ACTION POINTS For Establishing Medical Device Manufacturing Industry by PMO
o Policy & Rules
o Administrative & Coordination
A. MOC – Ministry of Commerce
1. Review Norms of FDI Policy. Restrict Shareholding of MNC’s
(i) FDI permitted for putting MFG units not for trading/warehousing.
(ii) MNC 100% owned subsidiary should be permitted to trade if Mfg .Revenue not less than 60%
(iii) Restrict Max Shareholding to 40% if Indian subsidiary trading revenue will be over 40%
(iv) Minimal 20% Shareholding for Indian Public/F.I’s .
(v) Do not consider 100% Auto Approval Routes for 100% FDI in Brown Field Take Over Projects.
(i) Focus on improving Existing Clusters – Delhi NCR, Ahmadabad, Chennai
(ii) SEZ – Medical Technology Parks etc.
3. Export acceleration strategies.
(i) Easy availability of Free Sales Certificate, not only from DGFT - DCGI, EXISTING
UNITS ON BASIS OF CE / Endorsement of DGFT Certificate
(ii) MDA & MAI – 15 Cr Cap to be waived
(iii) MEDICA, ARABHEALTH, Africa Health - trade fairs subsidized participation
(iv) Africa centric – PEPFAR US AID – Replication INDIA AID
(v) China – 17% subsidy on medical devices exports Vs. INDIA 2-3% reduced from 4-5%
(vi) MADE IN INDIA – INDIAN registered BRANDS 3% Additional FMS/DEPB
(vii) 25 % subsidy on Foreign trademark Registration fees and 50% for Product
(viii)Status Holder Privilege – Green Card for NOC Waiver
(ix) Accelerated Depreciation at double rate for income tax for ISO 13485 certified co.
(ix) Modernization fund – minimal interest loan to upgrade plant facilities – 5 years
B. MOF – Ministry of Finance
Ministry of Finance Correct/Rationalize Inverted Duty structure
Fiscal, Correct Inverted Duty Structure
Anomalies in Tariff to be corrected of 90.18, 90.21, 90.22, 90.27, 30.06 & 48.18:
- Reverting SAD from 0% back to 4%
- Increase Basic Duty on Devices to Min.10%
- Reduce Basic duty on Consumables to be 7.5%
- Maintain Basic Duty on Parts of Devices 5 %
- Keep Max. Basic Duty on Raw Material & Packing Material 2.5%
Remove disparity of High Seas Sales circumvention of VAT/Import duty
Address dual interpretation and recovery of additional Excise Duty on Reseller /Associate Co. invoice of JV Co.s
C. MOH – Ministry of Health
(i) Creation of Dept. of Medical Devices as Coordinator ( NHSRC ?)
(ii) Buy Indian Public Healthcare Policy
- 15% benefit for Indigenous products as for World Bank Tenders to neutralize Chinese 17% subsidy on exports.
- All public health tenders mandatory IS: 15579/ISO:13485 certification
(iii) Regulation of all Medical Devices but not as Drugs
(Incomplete & Incorrect regulatory framework is confusing investors)
Overdue Short Term actions by CDSCO / MOH:
Finalization & Issuance of Guidelines for
- Initial Factory Audit of QMS & Infrastructure.
- Export Labeling & Procedures / No NOC.
- Application of Additional Brand
- Application for Neutral Code No.
- Application of Free Sales Certificate
- Import of Non sterile Assembled Devices
- Clinical Evaluation ( Not as Clinical Trial for New Drugs)
- Adverse Event Reporting
Amendment of D & C Rule 76 & Schedule MIII
- GMP compliance as per IS:13485
- Risk Proportionate Infrastructure Requirements
- Revision of Batch Release Criteria on basis of Biological Indicator & Process Validation.
Overdue Long Term Measure: Appropriate (non Drug) Regulatory Framework
Remove Medical Devices from Definition of Drugs through an Ordinance
Introduce Bill for Patient Safety & regulating Medical Devices through a NRA under MOH
Rename CDSCO as IHPRA - Indian Healthcare Products Regulatory Authority – Drugs, Cosmetics, Medical Devices & Diagnostics
Regulatory controls to be split , shared and delegated between Centre, State , CAB’s
- E.g. Centre for Policy, Licensing, Registration for Mfrs / Exporters/Importers
Factory Audits QMS delegated to expert competent NABCB accredited CAB’s
State Authorities to Regulate Logistics & Sales
Involvement of ALL Stakeholders in Regulatory Review
Evaluation of Risk & Hazard by CAB for suitable corrective & preventive action (CAPA)
Reasonable time for addressing issues and implementing CAPA
Move for an Autonomous NRA – IHPRA (?)
NRA to have powers for speedy administrative action & for putting things RIGHT
Minimal/No reliance of judiciary and legal criminal action on registered units
Reliance of Judiciary/ Police and criminal action only on non registered units.
Regulatory Controls to be Risk Proportionate & 4 Tiered.
Medical Devices to meet defined Essential Requirements of Safety
GMP compliance to IS :13485 QMS for medium to High Risk devices & ISO 9001 for low risk
IHPRA & NABCB to supervise & accredit competent CAB’s
Regulations to encourage – MAKE in INDIA & Made in INDIA
Primary Manufacturers, Packers, Relabellers to be regulated by IHPRA.
Manufacturing to be at least assembly with substantial Domestic Value Additional.
