Call For Proposal

The occurrence of COVID-19 elevated intense attention not only within India but internationally however still we do not have fully approved (by US-FDA or CDSCO) medication for treating people infected with the novel coronavirus SARS-CoV-2. People infected with this new coronavirus have reported a wide range of symptoms – ranging from mild to severe illness - often appearing 2-14 days after exposure to the SARS-CoV-2 virus. As the disease counts rise in India, it is of utmost importance to develop therapeutics that could be helpful in treating the patients infected with Corona virus. Effective strategies for prophylaxis and holistic management are of paramount importance in curtailing the progress of the disease and reducing burden on hospitals.

The occurrence of COVID-19 elevated intense attention not only within India but internationally however still we do not have fully approved (by US-FDA or CDSCO) medication for treating people infected with the novel coronavirus SARS-CoV-2. People infected with this new coronavirus have reported a wide range of symptoms – ranging from mild to severe illness - often appearing 2-14 days after exposure to the SARS-CoV-2 virus. As the disease counts rise in India, it is of utmost importance to develop therapeutics that could be helpful in treating the patients infected with Corona virus. Effective strategies for prophylaxis and holistic management are of paramount importance in curtailing the progress of the disease and reducing burden on hospitals.

Click here to view RFP

The scope of this call remains broad and the proposal must address at least one of the following objectives:

• Development of therapeutics to address a rapid response towards the current COVID-19 outbreak: relevant “clinical ready”-assets including approved therapies or compounds in development, which could be repurposed for use in treating patients with the coronavirus.
• Development of therapeutics to address the current and/or future coronavirus outbreaks: identification of new potential assets and approaches that could be utilised including preventive strategies and combination approaches and could also address potential resistance. This may also include optimisation of promising treatments used in rapid response.

Proposals:

Research proposals with established, robust Proof of Concept i.e. TRL 4 and above (BIRAC website may be visited for TRL definitions) are invited in the following areas

• Novel molecules
• Drug repurposing (e.g.  but not limited to- antivirals, anthelmintic, antimalaria, anti- Inflammatory, immunomodulatory, anti-RA, anti-hypertensive, anti-coagulants, H2- blockers, protease inhibitors, etc.)
• Combination therapy for synergistic effects
• Biologics –
  • Neutralizing Antibody therapy
  • Hyperimmune Globulin
  • Immunomodulators
  • Recombinant proteins
  • Novel mAbs
  • Repurposed mAbs – (example Tocilizumab)
• Cell-based products and Gene Therapy products
• Stem cells such as UCMSC, WJMSC, BMMSC
• Exosomes and other novel Drug Delivery Systems

In addition to the above, development of in-vitro assays and in-vivo models (irrespective of TRL) for evaluating therapeutics will also be considered.

• All proposals must clearly define how samples are to be obtained, safety and documentation of sample collection process, transport and usage in the lab must be defined as per current COVID-19 sample handling guidelines issued by RCGM/DBT.
• Proposals requiring isolation of live virus and or testing of live virus mediated viral functions against a therapeutic agent must demonstrate access to verified BSL-3 facilities. They must also include the detailed SOPs for the same and obtain local IBSC and EC approvals prior to fund release.
• If pre-clinical animal models were not used prior to the trial, the same must be clearly justified in the proposal.
• Proposals must address both efficacy and toxicity aspects of the therapeutic approach.
• Proposals involving human clinical trials must describe cGMP production, toxicity testing and scalability of the therapeutic product as per drug manufacturing regulations and will require approval from CDSCO.
• Additionally, immunologic readouts should be part of the study design to evaluate the therapeutic approach.

• Study duration: All studies should be for a period of not more than 24 months given the urgency of the global health situation unless TEC/Apex recommends more than 24 months considering the requirements of the project. 

The proposals can be submitted by:

Company (Start up, 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), preferably with some (documented) commercially successful track record in relevant field.

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 

(NOTE: The applicant Company/LLP should have adequate in-house facility to address the project implementation (which shall be evaluated during the proposal evaluation) or incubated with any of the recognized incubation facility. DSIR certificate is not mandatory).

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.

Investigators should have documented strong expertise in the R&D subject matter of the proposed area.

Application can be submitted by any of the above entities (a - c) either singly or in collaboration

Collaborations between institutes and between research and clinical teams are encouraged. Investigators are encouraged to work with hospitals that have access to patients.

1. Proposals are required to be submitted online through BIRAC website only. Online proposal submission can be done by registered users. The RFP will be open for a period of 15 days. Process for submitting the proposals online is detailed below: 
2. Log on to the BIRAC website (www.birac.nic.in)  
3. Registered users may log-in using the credentials and new users need to register the institution with by clicking on New User Registration. 
4. In case of new user registration, a computer generated password is sent to the email-id provided at the time of registration.  
5. Upon login, the user is navigated to the page displaying the specific scheme link.  
6. Click on the link under Programmes and the active call would be highlighted.
7. Click on the active call against which the proposal needs to be submitted. 
8. Applicants should fill-up and submit their applications early honouring the established deadline, without waiting for the last date in order to avoid any last minute contingencies/clogging of website. The system stops accepting applications automatically at midnight of the last date of receipt of application. 
9. Applicants are advised to provide sufficient details in their applications to allow for an informed and fair evaluation/review process. Applicants are advised to provide self-contained proposals with essential supporting materials 
10. Requests for changes in the proposal once submitted will not be entertained. 
11. Providing incorrect information or employing corrupt or fraudulent practices shall be viewed adversely. 

Announcement Date: 15-10-2020
Last Submission Date: 31-10-2020 05:30 PM