Opportunities for Export of Ayurvedic Products to African Countries Ayurveda is the most ancient system of healthcare. India’s India’s share in the export of herbals is just 0.2% of the total global herbal market. So there is obviously vast scope for Indian manufacturers for entering the growing world wide opportunity of business in Herbal Pharmaceutical field.The world wide market of Herbal Medicines is US $ 60 billion (WHO 2002). The world health organization predicts the overall automotive medicine market to reach US $ 5 trillion by 2050. According to WHO, up to 80% of the world’s population still depend heavily on TCM for treatment.Traditional treatment.Traditional Medicines (TM) have been used by African Countries since ancient times India’s exports are much less than what
they import from other countries.Africa presents 6% of ASU&H exports. Major importing countries are Kenya and Nigeria.The major objective of this study is to critically appraise the potential for herbal ayurvedic products and identify the problems and prospects of these in select African Countries INTRODUCTION Ayurveda is the most ancient system of healthcare. India’s share in the export of herbals is just 0.2% of the total global herbal market. So there is obviously vast scope for Indian manufacturers manufacturers for entering the growing world wide opportunity of business in Herbal Pharmaceutical field.Traditional Medicines (TM) have been used by African Countries since ancient times India’s exports are much less than what they import from other countries. Africa presents 6% of ASU&H exports. Major importing countries are Kenya and Nigeria. eDemand for medicinal plants is increasing in Africa as the population populatio n grows. But constraints and challenges exist at all levels. Global Market for Traditional Medicines Medicines The world wide market of Herbal Herbal Medicines is to US $ 60 billion (WHO (WHO 2002). The world health organization predicts the overall automotive medicine market to reach US $ 5 trillion by 2050. Indian planning commission estimates massive increases in the export value to Rs.30 billion by 2006 and to Rs.100 billion by 2010. Germany, France, UK, Switzerland, Japan & USA are major importers of Indian Medicinal Plant Products. Within the European Union botanical medicine represent an important share of the pharmaceutical market.In India, the value of medicinal plant related trade is about US $ 10 billion per annum and this industry is growing at the rate of 7.15% annually with exports of US $ 1.1 billion per year. REVIEW OF LITERATURE WHO (2002) Traditional and folklore medicine handed on from generation to generation is rich in household remedies and community practice. According to an estimate of World Health Organization (WHO), nearly 80% of the population of developing countries countries rely on traditional medicine, medicine, mostly plant drugs for their primary health care needs. Gautam V.S (2003). Researchers here designed product market segmentation matrix in to four zones . They have placed Indonesia and other countries in Zone A, where Indian system of medicines is
recognised as alternate source of traditional healthcare system and variety of products can be sold there. M. DANIEL(2004) India is on the threshold of a herbal revolution. With the rich wealth of herbs, we can command the world herbal scene. But there are so many obstacles we have to cross before we become a superpower in the herbal scene Assocham Report 2008 Herbal product exports can be accelerated with the setting up of EPZs in about 12 Indian states as their demand soars at a rate of over 25 percent in countries like the US, Britain, Spain, Australia, Russia and Indonesia, OBJECTIVE The major focus of this study is to critically appraise market scenario of last 5 years and identify the opportunities and challenges for ayurvedic products, so as to develop a suitable strategy for export of Ayurvedic products to African countries METHODOLOGY This study is supported by desk research, which includes sources like World Health Organization, World Intellectual Property Organization, Dept. of Indian System of Medicines and Homeopathy, Department. of Commerce, Pharmaceutical Export Promotion Council their conferences and various articles and papers published in various magazines and news papers.
Table.1 India’s Total Export Ayurvedic products
Year
Total export In Rs.Lakhs
2003-04
19275.35
2004-05
39,982.34
2005-06
23,306.69
2006-07
25,953.88
2007-08
32,143.83
India export of ayurvedic products have shown an increasing trend in last fives years as evident from table 1 above which is 66.76% growth. Source; Dept of Commerce India Exports to African Countries Table. 2. Export of ayurvedic products
Values in Rs. Lacs
Countries
2003-04
2004-05
2005-06
2006-07
2007-08
KENYA
186.50
245.76
404.28
853.26
555.75
SOUTH AFRICA
390.68
404.89
324.33
319.32
116.90
709.35
622.68
435.08
208.59
244.83
208.22
174.44
253.34
184.19
62.75
NIGERIA
GHANA
Source;Dept.of Commerce
Data in above chart indicates that there is 196% growth in exports to Kenya. .It has been declined in other three countries in 2007-08. Reasons for such changes may be due to changes in regulation of these countries recently.
