition related concerns are irreversible and natural sources of nutrients are being consumed in insufficient quantities, the requirement of an external intervention has become a non-negotiable imperative that can supplement food diet to help prevent nutrition related disorders and promote wellness rather than treat illness. Such products have collectively been called as Nutraceuticals

Nutraceuticals Critical supplement for building a healthy India

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More than forty percent deaths in developing countries are attributable to risk factors linked to nutrition

8 of the top 15 risk factors are related to nutrition and contribute to nearly forty percent of total deaths and thirty percent of total disease burden in developing countries like India
15 leading risk factors in developing countries with high mortality rates*
Risk factors 1 Underweight
Unsafe sex

Percentage of deaths attributable to risk factors 13% 10% 7% 6% 5% 5% 4% 4% 3% 3% 3% 2% 2% 2% 1% 0% 5% 10% 15%

Percentage of disease burden attributable to risk factors 15% 10% 2% 6% 2% 2% 4% 1% 3% 3% 3% 1% 2% 1% 1% 0% 4% 8% 12% 16%

2 Blood pressure
Unsafe water, sanitation and hygiene

3 Cholesterol
Tobacco Indoor smoke from solid fuels

4 Low fruit and vegetable intake 5 Zinc deciency 6 Vitamin A deciency 7 Iron deciency
Physical inactivity Alcohol

8 Overweight
Unsafe healthcare injections

Nutrition related risk factors

Source: World Health Report 2002, WHO * Notes: Includes 66 countries. Key countries include South Africa, sub-Saharan African countries, Iraq, Egypt, Pakistan, Peru, South Korea, India, Myanmar, Nepal Other risk factors include physical inactivity, risk factors for injury, overweight, lead exposure, climate change, childhood sexual abuse, illicit drugs, urban air pollution, noise, airborne particulates, ergonomic stressors, carcinogens which contribute to the remaining 30% deaths and 44% disease burden

Food is composed of a wide distribution of nutrients, which have very specific metabolic effects on the human body. Nutrients are of two types - macro-nutrients and micro-nutrients Denition of key nutrients
Includes carbohydrates, fats & oils, proteins & amino acids Supply energy, and these essential nutrients are needed for growth, maintenance, and activity Needed in large amounts

Macro-nutrients

Nutrients
Includes vitamins, trace minerals (iron, zinc) Vitamins act as catalysts that help to trigger other reactions in the body while trace minerals contribute to the synthesis of glycogen, protein, and fats Needed in relatively small amounts

Micro-nutrients

Nutraceuticals Critical supplement for building a healthy India

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Such risk factors have led to significant adverse outcomes in India


Risk factors Key adverse outcomes

44% of Indian children are underweight1, which is much higher than most comparable countries. Further, the proportion of underweight children has reduced only marginally in last 10 years, showing slow pace of improvement. Other related adverse health outcomes are stunting2 and wasting3 and the proportion of these is also alarming at 38% and 19% respectively. Being underweight may reduce a childs IQ by 5%, while stunting may reduce it by as much as 11%. Percentage of underweight children below 5 years of age Underweight 43.5

1.4 Russia

3.7 Brazil

6.8 China India

Source: NFHS, World Bank, World Development Indicators 2007

Maternal mortality rate in India is much higher than that of comparable countries. About 20-40% of maternal dealth in India are due to anemia, the proportion of which has increased in the last decade. Maternal mortality rate per 10,000 live births, 2005
45

Iron deciency

74 2.8 Russia 4.5 China 11

79 52 56

Brazil

India

Percentage anemic children* 1998-99

Percentage women suffering from anemia**

2005-06

Source: WHO, NFHS

* Children between 6-35 months of age ** Married women in the age group of 15-49 years

Prevalence* of vitamin A deciency symptoms (1990-2003)


0.7-1.1%

Vitamin A deciency
India
* Pre-school children

0.5%

Prevalence of vitamin A deciency is much above WHO cut off levels resulting in approximately 330,000 child deaths every year

WHO cut-off level

Source: NFHS, Report of the Working Group on Integrating Nutrition with Health, 11th Five Year Plan (2007-2012) , India Micronutrient National Investment Plan 2007-2011 1 2 3 Underweight: Children under 5 years whose weight-for-age is less than -2 Standard Deviation (SD) Stunted: Children under 3 years whose height-for-age is less than -2SD disorder) Total goiter rate (Iodine deciency Wasted: Children under 3 years whose weight-for-height is less than -2SD

10%
14 Iodine

deciency

Prevalence of goiter caused due to Iodine deciency is twice the WHO cut off levels, adversely impacting Nutraceuticals Critical supplement for building a healthy India intellectual capacity by upto 15% 5%

deciency
India
* Pre-school children

approximately 330,000 child deaths every year


WHO cut-off level

Source: NFHS, Report of the Working Group on Integrating Nutrition with Health, 11th Five Year Plan (2007-2012) , India Micronutrient National Investment Plan 2007-2011

Total goiter rate (Iodine deciency disorder)


10%

Iodine deciency
India

5% WHO cut-off level

Prevalence of goiter caused due to Iodine deciency is twice the WHO cut off levels, adversely impacting intellectual capacity by upto 15%

Source: Report of the Working Group on Integrating Nutrition with Health, 11th Five Year Plan (2007-2012), India Micronutrient National Investment Plan (2007-2011 )

India has the largest burden of CVD and largest number of diabetes patients in the world Cardiovascular diseases DALYs (millions)
24.5 11.8 4.1 Brazil Russia China India 4.6 4.6 28.9 20.8

Diabetes Number of patients (millions)


31.7

Blood pressure, overweight, cholesterol

Russia
Source: WHO 2000

Brazil

China

India

Source: WHO 2009

Adverse outcomes are estimated to cost nearly 1% point to Indias GDP and so improvement in nutrition status is a critical part of the countrys agenda for progress An estimate of the cost of productivity lost on account of mortality due to nutrition related disorders was estimated to be 0.85% of the GDP in 2004 and is expected to increase upto 1.2% of India's GDP by 2015
Source: WHO 2009, Popkins et. al (2001), Ernst & Young analysis

Nutraceuticals Critical supplement for building a healthy India

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Analysis of India's dietary patterns provides a few key insights into the nutrition levels and needs of the population

Nearly 20% of the Indian population is undernourished implying a low calorie as well as nutrient intake

Percentage of population undernourished


19 12 7 3 9 20

India lags behind not only other developing countries but also some sub-Saharan African countries in terms of undernourishment

Russia

Brazil

Nigeria

China

Uganda

India

Source: Global Hunger Index, International Food Policy Research Institute 2008

Even in the population that shows sufficient calorie intake, the micronutrient consumption is not at desired levels

While the intake of calorie rich foods may be high, micronutrient rich foods are being consumed in low proportions. As a result, significant micronutrient deficiencies exist in urban as well as rural areas

Actual food intake as a percentage of ICMR recommended levels


109% 111% 93% 76% 76% 70% 83% 68%

Average intake of key micronutrients (percentage of RDA)

101% 83%

102%

RDA 81% Zinc 56% 65% 60% 58% 83% 90% 0% 20% 40% 60% 80% 100% 120%

71%

Vitamin A 33% Iron Cereals Edible oil Milk & milk Sugar products Calorie rich Rural Urban Pulses Vegetables Fruits Micronutrient rich

Source: India Micronutrient National Investment Plan 2007-2011

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Nutraceuticals Critical supplement for building a healthy India

At the same time, there is a growing population (340 million) which is consuming excess calories, with a disproportionately high level of fats

Nearly 340 million people - 30% of the population in urban areas and 34% of the population in rural areas - consume calories more than the norm
Percentage of population by level of calorie intake as a percentage of norm level*
11% 19% 13% 21% Calorie intake as a percentage of norm >150% 23% 23% 17%
Recommended range

Calories derived from fat as percentage of total calories for the excess calories consuming population

70%

32%

66%

Urban <100% 100%-120% >120%

Rural

120% 150%

Average

21% 16%

Rural
Source: NSSO 2004-05 *2700 kcal per consumer unit per day

Urban

Source: NSSO 2004-05

Also, there is a growing fitness need which has led to rapid rise in slimming centers and gymnasiums. This is driving enhanced nutrition requirements for this segment of the population
Growth in slimming centers and gyms market (INR billion)
4.5 CAGR 33% 1.9 CAGR 23% 2.5 4.6

Slimming centres 2005 2008

Gyms

Source: Ernst & Young FICCI Wellness report, 2009

Nutraceuticals Critical supplement for building a healthy India

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Nutraceuticals Critical supplement for building a healthy India

These patterns can be mapped into distinct population segments based on their food and nutrient intake

Sufcient/ excess

Over-nourished 80 million

Micronutrient intake

Under-nourished 3 380 million

ICMR norm for fruits and vegetables2

Decient

Calorie sufcient nutrient decient population- 570 million

Decient 80% of norm level as dened by NSSO

Adequate/excess

Calorie consumption

Undernourished population 380 million


Nearly 70 percent (280 million) of this segment would include those with inadequate purchasing power to consume a diet that would be adequate in calories and therefore decient in micronutrients Immediate need for this section of the population would be foundational to meet basic calorie nourishment and will have to be addressed by government intervention. Some programs under-taken by government include mid-day meal, micronutrient national investment plan and food security programs under Millennium Development Goals Remaining 30 percent (100 million)of this segment would include people with sufcient purchasing power but inadequate food consumption due to various reasons like chronic illness, low appetite, extreme diet consciousness

Calorie sufcient nutrient decient population 570 million


This segment would consist of people who are consuming adequate or excess calories than norm but not sufcient nutrients. This segment would typically include high and middle income group population with purchasing power enough to at least consume an adequate calorie diet This segment may have a need due to specic conditions like pregnancy, menstruation, obesity, stress and may need to increase awareness to maintain and promote a normal, healthy life

Over-nourished population 80 million


This segment would consist of those with sufcient purchasing power and with enhanced nutrient and calorie intake due to their special requirements such as professional sports, heavy exercising, extensive outdoor eld work

Source: NSSO 2004-05, India Micronutrient Initiative Plan 2007-2011, Ernst & Young analysis

Market size of this segment of the population is assumed to be insignicant as they are calorie decient but micronutrient sufcient implying that they could be an extremely health conscious segment with dependence on very low calorie foods but still managing to derive sufcient micronutrients 1 2 Population as per NSSO 2006-07 report As per most recent national initiative called the Micronutrient National Investment Plan 2007-2011, inadequate consumption of fruits and vegetables is a key reason for deciency of essential micronutrients. For the purpose of estimating decient and sufcient nutrition intake population segments, it has been assumed that persons who consume fruits and vegetables combined less than ICMR norm of 175 gms/ day would be decient in micronutrients The entire population below the food poverty line (as dened in the report of the National Commission on Macroeconomics and Health, 2005) has been considered as undernourished, irrespective of level of calorie consumption

Nutraceuticals Critical supplement for building a healthy India

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Nutrition related needs of population segments can be viewed as a hierarchy of foundation, condition specific and enhancement needs

Hierarchy of nutritional needs


Nutrition requirements of over-nourished people with enhanced nutrient and calorie intake due to their special requirements such as professional sports, heavy exercise, extensive outdoor eld work etc

Enhancement needs

These nutrition needs are for enhanced functioning


Nutrition requirements prevalent in people largely across the micronutrient decient segments during specic conditions such as nutrient-specic deciency due to lower intake, pregnancy, menstruation, post menopause, obesity, stressful and sedentary life

Condition specic needs

These nutrition needs are for addressing specic conditions


Nutrition needed by all segments of population to maintain and promote a normal, healthy life

Foundation needs

These nutrition needs are for maintaining normalcy of being

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Nutraceuticals Critical supplement for building a healthy India

