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Schemes for Promotion of Medical Devices Manufacturing

The Indian Government has identified the medical devices as a priority sector for the flagship 'Make in India' program and is committed to strengthen the manufacturing ecosystem. India is the fourth largest medical devices market in Asia. Currently, the Indian market has high reliance on imports but in recent times the exports have seen a surged. ‘Atma Nirbhar’ Bharat mission is providing an impetus to India’s vision of becoming a global manufacturing hub for medical devices. Recent initiatives for instance, The Production Linked Incentive Scheme (PLI) and Promotion of Medical Devices Parks Scheme, are a testimony to this. These schemes have been cogently constructed to incentivize large-scale manufacturing and to build required infrastructure for developing manufacturing clusters within India.

Scheme for Medical Devices Manufacturing
Scheme 1

Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices

Overview

1- The Production Linked Incentives Scheme (PLI) Scheme for Medical Devices manufacturing proposes a financial incentive to boost domestic manufacturing and attract large investment in medical devices segments such as cancer care devices, radiology and imaging devices, anaesthetics devices, implants etc.

2- Production Linked Incentives to the tune of $ 456 Mn

3- The Scheme is set to create global champions out of India and boost the “Make in India, Make for the World” mandate

List of approved applicants under PLI Scheme for Medical Devices

Notice on extension of timeline for submission of application till 8th April 2023

Notice dated 25th February 2023 inviting applications from eligible Category-B applicants 

Corrigendum on Scheme Guidelines dated 25th February 2023

Revised Scheme Guidelines dated 25th February 2023

Scheme
  • English
Guidelines
  • English

Highlights

  • Incentives

    Incentive

    Incentive of 5% on incremental sales (over Base Year: FY 2019-20) of goods manufactured in India

  • Target Segments

    Target Segments

    A broad range of product segments ranging from capital equipment, implants, and consumables

  • Eligibility

    Eligibility

    Eligibility subject to meeting the committed investment and minimum threshold sales

  • Tenure

    Tenure

    Tenure of the scheme is from FY 2020-21 to FY 2027-28

Target Segments Eligible under PLI Scheme

Medical Device Segment Indicative Eligible Products
Cancer care / Radiotherapy  Brachytherapy Systems, Rotational Cobalt Machine, Radiotherapy Simulation Systems, Linear Accelerator (LINAC), Workstations- Radiotherapy Planning, Proton therapy system and other products* in this target segment.
Radiology, Imaging and Nuclear Imaging Devices CT Scan, MRI, Ultrasonography, X-ray equipment, mammography, C-arm, Cath-Lab, Positron Emission Tomography (PET) Systems, Single-photon emission tomography (SPECT), Cyclotrons and other products* in this target segment.
Anaesthetics, Cardio-Respiratory and Renal Care  Needles-Anesthesia, Syringes-Anesthesia, Anesthesia workstation, Anesthesia Unit Gas Scavengers, Anesthesia Kits, Masks —Anesthesia, Anesthesia Unit Vaporizers, Anesthesia Unit Ventilators, Automated external defibrillators (AEDs), Dialyzer, Dialysis Machine, Peritoneal dialysis kits, Biopsy Kits- Renal, Dialyser reprocessing I Lithotripters-Extracorporeal —Renal, Oxygen Concentrators, and other products* in this target segment.
All Implants Cochlear Implants, Hip Implants, Knee Implants, Spinal and neuro-surgical implants, Urogynecologic Surgical Mesh Implants, Hernia Surgical Mesh Implants, Cerebral Spinal Fluid (CSF) Shunt Systems, Implanted Pacemakers, insulin pump, implanted neuro-stimulated device like Deep Brain Stimulator, Intraocular lenses, heart valves, stents and other products* in this target segment.

Note 1: Other products - For products not explicitly mentioned in the table above the Technical Committee shall decide whether such products shall be considered eligible under the target segment.

Note 2: A key component which constitutes a major part of the finished medical device has a distinct HS code for itself, will be considered as included in the corresponding target segment.

