A. COLLABORATIVE R&D PROJECTS

PROFORMA FOR SUBMITTING COLLABORATIVE PROJECT PROPOSALS:

1. ABSTRACT OF THE PROPOSAL(not exceeding three A-4 pages)

1. Title of the Project2. Objectives3. Project duration with milestones of phases.4. Significance and impact/value of the project.5. Cooperating partners.6. Details of partnership : (a) S&T (b) Financial 7. Total financial outlay.8. Brief C.V. of Project Investigators & Co-Investigators (both institutional and

industry) 9. Annual Report of industrial collaborator for the last financial year.10. Declaration of the collaborating organisations confirming their support and

participation in the programme as above.

II. PROJECT DETAILS :

(a) Detailed objectives and approach of the project (including its preamble, review of current scenario, methodology, importance and impact value, significance and references).

(b) Scientific and technological background of collaborating parties in relationship to developments nationally and internationally along with intellectual property scenario.

(c) Methodology and plan of work including time schedules, and monitoring mechanisms. The respective roles of the collaborating parties in carrying out the proposed project should be clearly identified and indicated.

(d) Details of available resources including personnel and equipment of collaborating parties (indicate separately).

(e) Brief particulars of the applicant firm/company giving details of major areas of R&D, S&T facilities available, current and last two years R&D budget, staff position and recent R&D achievements.

III. FINANCIAL REQUIREMENTS :

Recurring and Capital with phasing in time (indicate in the following format separately for INDUSTRY & INSTITUTION).

RECURRING(Rupees in lakhs)

------------------------------------------------------------------------------------------------------------Head 1st Year 2nd Year 3rd Year Total------------------------------------------------------------------------------------------------------------

1. Salaries & Wages2. Consumables & Materials3. Internal Travel4. Information & Documentation5. Patent Filing6. Overheads (Services)------------------------------------------------------------------------------------------------------------

(A) Sub-Total ------------------------------------------------------------------------------------------------------------CAPITAL

(Rupees in lakhs)------------------------------------------------------------------------------------------------------------Head 1st Year 2nd Year 3rd Year Total------------------------------------------------------------------------------------------------------------1. Equipment (New)2. Equipment Usage (Existing)3. Software etc.4. Others

(Please specify)------------------------------------------------------------------------------------------------------------

(B) Sub-Total------------------------------------------------------------------------------------------------------------

GRAND TOTAL (A+B)------------------------------------------------------------------------------------------------------------

Please specify the Equipment details along with justification for equipment costing above Rs. 5.0 lakh. Specify clearly if similar equipment is available in the institution.

Declaration

We, the undersigned are the collaborators of the project entitled "………………………….…………………………………………………………………". We the undersigned would do our utmost to support and to ensure effective participation of scientists from respective institutes towards the goal oriented, time bound, progress of the said project.

Signatories (INDUSTRY) Signatories (INSTITUTIONS) Name, Designation, Signature & Seal Name, Designation, Signature & Seal

1. Principal Investigator 1. Principal Investigator

2. Co-Principal Investigator 2. Co-Principal Investigator

3. Chairman/Managing Director 3. Head of the Institution

DECLARATION/CERTIFICATION BY HEAD OF THE INSTITUTION(TO BE GIVEN IN THE OFFICIAL LETTERHEAD)

It is certified that

a) The collaborative research project entitled……………………………………. ..………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………. with industry partner M/s……………………………………………………………….. proposed in the Drugs and Pharmaceuticals Research Programme does not in any way duplicate the work already done or being carried out elsewhere on the subject.

b) The same project has not been submitted to any other agency/agencies for financial support.

c) The emolument for the manpower proposed are those admissible to persons of corresponding status employed in the institute/university or as per the ministry of science and technology guidelines.

d) Necessary provision for the scheme/project will be made in the institute/university/state budget in anticipation of the sanction of the scheme/project wherever such provision is committed.

e) If the project involves the utilization of genetically engineered organism, it is agreed that we will ensure than an application will be submitted through our Institutional Biosafety Committee and we will declare that while conducting experiments, the biosafety guidelines of the department of Biotechnology would be followed in toto.

f) If the project involves field trials/experiment/exchange of specimen etc. will ensure that ethical clearances would be taken from concerned ethical committees/competent authorities and the same would be conveyed to the Department of Biotechnology before implementing the project.

g) It is agreed that any research outcome or intellectual property right(s) on the invention (s) arising out of the project shall be taken in accordance with the Agreement made in this regard among the collaborators of the said project.

h) We agree to accept the terms and conditions of the programme and execute legal agreement as required before commissioning the project.

i) The institute/university agrees that the equipment, other basic facilities and such other administrative facilities as per terms and conditions of the grant will be extended to investigator(s) through out the duration of the project.

j) The institute assumes to undertake the financial and other management responsibilities of the project.

