Building Aatmanirbhar Bharat in Indian Medical Device Sector
Vibrant and Growing Medical Device Sector in India - Explore export/import trends, schemes for domestic manufacturing, and PLI targets.
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Webinar onBuilding Aatmanirbhar Bharat in Indian Medical Device Sector 26-03-2021 Department of Pharmaceuticals Ministry of Chemicals and Fertilizers Government of India 1
Medical Device Sector: Vibrant and Growing Counted among the top global medical devices market Largest Medical Device Market in Asia 20th 4th Market size potential by 2025 Medical Devices clusters $50 bn 19 + India s Strengths The Indian medical devices industry consists of large multinationals, with extensive service networks, as well as small and medium enterprises (SMEs) The Medical Devices Rules, 2017 are harmonized with the international regulatory practices Many Indian and overseas medical technology companies are coming out with innovative products for the Indian market . Currently, exporting ventilators, PPEs, diagnostic kits, sanitizers and surgical gloves (2/3 ply) in the ongoing COVID pandemic Strong presence of experts, scientists and engineers 100% investment allowed under automatic route both for greenfield and brownfield projects 2
Medical Device Export and Import Total Export and Import of Medical Devices over past three financial years are as under(Values in USD million) Source: EEPC 3
Schemes for Medical Devices Medical Devices Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices Scheme for Promotion of Medical Device Parks 4
PLI Scheme for Medical Devices Target Segment Description of Medical Devices covered under Target No. Segment# Target Segment 1 Cancer care/Radiotherapy medical devices Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nuclear Imaging Devices Target Segment 2 Anesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices Target Segment 3 AII Implants including implantable electronic devices like cochlear implants and pacemaker Target Segment 4 # A key component which constitutes major part of the finished medical device will also be eligible 5
PLI Scheme for Medical Devices Continued The Scheme is applicable only to the Greenfield projects and intends to boost domestic manufacturing and attract large investments in the Medical Devices Sector. Financial incentive will be given to selected companies at the rate of 5% of incremental sales of medical devices manufactured in India and covered under the Target segments of the scheme, for a period of five (5) years. The tenure of the scheme is from FY 2020-21 to FY 2027-28. The total financial outlay of the Scheme is INR 3,420 crore. The last date for receiving applications under the scheme was 30.11.2020. A total number of 28 applications have been received from 23 applicants for the products spread across all the 4 Target Segments. Several meetings of Empowered Committee have been held. 14 applications have been approved by the Government 6
Promotion of Medical Device Parks The total financial outlay of the scheme is INR 400 crore for 4 Medical Device Parks. Maximum assistance under the scheme for one Medical Device Park would be limited to INR 100 crore. The tenure of the scheme is from FY 2020-2021 to FY 2024-2025. Financial assistance to a selected Medical Device Park would be 70% of the project cost of common infrastructure facilities. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the project cost. The application window of the scheme got closed on 15.10.2020. A total number of 16 States have submitted their proposals under the scheme. 7
Business Environment in India Ease of doing Business (EODB) Currently ranked 63rdin Doing Business 2020 Construction Permits: India s ranking has improved to 27 in 2019 from 184 in 2014 Getting Electricity: India s ranking has improved to 22 in 2019from 137 in 2014 Corporate Income Tax New domestic manufacturing companies to be taxed 15%, plus applicable surcharge and cess New Company should commence manufacturing on or before 31.03.2023. Public Procurement Order to benefit new investors Class I supplier 50% or more local content Class II supplier 25%-50% local content Non Local supplier 25% or less local content DoP issues Public Procurement (Preference to Make in India) Order, 2017 (Revision) dated 16.02.2021 for 135 IVD products as a opportunity for IVD industry. dated 25.03.2021 for 19 medical devices for which only Class I local supplier shall be eligible to bid irrespective of the purchase value. 8
Pharma Bureau Specialized body of technical experts to support investors & industry in the area of pharmaceuticals medical devices Legal FDI project management It will also work as Project Development Cell of the department to help investors to find potential partners in India for JV to assist investors for all kind of clearances such as land allotment, company incorporation, custom clearances, building plan approvals, environmental clearances, tax compliances etc Details: +91-11-23071162 pharma-bureau@gov.in 9
THANK YOU ALL THANK YOU ALL pharma pharma- -bureau@gov.in bureau@gov.in 10
