Department of Pharmaceuticals

Ministry of Chemicals and Fertilizers

Government of India

Operational Guidelines for the Scheme

“Strengthening of Medical Device Industry”

Central Sector Scheme under

Department of Pharmaceuticals

Dated the 08th November, 2024

 CONTENT
Chapter Topic Page No.
I 1. Introduction of the scheme

1.1 Background 1
1.2 Definitions 2-4
1.3 Objectives 4-5
1.4 Financial Outlay 5
1.5 Technical Committee(TC) 5
1.6 Scheme Steering Committee(SSC) 5-6
1.7 Functions of the Scheme Steering Committee (SSC) 6
1.8 Project Management Agency (PMA) 6-7
1.9 Scheme Outcomes 7
II 2. Common Facilities for Medical Devices Clusters Scheme

2.1 Assistance for Common Facilities 8-13

2.2 Assistance for Testing Facilities 14-18

III Marginal Investment Scheme for Reducing Import Dependence 19-22

Scheme

IV Capacity Building and Skill Development in Medical Device 23-33

Sector Scheme

V Medical Device Clinical Studies Support Scheme 34-38

VI Medical Device Promotion Scheme 39-43

VII Annexure- I 44-46

Annexure- II 47
Annexure- III 48
Annexure- IV 49-50
Annexure- V 51-53
Annexure- VI 54
Annexure- VII 55
Annexure- VIII 56-57
Annexure- IX 58
Annexure- X 59-60
CHAPTER-I:

1. Introduction to the Scheme

1.1 Background

Medical device is a sunrise industry in India, with double digit growth rate. Due to efforts of the
government in the last decade in creating a suitable eco-system and incentivizing production of medical
devices through PLI scheme, production of technology intensive medical devices such CT scan, MRI,
C-arm etc. has started in India. However, the dependence on imports still continues to be about 70%.
Moreover, to deepen our manufacturing capability along the value chains of different segments of
medical devices, it is essential to incentivize domestic manufacturing of key components/raw
materials/accessories etc., along with Medical Devices under the list of medical devices for which
exemption from the instructions of Department of Expenditure for Global Tender Enquiry are available
owing to lack of domestic manufacturing to meet the requirement of procurement of central government
hospitals, by providing support to industry in form of grant for marginal investment. Another challenge
faced by domestic medical device industry is high cost towards clinical investigations, which dissuades
them from investing resources in R&D and manufacturing facilities, which can lead to newer product
development, better safety and efficacy of devices, and enable access to markets abroad. As a nascent
industry, the sector also requires support for awareness generation, knowledge sharing and promoting
brand India. Availability of industry ready trained manpower is another constraint the industry faces.

To address these issues, after series of consultations and two Meditech Stackathons- a massive
exercise involving about hundred manufacturers to identify industry issues and map value chains across
eight medical device segments, the Department of Pharmaceuticals has formulated a scheme for
strengthening of medical device industry. The scheme has five components, which are as follows –

(i) Common Facilities for Medical Device Clusters

(ii) Marginal Investment Scheme for Reducing Import Dependence
(iii) Capacity Building and Skill Development in Medical Device Sector
(iv) Medical Device Clinical Studies Support Scheme
(v) Medical Device Promotion Scheme

The scheme has an outlay of Rs. 500 crore and tenure of the Scheme is 3 years from Financial Year
2024-25 to FY 2026-27. In the next three years the scheme will provide the much needed thrust to
address the unmet needs of the industry. The scheme is expected to have a multiplier effect in
augmenting the domestic manufacturing capacities with significant reduction in imports, and promote -
quality, human resource development, safety and efficacy of medical devices, and also enhance the
depth of medical device value chains in the country.

Merger of existing Schemes

The following two sub-schemes were already approved in the Department of Pharmaceuticals
(DoP) as part of scheme for ‘Development of Pharmaceutical Industries:

(a) Assistance to Medical Device Clusters for Common Facilities

(b) Human Resource Development in Medical Device Sector

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 Now, the above schemes have become part of the single scheme – SMDI, with modification in
the scheme guidelines and reduced financial outlay, as detailed in these guidelines.

1.2 Definitions

For purposes of this Scheme capitalized terms have the meanings set forth or referred to in this
Section.

i. “Animal Study” means a pre-clinical study conducted on animal models to generate the clinical
data related to a medical device for its safety, performance and effectiveness.
ii. “Annual turnover”: Annual turnover, in reference to a business or company, is a financial metric
that represents the total revenue generated by the company from its primary operations over a
specific period of 12 months. It is commonly calculated on an annual basis and provides an
indication of the company's sales performance and the scale of its business activities. The annual
turnover figure includes all income generated from the sale of goods or services, excluding any
taxes, discounts, or returns. It reflects the total value of all sales made during the specified period,
regardless of whether the payment has been received or not.
iii. “Articles of Association” has the meaning set forth in Section 2(5) of the Companies Act, 2013.
iv. “Application” Application submitted by an applicant to the Project Management Agency (PMA)
as per the Application form prescribed under these guidelines containing requisite information,
along with supporting documents and application fee.
v. “Application Window” Time period allowed for filing the applications. The application window
shall be opened based on notice issued by the department from time to time.
vi. “Beneficiary” means the entity(s) chosen, on an application approved by the SSC, to receive the
benefits of the Scheme.
vii. “Cluster development” means a development of clusters containing the Medical Devices
manufacturing units where the focus is concentrated in a selected area.
viii. “Common facilities” means all facilities intended for the shared use by the subscriber and will
consist of creation of tangible "assets" as Common Facility Centers (CFCs). The same is further
elaborated under Clause 10.7. The indicative list of common facilities is illustrative, and each
cluster could have its own specific requirement based on the nature of units being set up and the
products proposed to be manufactured.
ix. “Committed Investment” The amount of fresh investment which the applicant shall commit by
declaration at the time of applying under the scheme.
x. “Clinical Investigation” means the systematic study of an investigational medical device in or
on human participants to assess its safety, performance or effectiveness.
xi. “Clinical Performance Evolution” means the systematic performance study of a new in vitro
diagnostic medical device on a specimen collected from human participants to assess its
performance.
xii. “Effluent treatment plant” means a treatment plant exclusively established to treat the process
waste of any kind generated by medical device industries according to the prevailing law,
statutes, or rules.
xiii. “Eligible Product” Good manufactured in India and covered under one of the entries in the
Annexure 1 of these guidelines or recommended by the Technical Committee from time to time.
xiv. “Force Majeure” Extraordinary events or circumstances beyond human control such as an event
described as an act of God (like a natural calamity) or events such as war, strike, public health
emergency, riots, crimes (but not including negligence or wrong- doing, predictable/ seasonal
rain and any other events specifically excluded).

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 st
xv. “Financial Year” Financial Year begins on the 1st of April of a year and ends on 31 March
of the following year.
xvi. “Funding” It is the financial assistance provided to each selected participant based on the laid
down eligibility criteria.
xvii. “Grant-in-Aid” means any Grant issued by DoP as per Chapter-9 of GFR-2017.
xviii. “Medical device” means all devices, including an instrument, apparatus, appliance, implant,
material or other article, whether used alone or in combination, including a software or an
accessory, intended by its manufacturer to be used specially for human beings or animals
which does not achieve the primary intended action in or on human body or animals by any
pharmacological or immunological or metabolic means, but which may assist in its intended
function by such means for one or more of the specific purposes of:
a) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
b) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability
c) investigation, replacement or modification or support of the anatomy or of a physiological
process
d) supporting or sustaining life
e) disinfection of medical devices; and
f) control of conception.
xix. “Incentive” means the financial benefit to be provided to the selected applicant based on fulfilling
the criteria as mentioned herein the Scheme.
xx. “Investigational Medical Device” means medical device being assessed for clinical
performance, effectiveness, or safety in a clinical investigation.
xxi. “Logistic Center” means a place within which all activities relating to transport and the
distribution of medical devices- both international and national transit, are carried out by various
operators on a commercial basis.
xxii. “Medical devices testing laboratory” has the meaning set forth in subsection (ze) of section 3
of Medical Devices Rules,2017.
xxiii. “Micro, Small and Medium Enterprises” has the meaning set forth in the Micro, Small and
Medium Enterprises Development Act, 2006 [No. 27 of 2006].
xxiv. “Memorandum of Association” has the meaning set forth in Section 2(56) of the Companies
Act, 2013.
xxv. “New In-Vitro Diagnostic Medical Device” means any medical device used for in vitro diagnosis
that has not been approved for manufacture for sale or for import under Medical Devices Rules,
2017 and is being tested to establish its performance for relevant analyte or other parameter
related thereto including details of technology and procedure required.
xxvi. Performance Year of the scheme is FY 2024-25 to FY 2026-27.
xxvii. “Project Management Agency” refers to the agency appointed by the DoP to act on its behalf
for receipt and appraisal of applications, verification of eligibility and examination of disbursement
claims through any method / document deemed appropriate and for managing the Schemes in
accordance with these guidelines.
xxviii. “Post-market clinical follow-up” means a study carried out following marketing authorization
intended to answer specific questions (uncertainties) relating to safety, clinical performance
and/or effectiveness of a device when used in accordance with its labelling.
xxix. “Research and Development Lab” means a place used for experimentation aimed at the
discovery of facts, or scientific development of new products, Medical Devices, technologies, or
applications; but excludes industrial and manufacturing operations other than those required as
part of research.

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 xxx. “Scheme” means the “Scheme for Strengthening of Medical Device Industry (SMDI)”
Scheme of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of
India.
xxxi. “Scheme Steering Committee” has the meaning as set forth in para 7.
xxxii. “Special Purpose Vehicle” means a legal entity registered under the Companies Act, 2013 or
the Societies Registration Act, 1860 as amended from time to time
xxxiii. “Technical Committee” means a Technical Committee constituted by DoP to assist the Scheme
Steering Committee (SSC) for discharge its function
xxxiv. “Testing laboratory” means a public or private laboratory that (i) offers or performs tests of
medical devices, (ii) offers no service other than such tests, and (iii) is accredited by an
accrediting body.
xxxv. “Technology upgradation” means any correction, improvement, modification or enhancements
in the existing form of the technology with new features/releases that would have a substantial
likelihood of achieving greater impacts.
xxxvi. “Training Center” means a place where people undergo skills training for work.

1.3 Objectives

Based on the requirements of the Medical Devices industry, the new Scheme for Strengthening
of Medical Devices Industry has the following objectives: -

(I) Common Facilities for Medical Device Clusters: To strengthen existing infrastructure by
providing financial assistance to medical device clusters for creating Common Infrastructure Facilities,
boosting domestic manufacturing capacity and improving cluster quality. Further, to support any national
or state level Government or Private institutions to establish or strengthen testing facilities for medical
devices to support the arising needs of the Testing Laboratories for Medical Devices due to roll-out of
licensing regime of the Medical Devices w.e.f 1.10.2022, ensuring availability of more testing facilities
for evaluation of medical devices on behalf of the manufacturers, as mandated under the Medical
Devices Rules, 2017.

(II) Marginal Investment Scheme for Reducing Import Dependence: Medical Device Industry
needs specialized inputs /components in manufacturing of Medical Devices. These cannot be produced
by the general industry and are often imported by medical device manufacturers. They can be
incentivised through grant for manufacturing of essential/key components or upstream materials or
accessories or closely related products used in manufacturing of medical devices. Presently in respect
of 354 medical devices, exemption from the instructions of Department of Expenditure for Global Tender
Enquiry (GTE) for tenders of value below Rs. 200 crore is available owing to lack of domestic
manufacturing of these devices to meet the requirement of procurement of central government hospitals.
Marginal Investment Support for manufacturing of these medical devices within the country would lead
to reduction in import of these items.

(III) Capacity Building and Skill Development in Medical Device Sector: The main objective of
this component is to fill up the gap existing in the education and research in medical devices sector and
to ensure quality teaching, training and nurturing excellence in Medical Technology education for
generating critical mass of trained human resource to meet the requirements of rapidly innovating
multidisciplinary areas of Medical Technology and create R&D ecosystem for the sector.

(IV) Medical Device Clinical Studies Support Scheme: Support will be provided for conducting
Clinical Investigations or Pre-Clinical animal studies for medical device or Clinical Performance
Evaluation of new IVDs. This will promote manufacturing of quality products with better efficacy and
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safety. It will also enhance credibility of domestic manufacturers to produce high quality products,
opening up opportunities for them in markets outside the country.

(V) Medical Device Promotion Scheme: The scheme aims to promote Medical Device Industry by
bringing industry leaders, academia and policy makers together to share their knowledge and experience
for overall development of the sectors. Financial support will be provided to industry bodies/associations
and educational institutions to conduct meetings/ seminars/ workshops/ events/ road-shows/expos etc.
for which grant will be provided by the department. Also, support for manufacturer evaluation studies,
creation of database, international study missions etc. will be provided for promotion and development
of the medical device industry. Department may also directly incur expenditure on industry development
activities.

1.4 Financial Outlay

The scheme finance will come from the Department of Pharmaceuticals’ Budgetary Grants, with
an overall limit of Rs. 500 crore. The component-wise financial outlay will be as follows: -

S. Scheme for Strengthening of Medical Component The performance year

No. Devices Industry Outlay of the Scheme
(Rs. in crore)
1 Common Facilities for Medical Devices 110 2024-2025 to 2026-2027
Clusters
2 Marginal Investment Scheme for 180 2024-2025 to 2026-2027
Reducing Import Dependence
3 Capacity Building and Skill Development 100 2024-2025 to 2026-2027
for Medical Devices
4 Medical Device Clinical Studies Support 100 2024-2025 to 2026-2027
Scheme
5 Medical Device Promotion Scheme 10 2024-2025 to 2026-2027

1.5 Technical Committee (TC)

1.5.1 Technical Committee will be constituted by DoP to technically appraise proposals received
under different components of the scheme, provide technical guidance and recommendations to
the Scheme Steering Committee (SSC) in discharge of its functions. The TC may also give its
comments on any technical matter referred by PMA/DoP. The composition of the committee is as
given below.

i. One representative from Central Drugs Standard Control Organization (CDSCO)

ii. One representative expert from industry and academia each (sub-scheme concerned)
iii. One representative expert from ICMR, MSDE (sub-scheme concerned)
iv. Two representative experts having knowledge and experience in Process Development/
R&D/ Product Design/ Testing of Medical Devices/ Medical Devices Manufacturing etc.
relevant institute (NIPER, IISc, IITs, Council of Scientific, Industrial Research (CSIR),
National Council of Vocational Education and Training (NCVET) and in house faculty
constituted to advise on development of course content, assess the infrastructure
requirements and monitor progress of courses at the institutes or similar institutions (sub-
scheme concerned)
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1.6 Scheme Steering Committee (SSC)

1.6.1 The Department of Pharmaceuticals (DoP) will provide overall policy, coordination and
management support for the implementation of the Scheme. The proposals under the scheme will be
considered for approval by the Scheme Steering Committee (SSC), whose composition will be as
follows: -

i. Secretary, DoP – Chairperson;

ii. Financial Adviser, DoP - Member;
iii. Joint Secretary (Medical Devices), DoP - Member;
iv. Drug Controller General of India - Member;
v. Representative of Ministry of MSME - Member;
vi. Representative of Ministry of MeitY – Member;
vii. Representative of Ministry of DPIIT – Member
viii. Representative of Ministry of SDE - Member;
ix. Representative of D/o Health and Family Welfare- Member;
x. Representative of ICMR- Member
xi. Director /Deputy Secretary (Medical Device), DoP – Convener;
xii. The SSC may co-opt representatives of any Pharma and Medical Devices Industry Associations,
Financial Institutions/Program Management Consultant, R&D Institutions and Other Government/
Private sector expert organizations as members or special invitees as may be necessary from time
to time.

