Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-01102025-266585
EXTRAORDINARY
PART I- Section 1
PUBLISHED BY AUTHORITY
No. 300]
NEW DELHI, WEDNESDAY, OCTOBER 1, 2025/ASVINA 9, 1947
6602 GI/2025
(1)
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MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
NOTIFICATION
New Delhi, the 1st October, 2025
F. No. 50018/2/2022-NIPER. -The Central Government notified the Scheme for Promotion of Research and
Innovation in Pharma MedTech Sector vide Notification of even number, dated the 16th August, 2023. The Central
Government hereby makes the following amendments to the said Scheme, namely:—
1. In the Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (hereinafter referred to as the
principal scheme), for paragraphs 3.2 to 6, the following paragraphs shall be substituted, namely:-
'3.2 Component B – Promotion of Research and Innovation in Pharma MedTech sector
3.2.1 Financial assistance to industry and startups: With a view to enable Indian Pharmaceutical and
MedTech industry and startups to leapfrog up the innovation value chain, financial assistance will be
provided under Component B to support, in the priority areas specified in paragraph 5 ("priority areas"),
research and development (“R&D”) for development of products and technologies (“outputs”) or expeditious
validation of R&D outputs for market launch and large-scale commercialisation or both. Both Early Stage
Projects and Later Stage Projects will be eligible for disbursement of financial assistance.
3.2.2 Collaboration with academia: With a view to build world-class research infrastructure and atmosphere and
deepen the talent pool of qualified, trained students, for both Early Stage Projects and Later Stage Projects, industry
and startups will be encouraged to collaborate flexibly with reputed Government academic and research institutions
specified in the Scheme guidelines (“Academia”) to develop, translate and commercialise institutional intellectual
property and to augment institutional research capacities in India. While assessing applications under paragraph 3.2.8
in response to the call for proposals, a total of nine applications each for projects in collaboration with Government
institutions of national repute will be given preference in selection from among (a) Early Stage Projects as referred to
in paragraph 3.2.4 and (b) Later Stage Projects as referred to in paragraph 3.2.5. Selection based on such preference
will be subject to (i) the project being assessed as involving significant collaborative development of
product/technology and strong credentials of collaborative partners/team and (ii) the availability of applications that
meet the aforesaid criteria, failing which other projects may be selected. Collaboration with Academia may include,
among other things, in-licensing of intellectual property (IP) from or usage of assets made available by Academia as
well as the use of both existing and any freshly created research infrastructure facilities, provided that the cost of in-
licensing in the approved project cost is restricted to third-party-assessed fair value of in-licensed IP and the applicant
ensures that the terms of such collaboration are duly documented and not in conflict with its obligations under the
Scheme. Further, in case of in-licensing, such documentation will be in the form of a valid contract that sets out the
terms of licensing, including (i) appropriate usage rights for future commercialisation of outputs and (ii) the treatment
of any further IP that may be developed using such IP.
3.2.3 Other support: With a view to enhance the prospects of commercialisation of viable outputs, industry
and startups may also take advantage of mentorship support that may be provided under the Scheme, relevant
government initiatives such as MedTech Mitra and Patent Mitra, and the online platform under the
Scheme to facilitate discovery of opportunities for collaboration and partnership among various stakeholders,
such as industry, startups, Academia, investors, incubators, accelerators, innovation-promoting agencies and
non-governmental organisations.
3.2.4 Eligibility and scale of assistance for Early Stage Projects: The eligibility and extent of financial
assistance in respect of Early Stage Projects are as follows:
(a) Eligibility in terms of Technology Readiness Levels (TRLs): Projects of startups and MSMEs to
take products or technologies at TRL 1, 2 or 3 in any priority area to higher TRLs not beyond
TRL 5 will be eligible.
(b) Scale of assistance: Financial assistance may be to the extent of ₹5 crore per project. In case the
approved total project cost is up to 1 crore, no co-funding from the applicant will be required.
In case it exceeds ₹1 crore, half of the project cost exceeding ₹1 crore will be co-funded by the
applicant.
3.2.5 Eligibility and scale of assistance for Later Stage Projects: The eligibility and extent of financial
assistance in respect of Later Stage Projects are as follows:
(a) Eligibility in terms of TRLs: Projects of industry and startups to take products or technologies
at TRL 4, 5, or 6 in any priority area to higher TRLs will be eligible.
(b) Scale of assistance:
(i) Financial assistance may be to the extent of ₹100 crore per project, subject to the condition that
such assistance will be restricted to a maximum of 35% of the approved total project cost and the
remainder of the approved total project cost will be co-funded by the applicant.
(ii) Strategic Priority Innovations: For projects that promote innovative products and technologies
that address areas of India's public health concern for which market potential is relatively lower
("Strategic Priority Innovations" or "SPIs"), financial assistance may be to the extent of 50% of
the approved total project cost. Cumulative assistance to the said extent, approved for such
projects, will be capped at 20% of the total financial outlay for Component B. Such areas will be
specified in the Scheme guidelines, in accordance with policy directions of the Empowered
Committee.
3.2.6 Co-funding may include funds contributed by the applicant or mobilised from promoters, investors, other
government organisations, non-governmental organisations or any other person.
3.2.7 Other terms and conditions: For both Early Stage Projects and Later Stage Projects, the following
are other applicable terms and conditions:
(a) The eligibility to receive financial assistance is limited to the period of the Scheme.
(b) On successful achievement of approved timebound milestones, the Central Government,
including its nominated agency (in this Scheme collectively referred to as "Central
Government"), may, at its discretion and on the request of the beneficiary, provide additional
or follow-on financial assistance on terms mutually agreed upon.
(c) Beneficiaries of the Scheme will ensure that assistance received under the Scheme is publicly
acknowledged while publishing the findings related to R&D outputs.
(d) Other terms and conditions specified in the Scheme, and the terms and conditions contained in
the Scheme guidelines and the funding and share allotment agreements under the Scheme will
apply.
3.2.8 Selection of projects: Selection of projects under both categories will be done based on an
assessment of such factors as the Central Government may consider relevant, which may include, among
other things, the following:
(a) Impact on addressing India's public health priorities;
(b) Novelty and technical rigour and soundness of the proposed product or technology;
(c) Soundness of the funding and expenditure plan;
(d) Strong credentials, including credibility and track record, of the project team and the applicant
and any Academia partner for significant collaborative development; and
(e) Market potential and scalability of the proposed product or technology.
