The inside story

The inside story

The idea that food has therapeutic value is not a new one. Ayurveda, for instance, recommends diet regimes based on seasons and on an individual's constitution (see box: Take cues from traditional wisdom). And it's not just this ancient system of medicine. Traditional communities in most countries had dietary practices that placed a premium on nutrition. Tamarind, for example, is consumed in different forms by people all over the country: in south India, it's taken as part of daily food items such as sambhar, chutney and rasam, while in the north, tamarind water adds tang to the ubiquitous golgappas. According to P Pushpangadan, director, National Botanical Research Institute (NBRI), Lucknow, "Tamarind contains proteins and glycolipids that protect us from fluoride poisoning -- a distinct threat in both north and south India because well waters here have high levels of the chemical (though in the north this problem becomes acute in summer)." Similarly, mango drinks, barley water with lemon and black carrot preparations are consumed for their nutritional qualities in many parts of the country. Traditionally food was always regarded as season-specific and locale-specific. Food is medicine, say traditional healers.

But then the world changed. We moved from eating home-cooked and seasonally grown vegetable, to diets that are much more fashionable and convenient. Vegetables come out of season; food moves across regions; traditional grains disappear. The concord between diet regimes and local-seasonal requirements broke.

But the world did not change for the better. Diseases such as obesity, diabetes, cancer and asthma -- now seen as lifestyle-diet related -- increased and science began to rediscover the traditional wisdom of food as medicine. But food in its natural form made poor business, so industry isolated compounds like immunity boosting polysaccharides from Curcuma longa (turmeric) and found a new delivery system -- pills, tonics, powders and syrup -- emerged. Enter the world of nutraceuticals.

What exactly are they?
The term 'nutraceutical' literally means, 'of nutrition'. It was coined in 1989, by US physician Stephen De Felice, who defined nutraceuticals as, "food or parts of food, that provide medical or health benefits, including the prevention of disease". But the term remains a fuzzy one. It is often used interchangeably with functional food -- or natural foods, which have added benefits, such as brown rice and tofu. Dietary supplement -- those consumed along with regular food items for specific nutrient properties, such as protein drinks -- is another expression used concurrently with nutraceutical. Yet another expression used in conjunction with the term is herbal medicine. That's not all: terms such as sportaceuticals, aquaceuticals and oleuceuticals have started doing the rounds (see box: The "ceutical" cousins).

In India, the government-run Council for Scientific and Industrial Research (CSIR) has taken it upon itself to promote nutraceuticals. In 2002, it started a Rs 14-crore project, "Positioning Indian Nutraceuticals and Nutragenomics on the Global Platform." This five-year programme aims to develop and promote health-enhancing substances and find foods specific for people with specific genetic make up. CSIR was also one of the sponsors of the First Nutraceutical Summit at Mumbai in October 2003. At the meet, a wider variety of companies -- pharma majors of India such as Ranbaxy Laboratories Limited, Delhi and Nicholas Piramal India Limited, Delhi, multinationals such as Heinz and herbal medicine manufacturers such as Dabur India Limited, Gurgaon -- clamoured to get their products slotted as nutraceuticals. Makers of protein supplements, soy and milk products -- even garlic paste -- were in a frenetic rush to hitch themselves onto the nutraceutical bandwagon.

Why this rush?
Simply, because health foods are a good business proposition. Actual figures of sales potential vary -- perhaps, because there is no accepted definition of a nutraceutical. But by all counts, the industry is looking at a large market. Consider this: the spokesperson of the Bangalore-based Sami Labs believes that the Indian market for nutraceuticals would touch Rs 1,200 crore in the next four years. In his presentation at the First Nutraceutical Summit, S R Rao, chief general manager, Exim Bank, Mumbai reckoned that this market has already touched Rs 1,600 crore in 2001. Rao also noted that the global nutraceutical industry touched US $50.6 billion in 2001. According to this banker, the US is the leading market for nutraceuticals -- the growth in demand for these health products here is about 15 per cent per annum. Asia, according to Rao, is the fastest growing market followed by South America and West Asia. The department of the Indian systems of medicine (ISM), Union ministry of health and family welfare estimates the global market is US $62 billion and reckons that it will go up to as high as US $3 trillion by 2010. The worldwide market for vitamin supplements alone is estimated at US $40 million.

