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INDIA Needs Assessment Study INDIA ___________________________________________________________________ SUPPORT TO SUSTAINABLE EXPORT DEVELOPMENT OF INDIAN NATURAL MEDICINAL PRODUCTS: A NEEDS ASSESSMENT STUDY August 2008 Prepared by Josef Brinckmann ITC Consultant Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study TABLE OF CONTENTS CHAPTER 1 – INTRODUCTION A. Background B. Products Coverage C. Objectives D. Methodology CHAPTER 2 – TRADE ENVIRONMENT A. Natural Medicinal Products Market and Demand: a. Botanical Raw Materials b. Extracts, Oils and Oleoresins c. Finished Natural Health Products B. Indian Standards C. Main Export Markets D. Market Access Barriers: a. Negative and Positive Lists of Substances b. Quality Standards & Limits in Destination Markets c. Legislative Marketing Authorization Requirements CHAPTER 3 – TRADE PATTERNS AND EXPORT POTENTIAL A. Export Channels B. Indian Export Promotion Structure C. Indian Export Strategy for Natural Medicinal Products D. Export Markets with Supportive Structure for Ayurvedic Products & Services: a. Ayurvedic & Naturopathic Physicians Licensure and Regulation b. Ayurvedic & Naturopathic Physicians Associations c. Schools of Indian Systems of Medicine d. Treatment Centres and Clinics of Indian Systems of Medicine e. Indian Medicinal Natural Products already in Market E. Prospects and constraints for development of Ayurveda, Siddha, and Unani CHAPTER 4 – ENTERPRISES’ NEEDS A. Findings from Enterprise Interviews of Mission in India B. Findings from the Enterprise Survey C. Findings from other Relevant Studies CHAPTER 5 – TRADE SUPPORT INSTITUTIONS NEEDS AND CAPACITIES A. Boards: a. National Medicinal Plants Board, Ministry of Health & Family Welfare ii Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study b. Spices Board of India, Ministry of Commerce & Industry B. Export Councils: a. Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council b. Export Inspection Council, Ministry of Commerce & Industry c. Pharmaceuticals Export Promotion Council d. Shellac and Forest Products Export Promotion Council C. Institutes: a. Central Institute of Medicinal and Aromatic Plants b. Institute of Economic and Market Research D. Ministries: a. Ministry of Agriculture, Department of Agriculture & Cooperation b. Ministry of Commerce & Industry, Department of Commerce c. Ministry of Health & Family Welfare, Department of AYUSH d. Ministry of Health & Family Welfare, Pharmacopoeial Laboratory for Indian Medicine e. Ministry of Micro, Small and Medium Enterprises E. Research Councils: a. Central Council for Research in Ayurveda & Siddha, Ministry of Health b. Central Council for Research in Unani, Ministry of Health c. Central Council for Research in Yoga & Naturopathy d. Council of Scientific & Industrial Research F. Trade Associations & Trade Organizations: a. Association of Manufacturers of Ayurvedic Medicines b. Ayurvedic Drug Manufacturers Association c. Central Herbal Agro Marketing Federation of India d. Federation of Indian Herbal Industry e. Health Foods and Dietary Supplements Association of India f. Herbs and Herbal Export Promotion Association of India g. India Trade Promotion Organisation h. Indian Drug Manufacturers Association i. Medicinal, Aromatic & Dye Plants Stakeholders‘ Consortium j. The Associated Chambers of Commerce and Industry of India G. Other Organizations or Consultancies Providing Support to Industry a. Apex Cluster Development Service Pvt. Ltd. b. Asian Medicinal Plants & Health Care Trust iii Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study c. Foundation for MSME Clusters d. Foundation for Revitalisation of Local Health Traditions e. Herbal Centre for Research, Planning & Action f. Rawal Medherb Consultants Pvt. Ltd. CHAPTER 6 – CURRENT RESPONSE AND ONGOING TECHNICAL ASSISTANCE A. Agricultural Marketing Information System: A Central Sector Scheme of Directorate of Marketing & Inspection, Department of Agriculture & Cooperation, Ministry of Agriculture B. Capacity Building to enhance Competitiveness of Indian Agriculture and Registration of Organic Products Abroad: Ministry of Agriculture, Department of Agriculture & Cooperation C. Central Scheme for Development of AYUSH Clusters, Department of AYUSH D. Centrally Assisted Schemes for Medicinal Plants: National Medicinal Plants Board (NMPB), Department of AYUSH, Ministry of Health & Family Welfare E. Centrally Sponsored Scheme of Quality Control of Ayurveda, Siddha, Unani and Homoeopathy drugs, Department of AYUSH: a. Scheme No. 4: Assistance to ASU Drug Manufacturing Units to Establish in In- house Quality Control Laboratory b. Scheme No. 5: Assistance to ASU Manufacturing Units having a