nutraconsensus - grant thornton indiagtw3.grantthornton.in/assets/reports/gt_ficci...nutraconsensus...

Nutraconsensus Emerging insights on Nutraceuticals - players and policy makers

A whitepaper prepared by Grant Thornton and FICCI

FICCI-HADSA Nutraceuticals 2012 “Regulation, Categorisation and Commercialisation”

6 November 2012, Mumbai

Nutraconsensus 1

© Grant Thornton India LLP. All rights reserved. Member firm of Grant Thornton International Ltd Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune

Disclaimer: The information and opinions contained in this document have been compiled or arrived at from published sources believed to be reliable, but no representation or warranty is made to their accuracy, completeness or correctness. This document is for information purposes only. The information contained in this document is published for the assistance of the recipient but is not to be relied upon as authoritative or taken in substitution for the exercise of judgment by any recipi-ent. This document is not intended to be a substitute for professional, technical or legal advice. All opinions expressed in this document are subject to change without notice. Whilst due care has been taken in the preparation of this document and in-formation contained herein, neither Grant Thornton nor FICCI nor other legal enti-ties in the group to which they belong, accept any liability whatsoever, for any direct or consequential loss howsoever arising from any use of this document or its con-tents or otherwise arising in connection herewith.

Nutraconsensus 2

© Grant Thornton India LLP. All rights reserved. Member firm of Grant Thornton International Ltd Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune

Contents

Page

Foreword – FICCI 3 Foreword – Grant Thornton 4 A framework of definition 5 A framework of operation 10 A framework of regulation 31 Recommendations 42

Nutraconsensus 3

© Grant Thornton India LLP. All rights reserved.

Foreword: FICCI

Mr Ajit Singh Chairman-FICCI Task Force on Nutraceuticals Chairman-ACG Worldwide President-Health Foods & Dietary Supplements Association (HADSA)

As we enter our fourth successive year, FICCI and HADSA are delighted to bring together another

edition of the developments in the Nutraceuticals sector.

This whitepaper attempts to bring out the key trends in the developments of the nutraceuticals seg-ment in the BRIC regions over the last few years. It further benchmarks the regulatory aspects and challenges in operation, quality, control and market dynamics. While strategies adopted by key market players are often specific to countries, they often serve as an effective medium of learning for other regions with similar demographic profiles and population characteristics.

Increased consumer awareness, changing lifestyles and a marginal degree of under-satisfaction from

traditional drugs has given adequate impetus to this industry to expand its presence and visibility

through innovative marketing channels and riding the retail boom in countries like India.

The year 2012 is being envisioned as the year of nutraceuticals in India with a positive beginning in

the form of crystallisation of licensing, registration and quality control standards by the Food and

Safety Standards of India. Although much needs to be done to strengthen the mechanism of imple-

mentation and application of these guidelines, this has been a move which has been welcomed by the

industry and other users alike.

Nutraconsensus 4


Foreword: Grant Thornton

Mahadevan Narayanamoni Practice Leader, Healthcare and Life Sciences Advisory Partner, Corporate Finance Grant Thornton India LLP

It gives us immense pleasure to participate as Knowledge Partners with FICCI and HADSA for the

4th International Nutraceutical Conference on Regulation, categorisation and commercialisation of

Nutraceuticals.

As the world celebrates a 100 years of Vitamins, India continues to remain a leader as one of the most

undernourished populations in the world. Past efforts for removal of malnutrition have been ad-

dressed through some national efforts by the government and global aid agencies in the form of forti-

fication and specific eradication measures. India can now be viewed both as a developer and manufac-

turer of nutraceutical ingredients and products, and also as one of the strongest emerging market for

nutraceuticals. Players, domestic and international, have expressed a high degree of satisfaction with

the country moving towards a more regulated environment and see this as an enabler for weeding out

unproven and unapproved products which find a place on the retail shelf and are often administered/

used without appropriate medical advice/ knowledge.

This whitepaper attempts to bring out issues and concerns in the emerging markets and undertakes a

benchmarking of the cultural issues, operating and regulatory dynamics across these regions and in-

cludes recommendations for a multi-pronged strategy to address the nutritional needs of a vastly grow-

ing, ageing and unhealthy population.

Nutraconsensus 5


Nutraceuticals and functional foods combine traditional nutri-tive with drug-like functions of prevention

Nutraconsensus 6


Clarity in Definition

NUTRITION plus PHARMACEUTICAL equals NUTRACEUTICAL

DRUGS HEALTH AND WELLNESS COSMECEUTICAL

PHARMACEUTICAL NATURAL/ ARTIFICAL SUPPLEMENT

PRESCRIPTION THERAPEUTIC CLAIMS REGULATION BABY BOOMERS

SAFETY PROBIOTICS AND PREBIOTICS MEDICINE FUNCTIONAL FOODS

Although not clearly defined as such in regulatory parlance, the term “Nutraceuticals” has been a part of our medical history, knowingly or unknowingly, for the last several decades. Formally christened as “Nutraceuticals” in 1989 by Dr. Stephen De Felice (Foundation of Innovation in Medicine), they can be defined as “a food or part of a food that provides medical or health bene-fits, including the prevention and treatment of a disease”. While this definition has seen a contin-uous evolution over the years, nutraceuticals are now broadly defined “as natural, bioactive chem-ical compounds which have a health promoting, disease preventing or medicinal properties”.

The food versus drug debate……

Often regarded as synonymous to a drug, the key differentiator between a drug and a nutraceutical is the ability of the drug to act as a “treatment” for a disease whereas nutraceuticals simply have a supportive function and are often just used as “supplements”. Drugs (which are patent protected for the first few years) also need to confirm to stringent compliances (including clinical and animal trials) prescribed by regulators in respective countries. Nutraceuticals on the other hand are not subject to independent guidelines (more stringent in the US and Europe) and have a comparative-ly shorter approval process without the need for conducting clinical/ animal trials. Accordingly, nutraceuticals lie somewhere between a food and a drug.

Nutraconsensus 7


Celebrating a hundred years of Vitamins - 2012

Vitamins are organic nutrients which are essential

for life. The human body requires very small

amounts of these nutrients to ensure normal me-

tabolism, growth and physical well-being. Most

vitamins are not made in the body or only in insuf-

ficient amounts to meet our needs. They therefore

have to be obtained primarily through the food we

eat in which they are present in minute quantities.

Minerals, as with vitamins, are indispensable (essen-

tial) in small amounts to ensure that the body

grows, develops, and stays healthy. Minerals are

found in wide range of foods. The body uses min-

erals to perform many different functions — from

building blood and strong bones to transmitting

nerve pulses and maintaining a normal heartbeat.

Unlike micronutrients such as vitamins and miner-

als, macronutrients are required by the body in larger

amounts and include proteins, carbohydrates, and

fats. They, too, are indispensable for our health and

well-being.

Each of the 13 vitamins known today has specific

functions in the body, which makes each of them

unique and irreplaceable. No single food contains

the full range of vitamins, and inadequate vitamin

intake results in vitamin deficiency disorders. A bal-

anced and varied diet is therefore vital to meet the

body’s vitamin requirements. Of the 13 known vit-

amins, four are fat-soluble, namely vitamins A, D, E

and K. The others are water-soluble: vitamin C and

the B-complex, consisting of vitamins B1, B2, B6,

B12, niacin, folic acid, biotin and pantothenic acid.

1910 Umetaro Suzuki dis-covers prod-uct, later identified as Vit B1

1912 “Vitamin” coined by Casimir Funk 1912-1913 13 Vitamins identified and characterised

1934-1987 Industrial production of vitamins

1924-2000 Mandatory fortification of salt, flour, cereals, sugar, wheat, maize, dairy in many countries. Control over deficiencies such as iodine, iron, vitamin A,D, B

2000 onwards Deficiencies identified in several indus-trialised coun-tries

1900 1950 2000

1980’s – 1990’s Emerging physician acceptance Awareness through numerous journals and articles on benefits

Nutraconsensus 8


Nutrition is needed not only for sustaining growth but also for combating diseases in the hu-man life cycle. They can be classified on the basis of the form in which they are consumed, on the basis of their possible health benefits or even on the basis of the type of the user. Regula-tions in each country differ not only in terms of the definition of a nutraceutical but also in terms of the inclusion/ exclusions therefrom.

Segmentation Dynamics

Functional foods

Foods having specific psycho-

logical benefits or reduce the

risk of chronic diseases

Nutrition Fortified Foods

Probiotic food like yogurt

Protein powder

Paediatric nutrition

Dietary Supplements

Foods providing nutrients that

are not consumed in sufficient

quantity in a person's diet

• Vitamin & mineral supple-

ments

• Amino acids

• Antioxidants

• Herbal and non-herbal ex-

tracts

Functional Beverages

Liquids quenching thirst as

well as replenishing miner-

als, provide energy, prevent

ailments, and promote

healthy lifestyle

• Sports and energy drinks

• Fortified juices

• Glucose powder

• Malted beverages

Micronutrient deficiencies in developed and developing countries are some of the key drivers of age related ailments, lifestyle diseases, cognitive development, infant and women health issues and overall immunity of individuals. Nutraceuticals, largely for their role in health enhancement, are often also categorised on the basis of their end use • Disease prevention • Immunity Enhancement • Health foods and supplements, and • Personalised Nutrition (including sports nutrition)

Nutraconsensus 9


Emerging trends

Multiple micronutrient intervention

studies

On-going research in various corners of the world

aims to establish a link between single and multiple

micronutrient intervention studies and diseases of

the human body to arrive at a holistic nutritional

approach for combat. The evidence supporting

the role of interventions in the prevention of vari-

ous diseases however is still evolving. As an ex-

ample, food fortification with folic acid is being

researched for NTD reduction whereas food forti-

fication with Iodine for goitre reduction is already

an established and implemented area of scientific

research. The effectiveness of multiple interven-

tions depends on their appropriate combination

and sequencing. In addition to the sectors men-

tioned, water and sanitation which are also closely

interlinked are also being examined in parallel.

Partnering in Nutrition

Nutrition now plays a prominent role in the global

public health agenda and has also been identified

as the top investment priority at the recent Copen-

hagen Consensus 2012. There are several players

in the nutrition space, each with its own agenda,

structure and approach strategy. There is a need to

move away from multiple pilot scale programs and

launch large scale interventions and engage players,

policy makers and global agencies with govern-

ment support.

In home fortification

A promising approach (which finds mention in a

WHO report 2011), in- home fortification of food

was suggested to improve iron status and reduce

anaemia in infants, children and women. If com-

bined with commercial distribution schemes, this

approach could act as an effective means for large

scale intervention.

Food, Water and Sanitation – underpinning

the success of Nutrition

Food and Nutrition is being defined as “a situation

when all people at all times have physical, social

and economical access to food, which is consumed

in sufficient quantity and quality to meet their die-

tary needs and food preferences and is supported

by an environment of adequate sanitation, health

services and care, allowing for a healthy and active

life.”

New Dimensions

The usage of nutrients has increased from tradi-

tional forms (foods, supplements and beverages) to

new markets such as cosmetics, pet care, marine

life, sports, etc.

• Antioxidants for longevity, immunity and vitali-ty

• Increased demand from the highest risk cate-gories of baby boomers

• non-prescription based cosmetics with medici-nal (including anti-ageing) properties

• Functional and medicated confectionary foods and snack bars

• Fatty Acids (CLA and omega 3, 6 and 9) and Proteins and clinical evidence of their health benefits

• Pet Nutraceuticals • Sports Nutraceuticals • Functional Additives - Vitamins, proteins, fi-

bres

Naturally derived substances, consisting of herbal

and botanical extracts and animal- and marine-

based derivatives.

