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?