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CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India

GlobalData, the industry analysis specialist, has released its new report, "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape - India". The report is an essential source of information and analysis on India's healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets. The report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData's team of industry experts.

India is the second most populated country in the world with a population of approximately 1.22 billion in 2012, although the growth rate of the population is declining due to a decrease in the birth rate and an increase in net emigration. Unlike China and Japan, the working-age population accounts for the majority of the overall population. In order to derive maximum benefit, the government is currently working to develop human capital by increasing its spending on health and education. The country's pharmaceutical market was estimated at $18.4 billion in 2012 and is expected to reach approximately $56 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 15%, primarily attributed to -

  • Increasing coverage of healthcare insurance
  • Improving access to healthcare facilities
  • Government initiatives for the prevention and management of communicable diseases

Scope

The report provides information on India's healthcare, regulatory and reimbursement landscape, and includes -

  • Overview of the pharmaceutical and medical devices markets, comprising market size, segmentation and key drivers and barriers
  • Profiles and SWOT analysis of the major players in the pharmaceutical and medical devices market. The major players covered for the pharmaceutical market are Cipla, Sun Pharmaceuticals, Lupin, Ranbaxy Laboratories and Dr. Reddy's Laboratories. The major players covered for the medical devices market are Siemens Healthcare, GE Healthcare, Essilor International, Johnson & Johnson Vision Care and F. Hoffmann-La Roche.
  • Insightful review of the reimbursement and regulatory landscape, including details of the healthcare reimbursement process, regulatory agencies and approval processes for new drugs
  • Detailed analysis of the political and economic environment, including economic indicators, demographics, and healthcare infrastructure and expenditure
  • Overview of the opportunities for and challenges to growth in the healthcare market.

Reasons to buy

This report will enhance your decision-making capability by allowing you to -

  • Develop business strategies by understanding the trends shaping and driving India's healthcare market.
  • Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the Indian healthcare market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership
  • Identify, understand and capitalize on the opportunities and challenges in India's healthcare market.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Report Guidance

3. Overview of the Pharmaceutical and Medical Device Markets

  • 3.1. Pharmaceutical Market
    • 3.1.1. Market Overview
    • 3.1.2. Pharmaceutical Imports and Exports
    • 3.1.3. Supply Channels
    • 3.1.4. Market Segments
    • 3.1.5. Major Therapeutic Areas
    • 3.1.6. Major Players
  • 3.2. Medical Device Market
    • 3.2.1. Market Overview
    • 3.2.2. Overview of Top Five Segments
    • 3.2.3. Diagnostics Market
    • 3.2.4. Major Players
  • 3.3. Market Drivers and Barriers
    • 3.3.1. Drivers
    • 3.3.2. Barriers

4. Market Access

  • 4.1. Reimbursement and Payer Landscape
    • 4.1.1. Overview of Healthcare System
    • 4.1.2. Reimbursement Process
    • 4.1.3. Overview of Insurance Providers
    • 4.1.4. Patient Share of Healthcare Spending
    • 4.1.5. Drug Price Trends
    • 4.1.6. Pricing Policies
  • 4.2. Regulatory Landscape
    • 4.2.1. Overview of Regulatory Agencies
    • 4.2.2. New Drug Approval Procedure for Pharmaceutical Products
    • 4.2.3. New Medical Device Approval Process
    • 4.2.4. Licensing Process for Pharmaceutical and Medical Device Manufacturing
    • 4.2.5. Licensing Process for Pharmaceutical Exports and Imports
    • 4.2.6. Intellectual Property Rights
    • 4.2.7. Clinical Trial Regulations
    • 4.2.8. Pharmaceutical Advertising Regulations
    • 4.2.9. Pharmacy Regulations
    • 4.2.10. Labeling and Packaging Regulations