Nutraconsensus 10


The largest market for nutraceu-ticals is US, followed by Europe and Japan. The global market for Nutraceuticals is projected to reach US$250 billion by 2018 largely driven by the need for a disease free lifestyle. Growth is also seen in emerging countries like BRIC nations (Brazil, Rus-sia, India, and China), Mexico, Poland, and South East Asian countries including Taiwan, Thailand, Philippines, Vietnam, Malaysia, Singapore, North and South Korea. This white paper emphasises on growth trends in the BRIC countries and com-pares them to our most nour-ished counterpart – the US

Nutraconsensus 11


Global landscape

The Consumer

Consumers of nutraceuticals are demographically

diverse: a malnourished child in a developing coun-

try, a young mother and her infant, an aged man/

woman with prostate issues/ severe osteoporosis, an

aging baby boomer who is willing to experiment with

her food/ vitamin basket.

The Regulator

An evolving regulatory environment for nutrition

products with marketing and labelling guidelines has

made science based efficacy as an essential parameter

for judging the success of nutraceuticals. Regulations

vary as per the country of sale - DSHEA and FDA in

the US, Health Canada in Canada and FHC, FNFC,

FOSHU in Japan, EC directives in the EU, ANVISA

in Brazil, FSSAI in India and SFDA in China. While

a comparative benchmarking of these regulators has

been discussed later in this whitepaper, national

regulations are closely linked to cultural attitudes,

population and other demographic profiles of each

region. Contents of regulation also differ significant-

ly in terms of coverage, acceptance of claims, label-

ling and quality rules.

The Suppliers

These are primary producers of the raw materials in

the world - an agricultural producer, a processor or

specialised ingredient/ formulation suppliers.

The Channel

A Nutraceutical company could either follow a direct

B2C channel (direct marketing by Amway and Herb-

alife), or have a direct distribution network (sold at a

pharmacy/ retail stores) or enter into JVs with mar-

keting partners.

Material

Supplies

Nutra

Companies

Research

Agencies

Distribution

Network

Nutrition Support Groups

Regulator

Customer

Nutraconsensus 12


Learning from a nourished counterpart

USA

One of the earliest adopters of the fortified foods

regime, functional foods already represent around

5% of the overall US food market. While early forti-

fication was mostly done under public support (flour

fortified with Vit B, salt fortified with iodine, milk

enriched with Vit D), developments in the last few

decades have been driven largely through private

initiatives. The market today is dominated by many

large multinationals in collaboration with specialised

ingredient makers. Soft drinks and dairy are the key

functional foods currently being sold in the US mar-

kets.

Completely impervious to the financial crisis, this

segment continued to display healthy growth pat-

terns, factors fuelling which include:

A proactive adult population who understands

the need for nutrition

An ageing baby boomer population

Increased awareness about quality and safety

Solving the equation of diet and disease

An evolving labelling and marketing regulation

Brand evolution through some direct channels

An early maturity for most products and availa-

bility of newer products and newer brands

Key players

Competition is intensifying with growing sales, re-

sulting in excessive advertising, new (often hurried)

product introductions, the emphasis on quality and

efficacy have assumed significant importance in the

consumers mind.

Food and beverage conglomerates such as Danone,

Unilever, Nestle, Kellogg, Kraft and Coca Cola

have introduced tailored healthy foods and adopted

health, nutrition and wellness as much as possible

in their product baskets. Every major food corpo-

ration from Nestle to Kraft is involved in nutraceu-

ticals including Johnson & Johnson which has

launched a new supplement brand. Some of the

recent acquisitions in this arena by these players in

the US include - Kraft acquisition of $140 million

(Balance Bar and Boca Burger), Nestle acquisition

of the competing PowerBar ($130 million sales),

Quaker JV with Novartis.

The Yakult Story

A single niche brand displacing generalist brands

and market leaders!

Nutraconsensus 13


Illustrative list of players in the US region

US Company

Name Key brands

Nutrition Deal History

(2011/2012)

Operating dynamics and differen-

tiators

Nutraceutical Companies

Pfizer Nutrition Pfizer Consumer Healthcare

S-26 Gold, SMA and Promil

Pfizer Nutrition sold to Nestle for $11.85bn (2012) Acquires Emergen C (Sup-plement) Acquires Ferrosan’s Con-sumer Healthcare Business

More than 80% of Pfizer Nutrition sales were in emerging markets. Focus – “Infant Nutrition “ Dietary Supplements is the key focus area within Nutraceuticals.

Nestle

Infant Nutrition - Nan, Gerber, Lac-togen, Nestogen and Cerelac infant cereal

Nestlé Health Science to acquire a stake in Accera Nestle acquisition of Pow-erBar ($130 million sales)

Pfizer Nutrition acquisition to com-plement existing Infant Nutrition Portfolio.

Abbott

Glucerna Pediasure Ensure Muscle Health Immune Balance NutriPals

Long term supply agree-ment with Martek for infant nutrition (Martek acquired by DSM)

Child Health and Nutrition Working towards probiotics and prebiotics - Nutrition shakes.

Subsidiaries of Indian Companies

Valensa Interna-tional (EID Parry)

Saw Palmetto, Zanthin, Cranberol t, AstaCran, Valerex, Z-Omega, Amaranthol

EID Parry Ltd acquired stake US Nutraceuticals (Valensa) (2008)

Targets Baby Boomer Population Botanical Solutions Provider.

Natrol (Plethico) Natrol, Laci Le Beau, Trinovin, Prolab, Vedic Mantra, NuHair, Shen Min, Promensil

No history of recent acqui-sitions

Key focus areas - nutritional sup-plements, herbal teas and sports nutrition (through acquisition of Pro-lab Nutrition and Medical Research Institute).

Nutraconsensus 14


US Company Name

Key brands Nutrition Deal History (2011/2012)

Operating dynamics and differentia-tors

Ingredient Supplier

DSM Nutritional Products

Quali blends, Carotenoids (Carocare, Actilease), Life’sDHA, Resvida, GeniVida, fabuless, Pep-topro,

Acquires Cargill’s Cultures and Enzymes Business for Euro 85bn (2012)

Acquires Martek, Microbia and Vitatene (2010-11)

Alliances with Kemrock and Sinochem in India (2011)

Global supplier of nutritional and spe-cialty ingredients to food, beverage and dietary supplement manufacturers. Focus is on production of vitamins, minerals and micronutrients.

Direct Marketing

Amway Nutrilite, XS Energy Drinks, per-sonal care, home care, air and water purifiers, Artistry cosmetics

Plans to spend $185 million on U.S. manufacturing ex-pansion to meet growing global demand Nutrilite brands.

Direct selling companies with a multi-level marketing system

Grows, harvests and processes at its own organic farms.

Early China entry in 1995 Despite regulatory (direct selling relat-ed) changes, China remains its largest contributor of sales.

Herbalife Formula 1, Active Fiber l, Herbal-ife24, Prolessa™ Duo, Herbal-ifeKids

No history of recent acquisi-tions

Weight Management, Digestive Health, Energy & Fitness, Targeted Nutrition, Personal Care.

*Neither Grant Thornton nor FICCI express any personal views on the performance or market standing of any of the above companies and the same have only been presented as a segment illustrative.

Nutraconsensus 15


Quick Brick fact-files

Brazil Russia India China

2011 $trillion US GDP

2.48 1.85 1.86 7.31

GDP growth (Annual)

3% 4% 7% 9%

Area (Mn Sq. Kms)

8.52 17.08 3.29 9.60

Population (Mn)

197 142 1241 1344

Ages 0-14 (% of total)

25% 15% 30% 19%

Ages 15-64 (% of total

68% 72% 65% 73%

Ages 65 and above (% of total)

7% 13% 5% 8%

Population growth

1% 0% 1% 0.5%

Life expectancy

73 years 69 years 65 years 73 years

CHINA

Nutraconsensus 16


Emerging trends

Number of people who are under-nourished

11.7 million 2008

Prevalence of overweight (above

15 years) 57%2010

Prevalence of un-dernourishment

(%of population) 6%2008

Health expenditure per capita (current

US$)

$990 2010

GNI per capita (current US$)

$10720 2011

Maternal mortality ratio (per 100,000

live births)

56 2010

Prevalence of un-der nourishment (% of population)

19% 2008

Under-five mortali-ty rate:

69 per 1000 live

births 2009

Lifetime risk of maternal death

1 in 702009


US$)

$542010


$1410 2011

Infant Mortality Rate (per 1000 live

births)

522008

Number of people who are under-nourished

129 million 2008

Under-five mortali-ty rate:

21 per 1,000 live

births 2008

Malnutrition –Height for age (be-

low five years)

9.4%2010

Health expenditure per capita (current US$)

$2212010


$4940 2011

Maternal Mortality Ratio (per 100,000

live births)

372010

182008

Prevalence of overweight (% above 15 years)

49% 2010

Underweight (un-der-five, 000)

2222008

Infant Mortality Rate (per 1000 live

births)

12 2008


US$)

$525 2010


$10400 2011

Maternal mortality ratio (per 100,000

live births)

342010

BRAZIL RUSSIA

CHINA INDIA

Nutraconsensus 17


Building Nutra – BRIC by BRIC

Nutraceuticals have entered the world food market and have gained tremendous importance in the last few years in most developed companies. Such functional food and beverages are priced higher (result-ant higher profits) and provide additional economic benefits to players when compared to traditional foods. Globally, the US and Japan are the most developed markets for nutraceuticals, due to the consumer acceptability achieved in these regions. India, China and Brazil are developing nations which show huge potential for the nutraceuticals market. Also, India and China have emerged as a key sourcing destination for natural ingredients. Each of the countries in the BRIC region is in different evolution-ary stages of development and nutraceuticals are subject to differences in regulation, nutrition aware-ness, consumer demand, biological support and affordability. China and Brazil have an advanced regu-latory framework for the approval of nutraceuticals and their advertising, although these differ some-what in the specifics.

Copenhagen Consensus 2012 The Copenhagen Consensus 2012 Expert Panel finds that fighting malnourishment should be the top priority for policy-makers and philanthropists. For just $100 per child, interventions including mi-cronutrient provision, complementary foods, treatments for worms and diarrheal diseases, and behav-iour change programs, could reduce chronic under-nutrition by 36 per cent in developing countries. While a $100 per child may mean a significant sum for a developing country, this only constitutes a 15% increase in the current aid spending indicating a need for re-channelising some of our existing resources. The key investment priorities for advancing global welfare (especially in the developing countries) are:

BUNDLED MICRONUTRIENT IN-TERVENTIONS to fight hunger and improve education (Health/ Disease re-lated)

Malaria Combination Treatment (Health/ Disease related)

Childhood Immunisation Coverage (Health/ Disease related)

Deworming (Health/ Disease related)

TB treatment (Health/ Disease related)

R&D to Increase Yield Enhancement to fight hunger

Effective Early Warning Systems

Strengthening Surgical Capacity (Health/ Disease related)

Hepatitis B Immunisation (Health/ Dis-ease related)

Low‐Cost Drugs for Acute Heart Attacks (Health/ Disease related)

Salt Reduction Campaign (Health/ Dis-ease related)

Solar radiation management

Conditional Cash Transfers

HIV Vaccine R&D (Health/ Disease re-lated)

Information Campaigns on Schooling Benefits

Borehole and Public Hand Pump Inter-vention

Nutraconsensus 18


Nutraceutical trends in Brazil

Country specific developments and challenges

With a rich natural resources profile, a large domestic market and an exploding middle class (though small in number but high in value) segment, the demand for nutraceuticals in this region has indicated healthy growth rates over the last few years. Guidelines in Brazil are often comparable to several de-veloped countries although it has significant dependencies in the form of imported ingredients. An aging population, improved economy, improved personal wealth, more educated and savvy youth, as well as consciousness for health(with awareness of linking diet to chronic diseases), are all encourag-ing factors for growth in Brazil. The nutraceuticals industry in Brazil is roughly divided into two major industry sectors: the over-the-counter (OTC) market, and the health and wellness foods market. Nei-ther market is believed to have reached maturity, which indicates there is good potential for future growth. Current supply chain vulnerabilities in nutraceuticals are evident through its reliance on im-ported ingredients for processing foods (despites its own rich botanical heritage) and limited pro-cessing capabilities. Regulations are stringent (ANVISA), although need to be strengthened to provide impetus to research-ing its natural botanical heritage. The trend across the globe, including across Latin America, is toward more rather than less regulation - a more demanding legislation, and a greater need for high quality, sci-entific, technical, regulatory guidance for decision-makers. A few other notable nutraceutical trends in this country include:

A nutrition transformation from an under nourished to an over nourished (read obese) popula-tion

Pharmacies being the primary mode of distribution for OTC products

Vitamins and dietary supplements and herbal and traditional products also being the key drivers of the OTC segment sales.

