THE WEST BENGAL
CLINICAL ESTABLISHMENTS (REGISTRATION, REGULATION AND TRANSPARENCY) ACT, 2017 [Act No. 04 of 2017] [17th March, 2017] An Act to provide for
the registration, regulation and transparency of clinical establishments of the
State and for matters connected therewith or incidental there to. WHEREAS
it is expedient, in the public interest, to provide for registration,
regulation and transparency in the functioning and activities of clinical
establishments licensed under this Act, to preserve minimum standards of
facilities and service to be provided by them to the service recipients. It
is hereby enacted in the Sixty-eighth Year of the Republic of India, by the
Legislature of West Bengal, as follows:-- In
this Act, unless there is any repugnant in the subject or the context,-- (a) "adjudicating authority" means the
authority appointed under section 35; (b) "appellate authority" means the authority
appointed under section 26; (c) "clinical establishment" means the whole
or part of institution, facility with or without bed or beds, building or
premises of any Hospital, Maternity Home, Nursing Home, Dispensary, Clinic,
Polyclinic, Immunization or Vaccination Centre, Sanatorium, Physical Therapy
Establishment, Clinical Laboratory, Fertility Regulation Clinic, Wellness
Clinic or an establishment analogous to any of them by whatever name called,
used or intended to be used for the health care related services established
and administered or maintained by any person or body of persons, whether
incorporated or not; and shall include? (i) a clinical establishment for profit or not for
profit, owned, controlled or managed by,-- (a) a trust, whether public or private; (b) a Corporation (including a co-operative society),
not owned by the Government, registered under a Central Act, or State Act; and (ii) a single doctor establishment or medical clinic. Explanation.-- "medical clinic" shall mean a place used
or intended to be used for consultation and treatment by a registered medical
practitioner but shall not include any place utilised by a registered Medical
Practitioner solely for the purpose of consultation and advice, which shall
have to be displayed as 'Medical Consultation Clinic'. (d) "clinical laboratory" means any
establishment or premises used or intended to be used for the? (i) pathological, bacteriological, genetic,
radiological, chemical, biological or other tests, examination, analysis or
collection of sample and specimen or other diagnostic or investigative
services, procedure or intervention, or (ii) preparation of cultures, vaccines, sera or other
biological or microbiological products, with the aid of laboratory or other medical
equipment for the purposes of diagnosis, treatment or research of diseases; (e) "health care" means testing, treatment,
care, procedures and any other service or intervention towards the nursing,
preventive, promotive, curative, rehabilitative, palliative, diagnostic
research or other health related purpose or combinations thereof in any
recognized system of medicine for the convalescence, illness, sickness, injury,
infirmity, deformity, abnormality or pregnancy or any other physiological
condition whether of body or mind, and also includes any of these as a result
of participation in a medical research programme; (f) "improvement notice" means a notice
issued under section 23; (g) "license" means license issued under this
Act to keep or carry on a clinical establishment consequent upon registration; (h) "licensing authority" means the District Registering
Authority under section 5; (i) "maternity home" means any establishment
or premises used or intended to be used for the reception or accommodation for
women for the purpose of confinement and ante-natal and post-natal care in
connection with child-birth, sterilization, medical termination of pregnancy,
or anything connected therewith; (j) "notification" means a notification
published in the Official Gazette; (k) "nursing home" means any establishment or
premises used or intended to be used for the reception or accommodation for
persons suffering from sickness, illness, injury or infirmity whether of body
or mind for the purpose of observation, nursing, treatment and other health
care and includes a maternity home; (l) "physical therapy establishment" means any
establishment or premises used or intended to be used for the massaging,
electrotherapy, hydrotherapy, remedial gymnastics or similar services, for the
purpose of treatment of diseases or of infirmity or for improvement of health,
or for purpose of relaxation or for any other purpose whatsoever, whether or
not analogous to the purpose hereinbefore mentioned in this clause; (m) "prescribed" means prescribed by rules
made under this Act; (n) "prohibition order" means an order issued
under section 21; (o) "recognized system of medicine" means
Allopathy, Yoga, Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani Systems
of medicines or any other system of medicine recognized by the Government; (p) "registration" means registration done
under this Act; (q) "register" means the register maintained
by the "licensing authority", or the State Registrar under sections
9, or 10 of this Act, as the case may be, containing the number of clinical
establishments registered and the expressions "registered" and
"registration" shall be construed accordingly; (r) "registered medical practitioner" means a
medical practitioner registered under the relevant Medical Act and shall
