Key provisions of the Clinical Establishments Act of 2010 in India:

The Clinical Establishments (Registration and Regulation) Act of 2010, enacted by the Central Government, aims to regulate and register clinical establishments nationwide, establishing minimum standards for their facilities and services. As of August 23, 2021, this Act has been implemented in 11 states (Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, Bihar, Jharkhand, Uttar Pradesh, Uttarakhand, Rajasthan, Assam, Haryana) and 6 Union Territories (excluding the NCR of Delhi and Ladakh).

This law applies to all therapeutic and diagnostic clinical establishments, including public and private facilities, and doctor clinics, excluding those operated by the Armed Forces.

Key benefits of this Act include the establishment of a comprehensive digital registry of clinical establishments, standardization of norms for specific categories of establishments, enhanced transparency in the registration process, and improved accessibility of data to the public. It also facilitates multi-stakeholder participation through an institutional mechanism and boosts patient confidence through registration, enhancing the brand value of clinical establishments while serving as a deterrent against quackery and unethical practices.

The Clinical Establishments (Central Government) Rules of 2012 were issued under this Act through Gazette notifications on March 19, 2012, and May 23, 2012. The Clinical Establishments (Central Government) Amendment Rules of 2018 introduced minimum standards for Medical Diagnostic Laboratories or Pathological Laboratories. In 2020, the Clinical Establishments (Central Government) Amendment Rules modified part III (a), focusing on human resource minimum standards for these laboratories.

Additionally, a Gazette Notification dated May 24, 2021, established the National Council for Clinical Establishments.

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