An aging population that is concerned about the increased risk of diseases like diabetes, heart disease and cancer.

‘Organic is healthy’ mantra - Healthy lifestyles, including diet, are becoming part of mainstream awareness leading to a growth in ‘less sugar’, ‘slimming food’, ‘light food’, fortified foods. ‘fresh organic food’ (sugar, coffee, soya being chief crops)

Nutraconsensus 19


BRAZIL

Key consolidation activity (involving Brazil as a target) in 2011 and 2012

Month Target name Acquirer Transaction Details

Feb 2012 Probiótica Laboratórios (Brazil)

Valeant Pharma-ceuticals

Deal Size: $86.3 Mn Probiotica currently markets a full line of over-the-counter sports nutrition products and other food sup-plements.

August 2012 Tortuga Companhia Zootéc-nica Agrária

Royal DSM Enterprise Valuation: is € 465 mn. Tortuga deals in nutritional supplements with a focus on pasture raised beef and dairy cattle.

February 2012 Mylner Indústria E Comércio Ltda

Frutarom Indus-tries Ltd

Deal Size: $ 15.7 Mn. Mylner develops manufactures and markets flavour solutions, focusing mainly on sweet flavours for beverages and baked goods, natu-ral plant extracts and natural flavours products.

August 2012 Yoki General Mills Deal size: $ 1160 Mn Privately-held food company headquartered in São Bernardo do Campo, Brazil.

Nutraconsensus 20


Nutraceutical trends in Russia

Country specific developments and challenges

Russia’s evolution in the nutraceutical space has been marred by the presence of an equal number of unregu-

lated products as the number of regulated products. An illegal sales network of low quality (often dangerous

products) has forced policy makers to review regulation around nutraceuticals. In addition, most of the busi-

ness still stems from two or three key cities usually identifiable by population size, superior distribution net-

work and appropriate advertising impetus. Russian Nutraceutical sales largely include Vitamins, combination

dietary supplements and probiotic supplements.

Significant limitations have been imposed on the nutraceutical market with regard to advertising, promotion

and distribution, especially in “official” sales channels. Before such anti-dietary supplement regulations were

put, it was easy to unscrupulously obtain Traditional Chinese Medicine and minor brands from Eastern Eu-

rope without any significant constraints. Post introduction of stringent guidelines and new product registra-

tion procedures, global players can now penetrate the region by securing relationships with existing reputable

local players that understand the space and can navigate through the regulatory and product launch stages.

Existing multinational players who are already in the nutraceutical market include Amway, Herbalife, Nu Skin

and Sunrider (Direct Sales); and Nycomed, Ferrosan and Unipharm (Pharmacy channel). Some of the top-

most local Russian brands and the operating Companies are set out in exhibit in the following page:

Nutraconsensus 21


RUSSIA

Key local Russian Players and their Brands

Name Brand Differentiator

Evalar

CardioActiv, Ginkgo Biloba, Everyday Calm, Stress free, Slim by nature, Brome-lain

Market leader Cultivation of medicinal herbs and their processing extracts to packaging of fin-ished products Strategic direction of the company is the transfer of dietary supplements with prov-en clinical efficacy in the category of drugs done in collaboration with an established clinical trials outfit.

Diod

Capilar, Viardo, Iod-Active, Phase 2, arthro-Active, optometrist , Orvirem, Hypoxen – Pharmaceuticals, Mir ekologii' - Retail Chain

Development and production of natural non-drug and drug treatment of active cosmetics, medical and environmental technology, innovative substances for the prevention and treatment of socially signif-icant diseases. Also manufactures healthcare equipment, healthcare cosmetics, pharmaceuticals, and has its own retail chain.

Akvion ABC (Vitamins) Vetoron (beta-carotene) Qudesan (co-enzyme)

Develops, produces and promotes vitamin and vitamin-mineral complexes – supplied to several Russian companies for fortifica-tion Kardiosredstva, tools for vision correction, Energotropic drugs.

Nutraconsensus 22


Nutraceutical trends in India

Country specifications and challenges

Even with the lowest per capita GDP in the BRIC regions, India is poised to overtake China as the most

populous country (also with the largest number of undernourished children in the world), and represents an

extremely favourable market for the growth of nutraceuticals. At population levels like ours combined with

income disparities, the need for nutrition arises in each strata of our society. While approximately 42% of all

Indian children under age 5 suffer from malnutrition, nearly 300 million people are part of an expanding mid-

dle class. The middle class level, with increased disposable incomes has become aware of the importance of

diet and nutrition for long term good health. “Healthy habits need to start young. Only an appropriate blend

of micro/ macro nutrients in our diet can help us break through the health deficit” feels Rajiv Chopra, Presi-

dent, DSM India. An increasing working age population presents a market opportunity for development and

marketing of Nutraceuticals. Some key emerging trends in the Indian Nutraceutical space are set out below:

Focus on wellness and preventive care

Increased awareness and health consciousness

Growth currently driven by the functional food and beverages segment.

Health and wellness yet to reach the fat and oils segment

Increased accessibility through new distribution channels and greater visibility (example infant and sports nutrition)

A large diabetic population (similar to Brazil and China)

Vitamins used in several food fortifications

Mass market retailing is just getting off ground in India with FDI approvals and can represent a great way to market the nutraceuticals.

One third of the population being vegetarian, protein supplements in the form of soya/ rice/ others can assume great significance.

Flavoured powdered milk fortified with vitamins and minerals is a recent trend. In other parts of the country, milk scarcity drives soya and skimmed milk demand

Both India and China have traditional remedies and healing systems such as Ayurveda and TCM which form

the centre stage in terms of a tried and tested from of medicine with identifiable herb compounds. Dietary

supplement regulations in India continue to evolve leaving many wondering how emerging legislation will rec-

oncile modern, corporate research and regulations with ancient traditions.

Because nutraceuticals are not a part of pharmaceuticals and drugs formulation, rules and regulations also tend

to be different for this segment. Indian government has recently implemented the FSSAI regulations (Food

Safety and Standards Authority of India) although implementation parameters are not clearly understood by all

in the industry and are being explored.

Nutraconsensus 23


But challenges remain, as poor infrastructure, lack of adequate facilities for storage, transportation and cold

storage facilities continue to hinder growth. And while the Indian regulators have worked to improve the regu-

latory framework, there is still plenty of confusion around rules, regulations and licensing for a variety of dif-

ferent commodities.

India can be viewed both as a developer and manufacturer of nutraceutical ingredients and products, and as a

strong emerging market for nutraceuticals. .We now analyse some of the key players in India (without relying

on any specific selection criteria) and the marketing strategies adopted by them:

ZYDUS Zydus Wellness and Zydus Nutriva are the key drivers of the consumer, wellness and nutraceuticals division of this pharma major. Market strategy includes “Third Generation Nutraceuticals” Segment presence Protein formulae for all ages, diabetics and pregnancy and lactation, haematinics, tonics, calcium supple-ments, osteoporosis, osteoarthritis, menopause, male subfertility, obesity, specialized pregnancy care range, animal health products Cosmeceuticals. Key brands GRD (protein supplement), Fol-5 (folic acid), Globac Activ (iron), C-yum (calcium), Sugar Free D’lite (health drink), Nutralite (cholesterol free spread), Actilife (nu-tritional milk additive), Globac-Z. Key differentiators - Formed an Indian advisory board for rational use of nutraceuticals - Dedicated nutraceutical range with emphasis on women health, infant and child nutrition.

PLETHICO/ (including subsidiary NATROL) Dominant player in the herbal and nutraceutical seg-ment with a focus on - Sports Nutrition and Women’s Health. The

Company aims to bridge the gap demand sup-ply gap in the country to reduce dependencies on high cost and duty laden imports.

Alliance History Acquired Natrol in 2007 – a leading manufacturer and marketer of branded nutritional products in the United States. Several acquisitions in the CIS regions to obtain retail reach. Key brands Sports Nutrition - Natrol, MRI, Laci Le Beau, NuHair, ShenMin, Promensil, and Prolab Herbal - Mountain Herbz (herbal medicines and sup-plements), Travisil (herbal cough syrup & lozenges). Marketing Strategy India - Prescription by Doctors, Nutritionists and availability of products on the retail shelf supplement-ed through brand awareness campaigns. Natrol - distributes products in the US through more than 54,000 retailers.

PIRAMAL HEALTHCARE Established the consumer product division in 2007, Piramal Healthcare’s OTC range includes product categories like Vitamins & Nutrition, Analgesics, Der-matological, Antacids and Cough & Cold. Segment presence It entered nutraceuticals market in 2009 with Suprac-tiv Complete, a vitamin and mineral supplement for daily consumption. The product, a Rs 12 crore brand is the second biggest brand in the nutrition segment after Revital. Key brands Lacto Calamine, Saridon, Supractiv Complete, Triac-tiv, Itchmosol, i-Pill, Workz, Jungle Magic. Key differentiators Global presence in over 100 countries including man-ufacturing bases in USA, Great Britain, Sri Lanka, China and Canada.

Nutraconsensus 24


“The recent FSSAI guidelines are a welcome move for the nutraceutical industry in India. It represents a concrete idea which gives assurance on safety of food, safety of customer and the promise of a good product. The implementation mechanism and guidelines need strengthening and we feel that if the approvals were made for a formulation (rather than the product itself), this would help improve timelines for approval in a significant manner. We, as industry players, are willing to provide manpower and other form of implementation sup-port to FSSAI that may be needed.” - Sanjay Singh,

Head F&D (Nutraceuticals and Herbals), Plethico Pharmaceuticals

ELDER PHARMA A Mumbai based pharmaceutical manufacturing & marketing organisation, Elder entered the nutraceu-ticals segment in 2010 with launch of 'Coenzyme Q10' which helps to build immunity against cardio-vascular diseases, neuro-generative diseases. SEGMENT PRESENCE Presence across 5 therapeutic segments – women healthcare, anti-infective, wound & pain manage-ment, nutraceuticals, and life care products. KEY BRANDS Shelcal, Eldervit Range, Elmecob, I-Vit, Phytomega, Carnisure, Somazina (in-licensed brand), Amifru group, Nephrocaps and I-Vit group. Launched 3 nutraceutical products during 2011-12 - I-Vit, I-Vit Plus and D-360. KEY DIFFERENTIATORS Prescription based marketing Wide range of nutraceutical products with focus on women healthcare R&D division develops novel drug delivery system (NDDS) for a nutraceutical formulation called Coen-zyme Q (10) CO Q10, first of its kinds globally.