include a person who possesses any of the recognized medical qualifications and
who has been enrolled in the register of the respective Medical Council, viz.,
Allopathy, Dental, Homoeopathy Ayurveda, Unani and Siddha or any such Council,
Board or any other statutory body recognized by the Government of West Bengal; (s) "registered nurse" or "registered
midwife' means a nurse or midwife registered under the Bengal Nurses Act, 1934
(Ben. Act X of 1934); (t) "rules" means rules made under this Act; (u) "section" means the section of this Act; (v) "service provider" means a medical
doctor, nurse, midwife, other paramedical professional, social worker or other
appropriately trained and qualified person with specific skills relevant to
particular health care services including management of clinical establishment,
and any reference to service provider shall mean the same unless specifically
stated otherwise; (w) "service recipient" means person who
seeks, accesses or receives any health care, as outpatient or inpatient, from
any clinical establishment, or service provider, including for profit and not
for profit; (x) "standards" means the requirements that
the State Government may prescribe under section 7, for the registration of
clinical establishments; (y) "State Government" means the State
Government of West Bengal; (z) "trade practice" in relation to a
clinical establishment means any practice relating to the provision of services
by a clinical establishment, and includes? (i) anything done by the clinical establishment which
controls or affects the price charged for services rendered by the clinical
establishment, or the method of providing services by the clinical
establishment; (ii) a single or isolated action of any person in
relation to any trade; (aa) "West Bengal Clinical Establishment Regulatory
Commission",(hereinafter referred as the Commission), means a body constituted
by the State Government as described in Section 36 of this Act. It shall have
such regulatory, supervisory and grievance redressing functions for patients as
may be prescribed over the activities of clinical establishments licensed under
this Act. The
State Government may associate with itself any person or body whose assistance
or advice it may desire in carrying out any of the provisions of this Act. (1) The State Government shall, by notification,
designate the Director of Health Services (by whatever name called) or any
other officer subordinate to him as the State Registrar of clinical
establishments. (2) It shall be the responsibility of the State
Registrar of clinical establishments to compile and update the State register
of clinical establishments. (1) The Chief Medical Officer of Health of a district
other than the district of Kolkata shall be the Registering Authority as well
as licensing authority in respect of clinical establishments situated within
the district. (2) An officer not below the rank of Assistant Director
of Health Services as designated by the State Government shall be the Registering
Authority as well as licensing authority in respect of clinical establishments
situated within the district of Kolkata. Explanation.-- For the purpose of this section, the word
"Kolkata" shall have the same meaning as defined in clause (9) of section
2 of the Kolkata Municipal Corporation Act, 1980 (West Ben. Act LIX of 1980). No
person shall keep or carry on a clinical establishment without being duly
registered by the registering authority in respect thereof and except under and
in accordance with the terms of a license granted thereof. Explanation I.-- For the purpose of this section "person"
includes a body, group or association of individuals, and organization, a firm,
a trust or society (whether registered or not) or a company registered under
the law for the time being in force. Explanation II.-- For the purposes of this section, "carry
on" means to provide the service recipient in a clinical establishment
with any kind of services including consultation, treatment, diagnosis, or
nursing care. (1) The licensing authority, if satisfied that the
applicant and the clinical establishment has fulfilled such standards as may be
prescribed, shall register the clinical establishment and shall grant a license
in respect of the clinical establishment in such form and in such manner as may
be prescribed. (2) No license shall be granted in respect of a
clinical establishment unless it has? (a) provided such minimum standard of accommodation as
may be prescribed; (b) engaged such minimum number, and norms, of service
providers including registered medical practitioner, registered nurse, other
paramedical staff and other categories of employees with such qualification as
may be prescribed; (c) made arrangements for such minimum standard of
services including emergency care and referral services as may be prescribed; (d) installed such equipments and machineries as may be
prescribed; (e) made such arrangements for disposal of biomedical
wastes as may be prescribed; (f) made provisions for maintenance of such records and
registers in such form and containing such particulars as may be prescribed; (g) fulfilled any other condition that may be
prescribed. (3) Every license granted under sub-section (1) shall
be subject to the following terms and conditions:-- (a) continued fulfilment of the condition laid down in
sub-section (2); (b) that necessary precaution shall be observed so
guarding that the clinical establishment is not being used for unsocial or
