eChapters

In spite of its high protein (CP, 34-36%) content, castor bean meal as such is not used as livestock feed due to the presence of toxic factors viz., ricin, ricinine and allergen. Of the three, ricin is the most detrimental to animals. In order to detoxify the castor cake, a number of physical and chemical methods are employed. The efficacy of the treatments is assessed, based on the qualitative and quantitative changes in ricin content. Of all the detoxification methods, autoclaving (15 p.s.i., 60 min) and lime (4% w/w) treatments completely destroy the toxin. (Anandan et. al., 2005).

Estimation of Ricin

The raw and detoxified samples can be analysed for the toxin, ricin as per the method of Kabat et al. (1947) with modifications as suggested by Waller and Negi (1958).

Extraction of Ricin

The solvent extracted castor cake sample of 500 g is extracted with 2.5 l of water acidified with HCl to a pH of 3.8 by shaking the contents in a conical flask for 6 h. The contents are allowed to settle and are then filtered trough Whatman filter paper No.1 . The residue is treated with 1.5 l of distilled water, shaken for 3 h and filtered through the same paper. A second treatment with water is given to the residue and filtered again through the same filterpaper.

This filtrate contains all the ricin and portions of ricinine that are soluble in cold, dilute HCI. It is evaporated to a small volume by vacuum distillation below 40 °C. The filtrate is saturated with sodium chloride and centrifuged at 4000 rpm for 20 min. to separate the precipitate containing only ricin.

Cotton (Gossypium) seed meal (CSM), the by-product of cotton seed oil industry, is widely used as an animal feed. However, its utilization as an animal feed is limited due to the presence of gossypol, a polyphenolie binaphthyl aldyde, which is toxic to non-ruminants such as poultry and swine and young ruminants such as calves and lambs. The gossypol (free gossypol, FG) present primarily in the pigment glands of cotton seed, is mostly converted to bound gossypol due to condensation of aldehyde group with free amino groups of proteins to form a schiff base. Formation of schiff base though results in the detoxification of gossypol to some extent, it also lowers the nutritive value by reducing the availability of lysine, the limiting amino acid of cotton seed. Thus, bound gossypol, consequently total gossypol (TG) (free plus bound) content is an important factor of cotton seed meal.

The potential of atomic absorption spectrometry/spectrophotometry/ spectroscopy for determination of metallic elements was first realized by Alan Walsh during 1950. The standard equipment termed as atomic absorption spectrometer/ spectrophotometer (AAS) has now gained a reputation in the field of analytical chemistry for determination of very small concentrations of metallic elements and metalloids. As little as 0.01 ppm of many elements can be determined through this tool. Recently, the Zeeman background correction technique has further enhanced the quality of the results obtained from the flame-less graphite furnace atomizer. Combining the very latest in AA technology with the most powerful computing and software available many manufacturers have developed several designs/models of AAS based on flame or flame-less technique.

Infra red (IR) spectroscopy is an analytical technique that serves both qualitativeandquantitativedetectionoforganicconstituents.NearInfraRed spectroscopy (NIRS) is actually a regression technique. Its predictions are based on correlations between spectral information (light absorption) and reference data fed to the spectroscopy. The principle of a NIRS machine is that a feedstuff is illuminated with light of a specific and known frequency (or wavelength) in the near infrared region. The chemical bonds in organic molecules absorb or emit infrared light when their vibrational state changes. In the near IR part of the spectrum, large changes in vibrational state are observed (overtones). In the near IR, ‘overtones’ are observed (larger than expected energy transitions that occur when molecules get ‘over excited’) resulting in broad, less well defined peaks.The characteristics of these peaks make quantification difficult as the areas of the peaks are difficult to determine and,typically,indirect (statistical) technique have to be applied to obtain usable data.Water and the C-H bonds absorb strongly in the near IR region,as do the N-H and O-H bonds,but most other have only a weak peak or none at all. The absorption of light by the feedstuff is then measured as thedifferencebetweentheamountoflightemittedbytheNIRSmachineand the amount of light reflected by the sample. Modern equipment typically uses monochromators, specially constructed mirrors that reflect light in a wavelength-dependent manner, thus allowing exposure of the sample to a single wavelength at a time. This allows samples to be scanned over the entire near IR region (they are also referred to as scanning instruments). However, as the monochromator relies on mechanical positioning of the mirror for its wavelength accuracy, the spectra generated are less reproducible from machine to machine.

Samples those are relatively transparent, such as most gases and liquids, can be assayed easily from the light transmitted (transmittance). For opaque solid samples, however, many problems arise. IR light can only travel through a few microns of opaque material. A few microns, however, can be very difficult to work with, especially when the non-homogeneous nature of most agricultural products is considered. Thus, the major challenge in applying IR spectroscopy to solid samples is sample presentation. For this technique, the sample is put into a cup and illuminated with IR light. This light can have three different fates; it can be reflected off the surface of the sample, it can enter the sample where it may be absorbed if it encounters a bond that matches the light’s frequency or, if it does not encounter such a bond, it can bounce back out of the sample. The light bounced back (or reflected) from the sample is captured and its intensity measured.

Nutritional significance of tannins in feeds and fodders

Tannins are widely distributed in many types of browse plants, tree leaves, forages and feed ingredients. The structure of tannins are not completely well defined but they are polymers of phenolic and aliphatic hydroxy compounds. Although tannins and related polyphenols are considered as protein binders and, protease and cellulolytic inhibitors, they can also exert beneficial effects on rumen fermentation. There are two forms of tannins viz., hydrolysable and condensed. Hydrolysable tannins are considered to have less deleterious effects on protein digestion since these types of tannins might get hydrolysed under acidic gastric condition and release bound proteins. Attempts have been made to utilize this to advantage in protection of proteins from rumen degradation.The condensed tannins are resistant to hydrolytic degradation. The reduction in digestibility due to condensed tannins is not clear whether it is due to specific interference with cellulases or precipitation of proteins.

Certain feed ingredients have been incorporated as a source of tannins, in the diets of ruminants to benefit ruminal fermentation and performance. Inclusion of Bengal gram husk as a source of tannins in the diet of sheep prevented potentially digestible carbohydrate in the rumen, but digested post ruminally (Sreerangaraju et al., 2000).

The amount of feed or nutrient intake by an animal which is not excreted in the faeces is considered to be digested by the animals. The depiction of digested feed/nutrient as percentage of intake is known as digestibility coefficient. However, this does not represent the true value of digestibility of a feed or nutrient because during the period of recording some part of digested material is returned to the digestive tract after absorption in the body and excreted in the faeces. In addition to this some secretions of the digestive system and debris of epithelial cells are also eliminated in the faeces. These errors are quite large and highly variable for the nitrogenous constituents and minerals in the feeds. Due to these factors the determined digestibility coefficient is known as apparent digestibility coefficient. For the determination of digestion coefficient, only daily intake of feed or nutrients and faecal void values are recorded.

The availability of nitrogenous nutrients and minerals is more accurately determined by their retention (balance) in the body. Therefore, for the determination of the retention of nitrogen and minerals,metabolism trials are conducted. The routes of elimination of these constituents from the body are faeces, urine, expired air, skin secretions and milk (in case of lactating mammalian species). In a conventional balance study the loss of nutrient (s) through skin, being quantitatively little, is ignored. However, in case of some very specific study, collection of skin secretions and materials like shed hair and scurf are collected. For the collection of skin secretion (sweat) a special absorbant suit is used. In all routine balance studies, on male animals quantity of intake and void in faeces and urine are only taken into account.

Determination of True Protein

Apparatus

Wide mouth stoppered bottle, water bath plus those used for total nitrogen (crude protein) determination.

