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Step 5 of 5 · Your pack
Check every answer, fill what is missing, then submit it yourself.
Biotechnology Ignition Grant (BIG): your application
- No BIG call is open on 2026-10-01 (the last one, BIG-25, closed on 30-11-2025); this draft is ready for the next call.
Step 1: Basic Information
Applicant Type
Startup
Based on: entity type, incorporation date
Please select Company Name
Drop-down of companies registered on the BIRAC portal. If the company is not in the drop-down, register it first. The company name is activated within 24 hours of submitting the Company Registration form.
NeoPulse Diagnostics Private Limited
Based on: name
Title of Proposal
Write the brief name of proposal which is not exceeding 250 characters.
154 / 250 characters
A 20-minute, lab-free, heel-prick screen for neonatal sepsis at primary and community health centres: cartridge optimisation and pilot clinical evaluation
Based on: one liner, solution, follow-up 3
Proposal Duration (max of 18 month only)
In months.
18
Based on: follow-up 3, follow-up 8
Thematic Area
The proforma does not show the drop-down values. These options are the 7 project categories in Guidelines v9 s.3.1. BIRAC's TRL page groups thematic areas differently (Healthcare: Drugs, Biosimilars, Regenerative Medicine, Vaccines, Devices and Diagnostics; Agriculture incl. Aquaculture/Fisheries & Veterinary; Industrial Biotechnology; Bioinformatics & software), so the live drop-down may differ.
Devices & Diagnostics
Based on: sector, solution
Subthematic Area
Portal drop-down that depends on the Thematic Area. Values are not published in the proforma.
Point-of-care diagnostics (pick the closest value in the portal drop-down)
Based on: solution
Specify Other Subthematic Area
Other Subthematic Area field is applicable only when the Subthematic area is selected as others.
Not applicable unless the portal drop-down has no point-of-care diagnostics option.
Based on: solution
BIG Partner
Option labels as in the Nov-25 proforma. Guidelines v9 Annexure 1 lists the same 8 partners as C-CAMP Bengaluru; FITT New Delhi; IKP Knowledge Park Hyderabad; KIIT BioNEST Bhubaneswar; Venture Center Pune; FIRST, IIT Kanpur; SINE IIT Bombay; a-IDEA NAARM Hyderabad. Each call names its own partners. The BIG Partner receives and screens applications, runs online review, gives pre-TEP mentoring, does due diligence, signs the agreement and disburses funds.
Missing: choose your BIG Partner from the list in the call; Venture Center, Pune is the listed partner in your city, but any listed partner can be chosen
Based on: city
Have you applied through another BIG partner(s) in the current call
Mandatory (*).
No
Based on: follow-up 5
Is this the same proposal ?
Mandatory (*).
No
Based on: follow-up 5
Have you applied for BIG in earlier rounds?
Mandatory (*).
No
Based on: follow-up 5
Earlier BIG submissions
Filled when earlier or parallel BIG applications exist.
| Big Partner | Reference No. | Title | Status | Reason | Action taken | Proposal Same/similiar/different | If same/similar, improvisations made with regard to earlier submission |
|---|
Based on: follow-up 5
I accept the Terms and Conditions
Terms & Conditions are linked from the form.
Missing: read BIRAC’s Terms and Conditions and tick “I accept” yourself in the portal
Step 2: Startup Details
Startup Name, Address1, City/Town, State, Pin/Zip code, Mobile, Website
The proforma shows these filled with sample values. They appear to be pre-filled from the company registration (inferred).
Pre-filled from your BIRAC company registration. Check it shows NeoPulse Diagnostics Private Limited, Pune, Maharashtra, https://neopulse.example.
Based on: name, city, state, website
Date of Incorporation of the Company
Set date of incorporation of the Startup in format: dd-mm-yyyy
12-06-2024
Based on: incorporation date
Number of Years since Registration
Max 5 years only. Mandatory (*).
2
Based on: incorporation date
Registration Certificate Of Company
Mandatory (*).
Attach in the portal: Registration Certificate Of Company
Company's PAN Card
Mandatory (*).
Attach in the portal: Company's PAN Card
Memorandum of Association of company
Not marked mandatory in the proforma.
Attach in the portal: Memorandum of Association of company
Article of Association Company
Not marked mandatory in the proforma.
Attach in the portal: Article of Association Company
Are the Share of the Company held to the Extent of 51% By Indian Citizens (Including NRIs)?
Mandatory (*). OCI/PIO cardholders do not count as Indian citizens (Guidelines s.13).
Yes
Based on: indian ownership pct
Is any promoter holding 20% or more shares Of the applicant company, a co-promoter of another company(ies)/a partner of another LLP?
Mandatory (*).
No
Based on: follow-up 5
Details of promoter's other companies/LLPs
Filled when the previous answer is Yes.
| Name of the Promoter | Name of the LLP(s)/ Company(ies) | DIN Number(In case of company) | Company/ LLP working in biotech domain? |
|---|
Based on: follow-up 5
Is any partner of the LLP, a co-partner of Another LLP(s)/a co-promoter of another company(ies)
Marked mandatory (*) in the proforma.
