Phytopharmaceuticals: A new drug class regulated in India

Charu Gupta
Amity Institute for Herbal Research & Studies
Amity University UP

Dhan Prakash
Amity Institute for Herbal Research & Studies
Amity University UP

Nutraceuticals and functional foods on an average are globally becoming giant players in health sector. In a survey, it was reported that in year 2010 alone, there was a huge market growth of nutraceuticals and food supplements. Phytopharmaceuticals, nutraceuticals and functional foods have the potential to substantially reduce the expensive, high-tech, disease treatment approaches particularly common in developed countries. Charu Gupta and Dhan Prakash from Amity Institute for Herbal Research & Studies explores the world of Phytopharmaceuticals and nutraceuticals in this article.

A popular Hippocratic Oath states that "Let food be thy medicine and medicine be thy food". This oath truly illustrates the importance of nutraceuticals and functional foods in today's sedentary lifestyle. With the increase in the consumption of junk foods, there is a subsequent increase in lifestyle diseases like hypertension, obesity, diabetes etc. Functional foods and nutraceuticals have emerged out as an attractive natural alternative especially in European countries including US.

Today's consumers have become more health conscious and are aware of the side effects of the allopathic medicines. They look out for a healthier and natural option in the form of functional foods, dietary supplements and nutraceuticals. The major advantage of consuming these food supplements are that they just not only take care of the person's normal recommended dietary allowance (RDA) balance but also serve as a mechanism for performance enhancement and disease prevention(FICCI). Consumers prefer natural non-GMO (genetically modified organism) and organic foods, beverages and nutritional health supplements.

Phytopharmaceuticals plays a key role in the development of nutraceuticals and functional foods, prevention or treatment of several diseases and maintenance of good general health in human.

Phytopharmaceuticals are actually "Bioactive herbal formulations" that contains selective combinations of specific bioactive constituents of plants and/or their parts that possess health-promotive, disease preventing and medicinal properties. These phytochemicals are present in either whole plants or in their specific plant parts like stem, leaves, flowers, and roots. These can aptly be known as 'Herbiceuticals' having nutraceutical importance and include nonnutritive phytochemical(s) that maintain good health. They offer the benefits of both food nutrients and pharmaceutical like defensive or disease protective properties. Phytochemicals are the nonessential nutrients that are produced by the plants under stressful conditions in order to protect themselves. Nutraceuticals comprises of the concentrated source of these phytochemicals that are present in the purified form. Other related terminologies commonly used in this area include dietary supplements, geneticallyengineered designer foods, and functional foods. The important phytochemical constituents commonly found in plants are polyphenols, flavonoids, isoflavonoids, anthocyanidins, carotenoids, fibers, limonoids, glucosinolates, phytoestrogens, phytosterols and terpenoids. All these phytochemicals provide numerous health benefits including prevention and/or treatment of diseases and various other physiological disorders. Majority of foods, including whole grains, beans, fruits, vegetables and herbs contain all these important phytochemicals. However, amongst all these , fruits and vegetables contribute to the most significant source of phytochemicals. These phytochemicals function either alone or in combinations and contribute significantly in curing various health related ailments. Functional foods are closely related to nutraceuticals as they often contain nutraceuticals in a foodbased formulation, such as carotenoids , but others are novel biotechnological entities derived from foods, for instance, pre- and probiotics.

Phytochemicals, if consumed regularly in recommended doses, provides health benefits by protecting against chronic degenerative disorders, cancer, diabetes, high blood pressure, inflammation, microbial, viral and parasitic infections, psychotic diseases, spasmodic conditions, ulcers, cardiovascular and neurodegenerative diseases. These nutraceuticals either alone or in combination have tremendous therapeutic potential in curing various ailments . Nutraceuticals contain bioactive phyto-constituents in purified and concentrated form that offer several health and medicinal benefits.



Nutraceuticals and functional foods on an average are globally becoming giant players in health sector. In a survey, it was reported that in year 2010 alone, there was a huge market growth of nutraceuticals and food supplements. The importance of these products can be ascertained by the fact that in developing and poor countries mortality rate has been increased to up to nearly 40% due to poor nutrition. Thus to maintain the nutritional balance of the individual, it is necessary to take nutraceutical-type products.

As per the recent reports of the popular vision gain, the world market demand for all the nutraceuticals, dietary supplements and functional foods will further boost up to $241.25bn in 2015 alone. This data is justified and supported by the fact that the world’s ageing population is gradually increasing particularly in developed European countries. The aged people are becoming more health conscious across the globe. There are various nutraceuticals available in the market for these geriatric individuals. This has provided an important incentive for the global food industry, which is experiencing an increasing shift towards functional foods and nutraceuticals .

The major drawback of marketing of phytopharmaceuticals including functional foods and nutraceuticals is that they are not subjected to rigorous quality regulations as compared to pharmaceutical products particularly in developing countries where there are no stringent laws and government bodies to check the quality of these products, their promotion and distribution.

A food can become a nutraceutical simply by validating through scientific studies. Phytopharmaceuticals, nutraceuticals and functional foods have the potential to substantially reduce the expensive, high-tech, disease treatment approaches particularly common in developed countries.

