An Overview of Clinical Establishment
The Clinical Establishments (Registration & Regulation) Act, 2010, has been introduced by the Central Government of India to provide regulation and Registration of all the Clinical Establishment in India with a view to prescribe the minimum standards of facilities & services provided by them. This Act has taken effect in 4 states (Himachal Pradesh, Sikkim, Arunachal Pradesh, and all Union Territories) except the NCT of Delhi since March 2012. The states of Uttarakhand, Jharkhand, Haryana, Uttar Pradesh, Assam, Rajasthan, and Bihar have adopted the Clinical Establishments (Registration & Regulation) Act, under Clause (1) of Article 252 of the Constitution.
The Ministry has informed the National Council for Clinical Establishments & the Clinical Establishments (Central Government) Rules, 2012 under Clinical Establishments (Registration & Regulation) Act, vide Gazette notifications dated 19th March 2012 & 23rd May, 2012 respectively. The Clinical Establishments (Registration & Regulation) Act is applicable to all types (both diagnostic types & therapeutic types) of Clinical Establishments from the private & public sectors, belonging to all recognised systems of medicine, including single-doctor clinics. The only exception is Clinical Establishments regulated by the Armed Forces.
What is the Meaning of Clinical Establishment?
Clinical Establishment means:
- A Trust, whether private or public;
- A local authority;
- A department of the Government or the Government;
- A single doctor;
- A Corporation (including a Society) incorporated under a Provisional, Central, or State Act, whether or not owned by the Government.
But doesn’t include the Clinical Establishments owned, managed, or controlled by the Armed Forces.
Establishment of the National Council
The National Council shall consist of:
- Medical Council of India (MCI) constituted under Section 3 of the Indian Medical Council Act, 1956;
- Pharmacy Council of India (PCI) constituted under Section 3 of the Pharmacy Act, 1948;
- Dental Council of India (DCI) constituted under Section 3 of the Dentists Act, 1948;
- The Nursing Council of India is constituted under Section 3 of the Indian Nursing Council Act, 1947.
Functions of National Council
The National Council shall:
Conditions of the Registration for Clinical Establishments
- For Registration & continuation, every Clinical Establishment shall accomplish the following conditions, namely:
- The minimum requirement of personnel as may be prescribed;
- The minimum standards of facilities & services as may be prescribed;
- Provisions for maintenance of records & reporting as may be prescribed;
- Such other conditions as may be prescribed.
- The Clinical Establishment shall undertake to furnish within the staff & facilities available, such medical examination & treatment as may be needed to stabilise the emergency medical condition of any person who comes/is brought to such Clinical Establishment.
Documents Required for Obtaining Clinical Establishment License
Following are some vital documents required for obtaining a Clinical Establishment License:
Procedure for Clinical Establishment Registration
- Application for Provisional Certificate of Registration:
- For the purposes of Clinical Establishment Registration under Section 10, an application in the prescribed preform along with the suggested fee shall be made to the concerned authority;
- The Application for the Registration shall be filed in person or by online or by post;
- The Application for the Registration shall be made in such form & shall be accompanied by such information as may be prescribed under this Act/Rules made thereunder;
- If any establishment (clinical) is in existence during the commencement of this Act, an application for its Registration shall be made within 1 year from the commencement date of this Act and a Clinical Establishment which comes into effect after the commencement of the Act shall apply for Permanent Registration within a time of 6 months from the date of its establishment;
- If any Clinical Establishment is already incorporated under any existing law requiring Registration of such establishments, even then, it shall apply for Registration of Clinical Establishment as referred to in sub-section (1);
- The authority shall, within a period of 10 days from the date of receipt of such Application, grant a Certificate of Provisional Registration to the applicant in such form and containing such details and particulars as may be prescribed.
Note: Provisional Registration shall be valid for 1 year from the date of issue of the Registration Certificate and such Registration shall be renewable.
- Certificate of Permanent Registration:
- The authority shall, if it grants an application of the Clinical Establishment, issue a Permanent Registration Certificate in such form & containing such particulars as may be prescribed;
- The Registration Certificate shall be valid for a period of 5 years from the date of issue;
- For the purposes of subsection (1), the provisions of Sections 18, 19, 20 & 21 shall also apply;
- The Application for the renewal of Permanent Registration shall be made within 6 months before the expiry of the validity of the Permanent Registration Certificate and in case the renewal application is not submitted within the stipulated period, then the authority may allow the renewal of Registration on Payment of such enhanced fees & penalties as may be prescribed.
Cancellation of Registration
- If, at any time after any of such establishments has been registered, the authority is satisfied that;
- The conditions of the Registration of Clincial Establishment are not being fulfilled;
- The person entrusted with the Clinical Establishment management has been convicted of an offence punishable under this Act.
- If, after giving an opportunity to the Clinical Establishments, the authority is completely satisfied that there has been a breach of any of the provisions of this Act/the rules made thereunder, it may, by order, without prejudice to any other action that it may take against such Clinical Establishment, cancel its Registration.
- Every order made under Sub-Section (2) shall take effect:
Provided that the authority, after the Cancellation of Registration for reasons to be recorded in writing, may restrain the Clinical Establishment immediately from carrying on if there is imminent danger to the safety & health of patients.
Penalties under the Provision of the Act
Whoever contravenes any provision of the Clinical Establishments (Registration & Regulation) Act, 2010 shall be punishable for the 1st offence with a fine which may extend to Rs. 10,000/-, for any second offence with a fine which may extend to Rs. 50,000/- and for any subsequent offence with fine which may extend to Rs. 5 lakhs.
Monetary Penalty for Non-Registration
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Frequently Asked Questions
This Act provides for regulation & Registration of Clinical Establishments in the country with a view to prescribe basic minimum standards of facilities & services of the specific type being provided by such establishments.
It means a maternity home, dispensary, hospital, clinic, or any other institution that provides services, or facilities requiring diagnosis, care/treatment for injury, illness, deformity, or pregnancy in any recognised system of medicine.
If there is no change in the category, just intimate DRA and correct it during renewal.
The DRA (District Registering Authority) shall issue the Registration Certificate, the office of which is located in the office of the District CMO.