Traditional Medicines in African Countries Challenges The regulation of TM follow WHO Framework on key component of Drug Regulation with some adjustment to suit the country’s needs while on the other hand can still provide a control mechanism to
protect the community from the risk of non compliance in TM products. The essential regulatory element among others s legislation . Legislation in African Countries Despite its existence over many centuries and its expansive use during the last decade, in most African countries, traditional medicine, including herbal medicines, has not yet been officially recognised, and the regulation and registration of herbal medicines has not been well established. Although, in most African countries more than 80% of the population rely on traditional medicine for their primary health care needs, the governments have not yet promulgated regulation and recognition of the practice of traditional medicine. Even in countries where there is an apparent recognition, appropriate budgeting to facilitate the functioning of the Traditional Medicine Board is usually inadequate or totally lacking. In many countries in Africa, the entire traditional medicine community seems to be operating outside the framework of national legislation on the collection and trade in wild species. There is also a large inter-African trade in medicinal plants, again almost entirely outside the usual international trade controls. There is thus a need for the formulation and development of national as well as regional policies and legislation in terms of the trade and access to these resources if maximum benefits are to be reaped in order for such policies to be successful. Many African countries do not have procedures to register medicinal plant preparations although they are widely used for the health care needs of a majority of the people. The regulations, if any, are very stringent, requiring the same standards expected of modern medicines. m o re income and thereby become more aware of the value Ghana In the Republic of Ghana, the national policy on TM/CAM was issued in 2002. Laws and regulations on TM/CAM were issued in 1992. and the national programme in 2000. Herbal medicines are regulated as over-the-counter medicines and as a separate regulatory category. There are 340 registered herbal medicines in Ghana; however none is included on the national essential drug list. In Ghana, herbal medicines are sold in pharmacies as overthe-counter medicines, in special outlets and by licensed practitioners Kenya Herbal medicines are not regulated in Kenya. There is no registration system for herbal medicines and they are not included on the essential drug list. Herbal medicines in
Kenya are sold without restriction. Nigeria Herbal medicines are regulated as dietary supplements Health foods, Functional food as an independent regulatory category. There is registration system and currently 107 registered herbal medicines in Nigeria, but none is listed on the essential drug list. In Nigeria, herbal medicines are sold without restriction by licensed practitioners. South Africa The national policy on TM/CAM of the Republic of South Africa was issued in 1996 as part of the National Drug Policy. No regulatory status exists for herbal medicines, currently they are sold for self medication only. There is currently no national registration system for herbal medicines, although one is in development. In South Africa, herbal medicines are sold in pharmacies as over-the-counter medicines. Technical Barriers • Lack of harmonization in safety & quality evaluation parameters and registration procedures and high registration fees for TM products in developed countries leading to prohibitive transaction costs for exporter • Absence of uniform drug dossier formats for registration of herbal/TM products in developed countries and insistence on multiple GMPs like US-FDA/EU GMP instead of reliance on WHOGMP. Absence of harmonization & cooperation between regulatory agencies regarding • development of pharma monographs of medicinal plants. • Inadequate HS code classification for herbal substances/extracts/traditional •
•
medicinal products outlets, by licensed practitioners and without restriction.
Opportunities 1. Prevelance of Traditional Medicines Traditional Medicines (TM) have been used by since ancient times and empirically passed on from generation to generation. TM have been used to maintain, and promote the human health, prevention as well as to reduce symptomatic disorders and has made great contribution to health. The use of TM is still prominent and take an important role as an alternative to Conventional medicines. 2. Growing Market Table 2 above shows that Kenya is growing market. .Other countries are also growing but exports declined due to restricted regulations.