While food has been the major source for servicing these needs in the past, with growing modernization some traditional ways are being given up, thereby adversely impacting balanced nutrition

Nutrients concerned Water soluble vitamins (Vitamins B and C) and minerals Proteins, minerals and Vitamin B complex Calcium, Iron, Thiamine and Niacin Iron

Traditional ways being given up Fresh vegetables used for cooking

Adverse impact on nutrient intake due to modernization In the modern blanching processes adopted there is loss of ascorbic acid, water soluble vitamins and minerals just before freezing the vegetables Milling and polishing of cereals significantly reduces protein, mineral and Vitamin B complex Heavy milling and poor storage conditions result in a considerable loss of Calcium, Iron, Thiamin and Niacin Organic iron from the conventional karai is stated to fortify the food cooked in it a benefit absent in modern cookware like non-stick and teflon coated utensils Copper, although required in minor amount, is not gained from the stainless steel utensils used today. Deficiency is known to cause chronic diarrhea, mal-absorption problems and reduced immunity

Manual processing of cereals Fresh grinding of wheat at home Cooking in iron karai

Copper

Use of copper vessels for cooking and storing water

Source: Srilakshmi B. 2003 Food Science, American Association of Cereals Chemists, Carribean Home Economics, Ernst & Young research

There is an ever widening gap in nutrient intake due to which "normal life is no longer normal"

Nutraceuticals Critical supplement for building a healthy India

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Thus, the pressing need to complement food with external nutritional interventions has become a non-negotiable imperative to avert curative measures

While such interventions can be manifold, this report is focused only on products that can fulfill this role. These products have been collectively referred to as "Nutraceuticals" Nutraceuticals, an emerging concept, can be broadly categorized as products which are extracted from natural sources (nature-like) or manufactured synthetically (man-made), which supplement the diet to provide nutrition over and above regular food and help prevent nutrition related disorders.

Curative

Traditional medicine

Pharmaceuticals

Usage

Food
Preventive

Nutraceuticals

Natural

Nature-like

Man made

Source

Ideally, intake of nutrients through food would have been sufficient to prevent curative measures such as pharmaceuticals and traditional medicine to a large extent However, in the absence of requisite nutrition through food, an external intervention in the form of nutraceuticals has become imperative

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Nutraceuticals Critical supplement for building a healthy India

Section

II

Nutraceuticals market: global and India

24

Nutraceuticals Critical supplement for building a healthy India

Summary
As a concept, Nutraceuticals is in its stage of infancy with several developed countries having defined it only in last 15 years Of the global nutraceuticals market of USD117 billion (INR5148 billion), India has less than one percent share and is estimated to be around INR44 billion in size. But it has been growing much faster than global rates at a CAGR of 18% for the last 3 years driven by functional food and beverages categories There are four key underlying drivers for this growth: Affluence of working population with changing lifestyles Reducing affordability of sick care, driving consumers towards wellness Increasing physician awareness and media penetration Increased accessibility due to emergence of newer distribution channels However, the latent market in India is two to four times the existing market size (between INR89 billion and INR172 billion) with nearly 148 million potential customers. The market is latent because there some major impediments to effectively tap into this market. These are: Regulatory framework not yet implemented Inadequate resources for implementation of regulations High prices of nutraceuticals Lack of credibility of nutraceuticals

Nutraceuticals Critical supplement for building a healthy India

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Nutraceuticals is an evolving concept with varying definitions across countries

While some countries define nutraceuticals based on the segments it constitutes, others define it based on the benefits it provides to the consumers. There is also no clear consensus on inclusion or exclusion of traditional medicines. Further, some of the most developed countries have implemented legislation as recently as in 2004, so the concept itself is recent in such countries
The nomenclature for nutraceuticals varies across countries with Canada naming them as "Natural Health Products", USA calling them "Dietary Supplements" and Japan naming them "Foods for Special Health Use" (FOSHU) The definitions even by regulating authorities in different countries range from general to highly elaborate: There are distinct definitions and regulations for dietary supplements and functional foods in USA, Canada and Europe. Whereas in Japan, both dietary supplements and functional foods are governed under the same set of regulations.

USA and Canada actually list the constituents that a product must have to be called a nutraceutical, whereas Europe and Japan just provide general guidelines on the properties that a product should have to be called a nutraceutical. Traditional and herbal medicines are included in the definition of dietary/nutritional supplements in Canada. Japan does not mention traditional herbal medicines under FOSHU foods. USA includes herbs and botanicals in its definition. The Indian definition (as per the Food Safety and Security Act 2006) lists down the ingredients that a product should have, and it also specifies general properties of nutraceuticals. Traditional medicines though have been excluded from the definition.

Source: US Food & Drug Administration website; Health Claim Evidence Requirements in Japan,(Yamada et al); Health Canada Natural Health Products Directorate website; European Union Directive; European Parliament directive on food supplements; Department of Health & Ageing, Therapeutic Goods Administration, Australia website; The Russian Federation Chamber of commerce and Industry website, Food Safety and Security Act of India, 2006

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Nutraceuticals Critical supplement for building a healthy India

Denitions of nutraceuticals as per various legislations around the globe

Canada
Known as: Natural Health Products Governed by: Food and Drugs Authority Implemented in: 2004 The denition covers: Vitamins and minerals Herbal remedies Homeopathic medicines Traditional medicines such as traditional Chinese medicines Probiotics Other products like amino acids and essential fatty acids

European Union (EU)


Known as: Food supplements Governed by: Food Safety Authority Implemented in: 2002 The denition covers the following products: Concentrated sources of nutrients Other substances with a nutritional or physiological effect

Russia
Known as: Biologically active food supplements Governed by: Ministry of Health & Social Development Implemented in: 1997 The denition covers : Nutriceuticals (Vitamins, Minerals, amino acids, dietary bers) Para-pharmaceuticals ( bio-avonoids, alkaloids, essential oils, polysaccharides)

USA
Known as: Dietary supplements Governed by: Food and Drugs Authority Implemented in: 1994 The denition covers products (other than tobacco ) containing: Vitamins Minerals Herb/botanicals Amino acids Concentrate, metabolite, constituent, extract

Australia
Known as: Complementary medicines Governed by: Dept. of Health and Ageing Implemented in: 1991 The denition covers: Herbal medicines Vitamins and minerals Nutritional supplements

Japan
Known as: Foods for Specic Health Use Governed by: Japan Health and Nutrition Food Association Implemented in: 1991 Functional foods are foods that can have three functions: Nutrition Sensory satisfaction Physiological improvements

India
Regulation: Food Safety and Standards Act (FSSA) Effective from: Passed in 2006, yet to be implemented Foods for special dietary use are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specic diseases and disorders and which are presented as such wherein the composition of these foodstuffs must differ signicantly from the Indian Standard (IS) composition of ordinary- foods of comparable nature, if such ordinary foods exist and may contain one or more of the following ingredients, namely : Plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or combination Minerals or vitamins or proteins or metals or their compounds or amino acids ( in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits) Substances from animal origin Dietary substances for use by human beings to supplement the diet by increasing the total dietary intake

Source: US Food & Drug Administration website; Health Claim Evidence Requirements in Japan,(Yamada et al); Health Canada Natural Health Products Directorate website; European Union Directive; European Parliament directive on food supplements; Department of Health & Ageing, Therapeutic Goods Administration, Australia website; The Russian Federation Chamber of commerce and Industry website, Food Safety and Security Act of India, 2006

Nutraceuticals Critical supplement for building a healthy India

27

Drawing on the common aspects from the definitions across different countries, for the purpose of this report, definition of "Nutraceuticals" has been restricted to

Formulations or foods with health benefits that are taken orally in addition to the normal diet and can even be taken over prolonged periods in concentrations which are lower than the Recommended Daily Allowance (i.e. below the therapeutic range) to: Supplement the diet to help prevent nutrition related disorders Provide structure/function support that may help prevent specific diseases like diabetes, cancer, obesity through beneficial and proven effects that go beyond the known nutritional effects Fulfill special physiological needs of the body such as like pregnancy, lactation, sports, infancy and sedentary lifestyle

Further to this definition, following 3 categories have been considered under the purview of "Nutraceuticals"

Fun ct foo iona ds l

Foods that have specic physiological benets and/ or reduce the risk of chronic disease
Key product segments Nutrition fortified foods like fortified flour, fortified oil, fortified malted powder Probiotic foods like yogurt

3 Key nutraceuticals categories

Dietary supplements provide nutrients that are missing or are not consumed in sufcient quantity in a person's diet Key product segments

tary Die ents plem sup

Vitamin supplements Mineral supplements Macronutrients

Functional beverages

Antioxidants Tonics Herbal extracts like Chyawanprash, non-herbal extracts like cod liver oil

Liquids that quench thirst along with replenishing minerals, provide energy, prevent ailments, and promote healthy life styles
Key product segments Sports and energy drinks Fortified juices Glucose powder

28

Nutraceuticals Critical supplement for building a healthy India

The global nutraceuticals market is estimated at USD117 billion, (INR5148 billion) of which Indias share is a meager 0.9%

US, Europe and Japan are key markets for nutraceutical consumption
Geographic split* Switzerland 3% Italy 3% Japan 22% Rest of EU 6%

Indian nutraceuticals market in 2008 is USD 1.0 billion

Functional foods 54%

UK 2%

France 6% Germany 5% India 1% Rest of Asia 7% Others 9% Dietary supplements 32%


Source: Primary interviews, Industry sources, Ernst & Young analysis

Functional beverages 14%

US 36%

Source: Frost & Sullivan, Cygnus * Based on 2007 estimates

Globally, this market is expected to reach USD177 billion in 2013 growing at a CAGR of 7% driven by the fast growing dietary supplements category
Global nutraceuticals market
200 180 160 140 USD billion 120 100 80 60 40 20 0 Functional foods 40 2007 Functional beverages 39 57 38 49
% R7 AG C

71

2013 Dietary supplements

Source: BCC and Nutracueticals brochure FICCI

The dietary supplements category is expected to be the fastest growing product category globally with a CAGR of 11%.

Nutraceuticals Critical supplement for building a healthy India

29

The nutraceuticals market in India is estimated to be at least INR44 billion with functional foods forming largest category with 54% share

Indian nutraceuticals market (2008)

43.9

Functional foods 23.9

Functional beverages

6.0

Dietary supplements 14.0

Nutrition fortied foods

22.7

Sports and energy drinks Fortied juices

0.5

Vitamin supplements Mineral supplements

3.0 1.0

Probiotic foods 1.2

5.2

Glucose powder 0.3

Macronutrients 2.2 Antioxidants Tonics Extracts 2.4 1.4 4.0

Note: All gures are in INR billion. Source: Primary interviews, Industry sources, Ernst & Young analysis

The functional foods market is the largest followed closely by the dietary supplements market which has a 32% market share. The functional beverages market in India is relatively nascent.
Note: While we have not validated the efficacy of the products constituting these segments nor the studies backing their claims, the attempt here has been to estimate the market size of those segments where some research exists to substantiate health or nutrition claims. Segments such as iodized salt have been excluded from the market sizing exercise as large scale fortification of these products has led to consumption not primarily for the fortification benefits but for regular food value. Please note that in the energy drinks market, caffeine rich products have not been included.