Importers/Marketing Cos/Distributors not to be permitted to be Psuedo Manufacturers
Labeling to clearly define above and not ‘Make in India’ labeled as ‘Made in India’..
D. DOP – Dept. of Pharmaceuticals (Ministry of Chemicals & Fertilizers)
Dept. of Medical Device / Dept. of Pharmaceutical & Medical Devices
To create India as one of Top 5 Manufacturing Hubs for Medical Devices Worldwide and be Nodal interface of Manufacturing Industry with all Central Govt. Dept’s.
Objectives / Functional Role
a) Coordinate with Key Stakeholder Ministry of
- Finance, for creating a Rational Growth Inducing Tariff Environment
- Health, for Buy Indian Policy & Appropriate World Class Regulatory Framework
- Commerce for Developing Exports, Addressing Non Tariff Barrier of Importing Countries, Create Brand India & Restrict FDI to Manufacturing
- Industry, for Ensuring Indian Investor & Business Friendly Policy Regime
- Consumer Affairs, for Ensuring Consumer Protection & Affordable Devices with Fair Pricing
- Science & Technology, for Self Reliant Product Development & Indigenisation
- MSME, for Developing Capacity of Medical Device Enterprises at Micro, Small & Medium Level to go up the value chain
- Ministry of HRD, for Knowledge & Skill Development
- Prime Minister’s Office, for Ensuring Support of Speedy Policy & Legislative Changes
b) Catalyze Growth of the Indian Medical Device Sector – Make in India, Made by India, Made for India – structured Policy to be issued
c) Define Priority Devices to fight Priority Diseases with assistance of WHO & MOH
d) Implement Strategy to Shift India’s Import Depedency from Over 70% to Less than 30% in Next 5 Years for Priority Devices and Next 10 Years for all Devices
e) Create a Forum for Close Working between User, Developers, Academia, Manufacturers & Govt.
f) Create and Manage a Special Purpose Vehicle Fund for Govt. to Jointly Own Patents / IP’s Shareholding and infuse 100 Million $ or 5000 Crore Rs. as Equity for Long gestation R&D Projects under Made by India & Make for India Projects for Enterprises with NIL Foreign Equity
g) Facilitate Creation & Development of Clusters for Medical Devices
h) Facilitate Creation of Laboratories & Service Centers under PPP
i) Facilitate Skill Development of Personnel in Field of Manufacturing, Sales, Service & Regulations.
E. MOCA - Ministry of Consumer Affair (NOT NPPA) & Ministry of Finance (Customs)
Safeguard Consumers & Need for Level Playing Field with Imports
Discourage Artificial inflation and never ending inducements to Retailers/Corporate Hospital
(i) Enforce Labeling of Max. Retail Price on Unit Pack on Imports not only on shelf box.
(ii)Regulate max. Mark Up between Ex- Factory weighted average price and MRP.
(iii)Discourage Inflationary Max retail Price revision by Tax Mechanism
(iv)Plug loop hole of No MRP for Institutional Supplies.
Enforce Labeling of Country of Origin on Unit Pack
Enforce 2/3 rd shelf life at time of imports
F. MOST & MOIT – Ministry of Science & Technology – Ministry of Information
Infrastructure / Support system for R&D & Indigenous Development Goals :
• Blue Sky innovation
• Incremental Innovation
• Increase Device/procedure efficacy
• Reduce Device/procedure cost
◦ Tenders stating “Imported / US FDA Approved Only”
◦ Absence of Regulatory Framework
Funds/ Grants/Soft Loans for R&D (not only commercialization).
Patent filing support and cost reimbursement even for privately funded research
Subsidized access to Testing Labs/IP/Market Data/Standards (to be set up with PPP)
Talent hunt / Innovation development contests - incentives to promote Top 3 ideas adoptable by industry.
Inculcation of “unmet need identification” strategy even at primary healthcare levels.
Infrastructure: CLUSTERS IS THE KEY TO SUCCESS
Dedicated Med Dev Incubators with appropriate Infrastructure for:
◦ Mentorship into commercialization
◦ Interaction with Hospitals and Industry.
Online database for providing commercial access to the innovations
Online library to access to latest market information
Online access to BIS standards
Auto - Adoption of ISO standards by BIS
Exhibitions/Conferences/Forums created by GOI to bring Medics, Scientists, Developers Manufactures together
Free access to inventors to mentorship programmes.
Increased interaction between academia and industry
Up gradation of test Labs
Access to low cost testing
Accreditation of Labs
Training on Regulatory Requirements
- Short Term Courses @ NIPMER
- Distance e – Learning
VC Fund for patentable products
Tax benefits to Incubator Co.
Acceleration for R&D, Defining Priorities: Ministry of Health & WHO to map priority disease & Target List of priority Devices
Commercialization not Academic Acclaim
Forum/ Mechanism for close working between USERS, Developers & Manufacturers
Expediting Patent Application processing
Bringing in Utility model
Improved Access to Funding in transparent manner from DST,DBT,ICMR BIRAC etc.
Remove Impediments by NABL for research on IVD and giving tested blood samples
Create special purpose vehicles like China for Govt to jointly own patents/IP s shareholdings and infuse 50-100 million$ as equity for R & D projects.
Govt. Colleges and Hospital to allow trial purchases.
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Copyrights 2009. Association of Indian Medical Device Industry.