NANDAN Established in December 1999, NBL is a sustainable energy provider and herbal nutraceutical company headquartered in Hyderabad and listed overseas. KEY BRANDS NBL offers herbal and by- herbal products with focus on therapeutic value. Key products include Safed Musli Standardised Root Extract, Bio-Rhythm Cap-sules, Sorgasm Capsules, AloeActiv Beverage.

TABLETS INDIA LIMITED A part of Jhaver group, TIL’s therapeutic range in-cludes nutritional supplements, haematinics, hepa-toprotectives, novel antipyretic, Osteoporotic Formu-la, Respiratory Medicine. KEY BRANDS Bifilac, Hapenz, BioRS, Ecoflora, Astymin, Astyvit, Astyfer, Aminocal, Tilvit, Antoxyl Forte, Cefobeta, Ambrolite, Peglec, Glutazene, Neutrosec, Apetamin.

HEXAGON NUTRITION Hexagon Nutrition entered the nutrition industry in 1991. The broad segments are Food Fortification, clinical nutrition and Animal Nutrition. KEY BRANDS Clinical nutrition –Penta sure range, Meta Gluta Zs (Immunity), Obesi Go BLCD (Weight management), Geria Gold, Proactiv (Wellness nutrition).

NATURAL REMEDIES It manufactures and supplies standardized herbal extracts, phytochemicals and herbal veterinary healthcare products. Broad segments are Human Healthcare, Animal Health care and Phytocom-pounds. KEY BRANDS Human Healthcare-Allerease, Bacomind, Kalmcold, Gutgard, Ocibest.

UNIVERSAL MEDICARE (SANOFI) Sanofi, a global healthcare company operates in 7 core areas which are diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Gen-zyme. ALLIANCE HISTORY Aventis Pharma (part of the Sanofi Group) acquired Universal Medicare business of marketing and dis-tribution of branded nutraceutical formulations in India in November 2011. KEY BRANDS The portfolio of nutraceuticals and lifestyle man-agement products includes brands like Sea Cod®, Primosa, Multivite and Freeflex MARKETING STRATEGY Part of Sanofi’s Global marketing network and OTC and prescription based sales.

Nutraconsensus 25


INTERNATIONAL PRESENCE

“Women and child health continues to remain our primary focus area; we also believe that ad-dressing the wellness needs of the country’s growing geriatric population by ensuring a disease free life presents an excellent opportunity of growth. Our SHELCAL brand for example targets the nutrition needs (especially of calcium and vitamin D) of a broad based population segment – from the paediatric to the geriatric population.” - Himanshoo Nayak,

Head - Business Development, Elder Pharma

ADVANCED ENZYMES Deals in the production of plant, microbial and ani-mal-based enzymes. Product categories include Human Nutrition, Animal Nutrition, Food Processing, Bio Fuels, Bio Catalyst, Biologicals and Industrial Processing. KEY BRANDS Human Nutrition (Active ingredients) –Nattokinase, fungal Lactase, Peptizyme SP, Fungal Lipase.

DABUR Dabur is an Ayurvedic and Natural Health Care Company. It entered the nutrition supplements seg-ment with the launch of Dabur NUTRiGO in 2010. Products categories include Hair Care, Oral Care, Health Care and Skin Care. KEY BRANDS Dabur Chyawanprash, Dabur Honey and Dabur Glucose.

DSM Nutritional Products DSM is a global supplier of nutritional and specialty ingredients to food, beverage and dietary supplement manufactur-ers. Providing ingredients and ‘Health benefit Solutions’ globally, DSM focuses on the production of vitamins, minerals and micronutrients that enhance the health profile of products, as well as areas where end consumers are looking for answers and support. Health Benefit Solutions Eye Health, Bone Health, Essentials for women, Essentials for men, Essentials for kids and teens, Essentials for vege-tarians, Mind health, Hearty health, Beauty from within, Weight nutrition, Sports nutrition, Joint health, Immunity, Essen-tial nutrition and Healthy ageing.

ABBOTT NUTRITION Abbott Nutrition, a division of Abbott is a healthcare company to develop nutritional and related health care products .It offers a wide range of nutritional supplements in segments of infant and mother care, child, adult, sports and active living, therapeutic nutrition. Key Brands Similac, Advance, Similac Expert Care, Alimentum, Soy Isomil in infant formulas PediaSure and Pedialyte for children, Ensure and ZonePerfect for active adults, EAS for elite athletes and fitness en-thusiasts and Glucerna for people with diabetes.

GSK GSK consumer healthcare business operates in three areas - Over-the-counter (OTC) medicines, Oral healthcare and Nutritional healthcare. In 2010, GSK acquired Europe’s leading sports nutrition brand, Maxinutrition. GSK portfolio in-cludes a number of well-known brands such as Panadol, Sensodyne, Lucozade and Horlicks. Revenue from Consumer Healthcare is Euro 5.2 billion in 2011 (19% of the group revenue). Key Brands Lucozade and Ribena – energy and sports drink, Horlicks, Boost and Maltova - malted, milk-based drinks and foods and Viva, a vitamin supplement.

Nutraconsensus 26


Deals, alliances and expansion strategies

The Nutraceutical industry has shown strong growth potential and much of the early stage commer-

cial/regulatory risk has been reduced as international nutraceutical companies establish a record of doing busi-

ness in the market.

Whether one views the country as a developer and manufacturer of nutraceutical ingredients or as a strong

emerging market for nutraceuticals, the country is poised for unprecedented growth from domestic players and

already established international companies. Devising a strategy for deeper penetration into the Indian

Nutraceutical market will be foremost in the minds of large global players.

“Key stakeholders in the Indian Nutraceutical landscape need to focus on the following Critical Success Factors – providing access to food in the first place, ensuring the right quality and mix of food, weeding out adulteration, improving the general environment and ensuring the availabil-ity of clean drinking water for all.” RAJIV CHOPRA President, DSM Nutritional Products

HERBALIFE Herbalife International is a direct selling company which deals in nutrition and weight management. It has over 2 million independent distributors. SEGMENT PRESENCE Herbalife operates in more than 80 countries. Prod-uct segment includes Targeted nutrition, personal-ised weight management, Essential nutrition, Energy and Fitness, Skin care and Fragrances. KEY BRANDS Formula 1, Active Fiber l and Herbalife24, Shape Works. MARKETING STRATEGY Partnered with the Global Alliance for Improved Nutrition (GAIN) and DSM, nutrient suppliers, to distribute 20 million micronutrient sachets to those in needs in Ethiopia and Kenya The company has also opened five new markets in 2011.

AMWAY A global direct selling company, Amway markets product primarily dealing in the health, beauty, and home care segments. SEGMENT PRESENCE Presence in more than 80 countries including Americas, Europe, greater China, Japan and Korea, and SE Asia/Australia. KEY BRANDS Nutrilite, Artistry, XS Energy KEY DIFFERENTIATORS Amway’s business model is based on multi-level/networking marketing and distributes products globally through more than 200,000 distributors Also, Nutralitie is the only global vitamin and mineral brand to grow, harvest, and process plants on its own certified organic farms.

Nutraconsensus 27


INDIA

Key consolidation and M&A activities (involving India) in 2011 and 2012

Month Target Name Investor Transaction Details

August 2011 Universal Medicare- Nutraceutical Business

Sanofi India

Aventis Pharma Ltd. acquired nutraceutical business of Universal Medicare Pvt. Ltd. for a total consideration of $114.22 million (INR 5.67 billion). Under the agreement, Universal Medicare will manufacture the products that Sanofi/ Aventis will be acquiring on mutually agreed terms.

October 2012 Innoves Animal Health Pvt.

Hester Biosciences Innoves Animal Health Pvt. is engaged in the marketing of large animal health products.

September 2011 Octtantis Nobel Labs Pvt.

Vivimed Labs Octtantis Nobel Labs Pvt. is engaged in trading, manufacturing and marketing of pharmaceuticals and nutraceuticals formulations.

May 2011 30 plus brand from Ajanta Pharma

Dabur India Ajanta Pharma is a Mumbai based company. 30 plus is an energiser brand.

April 2011 Johnson & Johnson , Raricap

Bafna Pharmaceuticals Raricap is the trademark for manufacturing tablets for iron deficiency anaemia used in pregnancy of Johnson & Johnson

September 2010 Full Fit Socrus Bio Sciences Ltd Full Fit is an anti-obesity brand. The brand Full Fit is a formulation con-tains the herbal ingredients which have no side effects.

NA Elder Pharmaceuticals Private Placement The company offers various products in the fields of women’s healthcare, wound care and pain management, nutraceuticals, cardio-vascular, central nervous system, neuro drugs, and anti-infective.

Relying heavily on imports to meet its nutritional demands, activity in the domestic space has seen

the mushrooming of smaller (but focussed companies), increased visibility of some domestic com-

panies, and select brand oriented. With clarity in regulation, it is however expected that the more and

more international and domestic nutrition players will now be seen on an expanding retail shelf.

While some traditional players may still want to go the prescription route, it is expected that in the

post regulation scenario and retail-boom, nutrition products will find an entry into more and more

households in the next ten years. Already established as one of the leading ingredient suppliers, In-

dia will remain an attractive destination for significant consolidation activities in the near term.

Nutraconsensus 28


Nutraceutical trends in China

Country specifications and challenges

Although still heavily influenced by Traditional Chinese Medicine, all types of functional foods and supple-

ments are gaining acceptance in China. Traditionally dietary supplements were sold in small grocery stores;

however, a change in retail structure has led to the emergence of large format outlets such as hypermarkets and

convenience stores. Factors such as rising healthcare costs and an ageing population and diseases such as an

unhealthy immune system, fatigue and cholesterol regulation are expected to be key drivers for the develop-

ment of this sector in the future. High costs of insurance and healthcare have prompted the Chinese popula-

tion to resort to preventive medicine. Imported supplements are often associated with better quality and with

a burgeoning middle class population, the demand for nutraceuticals (considering approved TCM as a part of

the group) is expected to multiply four times the present.

China is one of the leading suppliers of nutraceutical ingredients to almost all of the leading players worldwide.

According to a recent study, China will evolve into the largest global producer and consumer of nutraceutical ingre-

dients by 2020, surpassing the U.S. and Western Europe. A survey indicates that consumers in China are ready

to switch to healthier alternatives of carbonated soft drinks and that brands are yet to offer the product op-

tions to fulfil this demand signalling a need for large players to respond to this demand and penetrate the mar-

ket. Launches of “Natural”, “Diet”, “Low calorie claims” are penetrating deeper into the natural beverages

market indicating an “On the move” consumption opportunity at convenience stores.

Nutraconsensus 29


CHINA

Key expansion activities (involving China) in 2011 and 2012

Month Target Name Transaction Details

June 2011 Zhejiang Medicine Private Placement

Deal Size: $201 Mn The Company offers synthetic vitamin E, natural vitamin E soft capsules, levofloxacin lactate tablets, vitamin A tab-lets etc. Raising capital on the Securities Exchange.

June 2010 Baby Care USANA Health Sci-ences Inc.

Deal Size: $ 62.15 Mn Develops, manufactures and sells nutritional products for the entire family, with an emphasis on infant nutrition.

March 2011 Guangdong Jiuji Biotech

Xiangxue Pharma-ceutical

Deal Size: $ 5.71 Mn Seller of healthcare equipment, chemicals, and cosmetics.

May 2011 Guangming Phar-maceutical

Shenzhen Kangzhe Pharmaceutical

Producer of health supplements, biological diagnostic reagent and bioengineering fields.