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Nutraceuticals Critical supplement for building a healthy India

Various nutraceutical product segments exist across the need hierarchy

Nutraceutical products aim to fulfill different consumer needs based on which they can be classified as Enhancement segments, Condition specific segments and Foundation segments

High protein supplements Energy drinks Sports drinks Glucose drinks Antioxidants Vitamin supplements Mineral supplements

Enhancement segments There are a few product segments such as sports and energy drinks catering to health enhancing needs of the consumers

Condition specic segments Product segments like vitamin supplements, mineral supplements etc. cater to the needs arising out of condition specic health concerns

Macronutrient supplements Nutrition fortied foods, e.g., (fortied our) Probiotic foods, e.g., (yogurt) Extracts, e.g., (chyawanprash) Child* Young adult* Adult*

Foundation segments Foundation products segments cater to the consumer trend towards wellness and healthier lifestyles. These product segments promote general well being are largely targeted at all age groups. Old age*

Lifecycle stages
*Note: Child: 0 4 years; Young Adult: 5 14 years; Adult: 15 59 years; Old Age: 60+ years Source: Ernst & Young Analysis

Though a product category can be classified into a specific need-segment based on its predominant use, some product types may transcend across need-segments For example cod liver oil, along with meeting foundation needs of boosting the immune system, will also cater to prevention needs of lowering cholesterol

Nutraceuticals Critical supplement for building a healthy India

31

...And product segments catering to foundation and condition specific needs are the largest and growing the fastest

While the global industry is growing at a CAGR of 7%, the Indian industry has been growing at a CAGR of 18% in the last 3 years

Glucose drinks Enhancement needs Sports and energy drinks 0.3 0.5 Mineral supplements 3.1 Tonics 1.4 2.4 Vitamin supplements 3.8 1.2 2.5 Fortied oil Fortied malted powder 0%-10% 11%-20% 21%-30% 4.6 15.7 5.2

Customer needs assessment

Condition specic needs

Antioxidants

0.9

Extracts Probiotic foods Fortied juices

Foundation needs

Macronutrients

2.2

Fortied our

Percentage growth rate (3 years CAGR)


Market sizes in INR billion

Dietary supplements

Functional foods

Functional beverages

Source: Primary interviews, Industry sources, Ernst & Young analysis

The functional food and beverages categories consisting of nutrition fortified foods, sports and energy drinks, fortified juices and probiotic foods are growing faster, driven by wider distribution across FMCG channels as well as aggressive mass marketing

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Nutraceuticals Critical supplement for building a healthy India

This growth in the nutraceuticals market in India is driven by several factors

4 3

ilty ssib cce A

18%

ess aren Aw
Increasing physician awareness and media penetration

ity abil ford Af

Increased accessibility due to emergence of newer channels

ce uen Af 1
Afuence of working population with changing lifestyles

Reducing affordability of sick care, driving consumers towards wellness

Affluence: Increased affluence of the ever-growing working population with changing lifestyles is leading to changes in dietary habits

Increase of working population by 30 million from 2005 to 2015

Increasing income levels of the Indian population

Percentage split of population


120% 100% 80% 60% 40% 20% 0% 32% 2005 29% 2010 60% 62% 63% 1.09 bn 8% 1.18 bn 9% 1.25 bn 10%

Projected distribution of income classes

6% 22%

9% 26%

11% 30%

72% 27% 2015 >60 years 2001-02 <0.09 mpa

65%

58%

2005-06 0.09-0.2 mpa

2007-08 >0.2 mpa

<15 years

15-60 years

Source: Census 2001

Source: NCAER 2005

Growing disposable income and lifestyle changes such as shift in dietary habits towards higher fat has resulted in increasing incidences of chronic disorders. This in turn is likely to fuel the demand for nutraceutical products.

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Nutraceuticals Critical supplement for building a healthy India

Affordability: Reduced affordability of sickness related expenditure is driving consumers towards wellness

Out-of-pocket expenditure constitutes 64 % of healthcare expenditure in India as compared to 18% globally


Composition of healthcare expenditure
70 Percentage of expenditure 60 50 40 30 20 10 0 Government exp. on healthcare India Out-of pocket exp. on healthcare 34 24 18 6 Private and social insurance 4 6 Other 44 64

Average cost of in-patient treatment both in rural and urban India has doubled in the last decade
Average cost of inpatient treatment
12000 10000 8000 INR 6000 4000 2000 0 Rural Urban 3900 6900 4800 10800

Global

1995-96

2004-05

Source: WHO statistical information system 2008

These factors are driving consumer towards health and wellness related services in order to lead healthier lifestyle and prevent spiralling sick care costs.
Share of consumers wallet on healthcare expenditure is expected to go on increasing
100 80 Share of wallet 56 60 40 20 0 5 14 6 12 3 4 1995 5 5.5 12 10.5 19 5 7 2005 22 6 9 2015 9 13 2025 12 12 25.5 34 25 5 9.5 14 INR billion

42

Growth in slimming centers, gyms and spas market (2005-2008)


5.0 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 4.5 4.6

CAGR 33%

CAGR 23% 2.5

CAGR 31% 2.5 1.1

1.9

Health care Communication & transportation Housing & utilities Food, beverages & tobacco
Source: Marketing white book 2008

Education & recreation Personal and household products Apparel FY2005

Slimming centers FY2008

Gyms

Spas

Source: Ernst & Young FICCI Wellness Report, 2009

Nutraceuticals Critical supplement for building a healthy India

35

Awareness: While increased physician awareness is driving prescriptions of nutrition supplements, penetration growth of media and diagnostic centers is helping create awareness

Physician awareness about health benefits of nutraceuticals has fuelled growth in nutrition related prescriptions at 26 % CAGR in recent years

High media penetration is improving consumer awareness

With growing diagnostic centers, the awareness about health disorders and deficiencies is increasing

Growth in nutrition related prescriptions


450 400 Numbers millions 350 300 250 200 150 100 50 0 FY 2005 FY 2007
26% GR CA

Media penetration (2007-08)


45% Number of people reached (Percentage of population) 40% 35% 30% 25% 20% 15% 10% 5% 0% Mobiles TV (Cable Print and satellite) 6% Internet 40%

Indian diagnostic market (INR billion)


GR CA .1% 16

410

36% 25% 64

156

260

116

2006

2010E

2012E

Source: Industry sources

Source: Industry reports Note: Population 1 billion

Source: CRISIL, Cygnus Research, Ernst & Young Research

Physician and consumer awareness together are driving growth of nutraceuticals.

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Nutraceuticals Critical supplement for building a healthy India

Accessibility: Emergence of newer distribution channels is fuelling accessibility to nutraceuticals

Emergence of wellness products and services related retail outlets is also driving accessibility of nutraceuticals

Growing organized retail has emerged as a new channel for distribution of nutraceuticals

Expected growth in wellness related retail stores (2007-2009)

Growth of retail shopping mall space (2001-2012)


) GR CA ar ye

1,400 1,200 Number of stores 1,000 800 600 400 200 0

29% CAGR 1,163

58% CAGR '000 sq. mtrs. 1,000 36% CAGR 737 400 400 86% CAGR 45 156 276% CAGR 6 85

30000 25000 20000 15000 10000 5000 0 259 2001 2008


% 75 (8 ) GR CA ar ye % 19 (4

24,300

700

12,755

32% CAGR 20 35 GNC

Apollo Med Plus Pharmacy

Medicine Fortis Reliance Shoppe Healthworld Wellness

2012

Existing 2007

Planned 2009
Source: ICRIER, India Retail Report

Source: Company websites; Ernst & Young analysis

Nutraceuticals Critical supplement for building a healthy India

37

The Indian nutraceuticals market is dominated primarily by pharmaceuticals and FMCG companies with very few pure play nutraceutical companies

Pharmaceutical and FMCG players active in the nutraceuticals space have diversified by introducing product extensions and developing variants under existing brand names.

Direct selling

Distribution channels

FMCG dominated segments with player such as Dabur, Nestle, Amul, Pepsico and pure-play nutraceuticals players such as Amway Sports drinks Nutrition fortied foods Fortied juices Pharmaceutical dominated segments with player such as GSKCH, Emami, Ranbaxy, Elder

Grocer

Energy drinks Probiotic foods

Glucose drinks Macronutrients Chemist

Extracts, tonics and stimulants

Mineral supplements Vitamin supplements Antioxidants 11+ players Fragmented

15 players Consolidated

610 players Extent of fragmentation

Source: Ernst and Young analysis Note: Extent of fragmentation has been derived based on the number of companies commanding greater than 80 percent market share

Largely, the market is fragmented. However, the FMCG dominated segments are relatively less fragmented as compared to the pharmaceuticals dominated segments.

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Nutraceuticals Critical supplement for building a healthy India

Many new players have announced aggressive investment plans

Player Alkem Laboratories

Expansion plan Alkem Laboratories has invested over INR1 billion to create exclusive manufacturing facilities for their health foods business. Alkem Health Foods is expected to generate a turnover of over INR3-5 billion annually within a few years. The company recently acquired a USD100 million nutraceutical company named Natrol Inc in the US and is planning to launch its 700 odd products in India and other global markets. Plethico, is also setting up a INR1 billion plant in Dubai to make medicated lozenges, is targeting a turnover of over INR30 billion within five years.

Plethico

Divi's Laboratories

Divi's Laboratories has set up a INR350 million nutraceutical plant and a separate arm, Divi's Nutraceuticals. The company has already developed potential vitamin products such as Astaxanthin, Betacarotene, Canthaxanthin and Lycopene.

Mission Vivacare GNC

Mission Vivacare is investing over INR800 million in modern manufacturing facilities to launch its products globally under the brandname - Mission VivaPrime. Its prime targets are the US and Europe. Plans are on to open 150 stores by 2009, has an exclusive master franchisee tie-up with Guardian pharmacy which is investing approximately INR1 billion Operates approximately 4900 stores worldwide Plans of investing INR1.2 billion in a manufacturing unit to roll out its entire range of products in India Plans of increasing footprint through Manipal Cure and Care as well as 50 additional health and wellness centers by 2011

Vitabiotics Robert Schwartz

Source: "Drugmakers cash in on health supplement segment", 22 August 2008 Business Standard, Primary interviews

Nutraceuticals Critical supplement for building a healthy India

39

Even though the current nutraceuticals market is pegged at INR44 billion, there exists a large latent potential market
Nearly 70% of the undernourished population (280 million) has inadequate purchasing power to consume a calorie sufficient diet and hence is not a latent potential market. However, out of the remaining 750 million population, nearly 148 million people can be potential customers for nutraceuticals based on their affordability. It is observed that the top 3 MPCE1 groups in urban areas and the topmost MPCE1 class in rural areas (collectively referred to as "segments with affordability" from hereon) spend a significant amount (25 per cent more than average) on processed foods & beverages and would, therefore, have greater affordability to buy nutraceuticals.
Per capita monthly average expenditure on processed foods and beverages (INR)
Spend above urban average MPCE classes >2540 126 91 59 1880 2540 1380 1880 930-1380 580-930 335-580 Below food poverty line 93 24 74 31
2

Percent population by MPCE classes (100%=1.03 billion)

271

2% 2% 3% 6% 7% 4% 0.4% 7%

Four segments with affordability make 14% of population or 148 million people

0 335 Rural - >1155 Rest of rural Urban average Rural average

69%

Source: NSSO 2006-07, Report of the National Commission on Macroeconomics and Health 2005

Note: 1. MPCE (Monthly per capita expenditure) As per NSSO definition, for a household, this is the total consumer expenditure over all items divided by its size and expressed on a per month basis. A persons MPCE is understood as that of the household to which he or she belongs. 2. People below food poverty line have been considered to be those with monthly per capita expenditure on food less than the minimum expenditure required to consume a diet sufficient in calories and nutrients as defined in the report of the National Commission on Macroeconomics and Health, 2005

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Nutraceuticals Critical supplement for building a healthy India

This latent potential market is estimated to be atleast two to four times the current market size (between INR89 billion and INR172 billion)

