india’s med tech market - s med tech market commercial & regulatory landscape...
TRANSCRIPT
India’s Med Tech Market Commercial & Regulatory Landscape
Opportunities and Challenges
MassMedic
Richard Paddock
Director, Med Tech
Intl Trade Administration
9 March 2012
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Contents
Applicable Background on India’s Economy
Medical Technology Products Market Regulatory Framework Evolving Policy and Regulatory Landscape Bilateral National Government Dialogues
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
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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
Market Size and Healthcare Expenditures
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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
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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
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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
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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
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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
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Proposed Central Drug
Administration
CDA
Pharmacovigilance
Regulatory Affairs and Enforcement
New Drugs & Clinical Trials
Biological & Biotechnology Products
Medical Devices and Diagnostics
Imports
Organizational Services
Training and Empowerment
Quality Control Affairs
Legal and Consumers Affairs
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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
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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
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Thank you!
Contact Information
Richard Paddock
Director, Med Tech
International Trade Administration
(202) 482-3360
Ms. Ruma Chatterjee
Senior Commercial Specialist
Market Access and Compliance office
New Delhi
Phone: 91-11-2347-2226