1.7 Functions of the Scheme Steering Committee (SSC)

(i) To provide direction for effective implementation of the Scheme.

(ii) To evaluate & approve proposals under the scheme
(iii) To monitor the implementation of the scheme.
(iv) To amend operational guidelines within the overall financial outlay of the scheme
(v) Reallocation of funds from one component to another component within the overall approved
outlay depending upon operational requirements.

1.8 Project Management Agency (PMA)

1.8.1 The scheme will be implemented by Project Management Agency (PMA) to be selected through
open tender/nomination basis. PMA will be a bridge between the SSC and the beneficiary & would act
as a catalyst in expeditious implementation of the projects in a systematic, professional and transparent
manner.

1.8.2 The PMA will report directly to the SSC and shall have the following responsibilities:

a. PMA will be responsible for providing secretarial, management and implementation support and
to carry out other responsibilities as assigned by DoP within the framework of scheme and
guidelines thereof.
b. PMA will be responsible for receipt and appraisal of applications, verification of eligibility and
examination of disbursement claims through any method/document deemed appropriate and or
managing the above-mentioned in accordance with these guidelines.

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 c. Assist SSC in drafting and issuing Expression of Interest (EoI)/ Request for Proposal (RFP) and
formulating criteria for evaluation to select the Projects from the Proposals received in response
to RFP.
d. Devise the prescribed application formats and list the supporting documents as well as the
appraisal methodology for approval of SSC/ DoP,
e. Preliminary examination of the proposals, and preparation of evaluation reports that will be
placed before the SSC for final selection of proposals.
f. Sensitization of the Industry/potential beneficiaries on the Scheme and its benefits and also
guiding them to apply for benefits under the scheme.
g. Preparing the Draft Agreement for selected beneficiaries for implementation of the scheme as
per guidelines.
h. Developing an online portal to receive the applications and maintain the MIS and data of the
applicants with all the details.
i. Assist the selected beneficiary in the selection of agencies/ experts for various services such as
capacity building, business development, technical or engineering support, in developing suitable
O&M framework for making the project more effective
j. Monitoring the approved projects through physical inspection, monitor implementation schedule
based on Quarterly Review Report & submit monthly & quarterly review of the projects report to
DoP/SSC for timely disbursement and utilization of the funds. PMA will also identify potential
project delays and failures to meet deadlines, proposing corrective actions in their Monitoring
Reports.

1.8.3 The Evaluation of the PMA shall be done on the basis of quality and timeliness of appraisal of
new projects brought to DoP/SSC for final approval, monitoring for ensuring completion of the
projects within the stipulated timelines mentioned in the approved DPR/Projects. If progress and
performance of the PMA is not satisfactory, DoP/SSC reserve the right to remove the PMA at
any time during the tenure of the scheme after serving a notice and considering its reply thereto.

1.9 Scheme Outcomes

(i) The NITI Aayog has developed an Output Outcome Monitoring Framework, on the basis of which
performance will be monitored.
(ii) A mid-term review of the scheme would be conducted, for which the Department of
Pharmaceuticals will engage the services of an approved independent agency. The review report
would be submitted to the Scheme Steering Committee (SSC) for taking course correction /
modification to the scheme /projects.
(iii) Stake holder consultations will be organized by DoP through PMA from time to time to obtain
feedback on the effective implementation and need for modifications in the Scheme.

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CHAPTER-II:
2. Common Facilities for Medical Devices Clusters Scheme

2.1 Assistance for Common Facilities (CF)

To strengthen the medical device clusters’ capacity for their sustained growth by creating
Common Infrastructure Facilities.

2.2 Assistance for Testing Facilities (TF)

To strengthen availability of more Medical Device Testing Laboratories in order to boost

manufacturing of quality medical devices

2.1 Assistance for Common Facilities (CF)

2.1.1 Objective

To strengthen the Medical Device clusters’ capacity for their sustained growth by creating
“Common Infrastructure Facilities”.

2.1.2 Intended Beneficiaries

i. Medical Devices manufacturing units in a cluster who have come together to form a Special
Purpose Vehicle (SPV) to execute the project of developing common facility. There shall be a
minimum of 5 Medical Device manufacturing units as members of SPV.
ii. Medical Devices clusters promoted by the State Governments: Such a Project Implementing
Agency shall be legal entity under the Indian law with foresight of the State Governments.
Such a cluster may be exempted from the requirement of formation of SPV & will be deemed
to be an SPV for the purpose of this Scheme, provided separate accounts are maintained for
the funds to be used for the projects assisted under Common Facilities for Medical Devices
Clusters (CF-MDC) and an Executive Committee (EC) is set up for implementation of the
project.

2.1.3 Eligibility Criterion for SPV

i. The SPV or the Executive Committee, as the case may be, will have representatives from cluster
members, financial institutions, State and Central Government and R&D organization.
ii. Individual manufacturing unit cannot hold more than 50% in the SPV.
iii. Medical Devices enterprises shall hold at least 51% equity of the SPV
iv. The combined net worth of members of SPV shall be equivalent to total grant amount applied for
and each SPV member must have a net worth of at least 1.5 times of their proposed equity
contribution.
v. The SPV members shall be legally independent entities without any related-party relationship
with each other as described under Accounting Standard (AS) 18 of the Companies (Accounting
Standard) Rules, 2006.

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2.1.4 Incentive under the scheme

The Department will assist in setting up of Common Facilitation Centres in the Medical Devices
clusters. This scheme will provide the grant-in-aid component of Rs. 20 Crore or 70% of the total cost of
purchase of equipment and machinery, for Central / State Government funded entities (50% in respect
of private entities) for use in setting up of Common Facilities, whichever is less and Rs. 5 Crore or 70%
for Central / State Government funded entities (50% in respect of private entities) for setting up of Testing
Facilities, whichever is less.

2.1.5 Physical and Financial Outlay

Physical Target (no.) Financial Outlay (Rs. in crore)

Financial
Year Common Testing Common Testing Total Grant-
Facilities labs Facilities labs in-Aid
Year 1 0 0 0 0 0
Year 2 1-5 1-4 40 15 55
Year 3 6-10 5-8 40 15 55
Total 5-10 4-8 80 30 110

2.1.6 Modalities for utilization of incentive

i. The cost of project shall include cost of land, building, internal infrastructure, administrative
and management support expenses including the salary of CEO, engineers, other experts
and staff during the project implementation period (before commissioning), preliminary
expenses, machinery & equipment, miscellaneous fixed assets and other support
infrastructure such as water supply, electricity and margin money for working capital.
However, Grant-in-Aid from DoP will not be utilized towards land component of the project
or construction of rest house, administrative buildings or any other building, which in the
opinion of SSC may be categorized as non-essential construction for the technical
requirements of project.
ii. In case the SPV provides an existing land and building, the cost of the same will be decided
on the basis of valuation report prepared by an approved agency of Central / State
Government Departments / Financial Institutions (FIs) / Public Sector Banks and the cost
of land and building may be taken towards contribution for the project.
iii. In case the SPV provides an existing land and building on lease separately, then the
minimum period of lease must be 30 years for both land and Building. In case the SPV
provides an existing land, building on the same land on lease, then the minimum period of
lease for combined land and building must be 30 years.
iv. Minimum of 30% or 50% of the approved project cost has to be contributed by the entity or
SPV, as the case may be respectively for the project & there will be no duplication of
funding for the same component/ intervention. SPVs may dovetail funds from other sources
as well for the project, provided there is no duplication of funding for the same component/
intervention. Resource raised through such dovetailing will be in addition to the 50%
contribution of the SPV.
v. Assistance for Administrative and other management support of SPV during the project
implementation period shall not exceed 5 % of the Grant-in- aid.
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 vi. Proportionate contribution by the SPV or the beneficiaries’ share should be made upfront.
Necessary infrastructure like land, access road, water and power supply, etc. must be in
place or substantial progress should have been made in this regard before DoP assistance
is released. Where bank finance is involved, written commitment of the bank concerned to
release proportionate funds will also be necessary before release of DoP assistance.
vii. Escalation in the cost of project over and above the sanctioned amount, due to any reason
will be borne by the SPV. The Central Government shall not accept any financial liability
arising out of operation of any Common Facility.
viii. Project Implementing agency / SPV shall be responsible for obtaining all necessary
statutory clearances in a timely manner.
ix. The Grants-in-Aid shall not be available to any individual production units, if any, owned by
a member of the SPV.
x. The Common Facility may be utilized by the SPV members and also by other Medical
Device units on ‘user charges’ basis to be decided by the SPV.
xi. User charges for services of Common Facility will be graded in such a manner that average
charges will be lesser than prevailing market prices, as decided by the Governing Council
of the SPV or the Executive Committee as the case may be. The SPV members would be
given reasonable preference in user charges.

2.1.7 Eligible Activities

An indicative list of eligible activities, for the Common Infrastructure Facilities(CIF) for the MD clusters,
under this Scheme are as under:

i. Research and Development Labs

ii. Designing and Testing Centre/ESDM/PCB/Sensors facility
iii. Biomaterial / Biocompatibility /Accelerated Aging testing Centre
iv. Medical grade moulding/milling/injection moulding/machining/tooling Centre
v. 3D designing and printing for medical grade products.
vi. Sterilization/ETO/Gamma Centre
vii. Animal Lab and Toxicity testing Centre
viii. Radiology Tube (Radiation)/Flat Panel Detectors/MRI Magnets/ Piezo electrical
crystals/power electronics facility
ix. Solid waste management/ETP/STP/Electronic Waste management unit
x. Common Warehouse & Logistics
xi. Emergency Response Centre/Safety/Hazardous Operations Audit Centre
xii. Centre of Excellence/Technology Incubator/Training Centre
xiii. Facilities for rapid prototyping microfluidics based medical devices
xiv. Facilities for rapid prototyping of medical devices using biomaterial and tissue engineering.
xv. Electro-magnetic interference & Electro Magnetic Compatibility Centre

The above list of activities is indicative and other allied activities can be taken up on approval of
SSC.

2.1.8 Project Proposal and its components

i. The project proposal must have technical recommendation from competent technical body
(e.g. for ETP, the State Pollution Control Board may be the competent body and in case of
Research Labs and Testing centers, NIPERs/IITs/CDL/ Sree Chitra Tirunal Institute for
Medical Sciences and Technology (SCTIMST) /NIITs/ IISC/Certified MDTL Testing
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 Laboratories notified by CDSCO (MD-40) may be the competent authority to grant technical
recommendations).
ii. In case of PMA / SSC are not satisfied with the technical recommendations, the PMA
/ SSC may ask the Entity/SPV to obtain technical recommendations from specific
competent experts.
iii. Project proposal may have the following details:
a. Business Plan including processes of the cluster units like manufacturing process, Gap
Analysis and proposed operations of the Common Facility such as technology,
marketing, quality control, testing, purchase, outsourcing.
b. Final projections and financial viability report.
c. Identification of impediments and bottlenecks
d. Action Plan for enhancing competitiveness of the units of the cluster and positioning
the cluster on a self-sustaining trajectory of growth. The proposal will have direct
linkages between the impediments/bottlenecks identified and the measures
recommended for improvement.
e. Implementation schedule for Action Plan to contain:
1. Activity-wise time schedule
2. Milestone for payments
3. Expected date of Commissioning
4. Delay and expected Risk
5. Monitorable quantified targets for reporting on outcomes.
iv. The Indicative chapters that may be included in the DPR is mentioned in
Annexure-I

2.1.9 Implementation Process & Timelines

i. PMA to invite project proposals for assistance under the scheme through newspaper
/website, setting a cut-off date for receiving applications.
ii. Applicants to submit complete project proposal in prescribed format to PMA.
iii. PMA to scrutinize the project proposals and submit it appraisal report with
recommendations to SSC within one month of the last day of receipt of application for
considering grant of in-principle approval.
iv. In-principle approval will be granted to those applicants who submit a complete project
proposal with technical recommendation and have availability of land.
v. Such 'in-principle' approval will be valid for a period of 6 months from the date of approval.
In case final approval is not accorded to the project within 6 months, in- principle approval
will automatically lapse, unless it is specifically extended by the SSC.
vi. PMA may guide the applicants, who obtain the 1st stage approval, to fulfill all necessary
conditions under the guidelines within 6 months.
vii. A project may be accorded final approval by the SSC, if the following conditions are fulfilled:
a. Establishment of project specific SPV;
b. Execution of shareholder’s agreement and other related agreements between the
SPV and its members;
c. Preparation of Project Proposal by SPV and its appraisal by PMA;
d. Procurement of requisite land by the SPV;
e. Establishment of project specific account with Scheduled Commercial Banks
by the SPV. DoP would credit funds into this account;
f. Tying up of sources of funds for the balance amount.
viii. Projects to be completed in 2 years. However, SSC can grant an extension of 1 year for
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 delays due to reasons not within control of SPV.
ix. In case of any deviation from the approved project proposal or time line, approval of DoP
must be sought for continuation of the project.

2.1.10 Selection Criteria

I. Preference in assistance will be given to project proposals by the SSC, based on category of
projects.
II. Preference in assistance will be given to those proposals which will utilize leverage for scaling
up production & financing of common cluster facility.

2.1.11 Schedule for release of Grant

i. The release of funds by the Department will be based on scrutiny by the PMA, approval by the
Scheme Steering Committee (SSC) in the following manner: -

Instalment Percentage Remarks/Pre-requisite

of Funds
1st 25  Raising of minimum 25% of SPV contribution and deposit in
the appropriate account.
 Signing of Indemnity Bond on final approval of the project by
SSC.
2nd 25  Against the production of Bills
 75% utilization of 1st instalment
 Proportionate expenditure incurred by the SPV.
3rd 25  Against the production of Bills
 100% utilization of 1st instalment
 75% utilization of 2nd instalment
 Proportionate expenditure incurred by the SPV.

