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The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly unveiled the first batch of 39 standard in-vitro diagnostic (IVD) evaluation protocols to detect high risk diseases like tuberculosis, malaria, dengue, chikungunya, Zika virus, typhoid fever, various respiratory viruses, Chandipura virus and Nipah virus.
ICMR director general Dr Rajiv Bahl said that after the Covid-19 pandemic, the diagnostic industry of India has grown immensely, and is ready to contribute to the public health system by developing IVD tests for timely detection of pathogens causing critical infectious diseases. This landmark initiative will contribute immensely in strengthening the quality of IVDs in India, and also enable them to compete for global licensure. He also said that the process of standard protocol development will continue, and the scope will be expanded to cover other diseases and IVD formats.
“It is important to keep pace with the enthusiasm of our diagnostic industry and create commensurate mechanisms for technical oversight, such as standard in-vitro diagnostics evaluation protocols, and a network of accredited laboratories for timely validation of new diagnostic kits and their introduction in the market. The ICMR and the CDSCO are working tirelessly to create this ecosystem within the country to support IVD kit validation,” Dr. Bahl explained.
Talking about the initiative, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) stated, “A Compendium of Standard IVD Evaluation Protocols has been jointly developed by ICMR and CDSCO. This collaborative effort marks a significant milestone of the MoU between ICMR and CDSCO aimed at strengthening the IVD testing capacity in India.”
He further added that this is the first initiative of its kind globally, where standardized evaluation protocols have been developed in collaboration between National regulatory authority and National nodal research Institute to assess the performance of in-vitro diagnostic (IVD) kits used for high risk diseases. This document will also serve as a valuable resource by providing a uniform testing protocol and setting minimum standards and acceptance criteria for various critical disease markers.
IVDs play a vital role in early diagnosis of disease, support surveillance and enhance patient care managements. As the healthcare landscape in India continues to evolve, ensuring the quality and performance of IVDs in pre and post market phase is crucial for accurate diagnosis and effective treatment.
“By streamlining the evaluation process, we also hope to accelerate the availability of high-quality diagnostic products to clinicians and patients, supporting the national vision of affordable, accessible and quality healthcare for all. We will continue to build on this initiative by adding more protocols and establishing more validation centres, ensuring that our regulatory framework remains robust and effective. This publication will contribute significantly to the advancement of diagnostic science and regulatory excellence in India,” Dr. Raghuvanshi concluded.
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