No (we are a private limited company, not an LLP)
Based on: entity type
Details of LLP partner's other LLPs/companies
Filled when the previous answer is Yes.
| Name of the Partner | Name of the LLP(s)/ Company(ies) | DIN Number |
|---|
Based on: entity type
Do you have a functional laboratory of your own
Mandatory (*).
No
Based on: follow-up 5
Address of the Functional Lab
Mandatory (*) when the startup has its own lab.
Not applicable: we have no lab of our own and work at our incubator (next question).
Based on: follow-up 5
Name of the Centre where you are/will be incubated
In case the startup selects the option as No (no own lab). Any bio-incubator, BIRAC-supported or not (Guidelines Annexure footnote).
Missing: name of the Pune bio-incubator where you are incubated (we hold your incubator letter but not its name)
Based on: follow-up 5, has lab or incubator
Is this Company a subsidiary to a parent company
Mandatory (*).
No
Based on: follow-up 5
Name of the Parent Company
If subsidiary.
Not applicable: not a subsidiary.
Based on: follow-up 5
CIN Number of the Company
If subsidiary (parent company's CIN).
Not applicable: not a subsidiary.
Based on: follow-up 5
Registration Date of the Parent Company
If subsidiary.
Not applicable: not a subsidiary.
Based on: follow-up 5
Step 3: Project Leader Details
Title, First Name, Last Name, Gender (Male/Female/Others)
Dr. Meera Kulkarni.
Missing: gender, as you want it recorded
Based on: founder 1 name
Designation at the company
Co-founder and CEO; Project Leader
Based on: founder 1 role
Mobile, Email
Missing: Project Leader’s mobile number and email
Please Upload Resume in Prescribed Format
Note: Please download to fill the details and signed copy to be uploaded in PDF format. The prescribed format is linked inside the portal. BIRAC's generic 'Format for Biographical Sketch' (formats/Resume_format.doc) has these sections: company/institute name; educational details (graduation onwards); professional career (most recent first); publication counts (books, papers, articles, patents, others); five most recent relevant publications with impact factor (summary of 100 words or fewer each); professional experience relevant to the project (do not exceed 150 words); ongoing research projects; projects completed in the last three years; a signed certification. Whether the BIG in-portal format is identical is not verified.
Attach in the portal: Please Upload Resume in Prescribed Format
Step 4: Team Members
Team Members (Add New for each member)
(If the proposal is aimed at development of an end product/technology to be used in clinical settings, it is mandatory to have a Clinician as a Team Member/ Advisor/Mentor. Resume goes in the prescribed format (see Step 3 note). Fill all the mandatory fields accordingly.
| Title | First Name | Last Name | Gender | Designation | Mobile | Resume (Prescribed Format) | |
|---|---|---|---|---|---|---|---|
| Arjun | Rao | Co-founder and CTO | Upload | ||||
| Research Associate (microfluidics) | Upload | ||||||
| Lab Technician | Upload |
Based on: founder 2 name, founder 2 role, founder 2 background, founder 1 background, follow-up 5
Step 5: Scientific Advisors or Mentor (If Any)
Scientific Advisors or Mentor Available (Add New for each)
Reviewers ask whether the team has identified relevant advisors/mentors and how it covers missing technical/business expertise gaps. For clinical-setting products the guidelines highly recommend a clinical advisor from the start.
| Title | First Name | Last Name | Designation | Affiliation | Resume (Prescribed Format) |
|---|
Based on: founder 1 background, follow-up 6
Step 6: Proposal Details
1. Proposal Summary (Max. 200 Words) [Provide a brief one paragraph overview of the proposal, i.e. the idea and the problem it may solve and brief project plan.]
Mandatory (*).
184 / 200 words
Newborns with suspected sepsis at primary and community health centres wait 48-72 hours for a blood culture that needs a microbiology lab most of these centres do not have, so clinicians either refer the baby and lose time or start antibiotics without a diagnosis. We are building a handheld, battery-powered reader and a single-use microfluidic cartridge that measures three host-response biomarkers (CRP, procalcitonin and IL-6) from a 50-microlitre heel-prick sample and gives a risk score in under 20 minutes, with no lab and no cold chain. Our laboratory prototype (TRL 4) gave results in 18 minutes on 48 spiked whole-blood samples and tracked a bench ELISA reference. Over 18 months we will (1) tune the cartridge for heel-prick whole blood, (2) make a pilot batch of 2,000 moulded cartridges, (3) run a pilot evaluation on about 150 newborns with suspected sepsis at a district hospital NICU, against blood culture, after ethics approval, and (4) file a provisional patent on the cartridge. Our team pairs a paediatrician with nine years in neonatal intensive care and a biomedical engineer who built point-of-care readers for six years.
Based on: problem, solution, usp, trl, follow-up 2, follow-up 3, follow-up 8, founder 1 background, founder 2 background
Please upload a concept note explaining the technology with necessary figures and diagrams
Sits under the mandatory Q1. The upload line itself is not asterisked.