Eligibility

Segment Rate of Incentive on Incremental Sales of Manufactured Goods for respective FY Threshold Minimum Incremental Sales of Manufactured Goods Maximum Incentive per applicant within a target segment 
All 4 segments of medical devices 

FY 2022-23: 5% 
FY 2023-24: 5% 
FY 2024-25: 5%
FY 2025-26: 5%
FY 2026-27: 5%

 

FY 2022-23: INR 60 Crore
FY 2023-24: INR 120 Crore 
FY 2024-25: INR 180 Crore
FY 2025-26: INR 230 Crore
FY 2026-27: INR 280 Crore

FY 2022-23: INR 8 Crore
FY 2023-24: INR 17 Crore 
FY 2024-25: INR 27 Crore
FY 2025-26: INR 32 Crore
FY 2026-27: INR 37 Crore 

Total Maximum Incentive- INR 121 Crore
  • Other Eligibility Criteria
    • Support to be provided to companies registered and manufacturing of target segments in India and having Net Worth (of applicant company including that of Group Companies) greater than Rs. 18 crores.
    • Scheme exclusive to greenfield projects defined under the guideline.
    • Applicant should not have been declared as bankrupt or defaulter or reported as fraud by any financial institution.
    • Eligibility under the PLI Scheme will not affect eligibility under any other scheme and vice-versa. 
    • Companies meeting the committed investment & minimum threshold sales will be eligible for the disbursement of investment. The subjected thresholds are detailed in the table as above.
  • Selection 
    • Applicants will be evaluated and ranked basis factors including manufacturing turnover, Existing Patent / Technology, R & D expenses, Existing ISO 13485 certification and regulatory approvals. 
    • A maximum of 28 applicants shall be selected under the Scheme basis score obtained as per the Evaluation.
    • A maximum of 10 applicants shall be selected under each target segment.
    • A minimum of 3 applicants, if available, shall be selected under each Target Segment.

Process Flow

Process Flow
Step 1

Application Process

  1. Submission of Application – Applicant
  2. Prima Facie Examination – Project Management Agency (PMA)
  3. Letter of Acknowledgement issued – PMA
    • Letter of Acknowledgement to be issued within 15 working days post completion of examination
  4. Application Appraisal - Empowered Committee and PMA
    • Applications to be finalized within 60 days from date of closure of application window 
  5. Application Approval – PMA (based on the decision of Empowered Committee)
    • Letter of Approval to be issued within 5 working days post receiving EC approval 
Approval Acceptance
Step 2

Approval Acceptance 

  • Within two weeks of receiving approval, an applicant must provide a bank guarantee along with undertaking Bank Guarantee. Please refer to format in Guidelines (LINK) Annexure 9
  • Bank Guarantee amount will be equivalent to 1% of the threshold of the investment for Year 1 and it is to be provided in favor of DOP
  • The Guarantee should be valid for 365 days and will be rolled over till the investment for the first year is made.  
Disbursement Process
Step 3

Disbursement Process

  1. Submission of Claim for Disbursement of Incentive – Applicant
    • Claim to be filed within 9 months from the end of the financial year to which the claim pertains.
  2. Verification of Claims and Application for Incentives – PMA
    • PMA shall process claim for disbursement of incentive within 60 days from the date of submission of claim and make appropriate recommendations to the Empowered Committee.
    • Empowered Committee will consider and approve claims for disbursement of incentive.
  3. Disbursement of Funds – PMA
    • PMA shall disburse funds after completion of all pre-disbursal formalities by the applicant and approval from Empowered Committee.

FAQs

Frequently Asked Questions

  • If a company misses a threshold (investment / incremental sale) in one year but compensates for that in the next year by having met the total cumulative figure – Then will the company be eligible for the missed incentive?

    In case an applicant does not meet minimum threshold criteria for any given year, the applicant shall not be eligible for disbursement of incentive for that particular year. However, the applicant will not be restricted from claiming incentive for subsequent years during the tenure of the Scheme, provided eligibility criteria are met for such subsequent years.

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  • Is assembly of products considered to be ‘Manufacturing’ under the scheme?

    All activities applicable under the Central Goods and Service Tax 2017 definition of 'Manufacturing' will be eligible under the PLI scheme for incentives. (refer scheme guidelines for more information).