3.2.9 Such impact on addressing India's public health priorities may, among other things, include
significant public health gains that may arise from useful data that may become available for use in further
R&D and AI-enablement, such as through the following:
(a) Voluntary commitments made in the application to make available pre-clinical and clinical
research data generated under the project as a public good; and
(b) Systematic, at-scale, privacy-preserving digital data capture by a medical device, by design.
4. Terms of financial assistance under Component B
4.1 Benefit-share
4.1.1 The Central Government will have the right to receive from every applicant to whom it has disbursed
financial assistance, including such assigns of such applicant as the Central Government may permit and its
successors-in-interest (such applicant, assigns and successors-in-interest are collectively referred to in the Scheme as
“beneficiary"), such share as is specified in paragraphs 4.2 or 4.3 ("benefit-share") in any commercial realisation
arising directly or indirectly from the approved project. The right to receive the benefit-share will be irrespective of
the manner of such realisation, which may include direct sale, licensing, assignment, transfer or any other act through
which commercial value is realised from the whole or any part of any output developed from any activity carried out
under an approved project, including from any further development using such output irrespective of whether such
further development is done during the period of the project or subsequently. Every output developed as aforesaid is
referred to in this Scheme as “project output", and every project output from which commercial value is realised as
aforesaid, is referred to in this Scheme as “commercialised output".
4.1.2 The right to receive benefit-share will arise on the first commercial realisation from any commercialised
output.
4.2 Benefit-share structure for Early Stage Projects
4.2.1 Every beneficiary to whom financial assistance is disbursed for an Early Stage Project will, prior to execution
of the funding agreement for such project, select one of the following options for benefit-share, which will be
specified under the funding agreement:
(a) Fixed rate payout: Benefit-share is 5% of the net sales from each commercialised output, per year,
starting from the first year of commercialisation. The benefit-share obligation will stand discharged
once the total payments made by the beneficiary equal the total financial assistance disbursed.
(b) Tiered rate payout: Benefit-share is (i) 2% of the net sales per year from the first year of
commercialisation till the third year, (ii) 4% of net sales per year from the fourth year till the sixth year,
and (iii) 6% of net sales per year from the seventh year onwards, for each commercialised output. The
benefit-share obligation will stand discharged when the payments made by the beneficiary equal the
total financial assistance disbursed.
(c) Share allotment: Benefit-share is by way of allotment of shares to the Central Government of aggregate
value equal to the total financial assistance disbursed, reckoned on fair value assessment basis in
accordance with the manner specified under the Scheme guidelines and further detailed in a share
allotment agreement to be entered into between the Central Government and the beneficiary prior to the
first disbursement. Such beneficiaries will also secure liquidity and minority protection rights of the
Central Government as further detailed under the said guidelines.
4.3 Benefit-share structure for Later Stage Projects
4.3.1 Every beneficiary to whom financial assistance is disbursed for a Later Stage Project will, at the time of
execution of the funding agreement, elect one of the following benefit-shares, which will be specified under the
funding agreement:
(a) Fixed rate payout: Benefit-share is 10% of the net sales from each commercialised output,
starting from the first year of commercialisation. The benefit-share obligation will stand
discharged once the total payments made by the beneficiary equal 150% of the total financial
assistance disbursed.
(b) Tiered rate payout: Benefit-share is (i) 4% of net sales per year from the first year of sale to the
end of the third year, (ii) 8% of net sales per year from the fourth year till the sixth year, and
(iii) 12% of net sales per year from the seventh year onwards, for each commercialised output.
The benefit-share obligation will stand discharged when the payments made by the beneficiary
equal 150% of the total financial assistance disbursed.
(c) Share allotment: Benefit-share is by way of allotment of shares to the Central Government of
aggregate value equal to 100% of the total financial assistance disbursed, reckoned on fair value
assessment basis in accordance with the manner specified under the Scheme guidelines and
further detailed in a share allotment agreement to be entered into between the Central
Government and the beneficiary prior to the first disbursement. Such beneficiaries will also
secure liquidity and minority protection rights of the Central Government as further detailed
under the Scheme guidelines.
4.4 Benefit-share computation for projects involving collaboration with Academia
4.4.1 For projects involving collaboration with the Academia, in case capital assets are transferred by the
beneficiary to the books of the Academia for their use without consideration and are certified by such Academia as
constituting public assets usable for R&D, for purposes of computation of benefit-share, the independently assessed
fair value of those assets will be netted out from the total financial assistance disbursed. All references in the Scheme
to "total financial assistance disbursed", in relation to benefit-share, will be construed accordingly.
4.5 Settlement, termination and clawback
4.5.1 The Central Government may, on the request of the beneficiary, allow discharge of benefit-share obligation
on one-time basis, on the terms and conditions specified in the Scheme guidelines and in the manner specified therein.
4.5.2 The Central Government will, on occurrence of any event specified in the Scheme guidelines and in the
manner specified therein, have the right to require one-time settlement of its right to receive benefit-share.
4.5.3 The Central Government may, on occurrence of any event specified in the Scheme guidelines and in the
manner specified therein, terminate an approved project, which will have the consequence of cessation of
disbursement of financial assistance, refund of unutilised balance of the financial assistance previously disbursed
along with interest accrued thereon and the requirement that the beneficiary furnish certain reports, statements etc., as
detailed in the guidelines.
4.5.4 Notwithstanding anything contained in the Scheme, the Central Government may, on occurrence of any event
specified in the Scheme guidelines and in the manner specified therein, terminate an approved project and exercise its
right to clawback.
4.5.5 The Empowered Committee will be authorised to give policy directions in respect of matters to be specified
in the Scheme guidelines under paragraph 4.5.
5. Priority areas
5.1 R&D for the development or expeditious validation in respect of the following are the priority areas under
the Scheme:
(a) New medicines: This refers to drugs that meet the criteria specified in Note 1 below and include-
(i) new chemical medicines/substances (including new chemical entities);
(ii) new biological entities (including novel therapeutic proteins, monoclonal antibodies and
precision medicine products for targeted therapies like gene therapy and cell therapy, vaccines,
blood-derived products synthesised using recombinant DNA technology or other
biotechnological process); and
(iii) phytopharmaceutical drugs.
