Call For Proposal

BIRAC Announces Call for Proposals in the area of Biosimilar Product Development, Shared Facilities for Biotherapeutics Development and Novel Cell Line Development 30th Dec, 2018 - 15th Feb, 2019 5 PM

Towards strengthening the emerging biotechnology enterprise in India, Department of Biotechnology (DBT) Ministry of Science & Technology has initiated the Mission Program entitled “Industry-Academia Collaborative Mission for Accelerating Discovery Research to Early Development for Biopharmaceuticals - Innovate in India (i3) Empowering biotech entrepreneurs & accelerating inclusive innovation” (“Program”). Biotechnology Industry Research Assistance Council (BIRAC) setup by DBT is theImplementing Agency of i3 Program (Program co-funded by World Bank loan) through a dedicated Program Management Unit (PMU).

The vision of the Program is to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals including vaccines, biologics, medical devices and diagnostics to a level that will be globally competitive over the next decade.

Click here to view detailed description

This call is to seek applications for development of Biosimilars, Novel Cell Lines and Establishing/ Strengthening facilities for Biopharmaceuticals.

This Request for Proposal (RFP) is to seek applications for the following:

A.   Biosimilar Product Development

Applications are invited for development of Biosimilars

  1. Biosimilar Product Development – Preclinical/Clinical Phase
  2. Clone Development for Biosimilars

 

B.    Shared Facilities for Biotherapeutics Development

  1. Cell Line Repository
  2. Process Development Lab and GMP manufacturing facility
  3. GLP compliant Analytical Facility

 

C. Scientific Research: Novel Cell Line Development (Cell line engineering and Cell line development)

Applications are invited to establish a platform technology for production of Biopharmaceuticals

 

The proposals can be submitted:

  1. Solely by Indian Company / LLP / Non-profit organizations / Society/Trusts/ Foundation/ Associations/ Government entities/ Institutes/ R&D Organizations/ Bioincubator/ Industrial Zones which is a legal entity OR
  2. Jointly by Non-profit organizations / Society/Trusts/ Foundation/ Associations/ Government entities/ Institutes/ R&D Organizations/ Bioincubator OR
  3. Jointly by an Indian Company and Non-profit organizations/ Government entities/ Institutes/ R&D Organizations / Bioincubator

 

Criteria Particulars for the Proponent entities

  • Indian companies

An Indian Company is defined as one which is registered under the Indian Companies Act, 2013 and minimum 51% of the shares of the Company should be held by Indian Citizens holding Indian passport [Indian Citizens do not include Person of Indian Origin (PIO) and Overseas Citizenship of India (OCI) holders].

  • Non-profit organizations/ Government entities/ Institutes/ R&D Organizations

This will include Academic Research Institutes, Universities, Research Foundation, Medical Colleges and Institutes – both public and private who are valid legal entities such as Trust, Society or established under central or state statute.

  • Incubation centres

Incubation centres registered as a legal entity and recognised under different ministries of the Govt. of India and having SIRO certification/ DSIR registration.

 

Relevant documents for submission in the application:

1) Applicant being an Indian academic scientist and researcher:-

  • Copy of passport (from academic scientists & researchers) or self-declaration of 
  • Citizenship attested by a gazetted officer.
  • Either incubation agreement; or letter of intent in favour of applicant, issued by Incubation centre (which states that the incubation centre is willing to give facilities to applicant for the project applied for).

 

2) Companies:-

  • Incorporation certificate.
  • Share holding pattern as per BIRAC format
  • Details regarding in-house R&D facility, if any; or Incubation agreement.
  • Audited financial details of last three financial years (i.e. 2015-16, 2016-17, 2017-18), if applicable.
  • Copy of passports of the shareholders (in support of 51% eligibility criteria) or self-declaration of citizenship attested by a gazetted officer.

 

3)Limited Liability Partnership:-

  • Incorporation/Registration certificate.
  • Partnership deed; or list of subscribers which states that minimum half of the partners are Indian citizens.
  • Copy of passports of Indian partners/subscribers or self-declaration of citizenship attested by a gazetted officer.
  • Research mandate/ details regarding in-house R&D facility, if any/ Incubation agreement.
  • Audited financial details of last three financial years (i.e. 2015-16, 2016-17, 2017-18), if applicable.

 

4) Indian institution/ universities/ public research organization:-

  • Affiliation/registration certificate or statute reference for establishment.
  • Details regarding in-house R&D facility, if any/ Incubation agreement.
  • If the institution/public research organization are registered under/as Society or Trust, then they have to submit the documents as mentioned in the case of Society/Trust.

 

5) Society/ Trust/ NGO/ Foundation/ Association:-

   a. Society

  • Society registration certificate.
  • Details regarding in-house R&D facility, if any / Incubation agreement.
  • CA certificate (supporting the fact that half of the members of the society are Indian citizens)

b. Trust

  • Trust deed.
  • Details regarding in-house R&D facility, if any / Incubation agreement.
  • CA certificate (supporting the fact that half of the members of the trustees are Indian citizens)

 

c. NGO/ Foundation/ Association

i.   Registration details/certificate.

ii. Details regarding in-house R&D facility, if any / Incubation agreement.

iii. If the NGO/Foundation/Association are registered under/as Society or Trust, then they have to submit the documents as mentioned in the case of Society/Trust

Proposals are required to be submitted online only. For submission of proposals, applicants need to register with BIRAC through “User Registration”. Additional information on user registration and proposal submission are available online at BIRAC website at www.birac.nic.in.

No Hard Copy to be submitted. Proposals submitted online only would be considered.

BIRAC will ensure maintenance of strict confidentiality of the proposals.

For any queries, please contact:

Head – NBM: technical.birac@gov.in

Announcement Date: 30-12-2018
Last Submission Date: 15-02-2019 05:00 PM

Copyright © 2019 BIRAC. All Rights Reserved.