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  • What are the eligible Investments, that will be calculated for the threshold Investment?

    The investments that are eligible for the threshold investment calculation are: 

    • Expenditure incurred on new Plant, Machinery, Equipment and Associated Utilities
      • Eligible investment includes expenditure on a new plant, machinery, equipment and associated utilities as well as tools, dies, moulds, jigs, fixtures (including parts, accessories, components, and spares thereof) of the same, used in the design, manufacturing, assembly, testing, packaging or processing of any of manufactured goods covered under target segments. 
    • Expenditure incurred on new Research and Development (R&D)
      • Eligible investment includes capital expenditure on R&D and product development related to Target Segments. 
    • Expenditure related to Transfer of Technology (ToT) Agreements
      • Eligible investment includes the cost of technology and initial technology purchase related to manufactured goods covered under Target Segments. 
    • Associated Utilities
      • Expenditure incurred on associated utilities as defined in the scheme guideline shall be considered as Investment for determining eligibility under the Scheme. 

    (refer scheme guidelines for more information)

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  • Will used machinery be allowed under the calculated Investment under the threshold Investment?

    Used / Refurbished machinery will not be counted in the investment calculation under the threshold.

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  • How are the applications for the scheme to be submitted?

    All applications will be submitted through an online portal maintained by the Project Management Agency (PMA). In case, the portal is not available; applications may be submitted in physical form to the PMA. The URL of the online portal will be made available on the website of the DoP.

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  • How will the incentive be calculated?

    The incentive applicable for a selected applicant will be computed as follows: 

    Net Incremental Sales of Eligible Product(s) x Rate of Incentive

    Where: 

    • Eligible Product(s) means the products stated in the approval letter.
    • Incremental Sales shall be Net Sales Turnover of Eligible Product(s) for the period of which claim for disbursement of incentive pertains minus the Net Sales Turnover of said Eligible Product(s) for the base year.
    • In case of return of Sales of Eligible Product(s), the Gross Sales Turnover shall be reduced by the amount corresponding to such return of sales. If the corresponding sales have been considered for claim processing for the earlier period, the sales return shall be adjusted with Gross Sales Turnover for the period in which the actual sales return takes place.
    • Rate of incentive: 5%

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  • What is the evaluation Criteria for selection of company under the PLI Scheme?

    Score will be given to a company based on 5 factors including manufacturing turnover, Existing Patent / Technology transfer, Existing ISO 13485, Average R & D expenses, and Regulatory approval. Applicants will be selected basis the score. (refer scheme guidelines for more information).

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  • Will exports be counted in the Incremental sale calculation?

    Exports of the Eligible Product(s) stated in the approval letter will be counted in the Incremental sale calculation.

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  • Will brownfield projects be eligible under the scheme? 

    No only Greenfield as per the scheme definition are eligible for the Production Linked Incentive scheme for Medical Devices. (refer scheme guidelines for more information).

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  • Can an Applicant apply for incentives under the scheme in multiple target segments? 

    There shall be no restriction on any applicant applying in more than one target segment. However, the applicant shall be required to submit a separate application along with the application fee for each target segment and shall be required to separately meet the eligibility criteria of threshold Investment and Incremental Sales of Manufactured Goods for each application.

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Scheme 2

Production Linked Incentive Scheme for Pharmaceuticals (PLI 2.0)

  • The Production Linked Incentive Scheme aims to enhance India’s manufacturing capabilities by increasing investment and production in the pharmaceutical and medical devices sectors and contributing to product diversification to high value goods in the sectors.
  • The Scheme intends to create global champions out of India who have the potential to grow and scale using cutting edge technology and thereby penetrate the global value chains. The Scheme includes a broad range of product segments ranging from biopharmaceuticals, APIs, and in vitro medical devices.
  • 55 Pharma Companies have qualified for the 15,000 Crore PLI Scheme, giving the ""Pharmacy of the World"" a boost to increase investment & production of Pharmaceuticals & Medical Devices.

 

The Scheme was notified vide Gazette Notification No.31026/60/2020-PolicyDoP dated 3 March 2021.

