The Hindu: Survey of Indian Industry 2004.

Nutraceuticals: A sunrise industry

Dr.Muhammed Majeed

Lifestyle related health problems such as hypertension, diabetes, heart attacks, arthritis, cancers are afflicting an increasing number of people across the globe and at an early age too.

Indeed, with prohibitive costs of healthcare and high-tech disease-treatment approach of modern medicine, there has been a paradigm shift and the buzzword is ‘preventive healthcare’. A holistic approach through right food, regular exercise regimen and food supplements is a means towards this end. This is what has brought the world focus on nutraceuticals.

Although nutraceuticals have been an integral part of medical cabinets in homes across the U.S. and Europe since the 1980s, they have made their presence felt in India only recently -- the chavanyaprash and health drinks notwithstanding. So, what exactly are these nutraceuticals that have caught the imagination of the new breed of health fanatics?

Nutraceuticals are defined as “food, or parts of a food, which provides health benefits, including the prevention and treatment of disease.” They are mainly obtained from plants, especially from those high in nutrition and have a blend of pharmaceutical and nutritional characteristics.

Primarily preventive in nature, nutraceuticals are in distinct contrast to drugs whose active chemical substances are used to treat an illness or symptoms of an illness. However, some nutraceuticals products also address specific health areas such as heart disease, bone health and digestive system health. They are others directed at reducing the risk of cancer, joint health and hormonal imbalances.

Two main categories

Nutraceuticals may be broadly classified into functional foods and dietary supplements. Functional foods are essentially consumed as food but are fortified with calcium, iron and other micro chemicals for health benefits.
These include fruit drinks containing calcium and iron, fortified foods like iron-enriched cornflakes, calcium rich wheat flour, modified foods like vegetable oils with improved fatty acid profiles, Vitamin E enriched eggs and food and beverages with added bio-active ingredients like ginseng tea.

Dietary supplements contain active ingredients of food or food components that are consumed in capsule, tablet, syrup or injectable forms. These include vitamins and minerals.

However, the dividing line between functional foods and dietary supplements is often blurred as they often overlap. Essentially, the two categories provide the body with the additional nourishment for therapeutic or curative purposes. Nutraceuticals is the broader of the two terms because it has been applied to foods and food components in both conventional and non-conventional forms.

The term “Nutraceuticals” was coined in 1991 by Dr. Stephen de Felice, founder- director of New York's Foundation of Innovation in Medicine, an American organization that encourages medical health research.

The emergence of nutraceuticals can be traced back to the 1980s in the U.S. The prohibitive cost of healthcare coupled with inadequate insurance coverage prompted the Americans in the 1980s to look at alternatives like Ayurveda, Chinese, Tibetan and other traditional medical systems.

By the mid-1980s, they gained wide acceptance as “alternative” medicine. They became a part of “complementary” medicine in the mid-1990s where doctors advised people to make “dietary supplements” a part of healthcare routine. By 2000-01, nutraceuticals became an integral part of “integrated” medical system.

Nutraceuticals are becoming popular mainly because they are considered safe, play a vital role in preventive healthcare and are useful in the treatment of chronic diseases.

Nutraceuticals emerged as an industry in the 1980s in the U.S. and soon spread their wings to European countries too. The last couple of decades have seen a whopping growth in the industry in terms of volume and sales.

The global nutraceuticals industry reached a market volume of $50.6 billion in 2001. The leading market for nutraceuticals is the U.S. with a turnover of about $ 29 billion. The projected rate of growth is 15 per cent annually. According to a market analysis by Scoping, sales of nutraceutical foods now exceed $90 billion worldwide.

In India, nutraceuticals is a relatively new market. Separate figures are not available as nutraceuticals sales are clubbed with pharmaceutical sales in the country. An ORG-Marg survey in October 2002 had estimated the sales of pharmaceutical industry at Rs 17,730 crores, of which the nutraceuticals has a share of Rs 2,060 crores or 12 per cent of the pharmaceutical segment.