Seal (Signature of the Head of Institution)

B. FACILITY

PROFORMA FOR SUBMITTING NATIONAL FACILITY PROJECT PROPOSALS :

I. ABSTRACT OF THE PROPOSAL (not exceeding three A-4 pages)

1. Title of the Project2. Objectives3. Project duration with milestones of phases.4. Significance and impact/value of the project. 5. Total financial outlay.6. Brief C.V. of Project Investigators & Co-Investigators II. PROJECT DETAILS :

Detailed objectives and approach of the project (including its preamble, review of current scenario, methodology, importance and impact value, significance and references).

Whether similar facility is available elsewhere? What is the uniqueness of the proposed facility ?

Methodology and plan of work including time schedules, and monitoring mechanisms.

Details of available resources including personnel and equipment of the institution. Who are the users of this facility ?

III. FINANCIAL REQUIREMENTS :

Recurring and Non-Recurring budget for the facility

RECURRING(Rupees in lakhs)

------------------------------------------------------------------------------------------------------------Head 1st Year 2nd Year 3rd Year Total------------------------------------------------------------------------------------------------------------1. Salaries & Wages2. Consumables & Materials3. Internal Travel4. Information & Documentation5. Patent Filing6. Overheads (Services)------------------------------------------------------------------------------------------------------------

(A) Sub-Total -----------------------------------------------------------------------------------------------------------NON-RECURRING

(Rupees in lakhs)------------------------------------------------------------------------------------------------------------Head 1st Year 2nd Year 3rd Year Total------------------------------------------------------------------------------------------------------------1. Equipment (New)2. Equipment Usage (Existing)3. Software etc.4. Others

(Please specify)------------------------------------------------------------------------------------------------------------

(B) Sub-Total------------------------------------------------------------------------------------------------------------

GRAND TOTAL (A+B)------------------------------------------------------------------------------------------------------------Please specify the Equipment details along with justification for equipment costing above Rs. 5.0 lakh. Specify clearly if similar equipment is available in the institution.

Declaration

We, the undersigned are the Investigators of the project entitled "………………………….…………………………………………………………………". We the undersigned would do our utmost to support and to ensure effective participation of scientists from respective institutes towards the goal oriented, time bound progress of the said project. Signatories (INSTITUTIONS)Name, Designation, Signature & Seal

1. Principal Investigator

2. Co-Principal Investigator

3. Head of the Institution

DECLARATION/CERTIFICATION BY HEAD OF THE INSTITUTION(TO BE GIVEN IN THE OFFICIAL LETTERHEAD)

It is certified that

a) The facility research project entitled……………………………………. ..………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………. submitted to Drugs and Pharmaceuticals Research Programme does not in any way

duplicate the work already done or being carried out elsewhere on the subject.

b) The same project has not been submitted to any other agency/agencies for financial support.

c) The emolument for the manpower proposed are those admissible to persons of corresponding status employed in the institute/university or as per the ministry of science and technology guidelines.

d) Necessary provision for the scheme/project will be made in the institute/university/state budget in anticipation of the sanction of the scheme/project wherever such provision is committed.

e) If the project involves the utilization of genetically engineered organism, it is agreed that we will ensure than an application will be submitted through our Institutional Biosafety Committee and we will declare that while conducting experiments, the biosafety guidelines of the department of Biotechnology would be followed in toto.

f) If the project involves field trials/experiment/exchange of specimen etc. will ensure that ethical clearances would be taken from concerned ethical committees/competent authorities and the same would be conveyed to the Department of Biotechnology before implementing the project.

g) The institute/university agrees that the equipment, other basic facilities and such other administrative facilities as per terms and conditions of the grant will be extended to investigator(s) through out the duration of the project.

h) The institute assumes to undertake the financial and other management responsibilities of the project.

