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Medical Device Industry in India the Evolving Landscape, Opportunities and Challenges

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Medical Device Industry in India the Evolving Landscape, Opportunities and Challenges Medical Device Industry in India The Evolving Landscape, Opportunities and Challenges September 2017 skpgroup.com AdvaMed (the Advanced Medical Technology SKP is a global professional services organization Association) is the world’s leading medical providing high-quality assurance, tax, advisory and technology trade association. Headquartered business process solutions. Our work is driven by a in the U.S., AdvaMed represents manufacturers culture of care and a feeling of responsibility towards of medical devices and diagnostics all over our client’s success. the world – from the largest to the smallest Working out of 10 cities across four countries, our companies – and has a global presence that multi-disciplinary teams serve clients from various includes India, China, Japan, Brazil and Europe. geographies and industries and have even supported AdvaMed advocates for the highest ethical various governments on cross-border investments. standards, timely patient access to safe and Our processes are rooted in a passion for providing effective products, and economic policies that workable and customized solutions and empower our reward value creation, to help achieve healthier people and clients to deliver and achieve more. lives and economies around the world. With over 70% of our client-base being international, For more information about AdvaMed, please we truly understand the needs of global companies visit our website at www.advamed.org. and the complexities that arise while doing business, and provide solutions that meet international standards. For more information about SKP Group, please visit our website at www.skpgroup.com. Foreword The Indian government’s 2017 National Health Policy deals A new national medical device policy in currently being with progressive universal healthcare for citizens, envisioning developed and the Indian government is actively engaged equitable health and well-being for all sections of society. The in discussions and consultations with various stakeholders. policy seeks to increase access and adoption, improve quality, Policymakers working collaboratively with stakeholders and lower healthcare delivery costs in the country. The in the healthcare eco-system are attempting to laydown a government has recognized the changing disease patterns roadmap that provides consistency and predictability. The in the country, the need to address the significant growing path to realizing healthcare goals is complex, and various burden of non-communicable diseases, and the emergence fundamental issues and challenges need to be addressed and of a robust and successful private healthcare industry. solved holistically. Long-term plans need periodic policy and The bulk of government spending will be directed towards regulatory interventions to ensure fair conduct within the reviving and strengthening primary healthcare systems, industry while providing the support needed for profitable focusing on rural and lower tier urban areas that lag behind and sustainable growth. These activities will enable the in quality and access. The government is likely to take on the medical device industry to accelerate rapidly and play a key role of a payer rather than a provider, resulting in improved role in making India healthier and stronger. outcomes and better utilization of healthcare expenditure in AdvaMed has partnered with SKP to publish this paper the country. entitled - Medical Device Industry in India - The evolving The global medical device industry is highly innovative landscape, opportunities and challenges. The paper also and technology driven, changing the face of healthcare examines various policies and regulations impacting the worldwide. Globally, it is a rapidly advancing industry industry and attempts to make recommendations on the impacting and improving aspects such as diagnosis, way forward from the perspective of different stakeholders. treatment, and delivery, but in India, it is still very nascent Extensive research, both primary and secondary with with low levels of penetration and adoption. This presents deliberations and discussions with several stakeholders an exciting opportunity to develop this industry and to play a across the healthcare chain have served as inputs for this larger role in the transformation of Indian healthcare. A good paper. understanding of the nature of this industry will help ensure AdvaMed and SKP would like to thank everyone for their that the country is poised to capitalize on opportunities insights and valuable contributions towards this paper. provided by medical technology to improve national healthcare. We hope that this paves the way for