The ORG-Marg survey puts the value growth of nutraceuticals industry at 7 per cent a year and volume growth at 4 per cent for India.

According to the Confederation of Indian Industries (CII), India’s healthcare industry is expected to grow at 13 per cent annually for the next six years, which should be music to the growing nutraceuticals industry.

Leading players in the nutraceuticals industry include Dabur, Alembic, Ajanta Pharma, Sami Labs Ltd, Universal Medi Care, Parry’s, Dr Reddy’s Laboratory, Pharmed, Wockhardt, Nicholas Piramal, Troika Pharmaceuticals, Glenmark Pharmaceuticals, and Ranbaxy. Companies like Amway, Twin Labs, General Nutrition Centers, Solgar Inc. were pioneers in the U.S. nutraceuticals market.

The foundation for a multi-crore dollar industry has been laid in India. The success stories of the early entrants have prompted major pharmaceutical companies to enter the nutraceuticals area. Johnson & Johnson, American Home Products and Procter & Gamble have entered the nutraceuticals business either by acquisition of smaller companies or starting their own nutraceuticals division.

In India, pharma companies generally make a beginning with standardized Ayurvedic products or nutraceuticals/ dietary supplements.

Some of the popular nutraceuticals products are Spirulina from Parry’s; Carofit, Ocugold and Macugold from Ajanta; Winofit, Cartiz, Evapro from Wockhardt; Rejoint from Nicholas Piramal; Primosa from Universal; Permixon from Saw Palmetto Harvesting Company; Promensil from Novogen; AntoxCare, OcuCare and CoQCare from Sami Labs Ltd.

U.S. regulatory exercises

For decades, the Food and Drug Administration (FDA) regulated dietary supplements as foods, to ensure that they were safe and wholesome. However, the US Congress passed Dietary Supplements Health and Education Act of 1994 (DSHEA) to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements.

As a result, dietary ingredients used in dietary supplements are no longer subject to the pre-market safety evaluations. They must, however, meet requirements of broad band safety provisions.

Through the DSHEA, the meaning of the term "dietary supplements" was expanded to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars and mixtures of these.

Though the DSHEA guidelines for safety of the products are limited, a nutraceuticals company has to ensure highest standards as its name and brand equity are at stake. However, maintaining high safety standards and ensuring efficacy has become voluntary practice and inevitable, as companies cannot afford to take any risk by offering sub-standard products. In India, there is no official regulatory body for monitoring nutraceuticals.

Thus, emphasis is laid on R&D where the products are put through rigorous clinical tests and scientific documentation. Multi-phase and multi-location clinical trials for efficacy, and safety give a company a distinct marketing edge over the others.

However, the nutraceuticals industry is not without its share of concerns. Tall health claims by some companies, lack of stringent tests for side-effects and toxicity, inaccurate efficacy claims make it necessary for nutraceuticals consumption be approved by doctors keeping in mind the health concern of the public.

It is also important that this emerging area be monitored by the drugs control department and not placed under Indian Standard of Medicine category. Nutraceuticals are marketed through three channels: as over-the-counter product, through multi-level marketing and the ethical route where doctors’ approval is the key.

India can emerge as a leader in nutraceuticals as it is a herbal goldmine – a home to almost all kinds of tropical, sub-tropical and temperate zone plants.

The advantage of knowledge based remedies (Ayurveda) gives the country a tremendous lead over others. India can emerge a major player globally in nutraceuticals industry if it develops clinical documentation and scientific basis to support claims of safety and efficacy.

The nutraceuticals industry is a complex and evolving industry and is developing its own set of rules for success. Market analysts and researchers are up beat about the potential.

The sun will shine on those companies who have the vision to establish new industry standards backed with strong research and credibility.

(The author is Chairman and Managing Director, Sami Labs Ltd)