So what's the industry doing to cash in? The eight principles of action enunciated by advertising major Leo Burnett's representative at the Mumbai meet, aptly describe the industry's behaviour. They are

• Aim for the breakfast table, not the medicine cabinet

• Smuggle your product into your consumer's life through his existing behaviour

• Taste matters

• Identify the right need of the consumer

• Keep the proposition simple and clear

• Differentiate or die

• Establish credentials

• Deliver perceptible results

The methods have had fair success. Ask Ajay Pal Gupta. This proprietor of Yamuna Chemists in New Delhi's Lodhi Road area says, "The share of health foods in my total sales have doubled in recent years: from 5 per cent to 10 per cent. College and school students, youngsters starting out on their first jobs, even pregnant women have become buyers of a range of products such as spirulina, vitamin supplements, protein drinks and derivatives from traditional medicine. Many feel consuming these will make up for their irregular eating habits, others assume that these will take care of their weight problems."

There are surer facts to attest the industry's success. The annual turnover of Parry Nutraceuticals Limited increased from Rs 7 crore in 2000 to Rs 17 crore in 2001. Sami Labs annual turnover is expected to touch Rs 200 crore this year -- it was 66 crore in 2002. Merina Benny of LivLong Nutraceuticals, Alwaye, Kerala puts it quite aptly: "Even by conservative estimates, companies can make profits of 30-40 per cent from one product." In many cases, it can be exorbitantly more. For example, the manufacturing costs of a 200 grammes sachet of anti-diabetic powder is about Rs 12. The price of the product can go up to Rs 140. Let's take another example. Pharma major Nicholas Piramal sells ten tablets of the multivitamin Supradyn for Rs 12, while another pharma biggie, Ranbaxy, sells the same combination -- under the brand name Revital with a bit of ginseng (a herb) -- for Rs 60. Supradyn is sold as a medicine and so is under the purview of the Drug and Cosmetics Act (DCA), 1940, which controls prices of essential drugs. Ranbaxy sells Revital as a dietary supplement and so can evade the act.

The industry is however, not satisfied with its success. At the Mumbai meet it demanded a legislation to govern nutraceuticals. On face of it, the demand does not seem to be an unfair one. After all, legislation can ensure some degree of protection to the customer. Arvind Junagade, secretary, Health Foods and Dietary Supplements Association contends, "Legislation will ensure that the products will be safe even if their effectiveness is uncertain." But the industry's pleas for a legislation could stem from totally different considerations. Right now, manufacturers of nutrition products cannot make health claims. Doing so would bring these products under the jurisdiction of the DCA. That's an onerous proposition: getting a product clinically verified can take up to 15 years and cost up to US $1.2 million. The industry believes that legal sanction for the term 'nutraceutical' can enable it to make some health claims, without worrying about the DCA.

And those itching to make such claims do not just include players in the pharma industry. Many in the food industry also hanker for a place on the nutraceutical bandwagon. Among them is the US multinational Heinz. The company initially sold its tomato ketchup at a price higher in India than that levied by competitors Kissan (Hindustan Lever Limited, Mumbai) and Maggi (Nestle India Limited, Gurgaon). The high prices deterred customers; Heinz lost out to its competitors. In its home country, the company markets its ketchup as a nutraceutical, low on carbohydrates and high on lycopene, a phytochemical that gives red colour to the tomatoes and helps in conversion of beta carotene to vitamin A. But it cannot make similar claims in India. Will legislation help Heinz in selling its products at a higher price to health savvy Indians? Let us take another example: Kraft, US' largest food company, has recently entered the health foods market. Many of the company's products are classified as junk food. Entry into the health food sector could be a good way to change image and also tap an increasingly swelling market.

So is it food or medicine?
Are nutraceuticals food or drug, ask regulators? In other words, does the product fall within the ambit of the Prevention of Food Adulteration Act (PFA), 1954, which regulates food and additives in the country. Currently PFA does not recognise nutraceuticals as a class; red colour from paprika (red chillies) or lycopene from tomato is not, for instance, a food grade colour. Also, products sold as capsules or tablets are not food.