Attach in the portal: Please upload a concept note explaining the technology with necessary figures and diagrams
2. Briefly state the Objectives and Proposed Approach [Describe how the proposed project addresses the problem. Clarify the current status of the innovation.] The description should cover the following points: 1). Strategy and/or methodology of work. 2). Scope and boundaries of the work, including any issues that will not be covered. 3). Data analysis (sample size, data collection)
Mandatory (*).
Objectives: (1) make our laboratory prototype work reliably on heel-prick whole blood; (2) produce a pilot batch of 2,000 moulded cartridges; (3) measure how well the risk score agrees with blood culture in a pilot clinical evaluation; (4) protect the cartridge design with a provisional patent. Current status: a working laboratory prototype at TRL 4. The reader and cartridge measure CRP, procalcitonin and IL-6. On 48 spiked whole-blood samples they gave results in 18 minutes, tracked the incubator lab’s bench ELISA, and kept the coefficient of variation under 15% for each marker. We have not yet tested clinical samples. 1. Strategy and methodology: we first tune the cartridge on spiked whole blood against the bench reference, then lock the design and order 2,000 cartridges from an outsourced moulder. Once the hospital ethics committee approves, we run the pilot at the district hospital NICU where our CEO worked: for about 150 newborns evaluated for suspected sepsis, one extra heel-prick drop is taken at the time of routine blood sampling, with parental consent. Clinicians do not see our result and treat as usual. 2. Scope and boundaries: the project ends with a pilot evaluation, at TRL 5. It does not cover a larger multi-site study, CDSCO approval, manufacturing scale-up or sales; those come after BIG. 3. Data analysis: we compare the risk score with blood culture and with the treating team’s final diagnosis, and report sensitivity and specificity with 95% confidence intervals, time to result, and the share of failed tests. 150 newborns is a pilot to estimate performance and size the next study, not to prove it.
Based on: trl, traction, follow-up 2, follow-up 3, follow-up 8, founder 1 background
3. Novelty [Explain how your idea is innovative and how it is different from the existing products in the markets or current state-of-the-art. Tabular representation of the difference between your idea and the other products in market or competitive product which are under development will be appreciated. Concrete market data is encouraged.]
Mandatory (*).
What is new is the combination: the test runs without a lab or a cold chain, needs only a 50-microlitre heel-prick sample, and is priced for a primary health centre. Our targets are ₹350 or less per cartridge and under ₹1.2 lakh per reader. Each current option misses at least one of these: - Blood culture: the gold standard, but 48-72 hours and a microbiology lab. - Central-lab CRP and procalcitonin: faster than culture, but need a lab and a cold chain. - Imported point-of-care analysers: priced for tertiary hospitals. - NeoPulse: under 20 minutes, three host-response markers combined into one risk score, no lab, no cold chain, heel-prick sample, PHC pricing. We will upload this as a table.
Missing: names and prices of the imported point-of-care analysers, and any competing products under development, for the comparison table
Based on: usp, competitors, problem, solution, follow-up 2, follow-up 4
Upload table
The comparison table Q3 asks for: the idea versus products on the market and competing products under development.
Attach in the portal: Upload table
4. Opportunity [What is the potential societal and market impact? Provide details of the problem you propose to solve.]
Mandatory (*).
The problem: neonatal sepsis is diagnosed by blood culture, which takes 48-72 hours and needs a microbiology lab that most PHCs and CHCs do not have. Clinicians there have to refer a sick newborn, losing time, or start antibiotics without a diagnosis. A 20-minute screen at the point of care would help them decide who needs referral and who needs treatment, and would give the public system a domestic alternative to imported analysers priced for tertiary hospitals. The market, by our own estimate: India records about 2.3 crore births a year, and hospital studies suggest roughly 1 in 10 newborns is evaluated for suspected sepsis, about 23 lakh evaluations a year. We assume around 40% happen at PHC/CHC level or in small maternity hospitals, about 9 lakh tests a year. At ₹350 a cartridge that is roughly ₹32 crore a year in recurring cartridge sales, plus readers for about 30,000 PHCs and CHCs. Buyers are public PHCs and CHCs, procured through state health missions, and small private maternity hospitals.
Based on: problem, customers, competitors, follow-up 1, follow-up 4
5. Challenges or risk factors associated with the project [What are the challenges and risk factors that you envision which may affect this project?] What are the critical success factors/potential barriers
Mandatory (*). The guidelines' 'Strategy to overcome challenges' criterion asks about regulatory, ethical and EHS barriers, availability of raw material/key resources, need for unique facility(ies), and patent rights/technology in-licensing, and about the team's way forward.
Critical success factors are clinical performance on real newborn blood and cost per test. 1. Clinical performance: the panel has only been tested on spiked samples, and heel-prick blood from sick newborns may behave differently. We tune the cartridge before the study, and the pilot evaluation is designed to show this early, inside the project. 2. Ethics and regulatory: testing on newborns needs ethics committee approval, which we have not yet applied for; we will apply in the first months. Selling a diagnostic in India needs CDSCO medical-device approval, which comes after this project. 3. Cost: a lab-made cartridge costs us about ₹900 against a target of ₹350 or less per test (bill of materials under ₹150 at volume). The outsourced pilot batch will show how far moulding brings this down. 4. Facilities: we have no lab of our own and work in the shared wet lab at our Pune bio-incubator; cartridge moulding is outsourced. 5. Patent rights: we have not yet run a freedom-to-operate search (see 10 ii).