Hierarchy of nutritional needs

Most likely consumer proles considered for market sizing*

Potential market range INR 1.2- 1.5 billion

Current market

People going to the gymnasium and engaged in moderate to heavy work-out routines, who have an enhanced need for nutrient intake which can be met through dietary supplements like whey proteins Enhancement needs For enhanced functioning People belonging to segments with affordability and likely to have the following conditions: Adults (>20 years) likely to face vitamin deciency disorders due to signicantly lower than recommended fruit & vegetable consumption Pregnant and lactating women with an increased requirement for Condition nutrient intake like proteins, iron specic needs Other women in the age group of 15-49 years suffering from any For addressing specic conditions form of anemia Children aged between 4 to 17 years and consuming proteins needed for growth at less than RDA levels People belonging to segments with affordability who consume sufcient or excess calories (at least 90% calorie intake of recommended norm) and need products to maintain and promote a normal, healthy life

INR 0.8 billion

INR 49.7 99.5 billion

INR 9.8 billion

Foundation needs For maintaining normalcy of being

INR 38.0 71.4 billion

INR 33.3 billion

Total

INR 88.9 172.4 billion

INR 43.9 billion

Source: NSSO 2004-05, NSSO 2006-07. NNMB 2007, Ernst & Young-FICCI Wellness report, 2009, Primary interviews, Industry sources, Ernst & Young analysis

Key assumptions*
Segments with affordability (as defined earlier) form the consideration set for this analysis The following three scenarios have been considered for analysis: Scenario 1: Segments with affordability in urban areas spend 25% of their processed foods and edible oil expenditure on products that cater to foundation needs. This is in line with their current spending levels on foundation product segments. In this scenario, there is no spend assumed on foundation products by the segment with affordability in rural areas. In case of condition specific needs, 50% of the current nutrient intake gap is met through nutraceutical products, while for enhancement needs 75% of the enhanced nutrient requirement is met through nutraceuticals. Scenario 2: Segments with affordability in urban areas spend 40% of processed foods and edible oil expenditure on products to cater to foundation needs. In this scenario too, there is no spend assumed on foundation products by the segment with affordability in rural areas. In case of condition specific needs, 75% of the current nutrient intake gap is met through nutraceutical products, while for enhancement needs 90% of the enhanced nutrient requirement is met through nutraceuticals. Scenario 3: In addition to segments with affordability in urban areas spending 40%, those in rural areas spend 10% of their processed foods and edible oil expenditure on products that cater to foundation needs. In case of condition specific needs, 100% of the current nutrient intake gap is met through nutraceutical products, while for enhancement needs 100% of the enhanced nutrient requirement is met through nutraceuticals.
*Refer Annexure 1 for details Nutraceuticals Critical supplement for building a healthy India 41

However, there are critical impediments to convert this latent opportunity into a market

4
Critical impediments to growth

3
High prices of nutraceuticals

Lack of credibility of nutraceuticals

2
Inadequate resources for implementation of regulations Regulatory framework not yet implemented

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Nutraceuticals Critical supplement for building a healthy India

Regulatory framework to govern the nutraceuticals market in India has not been implemented as yet

The Food Safety and Standards Act of 2006, passed by the Indian Parliament, brought into existence the Food Safety and Standards Authority of India (FSS or FSSA), which is the responsible body for framing rules and regulations to govern the nutraceuticals market. However, rules are yet to be framed and this scenario lends an environment that is not conducive for the growth of nutraceuticals. Genesis and current state of FSSA
Pre 2005 2005-2006 Post 2006

Multitude of laws and ministries governing food and food processing such as: The Prevention of Food Adulteration Act, 1954 The Fruit Products Order, 1955 The Meat Products Order, 1973 The Vegetable Oil Products (Control) Order, 1947 The Edible Oils Packaging Order Varied standards under these laws regarding manufacturing, processing, packaging etc. of foods.

A need felt for integrating all existing laws under one Group of Ministers (GOM) appointed by Government of India to propose the Integrated Food Law Food Safety and Standards Bill 2005 introduced in parliament and referred to the Standing Committee on Agriculture Recommendations made by standing committee incorporated FSS Bill passed by parliament and signed by President on 23 August 2006

While the act was passed in 2006, its implementation has not been enforced even three years down the line since rules have not been framed. Further, while there are panels that have been formed to take forward different aspects of the Act but too little has been achieved by such panels in this time period As a result, There is very limited check on the safety, efficacy and quality of the nutraceutical products. resulting in increased risk to health of consumers The claims made by many products are un-validated and left to discretion of safety officers, leading to increased chances of corruption This is also resulting in many court cases that are under disputed This is also acting as a deterrent for large foreign players planning to enter the Indian market

Source: Primary interviews and Ernst & Young analysis

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43

Even if regulations are established, resources available to enforce them are insufficient

There is a lack of resources in terms of Food safety officers and Central food laboratories to monitor compliance to regulations.
Monitoring reach Food processing units Current strength estimates 0.18 million food processing units 2,000 food safety officers Retail outlets Extent of inadequacy Understaffing is such that each food processing unit can be monitored only once in 2 years which is much below international norms Each retail outlet can be monitored once in only 12 years. Underlying assumptions Each food safety officer can handle 4 inspections per month of required quality

7 million retail outlets

Each food safety officer can handle 25 retail outlet inspections per month

Sample testing in lab 250 food testing laboratories

Each lab can handle 25 Each sample from retail outlets samples per day and food processing units can only be monitored once in 4 years.

Source: Primary interviews and Ernst & Young analysis

Case study (Attempted optimization of existing staff from Maharashtra FDA, 1995)
The Maharashtra Foods and Drugs department was understaffed. There were 200 food inspectors and 140 drug inspectors and both fell short of required numbers for the state. Coverage was inadequate due to not just understaffing but also because there were separate cadres of drug officers and food officers with limited resource sharing. In Maharashtra FDA, a drug inspector requires a basic qualification of B.Pharm whereas a food inspector requires any B.Sc qualification. This means that if trained on the job, all drug inspectors could technically learn and perform the duties of food inspectors too. With the number of establishments under foods category increasing, there was an effort by the department in the year 1995-96 to create a unified cadre of such Food and Drugs Control Officer having degree in B. Pharm thereby increasing the number of food inspectors to 340 (70 percent increase) . However, there was resistance faced from many food and drug Inspectors on account of organization level mapping. As a result of this, no consensus could be evolved and the proposal was dropped.
Source: Primary interviews

Authorities are aware of the severe shortages in the number of food safety officers and there have been attempts to increase the strength, but despite efforts the number of such resources continues to be inadequate.

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Nutraceuticals Critical supplement for building a healthy India

Prices of nutraceutical products are high, severely limiting growth in demand

Prices of nutraceutical products in the Indian market are prohibitively high when compared to the conventional foods. In a highly price sensitive market such as India, this is a severe limitation on the growth in demand for nutraceuticals.
Price of conventional food/ pharmaceutical INR11 INR18 INR20 INR15 Percentage increase in price for functional food functional beverages/dietary supplement 73% for low sodium variant 139% for nutrient fortified mix for atta 350% for energy drink 233% for vitamins in the form of dietary supplements

Product Conventional and functional foods Salt Atta Conventional and functional beverages Chilled beverages Pharmaceuticals and dietary supplements Multivitamin tablets

Quantity

1 kg 1 kg 330 ml 10 tablets

Source: Ernst & Young analysis Note: Prices based on various brands available in the market

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45

There is a lack of credibility of nutraceuticals in the minds of consumers

A survey of consumers in 13 Asia Pacific countries including India, showed that for most nutraceuticals more than 30% of the respondents felt that they do not offer any additional health benefits

Percentage of respondents who believe these products do not offer any additional health benets
42% Percentage of respondents 31% 24% 32%

Cholesterol reducing oils

Whole grain, high ber products

Fruit juices with added supplements/ vitamins

Iodine enhanced salt

Source: AC Nielsen Survey

This lack of belief in the benefits of nutraceuticals is further aggravated by the unsubstantiated claims made by certain products. This loss in credibility of nutraceuticals in the minds of consumers is the key limiting factor in the growth of the market.

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Nutraceuticals Critical supplement for building a healthy India

Some of the key ingredients with health claims used by Indian nutraceutical players Over and above the micro and macro nutrient ingredients available in the market, there are host of ingredients used by nutraceuticals companies with diverse set of heath claims providing structure function benefits such as carotenoids, dietary fiber, fatty acids, flavonoids, isothiocyanates, phenolic acids, plant stanols/sterols and polyols. Below mentioned are few examples of ingredients used by Indian nutraceuticals players.

Ingredient Omega 3 and Omega 6

Used by industry categories Functional foods (Nutrition Fortified foods): e.g. omega fortified malted beverages Functional foods (Probiotic foods): e.g. probiotic yogurt

Health claim as per industry sources Omega 3 and omega 6 benefit people suffering from inflammatory and autoimmune diseases, while also reducing cholesterol, and hence, various heart risks. Lactobacillus and bifidobacterium improve intestinal microflora and aid better digestive abilities. They help in prevent diarrhea, other gastrointestinal infections, irritable bowel syndrome, and other inflammatory bowel disease Beta glucan is a soluble fibre that soaks up the cholesterol in our digestive system and help Reduce the amounts of "bad" (LDL) cholesterol in the body Reduces the risk of many kinds of cancers, cholesterol and risk of coronary heart disease, chances of osteoporosis. Known for their cholesterol lowering ability. Prevent or delay heart disease and related complications, cataracts and macular degeneration, prostate and other cancers. Retard the aging process and boost immune function and promote healing of burns, eczema, and other skin problems.

Lactobacillus and bifidobacterium

Beta glucan

Functional foods: e.g. oat enriched foods Functional Beverages: e.g. soya milk drinks Functional foods: e.g. rice barn fortified oil

Phytoestrogens

Tocopherols

Ginseng Beta-carotene

Dietary supplements: e.g. Tonics and stimulants Dietary supplements: e.g. Beta-carotene in antioxidants

Believed to cure lethargy, arthritis, impotence, senility also effective anti-aging properties Helps prevent night blindness and other eye problems, skin disorders, enhance immunity, protects against toxins and cancer formations, colds, flu, and infections. Beta-carotene is also a powerful antioxidant and helps guard against cancer and heart disease.

Source: Frost & Sullivan, Websites of Tata Tea, Pepsico, Godrej, Saffola

Nutraceuticals Critical supplement for building a healthy India

47

Section

III

Way forward

48

Nutraceuticals Critical supplement for building a healthy India

Summary
Agenda for government Lay down rules to govern quality and claims of nutraceutical products Take measures to ensure availability of adequate resources for implementation of laid out rules Encourage R&D in the field of nutrition and deploy PPP models to serve needs of the undernourished segment of population Agenda for private sector Product development: Develop customer focused products addressing specific needs of different consumer segments Product differentiation: Differentiate products by focusing on credibility building and/or lowering prices of products Product promotion: Increase awareness of the benefits of nutraceuticals through advertizing and physician education

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49

Impediments

Way forward

I. Agenda for government 1


Lay down rules to govern quality and claims of nutraceutical products

Regulatory framework not yet implemented

A. Revise RDA levels to make them applicable for the Indian population's current lifestyle B. Develop rules which specify proven nutrients, permitted health claims, product approval process, standards and Good Manufacturing Practice

Inadequate resources for implementation of regulations

Take measures to ensure availability of adequate resources for implementation of laid out rules

A. Recruit and train a well-staffed cadre of food safety officers B. Scale up food control infrastructure by outsourcing testing of food samples to private laboratories

Encourage R&D in the field of nutrition and deploy PPP models to serve needs of the undernourished segment of population

A. Establish a dedicated fund focused on nutraceuticals research and support nutraceutical players by providing them with research infrastructure B. Deploy PPP models to cater to the needs of the undernourished section of the population Lack of credibility of nutraceuticals

II. Agenda for private sector 1 2


Product development: Understand consumer needs and invest in research to come up with products to meet those needs Product differentiation: Build credibility and lower prices of products
A. Adhere to all rules laid down by the government and obtain external institutional approval to build credibility of products B. Reduce prices to target a larger customer base

High prices of nutraceuticals

Product promotion: Increase awareness of the benefits of nutraceuticals through mass marketing, advertising and education of physicians

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Nutraceuticals Critical supplement for building a healthy India

Agenda for Government

Lay down rules to govern quality and claims of nutraceutical products

In India, while the Food Safety and Standards Authority, created as per the Food Safety and Standards Act 2006 (FSSA), has plans to lay down rules by end of 2009 based on panel recommendations, it will be enforced state by state over an extended period of time. Here, it is of critical importance that not only are the rules made exhaustive to govern quality and claims but their implementation is also expedited.