Reagents

1. Saturated solution of potash alum.
2. Stutzer reagent-Dissolve 40g of CuSO₄ in 2 litres of water in a wide mouth stoppered bottle. Add 10ml of glycerine and sufficient quantity of 30 % NaOH to make the solution alkaline (Litmus paper). Shake the contents and allow to settle. Discard the supernatant liquid. Collect the precipitate on a filter paper and transfer it to glass mortar with the help of spatula. Add 3ml of glycerine and a little water in the mortar and triturate the precipitate with a glass pastle. Transfer the triturated material to a wide mouth stoppered bottle, add 600ml of water, shake well and filter. Repeat the process till the precipitate (filtrate) is free from alkali and sulphate. Collect the precipitate and add 30ml glycerine. Dilute the emulsion to 320ml with water and preserve in a container.

Sampling of Milk for Analysis

A careful and accurate sampling is of utmost importance for the analysis of milk. It is a fundamental principle of sampling that the quantities withdrawn, must be proportional to the quantities contained in the respective containers and uniform throughout in its composition.Thorough mixing of milk must first be ensured either by stirring or by shaking gently. If milk from an individual animal is to be sampled, the sample should be taken from the middle of vessel containing the whole amount of milk. If the sample bottles have been standing for sometime, resulting in the separation of fat in the cream layer or lumps of fat appear, the bottles may be heated in a water bath upto 40°C to melt the fat before mixing. Milk should not be shaken very violently under any circumstance as it may result in an uneven distribution of fat.

Body condition scoring (BCS), although subjective in nature, is the only practical method of evaluation of body energy stores in dairy cows. The method of body condition scoring, originally proposed by Edmonson et al. (1987) and recommended by the NRC (2001) is described here. This method uses a 5 point scale, with BCS of 1 being extremely thin and a score of 5 being extremely fat. This system includes a combination of both visual appraisal and manual palpation on 8 separate body locations. Figure 1 shows the suggested BCS chart based on these locations. The assessor can score the cows using this chart with a fair accuracy, without much previous experience of scoring the cows. The scoring method is recommended for HF and Holstein crossbred cows.

Loss of BCS is expected during early lactation when a cow is mobilizing body fat in support of energy needs for lactation. Typical observed changes in BCS range from 0.5 to 1.0 condition score units during the first 60 days postpartum. A 1-unit decrease in BCS for a cow weighing 650 kg at calving (BCS 4) would provide 698 MCal of ME.That amount of ME is sufficient to support 564 kg of 4 per cent fat corrected milk.

When dealing with the evaluation of the feeds and calculating the requirements of energy and protein for ruminants, it becomes necessary to inter convert values among different systems and units. Since the accuracy of conversions/equivalents and formulae used for calculating the requirements vary with different systems/constants used, the conversion factors and formulae given here can be used only as guidelines for routine purposes in laboratory or farms in feed formulation.

1.1. Definition of Small-scale Enterprises

According to Shonekan’s keynote address at the Faculty of Business Administration Conference (1992), captured with the theme: “Management of Small and Medium Scale Enterprises in Nigeria.” He said,

“While it is difficult to have one universal definition of SMEs since there are usually many non-constant factors and variables, the spin-off industries are usually small or medium scale. In practical terms, SMEs constitute the bedrock of our national economy. They are our industrial feedstock, the engine of production for the bigger industries. The thriving economies of the world have a record of carefully structured SMEs. In Japan for instance, the bulk of manufacturing is at the small and medium scale levels. This situation also obtains in the ‘Asian Tigers’ (i.e. Malaysia, Taiwan, South Korea, Singapore, etc).”

2.1. Place of SME in Remeding The Nigerian Economic Paradox

This can best be explained by the two-gap economic model. The Two-Gap Models of development are contained in the Post-Keynesian growth models designed by Harrod and Domar. They tried to identify the pre-conditions for the economic growth of market economies. These two preconditions are es- sentially rooted in the Nigerian economy and these are (1) Internally: inad- equate savings would definitely translate to investment. The GAP between these two is called saving constraints (SAVING GAP). Closing this gap re- quires SME-financing. (2) Externally: inadequate foreign exchange arising from inability to export vis-à-vis high importation will lead to short fall in foreign exchange. The GAP between these two is called foreign exchange constraints (TRADE GAP) which can be corrected by facilitating the establishment of indigenous enterprises through a national embrace of the SME-initiatives. Ni- gerian leaders resorted to foreign aid assistance from developed countries, multilateral and bilateral international organizations to salvage the economy from total collapse; but, we can’t continue to carry the begging bow as our benefac- tors only give us fish and don’t teach us how to catch fish.

3.1. Approaches for Promotion Entrepreneurship Programmes in Nigeria

This book used the following typology of approaches:

1. Start: Stimulating local business start-ups that enter into new local markets, there - by avoiding the trap of yet another ‘me-too’ enterprise with low revenues. Promote business start-ups as a way of creating additional jobs and incomes, and promoting competition and structural change. However, these startups often lack innovative business ideas. Instead they enter sectors with a low entry threshold, but with high competition from other companies. Stimulating local start-ups that apply IB models could encourage players to enter new markets that are not yet saturated with competitors, while at the same time serving development goals. Possible target groups for this approach include university students, NGOs or experienced business people who create a spin-off company or leave their company to engage in a totally new business. In a country or sector where IB models are still rare, the first questions that arise are why this is the case, and whether potential markets exist for the use of IB models. Questions to ask include

4.1. Issues in Employment
4.1.1. What is employment?

Employment is a relationship between two parties, usually based on a contract, one being the employer and the other being the employee.

(a) Employee

An employee contributes labor and expertise to an endeavor of an employer and is usually hired to perform specific duties which are packaged into a job. In most modern economies, the term “employee” refers to a specific defined relationship between an individual and a corporation, which differs from those of customer or client. Other types of employment are arrangements such as indenturing which is now highly unusual in developed nations but still happens elsewhere.

Enterprises

5.1. Worldview on the Issue of Small and Medium Enterprises

Research on successful and unsuccessful new and young growing enterprises can aid understanding of growth processes and barriers to growth. Research on how the growth of new enterprises can be better supported, particularly through education at colleges and universities also would be useful. Hence, all over the world increasing attention is being paid to the potential of university education to facilitate high growth enterprises. For example, research has demonstrated that a high-growth entrepreneur in Europe is better educated than other entrepreneurs and the general population. In Europe, most founders of technology based enterprises have a university degree. Research carried out in Germany has shown that enterprises started by individuals with university degrees tend to grow faster than enterprises founded by n on -academics (Egeln, 2000). (Ley, 2006) states that, Research is also needed on how to motivate and nurture the entrepreneurial potential of female students who traditionally may be less inclined to found and manage innovation-oriented high-growth firms. Another group of specific interest is ethnic and immigrant entrepreneurs, who - though often not innovative in the beginning - may introduce novel business practices and subsequent product and service innovations within established communities.

Nigeria: Economic and Non-Economic

6.1. Issues in Growth and Development in Nigeria

Nigeria has attempted through various reform programmes to better the lots of her citizens by providing dividend of development, such as education, health, social infrastructure. Broadly speaking, the features of an underdeveloped economy create obstacles in the way of economic development, and hamper economic progress. These features emerge out of economic, social, political, religious and institutional factors. It would be wrong however to conclude that only economic factors are responsible for poverty or economic backwardness of a country. Non-economic factors are equally responsible for the under development of an economy. The factors discouraging economic development may be classified into economic and non-economic factors which are:

7.1. Rural Poverty in Nigeria

The Federal Republic of Nigeria has a population of more than 160 million - the largest in Africa - and a fast-growing economy. Agriculture is the mainstay of the economy, contributing about 40 per cent of GDP. The agriculture sector employs approximately two-thirds of the country’s total labour force and provides a livelihood for about 90 per cent of the rural population. Nigeria is the world’s largest producer of cassava, yam and cowpea - all staple foods in sub-Saharan Africa. It is also a major producer of fish. Yet it is a food-deficit nation and imports large amounts of grain, livestock products and fish. Nigeria’s huge agricultural resource base offers great potential for growth. Recent government policies have started to show results: The agricultural sector reportedly grew by 7 per cent a year between 2003 and 2007, and at a slightly lower rate in recent years. Still, the area of land under cultivation could be doubled. Of an estimated 71 million hectares of arable land, only about half is presently under production. And there is substantial scope for an increase in irrigation, which now covers only 7 per cent of irrigable land. Irrigation and other inputs would substantially increase average yields for major staple crops, which are below those in other developing countries.