Seal (Signature of the Head of Institution)

C. SOFT LOAN FOR PHARMA INDUSTRIAL R&D PROJECTS

PROFORMA FOR SUBMITTING R&D PROJECT PROPOSALS FOR LOAN BY PHARMA INDUSTRY UNDER DRUGS AND PHARMACEUTICALS RESEARCH PROGRAMME (DPRP) OF DEPARTMENT OF SCIENCE AND TECHNOLOGY (DST)

I. PROJECT DETAILS

Title of the Project Objectives Strategic advantages (not more than one page in single space) Project duration with detailed milestones of phases Total financial outlay Brief C.V. of Project Investigators & Co-investigators Approach of the project - its preamble, review of current scenario, methodology,

importance and impact value, significance and references Reasons and justification of the proposal indicating historical background,

circumstances in which the need have arisen, whether alternatives have been considered and what detailed studies have been made in regard to this proposal for its need, its economics and other relevant aspect (not more than two pages in single space)

Scientific and technological background in relationship to developments nationally and internationally along with intellectual property scenario

Methodology and plan of work including year-wise targets of the project Details of available resources including personnel and equipment (indicate

separately) A brief write-up on the functioning of the industry/R&D Centre (one page in single

space) Details of major areas of R&D, S&T facilities available, current and last two years

R&D budget, staff position and recent R&D achievements Expected outcome and market return (not exceeding one page in single space)

II. FINANCIAL REQUIREMENTS (Rupees in lakhs)

Head 1st Year 2nd Year 3rd Year TotalA. RECURRING

1. Salaries and wages2. Consumables and materials3. Internal travel4. Outsourcing cost if any (give details)5. Any other (provide details)6. Overheads (services)

Sub-total (A)

(Rs. in lakhs) Head 1st Year 2nd Year 3rd Year Total

B. NON-RECURRING – CAPITAL

1. Equipment (New)2. Equipment usage (Existing) – give

details separately3. Software, etc.4. Others (please specify)Sub-total (B)Total cost of the project (A+B)

(Rs. in lakhs)Description 1st Year 2nd Year 3rd Year Total

I. DST share as loan II. Industry share

a. Internal accrualb. Equityc. Bank loand. Venture Capitale. Any other

Total cost of the project (I+II) III. DECLARATION

We, the undersigned are the investigators of the project titled “--------------------------------------------------------------------------------------------------------------------“. We the undersigned would do our utmost to support and to ensure effective participation of scientists towards the goal oriented, time bound, progress of the said project.

Signatories (Industry)Name, Designation and Signature and Seal

1. Principal Investigator

2. Co-principal Investigator

3. Chairman/Managing Director

Note/Enclosures needed

1. Please specify the equipment details along with justification for equipment costing above Rs.5.00 lakhs.

2. The latest Annual Report of the company should accompany the proposal3. The copy of the DSIR recognition should be enclosed.4. Copy of the Regulatory Clearances like Drug Controller General of India (DCGI),

Review Committee on Genetic Manipulation (RCGM), Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Institutional Biosafety Committee (IBSC), Institutional Ethic Committee, etc. may be attached with the proposal.

5. Five copies of the proposal need to be submitted alongwith soft copy in CD/Floppy and also email to Head - TDT Division

6. Regarding the industry share its break-up as internal accrual, equity, bank loan, venture capital and any other should be substantiated with proof/letter.

IV. CERTIFICATE

1. The proposed R&D project titled “------------------------------------------------------------------------------------------“ submitted by M/s.--------------------------------

to DST does not in any way duplicate the work already done or being carried out elsewhere on the subject.

2. The same project has not been submitted to any other department/agency for financial support.

3. Proper patents search have been made and the proposed proposal does not fall under infringement of the existing patent.

4. If the project involves the utilization of genetically engineered organism, it is agreed that we will ensure that an application will be submitted through our Industrial Biosafety Committee and we will declare that while conducting experiments, the biosafety guidelines of the Department of Biotechnology would be followed in toto.

5. If the project involves field trials/experiment/exchange of specimen, etc. We will ensure that ethical clearances would be taken from concerned ethical committees/competent authorities and the same would be conveyed to the Department of Biotechnology before implementing the project.

6. It is agreed that any research outcome or intellectual property right(s) on the invention(s) arising out of the project shall be taken in accordance with the Agreement made in this regard of the said project.

7. We agree to accept the terms and conditions of the programme and execute legal agreement as required before commissioning the project.

(Signature of Chairman/Managing Director)

V. TERMS AND CONDITIONS FOR THE LOAN

1. The loan will be released by DST to the Industrial Partner (M/s…………………….) in installments, as per details set out in para 3 of Appendix 2.