Application Deadline: 15 August 2021

Scheme
  • English
Guidelines
  • English

 

Highlights

  • Tenure of the Scheme

    Scheme Tenure

    Financial Year 2020-21 to Financial Year 2028-29

  • Base Year

    Base Year

    Financial Year 2019-20

  • Incentives

    Incentives

    The total financial outlay is INR 15,000 Cr, allocated amongst 3 applicant groups based on revenue:
    Group A: INR 11,000 cr
    Group B: INR 2,250 cr
    Group C: INR 1,750 cr

Target Applicant Groups

The applicants shall apply within the following three groups:

  • Group A: Applicants having Global Manufacturing Revenue (FY 2019-20) of pharmaceutical goods and/or in vitro Diagnostic Medical Devices more than or equal to INR 5,000 Cr.
  • Group B: Applicants having Global Manufacturing Revenue (FY 2019-20) of pharmaceutical goods and/or in vitro Diagnostic Medical Devices between INR 500 (inclusive) Cr and INR 5,000 Cr.
  • Group C: Applicants having Global Manufacturing Revenue (FY 2019-20) of pharmaceutical goods and/or in vitro Diagnostic Medical Devices less than INR 500 Cr.

Selection of Applicants

The selection of applicants in each group (except in vitro Diagnostic medical devices) will be governed by the following parameters:

Group Selection parameter Weightage (%)
A / B Gross manufacturing investment of applicant/ group company in India in 10 years during FY 2010-11 to FY 2019-20 30
Number of ANDA / NDA of applicant/ group company from either USFDA / EDQM / UK MHRA / PMDA / Health Canada / TGA as on 01.04.2021 30
R&D expenditure of applicant/group company as a % of GMR from pharmaceutical goods in FY 2017-18 to FY 2019-2020 40
C Gross manufacturing investment of applicant/ group company in India in 10 years during FY 2010-11 to FY 2019-20 30
Number of ANDA / NDA of applicant/ group company from either USFDA / EDQM / UK MHRA / PMDA / Health Canada / TGA as on 01.04.2021 30
GMR from pharmaceutical goods in FY 2019-2020 40
C (MSME) Number of manufacturing plants in India owned by applicant/group company and approved by USFDA / EDQM / UK MHRA / PMDA / 50% 5 Health Canada/ TGA or having WHO-GMP compliance certification from a State Licensing Authority as on 01.04.2021 50
Total Investment Committed by the applicant under the Scheme 50

The selection of applicants for in vitro diagnostic medical devices will be governed by the following parameters:

Group Selection parameter Weightage (%)
A / B / C Gross manufacturing investment of applicant/ group company in India in 10 years during FY 2010-11 to FY 2019-20 30
Number of manufacturing plants in India owned by applicant/group company having manufacturing license from CDSCO/SLA or approved by USFDA / EU (CE) / UK MHRA / PMDA / Health Canada / TGA / CDSCO as on 01.04.2021 30
GMR from in vitro diagnostic medical devices in FY 2019-2020 40

Calculation of Incentive

The ceiling for incentive and additional incentive shall be as follows (in INR Cr):

Group Incentive Ceiling Ceiling of Additional Incentive, if any Total Incentive Ceiling Total Incentive Allocated
A 1,000 200 1,200 11,000
B 250 50 300 2,250
C 50 10 60 1,750
  • Additional incentive is not an entitlement and is contingent upon savings available from the unutilized incentives of other participants in that year.
  • In no case the total incentive including additional inventive, if any, given to a participant during the whole tenure of the scheme would be more than INR 1200 Cr for a Group A participant, more than INR 300 Cr for a Group B participant and more than INR 60 Cr for a Group C participant.
  • The incentive allocated for Group A and Group C applicants shall not be moved to any other category. However, incentive allocated to Group B applicants, if left underutilized at the end of the year can be moved to Group A applicants based on their performance. The modalities in this regard shall be finalized by the Department of Pharmaceuticals.