3. Govt Initiatives in Export Govt has given incentive to drug manufacturers, entrepreneurs, AYUSH Institutions etc. for Registration of their products for exports to focus countries. •
50% of the expenditure incurred on preparation of Drug Dossiers and Registration of ASU&H
products subject to a maximum limit of Rs.5.00 lakhs per product shall be provided to AYUSH units • Support for International Market Development and AYUSH promotion-related activities like exhibitions/ trade fairs, surveys & studies, data procurement and hiring of services of International consultants Up to Rs. 50.00 lakh • Sponsoring of AYUSH conferences / teaching and other collaborations with reputed institutions / universities in other countries through Indian Missions / Embassies. not exceeding Rs. 100 lakhs in one case. International conferences/road shows/trade forums organized by the Department / CII / FICCI / ITPO. Up to Rs. 50.00 Lakh • •
Support for fulfillment of international commitments for transfer and networking of AYUSH
technology/ regulatory information up to Rs. 25.00 Lakh. 4. Proper Regulation of Ayurvedic Drug Industry The Ayurvedic drug industry needs to .be properly regulated, with emphasis on Good Manufacturing Practices (GMP). Successful companies will be those who are with sophisticated sales and marketing skills and strong financial backing. Export of traditional products after value addition should be one of our top priorities. Strategy should be directed towards the rapid validation of traditional medicine. 5. Popularise Indian Medicines System The second phase would fashion the Indian medicine system and terminologies in the overseas markets and popularize them, considering the mindset of users. Earnest efforts have to be put in place to consolidate the past gains of traditional knowledge base and start developing entirely new herbal preparations based on India's biodiversity and make these products available to the international community CONCLUSION With its vast biodiversity, India would draw world attention as a source of eco-friendly medical systems that are in harmony with the nature. While India has the knowledge, skill and resources, it has neglected the opportunities in the global markets. It has however been languishing due to inadequate care and insufficient scientific approach to its promotion. There is need for understanding of regulatory requirements of different countries and for this Government help is needed. Global opportunities for Indian Herbals are on the rise. Generation of scientific information can help in increasing global opportunities Indian companies are investing more in research to en-cash on the global opportunities We have seen that India”s Export of Ayurvedic products is on rise. African countries are growing
market for herbal ayurevedic products. We can capture good share of market if Quality control, Good Manufacturing Practices, Good agriculture Practices,, Good Clinical Practices are followed.
THE AYURVEDIC MEDICINE INDUSTRY IN INDIA by Subhuti Dharmananda, Ph.D., Director, Institute for Traditional Medicine, Portland, Oregon
Ayurvedic medicines are produced by several thousand companies in India, but most of them are quite small, including numerous neighborhood pharmacies that compound ingredients to make their own remedies. It is estimated that the total value of products from the entire Ayurvedic production in India is on the order of one billion dollars (U.S.). The industry has been dominated by less than a dozen major companies for decades, joined recently by a few others that have followed their lead, so that there are today 30 companies doing a million dollars or more per year in business to meet the growing demand for Ayurvedic medicine. The products of these companies are included within the broad category of "fast moving consumer goods" (FMCG; which mainly involves foods, beverages, toiletries, cigarettes, etc.). Most of the larger Ayurvedic medicine suppliers provide materials other than Ayurvedic internal medicines, particularly in the areas of foods and toiletries (soap, toothpaste, shampoo, etc.), where there may be some overlap with Ayurveda, such as having traditional herbal ingredients in the composition of toiletries. The key suppliers in Ayurveda are Dabur, Baidyanath, and Zandu, which together have about 85% of India's domestic market. These and a handful of other companies are mentioned repeatedly by various writers about the Ayurvedic business in India; a brief description is provided for them, arranged here from oldest to newest: Dabur India Ltd. is India's largest Ayurvedic medicine supplier and the fourth largest producer of FMCG. It was established in 1884, and had grown to a business level in 2003 of about 650 million dollars per year, though only a fraction of that is involved with Ayurvedic medicine. Last year, about 15% of sales volume was pharmaceuticals, the remaining 85% were mostly non-medicine items such as foods and cosmetics. Dabur's Ayurvedic Specialities Division has over 260 medicines for treating a range of ailments and body conditions-from common cold to chronic paralysis. These materials constitute only 7% of Dabur's total revenue (thus, less than 50 million dollars). Dabur Chyawanprash (herbal honey) has a market share of 70% and chewable
Hajmola Digestive Tablets has an 88% share. Other major products are Dabur Amla Hair Oil, Vatika (Shampoo), and Lal Dant Manjan (Tooth Powder). Sri Baidyanath Ayurvedic Bhawan Ltd. (Baidyanath for short) was founded in 1917 in Calcutta, and specializes in Ayurvedic medicines, though it has recently expanded into the FMCG sector with cosmetic and hair care products; one of its international products is Shikakai (soap pod) Shampoo. Baidyanath has a sales volume of about 350 million dollars, but most of the product sales are in the cosmetic range. The company reports having over 700 Ayurvedic products, made at 10 manufacturing centers, with 1,600 employees. Included items are herbal teas, patent medicines, massage oils, and chyawanprash. Zandu Pharmaceutical Works was incorporated in Bombay in 1919, named after an 18 th-century Ayurvedic. The company focuses primarily on Ayurvedic products (in 1930, pharmaceuticals were added, but the pharmaceutical division was separated off about 30 years later). However, today Zandu has a chemicals division and cosmetics division. Its total sales volume is about 45 million dollars. One of its current projects is to develop a dopamine drug from a plant extract, applying for new drug status in the U.S. The Himalaya Drug Company was established in 1934 in Bangalore. It currently has a business level of about 500 million dollars and has a U.S. distribution division (Himalaya USA). It is known in the U.S. for the product Liv-52, marketed as a liver protector and therapy for liver diseases like viral hepatitis; the product was first marketed in India in 1955.
