ICMR invites EoI for joint development, commercialization of Salmonella vaccine
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-05-17 09:29 GMT | Update On 2024-05-17 09:36 GMT
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New Delhi: The Indian Council of Medical Research (ICMR) has issued a renewed call for Expression of Interest (EoI) from experienced Indian agencies for the joint development and commercialization of a broad specificity glycoconjugate vaccine targeting Salmonella Typhi, Salmonella Paratyphi, and Salmonella Typhimurium.
The decision to reopen the EoI comes after the initial call, published on 01.03.2024 under EoI No. EoI/MISC/2023/MD, received an inadequate number of responses. The original submission deadline was 31.03.2024.
According to the notification on the ICMR website, the new closing date for submissions is 12th July 2024.
"This is to notify that due to inadequate number of response received during the previous call for Expression of Interest (No. EoI/MISC/2023/MD dated 01.03.2024) published on the ICMR website with a closing date of 31.03.2024, the competent authority has decided to reopen the call for Expression of Interest for joint collaboration in R&D, manufacturing, and commercialization of broad specificity Salmonella vaccine useful, against typhoid and paratyphoid fever and Salmonella Typhimurium gastroenteritis," notification on the ICMR site stated.
" Interested vaccine manufacturers/ pharma companies/ R&D Institutions are encouraged to submit their interest as per the instruction given in the EoI document," ICMR stated.
"Industries/companies which had already submitted the proposal/application during the previous call, need not submit again. Their earlier proposal shall be considered during the process of current evaluation," the Council noted.
Objectives intended under this joint collaboration are as follows:
i. To validate the technology “broad specificity glycoconjugate vaccine against Salmonella Typhi, Salmonella Paratyphi and Salmonella Typhimurium” developed at ICMR-NICED, Kolkata
ii. To develop the product “broad specificity glycoconjugate vaccine against Salmonella Typhi, Salmonella Paratyphi and Salmonella Typhimurium” with proper regulatory compliances and it’s commercialization & marketing.
Scope of Work
i. ICMR is willing to collaborate with eligible organizations, companies, and manufacturers for undertaking validation, joint development and commercialization of Product i.e. broad specificity Salmonella Vaccine, in two phases:
Phase I: Independent validation of the broad specificity Salmonella vaccine developed by ICMR-NICED Kolkata.
Phase II: Joint R&D and co-development of the broad specificity Salmonella vaccine candidate for further scaleup, and regulatory permissions, clinical trial, commercialization, and marketing etc
ii. Company would be granted rights to undertake scientific/technical validation of the ‘Technology’ as a Phase-I, only after signing of a non-disclosure agreement (NDA)
iii. On successful completion of Phase-I with satisfactory results, the Company would be granted rights to undertake further research & development for scaleup, obtaining regulatory clearances, clinical trials, manufacturing, and commercialize the broad specificity Salmonella Vaccine.
iv. An Agreement following EoI and RFP is proposed to be executed on Non-exclusive basis with single/multiple companies to enable wider outreach of the broad specificity Salmonella Vaccine for societal benefit and public health use. All the related issues shall be governed by ICMR IP Policy, as revised and approved by the Competent Authority.
v. ICMR-NICED Institute has expertise in various techniques, methods, information, technicalknow-how relating to aforesaid technology which could be used for the co-development of broad specificity Salmonella Vaccine.
Role of ICMR
i. ICMR-NICED Institute shall provide the company selected through the EoI with the ‘Technology’ after signing a non-disclosure agreement (NDA) for independent validation of the ‘Technology’ during phase-I.
ii. If the Phase-I is successful, ICMR-NICED Institute will provide expert guidance & technical support for the co-development of broad specificity Salmonella Vaccine, in all phases. Such technical oversight by ICMR-NICED Institute would accelerate the development of the Product and its commercialization.
iii. ICMR would provide technical support through its team of experienced scientists in study planning, product development, development of study protocol, results/data analysis, outcome assessment, safety & efficacy assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company.
iv. ICMR through its Institutes would provide support and facilitation to conduct the R&D/clinical study of new technology/ product in India through its Affiliates/ Institutes, in collaboration with the company/institutions in a professional and mutually agreed-upon manner and timelines, which will be decided later under the Agreement.
v. ICMR shall have no financial implications unless otherwise specified.
Role of company
i. The Company shall have to undertake the technical/scientific validation of the technology as a Phase-I of this joint collaboration, and shall share the data generated after the validation to the ICMR.
ii. The Company shall have valid provisions to provide all necessary infrastructure/ material/ manpower required for product validation/ co-development/ scale-up either directly or otherwise.
iii. The Company shall have provisions to undertake the scale-up as required, manufacturing and commercialization of the broad specificity Salmonella Vaccine, in a set milestone.
iv. The Company agrees to share the technical data with ICMR and participate in all discussions in a professional and mutually agreed-upon manner.
v. The Company agrees to allow authorized personnel/scientist/team of ICMR to visit the designated lab/ production facility as and when required, as envisaged under this EoI and subsequent Agreement.
vi. The Company shall be responsible for obtaining all the regulatory approvals required for commercialization or starting from R&D for product development to its commercialization.
For more details, check out the full notification on the link below:
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