BIRAC-Call For Proposal

BIRAC Announces Request for Expression Of Interest REOI under MISSION COVID SURAKSHA - Enhancing capacity for conduct of Human clinical trials for COVID-19 Vaccine candidates

As part of the Government of India’s response to the COVID 19 Pandemic, the Department of Biotechnology (DBT), Ministry of Science and Technology, has been working with all stakeholders to address the urgent need of COVID 19 Vaccine. Biotechnology Industry Research Assistance Council (BIRAC) as a Government Enterprise has been identified by DBT to effectively implement Mission COVID Suraksha by setting up a Mission Implementation Unit (MIU).

COVID 19 pandemic is anticipated to lead to a loss of $2 trillion - $4.1 trillion -- 2.3% to 4.8% of the global gross domestic product. Recognizing its critical importance, rapid development and deployment of effective vaccines against COVID-19 is the need of the hour with ~66 candidates in clinical trials globally (data as per WHO compilation, accessed on 31st Oct’20).

Vaccine development is a lengthy, expensive process, typically taking an average of 10-15 years. But the current emergency does not provide this luxury of time. While the government efforts have helped quickly put together the best groups and encouraged them to accelerate the COVID vaccine development, it is now imperative that the COVID vaccine development and manufacture are taken up in a Mission mode and not in a project mode.

Therefore, to ensure a steady supply of vaccines in the next 12-18 months, DBT has established Mission COVID Suraksha. The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development. This will be a National Mission working to bring to the citizens of the country a safe, efficacious, affordable, and accessible COVID vaccine at the earliest with a focus on Atma Nirbhar Bharat and fulfil our commitment of serving not just the country but the entire globe.

It must be ensured that all vaccines being introduced through the Mission have preferred characteristics applicable for India and that is proposed to be achieved by strengthening the following functional domains:

  • Accelerating the production of clinical trial material, and clinical development for  licensure of COVID-19 vaccine candidates.
  • Establishing clinical trial sites, immunoassay laboratories, central labs and suitable facilities for animal challenge studies, and other testing facilities to support COVID-19 vaccine development

To enable the above, this Request for Expression of Interest (REOI) is to seek EOI/ application only for : Enhancing capacity for conduct of Human clinical trials for COVID-19 Vaccine candidates as per the instructions given below. Other published REOIs on Vaccine Development, Immunogenicity lab establishment and Animal challenge facilities may be accessed through BIRAC website.

Click here to view REOI details

Ensure availability and access to Good Clinical Practice (GCP) compliant clinical trial sites to vaccine developers. The trial sites will be both for supporting hospital-based sites for performing early stage clinical trials and large scale Phase III clinical trials through access to community based healthy population.

  1. Company (Small, Medium, or Large), incorporated under the Companies Act, 2013, having a minimum of 51% of the shares of the Company to be held by Indian Citizens (Indian passport holders).
  2. Limited liability Partnership (LLP) incorporated under the Limited Liability Partnership Act, 2008 having a minimum half of the persons who have subscribed their names to the LLP document as its Partners should be Indian citizens
  3. Academia (Public or Private Research Institute, University) having a well-established support system for research. The institute should have been established in India and have NAAC/ UGC/ AICTE or any equivalent recognition certificate or any other Public/Government supported organization
  4. Non-profit organizations/ Society/ Trusts/ Foundation/ Associations/ Government entities/ Institutes/ R&D Organizations/ which is a legal entity

NOTE: Funding is not available for Contract Research Organizations or Site Management Organization

  • The Expression of Interest can be submitted online as per the required format. The website will provide a detailed user guide to facilitate the online proposal submission.
  • The process for submitting the proposals online is detailed below:
  • Go to BIRAC's website  https://www.birac.nic.in
  • Click on the Call for Proposal and then-current call tab in order to view the call    detailed description.
  • Click on the active call against which you wish to submit the Proposal.
  • Further details on 'How to Submit a Proposal' would also be available in BIRAC 3i          Portal.
  • If you are already a registered user, then kindly enter your login credential at the link in order to submit proposal: https://birac.nic.in/login.php
  • If you are a new user and your company/organization is not listed in the drop-down         on the registration page, then you need to register your company/organization by clicking on link: https://birac.nic.in/desc_new.php?id=327
  • Once you register your company/organization, then your organization will be activated within 24 hrs. After activation, please create your login  credential by browsing the same link : https://birac.nic.in/desc_new.php?id=327 . After registration, you will receive an auto-generated link on the registered email id entered at the time of registration.
  • Once you login into https://birac.nic.in by using login credentials, then kindly click on  "COVID Suraksha" on the dashboard to submit the proposal.
  • Applicants are advised to fill?up and submit their applications early without waiting for the last date in order to avoid any last-minute contingencies. The system  stops accepting applications automatically after 5:00 PM of the last date of submission.
  • In case of any query may please drop an email at pmubmgf5@birac.nic.in without any delay.
  • Applicants are advised to provide sufficient details in their applications to allow for an informed and fair evaluation/review (Refer Annexure 1).
  • Applicants are advised to provide self?contained proposals with essential supporting materials provided as uploads.
  • Requests for changes in the EOI once submitted will not be entertained.
  • Please read through this REOI in its entirety and ensure that your technical details, budget, and organization details are in compliance with the eligibility criteria provided. The Applicants should read the guidelines for clear instruction and other details for comprehensive preparation of EOI.  Proposals for projects that do not meet the eligibility criteria and/or do not directly respond to the call area will not be reviewed, regardless other parameters.
  • The proposed budget shall be made INCLUSIVE of all applicable taxes and shall be considered accordingly. The commitment of the applicant to put in its resources as part of the Project will be specified distinctly.
  • Information on all relevant pre-existing agreements/ MoUs in connection to the proposed technology, background IP, outsourcing, consultancy, IP licensing, technology transfer, material transfer, etc. should be provided at the time of proposal submission.

Announcement Date: 05-12-2020
Last Submission Date: 25-12-2020 05:00 PM

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