Or will these products be considered as medicines under the Drugs and Cosmetic Act of 1940, with its demands for testing efficacy and quality control? Industry says, the US and EU, have separate laws and directives to govern dietary food supplements, which are neither food nor drugs. And instead of strengthening the existing act, they want an act similar to the one in the US - the Dietary Supplements Health and Education Act (DSHEA), 1994.

In these countries, the key issue was to regulate the "health claims" of the product. Initially, vitamins and minerals were exempt from regulation as drugs, as long as they did not make health claims. In 1990, the US passed the Nutrition Labeling and Education Act, which allowed certain health claims for food -- calcium with osteoporosis, cholesterol with heart disease -- as long as the claim was based on an authoritative statement by a governmental scientific body. Then, when dietary supplements were brought under DSHEA, the producing company was made responsible for ensuring that any supplement it manufactures is safe and that the claims about health effects are supported by "adequate evidence". Nutraceuticals are permitted to claim, additionally, that they have beneficial effects on "structures" or "functions" of the body. But the label must include a disclaimer that the US Food and Drug Administration has not evaluated the claim. Measuring efficacy of the claim is a key concern of these regulators across the world (see box: Do they show the way?).

So what can we do?
But in India, there are significant differences. In the US, Ayurveda, unlike homeopathy, is not considered a traditional medicinal system and Ayurvedic drugs have to be sold as dietary supplements, governed by DSHEA. In India, traditional medicinal systems (Ayurvedic, Unani and Siddha) are governed by the same DCA, but with different conditions. As long as companies follow the traditional drug recipes, processes and ingredients, they will get licenses to operate. In other words, traditional drugs and often health supplements and cosmetics, get special treatment under this act, which allows them to operate without first proving efficacy, safety and standardisation. And they can qualify as having medicinal properties.

This is what pinches the new industry, which is borrowing from traditional medicine to push its products. The industry claims its products are "different" but wants the same privileges. Then also, the current law of traditional Indian medicines recognises only the medicines mentioned in ancient texts -- and only the 550 plants mentioned in these texts. Imported herbs such as ginseng -- the one used in Revital -- and ginkgo, echinacea and St John's wort -- used in the CSIR project -- cannot be brought under its purview.

This is why industry wants a different protection. In India, a committee was formed in 1995 and a bill drafted, mainly to deal with herbs of foreign origin. But practitioners of traditional medicine resisted this intrusion into their domain. The "modern supplement" industry did not want the "traditional" industry to control them and with constant quibbling over who would control, the idea was dropped.

The department of ISM then took up the initiative and proposed a bill in 2000-2001. A skeletal framework was even worked out based on US legislation. There was also a provision to include traditional systems of medicine. Products had to carry a label specifying that they do not cure. The bill did a round of the different ministries but this time it is alleged that the modern nutraceutical industry fought back.

Currently, there are two parallel processes underway. The Union ministry of food processing industries has proposed an integrated food law. The proposed law does not have a section on dietary supplements. But K P Sarin, executive secretary, All India Food Processors Association, is quick to allay any misgivings. "The government can make an amendment to the act, if these nutraceuticals are to be included as food," he says.

At the same time, the ministry of health and family welfare has gone back to the original idea on a bill to regulate nutraceuticals -- on the initiative of the department of health this time. The ministry has before it the recommendations of a committee, headed by CSIR director R A Mashelkar, as guidelines. It has recommended classifying nutraceuticals as food. The committee has argued the need for separate regulations that define dietary supplements. It has also called for laying criteria for permissible limits of ingredients, a procedure to evaluate their safety and efficacy and provisions related to their advertisements. At the same time, products that claim or are intended to diagnose, cure, prevent or treat a disease are to be classified as drugs.

The committee has also proposed regulations that would cover combination products of botanical herbs, which are part of the traditional systems, with other chemical-based active ingredients. In other words, traditional medicines, which cannot be patented under the Indian systems, would now become proprietary.