What needs to be done?

A B

Revise RDA levels to make them applicable for Indian population's current lifestyle Develop rules which specify proven nutrients, permitted health claims, product approval process, and Good Manufacturing Practice

i ii iii

Recognize list of nutritional ingredients with proven health benefits Define the list of permitted health claims and specify quantity of ingredients required to make those claims Setup a process for introduction of new nutraceutical products and define the nature and range of evidence required to substantiate product claims

Case study of Japan:


After the introduction of FOSHU regulation in Japan, in the year 1991, the number of FOSHU approved products increased from 2 in 1993 to 192 in 2000 (CAGR of 90%). The sales of FOSHU approved products, however, increased slowly till 1996 and picked up pace from year 1997 onwards ( CAGR of 82% till year 2000) thus indicating that with effective implementation of regulation, market growth is not hindered in the long run but infact it grows in a compliant manner.

400 300 200 100 0 2 1993 69 1995 6.2 80 50 5 100 50 1998 1999 9.8 153 150

15 300 192

15 10 5 0

1997

2000

No. of FOSHU approved products


Source: Japan health food and nutrition association

Sales of all FOSHU approved products (USD 10 million)

Sales per product (USD million)

Nutraceuticals Critical supplement for building a healthy India

51

1.A. Revise RDA levels to make them applicable for Indian population's current lifestyle
India is currently using the RDA (Recommended Dietary Allowance) system with norms last defined 20 years ago (year 1989) by ICMR (Indian council of Medical Research). These norms are outdated and do not reflect the lifestyle changes as well as the considerable nutritional research accumulated in this period. The need for urgently revising these norms has also been identified in the 10th Five Year Plan acknowledging that the existing RDA norms are overstating nutrition needs and should undergo revision. At the same time, countries such as the US, Canada, Australia and New Zealand have replaced the RDA system with more advanced systems (Dietary Reference Intakes in the US and Canada, Nutrient Reference Values in Australia and New Zealand). These advanced systems have noteworthy merits for India to learn from but the time taken to adopt them would also be significant, and is a longer term measure that is needed.

What needs to be done?

2 1
Introduce a more appropriate system to plan diets for population groups and individuals based on concepts such as Dietary Reference Intake (DRI)* RDA is an "average level" of nutrient intake which prevents the development of deficiency disorder. They are meant to assess and plan dietary adequacy of population groups. But they end up being used to plan diets of individuals which can be misleading. There are advanced concepts such as the Dietary Reference Intake (DRI) framework which are used in some developed countries. DRI provides the nutrient norms that helps prevent the development of risk factors for chronic diseases related to inadequate intake for that nutrient. DRI norm is an umbrella which includes RDA level, Tolerable Upper Intake level, Adequate intake level and Estimated Average Requirement level. Each one of these levels have specific application when it comes to establishing the recommended intake at an individual or group level.

Revise RDA levels to factor in effects of changed lifestyles and new research in the field of nutrition Revision of RDA levels should be taken up as an immediate activity: As per the 10th Five Year Plan, the reference (male and female) weights used to calculate RDA in 1989 for Indians were not accurate. They were higher than the average weight of Indian men and women Also, since then the trends of physical activity and dietary habits of Indians has changed considerably Considerable nutritional research has also accumulated in the last 20 years which would change some base assumptions of calculating RDA

Need

Energy requirements for average Indian male is nearly 13% lower across activity categories compared recommended levels as per RDA of 1989 Energy requirements of average Indian male

Comparison of RDA and DRI levels in USA for some nutrients shows considerable changes in recommended levels of nutrients between 1989 and 1997 Vitamin A levels for women 19 to 50 years
12.5% 3000

Folate levels for women 19 to 50 years


122% 1000 400

Case
13% 2425 2115

13% 2875 2492

13% 3800 3293

800 Heavy 1989 RDA

700 1997 DRI

180 1989 RDA

Sedentary

Moderate Activity category

1997 DRI

Recommended as per 1989 RDA Requirements as per average Indian male weight
Source: 10 Five Year Plan, planning commission
th

Recommended Dietary Allowance (RDA) Tolerable Upper Intake Level (UL)


Source: US Department of Agriculture, food and nutrition information center

*Refer Annexure 2 for details

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Nutraceuticals Critical supplement for building a healthy India

1.B.

Develop rules which specify proven nutrients, permitted health claims, product approval process, standards and Good Manufacturing Practice

Rules with regards to proven nutrients, permitted health claims, product approvals, standards and GMP need to be defined exhaustively.

What needs to be done?

i ii iii

Recognize list of nutritional ingredients with proven health benefits Define the list of permitted health claims and specify quantity of ingredients required to make those claims Setup a process for introduction of new nutraceutical products and define the nature and range of evidence required to substantiate product claims

Scientific panels have been set-up within the FSSA for defining rules to govern nutraceuticals market & label claims. Apart from Codex guidelines some of the practices that can be referred to while framing these rules are illustrated in the table below:

Summary of international practices


USA Regulation governing nutraceuticals What are the regulations governing nutraceuticals across countries? Dietary Supplement Health and Education Act (DSHEA) Foods for Special Health Use (FOSHU) Act; Foods with Nutrient Function Claims (FNFC) Act Natural Health Products Regulation Food Safety & Standards Act Japan Canada India

Key clauses for maintaining quality standards Is a defined list of proven nutraceutical ingredients and their functions available? Can a new product having ingredients which are already marketed be launched without approval/license? Can a new product having a "new dietary ingredient" not previously marketed be launched without approval/license? Is Good Manufacturing Practices (GMP) in place for manufacturing of nutraceuticals? Management of claims on label Is a claim specifying the beneficial effect on structure or function of the body permitted? To be decided The act only specifies that claims should not be false or misleading. Rules to govern claims are yet to be laid down. To be decided The act only specifies that claims should not be false or misleading. Rules to govern claims are yet to be laid down. To be decided Rules of the act not laid down yet, hence no list currently available To be decided Regulations which specify the approval process have not been framed yet To be decided Regulations which specify the approval process have not been framed yet

(Each new product needs FOSHU approval) (Pre-marketing notification along with evidence of safety has to be submitted) (Each new product needs FOSHU approval) (Each new product needs approval and product license) (Each new product needs approval and product license)

To be decided Rules specifying GMP/standards would be part of the rules of the act when they are laid down

(Permitted without validation but with a disclaimer)

(The claim and the supporting evidence is tested and validated in the approval process)

(The claim and the supporting evidence is tested and validated in the approval process)

Is a risk reduction claim pertaining to any specific disease or condition permitted?

(Only for a pre-defined list of nutrients with proven results)

(The claim and the supporting evidence is tested and validated in the approval process)

(The claim and the supporting evidence is tested and validated in the approval process)

Enforcement and monitoring of regulations Is monitoring done through inspections and random sampling of products in market? Is a record of adverse events required to be maintained? To be decided Act has not been implemented yet.

(Exception based monitoring through sample testing)

(Exception based monitoring through sample testing)

(Mandatory. Alerts issued to consumers based on no. of adverse events reported)

(Mandatory. Alerts issued to consumers based on no. of adverse events reported)

To be decided Rules yet to be laid down in the act with regards to manufacturer maintaining a record of all adverse events

Source: US Food & Drug Administration website; "Health Claim Evidence Requirements in Japan,(Yamada et al); Health Canada Natural Health Products Directorate website; Food Safety and Standards Act of India, 2006

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Recognize list of nutritional ingredients with proven health benefits

What needs to be done?


Based on overall health and nutrition status of the country, key risk factors to health need to be identified. Nutrients or functional ingredients which have science based evidence of reducing these risks should be identified and included in the list of recognized ingredients for nutraceuticals. This list can be expanded as products with new ingredients get approval after scientific evaluation.

Approved functional ingredients differ by country


Functional food category Japan Foods for gastrointestinal health (Oligosaccharides, Lactobacillus, Bifidobacterium, Psyllium husk, indigestible dextrin, wheat bran, low molecular sodium, alginate, partially hydrolyzed guar gum) Foods for those with high blood pressure (GABA, peptides) Foods for those with high blood glucose (Indigestible dextrin, L-arabinose, wheat albumin) Foods for dental health (Xylitol polyols, tea polyphenols, CPP-ACP) Foods for bone health (Soy Isoflavone) Foods for those prone to anemia (Heme iron) Foods for people with high cholesterol/ triglyceride levels and body fat (Soy protein, chitosan, low molecular sodium alginate, peptides, diacylclycerol, plant sterol/ stanol (esters), green tea catechin, middle chain fatty acid, degradation products of globin protein, Psyllium husk) (Beta-glucan, Psyllium, Quitosan, plant sterols, soy protein, Omega-3) Approved functional ingredients* Brazil (Dietary fiber, lactulose, fructooligosaccharides, inulin)

Foods for people with high cholesterol/ triglyceride levels and body fat
Source: The World Bank - Agricultural and Rural Development Discussion Paper 30 "Health Enhancing Foods" *Refer Annexure 3 for details

(Lutein, lycopene)

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ii

Define the list of permitted health claims and specify dosages of ingredients required to make those claims
What needs to be done?

The scientific panel on management of claims within the FSSA needs to frame a policy on the nature of claims that would be acceptable The level of regulatory control needs to be in line with the nature of claim while a low level of control is sufficient for nutrition content claims, a high level of control is required for risk reduction claims ( types of claims and their definitions are provided below) For nutrition content claims and health claims, rules could specify the ingredient content limits. Further, for health claims a list of acceptable claims needs to be identified based on scientific evidence

Claims made on the labels of nutraceutical products are generally classified into three types and the level of regulatory control exercised on each type could vary as shown: Nutrition claims Health claims

1
Types

Nutrition content claims Nutrition claims state, suggest or imply that a food has particular nutritional properties. Foods which claim to be sources of Energy Protein Carbohydrates Vitamins Minerals Source of calcium

Structure/function claims Structure-function claims describe A nutritional ingredients effect on a structure or physiological function in the human body, or Its support of an anatomical, physiological, or mental function Non-specific claims of overall health are also included "Maintains healthy gums" "A factor in the maintenance of good health" Medium No pre-approval is required Pre-launch notification to FDA is required along with evidence of claim Along with the claim a disclaimer is required on label mentioning that the claim is not FDA approved

Risk reduction claims Risk reduction claims describe the relationship between using a medicinal ingredient and reducing the risk of developing a specific disease or abnormal physiological state

Definition

Examples

High in fiber and low in fat

"Reduces risk of heart disease" "Lowers blood cholesterol"

Level of regulatory control required Case (US FDA claim regulations*)

Low No pre-approval of FDA is required No evidence is required to be submitted Nutrients and quantities are required to be mentioned on label

High Claim has to be for one of the ingredients in the preapproved list of proven and qualified health claims The quantities of nutrients required for the claim to be made are also required to be specified

Source: Codex guidelines for use of nutritional and health claims; US FDA website *Refer Annexure 4 for details

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iii

Setup regulatory process for introduction of new nutraceutical products

What needs to be done?