immoral purpose or both; (c) that the clinical establishment shall not resort to
any unethical or unfair trade practices including unfair pricing for different
services; (d) that such measures shall be taken to keep the clinical
establishment in such satisfactory, sanitary and hygienic condition as may be
prescribed; (e) that such information is to be displayed and in
such manner as may be prescribed; (f) that such reports in such form containing such
particulars and such necessary documents shall be submitted to such authorities
at such intervals or on demand, as may be prescribed; (g) that such medical and other reports, records and
documents shall be made available to the licensing authority or the service
recipient or his representative on demand, as may be prescribed; (h) that report shall be submitted to the licensing
authority as soon as a person who has been received or accommodated or both in
the clinical establishment is found to be suffering from any such infectious or
dangerous disease or other condition as may be notified; (i) that every case of a victim of accident, injury, or
trauma, received or accommodated or both thereto shall be reported to the
police station within the jurisdiction of which such clinical establishment is
located after providing immediate medical treatment; (j) that every clinical establishment shall provide
necessary medical treatment to victims of road traffic accident, persons
suffering from sudden calamities, acid attack victims and rape victims irrespective
of their ability to bear the treatment cost at the relevant time: Provided
that the clinical establishment shall have the right to recover the cost from
the service recipients or his representatives in due course of time; (k) that there should be no delay in releasing the Dead
Body of patients or service recipients to their representatives due to billing
or other issues, including inability to pay the treatment cost. Provided
the clinical establishment shall have the right to recover the cost and charges
from the representatives of the service recipients in due course; (l) that every clinical establishment shall maintain a
Public Grievance Cell for lodging of any complaint regarding treatment,
improper billing, deficit in service, attending staffs' behaviour etc. and for
redressal thereof; (m) that every clinical establishment shall set up a
proper Help Desk to maintain regular and proper communication with the service
recipients or their representatives regarding treatment, recipient's condition,
regular billing etc. and for their proper counseling; (n) that every clinical establishment shall immediately
after coming into force of this Act, implement e-Prescription, maintain
Electronic Medical Records and provide a set of all medical records and
treatment details along with the discharge summary at the time of discharge of
the service recipient; (o) that every clinical establishment shall strictly
follow the fixed rates and charges including the Package Rates for
investigation, bed charges, operation theatre procedures, Intensive Care,
ventilation, implants, consultation and similar tests and procedures, and any
additional treatment or procedure shall not attract additional charges over and
above such fixed rates and charges including the Package Rates; (p) that every clinical establishment shall provide
proper estimates for treatments not covered in fixed rates and charges
including the Package Rates, to the service recipients or representative of
service recipients during initiation or due course of treatment, and final
bills shall not exceed estimates by a certain percentage, as may be prescribed
by the Government; (q) that every clinical establishment shall strictly
discourage repetitive laboratory tests for any service recipient, unless
essential; (r) that every clinical establishment having more than
100 beds may endeavour setting up Fair Price Medicine Shop and Fair Price
Diagnostic Centre; (s) that any clinical establishment which has received
land or other facility from the Government during initiation and in course of
continuance of their projects shall be responsible to provide completely free
treatment to 20 percent of Outdoor Patient Department patients and 10 percent
of Indoor Patient Department patients in such manner as may be prescribed: Provided
that clinical establishments, owned and managed by corporate entities that have
not availed such benefits, may endeavour to provide completely free treatment
to 20 percent of Outdoor Patient Department patients and 10 percent of Indoor
Patient Department patients as part of their Corporate Social Responsibility; (t) that every clinical establishment shall mandatorily
obtain express consent of the patient party for continuation of ventilation
support to the patient after brain death; (u) that no person shall be subject to any
discrimination in any form or manner, by the clinical establishment in access
to facilities, goods, care and services including admission, on any of the
grounds of nationality, sex, physical or mental disability, occupation,
religion, sect, language, caste, political or other opinion, actual or
perceived health status and disease condition like Human Immunodeficiency Virus
(HIV) infection or Acquired Immunodeficiency Syndrome (AIDS) or such other
diseases as may be prescribed or such other arbitrary grounds; (v) that no person shall be denied, under any
circumstances, including inability to pay the requisite fee or charges, such