Nutraceutical products range from isolated nutrients, dietary supplements and specific diets to genetically engineered foods, herbal products, and processed foods such as cereals, soups, and beverages. Examples of some popular nutraceuticals include glucosamine from ginseng, omega-3 fatty acids from linseed, epigallocatechin gallate from green tea, lycopene form tomato etc. All these products possess several therapeutic benefits.

Chemically nutraceuticals may be classified as carbohydrate derivatives (ascorbic acid, oligosaccharides, non-starch polysaccharides), amino acid derivatives (amino acids, allyl-S compounds, capsaicinoids, isothiocyanates, indoles, folate, choline), microbes (probiotics, prebiotics), fatty acid and structural lipids (n-3 PUFA, CLA, MUFA, sphingolipids, lecithins), minerals (Ca, Zn, Cu, K, Se), isoprenoid derivatives(terpenoids, carotenoids, saponins, tocotrienols, tocopherols, terpenes), and phenolic compounds (couramines, tannins, lignins, anthocyanins, isoflavones, flavonones, flavanoids.

The vitamins A, B6, B12, D, E, folates have been suggested to have anti -cancer, immune-protective and cancer-reducing activity in individuals who used selfmedication.

These nutraceuticals play an important role in maintaining optimal immune response; their deficient or excessive intakes can have negative impact on health. Several preclinical and clinical trial studies have shown that the regular consumption of whole grains, fruits, and vegetables reduces the risk of chronic diseases associated with oxidative damage. Carotenoids, tocopherols, ascorbates, lipoic acids and polyphenols are strong natural antioxidants with free radical scavenging activity.

Besides, there are several endogenous antioxidant enzymes like super oxide dismutase (SOD), catalase, glutathione peroxidase, glutathione- reductase, minerals like Se, Mn, Cu, Zn, vitamins A, C and E, carotenoids, limonoids and polyphenols exert synergistic actions in scavenging free radicals. Thus all the governing bodies around the world have accepted nutraceuticals as possible nutraceutical therapy in main stream of medical education and health.

Since there are not still any stringent government regulatory bodies, majority of nutraceuticals are purchased based on self-prescription and own individual experiences. It has been found that the benefits of nutraceuticals are phenomenal in the controlled clinical trial studies.





Phytopharmaceuticals development using Biotechnology
Biotechnological tools can also be used to develop and improve phytopharmaceutical & nutraceutical products and functional foods. The major advantage is to increase the production of enzymes and other metabolites production through recombinant microbiology. Furthermore, the thermal stability of the enzymes and metabolites and their ability to tolerate wide pH range can further be improved using these biotechnological tools.

Through the use of genetic engineering, it is possible to isolate a specific gene(s) coding for enzymes or other metabolites of interest, from organisms of unknown genetics. For example, it is known that omega-3 fatty acids protect against cardiovascular disease. The various food sources of omega-3 fatty acids are fish, flax seed and some vegetable oils.

It is possible to produce a vegetable oil that can have 10-20 times the amount of omega-3 fatty acids compared to present day oils using modern biotechnological tools like genetic engineering. Such types of oil can be used to include in the diet of patients prone to heart disease. Conventional plant-breeding methods can also improve nutraceutical quality and production by enhancing both agronomic and medicinal traits.



In vitro propagation or tissue culture techniques of plants also holds potential for the production of high-quality plant-based medicines.

Besides these, nutritional genomics is a recently used terminology in the area of nutraceutical development which includes nutrigenomics (the science of study of interaction of dietary components with the genome and the resulting proteomic and metabolomic changes) and nutrigenetics(understanding the gene-based differences in response to dietary components and developing tailor-made nutraceuticals that are most compatible with health based on individual genetic makeup).

Phytopharmaceuticals sometimes known as Natural health products are now available in the market in many dosage forms like tablets, capsules, powder, vati, tinctures, solutions, ointments, drops and cream to name a few. These are all the concentrated forms of the bioactive phytochemicals they are designed to maintain or promote health, restore or correct human health function(s) and treat or prevent disease. Some of the common examples of these phytopharmaceuticals include beta-glucan extracted from oats, antioxidants from blueberries, iso-flavonoids from soy, sterols from wood pulp, essential fatty acids from marine or vegetable oil, and soluble fibers from fenugreek. The products that are obtained after grounding, drying, powdering and pressing from plant materials include Echinacea, fenugreek, valerian and ginseng. The products produced, extracted and purified from animals or microorganisms include elk velvet, essential fatty acids, enzymes , carotenoids and probiotics; and products from marine sources include glucosamine, chitosan, algae, seaweed, kelp and fish oils; and vitamin and mineral supplements.

Conclusion
As discussed about the promising role of phytopharmaceuticals in the promotion of human health and disease prevention; the health professionals, nutritionists and regulatory toxicologists should strategically work to plan appropriate regulation to provide the ultimate health and therapeutic benefits to mankind. Thus long term clinical trials are required to scientifically validate the efficacy of phytopharmaceuticals in various medical conditions. Besides this, the mode of interaction of phytopharmaceuticals with food and drugs is another area that should also be taken into consideration in the clinical trial studies. Also the effect of different processing methods on the bioavailability and effectiveness of nutraceuticals should also to be ascertained.