1. Short title and commencement – (1) these
rules may be called the Clinical Establishments
(Central Government) Rules, 2012.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. Definitions • In these rules, unless the
context otherwise requires,-
(a) "Act’ means the Clinical Establishments
(Registration and Regulation) Act, 2010;
(b) "Secretary" means the Secretary of the National
Council for clinical establishments,
c) Words and expressions used and not defined in these rules, but defined in the Act, shall have the same meanings respectively assigned to them in the Act.
3. Appointment of Secretary of the National
Council by the Central Government¬
(1) The officer of the rank of Joint Secretary dealing with the subject of Clinical Establishments in the Ministry of Health and Family Welfare, Government of India shall be the ex-officio' Secretary of the National Council for clinical establishments established under sub-section (1) of section 3 of the Act.
(2) The Secretary of the National Council shall be responsible for the control and management of the secretariat of the National Council and supervision of the other staff of the National Council Secretariat and perform such other duties as may be required of him by the National Council for the purposes of the Act.
(3) 'He shall attend the meetings of the
National Council for clinical establishments.
(4) The duties and responsibilities of the staff of the National Council shall be such ,as 'may be laid down from time to time by the Secretary of the National Council.
4. National Council and its sub – committees. –
(1) The National Council shall classify and categories the clinical establishments of recognized systems of medicine and submit the same to the
Central Government for its approval.
(2) For the appointment of each sub-committee the
National Council shall define the functions of the sub-committee, number and nature of members to be appointed thereon and timeline for completion of tasks. At the time of formation of each Sub- committee, effort should be made to ensure that there is adequate representation from across the country in each committee from experts in the relevant fields across the private sector, public sector and its organizations, non-governmental sector, professional bodies, academia or research institutions amongst others.
(3) The Chairperson of every such sub-committee
shall be appointed by the National Council at the time of the appointment of the sub-committee.
(4) The proceedings of the meetings of the sub- committees shall be preserved in the form of minutes.
(5) Any recommendations made by the sub- committees shall be placed before the National Council for its consideration and further necessary action.
(6)The National Council of clinical establishments may request the State Councils or Union territory Councils to provide inputs for its consideration on particular matters. If required, the State Councilor Union territory Council shall at the request of the National Councilor the Central Government, as the case may be, constitute sub-committee consisting of members of the State and Union territory Council and field experts for such period not exceeding one year for deliberations and making recommendations on a particular matter or issue.
5. Allowances for the members of the National
Council and sub committees. – The official
members of the National Council for clinical establishments shall draw their travel and daily allowances as per the Government of India rules from the same source from which their salary is drawn. The non-official members of the Council shall be paid travel allowance and daily allowances in accordance with the Government of India rules as applicable, from time to time for the Group 'A' officers of Junior Administrative Grade.
6. State Council or Union Territory Council
representation in the National Council meeting.- The National Council may invite representative(s) from one or more State councils or Union territory councils to participate in its meetings, as may be considered appropriate and the expenses on account
of participation by such representatives will be met
by the National Council.
7. Common registration form for compilation of the State and National Register. In order to ensure
uniformity in collection of information by the State Governments or Union territory's administration and data flow in connection with the compilation and maintenance of the State Registers and the National Register in digital format for the purpose of sections 38 and 39 of the Act, the National Council shall also develop the standard application form for registration of clinical establishments
8. District Registering Authority (1) Qualifications and the terms and conditions for appointment of the members of the authority.- The district registering authority established by way of notification by the State Government under
clause (c) of sub-section (1) of section 10 of the Act shall consist of three other members who shall be nominated by the District Collector or District Magistrate and they shall include the City Police Commissioner or Senior Superintendent of Police
or Superintendent of Police, or his nominee, as the case may be, a senior level officer of the Local Self Government at the district level, one representative from a professional medical association or body having presence preferably in the district or within the State, as the case may be, for a tenure of two years.
(2): Filing of –casual vacancy. – If a casual-
vacancy occurs whether by reason of .death, resignation or inability to discharge functions owing to illness or any –other in capacity of a
nominated member, such vacancy shall be filled by the District collector or District Magistrate by making a fresh appointment and :the member so appointed shall hold office only for the remaining tenure of the :person whose place he is so appointed.