emergency life-saving medical treatment and critical care by the clinical
establishment as may be prescribed: Provided
that the clinical establishment has the right to recover the cost from the
service recipient or his representative in due course of time; (w) that the clinical establishment shall actively
participate in the implementation of all National and State Health Progammes
including prevention of spread of communicable diseases in such manner as the
State Government may specify from time to time and furnish periodical reports
thereon to the authorities concerned; and (x) any other terms and conditions which may be prescribed. (4) Every license granted under sub-section (1) shall,
unless suspended or cancelled earlier under this Act, remain in force and be
valid for such period with effect from the date on which it is granted as may
be prescribed. Notwithstanding
anything contained in sub-section (2) and sub-section (3) of section 7, the
State Government may, for reasons to be recorded in writing, relax for such
clinical establishment or in such circumstances as may be prescribed, all or
any of the terms and conditions to which a license granted under sub-section
(1) of section 7 shall be subject. (1) The licensing authority shall maintain in digital
or in such form and containing such particulars, as may be prescribed by the
State Government, a register to be known as the District Register of Clinical
Establishments in respect of clinical establishments of the district. (2) Each licensing authority shall supply in digital or
in such other prescribed format to the State Registrar of clinical
establishments a copy of every entry made in the register of clinical
establishments in such manner, as may be prescribed to ensure that the State
Register is up-to-date. The
State Registrar shall maintain in digital or in such other form and containing
such particulars, as may be prescribed by the State Government, a register to
be known as the State Register of clinical establishments in respect of
clinical establishments of the State. (1) Clinical establishment of different systems shall
be defined and classified into such categories as may be prescribed by the
State Government, from time to time. (2) Different standards may be prescribed for
classification of different categories referred to in sub-section (1). (1) Every person intending to open, keep or carry on a
clinical establishment shall submit an application in the prescribed proforma
along with the prescribed fee to the licensing authority for the purposes of
registration in respect of a clinical establishment under section 6 and for the
grant of a license thereof subject to the provision of section 7 or for the
renewal of the registration and license under section 19. (2) Every application made under sub-section (1) shall
contain such particulars and shall be accompanied by such evidence of the
clinical establishment having complied with the prescribed minimum standards in
such manner, as may be prescribed. (3) Any change in address or situation of or of staff
belonging to, or any other particulars mentioned under sub-section (2) shall be
communicated by the applicant or the person carrying on the clinical
establishment to the licensing authority not later than thirty days after such
change with specific mention as to the exact date when such change occurred. (4) No applicant under sub-section (1) shall try to
obtain the license by means of misrepresentation of facts, fraudulent
practices, falsifying documents, or using unfair means. On
receipt of application made under sub-section (1) of section 12, the licensing
authority shall, if it is satisfied after causing such enquiries as may be
necessary and after following the criteria as may be prescribed, pass an order
within the prescribed period from the date of receipt of application, either-- (a) granting the application for registration and
license or renewal of registration and license; or (b) rejecting the application, and shall send a copy of the order to the applicant
by registered post or in such other manner as may be prescribed: Provided
that if {he licensing authority rejects an application for registration and
license or renewal of registration and license, it shall record its reasons
therefor. (1) The licensing authority may reject the application
made under sub-section (1) of section 12 if he is satisfied? (a) that the applicant or the clinical establishment
does not fulfil the conditions laid down in sub-sections (2) and (3) of section
7; or (b) that the applicant does not fulfil the condition
laid down in sub-sections (1) and (2) of section 12; or (c) that the applicant is trying to obtain the license
in contravention to the sub-section (4) of section 12; or (d) that the real objective of the applicant is to use
or allow the clinical establishment to be used for anti-social or immoral
purposes; or (e) in the case of a nursing home other than a
maternity home that such nursing home is not or will not be under the charge of
a registered medical practitioner resident therein round the clock and that the
nursing of persons received and accommodated therein is not or will not be
under the superintendence of a registered nurse resident therein round the
clock; or (f) in the case of a maternity home that such maternity
home is not or will not be under the charge of a registered medical
practitioner resident therein round the clock and that the attendance on every
