HC Sets 3-Month Timeline for Centre to Notify Sample Collection Standards
Delhi High Court
New Delhi: The Delhi High Court has directed the Ministry of Health and Family Welfare (MoHFW) to complete the process of notifying the minimum standards for sample collection and sample transport policy across India within 3 months. The directive follows the submission of a comprehensive status report by the Health Ministry, outlining the procedural steps already taken in the matter.
The court’s intervention is aimed at ensuring uniformity and safety in diagnostic practices nationwide. According to the report, the Health Ministry has laid out a structured approach to formulate and enforce these minimum standards. The process begins with the formation of specialized sub-committees consisting of domain experts from fields such as pathology, microbiology, haematology, and biochemistry. The subject experts held detailed internal deliberations, drafted minimum standards that were technically finalized and vetted by subject experts, and the finalized draft minimum standards were approved by the Directorate General of Health Services.
Feedback received from stakeholders will be evaluated by the National Council for Clinical Establishments (NCCE), which has the authority to assess and incorporate relevant suggestions before granting final approval.
Medical Dialogues had earlier reported that the Delhi High Court bench disposed of the plea for minimum standards regarding Sample Collection, Sample collection centers and Sample Transport Policy and related issues for all clinical establishments, as it noted that the Court neither has the domain knowledge with regard to sample collection nor it has the jurisdiction to set standards or frame the rules. Disposing the plea, the bench directed the Central Government to consider the petitioner's application as a representation and arrive at a decision within twelve weeks in 2023, and the status report was finally drafted in 2025. The case pertains to the petitioner, Dr Rohit Jain, who filed a new application seeking elaboration of the prayers, namely for the establishment of minimum standards for sample collection/sample collection centres and sample transport policy for medical diagnostic laboratories.
As per the Ministry’s update, the finalized draft standards have already received technical approval from the Directorate General of Health Services (DGHS) and are now awaiting formal review by the National Council for Clinical Establishments (NCCE). Once the NCCE approves the minimum standards, the next step is to officially notify them in the Gazette of India to make them legally binding.
The Ministry’s counsel stated that the approved minimum standards are currently in the final stages of being notified and are under legal review by the Ministry of Law & Justice.
The Ministry confirmed that the standards for sample collection centres are already in the advanced stages of the notification process. The document is currently under legal examination by the Legislative Department, indicating that formal notification may soon follow.
“The Court, on the assurance given by counsel for the Ministry, on instructions, states that the draft minimum standards shall be notified expeditiously. The Court is inclined to dispose of the petition with the direction that the minimum standards that have been approved and are only awaiting the notification. The process may be accomplished within the next three months,” the court added.
To read the order, click on the link below:
