On July 17, 2019, the Health Ministry placed the draft notification on Clinical Establishment (Central Government) Third Amendment Rules, prescribing 'minimum standards for different categories of Clinical establishments of Allopathy and AYUSH in public domain for comments/suggestions regarding1.

Background of Clinical Establishment Rules

The Clinical Establishment Act ('Act') was drafted in 2010 to provide registration and regulations to clinical establishments in the country that provide basic health amenities, the key feature of the Act being:

  • Generation of the reliable database giving relevant information about all the clinical establishment overall the country,
  • Classification of various clinical establishments based upon the categories and minimum standards,
  • Defining the minimum standards for all the clinical establishments, and
  • Assist the Government in obtaining information and data required from clinical establishments for public health interventions including outbreak and disaster management.

At present minimum standards are only available for medical diagnostics labs, according to the Rule 8A as inserted in Clinical Establishments (Central Government) Amendment Rules, 2018:

Rule 8A of Act, says that "Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) — Every clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Schedule."2

Now, therefore the Health Ministry to bring uniformity in the standard of healthcare services provided by several establishments, has proposed for the third Amendment of Clinical Establishments (Central Government) Rules. The amendment proposes to set the minimum standards of the clinical establishment for Allopathy and AYUSH under Rule 8B of the Clinical Establishment Act, 2010. The Rule 8B states that:

Rule 8B: "Minimum standards Of Hindi and English versions of approved minimum Standards for following categories of Allopathic Clinical Establishment".3

Minimum Standards (General) of Clinical establishments as listed under:

  • Clinic or Polyclinic: only Consultation, With Dispensary, With Diagnostic Support and With Observation facility
  • Mobile Clinic: Only Consultation' With Procedures and Dental Mobile 3.
  • Hospitals: Level 1 to 3
  • Health Check-up Centre
  • Dental Lab
  • Physiotherapy
  • Dietetics
  • Integrated Counselling Centre

These set of common minimum standards are equally applicable to a single practitioner or more than one doctor clinic manned by a general physician or specialist doctor or super specialist or a group of doctors who are themselves providing patient care services like dispensing of medicines, injection and dressing.


The new amendment has been proposed in order to ensure registration and regulation of all the clinical establishments around the country. This will help in bringing uniformity in the healthcare sector so that public can approach the health facility with ease and they are given a standard treatment.


1. https://mohfw.gov.in/sites/default/files/clinicalestablishment.pdf

2. http://clinicalestablishments.gov.in/WriteReadData/4161.pdf


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