BIRAC ANNOUNCES CALL FOR PROPOSALS FOR DEVELOPMENT OF MEDICAL DEVICES AND DIAGNOSTICS

Introduction

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 the Implementing Agency of i3 Program (Program co-funded by World Bank loan).

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.

The National Biopharma Mission announces a Request for Proposals to support product development of medical devices and diagnostics that address the Indian healthcare needs.

The objective of the Mission is to support:

• Development of medical devices and diagnostic products so as to advance their development and bring them closer to the market.
• Development of an ecosystem that would spur indigenous manufacturing in the medical devices and diagnostics sector.

KEY FEATURES OF THE CALL

This call seeks proposals to accelerate indigenous development of medical devices and diagnostic products. The primary focus of this call is towards therapeutic and diagnostic equipment in the following areas:

• Wound Management – Different types of wound management medical devices (with or without antimicrobial activity).
• Trauma and Emergency medicine.
• Surgical Tools – High end medical devices and robotic devices used for surgeries.
• Implants – Different types of medical devices of implantable nature for human use.

This call will support the following stages of product manufacturing and testing which can be completed in 30 months duration:

• Pilot batch manufacturing – Manufacturing of limited number of prototypes for further compliance and regulatory testing only. The number of prototypes should be based on the testing requirements.
• Compliance testing – Testing of equipment/ device/ material for biocompatibility (in-vitro only), physico-chemical testing, EMI-EMC testing etc. for certification.
• Preclinical testing – Preclinical testing in large animals only (including dogs, sheep, goat, pig and non-human primates) for medical devices. Proposals for testing in other animals such as mouse, rat, rabbit, hamster, guinea pig etc. will not be considered.
• Human clinical testing – Clinical investigation/ clinical performance evaluation of medical devices in humans. These studies need to be undertaken through a CRO.

Eligibility for Apply

The proposals can be submitted:

• Solely or by consortium of Indian Companies OR
• Solely or by consortium of LLP OR
• Solely or jointly by Non-profit organizations/ Government entities/ Institutes/ R&D Organizations OR
• Jointly by an Indian Company and Non-profit organizations/ Government entities/ Institutes/ R&D Organizations
• OR
• By a Consortium of Indian Companies along with Non-profit organizations/ Government entities/ Institutes/ R&D Organizations
• 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.

Limited Liability Partnership: A limited liability partnership is defined as one which is incorporated under the Limited Liability Partnership Act 2008. Minimum half of the persons who subscribed their names to the LLP document as its Partners should be Indian citizens. [Indian Citizens do not include Person of Indian Origin (PIO) and Overseas Citizenship of India (OCI) holders].

Relevant documents for submission in the application:

1. Applicant being an Indian academic scientist and researchers: –

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 in support of 51% eligibility criteria.
Details regarding in-house R&D facility, if any; or Incubation agreement.
Audited financial details of last three financial years (i.e. 2014-15, 2015-16, 2016-17), 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. 2014-15, 2015-16, 2016-17), 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:

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

Application Procedure

Proposals to be submitted online only. For proposal submission please log on to www.birac.nic.in. For details on Request for Proposal (RFP) and mission document,

Click Here

Call Opens: 31st October 2019;

Last date of Submission: 12th December 2019 (5:00 PM)

For queries please contact:

Mission Director, PMU-NBM: technical.birac@gov.in

Program Manager, NBM: nbm3.birac@nic.in

For more detail: Click Here