Based on: traction, follow-up 2, follow-up 3, follow-up 4, follow-up 5, follow-up 7
6. Has any preliminary work been carried out? Give status of work done? If no, please provide the background details.
Mandatory (*).
Yes. We built a working laboratory prototype of the reader and cartridge (TRL 4), funded by founder capital, and validated it at our incubator lab on 48 spiked whole-blood samples. It measured CRP, procalcitonin and IL-6, gave a result in 18 minutes, tracked the lab’s bench ELISA reference across the range tested, and kept the coefficient of variation under 15% for each marker. No clinical samples have been tested yet. The use case comes from Dr. Meera Kulkarni’s nine years in neonatal intensive care, where she saw sepsis diagnosis delayed.
Based on: traction, trl, raised, follow-up 2, founder 1 background
7. Please provide current and expected Technology Readiness Level (TRL) - Current TRL
Mandatory (*). The proforma shows no options. BIRAC uses a 9-level TRL scale with sector-specific definitions at birac.nic.in/desc_new.php?id=443.
TRL 4
Based on: trl
7. Please provide current and expected Technology Readiness Level (TRL) - Expected TRL
Mandatory (*). BIG funds work from ideation up to Proof of Concept, so the expected TRL should reflect PoC.
TRL 5
Based on: follow-up 3
8. Proposed end-outcomes (Your BIG Project is expected to result in the following end-outcomes).
Mandatory (*). The proforma does not say whether one or several can be ticked.
A Product for customers
Based on: revenue model
9. Future Plan of Commercialization [What do you envision to be the key next step to making impact with this innovation (e.g., sponsored research support, licensing, venture financing)? What is the time frame?] Commercialization plan should indicate: 1). Market entry strategy. 2). Timelines and Milestones. 3). Data analysis (sample size, data collection)
Mandatory (*). Reviewers ask about the go-to-market strategy, identified target customers, and potential business partners/mentors.
Key next step after BIG: a larger multi-site clinical study and CDSCO approval, built on the pilot data. 1. Market entry: small private maternity hospitals first, because they can buy directly; then public PHCs and CHCs through state health mission procurement, starting with Maharashtra. We sell the reader and charge per test for cartridges (target ₹350 or less per test, reader under ₹1.2 lakh). 2. Timelines and milestones: 3. Data: the pilot’s sensitivity, specificity and failed-test rate on about 150 newborns will size the next study and support the case to procurers.
Missing: how you plan to fund the multi-site study and CDSCO approval, for example investment, a follow-on grant or a partner
Missing: target dates after the project for the multi-site study, the CDSCO filing and first sales
Based on: revenue model, customers, follow-up 3, follow-up 4
10. Intellectual Property i. Does the applicant or the applicant company own any IP related to this project. If yes, give details. (Please mention Patent Number, Patent Title and Patent Assignee)
No. We have no granted patents and no filed applications. We plan to file a provisional patent application on the cartridge design during this project and have budgeted for it.
Based on: ip, follow-up 8
10. ii List Of Patents That Appear To Cover Any Part Of The Technology Of Interest Or Similar (And Possibly Overlapping) Technologies And Thereby Restrict The Freedom-To-Operate In The Envisaged Area. (Please mention Patent Number, Patent Title and Patent Assignee)
Missing: patent number, title and assignee of any patents found in a freedom-to-operate search on the cartridge and reader; no search has been run yet
Based on: follow-up 7
10. iii. If there are patents that are overlapping and may restrict FTO, does the applicant have the required license/s to practise these inventions for the purposes of the proposed project? Please provide license agreement details if any or provide information of the proposed next steps to obtain said license/s.
Missing: whether any patent found in the freedom-to-operate search needs a licence, and your plan to obtain it
Based on: follow-up 7
11. Relevant References
Mandatory (*).
Internal: spiked-sample validation of the prototype (48 samples), at our incubator’s lab.
Missing: the published studies you rely on for the biomarker panel, blood-culture turnaround, and the births and suspected-sepsis figures behind the market estimate in Q4
Based on: follow-up 2, follow-up 5, follow-up 1
12. Please upload declaration document on ethical/legal/safety/regulatory issues involved, if any
BIRAC's general 'Documents Required' page lists relevant regulatory approvals as DCGI | RCGM & GEAC | National Biodiversity | Pollution Control Board.
Attach in the portal: 12. Please upload declaration document on ethical/legal/safety/regulatory issues involved, if any
13. Upload a Presentation (Click here to download format)
Mandatory (*). The format (1596694138_big_presentation_format.pdf) is linked from inside the portal. It returned 'Unauthorised Access' at webcontent/ and a login page at user/download.php on 2026-09-30.