2. The partners hereby agree to the general terms and conditions of the loan as follows:

2.1 The loan will be an unsecured loan carrying a simple interest of 3% per annum on the outstanding amount of the loan.

2.2 Interest will become due from the date of release funds in the project to industrial partners.

2.3 The repayment of the loan will be in 10 annual equal installments.2.4 The project implementation period will be the moratorium period and will

not be liable for repayment of installments and interest. However, the interest accrued during the implementation period will be amortized and will be payable in a maximum of 5 installments.

2.5 The interest will be payable every year along with the loan installment of repayment.

2.6 The Industrial Partner undertakes to ensure timely repayment of the loan along with installment of interest as per the schedule notified. Any delays in repayment will entail payment of penal interest @ 12% P.A. compounded monthly for the period of delay. Successive two defaults will entail recall of the total outstanding loan immediately.

2.7 The Industrial Partner shall maintain a separate account for the expenditure from loan amount for the project.

2.8 The Industrial Partner shall utilize the loan only for the purpose of the project and not for any other purpose including civil constructions & renovation of the R&D and associated facilities. Diversion of funds to other purposes will entail cancellation of the loan and immediate repayment of the outstanding loan amount with a penal interest @ 12% compounded monthly.

2.9 The Industrial Partner will meet any expenditure incurred on the project over and above the loan amount.

3. The Industrial Partner must have an R&D Center, which has valid recognition of Department of Scientific and Industrial Research (DSIR), Government of India; if not registered, the firm undertakes to get the R&D Center so recognized within 12 months. Failing which, unless and otherwise extended the period, the firm may be asked to return the loan amount.

4. In case of reorganization of the Industrial Partner through merger, acquisition, termination, closure etc., the Industrial Partner undertakes to settle the DST loan even prior to initiating such measures.

5. The provision of the grant to the institution or loan to industry partner does not create any liability explicit / implicit on DST of the manpower engaged for the project.

6. In case the Industrial Partner decides to abandon the project or for breach of any of the terms and conditions, the entire amount of the loan outstanding on that date shall become recoverable forthwith and it shall be open to DST to affect the recovery, in any manner it thinks fit, from the firm.

7. In the event that industrial Partner wishes to pay any amounts ahead of the schedule, there shall be no prepayment penalty levied.

8. Notwithstanding anything contrary in the agreement, the terms conditions are subject to change as decided by the Government of India from time to time, the Industrial Partner agrees to abide and honour such directions and decisions of Government of India.

9. 5% of DST share of loan will be released after final project monitoring based on the project completion report and audited UC/SE submitted by the industry.

D. GRANTS-IN-AID TO INDIAN PHARMA INDUSTRY

PROFORMA FOR SUBMITTING R&D PROJECT PROPOSALS FOR GRANTS-IN-AID TO INDIAN PHARMA INDUSTRY (INCLUDING NEW AND SMALL) FOR CLINICAL TRIALS FOR DEVELOPING DRUGS FOR NEGLECTED DISEASES UNDER DRUGS AND PHARMACEUTICALS RESEARCH PROGRAMME (DPRP) OF DEPARTMENT OF SCIENCE AND TECHNOLOGY (DST)

The format includes the following:

1. Title of the project2. Objectives3. Project duration with milestones of phases4. Significance and impact/value of the project5. Details on the methodology 6. Details of the Patent Expiry Date / developed in-house or imported technology.7. Information on registration status with Clinical Trial Registry of ICMR8. Status on the regulatory clearances such as DCGI for Phase-I, II & III, Institutional

Ethics Committees, collaborating hospitals / centres etc. 9. Copies of the Research Publications about the particular drug.10. Copy of the clinical study protocol developed11. Industry’s investment for the particular drug development as well as for the clinical

trial for the activities other than what is expected from DST.12. Total financial outlay (excluding expenditure towards capital equipment, land &

building and existing manpower which have to be met by the industry from its own resources)

13. Undertaking by Chairman / Managing Director / Head of the Organization stating that the proposal was not submitted to any other agency in Central Government / State Government and International Organizations is required. If the support is received or expected, the details thereof need to be provided. All the other regulatory procedures will be strictly adhered and other terms & conditions will be followed as per the agreement to be executed before the start of the project.

14. Brief C.V. of Project Investigators & Co-investigators15. Company’s Latest Annual Report / Memorandum of Articles of Association16. Number of copies of the proposal to be submitted : 5 copies (including soft copy as

word in CD)17. Other details on whom to submit is provided in the website

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