In response to an increase in Covid-19 instances, India's main drug regulatory authority has updated the list of government-approved laboratories in charge of evaluating the performance of diagnostic test kits. The Central Drugs Standard Control Organisation (CDSCO) has increased its approved testing network for Covid-19, dengue, chikungunya, and influenza kits but has removed facilities for autoimmune and genetic condition test evaluations from the new list. 

The amended notice includes seven laboratories for testing In-Vitro Diagnostic (IVD) devices used to diagnose SARS-CoV-2, the virus that causes Covid-19. The National Institute of Biologicals (NIB) in Uttar Pradesh does RT-PCR and RT-LAMP tests, while Viral Research and Diagnostic Laboratories (VRDLs) in New Delhi, Assam, Telangana, Puducherry, and Karnataka conduct RT-PCR evaluations. 

The modification follows a confirmed increase in Covid-19 instances. According to the Ministry of Health and Family Welfare's most recent weekly report, India saw over 8,500 new Covid-19 infections in the last week, the highest number since November 2023. 

At the same time, the CDSCO has deleted a previously included clause that allowed any central or state government hospital lab to evaluate the performance of autoimmune disease detection and human genetic testing kits. This absence significantly reduces the number of disease categories covered by the IVD testing methodology from 23 to 22. 

The regulatory move has caused alarm among clinical geneticists and immunologists. "Removing testing support for autoimmune and genetic kits could slow down innovation and accessibility in these critical areas," said Dr Prabha Sen, a clinical immunopathologist at a Delhi government hospital. "We cannot ignore non-communicable and rare diseases, even though Covid preparedness is essential." 

Meanwhile, the government has greatly expanded its laboratory capacity for vector-borne and seasonal viral diseases. The number of labs licensed to evaluate dengue kits increased from 12 in 2023 to 18 in 2025. Chikungunya has increased from 8 to 13, and influenza from 7 to 13. 

To obtain clearance for sale or distribution, diagnostic kit makers must submit a Performance Evaluation Report (PER) under the Medical Devices Rules of 2017. This PER must be generated by a laboratory that has been approved by CDSCO, registered under Rule 83, or accredited by national bodies such as NABL (for lab quality) or NABH (for hospital-based labs). 

CDSCO's 2018 guidance document explicitly states that review is required, particularly for higher-risk devices (designated as Class B, C, or D). The previous agreement allowed licensed government labs from hospitals to conduct such studies, but this provision is now absent in the updated version, raising regulatory and accessibility concerns. 

Experts believe a balanced regulatory approach is critical. "We need a wider, not narrower, testing net, especially as precision medicine and rare disease diagnostics evolve," stated Dr Anjali Joshi, a genomics policy advisor. 

As India expands its infectious disease surveillance and diagnostic system, the omission of non-infectious testing provisions may result in gaps in long-term healthcare infrastructure.