4th 25  100% utilization of 2nd and 3rd instalment

 SPV has mobilized and spent its 100% share in proportion
to the first three grants.

ii. The SPV shall submit the Utilization Certificate (UC) in prescribed form, generated through
PFMS portal, duly certified by CA and countersigned by Head of SPV for the amounts utilized
in accordance with GFR-2017. Also, the expenditure details need to be uploaded in the CNA
module of PFMS before processing the case for subsequent instalments. Accounts of SPV
shall be subject to audit by the Comptroller & Auditor General of India.

2.1.12 Maintenance and ownership of assets

i. SPV shall be responsible for O&M of assets created under the scheme by way of
collecting user charges from the members/users;
ii. SPV shall ensure that the services of the facilities created under the scheme are
extended to the cluster in general, in addition to the member enterprises;
iii. The Assets acquired by the SPV out of government assistance shall not be disposed,
12
 encumbered or utilized for the purposes other than for which the funds have been
released.
iv. A register of permanent and semi-permanent assets acquired wholly or mainly out of
the funds provided by Government of India should be maintained as per GFR.
v. If for any reason SPV is liquidated, Government of India shall have the first right to
recover the grant funds provided by it. The assets created with such grant funds and
any unutilized fund shall be vested with the Central Government. The Memorandum of
Association & Articles of Association of the SPV with the Government shall incorporate
this provision.

2.1.13 Expected Benefits

i. Improvement in quality standards of medical devices

ii. Improvement in regulatory compliance specified for medical device
iii. Increased availability of trained personnel for Medical Devices clusters
iv. Increased competitiveness of Medical Devices units in the cluster
v. Reduction in the manufacturing cost of Medical Devices

2.1.14 Monitoring

I. The PMA shall carry out regular monitoring of the implementation of the scheme and each project
approved thereunder. The PMA shall prepare Monitoring Reports in the frequency and format
as decided by the SSC and assist the SSC and DoP in monitoring the Scheme.
II. PMA will provide full access to scheme monitoring portal to the Department of
Pharmaceuticals for monitoring purpose and shall monitor approved projects through physical
inspection, implementation schedule based on Program Evaluation and Review Technique
(PERT)/ Critical Path Method (CPM)/ Gantt Chart and submit monthly & quarterly reports of
review of the projects to DoP/SSC for timely disbursement and utilization of the funds.
III. PMA shall identify potential delays and failure of projects to meet deadlines and propose
corrective action as part of the Monitoring reports.

13
2.2 Assistance for Testing Facilities (TF)

2.2.1 Objective

To strengthen availability of more Medical Device Testing Laboratories in order to boost

manufacturing of quality medical devices.

2.2.2 Intended Beneficiaries and Eligibility Criteria

i. Central/ State Government or Private institutions interested to establish or strengthen

testing facilities for medical devices to test Class A, B, C and D medical devices including In-
vitro diagnostic medical devices under MDR, 2017.
ii. Such legal entity under the Indian law will open a separate account for the funds to be utilized
for the projects assisted under the sub-scheme.

2.2.3 Incentive under the scheme

For Testing Facilities (TF) of Medical Device (MD) products, the limit of support will be 70% of
the approved Testing Facilities project cost or Rs. 5 cr., whichever is less in case of state government
funded entities and 50% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, in
case of Private Institution, as per the approval of SSC. Any expenditure above the prescribed limit shall
be borne by the selected applicant.

2.2.4 Physical and Financial Outlay

Year Physical Target (In No.) Financial Outlay (Rs. in Crores)

Testing labs Testing labs
Year 1 0 0
Year 2 1-4 15
Year 3 5-8 15
Total 4-8 30

2.2.5 Modalities for utilization of incentive

i. The cost of project shall include cost of land, building, internal infrastructure, administrative
and management support expenses including the salary of Manager, Lab Technicians, Medical
Device Officers and other experts and staff during the project implementation period (before
commissioning), preliminary expenses, machinery & equipment, miscellaneous fixed assets
and other support infrastructure such as water supply, electricity and margin money for
working capital. However, Grant-in-Aid from DoP will not be utilized towards land and building
components of the project or construction of rest house, administrative buildings or any other
building, which in the opinion of SSC may be categorized as non-essential construction for the
technical requirements of project.
ii. In case, the Central/State Government or private Institution provides an existing land and
building, the cost of the same will be decided on the basis of valuation report prepared by an
approved agency of Central / State Government Departments / Financial Institutions (FIs) /
Public Sector Banks and the cost of land and building may be taken towards contribution for
the project.
14
 iii. In case, the Central/State Government or private Institution provides an existing land and
building on lease separately, then the minimum period of lease must be 30 years for both land
and Building. In case the National or State Government or private Institution provides an
existing land, building on the same land on lease, then the minimum period of lease for
combined land and building must be 30 years.
iv. Minimum of 50% of the approved project cost has to be contributed by private Institution for
the project & there is to be no duplication of funding for the same component/ intervention. For
the Central/State Government Institution, Minimum of 30% of the approved project cost has to
be contributed. The Central/State Government or private Institution may dovetail funds from
other sources as well for the project, provided there is no duplication of funding for the same
component/ intervention. Resource raised through such dovetailing will be in addition to the
50% contribution of the Institution.
v. Assistance for Administrative and other management support of the Institution during the
project implementation period shall not exceed 5 % of the Grant-in- aid.
vi. Proportionate contribution by the Central/State Government or Private Institution’s share
should be made upfront. Necessary infrastructure like land, access road, water and power
supply, etc. must be in place or substantial progress should have been made in this regard
before DoP assistance is released. Where bank finance is involved, written commitment of the
bank concerned to release proportionate funds will also be necessary before release of DoP
assistance.
vii. Escalation in the cost of project over and above the sanctioned amount, due to any reason will
be borne by the Central/State Government or Private Institution. The Central Government
shall not accept any financial liability arising out of operation of the testing facility.
viii. Central/State Government or Private Institution shall be responsible for obtaining all
necessary statutory clearances in a timely manner.
ix. User charges for services of Testing facilities will be graded in such a manner that average
charges will be lesser than prevailing market prices.
x. The Testing Facility may be utilized by the respective National or State Government or
Private Institution on ‘user charges’ basis as decided by it.

2.2.6 Eligible Activities: An indicative list of eligible activities, for the testing facilities for the MD
clusters, under this Scheme are as under:

i. Component Testing Centre for ESDM/PCB/Sensors facility

ii. Electro-magnetic interference & Electro Magnetic Compatibility testing lab
iii. Biomaterial / Biocompatibility /Accelerated Aging testing lab
iv. Electronic and Electrical measuring, calibration and testing center
v. AERB and NABL Certified X-ray Radiation testing lab
vi. Other Medical Devices testing lab etc.

2.2.7 Project Proposal and its components

i. The project proposal must have technical recommendation from competent technical body
(e.g. CDSCO/ National Institute of Biologicals (NIB)/ National Accreditation Board for Testing
and Calibration Laboratories (NABL), NIPERs/ IITs, Council of Scientific and Industrial
Research (CSIR), Sree Chitra Tirunal Institute for Medical Sciences and Technology
(SCTIMST) etc. may be the competent authority to grant technical recommendations). In case
of PMA / SSC not being satisfied with the technical recommendations, the PMA / SSC may
ask the SPV to obtain technical recommendations from specific competent experts.

15
 ii. Project proposal may include have the following details:

a. Details about the Medical Devices testing Facilities;

b. Benefit/Objective/ Salient features of the Medical Devices Testing Facilities
c. Premises showing location and area of the different sections;
d. Qualification, experience of technical staff employed for testing and the person in-
charge of testing;
e. List of equipment with specifications and their utilisation procedure;
f. Classes of medical Devices and list / type of tests that are proposed to be performed in
the facility along with the Procedure of testing going to be followed; This should contain
the Standards of Medical Devices – BIS or ISO or the respective Standards.
g. Tests and the purpose of the testing should also be furnished.
h. Type of support provided by Medical Devices Testing Facilities to manufacturer and
Medical Devices Industry.
i. PERT/Critical Path Method (CPM)/ Gantt Chart for completing the Medical Devices
Testing Facilities;
j. Action Plan for getting MD-40 issued by the CDSCO to get notified as MDTL under
MDR-2017.
k. Action Plan for getting accreditation certificate issued by National Accreditation Body
for Testing and Calibration Laboratories or any other similar body as may be notified
by the Central Government.
l. Details of Fees to be charged for Medical Devices product testing from users.
m. Operation & Maintenance plan of the Medical Devices Testing Facilities
n. Action plan for enhancing competitiveness of Medical Devices Testing Facilities and
positioning the Medical Devices Industry on a self-sustaining trajectory of growth. The
proposal will have direct linkages between the impediments/bottlenecks identified and
the measures recommended for improvement.
o. Implementation schedule to contain:

I. Activity-wise time schedule

II. Milestone for payments
III. Expected date of Commissioning
IV. Delay and expected Risk
V. Monitorable quantified targets for reporting on outcomes

2.2.8 Implementation Process & Timeline

i. PMA to invite project proposals for assistance under the scheme through newspaper / website,
setting a cut-off date for receiving applications.
ii. PMA will handhold applicants to get registered and notified as a Medical Device Testing
Laboratory to carry out testing or evaluation of a medical device on behalf of a manufacturer.
Application will be made to the Central Licensing Authority accompanied with a fee through
online portal of the Central Government as per the mandate under Medical Device Rules, 2017
and as per further amendments from time to time.
iii. PMA to scrutinize the project proposals and submit it appraisal report with recommendations
to SSC within one month of last day of receipt of application for considering grant of in-principle
approval.
iv. In-principle approval will be granted to those applicants who submit a complete project
proposal with technical recommendation and have availability of land.
16
 v. Such in-principle approval will be valid for a period of 6 months from the date of approval. In
case final approval is not accorded to the project within 6 months, in-principle approval will
automatically lapse, unless it is specifically extended by the SSC.
vi. PMA will guide the applicants, who obtain the 1st stage approval, to fulfill all necessary
conditions in the guidelines within 6 months.
vii. A project will be accorded final approval by the SSC if the following conditions are fulfilled:

a. Registration of Institution;
b. Business Plan including processes, final projections and financial viability report and
identification of impediments and bottlenecks
c. Execution of shareholder’s agreement and other related agreements between the
Institutions or Entrepreneurs in case of partnership, collaboration etc.;
d. Preparation of Project Proposal by Institutions or Entrepreneurs and its appraisal by
PMA;
e. Procurement of requisite land by the Institutions or Entrepreneurs;
f. Establishment of project specific account with Scheduled Commercial Banks by the
Institutions or Entrepreneurs. DoP would credit funds into this account;
g. Tying up of sources of funds for the balance amount.
h. Project Specific bank account shall be opened by Institutions or Entrepreneurs

viii. Projects to be completed in 2 years from the date of final approval of SSC. However, SSC can
grant an extension of 6 months for delays due to reasons not in control of the applicant.
ix. In case of any deviation from the approved project proposal or time line, approval of DoP must
be sought for continuation of project.

2.2.9 Selection Criteria

The selection of beneficiary will be based on appraisal by the PMA and recommendations of
the technical Committee. Decision of the SSC will be final.

2.2.10 Schedule for release of Grant

(i) The release of funds by the Department will be based on scrutiny by the PMA and
approval by the Scheme Steering Committee in the following manner:-

Installment Percentage Remarks/Pre-requisites

of
Funds
1st 25  Raising of minimum 25% of SPV contribution and deposit
in the appropriate account.
 Signing of Indemnity Bond on final approval of the project
by SSC.
2nd 25  Against the production of Bills
 75% utilization of 1st instalment
 Proportionate expenditure incurred by the applicant.

17
 3rd 25  Against the production of Bills
 100% utilization of 1st instalment
 75% utilization of 2nd instalment
 Proportionate expenditure incurred by the applicant.
4th 25  100% utilization of 2nd and 3rd instalment
 The Institution has mobilized and spent its 100% share in
proportion of the first three grants.
 Submission of Accreditation certification from
NABL/AERB and Notified as Medical Device Testing
Laboratory by Central Licencing Authority(CDSCO)

(ii) The Institution(s) or organization shall submit the Utilization Certificate (UC) in prescribed form
(GFR-12A), generated through PFMS portal, duly certified by CA and countersigned by Head of
Institution(s) or organization for the amounts utilized in accordance with GFR-2017. Also, the
expenditure details need to be uploaded in the CNA module of PFMS before processing the case for
subsequent instalments. Accounts of SPV shall be subject to audit by the Comptroller & Auditor General
of India.

2.2.11 Maintenance and Ownership of Assets

i. Institution(s) or organization shall be responsible for O&M of assets created under the scheme
by way of collecting user charges from the members/users;
ii. Institution(s) or organization shall ensure that the services of the facilities created under the
scheme are extended to the cluster in general;
iii. The Assets acquired by the Institution(s) or organization out of government assistance shall
not be disposed, encumbered or utilized for the purposes other than for which the funds have
been released.
iv. A register of permanent and semi-permanent assets acquired wholly or mainly out of the funds
provided by Government of India should be maintained as per GFR.
v. If for any reason Institution(s) or organization is liquidated, Government of India will have the
first right to recover the grant funds provided by it. The assets created with such grant funds
and any unutilized fund shall be vested with the Central Government. The Memorandum of
Association & Articles of Association of the Institution(s) or organization shall incorporate this
provision.

2.2.12 Monitoring

(i) The PMA shall carry out regular monitoring of the implementation of the scheme and each
project approved thereunder. The PMA shall prepare Monitoring Reports in the frequency
and format as decided by the SSC and assist the SSC and DoP in monitoring the Scheme.
(ii) PMA will provide full access to scheme monitoring portal to the Department of
Pharmaceuticals for monitoring purpose and shall monitor approved projects through
physical inspection, implementation schedule based on Program Evaluation and Review
Technique (PERT)/ Critical Path Method (CPM)/ Gantt Chart and submit monthly &
quarterly reports of review of the projects to DoP/SSC for timely disbursement and
utilization of the funds.
(iii) PMA shall identify potential delays and failure of projects to meet deadlines and
propose corrective action as part of the Monitoring reports.

18
CHAPTER-III:
3. Marginal Investment Scheme for Reducing Import Dependence Scheme

3.1 Objective

To promote domestic production of key components, raw materials and accessories used in
manufacturing of medical devices, including in-vitro diagnostic devices, in order to reduce
dependence of Indian medical device manufacturers on imported key components and raw
materials and increase the depth of our value chains.