Note 1: For the purposes of the Scheme, a new medicine will meet the criteria that it has not been used
in the country to any significant extent, except in accordance with the provisions of the Drugs and
Cosmetics Act, 1940 and the rules made thereunder, as per conditions specified in the labelling thereof
and has not been approved as safe and efficacious by the licensing authority concerned with respect to
its claims. Such a new medicine may include an active pharmaceutical ingredient, an Ayurvedic,
Siddha or Unani drug, a Sowa-Rigpa drug and a homoeopathic medicine.
The following definitions may be referred to in this connection:
(1) The definition of “active pharmaceutical ingredient” as given in clause (c) of sub-rule (1) of rule
2 of the New Drugs and Clinical Trials Rules, 2019;
(2) The definition of "Ayurvedic, Siddha or Unani drug" as given in clause (a) and sub-clause (i) of
clause (h) of section 3 of the Drugs and Cosmetics Act, 1940;
(3) The definition of "drug" as given in clause (b) of section 3 of the Drugs and Cosmetics Act,
1940;
(4) The definition of "homoeopathic medicine" as given in clause (dd) of rule 2 of the Drugs Rules,
1945;
(5) The definition of "phytopharmaceutical drug" as given in clause (aa) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019; and
(6) The definition of "Sowa-Rigpa drugs" and "Sowa-Rigpa proprietary medicine" as
given in clauses (hh) and (hi) of rule 2 of the Drugs Rules, 1945.
(b) Complex generics and Biosimilars: This consists of the following categories of drugs:
(i) Complex generic: This refers to the following:
(1) A new drug approved by the Central Drugs Standard Control Organisation
(CDSCO) for certain claims and proposed to be marketed with modified or new
claims including indication, route of administration, dosage and dosage form.
(2) A new drug approved by the Central Drugs Standard Control Organisation
(CDSCO) as a novel drug delivery system.
Note 2: In this connection, the following may be referred to:
(I) In respect of item (1), sub-clause (ii) of clause (w) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019; and
(II) In respect of item (2), sub-clause (iv) of clause (w) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019, insofar as the said sub-clause
refers to novel drug delivery system.
(ii) Biosimilar: This refers to a biological product which is similar in terms of quality,
safety and efficacy to reference biological product licensed or approved in India, or any
innovator product approved in International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) member countries.
Note 3: The definition of "similar biologic" as given in clause (gg) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019 may be referred to in this connection.
(c) Novel medical devices: This refers to medical devices that have not been previously approved
by CDSCO. It covers all novel medical devices, including the following:
(i) AI/ML based medical devices with software development, Software as Medical Device
(SaMD) and Software in Medical Device (SiMD);
(ii) Medical diagnostics and screening devices with genetic technology;
(iii) Robotic medical devices for surgical procedures;
(iv) Medical devices with telemedicine facilities; and
(v) Any novel in vitro diagnostic medical device, including biomarkers, that enables precision
medicine.
Note 4: The expression “medical device" is defined in the Medical Devices Rules, 2017 and the
Gazette notification no. S.O. 648(E), dated 11.2.2020 of the Ministry of Health and Family
Welfare.
5.2 In case a project for R&D for the development of products or technologies in a priority area or for
their validation involves both a new medicine [clause (a) of paragraph 5.1] or a complex generic or biosimilar
[clause (b) of paragraph 5.1] and a novel medical device [clause (c) of paragraph 5.1], depending on whether
the intended use of such products or technologies is primarily for the therapeutic purposes of such new
medicine, generic or biosimilar or for the purposes of such device, the project will be treated as falling within
the priority area referred to in clause (a), (b) or (c) of paragraph 5.1, as the case may be.
5.3 Strategic Priority Innovations: As mentioned in paragraph 3.2.5(b)(ii), higher financial assistance to the
extent of 50% of the approved total project cost may be provided for SPIs that address areas of India's public
health concern for which market potential is relatively lower, as specified in the Scheme guidelines. Such SPIs
may be in any of the aforesaid three priority areas and may include, among other things, orphan drugs and
drugs that address antimicrobial resistant priority pathogens.
6. Financial outlay
6.1 The Scheme has a financial outlay of ₹ 5,000 crore, over the period from the financial year 2023-24
to the financial year 2029-30, as under:
S. No. | Details | Outlay
| | (in crore ₹)
-------+---------+--------------
1. | Component A | 700
2. | Component B | 4,200
3. | Administrative cost | 100
-------+---------+--------------
Total | | 5,000
6.2 The outlay for administrative cost will cover all costs other than the financial assistance under
Components A and B, including the cost of other support referred to in paragraph 3.2.3 and that incurred on
governance and implementation mechanisms and measures referred to in paragraph 7.
6.3 The Central Government may extend the period of the Scheme.'.
2. In the principal scheme, in paragraph 7,-
(a) for the words “Monitoring and Evaluation:”, the words “Governance and implementation
mechanisms and measures" shall be substituted;
(b) for the words “the guideline thereof”, the words “the Scheme guidelines, and to give policy directions
under the Scheme" shall be substituted;
(c) for the words “incentive rates and ceiling", the words “the extent of financial assistance" shall be
substituted;
(d) after the word “DHR, AYUSH,”, the word “MeitY” shall be inserted;
(e) for the words “which will examine", the words “which will consider the recommendations of the
Technical Committee" shall be substituted;
(f) for the words "claims for disbursements”, the words “claims for disbursements, consider requests for
additional or follow-on financial assistance on the recommendations of the Technical Committee and as
per policy directions of the EC," shall be substituted;
(g) for the words “A technical committee of 5-7 members with representatives from scientific departments,
CDSCO, experts from industry and academia" the following words shall be substituted, namely:-
"A technical committee will be set up with representation from among Scientific
Ministries/Departments/organisations as referenced in the General Financial Rules, 2017, Ministry
of Ayush, Department of Pharmaceuticals, CDSCO, experts from industry and academia, and
additional subject matter experts co-opted as necessary from subject-wise panels of experts.