Turnover of up to Rs 20.00 Crores for Acquiring US FDA/EU GMP Certification F. Export Development (X-Plan) Schemes: Spices Board of India (SBI), Ministry of Commerce & Industry G. Market Access Initiative (MAI) Scheme: Ministry of Commerce & Industry H. Marketing Development Assistance (MDA) Scheme, Ministry of Commerce & Industry I. Registration-cum-Membership Certificate (RCMC), Pharmaceuticals Export Promotion Council (PHARMEXCIL) J. Technology Development and Demonstration Programme (TDDP), Department of Scientific and Industrial Research (DSIR), Ministry of Science & Technology K. Vishesh Krishi Upaj Yojana Scheme: Shellac and Forest Products Export Promotion Council (SHEFEXIL) L. Other Indian Governmental Responses M. Technical Cooperation from other Governmental or International Organizations a. German Technical Cooperation (GTZ) in India b. International Trade Centre (ITC) / UNCTAD / WTO Export-Led Poverty Reduction Programme (EPRP) iv Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study c. International Trade Centre (ITC) / UNCTAD / TWO South-South Trade Promotion Programme d. United States Agency for International Development (USAID) in India CHAPTER 7 – PRIORITY OBJECTIVES CHAPTER 8 – ESTIMATED RESOURCE REQUIREMENTS CHAPTER 9 – FUTURE STEPS APPENDICES v Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study List of Tables Table 1: ITC HS Codes for Medicants of Indian Systems of Medicine Table 2: ITC HS Codes for Medicaments of Indian Systems of Medicine Table 3: Natural Raw Material Exports / HS 4-Digit Code Chapter / Apr-Mar 2005- 2007 / Value: Rs. Lacs / % Growth Table 4: Selected Botanical Exports: Herb Name / HS 8-Digit Code / Apr-Mar 2002- 2007 / Quantities: kilograms (kg) / % Growth Table 5: Selected Extracts and Oils Exports: Herb HS 4-Digit Code Chapter / Apr- Mar 2005-2007 / Value: Rs. Lacs / % Growth Table 6: Exports of Indian Finished Medicinal Natural Products / Value: Rs. Lacs / % Share of Total Indian Exports Table 7: Indian Natural Ingredients with AGMARK Standards Table 8: New Botanical Monographs Added to IP 2007 Table 9: Top 10 export destinations for Ayurvedic Products / Value: Rs. Lacs Table 10: Top 25 Countries of Export of Chemexcil‘s Items (Rs. in millions) Table 11: NHPD Guidance Documents on Quality Requirements Table 12: EMEA Guidance Documents on Quality Requirements Table 13: FDA Guidance and Regulations on Quality Requirements Table 14: Market Access: Comparison of basic pre-marketing submission requirements for herbal products in Australia, Canada, European Union, and United States of America Table 15: NHPD Product License Application Requirements Table 16: Market Access: Comparison of basic requirements in the USA for natural products that are foods, supplements, or drugs Table 17: Indian Export Promotion Organizations and Product Groups Table 18: Practitioner Associations Listed in Schedule 1 of Australian Therapeutic Goods Regulations Table 19: List of Practitioner Bodies Recognized by Government of Malaysia T/CM Division Table 20: Utilization of T/CM by the Malaysian population based on categories Table 21: Example Entry for ASU Ingredient Labeling Standards in Selected Foreign Markets vi Support to sustainable export promotion of Indian natural medicinal products: A needs assessment study Table 22: Range of Products of Respondents / Percentage (%) of Turnover Represented Table 23: Markets: % Domestic vs. Export by Destination Table 24: Products and Production Needs for Increasing Exports Table 25: Quality Control Laboratory: In-house or Independent Table 26: List of Tests Carried Out on Finished Products Table 27: Selected Top Products for Determination of Conservation Status in India and Legal Status in Foreign Markets Table 28: Top Medicinal Natural Ingredients Prioritized for Export Development Table 29: HS Codes used by Survey Respondents Table 30: Examples of Indian Products with Product Registrations in Foreign Markets Table 31: Levels of Evidence compiled in support of Safety, Efficacy and Quality of Products Table 32: Problems or Market Access Barriers hindering Export Sales Goals Table 33: Levels of Support from Trade Association Memberships Table 34: Other Market and Export Promotion Activities Respondents believe Government of India should focus on Table 35: Finance and Fiscal Conditions Respondents believe are Necessary to Improve the Capacity to Support Increased Exports Table 36: Finance and Fiscal Support Respondents Receive from Finance Institutions Table 37: Raw Materials Purchased on Spot Market or via Supply Agreements Table 38: % of Raw Materials Cultivated vs. % Wild Collected Table 39: Capacity of Raw Material Suppliers for Sustainable Scale-up
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