woman before, at or after child birth or sterilization or medical termination
of pregnancy or on any child born is not or will not be under the
superintendence of a registered midwife resident therein round the clock; or (g) that for reasons connected with the location,
constructions, accommodation, staffing or equipment, the clinical establishment
is not fit to be used as a clinical establishment of such a description as the
clinical establishment mentioned in the application. (2)
The
licensing authority may, before rejecting an application communicate to the
applicant the deficiencies on the grounds of which the application can be
rejected and issue him an improvement notice as per provision of section 23
directing him to rectify the deficiencies within such time as he may deem fit. (3)
If
within such time as deemed fit by the licensing authority or within such
further time as may be allowed by him, the applicant is unable to rectify the
deficiencies, the licensing authority may reject the application. (4) The licensing authority shall in every case where
the application is rejected, record the grounds for rejection: Provided
that no application shall be rejected, unless the applicant has been given an
opportunity of showing cause in support of his application. The
rejection of an application shall not debar a clinical establishment from
applying afresh for registration and license under section 12, and after
providing such evidence, as may be required, of having rectified the
deficiencies on the grounds of which the earlier application was disallowed. One
license in original shall be kept affixed in a conspicuous place in the
clinical establishment in such manner so as to be visible to everyone visiting
such establishment. In
case the license is lost, destroyed, mutilated or damaged, the licensing
authority shall issue a copy of license on the request of the clinical
establishment and on the payment of such fees, as may be prescribed. In
the event of change of ownership or proprietorship or change of management or
on ceasing to function as a clinical establishment, the license shall be
surrendered to the licensing authority and the owner or proprietor or
management of the clinical establishment shall apply afresh for grant of
license. (1) Application for renewal of registration and license
shall be made at least a period of thirty days before the date of expiry of the
validity of the registration and license: Provided
that in case the application for renewal is made-- (a) after the said period but before the date of expiry
of the validity of the registration and license; or (b) after expiry of the validity of the registration
and license, the
licensing authority shall allow renewal of registration and license on payment
of such enhanced fee for each day and on such terms and conditions, as may be
prescribed. (2) In the event of failure of the licensing authority
to communicate the fact of granting or rejection of application for renewal of
registration and license after the expiry of the prescribed period from the
date of receipt of such application, the license shall be deemed to have been
renewed and the person can keep or carry on the clinical establishment in
accordance with the provision of this Act until such communication is received. (1) If, at any time after any clinical establishment
has been registered and licensed, the licensing authority is satisfied,-- (a) that the conditions of the registration and
licensing are not being complied with; or (b) that any of the grounds which would have entitled
the licensing authority to refuse the application for registration and license,
exist; or (c) that the person entrusted with the management of
the clinical establishment has violated any of the directions including
improvement notice of the licensing authority or the Commission; or (d) that the person entrusted with the management of
the clinical establishment has contravened any of the provision of this Act and
rules made there under, the licensing authority, notwithstanding anything
contained in section 23, may issue a show cause notice as to why its
registration and license under this Act should not be cancelled for reasons to
be mentioned in the notice. (2) If after giving a reasonable opportunity of being
heard to the clinical establishments, the licensing authority is satisfied that
there has been a breach of any of the provisions of this Act or the rules made
there under, he may, without prejudice to any other action that he may take
against such clinical establishment, cancel its registration and license. (1) If,-- (a) any clinical establishment is convicted of an
offence under this Act; or (b) the clinical establishment is being kept or carried
on without a valid license; or (c) the license of the clinical establishment is
cancelled; or (d) the licensing authority is satisfied that an
imminent danger to the health and safety of any member of the public or patient
exist with respect to that clinical establishment, the licensing authority
may,after giving the clinical establishment an opportunity of being heard, by
an order, impose the following prohibitions, namely:-- (i) a prohibition on the use of the process or
treatment for the purposes of the service delivery by the clinical
establishment; (ii) a prohibition on the use of the premises or
equipment for the purposes of the service delivery by the clinical
establishment. (2) As soon as practicable after the making of an order