Attach in the portal: 13. Upload a Presentation (Click here to download format)
Step 7: Any Other Information Relevant to the Project
Please Upload any Additional Relevant Document
The proforma shows three upload slots.
Attach in the portal: Please Upload any Additional Relevant Document
Step 8: Proposal Objective and Work Plan
Proposal Objective and Work Plan
Maximum of 4 rows can be added. Reviewers ask whether timelines and deliverables are reasonable and achievable within INR 50 lakh. Clear, measurable milestones are finalised with the BIG Partner during due diligence, and funds are released on milestone progress.
| Objective | Start Time | End Time | Methodology/Experimental Design Detailed Work Plan | Alternate Strategies |
|---|---|---|---|---|
| Tune the cartridge and reader for heel-prick whole blood | Month 1 | Month 6 | Adjust sample metering, reagent drying and read time on spiked whole blood; check each change against the bench ELISA reference; lock the design. | If one marker stays unreliable on whole blood, take the two stable markers into the pilot and keep developing the third. |
| Produce a pilot batch of 2,000 moulded cartridges | Month 4 | Month 9 | Transfer the locked design to an outsourced moulder; assemble with our laminator; test batch samples against the reference before release. | If moulded parts fail checks, use lab-made cartridges for the pilot and fix the moulding in parallel. |
| Pilot clinical evaluation on about 150 newborns with suspected sepsis | Month 3 | Month 16 | Apply for hospital ethics approval in month 3; at the district hospital NICU, test one extra heel-prick drop taken at routine blood sampling, with parental consent; compare with blood culture and final diagnosis; clinicians do not see our result. | If enrolment is slower than planned, extend enrolment and report the interim results at the end of the project. |
| Analyse results, protect the IP and plan the next study | Month 2 | Month 18 | Run a freedom-to-operate search and file a provisional patent on the cartridge; report sensitivity and specificity with 95% confidence intervals; size the multi-site study. | If the search finds blocking patents, design around them or seek a licence before filing. |
Based on: follow-up 2, follow-up 3, follow-up 4, follow-up 8, ip
Step 9: Details of Equipment & Accessories
Details of Equipment Accessories
Note: Please select and remove unused rows. Fill all the mandatory details. Equipment is the non-recurring budget head (Guidelines s.11). During due diligence the budget is usually justified by checking quotations.
| Infrastructure/Equipment | Justification | Total Estimated Value (Rs. In Lakh) |
|---|---|---|
| Benchtop plate reader | Reference measurements to check every cartridge change and the pilot batch | 6.0 |
| Laminator | Assembling moulded cartridge parts in-house | 1.5 |
Based on: follow-up 8
Step 10: Human Resources to be Involved
Human Resources to be Involved
Fill all the necessary fields.
| Position | No. of Position | Qualification | Experience (In Year) | Age Limit, if any (In Years) | Duration For Which To be hired (in Years) | Role in the Project | Proposed Annual Salary (Rs. In Lakh) | Total Cost |
|---|---|---|---|---|---|---|---|---|
| Research Associate | 1 | M.Tech (microfluidics) | 2 | 1.5 | Cartridge development and testing | 6.0 | 9.0 | |
| Lab Technician | 1 | B.Sc MLT | 3 | 1.5 | Assays, reference testing, sample handling | 3.6 | 5.4 | |
| Clinical Research Coordinator | 1 | Life-sciences graduate with clinical-research experience | 1.0 | Ethics submission, consent, enrolment and data at the NICU | 4.8 | 4.8 |
Based on: follow-up 5, follow-up 8
Step 11: Budget Details
Equipment/ Accessories - Total
Calculated by the portal. 'You just need to review the calculation and save the form.'
7.5
Based on: follow-up 8
Budget Details
You just need to review the calculation and save the form. Guidelines s.11 recurring heads: manpower, consumables, incubation space rentals and services, travel, IP costs, outsourcing, contingency, any other operational costs. Non-recurring: equipment. The total must stay within INR 50 lakh.
| Human resources (A) | Consumables (B) | Other Heads (C) | Total (A+B+C) |
|---|---|---|---|
| 19.2 | 6.0 | 17.1 | 42.3 |
Based on: follow-up 5, follow-up 8
Step 12: Declaration
Upload the Declaration Document Prescribed Format
You need to upload the declaration document in the prescribed format. BIRAC's generic declaration format (formats/declaration.doc) has the company and collaborators certify: the particulars are true; they will abide by the scheme guidelines; the work does not duplicate work done elsewhere; the same proposal has not been submitted to any other agency (or which agency, with status); ethical clearances and DBT biosafety guidelines will be followed; and the company takes on the project's financial and management responsibilities. It is signed by the company, Project Coordinator, Key Investigator(s) and forwarding authority. Whether the BIG in-portal format is identical is not verified. Guidelines 7.2.2 separately require an undertaking that the same objectives/deliverables have not been funded by any other agency.
