CDSCO Expands Testing Capabilities: Five New Laboratories for Sickle Cell Disease IVDMDs


In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has taken steps to enhance the testing infrastructure for in vitro diagnostics medical devices (IVDMD) related to sickle cell disease in India. This expansion of testing capabilities involves the approval of five laboratories across the country to assess the effectiveness and reliability of these essential medical devices.

The Growing Importance of IVDMD Testing

The CDSCO, responsible for regulating pharmaceuticals and medical devices in India, has recognized the importance of in vitro diagnostics in healthcare. These devices play a crucial role in diagnosing various diseases, including sickle cell disease, by analyzing specimens taken from the human body. Therefore, ensuring the accuracy and effectiveness of IVDMDs is paramount to making informed healthcare decisions.

Welcoming Five New Laboratories

The recent update from CDSCO lists five new laboratories approved for conducting performance evaluations of IVD reagents and kits specifically designed for detecting sickle cell disease. These laboratories include:

  1. ICMR-National Institute of Immunohaematology (NIH), Mumbai
  2. ICMR-National Institute of Research in Tribal Health (NIRTH), Jabalpur
  3. ICMR-Regional Medical Research Centre (RMRC), Bhubaneswar
  4. Regional Medical Research Centre (RMRC), Dibrugarh, Assam
  5. ICMR-National Institute for Implemented Research on Non Communicable Diseases (NIIRNCD), Jodhpur, Rajasthan

This expansion brings the total number of approved categories for IVDMD testing by CDSCO to an impressive 23.

Broadening the Scope

The significance of IVDMD testing extends beyond sickle cell disease. CDSCO mandates performance evaluation reports for various categories of In Vitro Diagnostics, including those related to HIV, HBV, HCV, blood grouping reagents, cancer, tuberculosis, malaria, and many others. These evaluations ensure the reliability and accuracy of these medical devices, contributing to better patient care and diagnosis.

Streamlined Regulatory Processes

Under the Medical Devices Rules (MDR) of 2017, applicants seeking licenses to manufacture or import Class B, C, or D IVDs must submit performance evaluation reports alongside their applications. To facilitate this process, CDSCO has released draft guidance outlining the procedures for performance evaluation and external evaluation of IVDMDs. This guidance aims to ensure transparency and consistency in evaluating the performance of these critical medical devices.

Ensuring Quality Healthcare

The importance of accurate diagnostic information cannot be overstated. Clinical laboratory tests, often relying on IVDMDs, play a pivotal role in healthcare decision-making. Ensuring the reliability of these devices is essential for patient management and treatment. The CDSCO’s commitment to regulating IVDMDs underscores its dedication to maintaining the highest standards of healthcare in India.


With the addition of five new laboratories for IVDMD testing, CDSCO takes a significant step towards enhancing the healthcare infrastructure in India. The rigorous evaluation of these medical devices ensures that patients receive accurate diagnoses, ultimately leading to better healthcare outcomes. As technology advances and healthcare becomes more data-driven, the role of IVDMDs in patient care continues to grow, making their quality and reliability more critical than ever.

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