India diagnostic laboratory regulations face scrutiny over uneven standards

India’s diagnostic laboratory regulations are under scrutiny due to perceived discrepancies between standards for government health beneficiaries and general diagnostic facilities. Healthcare advocates have highlighted a gap between the Central Government Health Scheme (CGHS) empanelment requirements and the Clinical Establishments Amendment Rules, 2018.

Under CGHS guidelines, laboratories must maintain National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation, employ full-time pathologists and quality managers, and meet specific daily patient volume thresholds. These guidelines also mandate specific automated equipment, such as haematology and biochemistry analysers. In contrast, the Clinical Establishments framework categorizes laboratories into basic, medium, and advanced tiers, with varying standards for infrastructure, staffing, and operational practices based on their scope of services.