3.2 Intended Beneficiaries

Central/ State Government Organizations, Companies/LLPs registered in India, Special Purpose

Vehicle (SPV) registered under Companies Act or Societies Registration Act to manufacture key
components / raw materials / accessories used in manufacturing of finished medical devices
including in-vitro diagnostic medical devices.

3.3 Eligibility Criteria

a) Medical devices/in-vitro diagnostic manufacturers having manufacturing facility and/or intending

to produce key components, input materials, accessories, which may reduce import
dependence and enhance the depth of domestic value chains

b) Manufacturers of critical raw materials such as polymer, glass, metal, textile, paper, etc., having
manufacturing facility and/or intending to manufacture medical grade raw materials or
components or accessories for use in manufacturing of medical devices/ in-vitro diagnostic
applications.

c) Manufacturers or importers who intend to manufacture any medical device or in-vitro diagnostic
equipment that is on the GTE list and whose manufacture would lead to reduced import
dependence.

3.4 Incentive under the scheme

3.4.1 The selected applicant will be incentivised through one-time capital subsidy on re-imbursement
basis for manufacturing key components/ raw material/ finished devices/ accessories to reduce import
dependence as per the table below: -

S. No Turnover of the company Eligible incentive

1 Up to 250 crore 20% of investment in the project or 10 crore
whichever is less.
2 250 crore to 1,000 crore 15% of investment in the project or 10 crore
whichever is less.
3 Above 1,000 crore 10% of investment in the project or 10 crore
whichever is less.

3.4.2 Central/State Government Organizations will be supported with a grant of 20% of the investment
in the eligible project or 10 crore, whichever is less.

19
3.5 Physical and Financial Outlay

Financial Financial Outlay (Rs. in

Physical Target (no.)
Year Crore)
Facilities for key components, raw materials or Grant-in-Aid
accessories used in the manufacturing of
medical devices
Year 1 0 0
Year 2 15 90
Year 3 15 90
Total 30 180

3.6 Modalities for computation of incentive

a) The total cost of project may include cost of land, building, internal infrastructure, machinery &
equipment, miscellaneous fixed assets and related utilities such as water supply, electricity,
steam etc. However, subsidy or grant from DoP will be computed strictly on the basis of fixed
investment excluding land costs.
b) Escalation in the cost of project over and above the sanctioned amount, due to any reason, will
be borne by the Central/ State Government or Private Institution or the Manufacturer. The
department shall not accept any financial liability arising out of operations.
c) The Central/ State Government or Private Institution or the Manufacturer shall be responsible
for obtaining all necessary statutory clearances in a timely manner.

3.7 Eligible Activities:

An indicative list of key components, raw materials, accessories used for manufacturing of
medical devices/in-vitro diagnostics is given at Annexure-II. The SSC will be empowered to
include additional items and/or revise the list as per exigencies from time to time and/or approve
additional items beyond the list, if recommended by the technical committee after scrutiny of the
applications received in this regard.

3.8 Project Proposal and its components

Project proposal may include, but not limited to have the following details: -

a. Details about the proposed manufacturing facility.

b. Benefit/Objective/ Salient features and rationale to justify how the produced key
component, raw material, and accessories will reduce import dependence.
c. Premises showing location and area of the different sections.
d. List/segment of medical devices/in-vitro diagnostics for which the key components/raw
materials/accessories are proposed to be manufactured.
e. Market size of the key components and other materials/ accessories used in
manufacturing of finished medical devices.
f. PERT/CPM/ Gantt Chart for completing the manufacturing facility.
g. Action Plan for getting statutory approvals for the manufacturing facilities.
h. Details of expected increase in Domestic Value Addition in the finished medical device.

20
 i. Operation & Maintenance plan of the project.
j. Action Plan for making the project self-sustaining.
k. The impediments/bottlenecks identified and the measures recommended for
improvement.
l. Implementation schedule to contain:

I. Activity-wise time schedule

II. Milestone for payments
III. Expected date of Commissioning
IV. Delay and expected Risk
V. Monitorable quantified targets for reporting outcomes

3.9 Implementation Process & Timeline

i. PMA to invite project proposals through newspaper/website and set a cut-off date for receiving
applications.
ii. PMA shall handhold applicants to get application registered for manufacturing key
components, raw materials, accessories used in manufacturing of finished medical devices to
reduce import dependence.
iii. PMA to scrutinize the proposals and submit its appraisal report with recommendations to the
Technical Committee within one month for in-principle approval by SSC.
iv. In-principle approval will be valid for a period of 6 months from the date of approval. In case
final approval is not accorded to the project within 6 months, in-principle approval will
automatically lapse, unless it is specifically extended by the SSC.
v. A project may be accorded final approval by the SSC if the following conditions are fulfilled:
- Business plan including processes, final projections and financial viability report, identification
of impediments and bottlenecks
- Execution of agreement and other related agreements between Institutions or entrepreneurs
in case of partnership, collaboration etc.;
- Procurement of requisite land by the applicant;
vi. Project Specific bank account shall be opened by the applicant.
vii. Projects to be completed in 2 years from the date of final approval of SSC. However, SSC can
grant extension for one year for delays due to reasons not in control of the manufacturer.
viii. In case of any deviation from the approved project proposal or time line, approval of DoP must
be sought for continuation of the project.
ix. PMA shall be allowed to inspect the manufacturing facility if required and the applicant shall
make the required documents/ assets available to the PMA or its authorized agency for
purpose of verification.
x. Applicant may be required to furnish an undertaking as decided by the SSC.

3.10 Selection Criteria

i. Preference in assistance will be given to project proposals by SSC based on appraisal of

project proposals by the PMA and TC.
ii. Preference will be given to those proposals which will lead to substantial reduction in import
dependence and contribute to more domestic value addition.

21
 3.11 Schedule for release of grant/subsidy

The release of funds by the Department will be based on scrutiny by the PMA, recommendation
of Technical Committee, and approval by the Scheme Steering Committee

Disbursement Remarks/Pre-requisites
1. After full completion of the project and commissioning of the
10-20% of the project cost or product.
Rs.10 crore whichever is less 2. Submission of certificate from Chartered Engineer
on re-imbursement basis. empaneled by the PMA verifying the plant and machinery
installed.
 3. Submission of Certificate from Statutory Auditor empaneled
by the PMA for Investment made under eligible heads by the
applicant in the manufacturing facility and First Sales
Invoice.
4. Verification report by the PMA.

3.12 Maintenance and Ownership of Assets

i. The Central/ State Government or Private Institution or the Manufacturer shall be

responsible for O&M of assets created under the scheme.
ii. The Assets acquired by the Institution(s) or organization out of government assistance shall
not be disposed of, encumbered or utilized for purposes other than for which the funds have
been released.
iii. If for any reason, Institution(s) or organization is liquidated during the implementation of the
project, Government of India will have the first right to recover the grant funds provided by it.

3.13 Monitoring

3.13.1 The PMA shall carry-out regular monitoring of the implementation of the scheme and each
project approved thereunder. The PMA shall prepare Monitoring Reports in the frequency and
format as decided by the SSC and assist the SSC and DoP in monitoring the Scheme.
3.13.2 PMA will provide full access to scheme monitoring portal to the Department of
Pharmaceuticals and shall monitor approved projects through physical inspection,
implementation schedule based on Program Evaluation and Review Technique (PERT)/
Critical Path Method (CPM)/ Gantt Chart and submit monthly & quarterly reports of the projects
to DoP/SSC for timely disbursement and utilization of funds.
3.13.3 PMA shall identify potential delays and failure of projects to meet deadlines and
propose corrective action as part of the monitoring process.

22
CHAPTER-IV
4. Capacity Building and Skill Development in Medical Device Sector Scheme

4.1 Objective

The main objective of the component is to fill the gap existing in the education and research in
medical devices sector and to ensure quality teaching, training and nurturing excellence in Medical
Technology education for generating critical mass of trained human resource to meet the
requirements of rapidly innovating multidisciplinary areas of Medical Technology and create R&D
ecosystem for the sector.

4.2 Intended Beneficiaries and Eligibility Criteria

• Govt. universities/ institutes offering Postgraduate/PG Diploma/ Graduate/ Diploma/

Certificate courses in medical devices.
• Students willing to work in the medical device sector.
• Existing work force(regulators/technicians) already working in medical device sector.

4.3 Components of the scheme:

The Scheme has the following two components:

4.3.1 Component A: Support for running post graduate courses (MS/MTech/ PG-Diploma) in
Medical Devices in existing institutes.

Financial assistance will be provided to Center Government Universities/Institutes for running multi-
disciplinary post-graduate courses in medical device with objective of building infrastructure for
education and research in medical devices and developing skilled workforce adaptable to
changing requirements of Medical Device sector. These would be advanced level courses
designed to train the students in multidisciplinary areas of MedTech. The teaching courses would
be supported in the areas of Life Sciences and Biotechnology covering broader areas of basic
sciences, medical, engineering, pharmacology, and allied areas with focus on specialized and
new/emerging areas of medical devices which need to be incorporated as electives and core
courses for imparting quality education and hands on training in Medical Technology. The Course
curriculum would be approved by the relevant competent authority for the University/ Institute as
per guidelines laid out in National Education Policy, 2020 (NEP- 2020) and National Credit
Framework and in accordance with the expertise of core/collaborating faculty.

Admission of the students will be made through competitive examination open to students from
medical, engineering, IT and Pharmaceutical backgrounds. Department of Pharmaceutical will
provide up to 75% of the cost of the course or Rs 21 Cr., whichever is lower, on reimbursement
basis. The remaining 25% of the cost will have to be borne by the institute concerned.

4.3.2 Component B: Capacity development in Medical Devices - design, production and testing

Financial assistance will be provided to the Central/State Government Universities/Institutes and

Private Institutions (approved by NCVET) for running diploma, certificate and short- term training
courses for existing workforce (clinical technicians, regulators) of medical device industry,
students from pharmacology, engineering, technology and medical background willing to work in
23
 medical device industry to equip them for the medical device sector and make them compatible
with the requirements of the industry on reimbursement basis. Financial support based on the
number of students (Rs. 25,000/student/month for diploma and Rs 10,000/student/month for
certificate/ skill development training programs) will be provided to the trainee institute for the
number of students enrolled.

4.4 Base Year: Financial Year 2023-24.

4.5 Annual Utilization Certificate - The release of grants-in-aid on reimbursement basis and the
terms and conditions thereof including submission of utilization certificates shall be subject to the
provisions of General Financial Rules.

 Each year a simple statement of accounts giving the funds received and expenditure
incurred by 31st March needs to be submitted for release of the first instalment for the
next year duly signed by the Accounts Officer of the Institute/ PMA.
 An audited statement would be essential for release of the next instalment of the annual grant
from the second year onwards.

4.6 Final Settlement of the Accounts- The final settlement of the Accounts, which will be done only
after the receipt of the following:

 Final audited statement of expenditure

 Final utilization certificate
 List of equipment procured for the project along with their cost, date of purchase, and
suggestions for disposal.

The grant paid by the DoP shall be refunded by the institution as and when the programme is
discontinued midway or the detailed conditions as laid down and approved by the DoP are not
followed. All raw data (in all forms) should be made available/accessible to DoP, if needed.

4.7 Integrity Compliance: Integrity compliance refers to the systematic and conscientious efforts
taken by individuals, organizations, or entities to ensure that their actions, decisions, and operations
are conducted in a manner that upholds high ethical standards, honesty, transparency, and legality.
It involves implementing policies, processes, and controls to prevent and detect any behaviours or
practices that could compromise integrity, such as corruption, fraud, conflicts of interest, and other
unethical conduct. Integrity compliance aims to create a culture of integrity within an organization
and maintain the trust of stakeholders while also ensuring compliance with relevant laws and
regulations. An undertaking to be submitted by both PMA & Institute as described in Annexure-III.

4.8 Eligibility criteria

Central Govt. Institutes having facilities in either one or more disciplines identified under the focus
areas of the scheme (Medical Devices) by the DoP & PMA.

The applicant institutions will be selected based on their Proposals for financial assistance for
Postgraduate (MSc/MTech/ PG Diploma) and Certification/Training courses submitted in the
prescribed format, highlighting the learning outcomes against each course-curriculum, core or
optional, and the practical-hands-on- exposure given to the students on pre- defined objective criteria
to assess their eligibility.

24
4.8.1 Component A: Support for running post graduate courses (MS/MTech/ PG-Diploma) in
Medical Devices in existing institutes

Support to up to 4-8 selected Central Government institutions/ year [for 3 batches] for
running PG coursework for Students [batch size of 30] selected by the Institution through their
approved admission process. Department of Pharmaceutical will provide up to 75% of the cost of
the course or Rs 21 Cr., whichever is lower, on reimbursement basis. Out of which, up to Rs. 15 Cr
as non-recurring expenses for infrastructure/Lab Equipment & machinery and Rs. 6 Cr as recurring
expenses for salary, wages, and consumables etc. will be provided to an Institute. The remaining
25% of the cost will have to be borne by the institute concerned.

4.8.1 Eligibility Criteria:

4.8.1.1 Government University/Institution should have in house faculty members or may hire
Professor of Practice/ Industry Expert faculty necessary for running the course for
proposed teaching program in Medical Technology for a batch strength of 20-30
students/year.
4.8.1.2 The institute must also have teaching facilities for other inter-related courses, viz., medical
science, manufacturing, medical electronics, mechanical/electrical engineering,
bioengineering, Information Technology, Pharmacology, IP and departments imparting
education in allied areas at the premise or in collaboration with other institutes.
4.8.1.3 Institutions will have flexibility to draw structure / content of course with mandatory inclusion of
course component inputs shared by DoP as specified in Annexure-IV.
4.8.1.4 It will be ensured that course curriculum is approved by the relevant competent authority
for the University/ Institute and in accordance with the expertise of the core/collaborating
faculty and Course curriculum should be in line with National Education Policy, 2020
(NEP 2020) and credits for course should be as per National Credit Framework (NCrF)
with mandatory component as mentioned in Annexure-V
4.8.1.5 The selected institutions should incorporate the recommendations provided by DoP, as
outlined in Annexure-VI into their coursework.
4.8.1.6 Critical equipment for initiating the course. A suggested list of lab equipment necessary
to initiate the course has been attached in Annexure-VI
4.8.1.7 The Institute must provide the laboratory experience at the premises or in collaboration with
other institutions. Students should be directed to common instrumentation facilities,
wherever feasible, to prevent duplication of resources and for optimum utilization of the
facilities available.
4.8.1.8 The institute must provide clinical immersion (1-2 months) and apprenticeship (3-6 months)
for the students.
4.8.1.9 Shortlisted Institution should have adequate supporting staff like laboratory assistants/
attendants, LDC/UDC/Stenographer, Peon etc.
4.8.1.10 Shortlisted Institute should meet Eligibility Criteria (such as Infrastructure etc.) as attached in
Annexure-V.
4.8.1.11 Admission of the students will be made by the individual institutes, as per the standard
process adopted by them to admit graduate students from medical, engineering, IT and
pharmaceutical background etc. Selection procedure should ensure the selection of
diverse cohort of students.