June 2012 Northeast Pharma-ceutical Group Co.

Liaoning Fangda Group Industrial

Deal Size: $43.79 Mn Vitamin Series, Antibiotics, Anti-AIDS, Digestives, Narcot-ic medicines, Cardiovascular and Cerebrovascular medi-cines.

June 2011 Jiangsu Spring Fruit Biological Products

Yihai Kerry Invest-ments

Vitamin E oil manufacturer.

2011-12 Lonza Facility Set Up For Vitamin B3 – Niacin.

Nutraconsensus 30


Regulatory standards and legislative practices are changing and constantly evolving across the globe. With globalisation of nutritional supplements market and increasing chal-lenges, it becomes impera-tive to have a sound regula-tory framework for safety of consumer health and ensure fair practices in international trade

Nutraconsensus 31


Regulation and Standardisation

Legal status, the world over

The regulatory environment in developed countries is often governed or controlled by government

agencies which look into regulatory matters on nutrition related scientific health claims and also other

aspects such as manufacturing, packaging, labeling, and marketing of functional foods and dietary sup-

plements. The regulatory regime ensures the safety of consumer health and encourages fair practice in

international trade through the development of guidelines on food standards, codes of practice and

other recommendations. The FAO and WHO have developed together the Codex Alimentarius

Commission which aims to integrate, harmonise global food standards and create coordination

amongst non-governmental and international agencies. In practice, however, most countries follow

their own established regulatory system as it still remains unclear about the approach used in setting

guidelines for the Safe Upper Limit (SUL) of vitamins and minerals and consensus on matters like the

reduction of disease risk claims and scientific substantiation are yet to be reached.

Regulations in the US

In the USA, the FDA through the DSHEA has a separate set of regulations for dietary supplements

and dietary ingredients and does not cover food additives and medicines. All companies, domestic and

foreign engaged in the manufacturing, packaging, labeling etc. of dietary supplements must comply

with good manufacturing practice (GMP) for quality control. Under DSHEA, manufacturers are re-

sponsible for product safety and labeling, however, the FDA bears the burden of proving that a prod-

uct is unsafe or improperly labeled. Also, in general, registration and product approval is not required

for dietary supplements.

Three types of claims are allowed in the U.S. The first two are allowed without FDA premarket ap-

proval, provided they are not false or misleading:

1) Nutrient content claims: Claims relating to the level of nutrient in the food. For example, the prod-

uct is “low fat”, or “contains 60 calories” or “contains no added sugar”

2) Structure/function claims: The role of a nutrient or an ingredient likely to affect the structure or

function of a human body. For example, calcium is good for bones, fibre for digestive health, vitamins

A/C/E for natural defenses, vitamin A for eyes, etc.

3) Health claims describe the relationship between a substance and a health related condition or dis-

ease. They are often written statements but also include symbols, specific labeling and any other form

of communication that establish a relation. Evaluation and review by the FDA is a must prior to use.

As per FDA, an example of an authorised health claim is “Three grams of soluble fiber from oatmeal

daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease.”

Nutraconsensus 32


Federal Trade Commission (FTC) is an independent agency responsible for consumer protection as

well as regulating the advertisement related to dietary supplements and the DSHEA is responsible for

product claims, product labeling and promotional activities undertaken at the point of sale. In order to

be compliant with the FTC law, the advertiser must identify claims and interpret ad meaning then veri-

fy by having substantiate claims and also validate claims based on traditional sues and consumer expe-

riences. Also, under DSHEA, all statements must have a disclaimer that the statement has not been

evaluated by FDA and that the product is not intended to "diagnose, treat, cure or prevent any dis-

ease."

Cosmetics: FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for regulating

the cosmetic products. Pre-market approval of the FDA is not required for most cosmetic products

(except those containing colour additives). Like DSHEA, here also manufacturer is responsible for the

ingredients and safety of the product before it reaches the market. Other major enactments of law gov-

erning cosmetics are the Federal Food Drug and Cosmetic Act and the Fair Packaging and Labeling

Act which require consumer products to be labeled with proper disclosure and honesty. The FDA also

maintains a Voluntary Cosmetic Registration Program (VCRP) for post market reporting for use by

manufacturers. It applies to only cosmetic products sold in the US and does not include skin care clin-

ics or spa. The FDA does not formally recognise a classification for “cosmeceuticals”, for the agency, a

product is either a cosmetic or a drug depending on its intended use.

Veterinary Products: Federal Food Drug and Cosmetic Act (FFDCA) set the regulatory framework for

animal feed including pet food. The provisions of DSHEA are not applicable for veterinary products.

European Union

The regulatory status of dietary supplements in the EU is diversified and complex due to the presence

of different legislations and practices within member states. The European Food Safety Authority

(EFSA) is the risk assessment regulatory body that also governs matters related to nutraceuticals. Di-

rectives have been issued by EFSA in the nutraceutical segment on matters such as food supplements,

nutrition and health claims, botanicals, novel food and novel food ingredients, the traditional herbal

medicinal products and foods for particular nutritional purposes. Set out below is a brief of some of

the directives issued.

Nutrition and Health claims Regulation 1924/2006 sets out framework to ensure that labeling claims

in the EU are validated by scientific evidence and contains guidelines which protect consumers

from misleading or false claims

Food Supplements Directive 2002/46/EC has guidelines for labeling requirement and also sets the

maximum level of intake of vitamins and minerals that can be added to a food supplement.

Apart from this, it contains the list of vitamins and minerals that can be added for specific nutri-

tional purposes in food supplements

Botanicals: Food supplements prepared from plants, algae have become available in the EU mar-

ket. Use of botanicals in food supplements are regulated by EFSA. The main purpose use scien-

tific based approach to assess the safety of botanicals used in food and supplements

Foods for Particular Nutritional Purposes Directive 89/398/EEC, which sets up specific directives

and rules for several areas such as infant or young children, weight management foods and other

specific areas.

Cosmetics: The Cosmetics Directive includes rules and procedures on what constitutes as safe

cosmetics and also guidance on restrictions on ingredients and monitoring labeling, packaging

and marketing requirements

Nutraconsensus 33


Vet Products: Committee for Medicinal Products for Veterinary Use governs the technical as-

sessments and the European Medicines Agency which governs the drugs and pharmaceuticals in

EU region look after the Marketing rules. Marketing authorisation is required for veterinary

products in EU.

United Kingdom

Products categorised as dietary supplements are mostly classified as food and are not regulated as a

therapeutic product under the Medicines Act. Also, stringent guidelines and product approvals appli-

cable for medicines in terms of dosage, ingredients, labelling and purity are not required for dietary

supplements. The Food Standards Agency (FSA) Expert Group on Vitamins and Minerals (EVM) has

published recommendations on what constitutes as a safe levels of intake for vitamins and minerals.

The food law and European level regulate the claims made for supplements. The Advertising Stand-

ards Authority (ASA), a self-regulatory body set up by the advertising industry has established codes

for the broadcast media (TV and radio advertising standards codes) to ensure marketing communica-

tion of dietary supplements is legal and honest.

Japan

In Japan, Foods for Specified Health Use (FOSHU) look into the food regulation, registration process

and labeling guidelines for food products that contain functional ingredients which affect the struc-

ture/function of the body. FOSHU approval is determined on a case-by-case basis while nutrient-

health claims are generic for any product, meeting the stipulated requirements.

Nutraconsensus 34


Regulatory Framework in developed countries – USA, European Union, and Japan

Regulatory/Non-Regulatory

Regulatory Acts Defined Nutraceutical Segments

Role of Regulatory Body

Labelling & Mar-keting Regula-tions

USA Regulatory body – Food & Drug Ad-ministration

Food & Drug Ad-ministration (FDA), Dietary Supple-ment Health and Education Act (DSHEA), Federal Food Drug and Cosmetic Act (FDCA), CODEX (Codex Alimentari-us Commission).

Functional Foods and Dietary Sup-plements.

Provide pre-approval to health claims; Defines dietary sup-plements; Regulates all foods and food additives; Regulates good manufacturing prac-tices for supple-ments; Develops standards and guidelines for foods for special dietary uses.

The food labelling regulations are complex and con-stantly developing. Monitors safety measures in case of any adverse reporting related to foods and product information such as labelling, health or functional claims, and package in-serts.

Europe Regulatory body – European Food Safety Authority

General Food Law Regulation, EC 178/2002, Europe-an Food Safety Authority (EFSA), Directive 2002/46/EC (food supplements), Directive 2004/27/EC (me-dicinal products), Directive 2001/83/EC, Novel Food Regulation EC 258/97, The Traditional Herbal Medicinal Products Directive 2004/24/EC.

Dietetic foods, food supplements, novel foods, herb-al medicines, etc.

Approves the health claims. Assess the laws of EU countries relating to supplements. Allows the registra-tion of products as medicines by devel-opers providing good quality herbal products. Classifies novel foods. Defines the claims made for products based on which a product can be de-fined as medicinal. Establishes a sci-ence-based ap-proach for theories relating to functional foods.

Mutual legislation regarding labelling is missing among EU countries. EFSA ensures that products sold are safe and prevents the miscommunica-tion of information to consumers.

Nutraconsensus 35



Regulatory Acts Defined Nutraceutical Segments


Labelling & Market-ing Regulations

Japan Regulatory (FOSHU) as well as non-regulatory (non-FOSHU)

Foods for Specific Health Use (FOSHU), Japan Health Food As-sociation (JHFA) - purposeful gov-ernment involve-ment that regu-lates the field, but does not overly restrict it.

Functional foods Focuses on health claims for specific products. Approves health claims. FOSHU approval process of 1 year to be followed by man-ufacturing compa-nies for their prod-ucts and a further short period required for review by the local authorities and the Ministry of Health and Welfare (MHW).

Japan has a well-defined product cate-gory and labelling system which helps in controlling the market-ing of non-approved products. Functional foods in Japan are a highly profitable business and generate further big profits as the FOSHU label allows for higher pricing of products.

Canada Regulatory body – Health Canada

Natural Health Product Regula-tions, Food and Drug Act, Canadi-an Food Inspec-tion Agency

Functional foods, Probiotics, natural health products (NHPs)

Define requirements for quality, efficiency and safety of prod-ucts. Manage health food claims for functional foods. Defines natural health products. Approve specific claims post review-ing the products in detail (processing method and nutrition content, etc.)

Define the require-ments for labelling, packaging, clinical trials, Gmp, site in-spection, and also reporting of adverse events.

Nutraconsensus 36


Consumer Awareness

Changing lifestyles

Increase in disposable income

Retail growth

Certain degree of dissatisfaction of modern medicine

Ageing population

Factors fuelling the growth of the Nutraceutical Industry

Regulations in the BRIC regions

The demographic, economic, and cultural changes that

have driven the development of functional food markets

in developed countries are also fuelling the growth in the

BRIC regions. While the domestic market environment

and demand factors in the opportunities available for

companies in developing countries, export markets may

offer profitable opportunities to overcome their limited

domestic demand of functional foods. Commercial ex-

port opportunities exist in value-added raw materials,

functional ingredients, and even in consumer products

for the functional food sector in the more mature mar-

kets. The following section examines the functional

foods sector in three of the emerging economies in the

BRIC regions – Brazil, Russia, China and followed by

developments in India.