Despite Nigeria’s plentiful agricultural resources and oil wealth, poverty is widespread in the country and has increased since the late 1990s. Some 70 per cent of Nigerians live on less than US$1.25 a day. Poverty is especially severe in rural areas, where up to 80 per cent of the population lives below the poverty line, and social services and infrastructure are limited. The country’s poor rural women and men depend on agriculture for food and income. About 90 per cent of Nigeria’s food is produced by small-scale farmers who cultivate small plots of land and depend on rainfall rather than irrigation systems. The poorest groups eke out a subsistence living but often go short of food, particularly during the pre-harvest period. The productivity of the rural population is also hindered by ill health, particularly HIV/AIDS, tuberculosis and malaria.

8.1. Major Obstacle to Nigeria Economic Growth

In Nigeria, high transport prices are rightly seen as a major obstacle to economic growth of the region. This has been documented in several studies. One of them (Amjadi and Yeats, 1995) even concluded that, in Nigeria, transport costs are a higher trade barrier than import tariffs and trade restrictions. In this paper, it is analyzed, identified and quantified the factors behind Nigeria’s high prices of road transport, with the purpose of helping policy-makers adopt appropriate actions to reduce transport prices to domestic and international trade. Before the presentation of the results, a distinction has to be made between logistics costs, transport prices, transport costs and vehicle operating costs in order to avoid the usual confusion. This distinction is useful because prices may or may not reflect transport cost:

9.1. Challenges for Nigeria

Nigeria, at independence in 1960, was largely a producer and net exporter of primary products. The six major agricultural products then were cocoa, rubber, palm oil, groundnut, cotton and palm kernel. Although there existed mining and quarrying activities, these were of negligible percentage and never counted for the economy as a whole. In other words, agricultural produce and raw materials constituted the sole foreign exchange earner for the country. Specifically, the Nigerian state as an exporter of agricultural goods had 69.4% of its total GDP for the year 1963/64 comprising the six aforementioned agricultural commodities (Olaloku, 1979:8).

The trend of having agriculture as the main foreign exchange earner for Nigeria stopped in the early 1970s when the country was suddenly awash with petrol dollars arising from the quadruple increase in the price of oil in the world market. From 1972 onwards, oil gained ascendancy over all other commodities as the largest contributor to the GDP, and also as a major foreign exchange earner. There was substantial increase in oil production accompanied by a sharp increase in the global market price of high-grade crude oil from low price of $3.8 per barrel in October 1973 to a skyrocketing price of $14.7 per barrel in January 1974. This trend continued till 1981 when the price of crude oil attained a high level of $38.77 per barrel. Within the same period, total revenue from oil rose correspondingly from ? 1 billion to ? 4 billion while external reserves increased from ? 180 million to ? 3.7 billion in 1975 (Osaghae, 1998:96).

10.1. Challenges and Opportunities in SMEs

The Nigerian transport system faces great challenges and also offers several opportunities. The predisposing factors include:

• The size of the country: With area coverage of 923,768.64 km2, spanning longitude 30E-160E and latitude 40N-140N Nigeria is a comparatively large country. It is inhabited by over 140 million people. Transportation is a crucial instrument for linking the country economically, socially and politically.

• Nigeria’s vast natural resources: Nigeria is endowed with petroleum, gas and solid mineral resources. The country is also blessed with abundant agricultural and forest resources, which vary by the three ecological zones of the country. The country is endowed with a highly productive open sea with abundant and diverse marine resources within her coastline of 852km bordering the Atlantic Ocean in the Gulf of Guinea and her maritime area of 46,000 km. This variation is a factor in spatial interdependence. Transport plays an important role in the exploitation and distribution of these resources and in the reduction of spatial inequality and in poverty alleviation.

11.1. Support for Start-Up Finance

Access to finance for start-ups is always difficult due to the problem of asymmetric information. Start-ups lack the kind of financial history which banks use to infer the pay back behaviour and the business capacities of the entrepreneur. Innovative start-ups face the additional problem that it is difficult to assess the viability of their business ideas or the prospects of the markets. In addition, banks and other potential investors often decline to get involved when the relatively small amount of capital requested by a new business is out of proportion with the efforts that the investors must make to screen and evaluate the start-up project.

These problems are even greater for companies engaging in IB models, as doing business with the poor is usually riskier - or perceived as more risky - due to BoP customers’ low ability to pay and the greater vulnerability of value chains. Support for start-up finance is therefore essential. Local IB start-ups often lack funding at all stages of the start-up process: the idea stage, when business opportunities are identified, the seed stage, when the market is assessed and the business model developed, and the start-up stage, when the company is formally set up and all the necessary equipment is procured. Different kinds of financial support will be necessary at all stages.

12.1. Practice of SMEs in Africa-Critical Review

Previous studies in Kenya have focused on the role of entrepreneurship education in job creation, enterprise management and economic development (Simiyu, 2010; Mwangi, 2011; Warren, 2011); hardly any have addressed the process of delivering entrepreneurship education. Research provides new knowledge to guide educational practice, by making an initial foray into the teaching of entrepreneurship education in Kenya. The envisaged entrepreneurially empowered TTI graduate is a product of the training function. This book examines factors which affect implementation of entrepreneurship education programme in TTIs in Kenya. The variables investigated were teaching methods, assessment methods, teacher’s network, and availability of training resources. The findings show that teachers do not accord entrepreneurship education t he appropriate pedagogical approach that it deserves; they seem resigned to using ineffective traditional pedagogies. Meanwhile, the subject is inadequately resourced by TTI administrations. The results of this research invite the attention of entrepreneurship educators, practitioners and stakeholders to employ effective strategies for dev eloping entrepreneurial key competencies in TTI trainees.

13.1 Internal and External Factors Affecting Small and Medium Enterprises

Margi Lévy and Philip Powell argued that growth is determined by a combination of the entrepreneur, strategy and the firm organization. The author also defined key influences on SMEs growth, internal factors that reveal how decisions and features effect the growth of a firm.

(a) Entrepreneurial influences

A firm’s growth is dependent on the managerial knowledge (Macpher son & Holt 2007, 172-192). Training is crucial for the productivity and quality as well as it influences the effectiveness, efficiency and motivation of the employees (Thassanabanjong et al., 2009). The SME owner has considerable personal influence over a firm’s strategies, tactics and operations to engage in decision process across the firm.

As a result, although a flat, informal organizational structure is likely to exist, decisions making tends to be quite centralized around the owner. The entrepreneurs’ personality and behavior are to be causal factors for or against growth - orientated achievement. It is characteristic of small business that power decision are centralized at the level of owner - manager, so his or her personality, skills, responsibilities, attitude and behavior will have decisive influence on business strategy. (Levy and Powell, 2005).

Market competition has a larger affect for SMEs chance of survival and uncertainty is high as most of the smaller companies tend to have smaller share of the capital. This leads SMEs to have one or two major customers and are do not have big influence on prices. Larger companies with higher market share usually determine prices. (Levy & Powell, 2005).