4.8.2 Financial mechanism:

4.8.2.1 Financial support up to 75% of the cost of the course or Rs 21 Cr., whichever is lower, will be
25
 given to existing central government institutions on reimbursement basis, having the
necessary infrastructure (building, space, lab etc.) and faculty to start the course. Support
for non- recurring expenditure (for upgradation of the existing infrastructure and lab
equipment) and for recurring expenditure (consumables, contingency, salary & wages,
etc.) will be provided for running the courses. The remaining 25% of the cost is to be
borne by the Institution itself.
4.8.2.2 Grant of up to Rs. 15 Crore for non-recurring expenses will be given to the institute to
upgrade its infrastructural facilities as relevant/required for conducting the
coursework, while up to Rs 6 Crore for recurring expenses such as salary, wages and
consumables etc., as considered necessary by the PMA/SSC.
4.8.2.3 The quantum of the amount of grant will depend on the quantum of facilities to be
upgraded / newly established as identified by the PMA and Steering Committee.
4.8.2.4 Financial assistance would be for the upgradation of facilities for conducting
coursework on Medical Devices for training.
4.8.2.5 The grant will be released (as reimbursement) to the Head/Director of the institute,
utilization certificate will be furnished by the institute to DoP & PMA.
4.8.2.6 The Institute will maintain a separate account of the funds received under the scheme
and will furnish the audited statement of accounts, carried out by ‘statutory audit body’
of the institute.
4.8.2.7 Faculty support up to 2+1 years (Scheme Financial Outlay) will be provided as
reimbursement basis to the universities/ institutes for running multi-disciplinary courses in
medical devices, with approval of the competent authority concerned subject to written
commitment by the institute to sustain the faculty through their own resources before the
end of the scheme. An undertaking will be submitted by the Institution as per Annexure-
III.

4.9 Component B: Capacity development in Medical Devices - design, production Quality

testing and regulation

Support to selected Central/State Government Universities/institutions and Private Institutions

(approved by NCVET) to provide Diploma to Students/ trainees/ existing workforce [batch size of
20] selected by the Institution through their examinations under this scheme in Medical Devices.
Department of Pharmaceutical will provide financial support as reimbursement basis up to Rs.
25,000/month per Student for diploma.

Support to selected Central Government institutions/ year [for 3 years] to provide Short-Term
training courses of 6 months to trainees/ existing workforce [batch size of 20 for 6 months I.e.,
40/year] selected by Institution on the basis of their evaluation criteria. Department of Pharmaceutical
will provide financial support up to Rs. 10,000/month per Student for these Short-Term training
courses.

7 to 15 selected institutions will be provided financial support based on the number of students (Rs.
25,000/month for diploma and Rs 10,000/student for certificate/ skill development training programs)
on reimbursement basis to the trainee institute for the number of students enrolled.

Some of these short-term courses can be offered in various formats, such as Hybrid mode or as
online MOOCs etc. as well as through evening/weekend batches allowing individuals to
conveniently manage the coursework alongside their current job without the need to leave their
present employment. All the Diploma, Certificate/ Short Term Skill Development Courses should
be as per NEP 2020 guidelines, aligned to NCrF and must be affiliated with the awarding body
26
 approved by approved by National Council of Vocational Education and Training (NCVET).

4.9.1 Eligibility and Selection of Institutes

4.9.1.1 Institutes/ organizations imparting training must have necessary infrastructure facilities for
training of about 20-30 candidates.
4.9.1.2 Institute/organization must have strong industry linkages for training of candidates for
hands on training and to provide a holistic learning experience.
4.9.1.3 Expertise and Experience: Institutes with proven track records of organizing successful
diploma /certificate / Graduate/ PG courses in the past 5 years, especially related to
pharma-MedTech sector would be given preference.
4.9.1.4 Curriculum and Course Offerings: Courses that cover topics such as medical device
testing & design, manufacturing processes, quality assurance, medical device
regulation, IP regulations etc. Each course offered under this Scheme should be
affiliated with relevant awarding body approved by NCVET and must be compliant to
NEP 2020 guidelines and National Credit Framework.
4.9.1.5 Availability of faculty and instructor: Qualified, trained faculty and instructor along with
guest faculty from industry would be encouraged.
4.9.1.6 Industry Partnerships and Collaboration: Number of MoU signed with industry in past 5
years, number of trainings done with industry, post training recruitment rate, etc.
4.9.1.7 The selected institutions will incorporate the suggested coursework as outlined in
Annexure-IV.
4.9.1.8 Shortlisted Institute should meet Qualifying criteria mentioned in Annexure-VII.

4.9.2 Financial mechanism:

4.9.2.1 Financial support based on the number of students Rs. 25,000/month for diploma and
Rs 10,000/month for certificate/ skill development training programs will be provided
to the trainee institute for the number of students enrolled.
4.9.2.2 The amount will be reimbursed to the parent institute for the expenditure incurred by the
institute in running the course. SSC may decide on the cost components which may be
admissible towards reimbursement and may also stipulate conditions for running the
course, such as maximum fees that may be charged from the trainees. The parent
institute will submit utilization certificate under the GFRs for the expenditure incurred.
4.9.2.3 The amount released under the scheme will be kept in a separate account by the
institute concerned and a separate account of expenditure will be maintained.
4.9.2.4 The institute shall submit the utilization report and audited statement of accounts
carried out by the statutory body of the institute.

4.10 Support can be withdrawn from Universities/Institutions under following conditions-

 If the total number of students admitted in a particular academic session is less than
50% of its intake.
 If the core faculty strength is less than applicable student teacher ratio
 Any administrative difficulties in running programme
 Delay in implementation of the program.
 Unable to impart quality teaching and training to students based on their feedback to DoP.

4.11 Selection of the applicants:

27
  Selection of the applicants in each component will be governed by the parameters given in
Annexure- V & VII
 All eligible applicants shall be ranked based on marks obtained in the evaluation criteria as
given in Annexure - V & VII
 The applicant securing highest marks shall be ranked 1, followed by applicant securing
second highest marks and so on.
 The selection of the applicants shall be in the order of their ranks.
 If two or more applicants have the same score, the applicant having higher marks in respect
for academic criteria will be ranked higher for component A. As regard Component B, the
institutes with higher industry recruitment rate will be ranked higher.
 Number of applicants to be selected: Component A: 4-8/ Component B: 7-15

4.12 Physical and Financial Outlay

Physical Target (no.) Financial Outlay (Rs. in crore)

Financial Total
Year Component Component -
Component - A Component - B Grant-
-A B
in-Aid
Year 1 0 1-7 0 0 0
Year 2 1-4 1-7 42 8 50
Year 3 5-8 8-15 42 8 50
Total 4-8 7-15 84 16 100

4.13 Call for Application:

 The applicant is required to submit the application as per the form prescribed in
Annexure-VIII to the PMA.
 The Scheme will be open for applications during the Application Window which is 30 days
twice in a year (No application shall be accepted after the end of the Application
Window.)
 A period of 30-40 days will be considered as application under scrutiny after the closure
of application window.
 An applicant needs to submit the application in the format as at Annexure-VIII.
 On the receipt of an application in the prescribed format, PMA will conduct an examination
as per the checklist. The aforesaid examination shall be completed within 30 working days
from the date of the receipt of the application or any subsequent submission of the revised
application if the original application was returned as incomplete earlier. Thereafter, the
PMA shall issue an acknowledgement of receipt of the application. This acknowledgement
shall not be construed as approval of the Scheme.
 In case, on the above-mentioned examination, an application is found to be incomplete,
PMA shall inform the applicant accordingly within 30 working days of receipt of the
application. An applicant must complete an incomplete application within 30 days of such
communication from PMA, failing which the application will be closed under intimation to
the applicant.

4.14 Approval and disbursement of funding under the Scheme

 An application, complete in all aspects, will have to be submitted before the due date.
28
 Acknowledgement will be issued by PMA after initial scrutiny of the application.
 The eligible applicants will be appraised on an ongoing basis and considered for approval,
based on predefined selection criteria. PMA may seek advice from the Advisory Committee
for technical assistance on same.
 The funding shall be released to the selected participants under the scheme who meet the
required criteria on reimbursement basis.
 Timely disbursals of funding by the PMA will be monitored by DoP and reviewed by the
Steering Committee, subject to budgetary allocations.
 The funding will be provided as defined in scheme guidelines in respect of a maximum
period of 2+1 years from the date of approval.
 The progress in approval of applications and disbursal of funding shall be monitored on
an on-going basis against the monitoring framework to be specified in the guidelines.
 The PMA shall recommend two (02) waitlisted applicants, if available, along with selected
applicants for each target segment.
 All the applications will be finalized within 60 days from the date of closure of the
application window.
 After receiving approval from the DoP, the PMA will issue a letter to the selected applicant
within 5 working days, communicating approval under the Scheme. The approval letter
shall clearly mention the following:

i. Name of Applicant
ii. Course(s) Selected
iii. Funding Allocated
 The selected applicant shall submit, within two weeks of the date of issuance of approval
letter by the PMA, the details of No lien account on bank’s printed letter head as per
Annexure-IX.
 The aforesaid approval letter shall not be construed as a guarantee for disbursement of
incentive as the same will be dependent upon verification of eligibility after submission of
disbursal claim and other criteria defined in these guidelines.
 If the selected applicant is found to be ineligible at any stage, or if it has not compiled with
notifications, orders, guidelines etc., of the Scheme, or declines the offer of the approval
under the Scheme at any stage, for any reason, the offer letter issued shall stand
cancelled. In such case, the offer shall be extended to the waitlisted applicant for the period
remaining.
 For claiming incentive under the Scheme, applicants will be required to submit claims for
disbursement of incentive to the PMA. Applicants must ensure that the claims are complete in
all respects and are accompanied by all the documents required as per prescribed format and
made available on the online portal.
 An applicant may submit a claim for disbursement of incentive on an annual basis. Claims
for any period shall be made only once, unless withdrawn, and no subsequent part claims
shall be allowed for the said period.
 Claims for disbursement of incentive shall be filed along with supporting documents within one
month of the closure of the given financial year. If the claim is found to be in order, same shall
be released after submission of final audited account and UC.
 The PMA shall examine and verify eligibility and assess incentive payable to an applicant
based on the method laid down in these guidelines and the approval letter issued to the
applicant.
 The PMA may seek the advice of the Advisory committee for technical assistance. PMA will
29
 have the right to verify any document(s) in relation to the claim for incentives, including but
not limited to Statutory Auditor or Independent Chartered Accountant certificates,
whichever is applicable, and returns furnished to various Ministries / Departments/
Agencies.
 The PMA will have the right to carry out physical inspection of an applicant’s institute
through site visit, if and when directed by SSC.
 In case of any doubt with respect to determining eligibility and incentive amount due, or
any other matter in discharge of its duties and responsibilities, the PMA may refer such
matter to DoP for clarification and the decision of DoP shall be final in this regard
 The PMA shall process claim for disbursement of incentive within 60 days from the date of
receipt of such claim and make appropriate recommendations to SSC.
 SSC will consider claims for disbursement of incentive, as examined and recommended
by the PMA:
a. PMA will maintain a separate Bank Account for receipt of funds from DoP related to the
incentives and make disbursements of incentive amount to the applicants upon approval
of the claim by DoP. All interest earned on this account shall accrue to the Consolidated
Fund of India.
b. PMA shall disburse the incentive through direct transfer (via PFMS) after approval of the
claim and completion of all pre-disbursal formalities by the applicant.
 DoP shall make budgetary provisions for disbursal of incentives under the Scheme. The PMA
will submit budgetary requirements to DoP as a consolidated amount on quarterly basis.
 The PMA shall furnish applicant wise statement of all claims received, processed and
approved and all incentives, disbursed and pending, to DoP on quarterly basis.

4.15 Monitoring and Evalution

The work and progress of the scheme will be evaluated periodically by the PMA and the
Department of Pharmaceuticals.

4.16 Project Administration

As regard administration of the scheme, a Project Management Agency (PMA) will be

appointed by the Department of Pharmaceuticals. No regular posts need to be created at the PMA
specifically for the purpose.

4.17 Implementing Agency

The scheme will be implemented by DoP, which will exercise overall managerial control. The
funds for implementation of the scheme in respect of approved projects /proposals will be released
by DoP.

4.18 Terms and Conditions:

The general and specific category-wise terms and conditions of the Scheme are as per
Annexure III to X.

4.19 Role of PMA

The scheme shall be implemented and monitored through a Project Management Agency (PMA)

30
which will be responsible for providing secretarial, management and implementation support and to
carry out other responsibilities as assigned by DoP within the framework of scheme and guidelines
thereof. The PMA, on behalf of DoP, will be responsible for receipt and appraisal of applications,
verification of eligibility and examination of disbursement claims through any method / document deemed
appropriate and or managing the above-mentioned in accordance with these guidelines.

The PMA shall be responsible, inter alia, for:

4.19.1 Development and maintenance of dashboard for:

COMPONENT A

 Enrollment of students, completing coursework and being

successfully placed.
 Number of Faculty available in the institution for the course.
 Course Design – Elective and compulsory subjects.
 Record of Students Any startup / entrepreneurship idea incubated or formulated.
 Placement Report of Students.
 Feedback Evaluation on Coursework Component for posterity.

COMPONENT B

 Enrollment of the students and their completing coursework

 Record of professionals trained on Quarterly / Yearly basis
 Record of professionals absorbed in Industry and Salary Increments, if any
 Feedback Evaluation on Coursework Component for posterity

4.19.2 Industrial Training Output Monitoring

 Regularly review the scheme's objectives and make necessary

adjustments based on feedback and changing needs.
 Incorporate new technologies and advancements in medical
technology to keep the training up to date

4.19.3 Track Enrollment and Participation Rates

 Monitor the number of students and professionals enrolling in the program.

 Track participation rates to ensure a sufficient pool of candidates are benefitting from the
scheme.

4.19.4 Retention Rate and Completion Rates

 Monitor the retention rate of enrolled candidates throughout the training period.
 Track the completion rate of students successfully finishing the training program

4.19.5 Feedback from Trainees

 Conduct regular surveys to gather feedback from trainees about the quality and relevance
31
 of the training.
 Use the feedback to make improvements and address any concerns.

4.19.6 Employment and Placement Rates

 Track the rate of successful employment and placement of trainees after completing the
training.
 Assess the scheme's impact on enhancing employability and career opportunities for the
participants.

4.19.7 Employer Feedback

 Gather feedback from employers who hire graduates of the training program.
 Evaluate their satisfaction with the skills and knowledge of the trainees.

