The Delhi High Court allowed the contempt petition filed by Dr. Rohit Jain against the Ministry of Health & Family Welfare seeking enforcement of earlier court directions for framing and notification of mandatory minimum standards for the collection, packaging, storage, and transport of clinical samples used in diagnostic laboratories.
The petitioner had originally filed a writ petition, highlighting the absence of enforceable uniform standards for handling clinical samples used in diagnostic laboratories, which posed significant risks to sample integrity, diagnostic accuracy, and patient safety.
Following earlier court orders in January 2023, the Ministry was directed to treat the petitioner’s representations as a formal request and decide the matter within a fixed timeline. The Ministry had formed expert sub-committees of specialists across various disciplines, like pathology, biochemistry, hematology, and microbiology, to draft the standards. These drafts were circulated for public consultation. Despite these steps, final approval and official notification had been pending, which prompted the instant contempt petition.
The dispute centres around concerns that inconsistent or deficient protocols in the collection and transport of clinical samples compromise the reliability of diagnostic results and endanger public health.
The Bench comprising Justice Anish Dayal took note of the Ministry’s status report indicating that expert sub-committees had extensively deliberated and technically finalized draft standards. These drafts were approved by the Directorate General of Health Services (DGHS) and had undergone public consultation. The National Council for Clinical Establishments (NCCE) was reviewing the feedback, and the draft standards were in the advanced stages of legal vetting by the Legislative Department of the Ministry of Law & Justice. Given the significant public health implications and previous delays, the Court stressed the urgency of formalizing these standards into legally enforceable notifications.
The Delhi High Court disposed of the contempt petition after recording the Ministry’s assurance to notify the approved minimum standards promptly and setting a strict, non-negotiable three-month deadline for the notification process to be completed. The Court ordered publication of its order on the judicial website to ensure transparency and public awareness.
With increasing reliance on diagnostic testing, especially amid ongoing infectious disease challenges like COVID-19, uniform mandatory standards have become vital to safeguarding quality and safety across labs and collection centres. The Court’s intervention serves as a judicial mechanism to ensure accountability and uphold patient safety by compelling timely health regulatory reforms.
Appearances:
For the Petitioners: Ms. Mrinmoi Chatterjee, Adv.
For the Respondents: Mr. Amit Gupta, SPC, Mrs. Prena Dhall (GP), Advs. for UOI. Ms. Monika Arora, Mr. Subhrodeep Saha, Mr. Prabhat Kumar, Ms. Anamika Thakur, Advs. for UOI.