 

Eligible Investment

General Terms and Conditions

  1. Investment, as defined in these guidelines, shall be considered for determining eligibility under the Scheme provided such Investment is made on or after 1 April 2020.
  2. No second hand/ used/ refurbished plant, machinery, equipment, utilities or research and development equipment shall be considered as eligible investment for the purpose of this Scheme.
  3. Expenditure on consumables and raw material used for manufacturing shall not be considered as Investment.
  4. The date of purchase invoice would be considered as the date of investment under the Scheme.
  5. The heads of investment, based on which eligibility is being determined, should be: in the books of accounts of the applicant as certified by the 7 Statutory Auditor or Independent Chartered Accountant, whichever is applicable, except the eligible investments w.r.t. expenditure on R&D, product registration which may be in the nature of capital/revenue expenditure where such is certified by the Statutory Auditor/ ICA.
  6. Copies of contractual agreements are to be provided in case of purchase/licensing of technology or Intellectual Property Rights (IPRs).
  7. The investment made by applicant, which has been considered for PLI Scheme for Bulk Drugs or any other PLI Scheme shall not be considered again for the purpose of eligible investment under this Scheme.
  8. Research and Development (R&D): Expenditure incurred on Research and Development as defined in Clause 2.15.21 of the guidelines shall be considered as Investment for determining eligibility under the Scheme.
  9. Transfer of Technology (ToT) agreements: Expenditure incurred on ToT as defined in Clause 2.15.32 of the guidelines shall be considered as Investment for determining eligibility under the Scheme.

Product Categories

The scheme shall cover pharmaceutical goods under three (03) categories as mentioned below:

  1. Category 1
    1. Bio-pharmaceuticals
    2. Complex generic drugs
    3. Patented drugs or drugs nearing patent expiry
    4. Cell based or gene therapy drugs
    5. Orphan drugs
    6. Special empty capsules like HPMC, Pullulan, enteric etc.
    7. Complex excipients
    8. Phyto-pharmaceuticals
    9. Other drugs as approved3
  2. Category 2
    1. Active Pharmaceutical Ingredients / Key Starting Materials / Drug Intermediates except for the 41 eligible products already covered under the “Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs) / Drug Intermediates (DIs) / Active Pharmaceutical Ingredients (APIs) in India” notified by Department of Pharmaceuticals (DoP) vide Gazette Notification no.- 31026/16/2020- Policy, dated 21/07/2020 in Part-I, Section 1 of the Gazette of India (Extraordinary)
  3. Category 3 (Drugs not covered under Category 1 and Category 2)
    1. Repurposed drugs
    2. Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs
    3. In vitro diagnostic devices
    4. Other drugs not manufactured in India
    5. Other drugs as approved3

1 Expenditure incurred for Research and Development (R&D): This shall include expenditure on R&D and product development including clinical trial costs
in India only. All non-creditable taxes and duties would be included in such expenditure.
2 Expenditure incurred on Transfer of Technology (ToT) agreements: This shall include expenditure on cost of technology and initial technology purchase
in relation to the eligible product. All non-creditable taxes and duties would be included in such expenditure.
3 Decision will be taken by DoP to include any drug based on requirement, CDSCO approvals, TC opinion which shall take into account the current levels
of production, availability, etc. The decision of DoP shall be aligned with the objectives of the scheme.

Frequently Asked Questions

FAQs

  • Does a company applying for multiple products falling in different categories have to make a single application?

    Single application is to be made, whether it is for one or multiple products.

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  • Is there a requirement to submit a projection/project report with respect to future investments as part of the application process?

    A brief technical plan on investments, proposed locations, project cost, means of finance, implementation plan etc. would be required to be submitted by all selected applicants.

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  • Is export incentive included in the calculation of GMR for the base year?

    No, as only the manufacturing revenue of the Applicant/ Group Companies is being considered in the definition of GMR given in clause 2.12 of the Operational Guidelines.

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  • For calculating GMR - I goods are procured on a contract manufacturing basis, would the revenue from sales of such products would be counted towards GMR.

    In case the sales of products manufactured under contract manufacturing is booked as manufacturing revenue in the books of accounts and Statutory Auditor’s certificate is submitted by the applicant as per the Scheme, the same would be considered for calculating GMR.

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  • Clause 2.13 - Definition of the term 'group company' would cover a group company outside India as well. Confirmation needed.