Attach in the portal: Upload the Declaration Document Prescribed Format
Budget
| Head | Amount | Why |
|---|---|---|
| Manpower (recurring) | ₹19,20,000 | Research associate ₹6 lakh/yr and lab technician ₹3.6 lakh/yr for 18 months, clinical research coordinator ₹4.8 lakh/yr for the 12-month study (f8). |
| Consumables (recurring) | ₹6,00,000 | Reagents and antibodies for cartridge tuning, reference testing and the pilot (f8). |
| Incubation space rentals and services (recurring) | ₹3,60,000 | Shared wet lab at our Pune bio-incubator at ₹20,000 a month for 18 months (f5). |
| Travel (recurring) | not costed | Not yet estimated: needs trips to the district hospital NICU, BIG Partner reviews and the investor interactions BIG requires (at least two). |
| IP costs (recurring) | ₹2,50,000 | Provisional and then complete patent filing on the cartridge, with attorney fees (f8). |
| Outsourcing (recurring) | ₹6,00,000 | Pilot batch of 2,000 moulded cartridges from an outsourced moulder, as quoted (f8). |
| Contingency (recurring) | not costed | Not yet set: only ₹0.2 lakh remains under the cap, so decide a contingency and trim other heads to fit. |
| Any other operational costs (recurring) | ₹5,00,000 | Clinical study costs: ethics fees, sample handling and blood-culture reference tests (f8). |
| Equipment cost (non-recurring) | ₹7,50,000 | Benchtop plate reader ₹6 lakh for reference measurements and laminator ₹1.5 lakh for cartridge assembly (f8). |
Programme limits: Up to INR 50 lakh grant-in-aid, for up to 18 months. No applicant co-contribution is specified
For you to add, in order 27
- BIG Partner: choose your BIG Partner from the list in the call; Venture Center, Pune is the listed partner in your city, but any listed partner can be chosen
- I accept the Terms and Conditions: read BIRAC’s Terms and Conditions and tick “I accept” yourself in the portal
- Registration Certificate Of Company: upload the Certificate of Incorporation (you hold it)
- Company's PAN Card: upload the company PAN card (you hold it)
- Memorandum of Association of company: upload the Memorandum of Association (you hold it)
- Article of Association Company: upload the Articles of Association (you hold it)
- Shareholding Pattern of the Company Indicating Name And Address Of Foreign Shareholders, Overseas Corporate Bodies And Shares Held By NRIs: upload a shareholding pattern, ideally CA-certified in BIRAC’s format
- Name of the Centre where you are/will be incubated: name of the Pune bio-incubator where you are incubated (we hold your incubator letter but not its name)
- Title, First Name, Last Name, Gender (Male/Female/Others): gender, as you want it recorded
- Mobile, Email: Project Leader’s mobile number and email
- Please Upload Resume in Prescribed Format: upload Dr. Meera Kulkarni’s signed resume in BIRAC’s prescribed format (PDF)
- Team Members (Add New for each member): title, name, gender, mobile and email for each team member, and a signed prescribed-format resume for each
- Scientific Advisors or Mentor Available (Add New for each): name, designation and affiliation of any scientific or business advisor or mentor, with their resume
- Please upload a concept note explaining the technology with necessary figures and diagrams: upload a concept note with figures of the reader, the cartridge and the assay workflow
- 3. Novelty [Explain how your idea is innovative and how it is different from the existing products in the markets or current state-of-the-art. Tabular representation of the difference between your idea and the other products in market or competitive product which are under development will be appreciated. Concrete market data is encouraged.]: names and prices of the imported point-of-care analysers, and any competing products under development, for the comparison table
- Upload table: upload the comparison table described in Q3
- 9. Future Plan of Commercialization [What do you envision to be the key next step to making impact with this innovation (e.g., sponsored research support, licensing, venture financing)? What is the time frame?] Commercialization plan should indicate: 1). Market entry strategy. 2). Timelines and Milestones. 3). Data analysis (sample size, data collection): how you plan to fund the multi-site study and CDSCO approval, for example investment, a follow-on grant or a partner
- 9. Future Plan of Commercialization [What do you envision to be the key next step to making impact with this innovation (e.g., sponsored research support, licensing, venture financing)? What is the time frame?] Commercialization plan should indicate: 1). Market entry strategy. 2). Timelines and Milestones. 3). Data analysis (sample size, data collection): target dates after the project for the multi-site study, the CDSCO filing and first sales
- 10. ii List Of Patents That Appear To Cover Any Part Of The Technology Of Interest Or Similar (And Possibly Overlapping) Technologies And Thereby Restrict The Freedom-To-Operate In The Envisaged Area. (Please mention Patent Number, Patent Title and Patent Assignee): patent number, title and assignee of any patents found in a freedom-to-operate search on the cartridge and reader; no search has been run yet
- 10. iii. If there are patents that are overlapping and may restrict FTO, does the applicant have the required license/s to practise these inventions for the purposes of the proposed project? Please provide license agreement details if any or provide information of the proposed next steps to obtain said license/s.: whether any patent found in the freedom-to-operate search needs a licence, and your plan to obtain it
- 11. Relevant References: the published studies you rely on for the biomarker panel, blood-culture turnaround, and the births and suspected-sepsis figures behind the market estimate in Q4
- 12. Please upload declaration document on ethical/legal/safety/regulatory issues involved, if any: upload the ethical/legal/safety/regulatory declaration, noting that the pilot needs hospital ethics committee approval
- 13. Upload a Presentation (Click here to download format): upload a presentation in BIRAC’s BIG format (the format is downloadable only after portal login)
- Please Upload any Additional Relevant Document: optional: upload the incubator letter you hold and, if you have one written up, a report of the spiked-sample tests
- Details of Equipment Accessories: quotations for the plate reader and laminator; BIRAC usually checks quotations during due diligence
- Budget Details: travel and contingency estimates; only ₹0.2 lakh is left under the cap, so other heads may need trimming
- Upload the Declaration Document Prescribed Format: upload the signed declaration in BIRAC’s prescribed format
How this was drafted
The follow-up questions it asked the founder
How big is the market you are going after, and how did you estimate it?