14.1. Characteristics of Social Entrepreneurs Compared to Corporate Entrepreneurs

Prior research has found many parallels between social and commercial entrepreneurs when it comes to personality and behavioural traits (Drucker, 1989; Gitman & McDaniel, 2008; Gordon, 2006). There are some essential personal characteristics of these entrepreneurs that contribute to the success of the venture. A recent empirical study conducted by Sharir and Lerner (2006) identifies eight variables that contribute to success of a social venture. Out of these eight variables, five are directly related to the qualities of the entrepreneur, namely, the entrepreneur’s social network , commitment , previous management experience, ability to integrate the vision and to establish strategic alliances . Similarly, a study of the characteristics of social entrepreneurs in the United States found that social entrepreneurs are more likely to have high social capital (Ryzin, Grossman, DiPadova-Stocks & Bergrud, 2009). Although such studies of the personal characteristics of social entrepreneurs provide useful information about the leadership and organisational skills of such individuals, they do not explain the essence of these traits, why they are important and how social entrepreneurs use them to achieve their social mission and create and sustain social change. More research is required to understand what values, motives and behavioural repertoires distinguish a social entrepreneur from a corporate entrepreneur.

15.1. General Barriers and IB Strategies to Overcome

There are extensive barriers when it comes to doing business with people at the base of the pyramid. This is because of the market inefficiencies and high transaction costs that can render businesses unprofitable, particularly in the short run. For instance, customers in remote rural areas are hard to reach as the necessary infrastructure is not available. General barriers to IB models include:

• Shortages of adequate infrastructure such as roads, energy, water etc., particularly in rural areas and urban slums.

• The need to create a market (i.e. encourage demand): many goods and services are known as ‘push’ products (e.g. waste management and preventive healthcare). It is necessary to raise awareness about them in order to stimulate demand; new distribution channels must also be created.

• The lack of knowledge and skills among the poor, to act either as clients or as suppliers and employees.

• Complex or hostile regulatory or legal environments, affected by weak institutions and insufficient enforcement of rules and contracts. IB models overcome these barriers through innovation and by employing additional, targeted measures. Indeed, the strategies they use to overcome barriers to doing business with the BoP are one of the main defining features of IB models. These measures can be categorised as follows.

16.1. Overview of Medium and Small Enterprises (MSE) Growth

In most developing countries, MSEs constitute the vast majority of firms, generating a substantial share of both overall employment and output. Given their significant economic role, one might expect MSE growth to drive overall increases in output and income levels. In many cases, however, their largest economic contribution appears to be one of maintaining, rather than generating new, employment and income for the poor. At an aggregate level, MSEs demonstrate impressive growth, 3 especially when compared with larger firms. However, many individual MSEs grow slowly or not at all, in some cases, due to a conscious decision on the part of the business owner. Overall growth rates are often fueled by the rapid expansion of a narrow group of highly performing MSEs. In dev e loping as well as in developed countries, there appears to be a small group of “gazelles”, firms that outperform their peers and drive aggregate employment and productivity growth for the small business sector. Why do some MSEs expand rapidly, while others stagnate? What factors account for the wide variation observed in MSE growth trajectories? This paper explores a wide array of specific factors, but it is first useful to consider a broader conceptual frame work of opportunities and capabilities. Clearly, opportunities for profitable business activities shape the ability of an entrepreneur to expand his or her firm.

17.1. The Nigerian Unemployment Milieu: Control Measures taken by the Government

At this juncture, the little efforts that have been made by the government to control unemployment to an extent shall be examined. Records from the Central Bank of Nigeria (1987), show the following efforts made by the government:

1. Youths Empowerment/ employment and skills programme. This was done in terms of provided minor jobs or ‘white-colar’ jobs.

2. Agricultural programmes such as the ‘Operation Feed the Nation’ by the Obasanjo Military Administration.

3. Provision of small scale industries and graduates employment.

4. Special public works (which were temporary). Some of these efforts are still in place while others are forgotten. For example, on the pages of the Businessday Newspaper, on August 4th (pg 13), 12th (pg 49), 21st and 27th, 2009 were the following headings revealed:

18.1. Basic for Government Intervention in the Economy

One of the most powerful arguments to justify government intervention in the economy in the economy is the so-called concept of market failure. In a typical free enterprise system where demand and supply forces operate, the efficiency which results only relates to economic welfare. The social cost implications of economic activities tend to be ignored. Governments therefore intervene in the economy with the social welfare objective in mind. One popular way by which governments have intervened in the economy is through ownership of particular industries or outright nationalization of some private enterprises. The advantages usually claimed for such an action are as follows:

19.1. Remedies to Combat Unemployment in Nigeria

(a) Rural development

One way of stemming the rural-urban drift, and thus control the resulting unemployment in our urban centers, it for the government to develop the rural areas. Not only should amenities be provided, but jobs should be created in the rural areas to stem the exodus. Fortunately, the Babangida administration seemed to have realized this with the huge amount allocation for the development of rural areas in the 1986 and 1987 budgets.

(b) Population control

Government must intensity the effort to control population growth Nigeria already has a huge population and with an estimated growth rate of about 3 percent annually, this can only compound the unemployment in the face of inadequate resources. It is therefore advocated that the government should renew the family planning campaign to check the population growth.

1.1 Weather

Firstly, what is weather? Simply, the conditions in the atmosphere above the earth is called weather. It refers to the conditions such as wind, rain and temperature, prevailing at a particular location during periods of hours or days. We often ask “what’s the weather like today”? Any individual can answer to this question as it requires only a short term experience or say exposure to the atmosphere. The TV news forecasters predict weather each day and inform about the temperature, cloudiness, humidity, or possibility of storm in the next few days. Weather is localised, say, it’s a hot and cloudy weather in one part of the country and dry and windy on the other part.

1.1.1 What are the factors that influence weather?

Before we try to understand the factors that influence weather, we must understand what the components that describe a weather conditions are? Is it the rains, or the air temperature or both? The answer to this question is not so easy, and it’s a bit complicated. There are many components that constitute weather. Weather components include rain, cloud cover, sunshine, winds, hail, snow, sleet, storms, thunderstorms, heat waves and many more. These components are sometimes referred as weather parameters or climate elements. Each of these components define weather patterns of a particular area. These components determine the status of local atmospheric conditions. Again, as a basic definition, weather is the state of the atmosphere and majority of weather phenomena occur in the lowest layer of the atmosphere, called as the troposphere. Does it mean that ground conditions such as the topography, water bodies and vegetation of a particular area has nothing to do with it? No, it is not so. The state of the atmosphere is subjected to various processes taking place not only in the atmosphere but also in the ocean, the sea-ice, the vegetation, etc. Weather parameters or the components of weather form a sequence of events, and the influences are far reaching and they do not remain solely in the atmosphere. For example, terrestrial radiation impacts the air temperature, air pressure and humidity. The terrestrial location also influences the cloud formation. The clouds may or may not turn into precipitation depending on the outcome (cloud or rain), which is by and large governed by troposphere. Likewise, a lack of precipitation affects not only weather conditions, but also soil moisture conditions that may result in lowering of water levels (ground water table) in soil. Wind speed and direction are governed by the atmospheric pressure and air temperature. So, all these parameters or components are interrelated and the weather conditions are the outcome of their interactions. Therefore, we can say that, the three main components of weather are temperature, precipitation and solar radiation. These components are influenced by different factors.

Climate change is caused by both natural as well as anthropogenic causes and it has been changing since the inception of earth-atmosphere (Figure 2.1). In a broader sense, anthropogenic activities (human activities) also must be considered as natural one in longer time scale as human and their activities are also a part of natural-ecosystem-functions. Among the natural phenomena, volcanic eruptions and continental drifts significantly affect the earth’s precipitation and temperature. A huge volume of CO₂ is released due to volcanic eruption at a little span of time-period which heated up the earth-atmosphere. Climate variability is primarily governed by rise in sea temperature, movement of warm water from the Western Pacific towards Peru, and El Nino which occurs at an intervals of 3-7 years. Climate variability also influenced the alteration in temperature and precipitation world wide. And persistent climate variability cause long term climate change. Therefore, basically three drivers that causes climate change are, the alteration in the energy of sun received by earth-atmosphere (natural causes), variations of ref lectivity of earth-surface- atmosphere system (natural as well as anthropogenic causes) and fluctuations in the greenhouse effect (natural as well as anthropogenic causes).