    Yes, provided they satisfy the conditions for Group Company laid down in clause 2.13 of the Operational Guidelines.

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Scheme 3

Promotion of Medical Device Parks

Overview

  • Promotion of Medical Device Parks aims to strengthen the infrastructure base and develop a robust manufacturing ecosystem for medical devices in the domestic market. Grants under the Scheme for development of world-class standard testing and infrastructure facilities will build momentum for domestic production and deepen the value chain of Medical Devices in India. Additionally, these are expected to reduce the cost of manufacturing significantly, leading to better accessibility and affordability of medical devices in the country. 
  • The total financial outlay of the scheme is Rs. 400 crore and the tenure of the scheme is from FY 2020-2021 to FY 2024-2025
  • Proposal from 16 States/UTs were received under the scheme
  • Based on the evaluation, the proposals of State Government of Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh have been given “in-principle” approval under the scheme. 
  • The scheme reflects the spirit of co-operative federalism where the Central Government and State Governments will partner to develop the Medial Device parks for better performance of the sector. 
Scheme
  • English
Guidelines
  • English

Revised Guidelines for Category B applicants  Click Here

Highlights

  • Infrastructure

    Infrastructure

    World-Class Standard testing and Infrastructure facilities to provide access and reduce costs of frequently used infrastructure

  • Tenure

    Tenure

    The tenure of the scheme is from FY 2020-2021 to FY 2024-2025.

  • Incentives

    Financial Incentive

    Grant of up to 100 Crore Per Park

  • Medical Parks

    Medical Parks

    4 medical device parks to be set up across 4 states

Incentive & Common Indicated Infrastructure

  • Incentive
    • Outlay of INR 400 crores to provide financial assistance for building common infrastructure for medical devices parks across 4 states.
    • Grant per park up to INR 100 Crore or 70% project cost (whichever is less) 
    • Grants in the North East States and Hilly States (i.e. Himachal Pradesh, Uttarakhand, UT of Jammu & Kashmir and UT of Ladakh), to be INR 100 Crore or up to 90% of project cost (whichever is less)
  • Indicated Common Infrastructure: 
    • Component Testing Centre/ESDM/PCB/Sensors facility
    • Electra-Magnetic Interference & Electra Magnetic Compatibility Centre
    • Biomaterial / Biocompatibility /Accelerated Aging Testing Centre
    • Medical Grade Moulding/Milling/Injection Moulding/Machining/Tooling Centre
    • 3D Designing and Printing for Medical-Grade Products.
    • Sterilization/ETO/Gamma Centre
    • Animal Lab and Toxicity testing Centre
    • Radiation Testing Centre
    • Radiology Tube/Flat Panel Detectors/MRI Magnets/ Piezo Electrical Crystals/Power Electronics Facility
    • Solid waste management/ETP/STP/Electronic Waste management Unit
    • Common Warehouse & Logistics (Clearing and Forwarding, Insurance, Transportation. Customs, Weighbridges, etc.) Centre
    • Emergency Response Centre/Safety/Hazardous Operations audit Centre
    • Centre of Excellence/Technology incubator/ ITI/Training Centres

Process Flow

Proposal
Step One

Proposal  

  • The State Govt. to identify suitable location for establishment of Medical Devices Park keeping in mind factors for ease in doing business.
  • Submission of undertaking by the State Govt. declaring the non-increase of land lease and utility charges beyond 5% per annum for the next 10 years.
  • Proposal to be submitted by the State Govt. within 60 days of the issuance of the guidelines.
In-Principle approval under the Scheme 
Step Two

In-Principle approval under the Scheme 

  • Department of Pharmaceuticals will issue a letter of in-principle approval to the selected States, post receiving in-principle approval
Detailed Project Report 
Step Three

Detailed Project Report 

  • Detailed Project Report to be submitted to Department of Pharmaceuticals by the selected State Govt.  within 180 days of the date of issuance of the in-principle approval letter.
  • States to be ranked based on 11 factors including Utility charges, state policy infrastructure, Connectivity, Lease rate, area of the proposed park, Power and water availability, Stamp Duty and Registration charges, Ease of Doing Business Ranking, Availability of Technical Manpower, etc.
Final approval under the Scheme 
Step Four

Final approval under the Scheme 

  • Department of Pharmaceuticals will issue letter of final approval to the selected State after due processes are complete

FAQs

Frequently Asked Questions

  • Is the list of common facilities applicable in the scheme exhaustive? 