The Technical Committee will review project proposals and submit its recommendations for
consideration of the Project Appraisal and Approval Committee. It may also recommend
engagement of professionals and expert agencies for assisting in the discharge of its functions.”;
(h) after the words “appraisal of the applications”, the words “and proposals for additional or follow-on
financial assistance" shall be inserted;
(i) for the words “disbursement of incentives”, the words “disbursement of financial assistance” shall be
substituted;
(j) for the words “done by selected applicants", the words “done by beneficiaries” shall be substituted;
(k) after the words “elaborated in scheme guidelines.”, the following paragraph shall be inserted, namely:—
“Other implementation aspects:
The Department of Pharmaceuticals will take measures as necessary for successful implementation
of the Scheme, which, among other things, may include the following:
(a) To frame guidelines for implementation of the Scheme and to carry out suitable revisions
pursuant to directions of the EC;
(b) To engage appropriate agencies to provide support to approved projects through
mentorship, convergence and online support for facilitating discovery of opportunities on
the platform created by the Department for collaboration and partnership among various
stakeholders;
(c) To establish a Project Management Unit to assist in the administration and management of the Scheme; and
(d) To leverage, for harnessing the benefits of convergence and specialisation, any special purpose vehicle that
has the mandate to foster inter-sectoral coordination and promote public-private partnerships in biomedical
and health research-related areas.”."
3. In the principal scheme, in paragraph 8,-
(a) for the words “financial assistance/funding”, the words “financial assistance” shall be substituted;
(b) in clause (a), for the word “company”, the words “eligible entity as specified in the Scheme guidelines,
which is" shall be substituted;
(c) for clause (d), the following clause shall be substituted, namely:-
“(d) Selected applicants will have to furnish documentation to evidence financial closure for the
project within the timeframe and in the manner specified in the Scheme guidelines, before being
considered for disbursement of financial assistance. Failure to evidence financial closure as said
would render the selected applicant ineligible to be a beneficiary under the Scheme.”;
(d) in clause (e), for the word “incentives”, the words “financial assistance” shall be substituted;
(e) for clause (f), the following clause shall be substituted, namely:—
“(f) Disbursement of instalments of approved financial assistance will be made into the beneficiary's
project-specific dedicated bank account, on achievement of approved timebound milestones and
crediting into such account the co-funding amount, where applicable, in proportion to the
instalment amount.”; and
in clause (g), for the words "disbursal of incentive shall", the words "disbursement of financial
assistance will" shall be substituted.
The principal scheme, as amended by this Notification, is set out in the Schedule.
AWADHESH KUMAR CHOUDHARY, Senior Economic Adviser
SCHEDULE
Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP)²
1. Introduction
1.1 Pharmaceutical sector requires continued research to remain competitive. However, to leapfrog substantive
measures are needed to venture into new areas to garner more value to the product and achieve increased exports.
Expansion of the industry's presence in the innovation accounts for 2/3rd of the global pharmaceuticals opportunities.
1.2 Currently the Indian pharma constitutes 3.4% market share of the global pharma industry. If the Industry
adopts a business-as-usual approach, the market value would grow to around 108 billion USD by 2030 with 11%
CAGR. The global pharma market positioned at 1230 bn USD in 2020, is expected to grow to 3206 bn USD by 2030
at a Compound Annual Growth Rate of 8.5%. It is envisioned that a focus on growth enablers can help India grab a
4% market share reaching 130 bn USD market size and a 5% market share will position India at 160 bn USD. (Global
Pharmaceutical Market opportunities and strategies report, 21 Oct 2020).
1.3 Indian pharma industry has largely remained confined to generic drugs where they are holding global
leadership. The total amount spent on pharma R&D in terms of USD bn in US is 50-60, China is 15-20 and in India it
is ~3. In the financial year 2021, the investments in R&D by the top ten Indian Pharma Companies amounted around
7.2% of their sales. There is a need to increase the R&D expenditure in the country by further promoting the research
and innovation. There is urgent need to shift the focus to new areas where future trajectory of pharma industry lies.
*As amended vide Notification F. No. 50018/2/2022-NIPER, dated the 1st October, 2025
Accordingly, six moon-shot (priority) areas have been identified which hold potential for the future and will help
industry to leapfrog in these areas.
1.4 At present a major component of Indian exports are low value generic drugs while a large-proportion of the
demand for patented drugs is met through imports. This is because the Indian Pharmaceutical sector lacks in high
value production along with world class pharma R&D. In order to encourage the global and domestic players to
enhance investment and production in these product categories, a well-designed and suitably targeted intervention is
required to promote specific high value goods such as bio-pharmaceuticals, complex generic drugs, patented drugs or
drugs nearing patent expiry, cell based or gene therapy drugs.
1.5 The medical device sector is also an essential and integral constituent of the healthcare sector. The medical
devices constitute a multi-disciplinary sector, with the following broad classification: (a) Electronic equipment; (b)
Implants; (c) Consumables and Disposables; (d) Surgical instruments and (e) In-vitro Diagnostic Reagents.
1.6 The market size of the medical devices in India is estimated to be 11 Billion USD approximately 90,000
Cr) in the year 2020 and its share in the global medical device market is estimated to be 1.5%. The sector in India is at
a growth stage with CAGR of 10-12% over the last decade. The growth of medical device sector in India is primarily
driven by growing and ageing population, increased per capita and disposable income, demand for healthcare
infrastructure, rise in preventive testing and spread of healthcare services and insurance programs. Recently, the
contribution of India's medical devices sector has become even more prominent as it supported the domestic and
global battle against COVID-19 pandemic by the production of medical devices & diagnostic kits, such as Ventilators,
IR Thermometers, PPE Kits & N-95 masks, Rapid Antigen Test Kits and RT-PCR kits. The current pandemic has also
created a demand for innovative products focusing on digital devices, miniaturization, wearables, etc., which offer
opportunity to leverage Indian IT skills and digital ecosystem to capture higher value in the global market.