5. Country Analysis

  • 5.1. Political Environment
    • 5.1.1. Political Structure
    • 5.1.2. Analysis of the Current Political Environment
    • 5.1.3. Healthcare Policy Initiatives
  • 5.2. Economic Landscape
  • 5.3. Economic Indicators
    • 5.3.1. Gross Domestic Product
    • 5.3.2. Gross National Income
    • 5.3.3. Inflation
    • 5.3.4. Currency Exchange Rate
    • 5.3.5. Foreign Direct Investment
    • 5.3.6. Foreign Exchange Reserves
    • 5.3.7. Trade Balance
    • 5.3.8. Gross Fiscal Deficit
    • 5.3.9. External Gross Debt
    • 5.3.10. Major Industries
  • 5.4. Demographics
    • 5.4.1. Population
    • 5.4.2. Education and Literacy
    • 5.4.3. Employment
    • 5.4.4. Disease Burden
  • 5.5. Healthcare Infrastructure
    • 5.5.1. Healthcare Facilities
    • 5.5.2. Healthcare Parameters
    • 5.5.3. Environmental Health
    • 5.5.4. Healthcare Personnel
  • 5.6. Healthcare Expenditure
    • 5.6.1. Components of Healthcare Spending
    • 5.6.2. Share of Public and Private Sectors
    • 5.6.3. Spending in Pharmaceutical R&D
  • 5.7. Trade Associations
    • 5.7.1. Indian Pharmaceutical Association
    • 5.7.2. Indian Drug Manufacturer's Association
    • 5.7.3. Organization of Pharmaceutical Producers of India
    • 5.7.4. Indian Pharmacy Graduates Association
  • 5.8. Trade Fairs

6. Opportunities and Challenges

  • 6.1. Opportunities
  • 6.2. Challenges

7. Appendix

  • 7.1. Abbreviations
  • 7.2. Bibliography
  • 7.3. Methodology
    • 7.3.1. Coverage
    • 7.3.2. Secondary Research
    • 7.3.3. Forecasting
    • 7.3.4. Expert Panel Validation
  • 7.4. Disclaimer

