ICMR Portal for Hemoglobinopathies Kit Validation

Introduction

Sickle Cell Disease (SCD) is a major public health concern in India, particularly affecting tribal and other vulnerable populations. It is an inherited blood disorder that alters the shape of red blood cells, leading to complications such as anemia, pain episodes, and organ damage.

To ensure accurate and reliable diagnosis, the Indian Council of Medical Research (ICMR) plays a crucial role in validating sickle cell diagnostic kits before they are introduced into the market. This validation process adheres to strict national standards and regulatory guidelines set by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017, ensuring the quality and effectiveness of these diagnostic tools.

Indian Council of Medical Research (ICMR), New Delhi, is the apex body in India for the formulation, coordination, and promotion of biomedical research. Established in 1911, it is one of the oldest medical research institutions. ICMR plays a central role in ensuring that healthcare products, including diagnostic kits, meet the highest standards of safety, reliability, and effectiveness.

To support the National Sickle Cell Anemia Elimination Mission (launched in July 2023), ICMR has developed a structured validation system for Sickle Cell Diagnostic Kits, including Point of Care Tests (PoCTs). This system ensures compliance with national quality standards and Medical Device Rules, 2017, facilitating validation through CDSCO-enlisted ICMR laboratories.

The platform streamlines collaboration between diagnostic companies and validation centers, making the submission and testing processes more efficient. It also allows non-ICMR diagnostic laboratories to conduct independent performance evaluations of sickle cell diagnostic kits, ensuring they meet strict quality standards for accuracy, reliability, and safety.

Through this initiative, ICMR significantly contributes to the elimination of sickle cell anemia in India by ensuring healthcare providers have access to validated, high-quality diagnostic kits. This platform exemplifies ICMR’s commitment to advancing healthcare through innovation, research, and collaboration.

About Us – ICMR’s Role in Sickle Cell Diagnostic Kit Validation

Introduction