3) Powers of the District Health Officer or Chief
Medical Officer for the purposes of provisional registration of clinical establishments.- The District Health Officer or the Chief Medical Officer (by whatever name called) shall exercise the following powers for the purposes of provisional registration of clinical establishments under sub- section (2) of section 10 of the Act, namely:-
( (a) for the purposes of provisional registration of
the clinical establishment, an application in the prescribed proforma as adopted by the State government with the requisite fee as the State
Government may by rules determine;
(b) the application shall be filed in person or by post or online;
(c) the District Health Officer or Chief Medical Officer shall, within a period of ten days from the date of receipt of such application, grant to the applicant a certificate of provisional registration in such form, particulars and information, as the State Government may by rules determine:
d) the District Health Office; or Chief Medical
Officer shall not conduct any inquiry prior to the grant of provisional registration;
(e) notwithstanding the grant of the provisional
certificate of registration, the District Health Officer or Chief Medical Officer shall, within a period of forty-five days from the grant of provisional registration, cause to be published in such manner, as the State Government may by rules determine, all particulars of the clinical establishment so registered provisionally;
(f) where the clinical establishments in respect of
which standards have been notified by the Central Government provisional registration shall not be granted or renewed beyond-
(i) the period of two years from the date of notification of the standards in case of clinical establishments which came into existence before the commencement of this Ad;
(ii) the period of two years from the date of notification of the standards for clinical establishments which came into existence after the commencement of this Act but before the notification of the standards; and
(iii) the period of six months from the date of notification of standards for clinical establishments which come Into existence after standards have
subject to the conditions as mentioned above, every provisional registration shall be valid till the last day of the twelfth month from the date of issue of the certificate of registration and such registration shall be renewable;
(g) the application for renewal of registration shall
be made to the District Health Officer or Chief Medical Officer within thirty days before the expiry of the validity of the certificate of provisional registration and, in case the application for renewal’s made after the expiry of the provisional registration, the authority shall allow renewal of registration on payment of such enhanced fees, as the State Government may by rules determine.
(h) in case the certificate is lost destroyed, mutilated
or damaged, the authority shall issue a duplicate certificate on the request of the clinical
establishment and on the payment of fees as the
State Government may by rules determine.
9. Other conditions for registration and continuation of clinical establishments.- For
registration and continuation, every clinical establishment shall fulfill the following conditions, namely :-
(I) every clinical Establishment shall display the
rates charged for each type of service provided and facilities available, for the benefit of the patients at a conspicuous place in the local as well as in English language:
Every clinical Establishment
shall display the following rates:
Room Rent (Category wise)
(II) the clinical establishments shall charge the rates
for each type of procedures and services within the range of rates determined and issued by the Central Government,from1ime to time, in consultation with the State Governments;
the clinical establishments shall charge the rates for each type of procedures and services from a broad range of rates proposed
by IMA Haryana
It is difficult to define
and quantify hundreds of procedures with lot of modifications as per the specific needs of a patient.
Also, the rates shall depend upon the type of setup and regional socio-economic variations including different locations. The experience and expertise of the professionals shall be another variable to be considered.
(iii) the clinical establishments shall ensure
compliance of the Standard Treatment Guidelines as may be determined and issued by the Central Government or the State Government as the case may be, from time to time:
Remove this OR
the clinical establishments shall ensure compliance of the Standard Treatment Guidelines as may be determined and issued by the Central Government or the State
Government as the case may be, from time to time after
discussing with IMA, Haryana
There are no standard
National guidelines available, so it can not apply.
(iv) the clinical establishments shall maintain and
provide Electronic Medical Records or Electronic Health Records of every patient as may be determined and issued by the Central Government or the State Government as the case may be, from time to time;
(iv) the clinical establishments
shall maintain Medical and health records in register (physical) or Electronically as the case may be, of every patient as may be determined and issued by the Central Government or the State
Government as the case may be, from time to time;
(v) Every clinical establishment shall maintain
(v) Every clinical establishment
information and statistics in accordance with all
other applicable laws for the time being in force and the rules made thereunder.
shall maintain information and
statistics registers or electronically in accordance with all other applicable laws for the time being in force and the rules made thereunder.