List of Tables

  • Table 1: Pharmaceutical Market, India, Revenue ($bn), 2007-2012
  • Table 2: Pharmaceutical Market, India, Revenue ($bn), Forecast, 2013-2020
  • Table 3: Pharmaceutical Market, India, Imports and Exports ($bn), 2007-2012
  • Table 4: Pharmaceutical Market, India, Price Margins of Distribution Channel (%), 2007
  • Table 5: Pharmaceutical Market, Global, Drugs Going Off-patent, Revenue ($m), 2011-2015
  • Table 6: Pharmaceutical Market, India, Biologics Market, Revenue ($bn), 2007-2012
  • Table 7: Pharmaceutical Market, India, Major Therapeutic Areas, Turnover ($m), 2010
  • Table 8: Cipla, Global, Major Products, 2013
  • Table 9: Sun Pharma, Global, Major Product Segments, Revenues ($m), 2011
  • Table 10: Lupin, India, Major Products, 2013
  • Table 11: Dr. Reddy's Laboratories, India, Major Products, 2012
  • Table 12: Medical Device Market, India, Revenue ($bn), 2007-2012
  • Table 13: Medical Device Market, India, Revenue ($bn), Forecast, 2013-2020
  • Table 14: Medical Device Market, India, Revenue by Segments ($m), 2012
  • Table 15: Medical Device Market, India, Ophthalmic Devices Market, Revenue ($bn), 2007-2012
  • Table 16: Medical Device Market, India, Ophthalmic Devices, Sales Trend for Major Players ($m), 2011
  • Table 17: Medical Device Market, India, In Vitro Diagnostics Market, Revenue ($m), 2007-2012
  • Table 18: Medical Device Market, India, In Vitro Diagnostic Devices, Sales Trend for Major Players ($m), 2011
  • Table 19: Medical Device Market, India, Hospital Supplies Market, Revenue ($m), 2007-2012
  • Table 20: Medical Device Market, India, Hospital Supplies, Sales Trend for Major Players ($m), 2011
  • Table 21: Medical Device Market, India, Cardiovascular Devices, Revenue ($m), 2007-2012
  • Table 22: Medical Device Market, India, Cardiovascular Devices, Sales Trend for Major Players ($m), 2011
  • Table 23: Medical Device Market, India, Diagnostic Imaging Devices, Revenue ($m), 2007-2012
  • Table 24: Medical Device Market, India, Diagnostic Imaging Devices, Sales Trend for Major Players ($m), 2011
  • Table 25: Medical Device Market, India, Diagnostics Market, Revenue ($bn), 2007-2012
  • Table 26: Medical Device Market, India, Diagnostics Market, Revenue ($bn), Forecast, 2013-2020
  • Table 27: Medical Device Market, India, Major Medical Device Companies, Revenue ($m), 2011
  • Table 28: Siemens, Global, Major Products, Revenue ($m), 2012
  • Table 29: Essilor International, Global, Major Segments, Revenue ($m), 2011
  • Table 30: Johnson & Johnson Vision Care, Global, Major Products, 2012
  • Table 31: Roche, Global, Major Products, Revenues ($m), 2012
  • Table 32: Healthcare System, India, Surgical Procedure Cost ($'000), 2011
  • Table 33: Healthcare System, India, Major Public Insurance Schemes, 2012
  • Table 34: Healthcare System, India, Insured Population, Share (million), 2012
  • Table 35: Healthcare System, India, Health Insurers, Accounts ($m), 2012
  • Table 36: Healthcare Spending, India, Patient`s Share (%), 2007-2012
  • Table 37: Drug Price Change (%), India, 2007-2012
  • Table 38: Healthcare System, India, New Drug Application, Specific Requirements, 2013
  • Table 39: Healthcare System, India, Clinical Trial Approval, Specific Requirements, 2013
  • Table 40: Economic Landscape, India, Major Sectors, GDP Growth (%), 2012-2013
  • Table 41: Economic Indicators, India, GDP Per Capita ($), 2007-2012
  • Table 42: Economic Indicators, India, GDP Per Capita ($), Forecast, 2013-2020
  • Table 43: Economic Indicators, India, GDP, Annual Growth (%), 2007-2012
  • Table 44: Economic Indicators, India, GDP, Annual Growth (%), Forecast, 2013-2020
  • Table 45: Economic Indicators, India, GNI Per Capita ($), 2007-2012
  • Table 46: Economic Indicators, India, Average Consumer Price Index, 2007-2012
  • Table 47: Economic Indicators, India, Average Consumer Price Index, Forecast, 2013-2020
  • Table 48: Economic Indicators, India, Average Consumer Price, Annual Change (%), 2007-2012