Nutraconsensus 37


Regulatory Framework in developing countries – Brazil, Russia, and China


Regulatory Acts

Defined Nutraceutical Segments


Labelling & Market-ing Regulations

Brazil Health claims ‐ reference to the cure or prevention of

disease ‐ are not allowed

National Health Surveillance Agency (ANVI-SA), State Food and Drug Administration (SFDA)

Functional Foods

Coordinates, supervises, and controls activities regarding registration, information, inspection, risk control, and rulemak-ing to assure health sur-veillance over food, bev-erages, water, ingredi-ents, packages, technol-ogies, contamination limits, and veterinary residues, Check natural or synthetic substances having a demonstrated and physiologic activity, Regulates foods that have a functional or health claim associated with their use

Russia Non regulatory Russian Minis-try of Health

Dietary sup-plements

The process for register-ing dietary supplements takes around 6 months and once all the require-ments are fulfilled, there is a short period required for issuing and register-ing the certificates.

Significant limitations have been imposed on the nutraceutical market with regard to advertising, promotion and distribution, espe-cially in “official” sales channels

Among the BRIC countries Brazil leads the vitamins and minerals market. China is home to the second largest

vitamins and minerals market, led by multi‐vitamins, while its single minerals category displays rapid growth.

Among the developed country manufacturing packaging labelling and marketing of nutraceuticals and dietary

supplements are regulated by the well-furnished and managed government regulatory body. But in the develop-

ing country like India, regulations have been evolving over the last decade with a formalisation of the policy in

2011-12.

Nutraconsensus 38


Evolution of the Nutraceutical Regulation in India

The Food Safety and Standards Regulations, 2011. How is it different from the previous

(multiple) law/s?

Prior to the FSSA, there were multiple laws and regulations governing food safety and standards. Nutraceuti-cals were clubbed under Prevention of Food Adulteration Act and Rules (PFA). Food was classified as either fortified or propriety. Later in 2006, all the existing laws were consolidated to form one single statute in order to ensure systematic and scientific development of the food processing industry. Food was classified under the following heads:

Novel foods

Genetically modified food

Propriety Food

Standardised Food

Foods for special dietary use

Functional foods/Nutraceuticals/Health Supplements The Food Safety and Standards Regulations, 2011 notified in the Gazette of India came into force on 5th Aug 2011 to regulate manufacture, distribution and sale of nutraceuticals, functional foods and dietary supplements in India.

Licensing and Registration requirements

Every Food Business Operator(FBO) in the country will have to obtain registration and license in accord-ance with the procedure laid down in FSSAI (Licensing and Registration of Food Business)Regulation 2011

A manufacturer cannot commence business unless he is registered or has a valid license.

Petty food manufacturers(annual turnover less than Rs.12 lakh) have to register with the Commissioner-ate and manufacturers whose turnover is greater than 12 lakhs to obtain PA or food licence from FSSA office

Existing licenses/registration should be converted into FSSAI license/registration before 5 August 2012 (now extended by a few months)

An application for the grant of a license shall be made in Form B of Schedule 2 to the concerned Licens-ing Authority. The license shall be issued within 60 days from the date of issue of an application ID num-ber

After the issue of Application ID number the Licensing Authority may direct the Food Safety Officer to inspect the premises in the manner prescribed by the FSSAI in accordance with these Regulations.

The Licensing Authority shall issue a License in Format C under Schedule 2 of these Regulations

Registration or license granted under these Regulations shall be valid and subsisting, unless otherwise specified, for a period of 1 to 5 years.

Increased regulation should encourage manufacturers to devise long-term market strategies…..and weed out unscrupulous players and products from the market.

Nutraconsensus 39


FSSAI regulations 2011 at a glance

Challenges faced by the Supplier/Manufacturer with the introduction of the new law

Product Approval

Prior to FSSAI, a company could manufacture a product if it had the license of Prevention of Food Adultera-

tion (PFA). But now, product approval certificate is mandatory to obtain a FSSAI license. An applicant has to

apply for each ingredient separately for New Product/Ingredient. For obtaining product approval the food

business operator will make an application in the prescribed format with an initial payment of non-refundable

INR 25,000. This tends to create technical hurdles as well as increase the cost incurred by the manufactur-

er/supplier. In a recent case, Tamil Nadu Food Supplement Manufacturers and Traders Association (TFSM-

TA) has decided to move court seeking amendment to FSSA rules.

FBO can now commence business

Food Business Operator (FBO)

Fill application Form A for registration

Submit documents

Attach self-declaration form

NO

Registration/license is

mandatory

YES

Grant registration/ license within the

stipulated time

YES

YES

Check criteria for Central license or State

license

Fill application Form B for license

Submit documents

Licensing authority may seek additional information

Issue of Unique Application number

Appoint Food Security

Officer (FSO)

Send notice of inspec-tion to FBO

FBO to comply with the required alterations

FSO to submit inspection report

Meets eligibility?

Inspection required?

Nutraconsensus 40


Separate Food License for packed food items

In order to prevent misrepresentation of claims on labels, the FSSAI has recently sent notices to manufacturers

of food supplements like Pediasure, Bournvita, NutriChoice asking them to provide scientific basis of their

claims. The act has made it mandatory to have separate licenses for these items.

Timelines

While specific timelines have been mentioned in the guidelines actual implementation of some of the above

process steps may take longer than prescribed timelines as the procedures, implementation agencies and their

operations are in the process of formalisation. Considering the fact that an approval process lasts for only a

period of one year, companies with a larger portfolio would be involved in the approval process for significant

time periods every year. While these appear to be teething issues in the implementation of the regulation, inter-

im relief through specific approvals) is being awarded in terms of temporary licenses for products which are

already being sold in the market. Foreign players, however, disagree on selling products until final confirmed

approvals for all products are in place.

Facility Approvals

Operators also feel that a certain level of facility based approvals should also be added to the current regime

(like pharma) so as to save timelines for process based formalities which may be common for a basket of

products that are being manufactured at a facility.

Documentary evidence

There does not appear to be complete clarity on the documents required to be submitted during the approval

process and monitoring agencies seem to be taking time before responding with specific pending requirements.

Also clarity is required in terms of products which are manufactured outside India (to prevent dumping of re-

jected overseas products in the country).

Labelling/ Advertising

Legislation on product quality and standards (included in the FSS (Packaging and Labelling) Regulations, 2001)

need to be adequately supported by a claims monitoring agency for product labels and advertisements directed

at attracting the consumer to the product. Regulations currently prohibit the making of any health claim on

proprietary/ functional/ novel foods without FSSAI approval and no claims should be made which are false,

misleading or deceptive. What is a correct/ misleading health claim is it proven, what the process of approval

is and associated timelines are some of the questions which still remain unanswered.

Marred by issues around ambiguity and multiplicity for the last decade, guidelines for Nutraceutical regulations have made a hurried but long awaited debut in the Indian market in 2011-12. Welcomed by all, these guidelines appear to face teething issues in terms of actual implementation and transition of old, existing products into the new regime. While nodal and monitoring agencies have been framed for the effective im-plementation of these rules, still much needs to be done to supplement the manpower to handle the volume of applications in a country, which is poised to become one of

the largest consumers of Nutraceuticals in this decade.

Nutraconsensus 41


Growing market sizes, heightened attention to product safety and the continuing harmonisation of food

supplement regulations show a global trend toward more regula-tion and India, although a late en-trant, has emulated these guiding principles of Nutrition Regulation

across the globe

Nutraconsensus 42


Recommendations and way forward

Some of our recommendations for growth of this sector in a regulated environment are included in the

paragraphs below:

Transformational Partnerships

The National Health Agenda, though currently

viewed from the lens of ‘public’ health only, needs to

be viewed through experienced industry players and

institutional agencies as well. A key learning from

the Copenhagen Consensus 2012 for our policy

makers is to ensure that Bundled Micro-Nutrient

Intervention should form a core area of fund alloca-

tion in our Budget. Independent pilot plans for

meeting the nutrition needs of the country need to

be supplemented with large scale alliances of public

and private partners to increase access to the missing

nutrients necessary for the growth of health of peo-

ple, communities and economies. These alliances

can then be supported by public and private sector

donors and participation from domestic and interna-

tional players (who may have experience of imple-

menting these in other developing economies).

Some examples for the kind of alliances which can

be layered under one another to address a collective

agenda of malnutrition include:

National multi-stakeholder PPP model

Sectoral partnerships

Private sector led initiatives (by experienced glob-

al players)

Building institutional capacity with industry

representation

The improved and stringent regulatory environment

should be augmented with institutional capacity and

include member representatives such as producers,

processors as well as the government regulatory bod-

ies, as necessary for addressing matters around:

technical assistance on potential technologies

evaluation of scientific benefits and evaluation

of claims

best practices in quality standards including

learning from products which are already ap-

proved in other regulated markets

manpower support with experienced specialists

for speedy transition and redressal of issues and

avoidance of delays

change enablement support for smaller and

newer entrants in the market

Continued research and innovation

There has been a continued scientific evaluation in

the areas of biodiversity and the beneficial health

effects on functional food and nutritional uses in the

markets. Scientific evidence for safety and functional

effectiveness of these compounds is essential in or-

der to realise their potential in the production of high

market valued products.

New value-added components could also come from

local food crops, medicinal plants or non-food

sources.

Economics of Nutrition

Providing information and support for strategic decision-making:

To a supplier of raw material ingredients, the target

markets for food supplements, traditional medicine

and functional food all appear to be interlinked. In

order to strengthen the functional food programs, it

becomes imperative to identify the potential sectors

on a case by case basis and assess their profitability. .

Before a product decision is made, it is helpful to

Nutraconsensus 43


understand the likelihood of market acceptance by

studying each market segment in depth. Each mem-

ber of the supply chain must be given an opportunity

to make rational and informed choices. This can

happen only if the market and regulatory information

is made available to them.

Strengthening mass communication for

specific health nutrition factors

Child and women’s health and sports nutrition ap-

pear to be the focus areas of almost all industry play-

ers in the developing regions. A national emphasis

on such matters, which is already present in case of

infant and women nutrition to an extent, needs to be

extended to emphasising on the importance of sports

activities in school curriculum as well as in the

younger and middle aged population.

Change enablement

The FSSAI regulations include the set-up of nodal

agencies for the immediate implementation of the

guidelines. Industry representatives feel that several

time limits are currently not being complied with for

existing product applications and there have been

significant delays resulting in financial losses for the

cautious players. Interim, temporary approvals need

to be allowed for players and products which have a

long history of having sold these products in the

domestic and international market.

A formulation or a facility based approval

Current approval processes designed for each and

every product (whether new or already being market-

ed) is a lengthy process and also holds validity only

for a defined time period. This may be streamlined

with practices in the pharma industry where both

product and facility approvals can co-exist and re-

newals are less stringent and less time-consuming

process.

Labelling and Claim Evaluation

In a vastly illiterate and scientifically ill-informed

population like India, any misleading information

(through advertising/ packaging/ labeling) that has

been printed on to the label of the dietary supple-

ments meant for mass consumption may cause a ma-

jor national crisis. Though National institute of Nu-

trition and the FSSAI have issued guidelines and

norms for packaging and labeling urgent attention of

the government or the regulatory body in this direc-

tion which covers all aspects of Advertising, Packag-

ing and Labeling and evaluate all products before

they enter the market (and not in the form of post

facto approvals/ withdrawals, as is currently the

case).