3.1 Chemistry of greenhouse gases (ghgs)

Greenhouse gases (GHGs) are atmospheric-gases that have capabilities to absorb and radiate-back the infrared (IR) radiation in the earth-atmosphere system (Figure 3.1). In this process the atmospheric-gases absorb and radiate- back IR radiation in lower atmosphere effectively emitting and absorbing heat energy heat energy. They maintain the heat budget of earth-atmosphere and keep our plant warm. If we typically see the chemistry of those gases, the key point is that they should have dipole moments. This is the property which makes them capable to absorb and radiate-back the range of IR radiation. In a molecule when valence-electrons are not equally shared in a bond between the two atoms, a slight positive charge is developed above one atom and a negative charge on the other atom. That charge difference of the different atoms in a molecule generates the dipole moment. For instance, in water vapour (H₂O- vapour), an unequal sharing of electrons and or separation of charge causes dipole moment. In H₂O, the centre has a positive charge at the hydrogen atoms and negative charges are located on the oxygen atom. The magnitude of dipole- charges, vibration and stretching of O-H bond generates certain frequency of the oscillating dipole moment that actually regulates the absorption capacity of IR radiation by H₂O vapour.

The measurement of greenhouse gases (GHGs) has been started during middle of the last century. Initially, CO₂ and water vapour were measured with other common meteorological variables like temperature, sunshine hours, rainfall, humidity etc., for monitoring the weather condition and pollution. The absolute or relative concentrations of gasses in atmosphere are used to measure basically for monitoring purpose. However, limited studies were dealt with actual gaseous exchanges of fluxes. The concern about gaseous flux measurement and GHGs-exchanges started after 1900s when people got concerned about anthropogenic pollution, environmental sustainability and climate change issues. The GHGs-exchanges in earth-atmosphere systems primarily occur due to change in meteorological variables, soil responses and physiological activities of crops. If we are interested for environmental data inventories, then absolute GHGs concentrations of atmosphere at a specific time is required. However, presently researchers, students, environmentalists, climate scientists are primarily interested for quantitative data on GHGs fluxes and or GHGs-exchanges. They want to know what and how much quantity of a particular GHG is emitting from unit area at unit time.

Flux refers to the amount of any gas emitted per unit area per unit time. The dimension of that is M A^-11 T^-1. (Where, M= Mass/ Quantity; A= Area; T= Time). The SI unit of flux is g m²s^-1. Therefore, flux is a vector. It has magnitude as well as direction. As for example positive flux of CO₂ from earth surface means, CO₂ is moving out from earth surface to atmosphere. If it moves in opposite direction then the flux would be negative. In that case CO₂ gas may be absorbed by the soil surface from adjacent atmosphere. Similarly, GHGs fluxes of earth surface are either positive or negative. Generally, positive GHGs flux refers to emission of GHGs from earth to atmosphere and vice versa.

5.1 Impact of climate change on agriculture

Climate change has both positive and negatively impact on agriculture, food security and land degradation. Climate change could exacerbate the land degradation processes by increases in rainfall intensity, drought frequency and severity, dry spells, f looding, heat stress, sea-level rise and permafrost thaw. The 1/4^th of ice-free land area in the world is prone to human-induced anthropogenic degradation (Certini and Scalenghe, 2011; Hooke et al., 2012). Soil erosion rate is 20-100 times faster than that of soil formation in agricultural field. The erosion rate is least is zero-tillage (non-disturbed field) and maximum at conventional intensive tillage practices. Climate change further exacerbates the land degradation. The permafrost areas, dry-lands, low-lying coastal regions, river deltas are more vulnerable. The occurrence of drought in dry-land was increased by around 1% per year during 1961-2013 periods. On an average 380-620 million people globally experienced desertification who lived in dry-land areas (1980s and 2000s) in South and East Asia, North Africa, Middle East, Sahara region, and Arabian peninsula. Moreover, people who are already living in degraded/ desertified regions are more negatively affected by climate change.

Specifically, the land surface air temperature has increased about twice as much as the global average temperature since the pre-industrial era. The land-surface air temperature has increased relatively higher than the world’s average surface (land and ocean) temperature since the pre-industrial era (1850-1900). The average land-surface air temperature has enhanced by 1.53°C (1.38-1.68°C), whereas, world’s surface (including land and ocean) air temperature has enhanced by 0.87°C (0.75-0.99°C). Subsequently, global warming triggered the frequency, intensity and duration of heat waves and related damage. The direct and indirect impacts of climate change on global agriculture is summarised below for an overall idea about the importance of the issues.

What is mitigation of GHGs emission? We must be clear about the answer of this fundamental question. In simple term, the mitigation of GHGs emission is the way or means by which the emission of those gases could be reduced. As we know from the previous chapters of this book that the GHGs emission could be occurred from natural as well as anthropogenic activities. Natural activities included volcanic eruptions, ocean current fluctuations, continental drifts which are responsible for emission of huge amount of CO₂ and other GHGs. The reduction of emissions from those natural activities is beyond our capabilities. However, the human induced emissions of GHGs emission could be reduced. We studied in previous chapters that fossil fuel burning, industrial and energy sector pollution, deforestation, land use change and agricultural could contribute to GHGs emission considerably. Mitigation techniques are different for each of those sectors that governed by lot of interrelated factors. In actual sense, the mitigation of GHGs emission should includes all the measures that can curtail the anthropogenic emission from all sectors. But that is out of the scope of this book. In this book, we specifically address the mitigation principles, options and efficiency of different techniques/ practices in agriculture only.

In that aspect, the mitigation of greenhouse gases emissions in agriculture is defined as “the means and ways by which emissions of GHGs could be reduced from agriculture”. The ways and means actually referred to the techniques and practices and their amalgamation in agricultural sector both in production, processing and consumption aspects. So, mitigation is not only a techniques or combination of techniques it is actually an integrated approach for reducing greenhouse gases emission from agricultural systems. Primarily, there are two complementary approaches for mitigation of GHGs emissions from agriculture. Those two approaches are (i) supply-side and (ii) demand- side options or pathways. The supply-side approaches includes scientific land- use-changes, improvement of crop management, better livestock management practices, enhancing carbon storage in biota, soil carbon sequestration, significant substitution of fossil fuel by bio-fuels and use of renewable energy in agriculture. On the other hand, demand side approaches, taken in to account of shifting in the dietary pattern from non-vegetarian to vegetarian, curtail down the food loss and waste, and reducing the supply-chains (Figure 6.1). We can see, most of the approaches in supply-side are technology driven, while, approaches in demand-side are socio-economical and or policy driven. In this chapter we would thoroughly discuss the principles of mitigation, options of mitigation, mitigation cum adaptation approaches to reduce GHGs emission and climate change and few strategies to cope up with the vagaries of climate change.

7.1 Economics and Valuation of ghgs emissions

Since the late 20^th century, it has been largely accepted that cause of high concentration of GHGs in atmosphere is induced by human activities. Greenhouse gas emissions and related climate change has opened up debate on overall economic losses and ways to reduce these loses. Moreover, apart from curbing monetary losses; the global political leaders as well as reputed economists are looking towards making money by saving the emissions. Recently, the researchers have started to emphasize on the actual value added to the ecosystem by curbing emissions, discrete of the economic benefits. This section will discuss the economics and ecosystem services related to the management of GHG emissions.