The process for introducing a new nutraceutical whether approval based or notification based should be clearly specified as part of the rules and regulations of FSSA. For an approval based system, the authorities responsible for processing the application and granting approval should be identified and trained for standardization in implementation. For a notification based system, a channel should be set-up to hear, record and process consumer grievances or adverse event reports In the Indian context, opting for an approval based process may lead to a regulatory bottleneck and delays. On the other hand, a large proportion of the Indian consumers may not have adequate awareness or education levels because of which a notification based process might lead to compromising consumer safety. Hence a hybrid of the two processes needs to be conceived and implemented The nature and range of evidence required to substantiate a particular health claim needs to be defined clearly.

Process for introduction of a new nutraceutical product

Level of regulatory control

Approval/license based High Manufacturer applies for approval to the recognized authority (local governments, FDA) The application by manufacturer includes the evidence to substantiate product claims

Notification based Low For a new product with ingredients which are already marketed, no approval is required. Manufacturer notifies the FDA prior to launch. If there is a health claim associated with the product, then the notification includes evidence to substantiate claims The responsibility to ensure safety and efficacy of the nutraceutical product lies with the manufacturer Reduced burden on the FDA with lesser resources needed to control the market (labs & inspectors) Lesser time to market for new products Reduced scope for corruption which might be prevalent in strictly controlled environment where licenses are granted

Key features

The responsibility to ensure the safety and efficacy of the nutraceutical product in the market lies with the authority granting approval

Consumer safety can be ensured and misleading claims can be barred centrally

Advantages

Reduced effort on monitoring, through sampling and testing of products from the market Reduced reliance on consumer reporting of adverse events

Japan*: All new products have to get approval to be sold as a FOSHU product The application for a product is required to include documentation regarding:

USA: Products with ingredients which have already been marketed do not need approval. A notification has to be given with evidence to support health claims For new ingredients, the pre-marketing notification has to be 75 days prior to launch in which period the FDA can analyze evidence and raise concerns with the manufacturer The manufacturer is required to maintain a record of all adverse events reported by consumers. Monitoring Monitoring is done based on exceptions

Cases

Its effectiveness based on scientific evidence including clinical studies Its safety based on historical consumption pattern Analytical method for determination of the functional component Samples of the product are also tested in a public food laboratory before approval is granted

Source: Health Claim Evidence Requirements in Japan,(Yamada et al); US FDA website *Refer Annexure 5 for details

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2.

Take measures to ensure availability of adequate resources for implementation and enforcement of regulations
Current challenges What needs to be done?

Formalize mechanism to capture data on exact numbers Sharing of data on infrastructure and its electronic storage is critical to manage and track the inspection of all food processing units, retail outlets, stockists by food safety officers. Coordination and implementation across key stakeholders across public bodies such as local governments and state level FDAs is required and periodic status reports need to be made possible

Insufficient strength of Food Safety Officers (FSO) to inspect and evaluate food processing units, stockists and retailers

Evaluate gaps in number of food safety officers and recruit to fill those gaps State Food and Drug Administrations need to assess gap in required and available food safety officers and recruit to scale up and meet the required number

Authorize an external agency to evaluate and grant approval to products An external agency could be appointed to evaluate nutraceutical products for safety and efficacy based on the standards and GMP framed as a part of regulations

Inspection of nutraceutical products would require more specialized knowledge and processes

Approvals by this agency would be in the form of a mark on the product which would help build credibility for tested and proven products

Train Food Safety Officers to improve quality of inspection of facilities Food safety officers should be trained in a phase-wise manner to inspect facilities for manufacture, packaging, distribution and sale of nutraceuticals

Develop a network of central food testing laboratories Infrastructure needs be scaled up to have at least one central laboratory in each state as role model All central laboratories need to to follow Good Laboratory Practices or get accreditation Appoint private laboratories and outsource testing of food samples Evaluate competence of private laboratories Authorize competent laboratories to conduct tests on food samples for FDA

Insufficient facilities for testing and analysis of food samples


Approximately 250 laboratories The quality of equipment and analysis of these laboratories needs to be appropriately upgraded

Source: Primary interviews; Ministry of Food Processing industries website; Industry sources

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3.

Encourage R&D in nutritional food sector and deploy PPP models to serve needs of the undernourished segment of population
Current challenges

What needs to be done?

Establish a dedicated fund for nutraceuticals research Encourage research in the field of nutraceuticals by funding relevant research and development in nutraceuticals Provide R&D infrastructure support to nutraceutical players for conducting research

Lack of investment and focus on research & development in the

Allow use of public research facilities and food laboratories to nutraceutical companies to give an impetus to R&D Collaboration between industry and academia Encourage collaborations between education and research institutions and the industry so that there is a vigorous exchange of ideas. Set up a central nutraceutical technology and research center. This center can be a forum where eminent people from R&D institutions, medical institutions, nutraceutical manufacturers, regulators, researchers can interact and exchange ideas to fuel growth of the industry Public-private partnerships

Imbalance of nutritional ingredients in the food provided to the undernourished through government schemes

Deploy PPP models in the government schemes to supply food to the undernourished segment of the population The private partner could provide fortification of the food so that required nutrients are delivered. They can also provide surveillance and logistics management services to ensure the responsible supply of unadulterated micronutrients.

It is a part of the government agenda to meet nutritional deficiencies in the undernourished segment of the Indian population
Major goals of "National Nutrition Plan" to be met by 2012
Reduce the prevalence of underweight condition in children under five years to 20% Eradicate the prevalence of severe under-nutrition in children under five years Reduce prevalence of anaemia in high risk groups (infants, pre-school children, adolescent girls, pregnant and lactating women) to 25 % Eliminate vitamin A deficiency in children under five years as a public health problem and reduce sub-clinical deficiency of vitamin A in children by 50 % Reduce prevalence of Iodine deficiency disorders to less than 5 %
Source: 11th Five Year Plan, Working group on integrating nutrition with health

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These goals are to be achieved through multiple health and nutrition interventions planned by the government
Some nutrition interventions undertaken by different sectors of the government
Integrated Child Development Scheme (ICDS) Nutrition Program for Adolescent Girls (NPAG) Iron and Folic Acid supplementation of pregnant women Vitamin A supplementation of children of 9 to 36 months age group National Iodine Deficiency Disorders Control Programme Mid day meal for primary school children
Source: 11th Five Year Plan, Working group on integrating nutrition with health

However there are gaps in the implementation of these existing nutrition interventions which can be filled by ensuring participation of the private sector through Public Private Partnerships
Some Issues Role of private sector

Inadequate intake of micronutrients by the beneficiaries of government schemes

Partner with the government in supplementation and fortification of the food dispensed through government initiatives

Inadequate supplies reaching the point where food is dispensed

Provide surveillance and logistics management services to ensure the responsible supply of unadulterated micronutrients

Source: India Micronutrient National Investment Plan 2007-2011 , Micronutrient India ; Network for Social Accountability website ; Ernst & Young analysis

Case study 1 PPP to provide supplementary nutrition


Britannia "Tiger" biscuits, fortified with iron were distributed to school children as a part of the Mid Day Meal program in 2007 The biscuits were given in addition to the rice based meals. This provided the children with 10% of the daily RDA of iron. The Naandi foundation which partnered with Britannia in this particular project in Andhra Pradesh hopes to extend this program to other parts of the country.
Source: Naandi foundation website

Case study 2 PPP to fortify food provided as a part of government schemes


Heinz partnered with ICDS (Integrated Child Development Scheme) and an NGO to provide micronutrients to children in a three month Public Private Partnership project in 2007. As a part of this initiative, more than 17,000 children between 6 months and 6 years of age were given "sprinkles plus" a micronutrient powder mixed in their food. The successful implementation of this project demonstrated that anemia can be reduced if such initiatives are implemented at pre school level in the "anganwadis" of the ICDS. Heinz is working on a scale up project to reach several million at risk children with "sprinkles plus"
Source: Heinz website

Agenda for private sector

Agenda for private players in the nutraceuticals market

1 Product development Develop consumer focused products and product variants for different target segments

2 A. Build credibility Product differentiation Ensure publication of efcacy studies and research results in scientic/medical journals B. Lower prices Improve processes/technology to reduce cost of production

Obtain approval of reputed external institutions

Lower pricing of products to target a larger consumer base

3 Educate physicians about published research on nutrition Formulate health claims as per published research and approvals Use general media to communicate benets & differentiation

Product promotion

Physician awareness

Public awareness

Health

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1.

Product development: develop consumer focused products for different target segments
What needs to be done?

Develop consumer focused products for different target segments Enable easier diagnosis of nutrient deficiency

Understand nutrition needs of different segments of consumers Develop relevant nutraceutical products targeted at different consumer segments with regard to their preferences and taste Considering a large proportion of the population is not aware of their specific nutritional deficiencies, there is also a potential market for a nutrient deficiency diagnostic test/kit

Leverage traditional Indian knowledge in herbs and botanicals to develop new nutraceuticals

Convert the nutritional properties of herbs and botanicals as per knowledge derived from traditional Indian sources into products for consumer

Case study 1 Identifying customer needs and positioning products to meet these needs
Calcium Sandoz switched to the OTC route from the ethical pharmaceutical route in 2000 Since then, Novartis has continuously identified needs of different target segments of consumers and positioned variants for each segment.
Consistent growth in sales (INR million) of the Calcium Sandoz brand after introduction of multiple variants to cater to specic user needs 320 CAGR 15%

120

Launch of Calcium Sandoz Growth specically for children

Launch of Calcium Sandoz Woman for older woman

Launch of Calcium Sandoz Soft Chew in various avors targeted at children in their semi-teens 2006 2007 2008

2001

2002

2003

2004

2005

Source: Novartis India website; Industry sources

Case study 2 Collaboration with the government to innovate nutraceuticals from traditional medicine knowledge
Avesthagen and Indian Council of Medical Research (ICMR) A memorandum of understanding was signed between Avesthagen Limited, a knowledge based Lifesciences Company and the Indian Council of Medical Research (ICMR) for the formulation, coordination and promotion of biomedical research for three years. As per the agreement both the parties will be exploring possibilities to innovate nutraceutical development from traditional and folk medicine by knowledge sharing. The agreement will open new avenues for research on traditional Indian medicinal plants and their nutritional properties.
Source: Express Pharma, 115 September 2008

2.

Product differentiation: build credibility and lower prices of products

In the absence of intellectual property protection, product differentiation in case of nutraceutical products can be achieved either through building credibility of the brand/company or through prices lower than existing players in the market

Way forward

Adhere to all rules and regulations laid down to govern manufacture, distribution and sale of nutraceutical products Follow standards, GMP, claim regulations and approval process for nutraceutical products

Build credibility of the brand/company

Get results of efficacy studies published in medical journals as proof of efficacy and safety of the product Obtain approval of reputed and trustworthy external institutions for the product and its claim

Lower prices of nutraceutical products

Lower prices of nutraceutical products to target a larger consumer base instead of a niche segment Focus on cost reduction in manufacturing to help improve affordability of products

Case study 1 Reputed external institution in USA granting approvals to nutraceutical products
The USP (US Pharmacopeia) Dietary Supplement Verification Program in USA is a voluntary testing and auditing program. This program validates the quality, purity, and potency of dietary supplement finished products through: Comprehensive laboratory testing against standards A thorough manufacturing and quality control document review An on-site manufacturing facility audit Random off-the-shelf testing USP's expertise in setting standards of quality for medications for 200 years helps in lending credibility to products which carry its approval
Source: US Pharmacopeia Dietary Supplement Verification Program website

Case study 2 Efficacy studies for a product published and external institutional approval taken
A chilled fruit juice product "Sirco" from Provexis launched in the UK contains the patented Fruitflow bioactive food ingredient that reduces blood platelet aggregation, a significant contributing factor to thrombosis, which can cause heart attack or stroke. In May 2006, Provexis, announced a scientific endorsement for Sirco; two scientific papers, which detailed the clinical efficacy of Sirco, were published by the American Journal of Clinical Nutrition (AJCN), an internationally recognized journal in the nutrition field. This followed the 2005 announcement of a three year collaboration with registered heart health charity, Heart UK, which allowed Provexis formal approval for its Sirco product, allowing Sirco to wear the Heart UK logo on its packaging. Such endorsements on the packaging of the product from renowned institutions offer credibility to claims that the product is good for the heart.
Source: "Functional Food and Drink Consumption Trends"-Datamonitor

3.