Nutraconsensus 44


References

1. Micronutrients, Macro Impact:- The story of vitamins and a hungry world (www.sightandLife.com) 2. Nutrition Business Journal, S&P 3. International Journal of Pharmacy and Pharmaceutical Sciences - DIETARY SUPPLEMENTS: A LE-

GAL STATUS IN INDIA & IN FOREIGN COUNTRIES 4. Health Enhancing Foods Country Case Studies of China and India – The World Bank 5. Expert Panel Findings, Copenhagen Consensus 2012 6. Next-Generation Nutraceuticals, Business Insights 7. Nutraceuticals as therapeutic agents: A Review, Research J. Pharm. and Tech 8. An Overview Of Nutraceuticals Current Scenario, Journal of Basic and Clinical Pharmacy 9. Advanced analysis of nutraceuticals , Journal of Pharmaceutical and Biomedical Analysis 10. Hunger And Malnutrition, Challenge paper, Copenhagen Consensus 2012 11. Regulatory environment for nutraceuticals and functional foods, National Research Council of Canada 12. Nutraceuticals: What Are They And Do They Work? Kentucky Equine Research, Inc.,Versailles, KY 13. East Meets West: Bridging the Cultures with Innovative Food Solutions - Dr. Sharon Shoemaker + Dr.

Karen Lapsley, Moderators 14. Nobel Laureates: More Should Be Spent On Hunger, Health 15. Classification, Regulatory Acts And Applications Of Nutraceuticals For Health and Dietary Supple-

ments: A Legal Status In India & In Foreign Countries, International Journal of Pharmacy and Biological Sciences

16. Regulatory Perspective of Nutraceuticals in India, Interlinker 17. Health Enhancing Foods Opportunities for Strengthening the Sector in Developing Countries, The

World Bank 18. Multiple articles and references from www.nutraworld.com 19. Multiple articles and references from www.sightandlife.org 20. Food and Nutraceutical Regulations - Global Snapshot, www.fnbnews.com 21. Food-and-Nutraceutical-Regulations, foodsafetyauthorityindia.blogspot.in 22. NRC Publications Archive – Archives des publications du CNRC Regulations and standards –

23. http://www.fda.gov/ 24. http://www.fda.gov/food/dietarysupplements/default.htm,

http://ods.od.nih.gov/About/DSHEA_Wording.aspx 25. FTC - http://www.ftc.gov/ 26. FDCA -

http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm

27. CODEX - http://www.codexalimentarius.org/ 28. Health Canada - http://www.hc-sc.gc.ca/index-eng.php 29. FSSAI - http://www.fssai.gov.in/ 30. ANVISA - http://www.anvisa.gov.br/eng/index.htm 31. SFDA - http://eng.sfda.gov.cn/WS03/CL0755/ 32. EFSA - http://www.efsa.europa.eu/ 33. EU Directives: http://ec.europa.eu/eu_law/introduction/what_directive_en.htm 34. FSA - http://www.food.gov.uk/

http://www.nutraworld.com/

http://www.sightandlife.org/

http://www.fnbnews.com/

http://www.fda.gov/

http://www.fda.gov/food/dietarysupplements/default.htm

http://ods.od.nih.gov/About/DSHEA_Wording.aspx

http://www.ftc.gov/



http://www.codexalimentarius.org/

http://www.hc-sc.gc.ca/index-eng.php

http://www.fssai.gov.in/

http://www.anvisa.gov.br/eng/index.htm

http://eng.sfda.gov.cn/WS03/CL0755/

http://www.efsa.europa.eu/

http://ec.europa.eu/eu_law/introduction/what_directive_en.htm

http://www.food.gov.uk/

Nutraconsensus 45


35. FOSHU - http://www.foshu.com/ 36. FNFC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/01.html 37. FHC - http://www.mhlw.go.jp/english/topics/foodsafety/fhc/index.html 38. Russian Ministry of Health - http://government.ru/eng/power/23/ 39. http://pharmabiz.com/NewsDetails.aspx?aid=70232&sid=1 40. www.slideshare.net/Overview of FSS Act Rules Regulation2012 Deal References

41. Capital IQ 42. VCC Edge: http://www.vccedge.com/index_new.php 43. Nutritional Capital: http://www.nutritioncapital.com/ 44. http://www.business-standard.com/india/news/sanofi-arm-to-buy-universal-medicare%5Cs-

nutraceuticals-biz/446976/ 45. http://www.business-standard.com/india/news/hester-biosciences-acquires-innoves-animal-

health/489900/ 46. http://www.vivimedlabs.com/news/2011/vivimed-labs-acquires-octtantis-nobel-pvt-ltd/ 47. http://www.business-standard.com/india/news/dabur-buys-ajanta-pharma-capsule-brand-focusotc-

healthcare/434431/ 48. http://www.indiainfoline.com/Markets/News/Bafna-Pharma-to-acquire-Johnson-and-Johnson-

report/5111036623 49. http://profit.ndtv.com/news/market/article-socrus-bio-sciences-ltd-socrus-bio-acquires-anti-obesity-

brand-34-full-fit-34-19513 Emerging Trends

50. http://www.worldbank.org/ 51. http://www.who.int/en/ 52. http://www.wfp.org/nutrition

http://www.foshu.com/

http://www.mhlw.go.jp/english/topics/foodsafety/fhc/01.html

http://www.mhlw.go.jp/english/topics/foodsafety/fhc/index.html

http://government.ru/eng/power/23/

http://pharmabiz.com/NewsDetails.aspx?aid=70232&sid=1

http://www.vccedge.com/index_new.php

http://www.nutritioncapital.com/

http://www.business-standard.com/india/news/sanofi-arm-to-buy-universal-medicare%5Cs-nutraceuticals-biz/446976/

http://www.business-standard.com/india/news/sanofi-arm-to-buy-universal-medicare%5Cs-nutraceuticals-biz/446976/

http://www.business-standard.com/india/news/hester-biosciences-acquires-innoves-animal-health/489900/

http://www.business-standard.com/india/news/hester-biosciences-acquires-innoves-animal-health/489900/

http://www.vivimedlabs.com/news/2011/vivimed-labs-acquires-octtantis-nobel-pvt-ltd/

http://www.business-standard.com/india/news/dabur-buys-ajanta-pharma-capsule-brand-focusotc-healthcare/434431/

http://www.business-standard.com/india/news/dabur-buys-ajanta-pharma-capsule-brand-focusotc-healthcare/434431/

http://www.indiainfoline.com/Markets/News/Bafna-Pharma-to-acquire-Johnson-and-Johnson-report/5111036623

http://www.indiainfoline.com/Markets/News/Bafna-Pharma-to-acquire-Johnson-and-Johnson-report/5111036623

http://profit.ndtv.com/news/market/article-socrus-bio-sciences-ltd-socrus-bio-acquires-anti-obesity-brand-34-full-fit-34-19513

http://profit.ndtv.com/news/market/article-socrus-bio-sciences-ltd-socrus-bio-acquires-anti-obesity-brand-34-full-fit-34-19513

http://www.worldbank.org/

http://www.who.int/en/

http://www.wfp.org/nutrition

Nutraconsensus 46


Appendix

Regulation The National Health Surveillance Agency (ANVISA)

Ministry of Health and Social Development

The Food Safety and Standards Authority of India (FSSAI)

State Food and Drug Administration (SFDA)

Effective from

1999 1997 2006 2003

Definition Vitamin/Mineral supplements

Biologically Active Food Supplements-

Foods for Special Die-tary Use/Medical use

Special Dietary Food/Functional Food

Supplements fall with-in the food category when their levels do not exceed the Rec-ommended Daily Al-lowance (RDA) if ex-ceeded; these are then treated as medi-cines. Supplements are referred to as “Vitamin and /or min-eral supplements. Other ingredients, such probiotics or herbs, are not allowed in supplements and might be regulated under specific stand-ards in the food and/or medicine category.

According to the Minis-try of Health, BAS (nutraceuticals and parapharmaceuticals), are concentrates in-tended for internal consumption or inclu-sion in products to enrich the diet with biologically active sub-stances or their com-plexes. According to the above definition, the following products can be identified as biologically active sup-plements:

Polysaturated ac-ids

Mineral substanc-es, micro and macro elements.

Some aminoacids

Some mono and disaccharides

Food fibres

Microorganisms present in human body

Vitamins, whose daily dose does not exceed the one needed for the human body.

Foods for special dietary use are specially pro-cessed or formulated to satisfy particular dietary requirements that exist because of a particular physical or physiological condition and/or specific disease and disorder. The composition of these foods must differ signifi-cantly from the composi-tion of ordinary foods of comparable nature, if such food exists. Health Supplements in-clude Vitamins, minerals, proteins, fatty acids, ami-no acids, plants or botani-cals, other dietary sub-stances, substances from animal origin with known or established physiologi-cal effect, intended to supplement normal diet and usually marketed in unit dose or other dosage forms such as capsules, tablets, powders, solu-tions. Products with reduced calorie content as a formu-la for losing weight/slimming etc. Dieting foods are products of high nutritional content to satisfy particular dietary requirements which exist because of certain physio-logical conditions or spe-cific diseases/disorders usually without medical advice. Foods specially processed for Infants

Health Foods require pre market registration and approval by SDFA. Special Dietary food: food which is used to fulfil the specific dietary requirements of con-sumers. Special dietary food cannot make func-tional claims with re-gards to the product itself, but claims can be made with regards to the ingredients of the product itself, but claims can be made with re-gards to the ingredients of the product

Nutraconsensus 47


Emergence of Nutraceuticals and their Health Benefits

Lipids (except fatty acids)

Nutraceutical Matrix Possible Health Benefit

Plant sterols (Phytosterols) Vegetable oils (olive, sunflower, rice bran, seeds)

Phytosterols decrease cholesterol associated with LDL, have anti-cancer activity and modulate the immune function and inflammation.

Glycerolipids Seed oils Skin care and source of fatty acids

Phytosterols, γ-oryzanol and steryl ferulates octacosanol, and squalene.

Rice Antioxidant, decrease cholesterol absorption, pro-tect against atherosclerosis, nerve imbalance and disorders of menopause

Sterols Mediterranean mussel and Rapana venosa (hard-shellclam)

Skin-care

Glycerolipids Microalga Antimicrobial and anti- inflammatory activities

Sterols Italian walnut Decrease cholesterol and reduce the risk of coro-nary heart disease

Phytosterols and phytostanols Milk and yoghurt Decrease cholesterol levels

Phytosterols Tetraploid and hexaploid wheats

Decrease cholesterol levels

Squalene Vegetable oil Decrease cholesterol and anti-cancer activity

Terpenes and terpenoids Essential oils Antiseptic, carminative, antimicrobial, and antioxida-tive effects.

Terpenoids Quinoa flour (pseudo-cereal) Antibacterial and antineoplastic properties.

Milk lipids (triglycerides, diacylglycerides, saturated fatty acids and PUFAs).

Milk Immuno-suppressive, anti-inflammatory, andantimi-crobial properties.

Gangliosides Dairy products (milk) Protect against enteric pathogens, and prebiotic functions.

Carotenoid nutraceuticals


β-carotene, β-cryptoxanthin, mutatoxanthin, antheraxanthin, luteoxanthin, epoxycarotenoids esters. . .

Mandarin, Orange juices Antioxidant, inmunomodulation and cancer preven-tion

β-carotene, lycopene Thai fruits Antioxidant, anti-cancer, prevent degenerative dis-eases

β-carotene, lutein, lycopene Chestnut Antioxidant, inmunomodulation and cancer preven-tion

β-carotene Tea seed oils Antioxidant effects

Astaxanthin, β-carotene, lutein, cantaxanthin, violaxanthin, neoxanthin

Alga Antioxidant, inmunomodulation and cancer preven-tion.

Lycopene Tomato products, nutritional supplements

Antioxidant, anti-cancer

Nutraconsensus 48


Vitamins


Tocopherols (Vitamin E) Vegetable and vegetable oils Antioxidant, antitumor, hypocholesterolemic poten-tial and for the treatment of cardiovascular disease and angiogenic disorders

Tocopherols (Vitamin E) Microalga Antioxidant and prevents degenerative disorders

Vitamin B1 and B2 Mushrooms Antioxidant

Water-soluble vitamins (B1, B2, two B3 vitamers, B5, five B6 vitamers, B8, B9, B12 and C).