1.7 70% of human pathogens in last three decades globally have animal origin. Animal disease outbreak leads
not only to mortality and morbidity but also directly and indirectly impact economy through loss of productivity. It is
estimated that India has lost upwards of USD 40-45 Bn due annual disease outbreak. Most of the drugs developed are
similar for human and animal health albeit with different dosage forms. Animal health care is a rising sector. The
Indian Animal health care market has reached INR 73.4 Bn in 2022 and expected to reach INR 120.3Bn by 2028,
exhibiting a CGAR of 8.49% during 2023-28 (iMARC - Animal Health market forecast 2023-28). This scheme which
promotes R&D in pharmaceutical sector will also benefit animal health care market thus aligning with the vision of
"ONE HEALTH".
1.8 Further, R&D in the proposed areas will help in new drug discovery and new treatment solutions that will
reduce global burden of diseases impacting developing and developed countries.
2. Objectives
The objective of the scheme is to transform Indian Pharma MedTech sector from cost based to innovation-based
growth by strengthening the research infrastructure in the country. The aim of the scheme is to promote industry-
academia linkage for R&D in priority areas and to inculcate the culture of quality research and nurture our pool of
scientists. This will lead to sustained global competitive advantage and contribute to quality employment generation in
the country.
3. Salient features of the Scheme:
The scheme is proposed to have two components as follows-
3.1 Component A:
Strengthening the research Infrastructure – Setting up of Centres of Excellence at National Institute of Pharmaceutical
Education & Research (NIPERs):
Department has set up seven National Institutes of Pharmaceutical Education & Research (NIPERs) as institutes of
national importance for imparting postgraduate and doctorate education and conduct high end research in various
specializations in pharmaceutics. NIPERs have increasingly started giving higher importance to research, which is
evident from deciding on a 'Common Research Programme' (CRP), launch of NIPER Research Portal and enhanced
importance to industry academia linkage.
Subsequently, on amendment of NIPER Act in December 2021, a provision 'to establish Centres of Excellence for
drug discovery and development and medical devices' has been specifically included as one of the functions of these
Institutes.
Recently, in the Budget speech 2023-24, it has specifically been announced that 'Para 30: A new Programme to
promote research and innovation in pharmaceuticals will be taken up through centres of excellence. We shall also
encourage industry to invest in research and development in specific priority areas.'
It is, therefore, proposed to establish CoEs in the seven existing NIPERs at Mohali, Ahmedabad, Hyderabad,
Guwahati, Kolkata, Hajipur and Raebareli at a tentative cost of ₹ 700 cr over a period of five years in following
specializations:
(i) NIPER Mohali- Anti-Viral and Anti- Bacterial Drug Discovery and Development
(ii) NIPER Ahmedabad- Medical Devices
(iii) NIPER Hyderabad- Bulk Drugs
(iv) NIPER Kolkata- Flow Chemistry and Continuous Manufacturing
(v) NIPER Raebareli- Novel Drug Delivery System
(vi) NIPER Guwahati- Phyto-pharmaceuticals
(vii) NIPER Hajipur- Biological Therapeutics
This will help in building specific research capacities in the identified priority areas in a focused time bound
programme, tapping industry-academia linkage.
The CoEs will strengthen the research infrastructure in Pharma-MedTech sectors in the country by providing
advanced facilities to conduct research and will also help in nurturing talent pool by promoting industry academia
linkage.
3.2 Component B – Promotion of Research and Innovation in Pharma MedTech sector
3.2.1 Financial assistance to industry and startups: With a view to enable Indian Pharmaceutical and MedTech
industry and startups to leapfrog up the innovation value chain, financial assistance will be provided under
Component B to support, in the priority areas specified in paragraph 5 (“priority areas"), research and development
("R&D") for development of products and technologies ("outputs") or expeditious validation of R&D outputs for
market launch and large-scale commercialisation or both. Both Early Stage Projects and Later Stage Projects will be
eligible for disbursement of financial assistance.
3.2.2 Collaboration with academia: With a view to build world-class research infrastructure and atmosphere and
deepen the talent pool of qualified, trained students, for both Early Stage Projects and Later Stage Projects, industry
and startups will be encouraged to collaborate flexibly with reputed Government academic and research institutions
specified in the Scheme guidelines (“Academia") to develop, translate and commercialise institutional intellectual
property and to augment institutional research capacities in India. While assessing applications under paragraph 3.2.8
in response to the call for proposals, a total of nine applications each for projects in collaboration with Government
institutions of national repute will be given preference in selection from among (a) Early Stage Projects as referred to
in paragraph 3.2.4 and (b) Later Stage Projects as referred to in paragraph 3.2.5. Selection based on such preference
will be subject to (i) the project being assessed as involving significant collaborative development of
product/technology and strong credentials of collaborative partners/team and (ii) the availability of applications that
meet the aforesaid criteria, failing which other projects may be selected. Collaboration with Academia may include,
among other things, in-licensing of intellectual property (IP) from or usage of assets made available by Academia as
well as the use of both existing and any freshly created research infrastructure facilities, provided that the cost of in-
licensing in the approved project cost is restricted to third-party-assessed fair value of in-licensed IP and the applicant
ensures that the terms of such collaboration are duly documented and not in conflict with its obligations under the
Scheme. Further, in case of in-licensing, such documentation will be in the form of a valid contract that sets out the
terms of licensing, including (i) appropriate usage rights for future commercialisation of outputs and (ii) the treatment
of any further IP that may be developed using such IP.
3.2.3 Other support: With a view to enhance the prospects of commercialisation of viable outputs, industry and
startups may also take advantage of mentorship support that may be provided under the Scheme, relevant government
initiatives such as MedTech Mitra and Patent Mitra, and the online platform under the Scheme to facilitate discovery
of opportunities for collaboration and partnership among various stakeholders, such as industry, startups, Academia,
investors, incubators, accelerators, innovation-promoting agencies and non-governmental organisations.
3.2.4 Eligibility and scale of assistance for Early Stage Projects: The eligibility and extent of financial assistance
in respect of Early Stage Projects are as follows:
(a) Eligibility in terms of Technology Readiness Levels (TRLs): Projects of startups and MSMEs to take
products or technologies at TRL 1, 2 or 3 in any priority area to higher TRLs not beyond TRL 5 will be eligible.
(b) Scale of assistance: Financial assistance may be to the extent of ₹5 crore per project. In case the
approved total project cost is up to 1 crore, no co-funding from the applicant will be required. In case
it exceeds ₹1 crore, half of the project cost exceeding ₹1 crore will be co-funded by the applicant.