Product promotion: increase awareness of the benefits of nutraceuticals through mass marketing, advertising and education of physicians

What needs to be done?

Increase physician awareness

Get the relevant research published in research and medical journals so that it reaches the physicians as a part of their CME(Continuous Medical Education)

There is a need to educate the consumers about the relation between a healthy life and a diet rich in nutrition

Increase public awareness

Based on the profile of customers identify various media channels of communication such as TV, newspapers, magazines, direct selling etc. Create the right content for communication which addresses customer needs or creates awareness to activate latent needs Selection of the right strategy need not be cost/investment heavy

Case "Revital" is Ranbaxys adult health supplement which transitioned from prescription to OTC in 2002.

Increase in sales of Ranbaxys Revital after switching to OTC channels


CAGR 20% 83

Ranbaxy used a well thought out television creative to target the consumer directly through advertizing. "Revital" was positioned to fit into the users hectic lifestyle empowering them with energy strength & mental sharpness, enabling them to enjoy life to the fullest, hence making them live the brand punch line of Jiyo Jee Bhar Ke The advertising was spread over three phases: In the first phase the commercials sought to demonstrate the pre-use scenario and post-use benefits.

40

2002

2007

Source: Revitalizing the brand, Express Pharma 31 march 2006; Industry sources

The second phase showed how a consumer of "Revital" was able to make the most of his life which his colleagues and friends are unable to do. The third phase is in the form of testimonials by regular users of "Revital"

Annexure
Annexure 1: Estimation of potential market
Market size estimation for foundation needs: Target market of people belonging to segments with affordability and consuming at least sufficient calories but needing products to maintain and promote a normal, healthy life

Parameter

No. of consumers belonging to segments with affordability*

Percentage population willing to buy nutraceuticals for their general well-being

Amount willing to spend on products that meet foundation needs

Assumption

Population belonging to top 3 MPCE classes in urban areas and topmost MPCE class in rural areas The number of actual consumers will vary with each scenario with growing awareness

The population consuming at least sufficient food (>90% of norm of 2700 kcal/day), would have the propensity to further buy nutraceuticals to maintain their general well-being. The proportion of such population would vary with MPCE class
NSSO 2004-05

Amount willing to spend on such products would be in proportion to spend on food categories like processed food and beverages This spend would increase with increasing MPCE and would vary with each scenario

Source

NSSO 2006-07

NSSO 2006-07, Ernst & Young analysis

Potential market for foundation needs (INR billion)


Scenario 1 38.0 Scenario 2 60.8 Scenario 3 71.4

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Market size estimation for condition-specific needs (1/4): Target market of adults (>20 years) likely to face vitamin and mineral deficiency disorders due to significantly lower than recommended fruit & vegetable consumption

Parameter

No. of consumers belonging to segments with affordability

Percentage adults >20 years

Percentage adults consuming vitamins less than RDA

Vitamin intake gap per adult per day

Price per unit vitamin gap

Assumption

Population belonging to top 3 MPCE classes in urban areas and topmost MPCE class in rural areas

The overall age wise break-up of population for urban and rural areas was equated to the respective MPCE classes

Assuming that the households in which fruit and vegetable consumption is less than average (which is still lower than ICMR norms), will be facing deficiencies in vitamins The proportion of such households would vary with each MPCE class

The gap is arrived at for the most extensively tracked vitamins The extent of this gap varies with MPCE classes Further, the tendency to address this gap with nutraceuticals will vary with each scenario
NNMB 2007

Representative price of the most commonly used multivitamin supplement is considered

Source

NSSO 2006-07

NSSO 2004-05

NSSO 2004-05

Ernst & Young analysis Note: Prices based on various brands available in market

Potential market for vitamins for adults (INR billion)


Scenario 1 4.1 Scenario 2 6.2 Scenario 3 8.2

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67

Market size estimation for condition-specific needs (2/4): Target market of pregnant and lactating women with an increased requirement for nutrient intake like proteins, iron

Parameter

No. of women consumers belonging to segments with affordability

Percentage pregnant and lactating women in the age group of 15-49 years

Nutrient intake gap per pregnant woman per day

Price per unit nutrient

Assumption

Women belonging to top 3 MPCE classes in urban areas and topmost MPCE class in rural areas

The overall proportion of women in the age 15-49 years for urban and rural areas was assumed to be applicable for the respective MPCE classes Based on the birth rate figures, number of pregnant and lactating women were arrived at

The gap is arrived at for the key representative nutrients proteins and iron The extent of this gap varies with MPCE classes Further, the tendency to address this gap with nutraceuticals will vary with each scenario

Representative price of the most commonly used protein and iron supplements is considered

Source

NSSO 2006-07

NSSO 2004-05

NNMB 2007

Ernst & Young analysis Note: Prices based on various brands available in market

Potential market for nutrients for pregnant and lactating women (INR billion)
Scenario 1 20.1 Scenario 2 30.2 Scenario 3 40.3

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Market size estimation for condition-specific needs (3/4): Target market of other women in the age group of 15-49 years suffering from any form of anemiao

Parameter

No. of women consumers belonging to segments with affordability

Percentage non-pregnant, non-lactating women in the age group of 15-49 years

Percentage women consuming iron less than RDA

Iron intake gap (mg) per woman per day

Price per mg of iron

Assumption

Women belonging to top 3 MPCE classes in urban areas and topmost MPCE class in rural areas

The overall proportion of women in the age 15-49 years for urban and rural areas was assumed to be applicable for the respective MPCE classes The number of pregnant and lactating women is subtracted from the total figure

Women suffering from any form of anemia and belonging to this age group would have maximum impact due to loss of iron through blood during menstruation Proportion of such women belonging to the high income groups was considered

The extent of this gap varies with MPCE classes Further, the tendency to address this gap with nutraceuticals will vary with each scenario

Representative price of the most commonly used iron supplements is considered

Source

NSSO 2006-07

NSSO 2004-05

NFHS 3, 2005-06

NNMB 2007

Ernst & Young analysis Note: Prices based on various brands available in market

Potential market for iron for other women (INR billion)


Scenario 1 18.9 Scenario 2 28.3 Scenario 3 37.8

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Market size estimation for condition-specific needs (4/4): Target market of children aged between 4 to 17 years and consuming less than RDA proteins needed for growth

Parameter

No. of persons belonging to segments with affordability

Percentage children in the age group of 4-17 years

Percentage children consuming protein less than RDA

Protein intake gap (gms) per child per day

Price per gm of protein

Assumption

Population belonging to top 3 MPCE classes in urban areas and topmost MPCE class in rural areas

The overall proportion of children in this age group in urban and rural areas was assumed to be applicable for the respective MPCE classes

Households in which overall protein consumption is less than RDA limits, were considered The proportion of such households would vary with each MPCE class

The extent of this gap varies with MPCE classes Further, the tendency to address this gap with nutraceuticals will vary with each scenario

Representative price of the most commonly used protein supplements is considered

Source

NSSO 2006-07

NSSO 2004-05

NSSO 2004-05, Ernst & Young analysis

NNMB 2007

Ernst & Young analysis Note: Prices based on various brands available in market

Potential market for proteins for children (INR billion)


Scenario 1 6.6 Scenario 2 9.9 Scenario 3 13.2

Potential market for condition-specific needs (INR billion)


Scenario 1 49.7 Scenario 2 74.6 Scenario 3 99.5

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Market size estimation for enhancement needs: Target market of people going to the gym and engaged in moderate to heavy work-out routines, who have an enhanced need for nutrient intake

Parameter

No. of gym goers

Percentage needing enhanced protein nutritions

Additional protein intake needed (gm/day)

Price per gm of protein

Based on annual size of gym market and average subscription per user Assumption

Typically a proportion of these gym goers who are engaged in moderate to heavy work-out would be needing enhanced protein nutrition

Protein requirement of such people is usually 20% higher than RDA for an average sedentary male However, the tendency to address this additional requirement with nutraceuticals will vary with each scenario

Representative price of the most commonly used whey protein supplement

Source

Ernst & Young - FICCI Wellness report, 2009

Primary interviews, NNMB 2007, Ernst & Young research

Ernst & Young analysis Note: Prices based on various brands available in market

Potential market for enhancement needs (INR billion)


Scenario 1 1.2 Scenario 2 1.4 Scenario 3 1.5

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Annexure-2
An understanding of Dietary Reference Intakes (DRI) Reference values known in the United States as Recommended Dietary Allowances (RDAs) and in Canada as Recommended Nutrient Intakes (RNIs) were used through the 1990s. They were established primarily to set nutrition and health policy.

Need

In 1994, in response to significant changes in the nutrition field as well as the recognition that for many nutrients the single RDA values did not meet the expanding needs for nutrient reference values, the IOM began an initiative to develop a new, broader set of values known as the DRIs. The U.S. and Canadian governments supported this initiative In 1997, the first DRI report was released. In the subsequent years, RDA/AI levels for other nutrients were described

Dietary Reference Intakes Definitions Estimated Average Requirement (EAR): Reflects the estimated median requirement and is particularly appropriate for applications related to planning and assessing intakes for groups of persons.

DRIs

Recommended Dietary Allowance (RDA): Derived from the EAR and covers the requirements for 97% of the population. Tolerable Upper Intake Level (UL): Highest average intake that is likely to pose no risk. Adequate Intake (AI): Used when an EAR/RDA cannot be developed; average intake level based on observed or experimental intakes.

DRI has significant advantages over older RDAs. The new DRIs 1
Include upper levels of intake, where appropriate. Upper levels were not defined in the older RDAs prior to 1997. This provided a safe upper limit for nutrient intake.