But worries remain
The Mashelkar committee recommendations are also silent on the inordinate price disparities. The game plan of manufacturers is simple: avoid complicated drug regulations, which would demand proving efficacy and safety and come with price control mechanisms. Simultaneously, they want to avoid the traditional medicine category, as being different gets them a modern and effective label. Classifying nutraceuticals as food, in fact, ensures that their price cannot be controlled and a little bit of vitamins added can push price differences. Sanjeev Chaudhry, CEO of Gurgaon-based Solae Company, which makes soybean-based products and is part of the multinational Dupont, explains, "Legislation would ensure that good quality, reasonably-priced products are available to consumers. The price mismatch would be taken care of within six months to a year with new entrepreneurs entering the fray." But whether that really happens is another matter.

There is another worry. India has not been able to control piracy of herbs so far. The new legislation might actually increase the circulation of herbal dietary supplements and make biopiracy even more rampant. It is also a fact that the quality of herbal products has not been monitored so far. Will the new legislation ensure such checks?

Ayurveda practioners in fact, have a litany of complaints against nutraceuticals. They argue that once modern scientists work on an idea derived from traditional medicine, the original creators are left out of the picture. A related issue concerns patenting and if this new science, which does some value-addition, should be allowed to patent products, in the name of a new discovery. Many such as Akhilesh Sharma -- chairperson of the Delhi-based Global Society for Promotion of Ayurveda -- argue that nutraceuticals are actually useless in the long run. "We are trying to isolate active principles and whenever we have resorted to such practices, they have not worked," he says. In a similar vein, Ranjit Puranik, CEO, Shree Dhootapapeshwar Limited, a Mumbai-based maker of traditional medicine, explains, "The use of food for therapy is an integral part of traditional medicine. For example, in traditional medicine, diabetics are advised karela (bitter gourd). But consuming the vegetable is totally different from taking it in form of pills -- the latter will not help." There are other objections. "Many Indian companies market ayurvedic products such as Chyvanaprasam and Dasamoolarishtam as dietary supplements. This creates a feeling that all ayurvedic products fall in this category and do not require a physician's prescription," says D Ramanathan, general secretary, Ayurvedic Medicine Manufacturers Organisation of India, Kerala.

But what about lifestyle?
Sebastian Thomas of Parry Nutraceuticals puts the raison de etre for nutraceuticals succinctly: "With our current high pressure lifestyle, our food habits have changed. We skip meals, rely more on processed foods or eat out." Thomas' remedy: Spirulina pills. People in Aztec civilisation consumed spirulina for good health four hundred years ago. The good old alga has made a comeback: as a capsule. And so have many ingredients of our traditional recipes encased in glossy pills: haldi (turmeric), karela and neem among others. Our unhealthy lifestyles have led the industry to make a case for these.

But how about changing our lifestyles? After all traditional diet patterns were also intertwined with lifestyle regimes. And then, modern business has still not found a way to package traditional lifestyles? What cannot be sold, cannot be fashionable: is that going to be the adage of the future?

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Healthy kya?

HERBAL BEER
Looks, smells, even tastes like it. But is it beer?

WHAT GOES IN? Pub-crawlers beware, herbal beer is just raw mango mixed with herbs (Andrographis or kalmegh and Tinospora or guduchi), fermented for a week. Besides mango (Mangifera indica), other fruit such as amla (Phyllanthus emblica), guava (Psidium guajava) and oranges (Citrus spp.) can also be used as raw material. The product has been created at a research institute

NUTRA ELEMENT Guduchi is good for the heart, diabetes, blood pressure, leprosy and piles. Kalmegh is a traditional health booster that increases immunity, is effective against fever and acts as a liver tonic. Kalmegh is also used in herbal beer to simulate the bitter flavour of hops. Herbal beer is supposedly high in antioxidants, relaxes the heart and the digestive system, is a diuretic and also protects against gastro-duodenal ulceration. Tests on liver cell lines have shown that cells thrive with herbal beer while most die with regular beer. The product is a thirst-quencher with a pleasant aroma

STATUTORY WARNING Although it is called herbal, the alcohol content in this beer ranges between two and eight per cent, which is around the same as in some regular Indian beers

THE BUY-BUY STATUS The institute has shared the technique with a manufacturer and production of herbal beer is likely to roll by June 2005

OMEGA 3 FATTY ACIDS
PRODUCT FEATURES Can be sourced from flax seed, pumpkin seed, walnut, canola, soybeans and fish (that eat the algae)