Maize flour, green and golden kiwi and tomato pulp.

Antioxidant and co-enzymes

Vitamins B2, B3 and B6 Energy drinks Antioxidant and co-enzymes

Vitamin C (L-ascorbic acid) Fruits Antioxidant

L-ascorbic acid dehydroascorbic acid)

Buckwheats Antioxidant

S-methyl-L-methionine (vitamin U)

Centella asiatica Wound healing

Fat and water soluble vitamins Beer and bioactive drinks Antioxidant and co-enzymes

Proteins, peptides and aminoacids


Milk proteins, peptides Lactoferrin and immunoglobulin G.

Milk and derived products Antihypertensive, antimicrobial, anti-inflammatory and inmunostimulating activities. Important source of amino acids

Amino acids Sprouts, alga and sport drinks and tablets

Effect on the nervous system, antioxidant, anti-cancer and source of muscle energy

Peptide Fishes Antihypertensive, antioxidant and anticoagulant activities

Type II collagen Chick Can suppress Rheumatoid arthritis (RA) and promote healthy joints.

∼35 kDa antioxidant protein Curry leaves Antioxidant properties

Immunomodulatoryproteins Garlic (Allium sativum) Immunomodulation activity

Total proteins Ganoderma lucidum (fungi) Prevention and treatment of hypertension, diabetes, hepatitis, cancers and AIDS

Lysozyme-derivedpeptides Hen’s egg Antimicrobial activity

Cyclopeptides Cow cockle seed Estrogen like activity in vivo

Phaseolamin Kidney bean (Phaseolus vulg.) May reduce calorie absorbance, thereby promoting weight loss.

Selenopeptides Nuts Antioxidant, anti-cancer, anti-heart disease

Nutraconsensus 49


Glycosides


Saponins Vegetables

Stimulate muscle growth and raise Testosterone levels. Antidiabetic or anti-obese effects, antibacterial and antineoplastic properties

Chondroitin sulfate Raw materials, formulations and dietary supplements.

Treatment of osteoarthritis and some ophthalmologic diseases.

Polysaccharide (1,3-α-galactan)

Poria cocos (fungus) Anti-inflammatory effects

Saccharides Black currant pomace Antioxidant properties

Galactooligosaccharides Dairy-based prebiotic Ingredient.

Increased absorption of calcium and magnesium, and improved elimination of toxic compounds

Glucosamine Nutraceutical preparations and Tablets

Treatment of osteoarthritis

Glycosides (glucosinolates, glycyrrhetic acid, glycyrrzhin, liquiritin, steroidal glycosides)

Plants Choleretic, anti-inflammatory, anti-cancer, antioxidant, anorexant and diuretic properties

Phenolic compounds


Phenolic acids Seed-oil Antioxidant

Phenolics Fruits, Mushrooms, legumes

Antioxidant

Anthocyanins Fruits, Nutraceutical Capsules

Antioxidant

Anthocyanins Fruits, tubers Antioxidant

Phenolics Marula (Sclerocarrya birrea) Antioxidants and Antiatherogenic

Catecholamines Banana peel Antioxidant

Rutin Buckwheats Antioxidant

Flavone isomers lemon juice Antioxidant

Phenolics Potatoe Antioxidant

Phenolic acids Cooked meat Antioxidant

Flavonol Bean Antioxidant

Phenolics Moscatel sweet wines Antioxidant

Phenolics Carex distachya roots Antioxidant

Curcuminoids Curcuma longa Antioxidant

Lignans Flaxseed Antioxidant

Phenolic acids, proanthocya-nidins, and lignans

Triticale Antioxidant

Flavonoids Ulmus davidiana Antioxidant

Demethyloleuropein Olive fruit Antioxidant

Alkil phenols Anacardum Antioxidant

Flavonoids Hypericum perforatum Antioxidant

Phenolic acids, isoflavones Black Soybeans Antioxidant

Phenolics Pepper Antioxidant

Phenolic acids Malt Antioxidant

Catechins and condensed tannins

Green Tea Antioxidant

Phenolic acids Mangosteen Antioxidant

Phenolics Bergenia ciliate Antioxidant

Nutraconsensus 50



Phenolics Vanilla planifolia Antioxidant

Phenolics Grape Antioxidant

Flavonoids and phenolic acids Chinese herbal tea Antioxidant

Resveratrol Nutraceutical capsules Prevention of atherosclerosis

Phenolics Grape skin Antioxidant

Lignans Myristica fragrans (nutmeg) Anticariogenic

Prunate Prunus Anticarcinogenic

Polymethoxilated Flavones Orange Oil Antioxidant

Carnosic Rosemary Antioxidant

Licochalcone A Glycyrrhiza uralensis Lipase inhibition

Phlorotannins Alga (Ishige okamurae) Cholinesterase inhibition

Phytoestrogens Dietary supplements Estrogenic activity

Flavonol glycosides Ginkgo biloba Memory enhancing

Isoflavones Soy milk Estrogenic activity

Isoflavones Soy supplements Antimenopausial sympthoms

Phenolics Tamarix gallica Antioxidant and antimicrobial

Flavonoids Citrus peel Antiinflammatory, anticarcinogenic and antiathero-genic

Resveratrol Oligomers and Flavonoids

Carex folliculata Seeds Antioxidant, cytotoxicity and antibacterial

Phenolic acids Infant cereals Antioxidant & aroma

O-glucoside phenolic compounds

Olive by-products Antioxidant, maturity indicators

Isoflavones Soybean seeds Antimenopausial sympthoms

Isoflavones Red clover Antifungal activity

Isoflavones Nutritional supplements Estrogenic activity

Other potential nutraceuticals


Sulforaphane Crucifer vegetables (Brassica species)

Anticarcinogenic properties

Phenylpropanoid amide Transgenic tomato Antioxidant and chemotherapeutic effects

Phaeophytines Amaranthus tricolor (Amaranthaceae)

Antioxidant, cancer prevention

Monacolins Rice Cholesterol lowering and anticancer agent

Capsaicinoids Peppers Antioxidants, anti-mutagenic, anti-inflammatory and anti-tumoral properties

Acids (bitter acids, asiatic acid and asiaticoside)

Plants (Centella asiatica, hop)

Anticarcinogenic properties

Nutraconsensus 51


Nutraconsensus 52


About FICCI

Established in 1927, FICCI is a not for profit organisation and is the largest and oldest apex business

organisation in India.

FICCI has direct membership from the private as well as public sectors, including SMEs and MNCs,

and an indirect membership of over 83,000 companies from regional chambers of commerce. With a

Membership of over 500 Chambers of Commerce, Trade Associations Industry bodies, the Chamber

speaks directly and indirectly for over 2, 50,000 small, medium and large business units employing

around 20 million people.

The Head Office is located in Delhi. It has 8 State offices and 6 International Offices. FICCI-Western

Regional Council is the western regional arm of the Federation of Indian Chambers of Commerce &

Industry. In addition to supporting FICCI, New Delhi, FICCI-WRC organises its own conferences,

seminars, workshops and networks with visiting delegations from several developed and developing

countries.

FICCI-WRC actively provides sectoral services in Business Matching, Gems and Jewellery, Nutraceuti-

cals, Progressive Maharashtra, Textiles, Technical Textiles and Wellness.

About HADSA

The Health Foods and Dietary Supplements Association (HADSA), was founded in April 2002, keeping the consumer benefits in mind, and represents the interests of manufacturers and suppliers of healthcare products including vitamin, mineral and botanical (including organic, GMO, non-GMO), Health Food, Natural Ingredient, Cosmeceuticals, Sports Nutrition Products, herbs and other Dietary Supplements.

HADSA is a National, non-profit trade association committed to providing consumers with safe and effective products made to quality standards. Further, the association supports a science-based environ-ment for responsible marketing of Nutritional Supplements and ensures that consumers are provided with accurate information required to make informed choice.

Nutraconsensus 53


NEW DELHI National Office Outer Circle L 41 Connaught Circus New Delhi 110 001 T +91 11 4278 7070

GURGAON 21st floor, DLF Square Jacaranda Marg DLF Phase II Gurgaon 122 002 T +91 124 462 8000

MUMBAI 16th floor, Tower II Indiabulls Finance Centre SB Marg, Elphinstone (W) Mumbai 400 013 T +91 22 6626 2600

CHENNAI Arihant Nitco Park, 6th floor No.90, Dr. Radhakrishnan Salai Mylapore Chennai 600 004 T +91 44 4294 0000

BENGALURU “Wings”, 1st floor 16/1 Cambridge Road Ulsoor Bengaluru 560 008 T +91 80 4243 0700

KOLKATA

10C Hungerford Street 5th floor Kolkata 700 017 T +91 33 4050 8000

CHANDIGARH SCO 17 2nd floor Sector 17 E Chandigarh 160 017 T +91 172 4338 000

HYDERABAD 7th floor, Block III White House Kundan Bagh, Begumpet Hyderabad 500 016 T +91 40 6630 8200

PUNE 401 Century Arcade Narangi Baug Road Off Boat Club Road Pune 411 001 T +91 20 4105 7000

About Grant Thornton

About Grant Thornton International Ltd

Grant Thornton International is one of the world's leading organisations of independently owned and managed accounting and consulting firms. These firms provide assurance, tax and specialist advisory services to privately held businesses and public in-terest entities.

Clients of member and correspondent firms can access the knowledge and experience of more than 2500 partners in over 96 countries and consistently receive a distinctive, high quality and personalised service wherever they choose to do business. Grant Thornton International strives to speak out issues that matter to business and which are in the wider public interest and to be a bold and positive leader in its chosen markets and within the global ac-counting profession.

Our offices in India –

About Grant Thornton India LLP

Grant Thornton India LLP is a member firm within Grant Thornton International Ltd, one of the six largest global accountancy organisations, and the global leader in serving the needs of dynamic private-ly held businesses. From its origins in 1935, the firm has today grown to be one of the largest accounting and advisory firms in India with over 1,100 profes-sional staff based out of 10 locations in the country.

The firm’s mission is to be the advisers of choice to dynamic Indian businesses who have global ambi-tions- raise global capital, expand into global mar-kets or adopt global standards. The firm specialises in providing compliance and advisory services to growth oriented, entrepreneurial companies and adopts best in class international tools, methodolo-gies and risk management standards for all its ser-vices.

Grant Thornton India LLP is registered with limited liability with identity number AAA-7677 and its registered office at L-41 Connaught Circus, New Delhi, 110001.

Nutraconsensus 54


Nutraconsensus 55


Contact details

For FICCI-

Ms Piya Singh

Director

Federation of Indian Chambers Of Commerce & Industry

33-B, Krishnamai, Sir Pochkhanwala Road,

Worli, Mumbai 400 030

(T) - 022 2496 8000

(F) - 022 2496 6631 / 32

(E) – [email protected]

For Grant Thornton India LLP

Mahadevan Narayanamoni

Partner and Leader,

Healthcare and Life-sciences Advisory,

Grant Thornton India LLP

7th Floor, Block III,

White House, Hyderabad 500016

(T) - 040 6630 8200

(E)- [email protected]

We would be delighted to receive your feedback. Kindly mail us at- contact @in.gt.com Editorial team - Vrinda Mathur Design and Production - Sushant Hivale Sanjana Shankar Tavishi Bhargava

nutraconsensus - grant thornton indiagtw3.grantthornton.in/assets/reports/gt_ficci...nutraconsensus...

Documents