Uniform Diagnostic Practices Expected Nationwide Following Legal Push
New Delhi:
The Delhi High Court has directed the Ministry of Health and Family Welfare (MoHFW) to notify minimum standards for sample collection and transport across India within three months, marking a critical step towards ensuring safety and uniformity in diagnostic procedures.
The directive comes after the Health Ministry submitted a comprehensive status report, detailing procedural progress in setting these standards. The court emphasized that timely notification is necessary to make these standards legally binding and enhance patient safety in clinical establishments.
Expert-Led Standard Development
According to the Health Ministry’s report, a series of sub-committees comprising domain experts in pathology, microbiology, haematology, and biochemistry were constituted to draft the minimum standards. These drafts were technically vetted and subsequently approved by the Directorate General of Health Services (DGHS).
The draft standards are now under review by the National Council for Clinical Establishments (NCCE), which is tasked with assessing stakeholder feedback before giving final clearance. The standards will be notified in the Gazette of India after approval, thereby becoming enforceable regulations.
Court Declines to Set Standards, Focuses on Government Accountability
The court, while disposing of the original plea filed by Dr. Rohit Jain, clarified that it lacks both domain knowledge and jurisdiction to formulate such technical standards. Instead, it treated the petition as a representation and had earlier directed the Central Government to respond within 12 weeks.
Despite procedural delays, the Ministry confirmed that the notification process is in its final legal stages, with the Legislative Department of the Ministry of Law & Justice currently examining the documents.
Final Push for Compliance
Quoting the assurance given by the Ministry’s counsel, the High Court stated, “The draft minimum standards shall be notified expeditiously.” It instructed the Health Ministry to complete the notification process within three months.
Once notified, these standards are expected to standardize diagnostic protocols across India, particularly in sample collection centers and transport chains, addressing long-standing concerns about quality control and patient safety.
The move is being seen as a significant reform in regulating medical diagnostic laboratories and ensuring minimum quality benchmarks across clinical establishments.
