In a significant development aimed at enhancing healthcare practices, the Delhi High Court has directed the Ministry of Health and Family Welfare (MoHFW) to complete the notification of minimum standards for sample collection and sample transport within three months. The order came in response to a petition filed by Dr. Rohit Jain and was passed by Justice Anish Dayal on July 18, 2025.
The court was informed that the MoHFW had constituted four expert sub-committees consisting of specialists from Pathology, Biochemistry, Haematology, and Microbiology. These experts were tasked with preparing comprehensive draft guidelines to ensure standardized practices in sample collection and transport, which currently lack a uniform framework in India.
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“The minimum standards have been finalized and are now under legal vetting by the Legislative Department of the Ministry of Law & Justice,” the counsel for the Union of India submitted, assuring the court of imminent action.
According to the status report filed by the Ministry, the finalized draft standards were approved by the Directorate General of Health Services (DGHS). These drafts were also made available to the public to gather comments and suggestions through a consultation process. The feedback is to be reviewed by the National Council for Clinical Establishments (NCCE) to ensure the recommendations reflect practical and scientific considerations.
Following NCCE’s review and approval, the formal notification in the Gazette of India will be initiated. The court noted that the entire process is in its final stages, pending only legal clearance before gazette notification.
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“Guidelines for Collection, Packaging and Transport of Specimens for Testing for High-Risk Viral Pathogens” and
“Specimen Collection, Packaging and Transport Guidelines for 2019 Novel Coronavirus (2019-nCoV).”
While these provide some framework, the court acknowledged that they are not substitutes for a uniform national standard under the Clinical Establishments Act.
Based on the assurance given by the government’s counsel, the court disposed of the petition with a clear direction:
The minimum standards that have been approved and are only awaiting notification shall be notified expeditiously. The process may be accomplished within the next three months.
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The order, digitally signed and uploaded on the official website of the Delhi High Court, marks a major step toward bridging a regulatory gap in the healthcare system and ensuring safer and more efficient sample handling protocols nationwide.
Title: DR ROHIT JAIN v. SH APURVA CHANDRA