Charak Pharmaceuticals was founded in 1947, and currently has three distribution centers in India; it produces liquids, tablets, and veterinary supplies. It has gained a large advantage with its new product Evanova, a preparation containing 33 herbs and minerals and non-hormonal active ingredients used as a menopause treatment alternative to HRT. Soya is one of the main ingredients in this product. The product also contains Ayurvedic herbs that act like selective estrogen receptor modulators as well as asparagus root ( shatavari), which reduces the frequency and intensity of hot flashes. Vicco Laboratories was established in 1958. It mainly produces topical therapies based on Ayurveda and is best known internationally for its toothpaste product, Vajradanti, which has been marketed in the U.S. for more than 25 years. The Emami Group, founded in 1974, provides a diverse range of products, doing 110 million dollars of business annually, though only a portion is involved with Ayurvedic products, through its Himani line; the company is mainly involved with toiletries and cosmetics, but also provides Chyawanprash and other health products. Aimil Pharmaceuticals Ltd., incorporated in 1984 and engaged in manufacturing and sale of both generic and proprietary Ayurvedic medicines, with a business level of about 20 million dollars annually. Its wide range of Ayurvedic herbal formulations, covering most therapeutic segments, was honored by the Indian government's National Award for Quality Herbal Preparations and National Award for R & D in the year 2002. It is known for its proprietary formulas for hepatitis, diabetes, menstrual disorders,
digestive disorders, and urinary diseases. 2.2.2 THE JAPANESE MARKET Japan is one of the major consumer as well as one the largest importer of medicinal plants. In recent years (2005), Japan has imported to the tune of 79 million $ worth of MAP’s. About 80% of all natural medicinal materials distributed in Japan are used by
pharmaceuticals or extract manufacturers. The remaining 15-2 0% is sold in Tablet, Powder, Liquid or tincture from to end users by the Chinese style medicine compounds,Chinese style medicine practitioners, pharmacies and drug stores. The very fact that as compared to western medicines, the efficacy of natural medicines is slower but stable, caused demand for natural medicines rise sharply in the past. In recent year, however the market for natural medicines has been shrinking due to three reasonsa. Prescription for Chinese Natural Medicines are difficult to obtain. b. People are now aware that Chinese medicines can also have side effects. c. Government cuts on medical expenditures has shifted hospital demand to synthetic medicines that provide quick results leading to decline in natural medicines that require continuous use. The quality of the product plays an important role for the successful penetration into the Japanese Market. Japan Agricultural Standard (JAS) Law specifies the labeling of agricultural products and other related regulatory governed by the Ministry of Agricultural, Forestry and Fisheries of Japan (MAFF). In Japan there are three Laws pertaining to food safety and standards- The Food Safety Law, Food Sanitation Law , Japan Agricultural Standards law. The Food Safety Law sets the principles for developing a Food Safety regime and the role of food safety commission, a food related risk assessment body. The Food Sanitation law ensures the safety and sanitation of foods by the Ministry of Health, Labour and Welfare (MHLW), a food risk Management agency. The law prohibits the sale of food containing Poisonous or harmful substances. It also prescribes the standards for foods, additives, food apparatus, container, packages and certain toys. 2.2.2.1 Import Procedure Almost none of the natural medicines (including some species, extract, smoking agents, dye ingredients, gums and resins) can be produced domestically in their entirety. There are many items for which Japan relies completely on china. After sharp growth for many years, the market for Chinese natural medicines has begun to shrink, bringing down with it imports of natural medicines. The main partners of Japan for imports are china, USA and germany. Report on Export Potential of Medicinal Plants of Mahakaushal Region 23
2.2.2.3 Japans WTO commitments The average applied MFN (Most Favored Nation) tariff (MFN is the tariff level that a member of the GATT/WTO charges on a good to other members) for agriculture is 17.7%, compared with an overall average of 6.3%. 15.3% of duties applied to agricultural goods are non ad valorem. Some of the average tariffs for the subsectors may be underestimated, owning to the lack of estimates. Tariff quotas apply mainly to agricultural products; they cover some 1.6% of all tariff lines. The extent to which tariff quotas are filled varies by product for quota allocations sometimes require prior approval by the MAFF.
