The Central Drugs Standard Control Organization (CDSCO) has released an updated list of accredited laboratories authorized to conduct performance evaluations of In-Vitro Diagnostic (IVD) medical devices across the country.
This update, dated June 4, 2025, identifies a network of laboratories specializing in a wide range of diagnostic categories—from infectious diseases like HIV, Hepatitis B and C, Tuberculosis, and Malaria to non-communicable and genetic conditions such as cancer, congenital disorders, and Methicillin-Resistant Staphylococcus aureus (MRSA).
Key Highlights of the Updated List
National Institute of Biologicals (Noida) and several ICMR institutes including the National Institute of Virology (Pune), National AIDS Research Institute (Pune), and National Institute of Cholera and Enteric Diseases (Kolkata) feature prominently across multiple categories.
All India Institutes of Medical Sciences (AIIMS) in Bathinda, Raebareli, Bhubaneswar, Jodhpur, and New Delhi have emerged as critical testing hubs, playing a central role in evaluating diagnostic kits for diseases like Dengue, Chikungunya, Typhoid, Influenza, and more.
The Rajiv Gandhi Centre for Biotechnology (Thiruvananthapuram) is among the few facilities equipped to evaluate kits across nearly all listed disease categories, reflecting its advanced diagnostic infrastructure.
Specialized disease control institutes like the National Institute for Research in Tuberculosis (Chennai), National Institute of Malaria Research (Delhi), and Vector Control Research Centre (Puducherry) continue to lead evaluations in their respective fields.
Laboratories such as VRDLs (Viral Research and Diagnostic Laboratories) at Osmania Medical College (Hyderabad), AIIMS Jodhpur, and PGIMER Chandigarh are recognized for rapid diagnostic testing using technologies including ELISA and RT-PCR.
Expanded Scope to Support Regulatory Compliance
This updated list supports the regulatory framework introduced under the Medical Devices Rules, 2017, which mandates third-party performance evaluations for IVD devices before grant of manufacturing or import licenses. By enlisting reputable institutions across India, CDSCO aims to ensure standardized, evidence-based testing, promoting both public health safety and industry accountability.
Moreover, the update reflects India’s strengthening ecosystem for diagnostic innovation and regulatory oversight, as new AIIMS centers and ICMR-backed institutes have been included to increase accessibility and reduce turnaround time for testing.
What It Means for Manufacturers
IVD manufacturers—both domestic and international—must select from these authorized labs when submitting kits for performance evaluation. This move helps streamline processes and ensure alignment with global quality standards, as India moves toward becoming a manufacturing hub for diagnostic technologies.
As India continues to tackle both emerging and endemic diseases, this updated laboratory roster is expected to enhance the country’s diagnostic capabilities, accelerate product approvals, and improve disease surveillance—ultimately contributing to stronger health system resilience.
