ICMR: Development and Manufacturing of a Lateral Flow Based Point of Care Device for Serum Ferritin Quantification (India)

Ferritin is an important biomarker of iron status in the blood, indicating iron deficiency anemia when levels are low.

Objective 

• To undertake development and manufacturing of a Lateral Flow based Point of Care device for serum ferritin quantification (Device)

Scope

• ICMR is willing to collaborate with eligible organizations, companies, and manufacturers for undertaking development and manufacturing of Product/Device based on AnemiaPhone technology for assessing ferritin levels and iron deficiency at point of care.
• The Company will be granted the rights to undertake development, after which the ‘Product’ will undergo independent validation in an external setting. Upon receiving approval and successfully completing the validation process, the Company may be engaged for large-scale manufacturing of the “Lateral Flow based Point of Care device for serum ferritin quantification.
• Cornell University has expertise in techniques, methods and information relating to aforesaid technology which could be used for the production of the device used for assessing anemia.

Roles

• Role of ICMR:
  • ICMR along with Cornell University will provide expert guidance & technical support for the development of Lateral Flow based Point of Care device for serum ferritin quantification, in all phases. Such technical oversight by them would accelerate the development and manufacturing of the Product.
  • ICMR will also facilitate the validation, if required, as per the terms & conditions of the Agreement.
  • ICMR shall have no financial implications unless otherwise specified.
• Role of Company:
  • The Company shall have valid provisions to provide all necessary infrastructure/material/ manpower required for product development and manufacturing/validation/scale-up either directly or otherwise.
  • The Company shall have provisions to undertake the development and manufacturing as required, of the “Lateral Flow based Point of Care device for serum ferritin quantification” in a set milestone.
  • The Company agrees to share the technical data with ICMR and Cornell University and participate in all discussions in a professional and mutually agreed-upon manner.
  • The Company agrees to allow authorized personnel/scientist/team of ICMR and Cornell University to visit the designated lab/production facility as and when required, as envisaged under this EoI and subsequent Agreement.

Eligibility Criteria

• The following will be the minimum Pre-Qualification Criteria (PQC). Responses not meeting the minimum PQC will be summarily rejected and will not be evaluated further:
  • Pre-Qualification Criteria (General)
    • The proponent shall be a legal entity, registered as Institution/Company/LLP/Society/partnership firm/proprietorship firm under respective acts in India and shall have more than 51% of Company stakes by promoters from India.
    • The proponent must be registered in India with taxation and other administrative authorities.
    • The proponent should have proven prior experience of development And manufacturing and/or R&D with development/manufacturing during the last three years, either in-house or through agreed collaboration and must have marketed same/similar products in the past with a good track record.
    • The proponent has to be profitable and should not have incurred overall loss in past three (3) years. (applicable on commercial firms/organizations only)
    • The proponent should have good track record and currently not black-listed/barred by any Central/State Government/Public Sector Undertaking, Govt. of India, (applicable on commercial firms/organizations only).
    • The proponent should have a manufacturing unit in India.
    • 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 3 years.
    • GMP/quality certification (ISO or approved Indian certification) of manufacturing facility and GLP/necessary certifications for R & D
  • Specific Criteria (Based on the nature of the Proposal)
    • The proponent should have functional laboratory to carryout R&D for the product development
    • Capacity to produce at least………………(quantity) per week.

For more information, visit ICMR.