  • Table 49: Economic Indicators, India, Average Consumer Price, Annual Change (%), Forecast, 2013-2020
  • Table 50: Economic Indicators, India, Currency Exchange Rate (INR/$), 2007-2012
  • Table 51: Economic Indicators, India, Foreign Direct Investment ($bn), 2007-2012
  • Table 52: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2007-2012
  • Table 53: Economic Indicators, India, Imports of Goods and Services ($bn), 2007-2012
  • Table 54: Economic Indicators, India, Exports of Goods and Services ($bn), 2007-2012
  • Table 55: Economic Indicators, India, Gross Fiscal Deficit (% of GDP), 2007-2012
  • Table 56: Economic Indicators, India, External Government Gross Debt ($bn), 2007-2012
  • Table 57: Economic Indicators, India, Major Industries, GDP ($bn), 2012
  • Table 58: Demographics, India, Population (million), 2007-2012
  • Table 59: Demographics, India, Population (million), Forecast, 2013-2020
  • Table 60: Demographics, India, Urban and Rural Population, Share (%), 2007-2012
  • Table 61: Demographics, India, Age Groups, Population Distribution (%), 2007-2012
  • Table 62: Demographics, India, Age Groups, Population Distribution (%), Forecast, 2013-2020
  • Table 63: Demographics, India, Births (Per 1,000 Population), 2007-2012
  • Table 64: Demographics, India, Mortality (Per 1,000 Population), 2007-2012
  • Table 65: Demographics, India, Major Causes of Mortality ('000), 2008
  • Table 66: Demographics, India, Children <5 Years, Mortality Rate (Per 1,000 Live Births), 2007-2012
  • Table 67: Demographics, India, Immunization Rate (%), 2007-2012
  • Table 68: Demographics, India, Major Causes of Male Mortality ('000), 2008
  • Table 69: Demographics, India, Major Causes of Female Mortality ('000), 2008
  • Table 70: Demographics, India, Gender Ratio (Females Per 1,000 Males), 2007-2012
  • Table 71: Demographics, India, Life Expectancy at Birth (Years), 2007-2012
  • Table 72: Demographics, India, Literacy Rate (%), 2007-2012
  • Table 73: Demographics, India, Levels of Education, Students Enrollment (million), 2011
  • Table 74: Demographics, India, Unemployment Rate (%), 2007-2012
  • Table 75: Demographics, India, Major Communicable Diseases, Prevalence (million), 2011
  • Table 76: Demographics, India, Major Causes of Illness, DALY (Per 100,000 Population), 2009
  • Table 77: Healthcare Infrastructure, India, Public Hospitals, 2007-2012
  • Table 78: Healthcare Infrastructure, India, Major Private Hospitals, 2012
  • Table 79: Healthcare Infrastructure, India, Upcoming Health Cities, 2012
  • Table 80: Healthcare Infrastructure, India, Health Centers ('000), 2007-2012
  • Table 81: Healthcare Infrastructure, India, Hospitals by Bed Size, Share (%), 2010
  • Table 82: Healthcare Infrastructure, India, Urban-Rural Public Hospital Beds ('000), 2007-2012
  • Table 83: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008
  • Table 84: Healthcare Infrastructure, India, Hospital Beds (Per 1,000 Population), 2007-2012
  • Table 85: Healthcare Infrastructure, India, Physicians (Per 1,000 Population), 2007-2012
  • Table 86: Environmental Health, India, CO2 Emissions (Million Tons), 2007-2012
  • Table 87: Environmental Health, India, PM-10 Emissions (µg/cubic meter), 2007-2012
  • Table 88: Environmental Health, India, Waste Generation Per Capita (kg), 2007-2012
  • Table 89: Healthcare Personnel, India, Nurses (Per 1,000 Population), 2007-2012
  • Table 90: Healthcare Personnel, India, Pharmacists (Per 1,000 Population), 2007-2012
  • Table 91: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2007-2012
  • Table 92: Healthcare Expenditure, India, Healthcare Expenditure of Ministry of Health and Family Welfare, Share of Departments (%), 2011
  • Table 93: Healthcare Expenditure, India, Public-Private Share (%), 2007-2012
  • Table 94: Healthcare Expenditure, India, R&D Expenditure ($m), 2007-2012
  • Table 95: Major Healthcare Trade Fairs, India, 2013-2014

