Draft Gazette Notification: Minimum Standards for Clinical Establishments (2026)

Ministry of Health & Family Welfare | Directorate General of Health Services

The Government of India has released a draft notification proposing updated minimum standards for clinical establishments under the Clinical Establishments (Registration and Regulation) Act, 2010. The draft aims to standardize infrastructure, staffing, equipment, and operational practices across outpatient healthcare facilities.

1. Categories of Clinical Establishments Covered

The draft introduces six distinct categories of establishments, each with tailored minimum standards:

1. Clinic/Polyclinic for Consultation
2. Clinic/Polyclinic with Dispensary
3. Clinic/Polyclinic with Observation & Short Stay
4. Clinic/Polyclinic with Diagnostic Support Services
5. Sample Collection Centre
6. Mortuary

Each category is mapped to a specific Schedule (II to VII) under the amended rules.

2. Structure of Minimum Standards (Common Across Categories)

Across all categories, the draft follows a uniform framework of key sections, ensuring consistency:

• Scope of Services
• Infrastructure Requirements
• Furniture & Fixtures
• Human Resources
• Equipment & Instruments
• Drugs & Medication Management
• Statutory Requirements
• Registration & Recordkeeping
• Patient Assessment & Documentation
• Infection Control & Safety

This structured approach indicates a move toward standardized regulatory compliance across outpatient facilities.

3. Detailed Overview by each Category

A. Clinic / Polyclinic for Consultation (Schedule II)

Scope

• OPD consultation, examination, prescription
• Health education and promotion
• Multi-specialty services allowed (e.g., cardiology, dermatology, ENT, etc.)

Key Requirements

Infrastructure

• Minimum space:
  • Waiting area: ~35 sq ft
  • Consultation room: ~70 sq ft
• Clean, ventilated, well-lit premises
• Mandatory signage with clinic details

Human Resources

• At least 1 Registered Medical Practitioner (RMP)
• Minimum 1 support staff
• All practitioners must be registered with State Medical Council/NMC

Equipment

• Essential: stethoscope, BP apparatus, thermometer, weighing scale
• Emergency: Ambu bag, oxygen support

Drugs

• Mandatory emergency drug list (e.g., adrenaline, hydrocortisone, atropine, etc.)

Compliance

• Biomedical Waste Management Rules, fire safety, local regulations

Documentation

• Patient registration mandatory
• Proper OPD records with diagnosis and signature

Infection Control

• Hygiene, sanitation, safe waste disposal, accessibility for disabled

B. Clinic / Polyclinic with Dispensary (Schedule III)

Additional Feature

• In-house pharmacy/dispensing facility

Key Additional Requirements

• Dedicated pharmacy/storage area (~40 sq ft)
• Medicines must be dispensed only by a qualified pharmacist
• Strict medication safety checks:
  • Prescription verification
  • Dose, expiry, labeling
• No dispensing without prescription

Other requirements largely mirror consultation clinics, but with enhanced drug management protocols.

C. Clinic / Polyclinic with Observation & Short Stay (Schedule IV)

Scope Enhancement

• Allows patient observation up to 8 hours

Key Additional Requirements

Infrastructure

• Observation beds (65 sq ft per bed)
• Short stay facility

Furniture

• Mandatory patient bed

Equipment

• Additional:
  • IV stand
  • Wheelchair/stretcher

Human Resources

• Pharmacist mandatory (due to drug dispensing)

Documentation

• Maintain:
  • OPD records
  • Procedure records
  • Referral/emergency records

This category bridges OPD care and limited day-care services.

D. Clinic / Polyclinic with Diagnostic Support Services (Schedule V)

Scope Enhancement

• Includes diagnostic facilities such as:
  • Laboratory services
  • X-ray / USG
  • ECG
  • Sample collection

Implication

• Facilities must comply with diagnostic infrastructure and equipment norms in addition to clinical services

E. Sample Collection Centre (Schedule VI)

Scope

• Collection, storage, and transport of patient samples

Expected Focus Areas

• Cold chain maintenance
• Sample labeling & traceability
• Biosafety protocols
• Linkage with diagnostic labs

F. Mortuary (Schedule VII)

Scope

• Storage and handling of deceased bodies

Expected Requirements

• Cold storage infrastructure
• Infection control
• Legal documentation and identification protocols

4. Key Cross-Cutting Compliance Requirements

Across all categories, some critical compliance themes emerge:

1. Standardization of Infrastructure

• Defined minimum space norms
• Mandatory signage and transparency

2. Qualified Human Resources

• Mandatory registration of doctors
• Pharmacist requirement where drugs are dispensed

3. Equipment Readiness

• Essential + emergency equipment mandatory
• All equipment must be functional and maintained

4. Drug Safety & Availability

• Standard emergency drug list
• Strict dispensing protocols

5. Patient Data & Documentation

• Registration of every patient
• Proper clinical documentation
• Reporting of notifiable diseases

6. Infection Control & Safety

• Hygiene protocols
• Biomedical waste management
• Accessibility for disabled persons

7. Legal & Regulatory Compliance

• Fire safety
• Local authority approvals
• Biomedical Waste Rules compliance

5. Key Regulatory Insight

A notable clause specifies:

• If the system of medicine is not explicitly mentioned, the standards apply to Allopathic systems by default.

This has implications for AYUSH and other systems, which may require separate standards.

6. Stakeholder Consultation Details

The Ministry has invited comments from:

• State Governments / UTs
• Professional bodies
• Associations
• General public

Last Date for Submission:
📅 31 March 2026

Email for Submission:
📧 help.ceact2010@nic.in

Download the Draft Notification from this link :
https://mohfw.gov.in/sites/default/files/Minimum%20Standards%20Public%20Comments%20%281%29.pdf