ICMR (Indian Council of Medical Research) plays a key role in the validation of sickle cell diagnostic kits as per national standards. It recommends their assessment for use in healthcare settings across India.

CDSCO enlisted ICMR laboratories conduct the studies for validation of Sickle Cell Diagnostic Kits. These laboratories have the necessary expertise and infrastructure to conduct thorough testing as per national standards.

Manufacturers can apply for validation through the ICMR’s Portal for Sickle Cell Diagnostic Kits Validation by signing up or contact the ICMR competent authority:

Dr. Heena Tabassum
Program Officer & Scientist, NCD Division, ICMR HQ
Email: tabassum[dot]h[at]icmr[dot]gov[dot]in

Manufacturers need to submit the following:

• Detailed information about the test kit (technical dossier)
• Manufacturing of the kit and quality control measures
• Stability and shelf-life studies
• Important certificates like GMP/GLP etc. to show compliance with quality standards

The validation process includes:

• Initial Review – The manufacturer submits important documents like technical details, scientific data, and past test results.
• Lab Testing – The kit is tested in certified labs to check its accuracy and reliability.
• Data Analysis & Report – Nodal officers review the test results and prepare a report.
• Approval – The final report is sent to the competent authority at ICMR for further approval.

The validation timeline depends on factors like the number of samples, complexity of the kit, and testing steps. It typically takes around 6 to 8 weeks but can extend if additional approvals or tests are needed.

The manufacturer can request expedited processing, which is subject to approval by the competent authority on a case-to-case basis.

ICMR does not provide funding for diagnostic kit validation. The cost of validation is generally covered by the manufacturers.

If a kit fails validation, the manufacturer will receive a detailed report explaining why it didn’t meet the required standards. They can then make necessary improvements, conduct further testing, and resubmit for re-evaluation.

ICMR evaluates the quality of sickle cell diagnostic kits based on:

• Sensitivity, specificity, and accuracy of the kit.
• Consistency of results across multiple tests.
• Stability and shelf-life of the kit.
• Comparison with Gold-Standard testing methods such as HPLC.

The platform focuses on Sickle Cell Diagnostic Kits including Point of Care Tests (POCTs). These kits are designed to be used in healthcare settings where immediate results are needed to screen the disease, especially in rural and remote areas.

Point of Care Tests (POCTs) refers to quick diagnostic tests done at or near the patient’s location, such as in a clinic, hospital, or even at home. They provide fast results to help make immediate healthcare decisions. POC tests are typically easy to use and portable, making them especially useful in settings with limited access to specialized laboratory equipment.

Point of Care (POC) sickle cell screening test kits fall under Category A (In Vitro Diagnostic Devices), and they are classified as Class C medical devices under the Medical Devices Rules, 2017. This means they are considered moderate high-risk devices and must go through thorough testing and validation. These kits also need to follow the rules in Schedule IV of the Medical Devices Rules, ensuring they meet safety and quality standards before being available for use.

Sickle cell diagnostic kits are regulated under the Drugs and Cosmetics Act and the Medical Devices Rules in India. These kits are considered in vitro diagnostic devices and follow the guidelines set by the Central Drugs Standard Control Organization (CDSCO). Once the kits pass the validation process, they need to get a license from CDSCO before being allowed in the market for use.