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2) INDUSTRY SCENARIO Introduction Herbal medicine has been used in India for thousands of years and is increasingly been used worldwide during the last few decades as evidenced by rapidly growing global and national markets of herbal drugs. The global pharmaceutical market was worth US $550 billion in 2004 and is expected to exceed US $900 billion by the year 2009. According to WHO estimates, the present demand for medicinal plants is ~US $14 billion a year and by the year 2050 it would be ~US $5 trillion. Due to high prices and harmful side effects of synthetic drugs, people rely more on herbal drugs and this trend is growing, not only in developing countries but in developed countries too. India has 2.4% of world's area with 8% of global biodiversity. The forests of India are estimated to harbour 90% of India's medicinal plants diversity in the wide range of forest types that occur. In India, around 25,000 effective plant-based formulations are used in traditional and folk medicine. More than 1.5 million practitioners are using the traditional medicinal system for health care in India. It is estimated that more than 7800 manufacturing units are involved in the production of natural health products and traditional plant-based formulations in India, which requires more than 2000 Tones of a medicinal plant raw material annually. Unfortunately, the number of reports of people experiencing negative effects, caused by the use of herbal drugs, has also been increasing. There may be various reasons for such problems, poor quality of herbal medicines due to insufficient attention being paid to the quality assurance and control of these products. Although WHO has developed guidelines for the quality control of herbal drugs which provide a detailed description of the techniques and measures required for the appropriate cultivation and collection of medicinal plants, there is still a lacuna between this available knowledge and implementation, because farmers and other relevant persons like producers, handlers and processors of herbal drugs are not much aware of WHO's guidelines and they continue their work as before without any quality control measures which results in inferior quality of herbal drugs with lots of contaminants like heavy metals, pesticides and microbes. Hence, training for farmers and other relevant persons is an important measure to be taken to ensure good quality of raw herbal drugs. Contamination with excessive banned pesticides, microbial contaminants, heavy metals and chemical toxins causes various deformities like congenital paralysis, sensory neural defects, liver and kidney damage etc. These contaminants may be related to the source of herbal drugs, if these are grown under contaminated environment. Chemical toxins may come from unfavourable post harvest techniques, wrong storage conditions or chemical treatment during the storage period etc. Some of these environmental factors may be controlled by implementing good source, good agricultural practices (GAPs) and standard operating procedures (SOP) for producing good quality herbal products. Herbal medicines may be associated with a broad variety of microbial loading and exert an important impact on the overall quality of herbal products and preparations. Generally, herbs are valued for their distinctive aroma, colour and flavour. Unfortunately, they are often contaminated with high levels of bacteria, molds and yeasts; if untreated, the herbs will result in rapid spoila INDIAN HERBAL TRADE IN WORLD SCENARIO The utilization of herbal drugs is on the flow and the market is growing step by step. The annual turnover of the Indian herbal medicinal industry is about Rs. 2,300 crore as against the pharmaceutical industry's turnover of Rs. 14,500 crores with a growth rate of 15 percent. The export of medicinal plants and herbs from India has been quite substantial in the last few years. India is the second largest producer of castor seeds in the world, producing about 1,25,000 tones per annum. The major pharmaceuticals exported from India in the recent years, opium alkaloids, senna derivatives, vinca extract, cinchona alkaloids, ipecac root alkaloids, solasodine, Diosgenine/16DPA, Menthol, gudmar herb, mehdi leaves, papian, rauwolfia guar gum, Jasmine oil, agarwood oil, sandal wood oil, etc. The turnover of herbal medicines in India as over-the-counter products, ethical and classical formulations and home remedies of traditional systems of medicine is about $ one billion and export of herbal crude extract is about $ 80 million. The herbal drug market in India is about $1 billion. In India, It is estimated that there are about 25,000 licensed pharmacy of Indian system of medicine. Presently about 1000 single drugs and about 3000 compound formulations are registered. Herbal industry in India uses about 8000 medicinal plants. However, none of the pharma has standardized herbal medicines using active compounds as markers linked with confirmation of bioactivity of herbal drugs in experimental animal models. About 8000 drug manufactures in India, there are however not more than 25 manufactures that can be classified as large scale manufactures. The annual turnover of Indian herbal industry was estimated around US $ 300 million in Ayurvedic and Unani medicine was about US $ 27.7 million. In 1998-1999 again went up to US $ 31.7 million and in 1999-2000 of the total turnover was US $ 48.9 million of Ayurvedic and herbal products. Export of herbal drugs in India is around $ 80 million. In the present article, an endeavor has been made to present an overview of the comparison of Indian traditional herbal medicine in the international market. This article intends to contribute to this knowledge by giving a survey of published data regarding the microbial contamination of herbal plants, by dealing with methodological aspects and by considering the influence of different commonly used pharmaceutical preparation techniques on the microbiological status of the products. It also highlights heavy metal poisoning of these herbal products and the need for India to follow the Good Agriculture Practice (GAP) guidelines. As herbal medicinal products are complex mixtures, which originate from biological sources, great efforts are necessary to guarantee a constant and adequate quality. By carefully selecting the plant material and a standardized manufacturing process, the pattern and concentration of constituents should be kept as constant as possible, as this is a prerequisite for reproducible therapeutic results. China has successfully overcome such difficulties by modernizing its traditional medicine profession with government-sponsored GAPs. The cultivation practices offer Standard Operating Procedures for use of fertilizers, irrigation systems and disease management allied with insects and pest prevention and cure. GAPs also establish standards for noxious and harmful contaminants like heavy metals, pesticide residues and microbes in plants.
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