Advantages

Specifically highlight concepts of probability and risk for defining reference values. The EARs use the median values to calculate the RDA levels taking into account the distribution of dietary requirements for each nutrient (where possible). This accurate calculation of the DRIs was useful in their application to determine adequacy of diet at an individual level. The older RDAs used the average values determined from a group of the population and extrapolated to determine RDA levels... Incorporate chronic disease endpoints within the array of endpoints that may serve to establish adequate intake or upper intake levels where possible. The older RDAs used appearance of signs or symptoms of deficiency disorders as endpoints

Source: Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride/Standing Committee on the Scientific, Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine.USA; The Development of DRIs 1994-2004: Lessons Learned and New Challenges: Workshop Summary- Food and Nutrition Board, Institute of Medicine, National Academy of Sciences, USA

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Annexure-3
Case studies: Approved functions and functional ingredients
Japan:
In the mid 1980s Japan was faced with a crisis having an ageing population with its increasing health problems and the expected increases in health care costs as a result. This pushed government-initiated research to investigate, in-depth, the role foods can play in reversing and preventing the prevalent chronic health conditions. "Foods for Special Health Use" (FOSHU) regulations were framed and implemented by the Ministry of Health, Labor and Welfare (MHLW) in 1991, which recognized various health conditions for which a list of preventive foods was made. FOSHU functions and functional food components FOSHU function Foods for gastrointestinal health Approved products (number) Main functional ingredients 254 Oligosaccharides, Lactobacillus, Bifidobacterium, Psyllium husk, indigestible dextrin, wheat bran, low molecular sodium, alginate, partially hydrolyzed guar gum Soy protein, chitosan, low molecular sodium alginate, peptides, diacylclycerol, plant sterol/stanol (esters), green tea catechin, middle chain fatty acid, degradation products of globin protein, Psyllium husk indigestible dextrin, L-arabinose, wheat albumin G A B A, peptides Xylitol, polyols, tea polyphenols, CPP-ACP Soy isoflavone Heme iron

Foods for people with high cholesterol/ triglyceride level and body fat

117

Foods for those with high blood glucose Foods for those with high blood pressure Foods for dental health Foods for bone health Foods for those prone to anemia

71 64 34 26 3

Source: The World Bank - Agricultural and Rural Development Discussion Paper 30 "Health Enhancing Foods"; "Health Claim Evidence Requirements in Japan", Yamada et al

In April 2001, a new category was introduced by MHLW "Foods with Nutrition Function Claims" (FNFC) under which 12 vitamins including vitamin A; thiamin; riboflavin; vitamins B-6, B-12, C, E, D; biotin, pantothenic acid, folic acid, niacin as well as minerals calcium, iron, zinc, magnesium and copper have been standardized
Brazil:
Functional food regulations were introduced in Brazil in 1999, and since then over 200 products have been approved with 14 different functional property claims. Food Components and related approved functions Approved functions Foods for maintenance of healthy blood triglyceride levels Foods for protection against cellular damage from free radicals Foods for intestinal function Foods for balanced intestinal flore Foods to reduce absorption of fats/ cholesterol Foods for reduction of cholesterol Functional ingredients Omega 3 Lutein, Lycopene Dietary fiber, Lactulose Fructo-oligosaccharides, inulin, Beta-glucan, Psyllium, Quitosan, Plant sterols Soy protein

Source: The World Bank - Agricultural and Rural Development Discussion Paper 30 "Health Enhancing Foods"

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Annexure-4
Case study: Regulations governing nutrition and health claims
USA:
Claims on nutraceutical product labels are governed by DSHEA and NLEA in the USA

Nutrition content claims

No pre-approval required Guidelines provided for content level and evidence required

Structure/ function claims

No pre-approval required Pre-marketing notification to the FDA 30 days prior to marketing the product Manufacturer responsible for having sufficient evidence to back-up the claims made Disclaimer on the label stating that the claim is "not approved by FDA" and "the product does not prevent, cure, treat any specific disease or condition"

Risk reduction claims

Pre-approved list of permitted risk reduction claims for certain ingredients is available If the product contains one of these ingredients in specified quantities, the related claim can be made Pre-approved list of permitted risk reduction claims: Calcium and Osteoporosis Dietary Lipids (Fat) and Cancer Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease Dietary Non-cariogenic Carbohydrate Sweeteners and Dental Caries Fiber-containing Grain Products, Fruits and Vegetables and Cancer Folic Acid and Neural Tube Defects Fruits and Vegetables and Cancer Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble Fiber, and Risk of Coronary Heart Disease Sodium and Hypertension Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease Soy Protein and Risk of Coronary Heart Disease Stanols and/or Sterols and Risk of Coronary Heart Disease
Source: US Food & Drug Administration website

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Annexure-5
Case studies: Regulatory process for launch of a new nutraceutical product
Japan:
As per FOSHU, all manufacturers that seek approval for their products need to go through the approval process before they can market their product. Process of FOSHU approval

Manufacturer submits application to the Office of Health Policy on Newly Developed Foods (The Office) under the MHLW The application for a product should include documentation regarding: Its effectiveness based on scientific evidence including clinical studies Its safety based on historical consumption pattern Analytical method for determination of the functional component

5. Grant of approval 1. Submit application

Manufacturer 3. Submit samples & get analysis National Inst.for health & nutrition

4. Submit analysis

Ministry of Health, Labor & Welfare 2. Consultation & recommendation

Expert committees evaluate the application for efficacy Opinions of the Food Safety Commission is taken to evaluate safety

Council of pharma affairs & food sanitation

Food safety commission

Source: Health Claim Evidence Requirements in Japan,(Yamada et al)

If application is appropriate, the MHLW notifies the manufacturer to send samples for testing to the National Institution of Health and Nutrition After validation and testing of samples is done, the product is granted FOSHU approval

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Acknowledgements
Ajit Singh
President Health Foods and Dietary Supplements Association

Priya Parab
Proprietor Vihaan Naturals

Anil Bhanudas Sawant


Manager-Marketing Ayuherb Healthcare

Dr. R.B.Smarta
Managing Director Interlink Marketing Consultancy Pvt. Ltd.

Arun Kelkar
Managing Director Hexagon Nutrition Pvt. Ltd.

R. D.Joshi
(Former Secretary General OPPI) Director Business Processes Interlink Marketing Consultancy Pvt. Ltd.

Dr. Bhushan M. Karnik


Managing Director GCI Nutrients (India) Pvt. Ltd

Ranjit Puranik
Chief Executive Officer Shri Dhootpapeshwar Ltd.

Chanchal K. Chadha
Regional Vice President International Sales and Marketing NBTY Inc.

Dr. Vilas Shirhatti


Head - Technology Marico Industries

Deepali Shukla
Head - Marketing Amway India

Dr.S.K.Sharma
Manager - Marketing Zandu Pharmaceuticals

Farhat Navlakhi Saxena


Chief Executive Officer R R Oomerbhoy Pvt. Ltd.

S.W.Deshpande
Advocate Former Joint Commissioner FDA- Maharashtra

Himanshoo Nayak
General Manager Business development Elder Pharmaceuticals

Sanjay Singh
Technical manager Plethico Pharmaceuticals Ltd.

Dr. Michael Lelah


Technical Director NOW foods

Shrihari Shidaye
Vice President - Sales, Marketing and Business development Piramal Healthcare Ltd.

Dr. P.I. Suvrathan


Chairman Food Safety and Standards Authority of India

Dr. U.Y.Rege
Proprietor Mukta Technical Consultancy Services

Pradeep Patil
G.M - Marketing Zandu Pharmaceuticals.

Vikram Trivedi
Senior Research Manager R&D Zandu Pharmaceuticals

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Glossary of terms
Glossary of terms (1/3)
Term AI AJCN Antioxidants BCC B Pharm B Sc Chronic Illness/disorder CAGR CCP-ACP CME CVD DALY Adequate Intake American Journal of Clinical Nutrition A compound that helps to protect cells against damage by free radicals eg: flavonoids Business Communications Company Bachelor of Pharmacy Bachelor of Science Illness/disorder that is long term or permanent and requires prolonged treatment Compounded Annual Growth Rate. The standard formula is: (last number/first number)^(1/periods)-1 Casein Phosphopeptide-Amorphous Calcium Phosphate Continuous Medical Education Cardio Vascular Disease Disability-Adjusted Life Year.DALY is a measure of overall disease burden. It was originally developed by the World Health Organization. DALYs are calculated by taking the sum of these two components. In a formula: DALY = YLL (Years of Life Lost) + YLD (Years Lived with Disability). Dietary Reference Intake.DRI is a system of nutrition recommendations from the Institute of Medicine (IOM) of the US National Academy of Sciences. The DRI system is used by both the United States and Canada and is intended for the general public and health professionals. Dietary Supplement Health and Education Act Under the DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Estimated Average Requirement Food and Drug Administration Federation of Indian Chambers of Commerce and Industry Fast Moving Consumer Goods Foods with nutrients added in addition to the levels that were originally found eg: edible oils fortified with vitamins A and D Foods with Nutrition Functional Claims Foods for Special Health Use Food Safety Officers Food Safety and Standards Explanation

DRI

DSHEA

EAR FDA FICCI FMCG Fortified foods FNFC FOSHU FSO FSS

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Glossary of terms
Glossary of terms (2/3)
Term FSSA GABA GDP Food Safety and Standards Act Gamma-Aminobutyric acid Gross Domestic ProductGDP is a basic measure of a country's economic performance and is the market value of all final goods and services made within the borders of a nation in a year .It calculated as: GDP = private consumption + gross investment + government spending + (exports imports) Good manufacturing practice Group of Ministers Glaxo SmithKline Consumer Healthcare Integrated Child Development Scheme Indian Council of Medical Research Indian Council for Research and International Economic Relations Indian rupee Intelligence Quotient Kilo calories ( 1 Kilo Cal = 1000 calories) Low density lipoprotein Number of maternal deaths related to childbearing divided by the number of live births Million per annum Monthly Per Capita Expenditure National Accreditation Board for Testing and Calibration Laboratories National Council of Applied Economic Research National Family Health Survey Vitamin B3- important for normal function of gastrointestinal and nervous systems, deficiency of which leads to pellagra Nutrition Labeling and Education Act National Nutrition Monitoring Bureau National Sample Survey Organization Over The Counter Food containing live micro-organisms which on consumption in adequate amounts, confer a health benefit to the consumer eg: Probiotic ice cream Public Private Partnerships Recommended Dietary Allowance Explanation

GMP GOM GSK CH ICDS ICMR ICRIER INR IQ KCal LDL Maternal Mortality Rate MPA MPCE NABL NCAER NFHS Niacin NLEA NNMB NSSO OTC Probiotic food PPP RDA

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Glossary of terms
Glossary of terms (3/3)
Term RNI SD Thiamin UL USD USP WHO Recommended Nutrient Intakes Standard Deviation Vitamin B1 which helps to maintain appetite and growth, deficiency of which causes beri beri Tolerable Upper Intake Level US dollar United States Pharmacopeia World Health Organization Explanation

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About FICCI
Set up in 1927, FICCI is the largest and oldest apex business organization of Indian business. Its history is very closely interwoven with the freedom movement. FICCI inspired economic nationalism as a political tool to fight against discriminatory economic policies. FICCIs commitment is now directed at changing the economic landscape of India, through reforms that expand the space for private sector and public private partnerships. FICCI is the rallying point for free enterprises in India. It has empowered Indian businesses, in the changing times, to shore up their competitiveness and enhance their global reach. FICCI maintains the lead as the proactive business solution provider through research, interactions at the highest political level and global networking. In the knowledge-driven globalized economy, FICCI stands for quality, competitiveness, transparency, accountability and businessgovernment-civil society partnership to spread ethics-based business practices and to enhance the quality of life of the common people. FICCI- Western Regional Council is the western regional arm of the Federation of Indian Chambers of Commerce & Industry, which has 14 domestic and 7 overseas offices. In addition to supporting FICCI, New Delhi, FICCI-WRC organizes its own conferences, seminars, workshops and networks with visiting delegations from several developing countries. FICCI WRC actively provides sectoral services in brand protection, boating, business matching, design, gems & jewellery, nutraceuticals, progressive Maharashtra, textiles, technical textiles and wellness.

For more details contact: Dr. Vaijayanti Pandit/Ms. Amita Kardile (+91 9890069558)
Director FICCI Western Regional Council Plot no. 33B Krishnamai Building Sir Pochkhanwala Road, Worli Mumbai 400 030 Telephone: +91 022-24968000 Fax: +91 022-24966631/32 E-mail: drvpandit@ficci.com/amitak@ficci.com

Head Office
Federation of Indian Chambers of Commerce & Industry Federation House Tansen Marg New Delhi 110 001 Website: www.ficci.com

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Notes

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Information in this publication is intended to provide only a general outline of the subjects covered. It should neither be regarded as comprehensive nor sufficient for making decisions, nor should it be used in place of professional advice. Ernst & Young Pvt. Ltd. accepts no responsibility for any loss arising from any action taken or not taken by anyone using this material. 155 Nutraceuticals. Artwork by Deepti Khatri.