2.2.2.4 Labeling requirements Labeling required by the Ministry of Health, Labour and Welfare (MHLW) are as follows All food products must be in perfect condition from a food sanitation standpoint. The following information must appear on the product label in Japanese. The minimum size of type is approximately 8 points for all characters. It is recommended that the importer should double cheque the table to ensure conformity. The label should include the following information Name of the product. Country of origin. • •
Report on Export Potential of Medicinal Plants of Mahakaushal Region 24
Name of the importer. Ingredients, other than additives, in descending order of weight percentage . Food additives in descending order of weight on a separate line from other ingredients. The net weight in metric units only. A system of average net weight tolerances of packages or certain commodities are set by the MHLW. “Best before date” or “expiry of consumption” on products whose quality changes rapidly. Method of use, storage instructions, or preparation, when established by the MHLW for the product or when its absence could cause confusion. Labeling of biotechnology ingredients . Labeling Required by Ministry of Agriculture, Forestry and Fisheries (MAFF) Separate from labeling requirement under the MHLW food sanitation law MAFF requires manufactures to label their products in accordance with quality labeling standards established under the standardized quality labeling system of Japan Agricultural Standards (JAS) law. 2.2.2.5 Labeling requirements for frozen vegetables While selling frozen vegetable sealed in wrapping or containers, following items must be listed all together on the label under provisions of the Food Sanitation Law, the processed food product quality labeling standards and vegetable frozen food quality labeling standards under the JAS law and the measurement law. Labeling items to be listed are as under Product name List of ingredients and food additives, if any Producing area of raw material ( other than imports) Net contents Best before date Preservation method Cooking requirements, if any Pre- heat treatment indication (only for products requiring cooking) Country of origin Importer’s name and address • •
•
•
•
•
• •
•
Report on Export Potential of Medicinal Plants of Mahakaushal Region 25
2.2.2.6 Packaging and container regulations In accordance with the MHLW food sanitation law, no person shall sell, manufacture or import with the intent to sell or use in business, any apparatus or
container package which contains or bears toxic or injurious substances and may injure human health by having harmful influence on food and additives through contact. To prevent the use of harmful apparatuses, containers Packages, MHLW may establish standards for methods of manufacturing apparatuses containers/ Packages, MHLW has established specifications for synthetic resins, metal cans, and containers/ packages made of g lass, ceramic, enamel or rubber. In April 2000, Japan implemented a new package recycling law that requires paper and plastic packaging to be appropriately labeled and recycled. Private industry is being required to pay all costs associated with this recycling. For imported products, the cost will be born by importers. However, it is possible that Japanese importers will begin to take recycling costs into account while choosing the goods they import and some Japanese may ask their suppliers overseas to cooperate in supplying the additional labeling 2.2.2.7 Quality Regarding the quality of processed foods, the matters to be labeled collectively by manufacturers, processors/packers or importers (distributors if the distributors are in a position to make the quality labeling on behalf of manufacturers or processor/ pacers with the letters agreement to it. r eferred to as the manufacturer etc.) on the container or package of the processed food shall be as shown below. However this provision shall not apply to the case that any person manufactures or processes foods and sells them to the general consumers directly or provides the facilities to have them eat or drink these foods. The following points are therefore required to be highlighted on the label Name Name of ingredients Net contents Best before date ( Date of minimum durability) Instructions for storage Name or trade name and address of manufacturer etc. Report on Export Potential of Medicinal Plants of Mahakaushal Region 26
With regard to the products where liquid packing media are added to solid products and then the final products are sealed in cans or bottles (except those in which the drained weight is difficult to control), the drained weight and the total quantity of contents shall be labeled on the cans or the bottles by the manufacturer, etc. However this provision shall not apply to the case that the drained weight and the total quantity of contents are nearly the same or the purpose of adding liquid packing medium is to protect the contents. J apan has been importing Neem Oil & cake , Senna Leaves & Miscellaneous Herbal drugs from India.