    The list of common facilities/center given in the list are indicative and states are encouraged to plan for facilities, the implementing agency considers useful.

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  • How will funds for the Medical Parks be disbursed?

    Grant-in-aid will be released in four instalments in the following manner:

    Installment Percentage of Funds Remarks/ Pre-requisites
    First 30 On final approval of the project by the SSC and after the deposit of 30% of SlA's share in the project cost in the Trust and Retention Account (TRA) or Escrow or No Lien Account as the case may be, subject to the condition that all relevant environment clearances are in place.
    Second 30 60% utilisation of the first instalment and after the proportionate expenditure has been incurred by the SIA with proportionate physical progress of the Medical Device Park as per the DPR.
    Third 30 100% utilisation of first instalment and at least 60% utilization of second instalment and after the proportionate expenditure has been incurred by the SIA with proportionate physical progress of the Medical Device Park as per the DPR.
    Fourth 30 100% utilisation of second and third instalments and SIA has mobilized and spent its entire share in proportion to the grant and completed the project in all respects.

     

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  • Who will be responsible for Maintenance of Assets?

    State Implementation Agency shall be responsible for Operation and Management of assets created under the Scheme.

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  • Will grants be applicable for investment for construction of roads, buildings, etc.?

    No grant shall be given towards construction of roads, compound wall and buildings. However, as far as various scientific facilities/ centres are concerned, 30% of the estimated cost of the respective facility/ centre will be allowed from grant-in-aid towards the construction of the building.

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  • What is the evaluation Criteria for selection of state under the Parks Scheme?

    Score will be given to a state based on 11 parameters. The top 4 states will be selected for incentives under the parks scheme. The Evaluation Criteria is as follows: 

    S. No. Parameter Maximum Marks
    1 Utility charges 25
    2 State Incentive Infrastructure 12
    3 Connectivity of the Park 12
    4 Lease rate 10
    5 Total area of the proposed park 10
    6 Uninterrupted 24*7 availability 7
    7 Stamp Duty and Registration charges 5
    8 Ease of Doing Business Ranking of the State 5
    9 Availability of Technical Manpower 5
    10 Presence of Institutes for technology transfer 5
    11 Industrial Network 4

     

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  • Who are all the responsible authorities for the Scheme?

    • Project Management Agency (PMA)
      • Project Management Agency (PMA) will be nominated by Department of
      • Pharmaceuticals for providing secretarial, managerial and implementation support to DoP for effective implementation of the Scheme.
    • Technical Committee (TC)
      • Technical Committee, constituted by the DoP and experts having knowledge and experience in regulations, manufacturing of medical devices and R&D of medical devices will assist in technical matters referred to by the DoP & SSC.
    • State Implementing Agency (State Implementation Agency)
      • State Implementing Agency (SIA), a legal entity shall be set up by the State Government to implement the Medical Device Park Project.
    • Scheme Steering Committee (SSC): 
      • Proposals under the Scheme will be approved by the Scheme Steering Committee (SSC). The committee will comprise of:
        • Secretary, DoP - Chairperson
        • Financial Adviser, DoP - Member
        • Joint Secretary, Ministry of Environment, Forest and Climate Change -Member
        • Joint Secretary, Department for Promotion of Industry and Internal Trade -Member
        • Joint Secretary, Department of Health and Family Welfare — Member
        • DCGI, Central Drug Standard Control Organization - Member
        • Joint Secretary (Policy), DoP - Convenor
    • State Government 
      • Responsible for the submission of the Project Report and other information pertaining to the Medical Device Parks. 

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Team

  • Akriti Bajaj

    Akriti Bajaj

  • Sabhyata Verma

    Sabhyata Verma

  • Aditya Gupta

    Aditya Gupta

  • Rashika Vij

    Rashika Vij

Contact Us

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medicaldevices@investindia.org.in

Phone no. +91-11-23048155