Call for EoIs: Validation of Non-Invasive Hemoglobinometer Devices (India)

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. The ICMR has always attempted to address the growing demands of scientific advances in biomedical research on the one hand and the need of finding practical solutions to the health problems of the country, on the other.

Research on interventions for mitigation/detection of anaemia is, therefore, ICMR’s health research priority. Considering its national importance, ICMR intends to carry out a validation study of such non-invasive/Minimally invasive hemoglobinometer devices followed by health technology assessment for evaluating its suitability for the AMB programme.

Priority Research Goal

• Expanding the effective screening network of Anaemia in different age populations across India.

Objective

• To independently validate the ‘Product’ for effective/accurate diagnosis of anaemia, for addressing national health priority.

Scope of Work 

• ICMR is willing to collaborate with eligible organizations/companies to engage with ICMR by providing ‘Make in India’ non-invasive/ Minimally invasive hemoglobinometer devices for effective screening of anaemia.
• Following the Expression of Interest (EoI), the single/multiple companies qualifying the Pre-Qualification Criteria shall make available the noninvasive/ minimally invasive hemoglobinometers (the Product) to enable the independent validation study by ICMR at its validation centers/ hospitals to enable evaluation of the devices/products for their suitability for public use.

Role of ICMR

• ICMR would conduct a hospital based clinical study to validate the promising noninvasive/ Minimally invasive hemoglobinometer devices against gold standard method of hemoglobin measurement.
• ICMR would provide technical support through its team of experienced scientists in study planning, product validation, development of study protocol, results/data analysis, outcome assessment, product improvement, etc., if deemed fit upon the mutual understanding between ICMR and collaborative company.
• 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.
• ICMR would provide technical support in the validation of new technology/ product through its Affiliates/ Institutes.
• ICMR would return the product to the company after completion of the proposed validation study.

Role of Company 

• The Company shall provide Product and all necessary documents with essential regulatory approvals (as applicable) required to conduct validation of the Product by ICMR either directly or otherwise.
• The Company shall have valid provisions to provide all necessary infrastructure/material/manpower required, if any, for validation either directly or indirectly.
• The Company shall have provisions to undertake the scale-up as required, manufacturing and commercialization of the product, in a set milestone.
• The Company agrees to share the technical data with ICMR and participate in all discussions in a professional and mutually agreed-upon manner.
• 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.
• 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.
• The Company shall provide free-of-cost 5-6 devices, tentatively, depending upon the study population size and the number of sites, selected by ICMR to effectively undertake the study
• The Company shall have no financial implications unless otherwise specified

Process involved in Validation 

• Interested companies/manufacturers are invited to join hands with ICMR for validation of their Product(s). Under this EoI, the manufacturers/companies who are responsive and fulfilling all the technical requirements will be shortlisted based on their R&D plan, facilities and capabilities. On shortlisting, the qualified companies/manufacturers will only be contacted for making available required number of devices for conducting independent validation of the Product by ICMR. Such companies/manufacturers shall be responsible to provide the Product along with all the necessary documents and essential regulatory approvals.

Pre-Qualification Criteria (PQC)

• General Criteria
  • 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 manufacturing and/or R&D with 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 
  • The proponent should have functional laboratory to carryout R&D for the product development.

Rejection Criteria 

• The application is liable to be rejected if:
  • The proposal is not submitted as per the requirements indicated in the EoI.
  • Not in the prescribed format.
  • Not properly stamped and signed.
  • Received after the expiry of due date and time.
  • All relevant supporting documents are not furnished with the Pre-Qualification Criteria (PQC).
  • The proposal shall be substantially responsive without any material deviation, failing which the proposal shall be summarily rejected.
  • Applications not fulfilling the terms of the document will be summarily rejected.
  • Any other non-compliance.

For more information, visit ICMR.