further deliberations and helps in shaping the industry in a positive manner. Guljit Singh Abby Pratt Executive Chairman Vice President - Global Strategy and Analysis SKP Business Consulting AdvaMed Table of Contents 01 03 An overview of Make and Heal 05 07 Medical Device in India Market 2020 Case Studies Industry p15 p35 p43 p01 Executive 02 04 06 Summary Regulatory and Price Control Survey Business Policy – Impact Findings Environment and Implications p39 p09 p23 Abbreviations AIIMS All India Institute of Medical Sciences JV Joint Venture AIMED Association of Indian Medical Device Industry MDC Medical Disposables and Consumables AP Andhra Pradesh MEA Ministry of External Affairs AYUSH Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy MDP Medical Device Park BMS Bare Metal Stents MII Make in India BRICS Brazil, Russia, India, China and South Africa MSDE Ministry for Skill Development & Entrepreneurship CAD Coronary Artery Disease MNC Multinational Company CAGR Compounded Annual Growth Rate MoHFW Ministry of Health and Family Welfare CBU Central Buying Unit MRI Magnetic Resonance Imaging CDSCO Central Drugs Standard Control Organization MRP Maximum Retail Price CE Conformité Européene MTAB Medical Technology Assessment Board CLAA Central or State License Approval Authority NABCB National Accreditation Board for Certification Bodies CPAP Continuous Positive Airway Pressure NABH National Accreditation Board for Hospitals & Healthcare Providers CRS Chronic Rhinosinusitis NCR National Capital Region (Delhi area) CT Computed Tomography NHP National Health Policy CVD Cardiovascular Disease NMDP National Medical Devices Policy DCA Drugs and Cosmetics Act 1940 NCD Non-Communicable Disease DES Drug Eluting Stents NCMD National Centre for Medical Devices DCGI Drug Controller General of India NIC National Intervention Council DoC Department of Commerce NICU Neonatal Intensive Care Unit DoP Department of Pharmaceuticals NITI National Institution for Transforming India DRG Diagnosis Related Groups NLEM National List of Essential Medicines ECB External Commercial Borrowing NMD New Medical Device eHC eHealth Center NPPA National Pharmaceutical Pricing Authority EKG Electrocardiogram PCI Percutaneous Coronary Intervention EOU Export Oriented Unit PE Permanent Establishment EU European Union PED Product Engineering & Development FDI Foreign Direct Investment PPP Public Private Partnership GDP Gross Domestic Product PTD Price to Distributor GHTF Global Harmonization Task Force PTH Price to Hospital GMP Good Manufacturing Practices QCI Quality Council of India HSIDC Haryana State and Industrial Development Corporation R&D Research and Development HSSC Healthcare Sector Skill Council RDS Respiratory Distress Syndrome HTA Healthcare Technology Assessment SHI Statutory Health Insurance ICMED Indian Certification of Medical Devices SEZ Special Economic Zone IMF International Monetary Fund TRIPS Trade Related Aspects of Intellectual Property IOA Indian Orthopedic Association USD United States Dollar INR Indian Rupee US FDA US Food and Drug Administration IPR Intellectual Property Rights VAP Ventilator Associated Pneumonia IT Informational Technology WHO World Health Organization JCI Joint Commission International WTO World Trade Organization Executive Summary The healthcare industry in India in this sector. Government initiatives control regulation and the new Public has made rapid progress in the last around opening up FDI and Procurement Policy with preferential decade, but significantly lags behind infrastructure development are Market Access do not fully reflect other nations in availability and quality welcome initiatives that will enhance this and has alarmed many industry of equitable medical care and services the ecosystem for investment. The participants. A clear long term vision for citizens. This in turn presents Indian medical device industry and roadmap for the industry and an enormous opportunity given the appreciates government’s efforts to predictability of policy would excite large population, growing economic remove bureaucratic hurdles and the industry. The government needs prosperity, and the disease burden. improve the ease of doing business, to provide policy support for both Major issues such as availability of but believes that additional steps can the supply and demand side of the adequate infrastructure, trained be taken to strengthen its approach. medical device industry to successfully human resources, geographic spread, accelerate growth. Industry and Our discussions with the industry rapidly changing disease burden, and government need to work together leaders indicate that given the high/often catastrophic out of pocket to improve awareness, access, lack of scale in many products, the expenditures are challenges that the adoption, and affordability for medical government should prioritize certain government is
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