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Health Ministry Set to Notify Mandatory Clinical Standards for Diagnostic Samples

Legal vetting by the Ministry of Law and Justice paves the way for Gazette notification under a Delhi High Court three-month deadline

Overview

  • The Ministry of Health and Family Welfare informed the Delhi High Court that draft standards for the collection, handling and transport of diagnostic samples are ready for official notification
  • These draft minimum clinical standards are undergoing legal scrutiny by the Legislative Department of the Ministry of Law and Justice before publication in the Gazette of India
  • The court has directed the formal notification process be completed within three months to ensure swift implementation
  • Four expert sub-committees covering pathology, biochemistry, haematology and microbiology developed the guidelines following extensive internal deliberations
  • The new norms, approved by the DGHS and endorsed by the NCCE, aim to close gaps in ICMR guidance and prevent accreditation mismatches and past testing fraud