3.2.5 Eligibility and scale of assistance for Later Stage Projects: The eligibility and extent of financial assistance
in respect of Later Stage Projects are as follows:
(a) Eligibility in terms of TRLs: Projects of industry and startups to take products or technologies at TRL
4, 5, or 6 in any priority area to higher TRLs will be eligible.
(b) Scale of assistance:
(i) Financial assistance may be to the extent of ₹100 crore per project, subject to the condition that
such assistance will be restricted to a maximum of 35% of the approved total project cost and the
remainder of the approved total project cost will be co-funded by the applicant.
(ii) Strategic Priority Innovations: For projects that promote innovative products and technologies
that address areas of India's public health concern for which market potential is relatively lower
("Strategic Priority Innovations" or "SPIs"), financial assistance may be to the extent of 50% of
the approved total project cost. Cumulative assistance to the said extent, approved for such
projects, will be capped at 20% of the total financial outlay for Component B. Such areas will be
specified in the Scheme guidelines, in accordance with policy directions of the Empowered
Committee.
3.2.6 Co-funding may include funds contributed by the applicant or mobilised from promoters, investors, other
government organisations, non-governmental organisations or any other person.
3.2.7 Other terms and conditions: For both Early Stage Projects and Later Stage Projects, the following are other
applicable terms and conditions:
(a) The eligibility to receive financial assistance is limited to the period of the Scheme.
(b) On successful achievement of approved timebound milestones, the Central Government, including its
nominated agency (in this Scheme collectively referred to as "Central Government"), may, at its
discretion and on the request of the beneficiary, provide additional or follow-on financial assistance on
terms mutually agreed upon.
(c) Beneficiaries of the Scheme will ensure that assistance received under the Scheme is publicly
acknowledged while publishing the findings related to R&D outputs.
(d) Other terms and conditions specified in the Scheme, and the terms and conditions contained in the
Scheme guidelines and the funding and share allotment agreements under the Scheme will apply.
3.2.8 Selection of projects: Selection of projects under both categories will be done based on an assessment of such
factors as the Central Government may consider relevant, which may include, among other things, the following:
(a) Impact on addressing India's public health priorities;
(b) Novelty and technical rigour and soundness of the proposed product or technology;
(c) Soundness of the funding and expenditure plan;
(d) Strong credentials, including credibility and track record, of the project team and the applicant and any
Academia partner for significant collaborative development; and
(e) Market potential and scalability of the proposed product or technology.
3.2.9 Such impact on addressing India's public health priorities may, among other things, include significant public
health gains that may arise from useful data that may become available for use in further R&D and AI-enablement,
such as through the following:
(a) Voluntary commitments made in the application to make available pre-clinical and clinical research data
generated under the project as a public good; and
(b) Systematic, at-scale, privacy-preserving digital data capture by a medical device, by design.
4. Terms of financial assistance under Component B
4.1 Benefit-share
4.1.1 The Central Government will have the right to receive from every applicant to whom it has disbursed
financial assistance, including such assigns of such applicant as the Central Government may permit and its
successors-in-interest (such applicant, assigns and successors-in-interest are collectively referred to in the Scheme as
“beneficiary"), such share as is specified in paragraphs 4.2 or 4.3 (“benefit-share") in any commercial realisation
arising directly or indirectly from the approved project. The right to receive the benefit-share will be irrespective of
the manner of such realisation, which may include direct sale, licensing, assignment, transfer or any other act through
which commercial value is realised from the whole or any part of any output developed from any activity carried out
under an approved project, including from any further development using such output irrespective of whether such
further development is done during the period of the project or subsequently. Every output developed as aforesaid is
referred to in this Scheme as “project output", and every project output from which commercial value is realised as
aforesaid, is referred to in this Scheme as “commercialised output".
4.1.2 The right to receive benefit-share will arise on the first commercial realisation from any commercialised
output.
4.2 Benefit-share structure for Early Stage Projects
4.2.1 Every beneficiary to whom financial assistance is disbursed for an Early Stage Project will, prior to execution
of the funding agreement for such project, select one of the following options for benefit-share, which will be
specified under the funding agreement:
(a) Fixed rate payout: Benefit-share is 5% of the net sales from each commercialised output, per year,
starting from the first year of commercialisation. The benefit-share obligation will stand discharged
once the total payments made by the beneficiary equal the total financial assistance disbursed.
(b) Tiered rate payout: Benefit-share is (i) 2% of the net sales per year from the first year of
commercialisation till the third year, (ii) 4% of net sales per year from the fourth year till the sixth year,
and (iii) 6% of net sales per year from the seventh year onwards, for each commercialised output. The
benefit-share obligation will stand discharged when the payments made by the beneficiary equal the
total financial assistance disbursed.
(c) Share allotment: Benefit-share is by way of allotment of shares to the Central Government of aggregate
value equal to the total financial assistance disbursed, reckoned on fair value assessment basis in
accordance with the manner specified under the Scheme guidelines and further detailed in a share
allotment agreement to be entered into between the Central Government and the beneficiary prior to the
first disbursement. Such beneficiaries will also secure liquidity and minority protection rights of the
Central Government as further detailed under the said guidelines.
4.3 Benefit-share structure for Later Stage Projects
4.3.1 Every beneficiary to whom financial assistance is disbursed for a Later Stage Project will, at the time of
execution of the funding agreement, elect one of the following benefit-shares, which will be specified under the
funding agreement:
(a) Fixed rate payout: Benefit-share is 10% of the net sales from each commercialised output,
starting from the first year of commercialisation. The benefit-share obligation will stand
discharged once the total payments made by the beneficiary equal 150% of the total financial
assistance disbursed.
(b) Tiered rate payout: Benefit-share is (i) 4% of net sales per year from the first year of sale to the
end of the third year, (ii) 8% of net sales per year from the fourth year till the sixth year, and
(iii) 12% of net sales per year from the seventh year onwards, for each commercialised output.
The benefit-share obligation will stand discharged when the payments made by the beneficiary
equal 150% of the total financial assistance disbursed.
