The Indian Council of Medical Research (ICMR), New Delhi invites Expression of Interest (EoI) from eligible organizations, companies, and manufacturers for undertaking Transfer of Technology and commercialization of a colorimetric isothermal assay for detection of Corynebacterium diphtheriae, a diagnostic assay/kit useful in detection of diphtheria.

Overview

ICMR, through its constituent institutes ICMR–National Institute of Virology, Mumbai Unit and ICMR–National Institute of Epidemiology, Chennai, has developed a technology entitled "Development of a colorimetric isothermal assay for detection of Corynebacterium diphtheria." This technology employs a dual-gene targeting strategy for accurate identification and pathogenicity determination of C. diphtheriae by simultaneously detecting the dtxR gene (a species-specific marker) and the tox gene (encoding diphtheria toxin, present only in toxigenic strains). The assay enables rapid differentiation between toxigenic and non-toxigenic strains, supporting accurate diagnosis, surveillance, and effective public health response.

The technology has reached Technology Readiness Level (TRL) 5 (Third Party Validated). External validation was conducted via WHO, Delhi office, at the Diphtheria testing laboratory, KGMU, Lucknow, which is part of the network for diphtheria surveillance. An Indian patent application (No. 202111015391) and a PCT application (No. PCT/IN2022/050276) have been filed.

Objectives and Scope

The objective of this EoI is to license the technology for further development and commercialization. ICMR is willing to collaborate with eligible organizations, companies, and manufacturers for undertaking transfer of technology and commercialization of the product. The selected company or companies would be granted rights to undertake further development, manufacture, sell, and commercialize the technology on a non-exclusive basis. This non-exclusive approach allows for partnering with single or multiple companies to enable wider outreach for societal benefit and public health use.

The role of ICMR includes providing expert guidance and technical support through its team of experienced scientists in study planning, product development, protocol development, data analysis, safety and efficacy assessment, and product improvement. ICMR may also facilitate R&D and clinical studies through its affiliates and institutes. The role of the company includes providing necessary infrastructure, material, and manpower for product development, validation, scale-up, manufacturing, and commercialization, as well as obtaining all required regulatory approvals.

Eligibility and Pre-Qualification Criteria

Applicants must meet the following minimum pre-qualification criteria:

• Legal Entity: The proponent shall be a legal entity registered as an institution, company, LLP, society, partnership firm, or proprietorship firm under respective acts in India, with more than 51% of company stakes held by promoters from India.
• Tax Registration: The proponent must be registered in India with taxation and other administrative authorities (GST registration or exemption certificate, PAN card).
• Prior Experience: Proven prior experience of manufacturing and/or R&D with manufacturing during the last three years, either in-house or through agreed collaboration, and must have marketed same or similar products with a good track record.
• Financial Standing: The proponent has to be profitable and should not have incurred overall loss in the past three years (applicable to commercial firms/organizations only).
• Track Record: The proponent should have a good track record and currently not be blacklisted or barred by any central/state government or public sector undertaking.
• Manufacturing Unit: The proponent should have a manufacturing unit in India.
• Legal Clearance: The proponent and its promoters should not have been convicted for any offence in India by any competent court or judicial body during the past three years.
• Certifications: GMP/quality certification (ISO or approved Indian certification) of manufacturing facility and GLP/necessary certifications for R&D.
• Laboratory Facility: The proponent should have a functional laboratory to carry out R&D for product development.
• Production Capacity: The proponent should have the capacity to produce a minimum quantity per week (to be specified in the undertaking).

For MSMEs and start-ups, the Start-Up India, Make-in-India, and other relevant guidelines of the Government of India shall be applicable.

Application Process

Interested applicants are invited to submit their Expression of Interest through the Medical Innovation Patent Mitra portal at https://patentmitra.icmr.org.in/companyeoiregistration/. Applicants must first register by providing requisite company information, including details of the authorized representative. Upon successful registration, applicants are required to complete and submit the e-EoI form available on the portal.

The following documents must be furnished as part of the application:

• Declaration – Expression of Interest (Format 1)
• Authorization Letter (Format 2)
• Undertaking with regard to Blacklisting (Format 3)
• Undertaking with regard to Non-Conviction (Format 4)
• EoI document with each page duly stamped and signed by the Authorized Signatory
• Undertaking with regard to laboratory facility (Format 5)
• Production Capacity Undertaking (Format 6)
• Supporting documents as mentioned in Format 1
• MSME Certificate (if applicable)
• Concept note on business plan (not more than 5 pages) covering R&D, clinical studies, planning and execution, production, marketing, etc., with timeline
• Any other information the proponent may wish to provide

Deadline and Timeline

• EoI Document Number: ICMR/EoI/PM/24/Diphtheria RT-LAMP Assay/2026
• Date of Publication: May 14, 2026
• Last Date of Submission: May 20, 2026

Intellectual Property and Royalty

ICMR is the sole owner of the technology, including any underlying intellectual property and commercialization rights. In the case of co-development, background IP shall remain the sole property of the generating party, and any IP generated during collaboration shall be jointly owned by ICMR and the company. All IP-related provisions shall be governed by ICMR IP Policy. Selected companies shall be required to pay royalty at 2% on net sales, as applicable, according to ICMR Guidelines for Technology Development Collaboration.

Contact Information

For scientific issues:
Dr. Shyam Sunder Nandi
Email: nandibiotech@gmail.com
Mobile: 9082553865

For technical issues:
Medical Innovations Patent Mitra Team
Email: patentmitra.hq@icmr.gov.in

ICMR reserves the right to cancel this EoI and/or invite afresh with or without amendments, without liability or obligation, and without assigning any reason.