4.19.8 Skill Enhancement and Knowledge Upliftment

 Evaluate the skill enhancement and knowledge upliftment of trainees through pre and post-
training assessments.
 Analyze how the training has helped in filling knowledge gaps and improving practical skills.

4.19.9 Follow-up with Alumni

 Establish a follow-up system to track the progress of alumni in their careers.

 Measure their success and contribution to the medical technology field after completing the
training.

4.19.10 Gender Inclusivity

 Monitor the representation of both genders in the training program.

 Assess efforts to ensure gender inclusivity and equal opportunities for all.
4.19.11 Long-term Outcomes

Monitor the long-term impact of the scheme on the medical technology sector, including
advancements and innovations contributed by the trained professionals.

4.19.12 Comparison with Industry Standards

 Benchmark the training program against industry standards and best practices in medical
technology education.
 Identify areas for improvement to align with international standards.

4.19.13 Public Awareness and Outreach

 Assess the effectiveness of public awareness and outreach campaigns to promote the
scheme among potential candidates.
 Measure the scheme's visibility and its impact on attracting eligible participants

32
4.19.14 Application Monitoring

 Preparing operating procedures for processing, scrutiny, appraisal, verification, etc., as per
procedure/established practice and getting them approved from DoP.
 Receiving and processing of applications against the qualification and evaluation criteria for
the purpose of selection of participants.
 Inspection of the institute if required by the SSC

4.19.15 Departmental Support

 Placing the appraisal reports of shortlisted participants before the DoP for its concurrence.
 Preparation of agenda papers for meetings and providing secretarial assistance to DoP for the
same.
 Periodic submission of data at various stages of the scheme to DoP which includes
compilation of data on cumulative progress done by selected applicants.
 Providing all necessary documents and information as may be required for the conduct of
mid-term and end-of-term evaluation of the scheme. Providing utilization certificates in the
prescribed format wherever applicable from applicants.
 A dynamic dashboard/registry of all outgoing candidates exiting through the post-
graduate/diploma/certificate programs along with their skill sets and other details will be
maintained

4.20 Completion of documentary formalities and issuance of approval letter to all selected
institutes. Outcome of the scheme will be evaluated based on number of the manpower educated/
trained, number of manpower hired in the industry, number of start-ups created, number of IPs filed,
etc.

33
CHAPTER-V
5. Medical Device Clinical Studies Support Scheme

5.1 Objective

To support the medical device industry by fostering development of devices supported by clinical
evidence and generation of clinical data that demonstrates the safety and efficacy of the devices
manufactured in India. This will promote manufacturing of quality products with better efficacy and safety.
It will also enhance credibility of domestic manufacturers to produce high quality products, opening up
opportunities for them in markets outside the country.

5.2 Intended Beneficiaries

(i) Medical device manufacturers, having manufacturing facility in India, intending to generate pre-
clinical data by means of animal studies to demonstrate safety and performance of an investigational
medical device in animal models.
(ii) Medical device manufacturers, having manufacturing facility in India, intending to conduct clinical
investigation on human subjects to generate clinical evidence to demonstrate safety and performance
of an investigational medical device.
(iii) Medical device manufacturers, having manufacturing facility in India, intending to conduct Post
Market Clinical Follow-up (PMCF) studies on human subjects to generate clinical evidence to
demonstrate safety and performance of a medical device.
(iv) In-vitro diagnostics manufacturers, having manufacturing facility in India, intending to conduct
clinical performance evaluation on clinical samples to generate clinical evidence to demonstrate clinical
performance of a new in-vitro diagnostic medical device.
(v) Institutes of national importance like NIPERs, IISER, IITs, AIIMS, IISc, etc., and other reputed
Central Institutes or Laboratories involved in design and development, or in pre-clinical evaluation, or in
the clinical investigation or clinical performance evaluation of medical devices or IVDs.

5.3 Eligibility Criteria

(i) Medical device manufacturers, having manufacturing facility in India, involved in design and
development of an investigational medical device are eligible to apply to conduct animal studies as part
of pre-clinical study. Applicant should be holding a test licence issued under the provisions of the Medical
Devices Rules, 2017.

OR

(ii) Medical device or in-vitro diagnostic manufacturers, having manufacturing facility in India,
involved in design, development and manufacturing of an investigational medical device or a new in-
vitro diagnostic medical device, are eligible to apply to conduct clinical investigation or clinical
performance evaluation, as the case may be. Applicant should be holding permission to conduct clinical
investigation or clinical performance evaluation issued under the provisions of the Medical Devices Rules
2017.

OR

34
(iii) Medical device manufacturers, having manufacturing facility in India, involved in manufacturing
of class C and class D medical devices are eligible to apply to conduct Post Market Clinical Follow-up
studies. Applicant should be holding permission to conduct such study, as per regulatory norms, if any.

OR

(iv) Institutes of national importance like NIPERs, IISER, IITs, AIIMS, IISC etc. and other reputed
Central Institutes or Laboratories may conduct the clinical investigation / clinical performance evaluation
themselves or through any Clinical Research Organization approved by the Regulatory Authority. The
Startups working in the Incubation Centres under these Institutes may also apply through these
institutes.

5.4 Incentive under the scheme

The department will provide financial support in conducting clinical investigation/clinical performance
evaluation/Post Market Follow-up Study/animal studies to the eligible applicants as referred to in clause
5.3, in the form of grant on re-imbursement basis as per the following criteria:

 Pre-Clinical Studies - Rs. 2.0 crore or 25% of the expenditure incurred, whichever is less;
 Clinical Investigations – Rs. 5.0 crore or 25% of the expenditure incurred, whichever is less;
 Post Market Clinical Follow-up – Rs. 1 crore or 25% of the expenditure incurred, whichever is
less;
 Performance Evaluation of new IVDs – Rs. 1 crore or 25% of the expenditure incurred,
whichever is less;

5.5 Terms for disbursement of incentive

i. The cost of project should include cost of conducting single or multi sites clinical
investigation/PMCF. Expenditure incurred for subject enrolment, principal investigator fee, etc.
may be claimed for re-imbursement. The expenditure incurred for manufacturing the devices/new
IVD samples used during study will not be eligible for re-imbursement.
ii. Escalation in the cost of project over and above the sanctioned amount, due to any reason
will be borne by the applicant. The department will not accept any financial liability arising due to
delay in conducting/completion of clinical studies covered under these guidelines.
iii. The applicant shall be responsible for obtaining all necessary statutory clearances in a
timely manner.
iv. The incentive under the scheme shall be disbursed on reimbursement basis on
submission of statutory auditor certificate for the expenditure incurred during study and proof of
publication of clinical study results. In case where applicant is an Institute of national importance
like NIPERs, IISER, IITs, AIIMS, IISc, etc., or any other reputed Central Institute or Laboratory, the
expenditure incurred shall be certified by their respective finance/account wing.
v. Mere approval of the proposal by the Scheme Steering Committee for consideration of
the support does not guarantee disbursement of grant to the applicant. Disbursement of the grant
will be subject to fulfilment of conditions under which approval is granted and its verification by the
Project Management Agency up to the satisfaction of the SSC.
vi. The applicant will be required to sign undertaking/agreement as may be approved by the
SSC.
vii. The applicant shall make available all records which may be sought by PMA for purpose
of verification, allow PMA access to facilities which have been used in the study and
individuals/authorities who may have been involved in the project.
35
 viii. Re-imbursement of expenditure incurred will be restricted to Clinical Studies conducted
within India.

5.6 Eligible Activities

A list of eligible activities, under this Scheme is as under:

i. Clinical investigation of an investigational medical device.

ii. Clinical performance evaluation of the new in-vitro diagnostic medical devices.
iii. Conduct of animal studies as part of pre-clinical activity for investigational medical devices.
iv. Conduct of Post Market Clinical Follow-up studies for the devices approved under provisions
of Medical Devices Rules 2017.

5.7 Project Proposal and its components

Project proposal should have the following details:

a. Detailed process of conducting Clinical Investigations or Pre-Clinical animal studies for

medical device or Clinical Performance Evaluation of new IVDs.
b. Expected gains from the clinical investigation / clinical performance evaluation.
c. Complete cost estimates for the proposed study and other activities till rolling out of the
project.
d. Expected number of patients who will be benefitted in the study.
e. Expected overseas regulatory approvals for market authorization of the product with the help
of clinical data generated from the study.
f. Approved Protocol by CDSCO for conducting clinical investigation/clinical performance
evaluation/PMCF study.
g. Permission to conduct clinical investigation/clinical performance evaluation/PMCF study
issued under provisions of Medical Devices Rules 2017.
h. Identification of impediments and bottlenecks.
i. Implementation schedule in the Action Plan to contain:

1. Activity-wise time schedule

2. Milestone for payments
3. Expected date of Commissioning
4. Delay and expected Risk
5. Monitorable quantified targets for reporting outcomes.

5.8 Implementation Process & Timelines

i. Eligible applicants should submit complete proposal for conducting Clinical

Investigations/PMCF or Pre-Clinical animal studies for medical device or Clinical
Performance Evaluation of new IVDs
ii. PMA will scrutinize the proposals and submit its appraisal report with recommendations to
the Technical Committee constituted for the evaluation of the proposals within one month.
iii. PMA shall submit the proposals, complete in all aspects, along with the recommendation
of the Technical Committee to SSC for final approval.

36
 iv. Approved clinical investigations/animal studies/clinical performance evaluation, shall be
completed within 3 years or as per the approved timeline by the CDSCO. However, SSC
can grant an extension of 1 year for delays due to reasons not in control of applicants.
v. In case of any deviation from the approved project proposal or time line, approval of DoP
must be sought for consideration of financial support to the project.
vi. Financial support for clinical studies under this scheme may also be obtained along with
support from Indian Clinical Trial and Education Network (In-TENT) initiatives of the ICMR.
However, any duplication of financial support for the same purpose should be avoided.

5.9 Selection Criteria

I. Project proposals will be considered by SSC based on category of medical devices/new

IVDs for which clinical studies are being conducted.

II. Preference in assistance will be given to those proposals which involve conduct of clinical
investigation for investigational medical devices or for clinical performance evaluation for
new in-vitro diagnostic medical devices or where the medical device under study is
intended to be used for rare diseases, national health priorities and reducing dependence
on import of high end medical devices.

5.10 Physical and Financial Outlay

Financial Outlay
Physical Target (no.)
(Rs. in crore)
Year Support to pre-clinical studies, clinical investigation for medical
device and clinical performance evaluation for in-vitro Grant-in-aid
diagnostic medical device
Year 1 0 0
Year 2 20-30 50
Year 3 30-60 50
Total 30-60 100

5.11 Schedule for release of Grant

The release of funds by the Department will be based on scrutiny and verification by the PMA with
approval of the Scheme Steering Committee (SSC) in the following manner: -

Grant-in-Aid disbursement on
Pre-requisites
reimbursement basis
 Final approval of the project by SSC.
 Performance Evaluation of new IVDs  Verification of the records and documents by
– Rs. 1 crore or 25% of the the PMA.
expenditure incurred, whichever is  The expenditure incurred on new studies
less; taken up after the date of approval by the SSC
 Pre-Clinical Studies - Rs. 2 crore or will only be considered.
25% of the expenditure incurred,  Submission of Certificate from Statutory
whichever is less; Auditor along with supporting documents
such as receipts in respect of total
37
  Clinical Investigations – Rs. 5 crore expenditure incurred by the applicants for
or 25% of the expenditure incurred, conducting Clinical Investigations or Pre-
whichever is less; Clinical animal studies for medical device or
 Post Market Clinical Follow-up – Rs. Post Market Clinical Follow-up or Clinical
1 crore or 25% of the expenditure Performance Evaluation of new IVDs.
incurred, whichever is less;  Publication of the clinical data of Clinical
Investigation/Post Market Clinical Follow-up/
Clinical Performance Evaluation.
 Any other condition laid down by the SSC at
the time of approval of the proposal.

5.12 Maintenance and ownership of assets/data

i. The assets/data acquired by the applicant out of government assistance shall not be
encumbered or utilized for purposes other than for which the funds have been released.
ii. The clinical data generated through the study shall be maintained by the applicant for a
minimum of 20 years and such data shall be made available to any Government agency
as and when asked.

5.13 Expected Benefits

i. Improvement in quality standards of medical devices.

ii. Improvement in regulatory compliance specified for medical device
iii. Increase in export of Medical Devices based on Clinical Investigations or Pre-Clinical
animal studies for medical device or Post Market Clinical Follow-up Clinical Performance
Evaluation of new IVDs
iv. Promotion of domestic Contract Development and Manufacturing Organizations
(CDMOs) industry.

5.14 Monitoring

i. The PMA/DoP shall carry out regular monitoring of the implementation of the scheme and
each project approved thereunder. The PMA shall prepare Monitoring Reports in the
frequency and format as decided by the SSC and assist the SSC and DoP in monitoring
the Scheme.
ii. PMA will provide full access to the scheme monitoring portal to Department of
Pharmaceuticals and shall monitor approved projects through physical inspection,
implementation schedule based on Critical Path Method / Gantt Chart and submit monthly
& quarterly reports.
iii. PMA shall identify potential delays and failure of projects to meet deadlines and propose
corrective action as part of the monitoring process.

38
CHAPTER-VI
6. Medical Device Promotion Scheme

6.1 Objective

The scheme has two main objectives. The first objective is to promote Medical Device Industry
by bringing industry leaders, academia and policy makers together to share their knowledge and
experience for overall development of the sectors. The other objective of the scheme is to facilitate
growth and development of the sectors through conducting studies, organizing awareness programs,
creation of databases and promotion of industry.

6.2 Intended Beneficiaries

The medical devices industry in India will be the beneficiary of this scheme. Grants will be provided
to any of the following: -

a. Recognized Industry associations and bodies.

b. Organizations/Firms with track record in conducting studies/survey etc. in medical devices and
related sectors.
c. Government/quasi-government agencies with relevant experience.
d. Department may also directly incur expenditure on industry development activities.