NUTRA ELEMENT Fatty acids (alpha linolenic acid and linoleic acid) modulate cell membrane characteristics to minimise inflammations that lead to arthritis, coronary heart disease. Also said to safeguard against depression

RICE BRAN
PRODUCT FEATURES Available as rice bran oil. Also adds a nutritional element to products like biscuits and bread

NUTRA ELEMENT Rice bran phytonutrients help prevent conditions like cancer, heart disease, kidney stones, excessive calcium and hyperlipidemia (accumulation of fat)

PROTEIN
PRODUCT FEATURES Protein in biscuits and as powder and capsules have been around as one of the world's oldest 'nutras'

NUTRA ELEMENT Milk protein (casein), low fat and B-vitamins for convalescents who need dietary supplements. Biscuits come with added calories to help absorb proteins

SOY
PRODUCT FEATURES Products include tofu, soymilk. US soy food market worth US $3.2 billion and is growing by 15 per cent each year

NUTRA ELEMENT Soy protein is rich in argenine, glutamine. Promotes anabolic activity, forms muscle, prevents lactic acid build-up. Saponins, phytic acid reduce cholesterol. Genistein in soybean seeds prevents cancer, cardiovascular disease and post-menopausal ailments. But known to have caused allergic reactions

CREATINE POWDER
PRODUCT FEATURES Sports-enhancer: based on the theory that creatine levels in wild animals are higher than in captive ones

NUTRA ELEMENT Taken orally, gets absorbed directly in intestinal lumen, then enters the bloodstream

DATE (KHAJOOR) BEVERAGE POWDER
PRODUCT FEATURES In vanilla, chocolate, other flavours and dissolves easily in beverages

NUTRA ELEMENT Rich in vitamins A and B complex, folic acid, calcium, magnesium, phosphorus, iron, copper and zinc. Reduces sugar

SPIRULINA
Sprinkle the powder on your rasams and soups and even garnish your cooked veggies with it. Add it to homemade biscuits, burfi or murukku. Or take the easy route and just pop a spirulina capsule. It's also a terrific idea to try a lassi garnished delicately with spirulina on a hot day as it cools down the body

WHAT GOES IN? Blue-green algae that are a rich source of proteins (64 per cent), lipids (6 per cent) and minerals (8 per cent), including iron. Nutrients like phycocyanin, chlorophyll, carotenoids, vitamins, carbohydrates and minerals. Introduced in India in the 1990s, spirulina is one of the world's most popular health supplements

NUTRA ELEMENT Combats iron deficiency and also boosts vitamin A status (especially during pregnancy and lactation). Reduces plasma glucose level and cholesterol in diabetics, fights accumulation of fat, bronchial asthma and rheumatoid arthritis. It has even been found effective in preventing oral cancer

THE BUY BUY STATUS The product is available everywhere, in several brands. It is sold both in powder form and as tablets

TURMERIC
PRODUCT FEATURES Traditional ingredient (haldi) in cooked food, new popularity as 'nutra'. Sold as phytonutrient capsules and as food colour. Well-researched, cancer-prevention properties determined

NUTRA ELEMENT Active ingredients protect the liver from chemicals and fungal toxins. They also manage degenerative secondary complications of diabetes mellitus

GREEN TEA
Next time you need some refreshing tea, don't reach for that cup, just pop a tea pill. Yes, now there are actually tea tablets and capsules. Tea is rich in antioxidants, green tea being more potent than the regular, cured one

WHAT GOES IN? Extract of green tea (dry leaf), about 40 per cent polyphenols (active antioxidant) by weight

NUTRA ELEMENT Each capsule has active ingredients equivalent to 10 cups of tea. Antioxidants protect drinkers from different types of cancer (of the lung, stomach) and precancerous conditions. Polyphenols in it prevent mutation, inhibit tumour cell DNA synthesis and reduce production of harmful peroxide molecules. Catechins block biosynthesis of endogenous nitrosamines that could cause cancer. Other chemicals in the leaf inhibit aflatoxin- induced liver cancer. The brew or tablet is also a guard from the side effects of anti-cancer drugs. Natural antioxidants in the leaf have anti-aging properties. Polysaccharides help reduce sugar level in the blood. Pigments can prevent arteries from hardening, reduce blood cholesterol. The flavones are effective antibacterials and anti-fungals. Polyphenols have also been found effective against HIV

STATUTORY WARNING So what's new?