Our own estimate: India records about 2.3 crore births a year, and hospital studies suggest roughly 1 in 10 newborns is evaluated for suspected sepsis, so about 23 lakh evaluations a year. We assume around 40% of these happen at PHC/CHC level or in small maternity hospitals, about 9 lakh tests a year. At ₹350 a cartridge that is roughly ₹32 crore a year in cartridges, plus readers for about 30,000 PHCs and CHCs.
Which biomarkers does the cartridge measure, and what exactly did the spiked-sample testing show?
A three-marker host-response panel: CRP, procalcitonin and IL-6. We ran 48 spiked whole-blood samples at the incubator lab. Readings tracked the lab’s bench ELISA reference across the range we tested, the coefficient of variation was under 15% for each marker, and time to result was 18 minutes. No clinical samples tested yet.
How will you test the device on real samples during the project, where, and with how many newborns?
A pilot evaluation on about 150 newborns evaluated for suspected sepsis at the district hospital NICU where Meera worked. One extra heel-prick drop is taken at the time of routine blood sampling, with parental consent; clinicians do not see our result and treat as usual. We compare with blood culture and the treating team’s final diagnosis. The head of paediatrics has agreed in principle; we have not yet applied to the hospital ethics committee. We expect to end the project at TRL 5.
What price per test and per reader are you aiming for, what does a cartridge cost you today, and who will you sell to first?
Target ₹350 or less per cartridge, with a bill of materials under ₹150 at volume, and a reader under ₹1.2 lakh. A lab-made cartridge costs us about ₹900 today. We plan to sell first to small private maternity hospitals, which can buy directly, then to public PHCs and CHCs through state health mission procurement, starting with Maharashtra.
Who else is on the team, where do you do lab work, and is there anything to declare about earlier BIG applications, a parent company, or founders holding 20% or more of another company or LLP?
Two employees besides the founders: a research associate (M.Tech, microfluidics, 2 years’ experience) and a lab technician (B.Sc MLT, 3 years). We have no lab of our own; we work in the shared wet lab at the Pune bio-incubator where we are incubated, and pay it ₹20,000 a month. This is our first BIG application and we are applying through one partner only. We are not a subsidiary, and neither founder holds 20% or more of any other company or LLP.
Do you have any scientific or business advisors or mentors who will be named on the application?
Not answered, so the draft leaves a highlighted gap.
Has anyone run a prior-art or freedom-to-operate search on the cartridge and reader? If so, which patents came up?
Not answered, so the draft leaves a highlighted gap.
What will the 18 months cost, head by head (people, materials, equipment, outsourcing, the clinical study, patents)?
Salaries: research associate ₹6 lakh a year and lab technician ₹3.6 lakh a year for 18 months, plus a clinical research coordinator (life-sciences graduate with clinical-research experience) at ₹4.8 lakh a year for the 12 months of the study. Reagents and antibodies about ₹6 lakh. A pilot batch of 2,000 moulded cartridges from an outsourced moulder, quoted at about ₹6 lakh. Clinical study costs about ₹5 lakh (ethics fees, sample handling, blood-culture reference tests). A benchtop plate reader for reference measurements about ₹6 lakh and a laminator for cartridge assembly about ₹1.5 lakh. Provisional and then complete patent filing on the cartridge, about ₹2.5 lakh with attorney fees. No figure yet for travel or contingency.
