Nutraconsensus Emerging insights on Nutraceuticals - players and policy makers

Transcription

1 Nutraconsensus Emerging insights on Nutraceuticals - players and policy makers A whitepaper prepared by Grant Thornton India for FICCI FICCI-HADSA Nutraceuticals November 2012, Mumbai

2 Nutraconsensus 1 Member firm of Grant Thornton International Ltd Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune

3 Nutraconsensus 2 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 Member firm of Grant Thornton International Ltd Offices in Bengaluru, Chandigarh, Chennai, Gurgaon, Hyderabad, Kolkata, Mumbai, New Delhi and Pune

4 Nutraconsensus 3 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 issue attempts to bring out the key trends in the developments in the nutraceuticals segment in the last few years in the BRIC regions and a benchmarking of regulatory aspects, 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 positive beginnings 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 implementation and application of these guidelines, this has been a move which has been welcomed by the industry and other users alike.

5 Nutraconsensus 4 Foreword: Grant Thornton Mahadevan Narayanamoni National Leader, Healthcare and Life-sciences Advisory Partner, Corporate Finance 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 addressed through some national efforts by the government and global aid agencies in the form of fortification and specific eradication measures. India can now be viewed both as a developer and manufacturer 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 includes recommendations for a multi-pronged strategy to address the nutrition needs of a vastly growing, ageing and unhealthy population

6 Nutraconsensus 5 Nutraceuticals and functional foods combine traditional nutritive with drug-like functions of prevention

7 Nutraconsensus 6 Clarity in Definition part of our medical history, knowingly or unknowingly, for the last several decades. Formally efits, including the prevention and treatnuous evolution over the years, nutraceuticals are nchemical compounds which have a health promoting, The foo Often regarded as synonymous to a drug, the key differentiator between a drug and a nutraceutical supportive function and are ofte 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 comparatively shorter approval process without the need for conducting clinical/ animal trials. Accordingly, nutraceuticals lie somewhere between a food and a drug. 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

8 Nutraconsensus 7 Celebrating a hundred years of Vitamins Emerging physician acceptance Awareness through numerous journals and articles on benefits 1910 Umetaro Suzuki discovers product, later identified as Vit B Casimir Funk Vitamins identified and characterised Industrial production of vitamins 2000 onwards Deficiencies identified in several industrialised countries Mandatory fortification of salt, flour, cereals, sugar, wheat, maize, dairy in many countries. Control over deficiencies such as iodine, iron, vitamin A,D, B Vitamins are organic nutrients which are essential for life. The human body requires very small amounts of these nutrients to ensure normal metabolism, growth and physical well-being. Most vitamins are not made in the body or only in insufficient 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 (essential) in small amounts to ensure that the body grows, develops, and stays healthy. Minerals are found in wide range of foods. The body uses minerals 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 minerals, 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 balanced and varied diet is therefore vital to meet the tamins, 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.

9 Nutraconsensus 8 Segmentation Dynamics Nutrition is needed not only for sustaining growth but also for combating diseases in the human 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. Regulations in each country differ not only in terms of the definition of a nutraceutical but also in terms of the inclusion/ exclusions therefrom. Functional foods Foods having specific psychological 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 supplements Amino acids Antioxidants Herbal and non-herbal extracts Functional Beverages Liquids quenching thirst as well as replenishing minerals, 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)

10 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 various diseases however is still evolving. As an example, food fortification with folic acid is being researched for NTD reduction whereas food fortification with Iodine for goitre reduction is already an established and implemented area of scientific research. The effectiveness of multiple interventions depends on their appropriate combination and sequencing. In addition to the sectors mentioned, 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 Copenhagen Consensus 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 government 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 combined 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 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 dietary needs and food preferences and is supported by an environment of adequate sanitation, health services and care, allowing for a healthy and active New Dimensions The usage of nutrients has increased from traditional forms (foods, supplements and beverages) to new markets such as cosmetics, pet care, marine life, sports, etc. Antioxidants for longevity, immunity and vitality Increased demand from the highest risk categories of baby boomers non-prescription based cosmetics with medicinal (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, fibres Naturally derived substances, consisting of herbal and botanical extracts and animal- and marinebased derivatives

11 Nutraconsensus 10 The largest market for nutraceuticals 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, Russia, 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 compares them to our most nourished counterpart the US