List of Figures

  • Figure 1: Pharmaceutical Market, India, Revenue ($bn), 2007-2012
  • Figure 2: Pharmaceutical Market, India, Revenue ($bn), Forecast, 2013-2020
  • Figure 3: Pharmaceutical Market, India, Imports and Exports ($bn), 2007-2012
  • Figure 4: Pharmaceutical Market, India, Distribution Channel, 2013
  • Figure 5: Pharmaceutical Market, India, Drug Procurement System in Government Hospitals and Institutions, 2013
  • Figure 6: Pharmaceutical Market, India, Biologics Market, Revenue ($bn), 2007-2012
  • Figure 7: Pharmaceutical Market, India, Major Therapeutic Areas, Turnover ($m), 2010
  • Figure 8: Medical Device Market, India, Revenue ($bn), 2007-2012
  • Figure 9: Medical Device Market, India, Revenue ($bn), Forecast, 2013-2020
  • Figure 10: Medical Device Market, India, Revenue by Segments ($m), 2012
  • Figure 11: Medical Device Market, India, Ophthalmic Devices Market, Revenue ($bn), 2007-2012
  • Figure 12: Medical Device Market, India, Ophthalmic Devices, Sales Trend for Major Players ($m), 2007-2011
  • Figure 13: Medical Device Market, India, In Vitro Diagnostics Market, Revenue ($m), 2007-2012
  • Figure 14: Medical Device Market, India, In Vitro Diagnostic Devices, Sales Trend for Major Players ($m), 2007-2011
  • Figure 15: Medical Device Market, India, Hospital Supplies Market, Revenue ($m), 2007-2012
  • Figure 16: Medical Device Market, India, Hospital Supplies, Sales Trend for Major Players ($m), 2007-2011
  • Figure 17: Medical Device Market, India, Cardiovascular Devices, Revenue ($m), 2007-2012
  • Figure 18: Medical Device Market, India, Cardiovascular Devices, Sales Trend for Major Players ($m), 2007-2011
  • Figure 19: Medical Device Market, India, Diagnostic Imaging Devices, Revenue ($m), 2007-2012
  • Figure 20: Medical Device Market, India, Diagnostic Imaging Devices, Sales Trend for Major Players ($m), 2007-2011
  • Figure 21: Medical Device Market, India, Diagnostics Market, Revenue ($bn), 2007-2012
  • Figure 22: Medical Device Market, India, Diagnostics Market, Revenue ($bn), Forecast, 2013-2020
  • Figure 23: Medical Device Market, India, Major Medical Device Companies, Revenue ($m), 2011
  • Figure 24: Healthcare Market, India, Drivers and Barriers, 2013
  • Figure 25: Healthcare System, India, Milestones of the Insurance Regulatory System, 1938-2009
  • Figure 26: Healthcare System, India, Surgical Procedure Cost ($'000), 2011
  • Figure 27: Healthcare System, India, Local Purchase System, Private Hospitals, 2013
  • Figure 28: Healthcare System, India, Centralized Purchase System, Private Hospitals, 2013
  • Figure 29: Healthcare System, India, Tender Purchase System, Private Hospitals, 2013
  • Figure 30: Healthcare System, India, Local and Centralized Purchase System, Private Hospitals, 2013
  • Figure 31: Healthcare System, India, Purchase Channels, Private Hospitals, 2013
  • Figure 32: Healthcare System, India, Addition to a Hospital Drug Formulary, 2013
  • Figure 33: Healthcare Spending, India, Patient`s Share (%), 2007-2012
  • Figure 34: Drug Price Change (%), India, 2007-2012
  • Figure 35: Healthcare System, India, Structure of the Central Drugs Standard Control Organization, 2013
  • Figure 36: Healthcare System, India, New Drug Application Process, 2013
  • Figure 37: Healthcare System, India, Licensing Process for Manufacturing, 2013
  • Figure 38: Healthcare System, India, Organizational Structure of the Controller General of Patents, Designs and Trade Marks, 2013
  • Figure 39: Healthcare System, India, Patent Approval Process, 2013
  • Figure 40: Healthcare System, India, Trademark Registration Process, 2013
  • Figure 41: Healthcare System, India, Clinical Trial Approval Process, 2013
  • Figure 42: Economic Indicators, India, GDP Per Capita ($), 2007-2012
  • Figure 43: Economic Indicators, India, GDP Per Capita ($), Forecast, 2013-2020
  • Figure 44: Economic Indicators, India, GDP, Annual Growth (%), 2007-2012
  • Figure 45: Economic Indicators, India, GDP, Annual Growth (%), Forecast, 2013-2020
  • Figure 46: Economic Indicators, India, GNI Per Capita ($), 2007-2012
  • Figure 47: Economic Indicators, India, Average Consumer Price Index, 2007-2012