(c) Share allotment: Benefit-share is by way of allotment of shares to the Central Government of
aggregate value equal to 100% of the total financial assistance disbursed, reckoned on fair value
assessment basis in accordance with the manner specified under the Scheme guidelines and
further detailed in a share allotment agreement to be entered into between the Central
Government and the beneficiary prior to the first disbursement. Such beneficiaries will also
secure liquidity and minority protection rights of the Central Government as further detailed
under the Scheme guidelines.
4.4 Benefit-share computation for projects involving collaboration with Academia
4.4.1 For projects involving collaboration with the Academia, in case capital assets are transferred by the
beneficiary to the books of the Academia for their use without consideration and are certified by such Academia as
constituting public assets usable for R&D, for purposes of computation of benefit-share, the independently assessed
fair value of those assets will be netted out from the total financial assistance disbursed. All references in the Scheme
to "total financial assistance disbursed", in relation to benefit-share, will be construed accordingly.
4.5 Settlement, termination and clawback
4.5.1 The Central Government may, on the request of the beneficiary, allow discharge of benefit-share obligation
on one-time basis, on the terms and conditions specified in the Scheme guidelines and in the manner specified therein.
4.5.2 The Central Government will, on occurrence of any event specified in the Scheme guidelines and in the
manner specified therein, have the right to require one-time settlement of its right to receive benefit-share.
4.5.3 The Central Government may, on occurrence of any event specified in the Scheme guidelines and in the
manner specified therein, terminate an approved project, which will have the consequence of cessation of
disbursement of financial assistance, refund of unutilised balance of the financial assistance previously disbursed
along with interest accrued thereon and the requirement that the beneficiary furnish certain reports, statements etc., as
detailed in the guidelines.
4.5.4 Notwithstanding anything contained in the Scheme, the Central Government may, on occurrence of any event
specified in the Scheme guidelines and in the manner specified therein, terminate an approved project and exercise its
right to clawback.
4.5.5 The Empowered Committee will be authorised to give policy directions in respect of matters to be specified
in the Scheme guidelines under paragraph 4.5.
5. Priority areas
5.1 R&D for the development or expeditious validation in respect of the following are the priority areas under
the Scheme:
(a) New medicines: This refers to drugs that meet the criteria specified in Note 1 below and include-
(i) new chemical medicines/substances (including new chemical entities);
(ii) new biological entities (including novel therapeutic proteins, monoclonal antibodies and
precision medicine products for targeted therapies like gene therapy and cell therapy, vaccines,
blood-derived products synthesised using recombinant DNA technology or other
biotechnological process); and
(iii) phytopharmaceutical drugs.
Note 1: For the purposes of the Scheme, a new medicine will meet the criteria that it has not been used
in the country to any significant extent, except in accordance with the provisions of the Drugs and
Cosmetics Act, 1940 and the rules made thereunder, as per conditions specified in the labelling thereof
and has not been approved as safe and efficacious by the licensing authority concerned with respect to
its claims. Such a new medicine may include an active pharmaceutical ingredient, an Ayurvedic,
Siddha or Unani drug, a Sowa-Rigpa drug and a homoeopathic medicine.
The following definitions may be referred to in this connection:
(1) The definition of “active pharmaceutical ingredient” as given in clause (c) of sub-rule (1) of rule
2 of the New Drugs and Clinical Trials Rules, 2019;
(2) The definition of "Ayurvedic, Siddha or Unani drug" as given in clause (a) and sub-clause (i) of
clause (h) of section 3 of the Drugs and Cosmetics Act, 1940;
(3) The definition of "drug" as given in clause (b) of section 3 of the Drugs and Cosmetics Act,
1940;
(4) The definition of "homoeopathic medicine" as given in clause (dd) of rule 2 of the Drugs Rules,
1945;
(5) The definition of "phytopharmaceutical drug" as given in clause (aa) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019; and
(6) The definition of "Sowa-Rigpa drugs" and "Sowa-Rigpa proprietary medicine" as
given in clauses (hh) and (hi) of rule 2 of the Drugs Rules, 1945.
(b) Complex generics and Biosimilars: This consists of the following categories of drugs:
(i) Complex generic: This refers to the following:
(1) A new drug approved by the Central Drugs Standard Control Organisation
(CDSCO) for certain claims and proposed to be marketed with modified or new
claims including indication, route of administration, dosage and dosage form.
(2) A new drug approved by the Central Drugs Standard Control Organisation
(CDSCO) as a novel drug delivery system.
Note 2: In this connection, the following may be referred to:
(I) In respect of item (1), sub-clause (ii) of clause (w) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019; and
(II) In respect of item (2), sub-clause (iv) of clause (w) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019, insofar as the said sub-clause
refers to novel drug delivery system.
(ii) Biosimilar: This refers to a biological product which is similar in terms of quality,
safety and efficacy to reference biological product licensed or approved in India, or any
innovator product approved in International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) member countries.
Note 3: The definition of "similar biologic" as given in clause (gg) of sub-rule (1) of rule 2 of
the New Drugs and Clinical Trials Rules, 2019 may be referred to in this connection.
(c) Novel medical devices: This refers to medical devices that have not been previously approved
by CDSCO. It covers all novel medical devices, including the following:
(i) AI/ML based medical devices with software development, Software as Medical Device
(SaMD) and Software in Medical Device (SiMD);
(ii) Medical diagnostics and screening devices with genetic technology;
(iii) Robotic medical devices for surgical procedures;
(iv) Medical devices with telemedicine facilities; and
(v) Any novel in vitro diagnostic medical device, including biomarkers, that enables precision
medicine.
Note 4: The expression “medical device" is defined in the Medical Devices Rules, 2017 and the
Gazette notification no. S.O. 648(E), dated 11.2.2020 of the Ministry of Health and Family
Welfare.
5.2 In case a project for R&D for the development of products or technologies in a priority area or for
their validation involves both a new medicine [clause (a) of paragraph 5.1] or a complex generic or biosimilar
[clause (b) of paragraph 5.1] and a novel medical device [clause (c) of paragraph 5.1], depending on whether
the intended use of such products or technologies is primarily for the therapeutic purposes of such new
medicine, generic or biosimilar or for the purposes of such device, the project will be treated as falling within
the priority area referred to in clause (a), (b) or (c) of paragraph 5.1, as the case may be.