Origin

The initiative to curb the emissions started in 1992 with the United Nations Framework Convention on Climate Change (UNFCCC) at the Earth Summit in Rio de Janeiro. The Convention took place from 3 to 14 June, 1992. The UNFCCC is an international environmental treaty designed to “stabilize greenhouse gas concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system”. The UNFCCC had non-binding limits on greenhouse gas emissions for individual countries and the framework was only meant for formulating precise international treaties (called “Protocols” or “Agreements”). It contained no execution mechanisms, however, it considered some negotiations and suggestions to formulate the action plans and regulation guidelines under UNFCCC to fulfill the objective of reduction of GHG emissions to the desired level.

CEREALS

Rice (Oryza sativa)

1. Rice blast
Pyricularia oryzae

‘Rice blast’ occurs in more than 80 countries across the world. The disease is more prevalent in Thailand, Japan, America, Guyana, Philippines and India. It is particularly serious in places, where rice is irrigated or receives heavy rainfall and where high levels of nitrogenous fertilizers are applied. Rice blast was first reported in China in 1637, in Japan in 1704 and in India in 1913. In India, it is found in all rice growing states, particularly in Telungu Desam, Karnataka, Maharashtra, Uttar Pradesh. Assam, Tripura, West Bengal, Bihar, Orissa, Himachal Pradesh, Punjab, Madhya Pradesh, Gujarat, Kerala, Tamil Nadu and Pondicherry and causes considerable damage to rice crop. In Tamil Nadu, the disease occurs in all rice growing districts and attains epidemic proportions in some seasons. Several rice blast epidemics have occurred in different parts of the world, causing yield losses ranging from 50 to 90 %. In Tamil Nadu, a serious epidemic of the disease occurred in 1919 in the Thanjavur Delta.

Symptoms. The disease, though chiefly a foliage disease, attacks other parts of rice plants, such as leaf sheath, rachis, joints of the culms and even the glumes. On the leaves, the initial symptoms appear as small bluish or grayish specks, which remain circular in older leaves. On young leaves, they enlarge and become eye-shaped, diamond-shaped or spindle-shaped spots, extending over several centimeters in length and about 1.0 cm. in width. The central portion of the lesion appears pale green or grayish green and water-soaked in the beginning. In older spots, the center becomes white to gray with a dark-brown margin surrounded by a yellow hallow. The lesions may coalesce, cover large area of the leaves and eventually the entire leaves are killed. The shape, size and color of the spots vary depending upon the variety, growth stage of the plants and environmental conditions. Similar spots may be formed on the leaf sheath also. During severe incidence, large areas of the leaves dry and die and the entire crop presents a burnt appearance. Hence the disease is known as ‘blast disease’. Leaf blast is more severe during the seedling and maximum tillering stages. In the nursery, the seedlings show numerous spots on the leaves, which wither and die. In case of severe infection, large number of seedlings may die. Blast also affects the leaf collar, which results in the death of the entire leaf.

The disease attacks the stem-nodes at the heading stage leading to production of ‘white panicles’ or the stem may break at the infected node. Rarely the internodes are affected. Further, at heading the fungus also attacks the panicle neck, which is girdled and becomes shining black and shrivelled. This is the most destructive phase of the disease and is known as ‘neck blast’, ‘neck rot’ or ‘panicle blast’. If infection of the panicle neck occurs early, the grains become chaffy and the panicle remains erect. If panicle neck infection occurs late, the grains become partially filled and because of the weight of the grains, the panicle breaks at the neck- node and droops. Sometimes, only parts of the panicle and joints of the culms and some glumes are infected and develop brown to black spots (Fig. 1).

Under conditions highly favorable for the pathogen, even the varieties resistant to the fungus under normal conditions are also attacked and small, round or short elliptical spots develop. However, the spots normally do not enlarge as typical blast spots.

FRUIT CROPS

Banana (Musa species)

1. Panama disease of banana
Fusarium oxysporum f.sp. cubense

‘Panama disease’, ‘Fusarium wilt’ or ’vascular wilt’ of banana is one of the most serious and destructive diseases of the crop. The disease was first reported from Australia in 1874. Now, it is widely distributed all over the world, including America, Africa, Sri Lanka, Burma, Thailand, Malaysia, Indonesia, Hawai, Fiji, the Philippines, India, Australia and New Zealand. In India, it is prevalent in the states of Assam, Bihar, Karnataka, Kerala, Tamil Nadu, Telungu Desam, Maharashtra and West Bengal.

Symptoms. Usually the symptoms are manifested, when the banana plants are about 5 months old. However, under highly favorable conditions for the pathogen, even 2 - 3 months old plants show wilt symptoms. Initial visible symptoms appear as pale yellow streaks, lengthwise in the petioles of the oldest, lowermost leaves. Two types of symptoms follow this. In the first type, the old leaves turn yellow progressively and finally they break from the petiole and hang down. In the second type, the leaves break from the petiole and hang down, without becoming chlorotic. Gradually, all the leaves collapse and hang down, except the crown, which alone stands upright. The newly formed leaves show yellow blotches and wrinkling of the lamina. Often, the leaf sheaths covering the pseudostem show longitudinal splitting above the ground level. But, sometimes this symptom may not appear. The affected plants may die completely in about 4-6 weeks after the appearance of yellow streaks on the petioles.

The vascular strands show discoloration varying from yellow to dark- brown, which is the characteristic internal symptom of the disease. The discoloration usually appears first in the outer leaf sheaths and extends to the vascular strands of the pseudostem. Vascular discoloration is more pronounced in the corms, but is not common in the roots. When the rhizome of an infected plant is cut transversely, the discoloration of the vascular bundles is distinctly seen as numerous, pin-point like dots all over the cut surface. The roots of affected plants become black and rotten. The suckers growing from the diseased corms are systemically affected and they wilt and die very soon (Fig. 71).

The causal organism. The mycelium of the fungus is hyaline, septate, much branched and mostly intracellular. Few hyphae may also be present in the intercellular spaces. The hyphae are largely confined to the vascular bundles, often filling the cavity of the vessels. The fungus produces three types of spores viz., macroconidia, microconidia and chlamydospores. The sporodochia bearing conidiophores and conidia emerge through the stomata on the petioles and leaves. The conidiophores are vertically branched. Macroconidia are borne at the apical ends of the main and lateral branches and are formed in succession one after another. They are thin-walled, hyaline, pedicellate, sickle-shaped, with both ends somewhat pointed, 2 - 5 septate, mostly 3-septate and measure 22.0 - 36.0 x 4.0 - 5.0µ in size. Microconidia are produced from the branches of conidiophores or from the tips of hyphae in very large numbers. They are single-celled or two-celled, thin-walled, hyaline, ovate or elongated and measure 5.0 - 7.0 x 2.5 - 3.0µ in size. Terminal or intercalary chlamydospores are formed from the hyphae, as well as from the conidial cells. They are oval or spherical, thick-walled and usually occur in pairs. They measure 7.0 - 13.0 x 7.0 - 8.0µ in size (Fig. 71).

The fungus is a facultative parasite. It can invade the host mainly through wounds in the corms or roots. After entry, the fungus develops extensively in the vascular tissue of the corm and then proceeds systemically to the leaf sheaths and pseudostem through the vascular system. The fungus colonizes the vascular bundles and produces masses of mycelium, which bear conidia and chlamydospores, filling the cavity of the vessels. The plugging of vascular elements by the fungus obstructs the translocation of water and nutrients to the aboveground parts of the plant leading to wilting and death of affected plants.

Mode of survival, spread and epidemiology. The fungus is soil-borne in nature. It can survive saprophytically in the diseased corms and other plant parts for prolonged periods and cause fresh infection. The chlamydospores can also remain in a viable state in the soil and diseased plant parts for a long time. The disease can be easily spread through spores present in the infected banana trash and soil, which may be carried in surface flooded water. Suckers used for planting from diseased areas to other places spread the disease easily. Contact of the roots of healthy plants with the roots of diseased plants carrying the spores also leads to fresh infection. The entry of the pathogen is mostly through wounds in the roots or corms, especially deep wounds up to the xylem vessels, caused incidentally during cultural operations or by soil-inhabiting pests, particularly nematodes.