  • Figure 48: Economic Indicators, India, Average Consumer Price Index, Forecast, 2013-2020
  • Figure 49: Economic Indicators, India, Average Consumer Price, Annual Change (%), 2007-2012
  • Figure 50: Economic Indicators, India, Average Consumer Price, Annual Change (%), Forecast, 2013-2020
  • Figure 51: Economic Indicators, India, Currency Exchange Rate (INR/$), 2007-2012
  • Figure 52: Economic Indicators, India, Foreign Direct Investment ($bn), 2007-2012
  • Figure 53: Economic Indicators, India, Foreign Exchange Reserves ($bn), 2007-2012
  • Figure 54: Economic Indicators, India, Imports of Goods and Services ($bn), 2007-2012
  • Figure 55: Economic Indicators, India, Exports of Goods and Services ($bn), 2007-2012
  • Figure 56: Economic Indicators, India, Gross Fiscal Deficit (% of GDP), 2007-2012
  • Figure 57: Economic Indicators, India, External Government Gross Debt ($bn), 2007-2012
  • Figure 58: Economic Indicators, India, Major Industries, GDP ($bn), 2012
  • Figure 59: Demographics, India, Population (million), 2007-2012
  • Figure 60: Demographics, India, Population (million), Forecast, 2013-2020
  • Figure 61: Demographics, India, Urban and Rural Population, Share (%), 2007-2012
  • Figure 62: Demographics, India, Age Groups, Population Distribution (%), 2007-2012
  • Figure 63: Demographics, India, Age Groups, Population Distribution (%), Forecast, 2013-2020
  • Figure 64: Demographics, India, Births (Per 1,000 Population), 2007-2012
  • Figure 65: Demographics, India, Mortality (Per 1,000 Population), 2007-2012
  • Figure 66: Demographics, India, Major Causes of Mortality ('000), 2008
  • Figure 67: Demographics, India, Children <5 Years, Mortality Rate (Per 1,000 Live Births), 2007-2012
  • Figure 68: Demographics, India, Immunization Rate (%), 2007-2012
  • Figure 69: Demographics, India, Major Causes of Male Mortality ('000), 2008
  • Figure 70: Demographics, India, Major Causes of Female Mortality ('000), 2008
  • Figure 71: Demographics, India, Gender Ratio (Females Per 1,000 Males), 2007-2012
  • Figure 72: Demographics, India, Life Expectancy at Birth (Years), 2007-2012
  • Figure 73: Demographics, India, Literacy Rate (%), 2007-2012
  • Figure 74: Demographics, India, Levels of Education, Students Enrollment (million), 2011
  • Figure 75: Demographics, India, Unemployment Rate (%), 2007-2012
  • Figure 76: Demographics, India, Major Communicable Diseases, Prevalence (million), 2011
  • Figure 77: Demographics, India, Major Causes of Illness, DALY (Per 100,000 Population), 2009
  • Figure 78: Healthcare Infrastructure, India, Public Hospitals, 2007-2012
  • Figure 79: Healthcare Infrastructure, India, Health Centers ('000), 2007-2012
  • Figure 80: Healthcare Infrastructure, India, Hospitals by Bed Size, Share (%), 2010
  • Figure 81: Healthcare Infrastructure, India, Urban-Rural Public Hospital Beds ('000), 2007-2012
  • Figure 82: Healthcare Infrastructure, Diagnostic Units (Per 100,000 Population), 2008
  • Figure 83: Healthcare Infrastructure, India, Hospital Beds (Per 1,000 Population), 2007-2012
  • Figure 84: Healthcare Infrastructure, India, Physicians (Per 1,000 Population), 2007-2012
  • Figure 85: Environmental Health, India, CO2 Emissions (Million Tons), 2007-2012
  • Figure 86: Environmental Health, India, PM-10 Emissions (µg/cubic meter), 2007-2012
  • Figure 87: Environmental Health, India, Waste Generation Per Capita (kg), 2007-2012
  • Figure 88: Healthcare Personnel, India, Nurses (Per 1,000 Population), 2007-2012
  • Figure 89: Healthcare Personnel, India, Pharmacists (Per 1,000 Population), 2007-2012
  • Figure 90: Healthcare Expenditure, India, Healthcare Expenditure (% of GDP), 2007-2012
  • Figure 91: Healthcare Expenditure, India, Healthcare Expenditure of Ministry of Health and Family Welfare, Share of Departments (%), 2011
  • Figure 92: Healthcare Expenditure, India, Public-Private Share (%), 2007-2012
  • Figure 93: Healthcare Expenditure, India, R&D Expenditure ($m), 2007-2012
  • Figure 94: Healthcare Market, India, Opportunities and Challenges, 2013
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