The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for registration and regulation of all clinical establishments in the country with a view to prescrib the minimum standards of facilities and services provided by them. The Act has taken effect in the four States namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories except the NCT of Delhi since 1st March, 2012 vide Gazette notification dated 28th February, 2012. The States of Uttar Pradesh, Uttarakhand, Rajasthan, Bihar, Jharkhand, Assam and Haryana have adopted the Act under clause (1) of article 252 of the Constitution.

The Ministry has notified the National Council for Clinical Establishments and the Clinical Establishments (Central Government) Rules, 2012 under this Act vide Gazette notifications dated 19th March, 2012 and 23rd May, 2012 respectively.

The Act is applicable to all types (both therapeutic and dignostic types) of Clinical Establishments from the public and private sectors, belonging to all recognized systems of medicine, including single doctor clinics. The only exception is Clinical Establishments run by the Armed forces.