5.3 Strategic Priority Innovations: As mentioned in paragraph 3.2.5(b)(ii), higher financial assistance to the
extent of 50% of the approved total project cost may be provided for SPIs that address areas of India's public
health concern for which market potential is relatively lower, as specified in the Scheme guidelines. Such SPIs
may be in any of the aforesaid three priority areas and may include, among other things, orphan drugs and
drugs that address antimicrobial resistant priority pathogens.
6. Financial outlay
6.1 The Scheme has a financial outlay of ₹ 5,000 crore, over the period from the financial year 2023-24
to the financial year 2029-30, as under:
S. No. | Details | Outlay
| | (in crore ₹)
-------+-----------------------+--------------
1. | Component A | 700
2. | Component B | 4,200
3. | Administrative cost | 100
-------+-----------------------+--------------
Total | | 5,000
6.2 The outlay for administrative cost will cover all costs other than the financial assistance under
Components A and B, including the cost of other support referred to in paragraph 3.2.3 and that incurred on
governance and implementation mechanisms and measures referred to in paragraph 7.
6.3 The Central Government may extend the period of the Scheme.
7. Governance and implementation mechanisms and measures
Empowered Committee:
An Empowered Committee (EC) under the chairmanship of CEO NITI Aayog is proposed to be set up with Secretary
DoP, Secretary DoH&FW, Secretary DHR, Secretary AYUSH, Secretary DST, Secretary DSIR, Secretary DBT,
Scientific Secretary, O/o PSA and AS&FA DoP as members for administering the scheme.
The deliverables of Centres of Excellence (CoEs) being set up at NIPERs will be fixed by the department in
consultation with Board of Governors (BoGs) of the respective institutes. The CoEs will be reviewed based on set
deliverables.
The EC will conduct periodic review of the scheme. It will also be authorised to carry out any amendments in the
scheme and the Scheme guidelines, and to give policy directions under the Scheme. Further, the EC may revise the
extent of financial assistance, if required, within total financial outlay of the scheme. Detailed constitution,
functioning and responsibilities of the EC will be elaborated in the Scheme Guidelines.
Project Appraisal and Approval Committee:
A committee under the chairpersonship of Secretary, Pharmaceuticals will set up with representatives (not below the
level of Joint Secretary) from DST, DSIR, DBT, DGHS, DHR, AYUSH, MeitY and CDSCO which will consider the
recommendations of the Technical Committee and approve the projects, consider and approve claims for
disbursements, consider requests for additional or follow-on financial assistance on the recommendations of the
Technical Committee and as per policy directions of the EC, and take appropriate steps to contain the expenditure
within the prescribed outlay.
Technical Committee:
A technical committee will be set up with representation from among Scientific Ministries/Departments/organisations
as referenced in the General Financial Rules, 2017, Ministry of Ayush, Department of Pharmaceuticals, CDSCO,
experts from industry and academia, and additional subject matter experts co-opted as necessary from subject-wise
panels of experts.
The Technical Committee will review project proposals and submit its recommendations for consideration of the
Project Appraisal and Approval Committee. It may also recommend engagement of professionals and expert agencies
for assisting in the discharge of its functions.
The committee will examine issues referred to it by project appraisal and approval committee and provide inputs on
technical issues on various issues under the scheme.
Project Management Agency (PMA):
The scheme will be implemented through a project management agency that 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.
PMA would be responsible for receipt of the applications, appraisal of the applications and proposals for additional or
follow-on financial assistance, and verification of eligibility threshold criteria, examination of claims for disbursement
of financial assistance. Compilation of the data regarding progress and performance of the scheme including
cumulative investment in research and investment in priority areas of research in Pharma MedTech done by
beneficiaries. Detailed responsibilities of PMA will be elaborated in scheme guidelines.
Other implementation aspects:
The Department of Pharmaceuticals will take measures as necessary for successful implementation of the Scheme,
which, among other things, may include the following:
(a) To frame guidelines for implementation of the Scheme and to carry out suitable revisions
pursuant to directions of the EC;
(b) To engage appropriate agencies to provide support to approved projects through mentorship, convergence
and online support for facilitating discovery of opportunities on the platform created by the Department for
collaboration and partnership among various stakeholders;
(c) To establish a Project Management Unit to assist in the administration and management of the Scheme; and
(d) To leverage, for harnessing the benefits of convergence and specialisation, any special purpose vehicle that
has the mandate to foster inter-sectoral coordination and promote public-private partnerships in biomedical
and health research-related areas.
8. Approval and Disbursement of financial assistance
(a) Application under the Scheme can be made by any eligible entity as specified in the Scheme
guidelines, which is registered in India.
(b) An application, complete in all aspects, will have to be submitted before the due date.
Acknowledgement will be issued after initial scrutiny of the application.
(c) The eligible applicants will be appraised on an ongoing basis and considered for approval, based on
predefined selection criteria.
(d) Selected applicants will have to furnish documentation to evidence financial closure for the project
within the timeframe and in the manner specified in the Scheme guidelines, before being considered
for disbursement of financial assistance. Failure to evidence financial closure as said would render
the selected applicant ineligible to be a beneficiary under the Scheme.
(e) Timely disbursals of financial assistance by the project Management Agency will be monitored by
DoP and reviewed by the Empowered Committee subject to budgetary allocations by the Dept. of
Expenditure.
(f) Disbursement of instalments of approved financial assistance will be made into the beneficiary's
project-specific dedicated bank account, on achievement of approved timebound milestones and
crediting into such account the co-funding amount, where applicable, in proportion to the instalment
amount.
(g) The progress in approval of applications and disbursal of financial assistance will be monitored on
an ongoing basis against the monitoring framework to be specified in the guidelines.
9. Impact of the Scheme
(a) Focus on certain priority areas which will help India's pharma industry leapfrog and radically
strengthen its position in the world market as innovation accounts for 2/3rd of global pharmaceutical
opportunities
(b) Development of Research Infrastructure- The scheme would help in building world class research
atmosphere at NIPERs by establishing CoE and making a talent pool of qualified trained students.
(c) The scheme would help in launching of commercially viable products thereby accelerating the
growth of Indian Pharmaceuticals sector.
***
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AMIT KUMAR JAISWAL Digitally signed by AMIT KUMAR JAISWAL Date: 2025.10.01 19:36:48+05'30"