6.3 Eligible Activities

(i) Preparation of study reports on topics of importance for Indian Medical Device industry.
(ii) Support to Medical Devices Organizations and Bodies to organize seminars, conferences,
conventions, workshop & exhibitions (all such sessions individually referred to herein as the
“Event”).
(iii) Non-financial Logo support for Medical Devices events.
(iv) Creation of Database for the medical device sector.
(v) Organizing Mega events like annual India Medical Devices meet/ Medtech Expo and participating
in other national or international events.
(vi) Organize events for promotion and development of Medical Device Industry
(vii) Support Bodies under the department such as Export Promotion Council for Medical Devices in
their activities

6.4 Preparation of study/survey reports on topics of importance for Indian Medical Device
Industry / Creation of Database for the medical device sector

This will include conducting studies/surveys & preparation of reports/database etc. by professional
agencies of repute. The applications shall be invited through PMA on topics of importance for Medical
Device industry as given to them by DoP. PMA will scrutinize the applications and submit its
recommendation to SSC for approval and release of grant by the department will be as per following
norms:

(i) The study/survey reports will be done through firms empanelled with NITI AAYOG or equivalent
organizations (Ministries/Departments of Government of India), recognized industry
associations, non-profit companies/ organizations, Private companies of repute and Government
agencies.
39
(ii) DoP may implement this component through agencies selected on nomination basis. However,
such agencies will be Government Autonomous bodies, PSUs or Government academic
institutions.

6.5 Release of grants for preparation of study/survey reports

The applications shall be invited by PMA through an open and competitive bid, unless it is
decided to nominate an agency as per para 19.4(ii) above. The PMA will scrutinize the applications and
submit its recommendation to SSC for approval. If the grant is approved, it would be released in three
instalments by the department as per following norms: -

(i) 30% will be issued along with sanction order after executing surety bond in the prescribed format.
(ii) 30% grant will be released on submission of the draft report along with executive summary. If
required, presentations need to be arranged before the Department before this instalment is
released.
(iii) Final instalment of 40% will be released on submission of the final report and its acceptance
there on (10 hard copies and soft copies).
(iv) Any study report funded by the Government under the Scheme will be the property of the
Department of Pharmaceuticals. This will be suitably acknowledged and shall not be used for
any commercial purpose by the organization conducting study/ survey.

6.6 Support to Medical Device Associations / Bodies to organize seminars, conferences,

workshop & exhibitions etc. in the form of grant in Aid

This will include organization of seminars, workshops, conferences, conventions, exhibitions,

investor’s meet, trainings, knowledge improvement programs/activities etc. on issues/subjects relevant
to Development of Medical Devices sectors.

6.7 Organizations eligible for Grant

a. Government agencies such as academic institutions and autonomous bodies/ PSUs under the
Department in Medical Device and related sector.
b. National/ State level Industries Associations in Medical Device and related sector.
c. Bodies under the department such as Export Promotion Council for Medical Devices
d. Any specialized organization having demonstrated expertise in the field in which proposed
event is to be organized.

6.8 Implementation process

Eligible organizations seeking financial assistance shall apply at least 60 days prior to the
proposed event on online portal. Preliminary proposals giving details of the proposed event, topic/theme
of the knowledge dissemination event, likely speakers and participants and other details such as venue,
likely date etc. will be required to be submitted. PMA will scrutinize the applications received on online
portal and submit its recommendation to SSC for approval and release of grant by the Department.
Grant-in-Aid under this component may be given upto Rs. 10 lakhs for a single event.

40
6.9 Physical Target and Financial Outlay

Financial Outlay
Financial Year Physical Target (no.)
(Rs. in crore)
Year 1 1-8 2
Year 2 9-15 4
Year 3 16-23 4
Total 15-23 10

6.10 Organize of seminars, conferences, workshop & exhibitions on the Initiative/Subject

suggested by the Department

(i) For program being organized by Government Departments/ Institutions/ Agencies and for
program organized by autonomous bodies, private agencies, industry associations, private
institution, bodies under the department on the initiative/subject suggested by the Department
full funding (100%) may be provided subject to realistic assessment of income and expenditure
for the event and availability of budget
(ii) For activities organized by autonomous bodies, private agencies, industry associations, on their
own initiative and having relevance to the mandate of the Department, assistance may be
provided for not more than 75% of the cost of the event, with the concurrence of IFD.
(iii) For mega events, viz., India Medical Expo and other international events organized jointly by
Department of Pharmaceuticals, the grant-in-aid will be worked out based on the estimates
furnished and the parameters like expenditure incurred in the past by organizers etc. with the
concurrence of IFD.

6.11 General conditions for availing Grant/Assistance.

(i) The grantee institutions would comply with the provisions of GFR 2017 as applicable and would
comply with the instructions regarding EAT (Expenditure, Advance, Transfer) module of PFMS
(Public Financial Management System) as issued by Ministry of Finance from time to time.
(ii) In case of conferences/workshops etc., the organization should agree to the participation of at
least two Technical/Administrative officer(s) from Department of Pharmaceuticals free of charge
as full delegates.
(iii) Department’s fund will not be used for providing boarding/lodging, travel of speakers and
delegates, any expenditure of recurring nature, and grant would not be released to an event
manager.
(iv) All organizations receiving assistance under the Scheme will submit Utilization Certificate in GFR
12A format by 30th June of the subsequent financial year.

6.12 Terms and conditions for payments

The Grant-in-Aid will be released on submission of the following information /documents to PMA-

(i) Confirmed date of the event/programme.

(ii) Disclosure of sources of funding.
(iii) Confirmation from the organizers that no Utilization Certificate is pending in respect of previous
grant(s), if any, availed from this Department.

41
 (iv) Organizations receiving Grant for this component will be required to submit a report within two
months after organization of the event on following lines: -

(a) Proceedings of the event.

(b) Copies/cutting of advertisements/publicity done.
(c) List of participants.
(d) List of resource persons with topics/presentation by them.
(e) Suggestions/Queries of participants, if any.
(f) Outcome of the event/recommendations for various stakeholders.
(g) Performance-cum-Achievement Report.
(h) Follow up action taken/to be taken.
(i) Details of actual expenditure and income earned (from all sources) after the event duly
certified by Charted Accountant.
(j) Utilization Certificate in the prescribed proforma duly signed by the Head of the
Organization.

6.13 Logo Support

Request for Logo Support of the DoP, inauguration /delivery of keynote Address by the
Minister/MOS/Secretary /other senior Officers of DOP, Co-sponsorship by DOP without financial
commitment, participation by officers of the Department as delegates should be specifically mentioned
in the proposal clearly indicating profile of the organizations, performance of the past event, salient
features of the current event, details of participants, list of speakers and other relevant information.
Organizations will be permitted to use the Logo of the Department for display on publicity material as
well as during the event with the prior approval of the Department. The Organization will have to ensure
that while displaying the Logo of the Department of Pharmaceuticals, all the provisions of the Notification
G.S.R. 643 (E) dated 4th October, 2007 of the M/o Home Affairs regulating the use of the State
Emblemof India and time-to-time guidelines and conditions in this regard are strictly adhered-to. The
organization would be expected to submit a report within two months of the event, outlining the
proceedings, list of participants, recommendations, if any.

6.14 Creation of Database, MIS and IT Enabled systems for Medical Devices sector to enable
informed policy decisions and program formulation

Under this component grant will be provided to the Government Organizations / agencies with
proven expertise for creation of data base, MIS and /or IT enabled systems for the medical device sector.
Funds will be transferred to select implementing agency either in form of Grant-In-Aid or budgetary
allocation as the case may be. Suitable mechanism for selection of agency, monitoring and reporting of
progress will be developed by PMA in consultation with Department of Pharmaceuticals under the
supervision and guidance of SSC.

6.15 Organize any activity not covered under above components

Under this component Grant-in-Aid may be given to eligible organizations for organizing any
industry facilitation and support measures, help desk, Advisory Forum and Development Committee
meetings, etc. and any other activity, which may be decided with the approval of Secretary, Department
of Pharmaceuticals in consultation with Financial Advisor of the Department.

Awards may also be given to encourage Startups, Innovators, Industry and similar entities for
excellence in Medical devices sector in manufacturing, research, innovation, academic etc.
42
6.16 Expected benefits

The objective is to bring awareness about the policies and schemes of the Government and
promote Medical Device Industry within the country as well as outside. Events supported under the
scheme will bring industry leaders, academia and policy makers together to share their knowledge and
experience for overall development of the sector. Also identifying problems/issues faced by the industry
and possible solutions by way of workshops, seminars etc. Further, the studies and other activities are
aimed at creating knowledge base about the sector The impact of these awareness, consultative and
knowledge building initiates may not be directly linked to any physical output. Providing financial
assistance to agencies will lead to promotion of investment & growth of medical device sector and will
benefit the Meditech industry.

6.17 Monitoring

The PMA will monitor the implementation of the scheme component and ensure that study
/survey reports are to the satisfaction of Department of Pharmaceuticals. Department will directly monitor
that beneficiaries getting grant in aid under this scheme component achieve the desired results and
comply the norms under the guidelines, along with the financial rules.

**** ***** ****

43
 Annexure-I
Indicative chapters that may be included in the Detailed Project Report (DPR) to apply
under the sub-scheme of Common Facilities for Medical Devices Clusters

S. No. Contents
1.0 SPV Details with Checklist (minimum of 5 Medical Devices units, Medical Devices
enterprises shall hold at least 51% equity of the SPV.)

2.0 Introduction
3.0 States: Diagnostic Study
3.1 Demographic Profile
3.2 Existing Infrastructure
3.3 Enterprise Profile
3.4 Market Characteristics
3.5 Raw Material Sourcing
3.6 Product Mix
3.7 Industry Analysis
3.8 Weak Supply of Raw Material (based on Project)
3.9 Slow Growth in Market (based on Project)
4.0 Need Assessment
4.1 Quality Assurance and Standardization
4.2 Availability of Raw Material (based on Project)
4.3 Access to Technology (based on Project)
4.4 Access to Market (based on Project)
4.5 Human Resource (based on Project)
4.6 Access to Funds (based on Project)
4.7 Description of Project (based on Project)
4.8 Project Rationale (based on Project)
4.9 Location of the Project (based on Project)
4.10 Management Details
5.0 Potential Entrepreneurs
5.1 Member Activity Description

44
Sl. No. Contents
6.0 SWOT Analysis Of The Project
7.0 Proposed Project Components
7.1 Common Facility (based on Project)
7.2 Research and Development with Pilot Plant (based on Project)
7.3 Common Logistic Centers (based on Project)
8.0 Development of Project (based on Project)
8.1 Phase wise progress plan
9.0 Project Financials (based on Project)
9.1 Land Availability, Requirements & Proposed Utilization (based on Project)
9.2 Utilities Requirement Estimates (based on Project)
9.3 Details of Building and Estimates (based on Project)
9.4 Details of Land Development Expenditure (based on Project)
9.5 Details of Machinery, Equipment and Estimate (based on Project)
9.6 Details of Preliminary Expenses (based on Project)
9.7 Details of Pre-operative Expenses (based on Project)
9.8 Quality Control Testing Laboratory (based on Project)
9.9 R&D Centers (based on Project)
9.10 Clean Room & HVAC (based on Project)
9.11 Common Logistic Centre (based on Project)
9.12 Utility (based on Project)
9.13 Common Effluent Treatment Plants (CETPs) (based on Project)
9.14 Other necessary common Facilities requirement of the project (based on Project)
9.15 Details of Expenditure of Administrative (shall not exceed 5 % of the Grant-in-aid)
(based on Project)

9.16 Cost Paid for Land (based on Project)

9.17 Means of Finance (based on Project)
9.19 Description of fund Raising (based on Project)
10.0 Financial Appraisal of Project (based on Project)
10.1 Appraisal framework and objectives (based on Project)

45
Sl. No. Contents
10.2 Proposed Revenue Generation (based on Project)
10.3 Details of Expenditure (based on Project)
10.4 Expenditure of material (based on Project)
10.5 Expenditure of Utilities (based on Project)
11.0 Project Implementation (based on Project)
11.1 Implementation Schedule (based on Project)
11.2 Project operations (based on Project)
11.3 Expected Escalation in the cost of project over and above the sanctioned amount
11.4 Common Facilities user charges (lower fee for
small units and higher fee for medium ones) (based on Project)

11.5 MoU entered into among GOI, the State Government concerned and the SPV for
CFC
projects.
12.0 Benefits to the Stake Holders (based on Project)
12.1 Benefits to Cluster Members (based on Project)
12.2 Benefits to Pharma Sector (based on Project)
12.3 Benefits to the State (based on Project)
12.4 Economic Evaluation
12.5 Cost Minimization analysis
12.6 Cost Effectiveness Analysis
12.7 Cost benefit Analysis
12.8 Cost Utility Analysis
13.0 Impact on the Environment (based on Project)
14.0 Conclusion (based on Project)
15.1 Annexure 1 – ROC with Board Of Directors
15.2 Annexure 2 ( Property Documents )
15.4 Location of Plot
16.0 Annexure 3 ( Land Photo)
17.0 Annexure 4 ( Plan Copy )
19.0 Annexure 5 ( Sources Of Funds Bank Letter& A/C Statement )
20.0 PERT Chart (based on Project)
21.0 GANTT Chart (based on Project)
22.0 Annexure 6 (Financial Projections )

46
 Annexure-II
Indicative list of Key Components/ Raw Material /Accessories

1. Sensors or sensor modules used in diagnostic equipment

2. Embedded system software / Standalone software used in/for medical devices
3. Closure and containers for capital equipment
4. Syringe Dispensing Pump/ peristaltic pumps
5. Turbine system/compressor pump for ventilators
6. Optical Filters for diagnostic / IVD equipment
7. Electrodes (Na+, K+, cl+, Ca+, pH+, Ref)
8. Antigen/Antibodies for detection of various Analytes
9. Microwell plates
10. Detectors for medical imaging equipment except flat panel detector
11. Primers and Probes for IVD Kits
12. Nitrocellulose (NC) membrane used in Lateral Flow IVDs
13. Haemodialysis membranes
14. Polymer Tubing components for disposable medical devices
15. Metal Tubing Components for implants
16. Acrylic Blanks/sheets for Intraocular Lenses
17. Speech Processors for hearing aids/hearing implants
18. UHMWPE Raw material (sheet/bar)
19. Stainless steel/Carbon steel and Titanium alloys materials used as raw material in
medical devices manufacturing
20. Medical grade packaging material
21. Medical grade polymer granules/powders

Note: This is an indicative list, an applicant may apply for any other key component /
raw material /accessory, however, the application will be reviewed by the Technical
Committee for eligibility of the component/ raw material / accessory.

47
 Annexure-III

Undertaking from the Institute

We, [Institute Name], hereby undertake the following conditions for availing the Scheme
Financial Support on reimbursement basis to hire faculty to run the multi-disciplinary
courses in medical devices for a duration of up to 4 years:

 We understand that the financial support will be subject to compliance with the
guidelines and regulations set forth by the scheme's governing authorities.
 Regular progress reports and updates will be submitted to the concerned
authorities to demonstrate the effective utilization of the financial outlay and the
successful implementation of the courses.
 We commit to sustaining the faculty appointed for the multi- disciplinary courses
by utilizing our own resources before the end of the scheme's duration.
 In the event of any changes or deviations from the proposed plan, we will
promptly inform the competent authority and seek their approval.

