Insights of Clinical Establishment Act 2010 of India

Medical Law and Ethics

The Regulations on Healthcare Establishments were introduced in the year 2010 with a Parliament act. Because “Health” is a subject taken care of by states, it was then to be implemented by different states as per their requirement by passing separate Acts in their respective assembly. However, as of August 2021, only 11 states and 6 Union territories have currently implemented this Act.

May 9
Dr Sandip Patel
Founder & CEO - Docthub

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by The Central Government to provide for the registration and regulation of all clinical establishments in the country with a view to prescribe the minimum standards of facilities and services provided by them. As of 23 August 2021, the Act has taken effect in 11 States (Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Rajasthan, Assam, Haryana and 6 UTs (all except NCR of Delhi and Ladakh)  



The Act is applicable to all types of Therapeutic as well as Diagnostics clinical establishments belonging to the public and private sectors and doctor clinics except clinical establishments run by the Armed forces. 



Establishing a comprehensive digital registry of clinical establishments  

Uniform the standards of a specific category of clinical establishments 

Bringing transparency in the registration process and avail data in the public domain 

Enabling multi-stakeholder participation in an institutional mechanism  

Increase the confidence of patients through registration and improve the brand value of the clinical establishment 

The provisions of the Act are a deterrent against quackery and unethical practices 



The Clinical Establishments (Central Government) Rules, 2012 under this Act vide Gazette notifications dated 19th March, 2012 and 23rd May, 2012 respectively. 

Clinical Establishments (Central Government) Amendment Rules, 2018: Minimum Standards for Medical Diagnostic Laboratories or Pathological Laboratories. 

Clinical Establishments (Central Government) Amendment Rules, 2020: Amendment in part III (a), in respect of human resource minimum standards for Medical Diagnostic Laboratories (or Pathological Laboratories). 

Gazette Notification dated 24 May 2021, for Constitution of National Council for Clinical Establishments.