India s Med Tech Market Commercial & Regulatory Landscape Opportunities and Challenges MassMedic Richard Paddock Director, Med Tech Intl Trade Administration 9 March 2012
Contents Applicable Background on India s Economy Medical Technology Products Market Regulatory Framework Evolving Policy and Regulatory Landscape Bilateral National Government Dialogues 2
International Trade Administration Assist American firms facing foreign trade barriers Monitor other countries compliance with trade agreements (WTO and FTAs) Manufacturing and Services Division (MAS) engages with foreign governments to address industry-specific issues, conducts research and analysis. ITA s Office of Health and Consumer Goods 3
India - Commercial Environment Economic/Political Landscape in Brief Healthcare Products Market Profile Healthcare expenditure at 4.8 % of the GDP Government spend is 0.9 % (2010) 0.9 beds per 1000 people (global average is 3.3) Shortfall of 1.4 million doctor; 2.8 million nurses Governments and the private sector trying to address accessibility & affordability of healthcare Healthcare national and state issues 4
Market Size and Healthcare Expenditures Country Medical Device Market Total ($M) 2009 Medical Device Imports ($000) 2009 Medical Device Import Growth % 2009 Health Expenditures ($B) 2009 Health Exp Per Capital ($US) 2009 Health Exp as % GDP 2009 (World Av 10.4) Japan 21,712.80 9,532,153 16.4 332.4 2,616 6.5 China 6,694.60 4,982,492 22.6 230.7 173 4.7 Australia 3,369.60 3,144,417 17.1 86.9 4,087 8.7 S Korea 3,034.90 2,126,345 2.3 55.7 1,128 6.8 India 1,986.20 1,545,296 19.1 56.3 48 4.4 5
India s Evolving Regulatory Landscape for Medical Technology Products The Government of India is in the process of developing a regulatory regime for medical products Background - Legislation Actions and Prospects for Central Authority Current regulation of medical products D&C Act of 1940 and D&C Rules of 1945. In 2005, ten categories of products were notified for registration requirement and licensing - cardiac stents, drug eluting stents, catheters, intra ocular lenses, I. V. cannulae, bone cements, heart valves, scalp vein set, orthopedic implants, and internal prosthetic replacement Import license 6
Regulatory Framework Central and State Governments Ministry of Health and Family Welfare Provides technical advise on medical and public health Implements various health schemes and services Central Drugs Standard Control Organization Registration and/or import of drugs, devices, vaccine diagnostic products, blood products and other products Department of Biotechnology Develops policy, also promotes and funds research activities Engages in capacity building activities Department of Pharmaceuticals Pharmaceutical policy - including education and research Manufacturing of drugs by government companies 7
Regulatory Framework Central and State Governments National Pharmaceutical Pricing Authority Atomic Energy Regulatory Board Other Ministries Finance, Commerce, and Environment State Governments Manufacturing licensing for pharmaceuticals and devices Inspection of facilities and enforcement Promotion of biotech/medical parks and provides incentives 8
Responsibilities of Regulatory Bodies Central Government Laying down standards of drugs, cosmetics, diagnostics, and devices Market authorization of new drugs. Regulation of clinical research Grants import license Testing of drugs by Central Drugs Labs Guidance on technical matters Monitoring adverse drug reactions State Government Licensing and Enforcement Monitoring of manufacturing and sales establishments Warehousing Wholesale Distribution Retail sale Licensing of drug testing laboratories Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state 9
Proposed Central Drug Administration CDA Pharmacovigilance Imports Regulatory Affairs and Enforcement Organizational Services New Drugs & Clinical Trials Biological & Biotechnology Products Training and Empowerment Quality Control Affairs Medical Devices and Diagnostics Legal and Consumers Affairs 10
Challenges for Med Tech Companies in India s Med Tech Market Overview Absence of single nondiscriminatory, comprehensive and efficient regulatory system. Guidance documents still relate to drugs and not devices Pricing policies - information requirements Labeling and Barcoding New requirements for clinical trials/evaluation New adverse event reporting structure is as per drugs Implementation of AERB guidelines for imaging equipment 11
Bilateral Dialogues U.S.- India Health Initiative (HHS and MHFW) The High Technology Cooperation Group s - Life Sciences and Biotechnology Working Group provides a framework for discussing issues of mutual concern facilitate and promote high-technology trade Commercial Dialogue Public-private - facilitate trade across a broad range of economic sectors Trade Forum Policy Led by USTR, with Commerce participation Promotes policies to increase market access and enhances opportunities for trade and investments 12
Thank you! Contact Information Richard Paddock Director, Med Tech International Trade Administration (202) 482-3360 Richard.Paddock@trade.gov Ms. Ruma Chatterjee Senior Commercial Specialist Market Access and Compliance office New Delhi Phone: 91-11-2347-2226 Ruma.Chateterjee@trade.gov 13