[We hereby agree to abide by the above-stated conditions and acknowledge that an
undertaking, as above will be submitted to the competent authority to formalize our
commitment.]

Authorized Signatory:

[Name]
[Designation]
[Institute Name]

[Date]

48
 Annexure-IV

Selected Institute to incorporate the following areas in their coursework

The following areas may be covered in medical device courses:

For Component A (PG Course):

Mandatory Foundational Courses:

1. Regulatory and quality compliances in medical devices

2. Foundation of human biology for medical devices

A minimum of 4 Foundational Courses selected from the following options (1-6) must
be incorporated:

i. Mathematical modelling in medical device perspective (CAD/CAM etc)

ii. Materials in biomedical devices/engineering
iii. Basics in biosensors and bioelectronics
iv. Basics in design aspect of medical devices
v. IoT and machine learning in medical devices
vi. Cell and Molecular biology and bioinformatics in medical device perspective

Indicative list of specialization courses which can be included in the program:

i. Designing and prototyping of Medical Devices

ii. Advance Biomaterials
iii. Advanced fabrication approaches in medical devices
iv. Clinical translation of medical device
v. Medical imaging
vi. Tissue engineered medical device.
vii. Biomechanics
viii. Artificial organs
ix. Mathematical modelling and biological system controls in medical devices
x. In vitro diagnostics: principle and instrumentations
xi. Pre-clinical models (in vitro and in vivo)
xii. Additive manufacturing
xiii. Fluidics in medical devices
xiv. Bioelectricity
xv. Medical imaging
xvi. Bio-nanotechnology
xvii. Diagnostics and IVDs
xviii. Regenerative medicine
xix. Artificial intelligence in medical device
xx. Medical instrumentation

It is expected that a program will offer six foundational courses and two courses for any
of the specialization areas.

49
For Component B (certificate course)

Broad areas of Certificate Course should cover these themes only:

i. Testing of medical device (safety and standards)

ii. Design aspect of medical device
iii. Medical Device regulation
iv. Additive manufacturing (3D printing)
v. Electronics assembly for biomedical machining
vi. Production machining
vii. Quality assurance for manufacturing
viii. Maintenance of robotics machinery
ix. Analytical skills of calibration and validation
x. Compound assembly
xi. Fluidics in biomedical devices

50
 Annexure V

Parameters for Evaluation of Proposals Received for DoP Support under PG Program
in Medical Devices

[Component A] Name of the University/Institute:

Name of PG Course Proposed:

Name of Program Coordinator/Representative:

S. Criteria Weightage Remarks

No. (Total 100 of TF
Marks)
(A) Faculty 20

1. University/Institution should have a course relevant

faculty (either by teaching experience or
qualification) dedicated for the proposed teaching
program in Medical Devices.
(B) Course Curriculum 10

2. Syllabus should be in accordance with the model

course curriculum inputs shared by DoP and in
accordance with NEP 2020.
3. Learning Outcome:
(a) Hands on training and skill set proposed to be
provided
(b) Existing Industrial Partnership and Practical
Training (Industrial visit, Workshop, Industrial
Training Output Monitoring)
(c) Entrepreneurship Skills proposed to be Imparted

(C) Collaboration 5

4. Existing Collaboration, if any, with education/

research institute for Medical Device courses
 Academic collaboration
 Research collaboration
5. Student Exchange
 Existing Program
 Existing academic exchange collaboration
 Industrial training program

(D) Research Ecosystem in Medical Devices and similar 20

area

51
6.  Areas of Research & Development to be
specified.
 Existing Patents
(Filed/Granted/Commercialized)
 Research infrastructure
a. Laboratories (at least 2 in number) for practical to
accommodate minimum 20-30 students at a time.
b. Lecture halls/rooms (at least 2 in numbers) for
theory classes with the capacity of 20-30
students at a time.
c. One storeroom and one library room in the
Department.
d. One Room for Head of the
Department/Coordinator and 4 Rooms for other
core faculty members
e. One seminar/conference room.
f. Supporting staff like laboratory
assistants/attandants, LDC/UDC/Stenographer,
Peon etc.
g. Research papers/Joint Research Publication and
citation
h. NRF Ranking No. of Technology:
Developed/Perfected/Transferred/Commercialize
d
i. Entrepreurship Education and Training : Status of
Incubator
(E) Linkage Developed with Industry for Skill 15
Training (Summer/Winter Training) as per standards of
Sector Skill Councils
7. Skill Training Modules aligned with coursework

8. Existing Industrial Partnership and Practical

Training (Industrial visit, Workshop, Industrial
Training Output Monitoring)
9. Expert Engagements
 Guest lectures by Industry Experts
 International faculty
(F) Placement Strategy for Students enrolled in Medical 10
Device and similar field

10. Placement Support for industrial placements

11. Strategy for Engagement of Student in Higher
Studies (PhD and Post Doctoral):

12. Facility for Training and Hand holding Support for

Entrepreneurship

13. Career Counselling

(G) Any Other 20

52
14. Past Workshops (of medical device and similar area)
 Hands on training
 Workshops
 Industry expert talks
TOTAL 100

53
 Annexure-VI

Tentative List of Basic Instruments Required for initiating Medical Devices

Course and Testing Laboratory

1. Computational facility- Computers (routine and high-end)/software (CAD/CAM

etc)/servers/projectors/classroom aided materials/etc.
2. Biosensor and Bioelectronic lab- Material synthesis (basic
stirrers/ovens/furnace),FTIR/electrochemical analyser/multimeter/power supplies/precision
hand tools/soldering iron tools/oscilloscope/function generator/analog circuit-based
generator/etc.
3. Material fabrication facility-weighing balance/magnetic
stirrer/electrospinning/solvent baths/3d-printer/lathe machine/injection
moulding/plasma coater/lyophilizer/polymer extruder/FE-
SEM/SEM/TEM/AFM/UTM/contact angle/rheometer/ etc.
4. Cell and molecular biology lab- Cell culture lab (CO2 incubator/laminar
flow/microscope/centrifuge/refrigerated centrifuge/water bath/electrophoretic unit/RT-
PCR machine/transfer blot/nano drop/UV visible spectrophotometer/multimode
reader/incubators/etc.

54
 Annexure-VII

Parameters for Evaluation of Proposals Received for DoP Support under Diploma/
Short-Term Training in Medical Devices [Component B]

Name of the University/Institute:

Name of Diploma/ Training Course Proposed: Name of Program

Coordinator/Representative:

S. Eligibility Criteria Weightage

No
1 Academic Need 15
 Certified faculty – Trained and Certified by relevant awarding
body (approved by NCVET)
 Existing diploma, certificate and short- term training courses.
 Existing Training courses in IPR, regulatory affairs, and
medical devices or any similar fields if any.
 To initiate Courses in Following Areas
[Regulatory/Pharmacology/IPR/Quality Control and
Assurance/ Good Practices (GMP, GCP,
etc.Medical Instrumentation, Maintenance and Repair]
2 Existing Infrastructure 20
o Advanced Technology in Medical Device and similar arena
o Safety and Necessary equipment
o Availability of functional lab, library,
classroom for training of 20-30 students with facility of in-house
and on- spot training for the trainee
3 Placement
 Previous track record of placement
 Placement Cell in Institution for support 15
 Career Counselling
4 Earlier training program
 Quality training
 Workshops / Hands on Experience 15
 Support & Resources
5 Proximity to Medical Device industrial area 10
for Industrial Visit and Inhouse-Training
6 Customized training according to Industrial
demand/ market Demand
 Training based on market demand.
 Entrepreneurship Skills and start up ecosystem 10
developed.
 Industrial Training Output Monitoring
7 Existing Collaboration
 Industrial partnership (particularly with medical device
industry/hospitals)
 Industrial expert talks
 Industry academic collaboration 15
 Hand’s on Training
 MoU’s with stakeholders in Industry/Academic/Government
Total 100

55
 Annexure-VIII

Department of Pharmaceuticals Ministry of Chemical and Fertilizers Government of

India

CALL FOR PROPOSAL FOR STARTING CAPACITY BUILDING AND SKILL

DEVELOPMENT IN MEDICAL DEVICE SECTOR SCHEME IN MED-TECH PROGRAMME
IN PARTNERSHIP WITH DEPARTMENT OF PHARMACEUTICALS

The Department of Pharmaceuticals, Ministry of Chemical and Fertilizers is seeking

proposals from Indian Institutions for establishment of Training Centers under DoP
Human Resource Development Programme in Medical Technology.

Programme Activities: The Department of Pharmaceuticals will provide support for

following components under DoP Human Resource Development Programme in Medical
Technology:

i. Students’ Training Programme

ii. Technician Training Programme
iii. Refresher Course/Faculty Training Programme
iv. Entrepreneurship Development Training Programme
v. Medical Technology Finishing School Programme

Training Centre: Facilities in universities/institutes could be suitably modified and

strengthened to act as a Training Centre. This center will be expected to impart quality skill
training and enhance the job opportunities in the Medical Device sector.

Who can apply?

 Central University, Central autonomous Institute, Central Training Institute,

Research Institute, with proven track record of conducting teaching/ training
programmes in Medical Technology and related areas.
 The programme implementing University, Training Institute, Research Institute
and State Councils/Organization should have requisite networking and linkages
with other academic and research institutions to take advantage of existing
expertise.

How to Apply?

Interested institutions/agencies/organizations should submit the proposal in prescribed

format to PMA appointed by DoP within 30 days. Also visit the DoP website
https://pharmaceuticals.gov.in/ for complete information and format for submission of
proposal.

56
 Checklist for preliminary assessment of Institute

S. Parameter Data as per Comments from

No. Applicant PMA
1 Name of applicant
2 Application submission date
3 Details of the applicant:
 Type of Institute
(Autonomous/Independent/Deemed
to be University)
 Student already enrolled
 Recruitment Rate
 Faculty employed to different courses
4 Detail of course proposed
5 Course Structure
6 Details of Infrastructure in the institute
(Faculty/ Research facility Equipment/
Other supporting staff an d basic
infrastructure- Classroom/
7 Auditorium etc.
8 Detail of past MoU signed with the
9 industry/academic institution
10 NIRF Ranking

PMA is authorized to make physical inspection and examine the document and
as when required as per direction of SSC.

57
 Annexure-IX

DETAILS OF NO LIEN ACCOUNT

(To be furnished on bank’s printed letter head)

Ref. No. and Date:

Subject: No Lien account opened in favour of M/s _______for Course titled

“___________” under Capacity Building and Skill Development in Medical Device Sector
scheme.

Sir/ Madam,

At the request of M/s--------------------------------------------- , we have to advise you that we

have opened a separate no lien account bearing No in our books for the purpose of
crediting the
financial assistance aggregating to Rs. ---------- (Rupees -------------------- only) sanctioned
by you which may be availed of by the Institute under Capacity Building and Skill
Development in Medical Device Sector Scheme for Course entitled “---------------------------
-----------------” and the Course cost component put in by the Institute amounts to Rs. ------
---- (Rupees only).
We confirm that the said total sum of Rs. -------------- (Rupees ----------------- lakhs only), as and
when received by us either in part or in full, will be credited by us to the said no lien account
and that we will not exercise or claim any right of set off or lien on any balance lying to the
credit of the said account.
It is confirmed that we had not taken any other undertaking from the account holder contrary
to the certificate issued hereto.
We further confirm that we shall furnish to the PMA/ Department of Pharmaceuticals, as
and when required by it, a certified true copy of the No Lien Account.

Yours faithfully,
Chief Manager (Name & Seal of
the Bank)

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 ANNEXURE-X

Proforma for Integrity compliance of Scheme

(To be signed by full time Director/ Registrar / Head of Institute, Head of PMA depicting
the designation and submitted on official stationery of the applicant along- with the
authorization to do so)

FORMAT-A

1. Whereas, the applicant namely (Director/ Registrar / Head of Institute, Head of

PMA) has submitted an application under Capacity Building and Skill
Development in Medical Device Sector Scheme for Pharmaceuticals,
Government of India released on 8.11.2024 by Department of Pharmaceuticals
(DoP) seeking application pertaining to running Postgraduate Coursework in
Medical Devices.
2. Now, therefore, the applicant including its officers / representatives commits and
undertakes that he / she will take all measures necessary to prevent corruption. He
/ She commits to observe the following principles during his / her association /
engagement with DoP or its agencies or its consultants engaged with the process of
appraisal and verification of application for the approval of application and
disbursement of incentives:
a. The Selected applicant/PMA will not directly or through any other person or firm,
offer, promise or give to any of the DoP's officer(s) or consultant or agency
representative (appraisal or / and verification agency appointed by DoP to handle
the application) involved in the process of dealing with application or to any third
person any material or other benefit which he / she is not legally entitled to in order
to obtain in exchange any advantage of any kind whatsoever before or during or after
the process of the application for grant of approval or disbursement of incentives
under Scheme.
b. The Selected applicant/ PMA will not commit any offence under the relevant IPC
/ PC Act; Further, the applicant will not use improperly, for purposes of competition
or personal gain, or pass on to others, any information or document provided by
the DoP.
c. The Selected applicant shall disclose the name and address of the duly authorized
Agents
d. Representatives who will be dealing with DoP or its agencies and the
remuneration of these agents or representatives shall not include any hidden amount
or component to get the work done in undue manner or causing inducement of
whatsoever nature whether in cash or kind to influence the normal process or
practice of work.
e. The Selected applicant/PMA will disclose any and all payments he / she has
made, is committed to or intends to make to agents, brokers or any other
59
 intermediaries, other than regular employees or officials of the applicant, in
connection with the grant of approval or / and disbursement of incentives.
f. The Selected applicant/PMA will not offer any illicit gratification to obtain an unfair
advantage.
g. The Selected applicant/PMA will not collude with other parties to impair
transparency and fairness.
h. The Selected applicant/PMA will not give any advantage to anyone in exchange
for unprofessional behaviour.
3. The Selected applicant/PMA declares that no pervious transgressions occurred
in the last 3 years with any other Company in any country conforming to the anti-
corruption approach or with any other Public Sector Enterprises / Central or State
Government or its any instrumentality in India.
4. The Selected applicant/PMA agrees that if it is found that the applicant has made
any incorrect statement on this subject, the application will be closed or rejected and
DoP reserves the right to initiate legal action of whatsoever nature. In case if DoP
has disbursed the incentives under scheme, the amount disbursed to applicant be
recoverable along with interest calculated at 3 years SBI MCLR prevailing on the
date of disbursement, compounded annually besides blacklisting of the applicant
and initiation of legal action of whatsoever nature at the discretion of DoP.

The contents of the above undertaking have been gone through and after
understanding the same is being executed / given on………day of
................................................................................................ (month / year)

Signature (Name & designation with address)

Director/Head

60