Draft Gazette Notification of Minimum Standards for Clinical Establishments
The Ministry of Health & Family Welfare, through the Directorate General of Health Services, has issued a draft Gazette Notification dated March 10, 2026, proposing updated minimum standards for several categories of clinical establishments under the Clinical Establishments (Registration and Regulation) Act, 2010.
Establishment Categories and Key Sections
The draft notification introduces minimum standards for six specific categories of establishments:
- Clinic/Polyclinic for Consultation (Schedule II)
- Clinic/Polyclinic with Dispensary (Schedule III)
- Clinic/Polyclinic with Observation and Short Stay (Schedule IV)
- Clinic/Polyclinic with Diagnostic Support Services (Schedule V)
- Sample Collection Centre (Schedule VI)
- Mortuary (Schedule VII)
Each category is governed by a standard set of sections, including Scope, Infrastructure, Furniture and Fixtures, Human Resources, Equipment and Instruments, Drugs (where applicable), Statutory Requirements, Registration, Assessment, and Infection Control and Safety Considerations.
Critical Requirements for Establishments
Establishments must adhere to several core requirements to ensure patient safety and quality of care:
- Medical Staffing: Every clinic must have at least one Registered Medical Practitioner (RMP) registered with the State Medical Council or National Medical Commission.
- Infrastructure & Space:
- Consultation Clinic: Requires a minimum of 35 sq. ft. for a reception/waiting area and 70 sq. ft. for a consultation room.
- With Dispensary: Adds a requirement for a 40 sq. ft. store and pharmacy area.
- Short Stay: Requires 65 sq. ft. per bed for the observation facility.
- Essential Equipment: Establishments must maintain basic diagnostic tools like stethoscopes, non-mercury thermometers, and B.P. apparatus, as well as emergency equipment like resuscitation kits (Ambu bags) and portable oxygen concentrators.
- Emergency Medications: Clinics are required to stock a specific list of emergency drugs, including adrenaline, hydrocortisone, atropine, and IV fluids like normal saline.
- Statutory Compliance: Full compliance with local building codes, fire safety regulations, and the Bio-Medical Waste Management Rules, 2016 is mandatory.
- Infection Control: Facilities must maintain sanitized environments with non-slippery floors, seepage-free walls, and proper disposal of sharps in puncture-proof containers.
- Patient Rights & Information: A prominent signage in the local language must display the clinic name, doctor qualifications, consultation fees, and the validity of their registration under the Act.
Stakeholder Feedback Details
The Ministry is actively seeking comments and suggestions from states, professional bodies, and the general public to ensure transparency.
- Deadline for Comments: March 31, 2026.
- Submission Email: help.ceact2010@nic.in.
To download full draft, click here :
https://mohfw.gov.in/sites/default/files/Minimum%20Standards%20Public%20Comments%20%281%29.pdf