10(c) Provisional Registration
period shall be two years
Since it is a new law,
the clinical establishments should be given enough time to adapt to the newer regulations.
Also the District Registration Authority constitution and
related activities shall need time to become fully operational and understand the nitty gritty of the new law.
10(d) Remove this
Only brief summary of the particulars to be published and the detailed ownership status not to be mentioned.
Also the time period for inviting objections should be limited to one week only.
Since it is a public
notice; some undesired elements may not unnecessarily interfere with the smooth conduct of the registrations.
10(e) Fee for issue of duplicate
certificate : Rs. 500
Let it be a nominal
amount to meet the actual expenses incurred.
10(f) Change of ownership: In
the case of death of the owner doctor if the spouse/children/blood relations want to continue operating the clinical establishment, the same be allowed to continue to be run till the registration process in the name of the person concerned is transferred.
The person concerned shall apply for the change of registration within a month.
This is being
suggested on humanitarian grounds because closing down the clinical establishment on the death of the owner will cause undue harassment to the admitted patients as well as the doctor spouse who is already working there.
10(g) Before publishing the
names of the clinical establishments whose registration is due to expire, a month notice shall be given as
This is being
suggested because the owner might forget the date of renewal due to busy profession
reminder for renewal of the
10(h) Enhanced fee Rs. = 1000
upto one month delay Rs. 500 for successive one month delay.
10(i) Fee for permanent
51 to 100 beds: 5000
101 to 200 beds: 7500
201 to 500 beds: 10000
501 to 1000 beds: 20000
1001 to 1500 beds: 30000
1501 to 2000 beds: 50000
10(j) An undertaking by the
owner along with a brief report of compliance of each minimum standard to be submitted online.
10(k) Displaying information:
Only a brief summary of the particulars to be published; stating that the concerned clinical establishment has complied with the prescribed minimum standards.
The interval between the publishing of the information and inviting objections should be limited to one week only.
10(l) Expiry of period
Authority shall give an opportunity to personally interact before disallowing the application under Section 29 of the C.E. Act.
10(n) period for appeal:
10(o) Manner of Entry and
The inspection should be carried out by a MULTI member team. Intimation to be given one week prior to inspection.
The team should include
This is being
suggested to maintain transparency and avoid harassment if any to the owner of the Clinical Establishment.
President of IMA of the local
branch or Hony Secretary or member of IMA nominated by the IMA President.
10(p) fee as per subsection (i)
10 (q)The manner and period
for appeal: One month
10(r) fee for appeal: Rs.2000
10(u) Enquiry under section 41
and 42 :
The Enquiry Committee should include President/ Hony Secretary of local branch of IMA.
This is being
suggested to maintain transparency and avoid harassment if any to the owner of the Clinical Establishment.
10(v) period : one month
10(w) Information to the
authority : Once in three months
10 (x) Any other matter :
1. The clinical establishments existing before the implementation of the Clinical establishment Act; shall NOT be required to do STRUCTURAL CHANGES to fulfill the criteria of minimum standards.
2. The experienced staff working in the Clinical Establishments before the implementation of the Clinical Establishment Act shall be retained till the availability of qualified staff as per the requirement of the minimum standards under C.E. Act and shall be gradually replaced with qualified staff over a period of 3 to 7 years.
3. The Nursing Homes regularization policy of the Urban Local Bodies Department of Govt. of Haryana shall be modified as per the minimum standards of
Clinical Establishment Act.
4. A mechanism to grant all kinds of permissions under various Acts to the Clinical Establishments shall be developed to channelize through a single window system.
Submitted by Negotiating Committee
(on behalf of IMA Haryana)
Dr. Munish Prabhakar
President, IMA Haryana
Dr. Anil Hans Honorary Secretary, IMA, Haryana
Member of the Committee
1. Dr. A.P. Setia, Immediate Past President
IMA, Haryana State
2. Dr. Ajay Mahajan
Immediate Past Honorary Secretary, IMA, Haryana State
3. Dr. Ramesh Goyal, Past State President
4. Dr. Suresh Arora, Past President, IMA, Faridabad