How it reads against the published criteria
An estimate to help the founder improve the draft, not a prediction of selection.
| Criterion | Estimate | Note |
|---|---|---|
| Unmet Need | 15 / 20 | Clear, felt problem told by a neonatal clinician with nine years in intensive care; the market size is the founders’ own estimate with no cited sources yet. |
| Value Proposition/Differentiation | 12 / 20 | No lab, no cold chain and PHC pricing is a real differentiator, but competitor names and prices are missing and no IP is filed or searched. |
| Technical Viability | 18 / 30 | Working prototype and a costed, staged plan within ₹50 lakh; held back by spiked-sample-only data, no ethics approval yet and no freedom-to-operate search. |
| Team Strength/Passion | 10 / 15 | Strong clinician-plus-engineer pairing with the clinician in-house; no named advisors or mentors. |
| Business Perspective | 8 / 15 | Target customers and an entry sequence are named, but no customer conversations or partners are documented and post-project dates are open. |
| Potential (listed parameter, no points published) | — / — | Large public-health reach if clinical performance holds; not scored because BIRAC publishes no points. |
| Clarity/Team’s view (listed parameter, no points published) | — / — | Scope and boundaries are stated plainly; not scored because BIRAC publishes no points. |
| Commercialization Potential (listed parameter, no points published) | — / — | Reader-plus-cartridge model gives recurring revenue; the path depends on CDSCO approval and state procurement. Not scored. |
Where the questions come from
Built from BIRAC's BIG Scheme Guidelines Version 9 (October 2025, file 1761936564_big_new_guidelines_nov_2025.pdf), the official online-submission proforma big_user_guide_nov_25.docx (Nov 2025, 12-step portal manual), and the BIG-25 call notice (announced 01-11-2025, last date 30-11-2025; eligible = Company/LLP incorporated on/after 1 Nov 2020). All re-read on 2026-09-30. The live form sits behind a BIRAC portal login (birac.nic.in, 'BIG User' registration), so this is rebuilt from the proforma, not the live screens. No call is open on 2026-09-30: cfp.php 'Current Calls' is empty and BIG-25 is listed under Previous Calls. The guidelines say calls are issued at least twice a year (typically 1 Jan and 1 Jul) and are typically open for 30 days. The scheme page says about 45 days.
- The live application form sits behind a BIRAC portal login ('BIG User' registration at birac.nic.in) and was not accessed. Everything here comes from the official proforma big_user_guide_nov_25.docx (Nov 2025) and Guidelines Version 9 (October 2025), both re-read 2026-09-30.
- No BIG call is open on 2026-09-30. cfp.php 'Current Calls' is empty. The latest BIG call is the 25th (01-11-2025 to 30-11-2025; eligibility: incorporated on/after 1 Nov 2020). When the next call opens, re-read its cfp_view page for the dates, incorporation cut-off and BIG Partner list. The guidelines say calls come at least twice a year (typically 1 Jan and 1 Jul) and are typically open 30 days. The scheme page says about 45.
- The proforma publishes only two limits: the Proposal Summary (Max. 200 Words) and the Title (not exceeding 250 characters), plus 'Maximum of 4 rows' in the Work Plan. Portal limits for other Step 6 answers are not shown. Keep them concise, and do not assume a limit.
- The proforma gives no Thematic Area or Subthematic Area drop-down values. The Thematic options here are the 7 categories from Guidelines v9 s.3.1. The TRL options (1-9) come from BIRAC's TRL page, not the proforma.
- The BIG presentation format (1596694138_big_presentation_format.pdf) returned 'Unauthorised Access' at webcontent/ and a login page at user/download.php, so its slide structure is not captured. The BIG-specific resume and declaration formats are linked from inside the portal. The generic BIRAC formats (formats/Resume_format.doc, formats/declaration.doc) were read and summarised in help, but are not confirmed to be the BIG files.
- Rubric points (Unmet Need 20, Value Proposition/Differentiation 20, Technical Viability 30, Team Strength/Passion 15, Business Perspective 15) are the official guideline weights. 'Potential', 'Clarity/Team's view' and 'Commercialization Potential' are listed with no points. The guidelines' descriptor table uses different headings (Value proposition, Technical feasibility of the idea, Team Strength, Novelty, Commercialization strategy, Strategy to overcome challenges, BIG project plan). The descriptor wording is verbatim, but assigning descriptors to the weighted criteria is an inference.
- Clinician requirement conflict: the Nov-25 proforma (Step 4) says a clinician is 'mandatory' for clinical-setting products, while Guidelines v9 say 'highly recommended'. This definition treats it as hard (the stricter reading).
- The profile-field values for entity type, sector and stage (e.g. 'private_limited', 'proof_of_concept') are CapEasy vocabulary. The official wording is 'Company/LLP registered under the Indian Companies Act, 1956/2013'. The sources do not say explicitly whether one-person or public companies are eligible, or exclude any other entity type by name.
- BIRAC publishes no numeric TRL cut-off for BIG. 'Ideation to PoC' and the exclusion of late-stage validation suggest an early-TRL project (roughly TRL 2-4 at entry), but that is an inference, not a rule.
- No official source mentions DPIIT recognition or a state restriction for BIG, and neither is required on the sources read. Applicants choose one of the BIG Partners named in the call, and applying through more than one partner in the same call must be disclosed.
- The Step 6 concept-note upload is treated as required because it sits under the mandatory Q1. The proforma does not asterisk the upload line itself.
- Selection runs: eligibility check by the BIG Partner (scheme fit and stage, adequate technical detail, plagiarism) -> online review by 3-5 subject-expert reviewers plus a Review Committee -> face-to-face presentation to BIRAC's central Technical Expert Panel -> financial/technical due diligence and a possible site visit. Grantees must interact with at least 2 investors during the 18 months.