Light textured, sandy loam soils, with acid reaction and low soil moisture of 25 % favor the occurrence and development of the disease. Ratooning of infected banana plants increases the disease incidence to a great extent and leads to continuous accumulation of soil inoculum.

‘Fungi’ including ‘mushrooms’ are ‘Thallophytes’, which do not possess chlorophyll and have been classified under the Kingdom - Myceteae. They do not have stems, roots and leaves and they lack a vascular conducting system as in the case of plants. They propagate by means of spores, either asexual or sexual. Though almost all the fungi are microscopic, the mushrooms are among the largest fungi and had attracted the attention Scientists and Naturalists of many countries dating back to centuries. The Greek word ‘mykes’, which means ‘cap’, was given to the mushrooms because of the ‘cap-like’ appearance of the pileus and the Greek word ‘Mycology’ (mykes = mushroom + logos = discourse) denotes the study of mushrooms. What we call mushrooms, are actually the sporocarps produced by several species of fungi, while the mycelium that produces them live in various types of substrata and obtain nourishment from them. Usually, the fleshy, macroscopic fruiting bodies or sporocarps produced by fungi belonging to Basidiomycetes and Ascomycetes are called ‘mushrooms’

The Romans attributed the appearance of mushrooms and truffles to lightning hurled by Jupiter to the earth. Even now in India and several other countries, people believe that mushrooms appear only after lightning and thunder. The Greeks believed mushrooms as ‘Food for the Gods’. The Romans supplemented mushrooms in the food of soldiers for strength and vitality. The much-priced mushrooms were supposed to be the food delicacy of the elite society of the Romans and Greeks in olden days. The Chinese consider mushrooms as a cure for many diseases and they believe that mushrooms increase the longevity. A number of medicines in all forms are prepared from mushrooms by the Chinese.

To fully explore the history of medical and drug development, it would be necessary to go back as early as 13,000 BCE, where drawings on the Lascaux caves in France suggest that humans were using plants for medicinal purposes. Since then, medical traditions have evolved and dissolved across societies all over the globe. Natural products including plants, animals and minerals have been the basis of treatment of human diseases. The last two centuries have seen a focus on scientific medicine, with a focus on drugs whose effects that have been proved by the scientific method. Yet given this setting, many of the major pharmaceutical corporations have renewed their strategies in favor of natural product drug discovery. Numerous drugs have entered the international pharmacopoeia via the study of ethnopharmacology and traditional medicine. At this point in history, it is possible for both traditional and western medicine to benefit from collaboration between the two disciplines. For traditional medicines, newer guidelines of standardization, manufacture and quality control and scientifically rigorous research on the scientific basis for traditional treatments will be required. In return, traditional medical traditions can offer a more holistic approach to drug design and myriad possible targets for scientific analysis. Powerful new technologies such as automated separation techniques, high-throughput screening and combinatorial chemistry are revolutionizing drug discovery. Traditional knowledge can serve as powerful search engine, which will greatly facilitate intentional, focused and safe natural product drug discovery and help to rediscover the drug discovery process. By looking at the historical trends in drug and medical developments, it is possible to understand how current drug development will benefit from this partnership.

Historically, the terms alternative, complementary or traditional medicine (TM) all referred to a genre of health care practices or services that got bound together as a class through the logic of reductio-ad-absurdum, or because of their “absence from the mainframe of” what has come to be known as Modern Medicine (MM). However, since Stephen Fulder¹ , the identities of TM have become more distinct, MM-TM blending more active and, the line separating the two more fuzzy. To date, the World Health Organization offers the most comprehensive definition of TM² .

WHO defines traditional medicine as including diverse health practices, approaches, knowledge and beliefs incorporating plant, animal, and/or mineral based medicines, spiritual therapies, manual techniques and exercises applied singularly or in combination to maintain well-being, as well as to treat, diagnose or prevent illness.

The phraseology MM/TM is syntactically incorrect because it is contended that medicine as such, modern or otherwise, evolves and progresses through traditions. The major difference between the various traditions of health care practices is that MM rode the crest of the high wave of reductionist-scientistic rigor of modernity³ to reach the shore of global acceptability while the others never crossed the threshold of geographical and cultural locality, remaining untested, neither proved nor disproved. Darwinian principle of survival of the fittest also endorses a truism that survival is a proof of fitness. Given this principle, it makes sense that TM as we know of it today may be useful for promoting human health. Moreover, most TM considers human beings and their health in the context of their environment. This criteria, not only defines TM apart from MM but also provides for a reason as to why lately TM is emerging out of long hibernation. Developmentally, MM isolated “human” from its global environmental context as a static, stand-alone, complete, total and delimited system in itself. While this reductionist approach has a very high pay off for the first 90% of human health problems, it fails when dynamic non-linear complex systems elements kick in (I’m not exactly sure that you mean by this phrase). TM covers some parts of those hidden variables and thats the utility to modern mankind.

The R&D thrust in the pharmaceutical sector is focused on development of new drugs, innovative/indigenous processes for known drugs and development of plant based drugs through investigation of leads from the traditional systems of medicine. In addition, many nutraceuticals are being consumed from unregulated markets for their perceived benefits in health care and improvement of quality of life.

Natural pharmaceuticals, nutraceuticals and cosmeceuticals are of great importance as a reservoir of chemical diversity aimed at new drug discovery and can be explored as potential antimicrobial, cardiovascular, immunosuppressive, and anticancer drugs. Around 80% of all such products are of plant origin; their sales exceeded $ 65 billion in 2003. Examples of plant products and derivatives used by the pharmaceutical industry include Paclitaxel, Vincristine, Vinblastine, Artemisinin, Camptothecin, Podophyllotoxin and such.

The nutraceutical marketplace in Europe is estimated to be $ 9 billion, while the US marketplace, estimated to be $10-12 billion in 2003, is expanding at a compounded rate of more than 20% per year. US Congress has fueled the rapid growth of nutraceuticals with the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. Globally, there have been efforts to monitor quality and regulate the growing business of herbal drugs and traditional medicine.

Contrary to “Law of Finite Biology” though the number of genetic codes will exhaust soon in an exponential way (presumably leading to solutions to every known genetic anomaly related health problem), the number of NCE (New Chemical Entity), their number being finite⁹⁹ too, will run out of fuel soon too, despite unraveling of genomic decoding. The bleak scenario in the pharmaceutical field is a testimony to the latter surmise. As many a wise scholar has pointed out, the era of single molecule drug seem to drawing curtains. However, unlike what seems common sense, the era of combinational drug therapies of MM paradigm probably will not foot the bill. Just as very high speed serial computing simulates parallel processing but does not make real time parallel processing, mixtures of prima facie complementary medicinal molecules will perhaps not make combinational recipes. The fundamentals of non-linear dynamical complex systems (NLDCS) paradigm demand so. The odds against success with such efforts are close to odds of success of creating life one bit at a time out of mixing C, H and O molecules in a jar would be. The number of genes might be finite, but data on their combinations (and their corresponding effects) and more so on their permutations (one has to only imagine the vastness of those possibilities) would, as of now or in near future, cause an information overload and comprehension failure¹⁰⁰ (limitation of human biological brain apparatus) pitting researchers and industry against a futility barrier. However, TM provides a silver lining to these bleak analyses. Analytical comprehension of TM recipes, regimens or techniques might be unachievable by contemporary science, empirical testing of their efficacy and safety being doable and therefore taken care of, TM can provide an outlet to the drug discovery impasse because the same natural forces that shaped multi-gene interaction into complex and dynamical mode have created some of, if not all, TM solutions.

