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 19^th March 2012 & 23^rd 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 hospital, dispensary, clinic, nursing home, maternity home, or an institution by whatever name called that offers services, treatment or care for the injury, illness, deformity, pregnancy or abnormality or facilitates requiring diagnosis in any recognised system of medical establishment and maintained by any individual or body of persons, whether incorporated or not;
• A place established as an independent entity/part of an establishment referred to in sub-clause (i), in connection with the diagnosis/treatment of diseases where pathological, genetic, chemical, bacteriological, or other diagnostic or investigation services with the help of lab or other medical equipment, are generally carried on, established & maintained by any individual or body of persons, whether incorporated or not and shall consist of a Clinical Establishment owned, managed or controlled by:

1. A Trust, whether private or public;
2. A local authority;
3. A department of the Government or the Government;
4. A single doctor;
5. 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:

• Ministry of Health & Family Welfare, Director-General of Health Service, ex officio, who shall be the Chairperson;
• Four representatives out of which one is to be elected by the:

1. Medical Council of India (MCI) constituted under Section 3 of the Indian Medical Council Act, 1956;
2. Pharmacy Council of India (PCI) constituted under Section 3 of the Pharmacy Act, 1948;
3. Dental Council of India (DCI) constituted under Section 3 of the Dentists Act, 1948;
4. The Nursing Council of India is constituted under Section 3 of the Indian Nursing Council Act, 1947.

• Three representatives to be elected by the CCIM (Central Council of Indian Medicine) representing the Siddha, Unani, Ayurveda Systems of medicine constituted under Section 3 of the Indian Medicine Central Council Act, 1970;
• One representative to be selected by the Central Council of the IMA (Indian Medical Association);
• Two representatives from the North-Eastern Council were established under Section 3 of the North-Eastern Council Act;
• One representative from the paramedical systems line, excluding systems that have been given representation under Clause (b);
• Two representatives from the Zonal Council were set up under Section 15 of the States Reorganisation Act, 1956;
• One representative to be selected by the Central Council of Homeopathy constituted under Section 3 of the Homoeopathy Central Council Act, 1973;
• One representative of BIS is constituted under Section 3 of the BIS Act, 1986.

Functions of National Council

The National Council shall:

• Compile & publish a National Register of Clinical Establishments within 2 years from the commencement date of this Act;
• Develop the minimum standards & their periodic review;
• Collect the statistics regarding Clinical Establishments;
• Classify the Clinical Establishments into different categories;
• Perform any other function prescribed by the Central Government from time to time;
• Determine within a period of 2 years from its establishment the first set of standards for ensuring proper healthcare by the Clinical Establishments.

Conditions of the Registration for Clinical Establishments

• For Registration & continuation, every Clinical Establishment shall accomplish the following conditions, namely:

1. The minimum requirement of personnel as may be prescribed;
2. The minimum standards of facilities & services as may be prescribed;
3. Provisions for maintenance of records & reporting as may be prescribed;
4. 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:

• Trade License Certificate;
• Pollution Clearance Certificate;
• Clinical Waste Disposal / Bio-Medical Waste Agreement;
• Premises documents;
• Appointment Letters issued to Staff;
• Joining Letters Issued to Staff;
• Electrical Installations;
• Property Tax Receipt;
• Approved Building Plan;
• Current Fees / Rate Chart of Services Offered at the proposed CE;
• Premises Map/Drawing showing Dimensions and Measurements;
• Affidavit stating that all details furnished in the Application are correct;
• Staff Registration Certificates (Medical Council, Nursing Council, etc.);
• Fire NOC;
• Licensee Photo ID & Address Proof (Aadhaar Card/Voter Card/Passport);
• Ownership Deed (if premises is owned by Licensee);
• Partnership Deed (if applicable);
• Resolution Papers (if applicable);
• Memorandum and Articles of Association (if applicable);
• Society Registration Papers (if applicable);
• Rent Agreement (if Rented premises);
• Rent Receipt (if Rented premises);
• AERB Approval for X-Ray machines;
• Previous License (If Retention License is being applied for);
• Previous PCPNDT License (If Retention License is being applied for).

Procedure for Clinical Establishment Registration

• Application for Provisional Certificate of Registration:

1. 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;
2. The Application for the Registration shall be filed in person or by online or by post;
3. 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;
4. 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;
5. 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);
6. 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:

1. 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;
2. The Registration Certificate shall be valid for a period of 5 years from the date of issue;
3. For the purposes of subsection (1), the provisions of Sections 18, 19, 20 & 21 shall also apply;
4. 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

1. 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.

2. 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.
3. Every order made under Sub-Section (2) shall take effect:

• Where no appeal has been chosen against such order immediately on the expiry of the period prescribed for such appeal;
• Where such appeal has been preferred & it has been dismissed from the order date of such dismissal.

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

• Whoever carries on an Establishment without Registration shall, on the first contravention, be liable to a monetary penalty up to Rs. 50,000/-, for the second convention with a monetary penalty which may extend to Rs. 2 lakhs and for any subsequent contravention with a monetary penalty which may extend to Rs. 5 lakhs.
• Whoever deliserves in a Clinical Establishment which is not duly registered under the Clinical Establishments (Registration & Regulation) Act, 2010, shall be liable to a monetary penalty which may extend to Rs. 25,000/-;

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