THE BUY BUY STATUS As tablets and tea

SLIM CAPSULES
PRODUCT FEATURES Sold as the safe, natural way to get into shape

NUTRA ELEMENT Garcinia (kokum), a fruit rich in hydroxy citric acid, reduces the body's conversion of carbohydrates to fats. Areca catechu (supari) encourages healthy fat metabolism, decreases false hunger and sugar cravings

SUGARCANE SPREAD
PRODUCT FEATURES Process adds betacarotene to sugarcane juice. Ginger (adrak) and cumin (jeera) are add-ons for flavour

NUTRA ELEMENT Sugarcane is rich in minerals, vitamins. Cumin and ginger are anti-bacterial, increase immunity and act as anti-emetics

SATTU REMIX?
Good old sattu, now targeted at diabetics

WHAT GOES IN? A mix of microwaved cereals, pulses and extracts of medicinal plants. Pulses like soybean (Glycine), gram (Cicer), urad (Phaseolus), guar (Cyamompsis) and konch, also called velvet bean (Mucuna). Cereals are jau (Hordeum), buckwheat (Fagopyrum), amaranth (Amaranthus). Medicinal plants in this remix include ashwagandha (Withania) that raises immunity, provides energy, vidarikand (Pueraria), a general tonic for headaches and an aphrodisiac and punarnava (Boerhaavia) which works against fever and is a diuretic. Gudmar (Gymnema), karela (Momordica), jamun (Syzgium), vijaysar (Pterocarpus), as well as other plants like methi or fenugreek (Trigonella), cinnamon (Cinnamomum), bimba (Coccinia) and bel (Aegle) are anti-diabetic. Common spices, added for the taste factor, include Kali mirch or black pepper (Piper longum), safed musli (Chlorophytum tuberosum), turmeric (Curcuma longa) and elaichi (Elettaria cardamomum).

NUTRA ELEMENT The rise in diabetes-statistics in India has led to the revival of this "natural nutraceutical" that's nutritious, non-toxic, easy to digest and improves vigour in diabetics. It controls blood/urine sugar levels and tackles common diabetes-related problems like fatigue, drowsiness, frequent urination, excessive thirst and hunger. It is also helpful in controlling conditions like weight loss, swellings on legs, burning feet and palms, dry skin, hypertension, blurred vision and wounds that heal slowly. In adult diabetics, oral medicine-intake was found to have reduced (by 30-100 per cent) as were insulin doses (by 10-30 per cent).

THE BUY BUY STATUS Available; new players making moves. In future: Sattu tablets and capsules!

ECHINACEA
PRODUCT FEATURES Dietary supplement prepared from fresh plants and roots and standardised using three separate marker compounds

NUTRA ELEMENT Braces body's defence mechanism. Phytonutrients in Echinacea supply additional nutritional benefits

ENERGY FORMULA
Sold as healthcare supplement for sportspersons and keep-fit types

PRODUCT FEATURES High carbohydrate energiser

NUTRA ELEMENT Beta-carotene, vitamins B and C are complemented by electrolytes and glycogen for instant energy

ANTI-ARTHRITIC CAPSULES
PRODUCT FEATURES Active ingredients from turmeric and shallaki (Boswellia)

NUTRA ELEMENT Regular use boosts blood supply to joints for cartilage repair and mobility, arrests inflammatory responses like pain, swelling. Can be taken over long periods without gastric irritation and is not toxic to liver or kidney

CAROTENOIDS
PRODUCT FEATURES Sourced from Dunaliella salina, a saline water alga. Used as a powder or an oil. Rich in carotenoids such as beta carotene, alpha carotene and xanthophylls like zeaxanthin, cryptoxanthin and lutein

NUTRA ELEMENT These chemicals are the best kind of antioxidants

HUSK TABLET
PRODUCT FEATURES Fibre supplement, sold as tablets. It has ingredients like apple pectin, Psyllium or seed husk (isabgol) and cellulose

NUTRA ELEMENT Friendly acidophilus bacteria help digestion, keep colon healthy, boost nutrient absorption.