Ethnopharmacology and Traditional medines use natural resources as medicines. They have developed the knowledge of this through the generations of traditions and experiences. Therefore the protection of this knowledge and protection of natural resources both remain critical. Bioprospecting involves sustainable, ethical and legal processes to access natural resources and use them judicially so that the business needs do not pose any threat to nature and to people.

One important consideration is assuring the preservation of traditional knowledge, particularly oral knowledge, within communities, for the potential benefit of others. Developing mechanisms to document traditional knowledge, such as national inventories, can be beneficial in identifying cases where conservation or cultivation is needed, based on an understanding of existing natural resources used for medicinal purposes. Decisions about access and ownership of information can also be made (including those relating to intellectual property rights, where appropriate) once methods have been found to collect and preserve traditional knowledge. On the other hand, the livelihood of traditional healers may depend on maintaining the secrecy of their healing methods - one argument for consulting with traditional healers as part of the process of planning and executing the collection, storage and testing of traditional medicines.

Extending some form of intellectual property protection to traditional knowledge, of which traditional medical knowledge is a significant part, is being actively debated in WIPO and other international forums. Existing intellectual property regimes can offer protection for purified compounds (produced by scientists and companies) isolated from a natural medicine. But traditional medicines, whose method of action may not be well understood, and which often consist of mixtures of different active substances, may not meet criteria for patentability. The principal impetus for international debate is a desire to compensate the holders of traditional knowledge appropriately for the use of their knowledge by others, or to prevent so-called “biopiracy” where knowledge or genetic materials are used without the consent of the holder. China and Kenya are examples of countries that have modified their laws in an effort to accommodate traditional medicine. It is not intended that the Commission should enter into this debate, except in so far as aspects of it may be relevant to its terms of reference, in particular stimulating innovation in traditional medicine with the purpose of expanding access to affordable medicines.

Safety is a primary concern regarding traditional and complementary therapies. There are two aspects of safety evaluations. First, to ensure that the right quality of material and apt possesses are used from sourcing to marketing; and second, there is no contamination, adulteration or spiking. Few studies have reported adulteration with steroids in some traditional Chinese dermatological preparations. In an analysis of Chinese herbal creams prescribed for dermatological conditions, Keane et al. found that eight of eleven creams analyzed contained steroids194. Spiking with corticostreoinds has been observed in some market preparations claimed to be useful in the treatment of arthritis and asthma195. Recently, Saper et al. from Harvard Medical School have reported heavy metal content of Ayurvedic herbal preparations and have recommended mandatory toxic heavy metal testing196. There have been few reports of heavy metal toxicity following traditional medicine use197,198. Such studies are important and needed, however they are more related to the quality control failures of the mass manufacturing activities. Often they are wrongly used to limit the use of TM. In reality, such a QC failure should not be considered as a general negative notion to create a bias against TM. We certainly need effective QC and regulation of herbal medicines, without limiting public access to these preparations and ensuring public interest and constituting restrictive trade practice.

Despite its existence and continued use over many centuries, and its popularity and extensive use during the last decade, traditional medicine has not been officially recognized in most countries. Consequently, education, training and research in this area have not been accorded due attention and support. The quantity and quality of the safety and efficacy data on traditional medicine are far from sufficient to meet the criteria needed to support its use worldwide. The reasons for the lack of research data are due to not only to health care policies, but also to a lack of adequate or accepted research methodology for evaluating traditional medicine235.

The statement from General Guidelines for Methodologies on Research and Evaluation of Traditional Medicines (World Health Organization, 2000) highlights the need for consensuous in addressing the problems related to the quality of botanical drugs, which ultimately is a critical determinant of safety and efficacy of medicine. Further, the distribution and widespread sale of adulterated, misbranded, spurious botanical drug products and marked increase in misleading health claims of these products demands proper regulations on botanical medicine to protect public health236. Considering these two issues development of parameters for quality control standardization and regulatory norms for controlling the growing business of botanicals is a big task. Various regulatory authorities, research organizations and botanical drug manufacturers are constantly contributing to developing guiding principles addressing issues related to quality, safety and efficacy237. In this chapter we have highlighted problems associated with quality control of the botanicals and tried to guide a way towards a globally acceptable quality standard.

Typically herbal pharmaceutics may include any medicinal or functional food preparations such as phytopharmaceuticals, single or poly herbal formulations, and nutraceuticals made out of botanical materials. This includes two broad categories. First, there are many evidence based formulations and mixures that may or may not be based on traditional knowledge or practices. The second group includes all the traditional or ethnopharmacological preparations. Bringing herbal medications from either group to the market will require a pharmaceutics approach balanced with an understanding of the original context in which the treatment was used.

As an example, Ayurvedic medicines have been used safely for many years on a wide variety of patients. Medications that have not been altered from their original form have de facto gone through a type of safety testing. When a traditional medicine is prepared differently, then it is essential to validate the drug safety to be sure that the effects of the new procedure don’t cause harmful effects. In this same way, the value of animal testing to establish safety and toxicity is not as critical if the botanicals are used in traditional forms. Suitable animal models help in understanding the mechanism of action or pharmacodynamics of medicines. However, it is well known that no good animal models exist for many human diseases, such as asthma, diabetes, and rheumatism. The use of modern technology in making traditional preparations more contemporary and scientific is important but it should not compromise the original basis and principles described in tracditional medicine. The following examples highlight some of the concerns of this approach.

The development of a new drug begins typically in the chemistry laboratory and is followed by a wide range of biological studies in vitro (cells/tissues) and in vivo (animals), which forecast what the agent would do in humans. The focus of these studies moves from evaluating the safety of a drug for use in humans to looking at its clinical relevance. Pharmacodynamics involves a set of biological studies both in vitro and and in vivo to get a better understanding of the mechanism of action of a drug. Preclinical studies mainly include safety and toxicity to ensure its safety for use in humans. Typically, preclinical in vitro, in vivo, and Phase I testing may not be necessary if preliminary data on safety are available. However, preclinical data or clinical observations are still necessary to justify a rationale for use and safety in initial clinical studies.

Three main screening approaches are generally used in drug development. Simple Screening evaluates substances that have a particular property by one or two tests. There is no need for a series of tests in which the interpretation of results of one test may depend on others. Blind Screening is used for a new plant extract where no adequate pharmacological information is available. Blind screening may give clues for potential activity and worthiness to probe further for pharmacological activities. Programmed screening involves a new plant extract or substance with known pharmacological effects and results in more precise information.

This guidance explains when a botanical drug may be marketed under an over-the-counter (OTC) drug monograph and when FDA approval of a new drug application (NDA) is needed. In addition, this document provides guidance to sponsors on submitting investigational new drug applications (INDs) for botanical drug products, including those botanical products (or botanicals) currently lawfully marketed as foods and dietary supplements in the United States. This guidance also discusses several areas in which, because of the unique nature of botanicals, FDA finds it appropriate to apply regulatory policies that differ from those applied to synthetic, semisynthetic, or otherwise highly purified or chemically modified drugs (including antibiotics). In particular, the guidance states that applicants may submit reduced documentation of preclinical safety and of chemistry, manufacturing, and controls (CMC) to support an IND for initial clinical studies of botanicals that have been legally marketed in the United States as dietary supplements or cosmetics without any known safety concerns.

Review of Health Claims

Regulators of different countries have different procedures and views to review health claims of traditional medicine, herbal medicines, botanicals, functional foods, nutraceuticals, health products, diatory supplements and such other natural forms of materials intended to use for health promotion. However, if such products carry any therapeutic or health benefit claims then the regulators may provide general guidance and demand for sufficient evidence base in support of such claims. For instance, U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition (CFSAN) provides general guidance to review of health claims in functional foods and dietary supplements. Ethnopharmacological preparations involving herbal medicine and traditional medicines prepared from natural ingredients also will need similar process. The scientific review process for health claims of such products is comprehensive and mainly focuses on review of individual studies³²⁴