under sub-section (1), the concerned licensing authority shall? (a) serve a copy of the order on the clinical
establishment by registered post or by any such manner as may be prescribed;
and (b) affix a copy of the order at a conspicuous place on
such premises used for the purposes of the clinical establishment. (3) Every order made under sub-section (1) shall take
immediate effect: Provided
that the licensing authority, after issuance of prohibition order for reasons
to be recorded in writing shall take steps to inform the police authority to
restrain immediately the clinical establishment from carrying on health care
related services. Explanation.-- "Police authority" means an officer not
below the rank of Inspector-in-Charge or Officer-in-Charge of the local Police
Station area where the clinical establishment is situated. (4)
Every
order made under sub-section (1) shall contain a direction that no person shall
be freshly admitted in the clinical establishment either as an in-patient or an
out-patient and the in-patients of the clinical establishment shall be
transferred immediately to such other clinical establishment as the patient or
his representative opts or where it is not practicable to transfer the
in-patients to the clinical establishment so opted, to the nearest Government
Hospital, which shall be specified in that order and it shall also contain
directions as to the care and custody of such in-patients pending such
transfer. (5)
A
prohibition order shall cease to have effect upon the licensing authority being
satisfied, on an application made by the clinical establishment not less than
six months after the prohibition order has been passed, that the clinical
establishment has taken sufficient measures justifying the lifting of the
prohibition order. (6) The concerned licensing authority shall issue a
certificate to the effect that the clinical establishment has taken sufficient
measures justifying lifting of the prohibition order, within seven days of his
being satisfied on an application made by the clinical establishment for such a
certificate or the said officer shall? (a) determine, as soon as is reasonably practicable and
in any event within fourteen days, whether or not he is so satisfied; and (b) if he determines that he is not so satisfied, give
notice to the clinical establishment of the reasons for that determination. (1) The licensing authority or an officer authorized by
him, shall have the power to cause an inspection or inquiry in respect of any
clinical establishment, its building, laboratories and equipment and also of
the services rendered by the clinical establishment or any other matter
connected with the clinical establishment, and that establishment shall be
entitled to be represented thereat. (2) (a) Every officer authorized under sub-section (1)
shall conduct the inspection and submit a report to the prescribed authority
within seven days of completion of any inspection by him in such manner as may
be prescribed. (b) ??He
shall record his observation or inspection note in the inspection book to be
kept at the clinical establishment for this purpose. (1) If the licensing authority has reasonable ground
for believing that any clinical establishment has failed to comply with any
provision of this Act, he may, after ascertaining the opinion of the clinical
establishment thereon, by a notice served on that clinical establishment? (a) state the grounds for believing that the clinical
establishment has failed to comply with the rules; (b) specify the matters which constitute the clinical
establishment's failure so to comply; (c) specify the measures which, in the opinion of the
said authority, the clinical establishment must take, in order to secure
compliance; and (d) require the clinical establishment to take those
measures, or measures which are at least equivalent to them, within a reasonable
period (not being less than fourteen days) as may be specified in the notice. (2)
The
clinical establishment shall report to the licensing authority, the action, if
any, which is proposed to be taken or has been taken upon the results of such
inspection or inquiry and such report shall be furnished within such time, as
the authority may direct. (3)
Where
the clinical establishment does not, within a reasonable time, take action to
the satisfaction of the licensing authority, he may, after considering any
explanation furnished or representation made by the clinical establishment,
issue such directions as that authority deems fit, and the clinical
establishment shall comply with such directions. (4)
If
the clinical establishment fails to comply with an improvement notice, its
license may be suspended for such period to be mentioned in the order. (5)
Every
order made under sub-section (4) shall contain a direction that no person shall
be freshly admitted in the clinical establishment as an inpatient or an
outpatient. (6) If the clinical establishment, during the period
mentioned in the order of suspension? (a) still fails to comply with the improvement notice,
the licensing authority may, after giving the licensee an opportunity to show
cause, cancel the license granted to him; or (b) complies with the improvement notice to the
satisfaction of the licensing authority, he may revoke the suspension order
within a reasonable period not exceeding fourteen days. (1) Subject to such rules as may be made under this
Act, any officer of the State Government authorized by the State Government in
this behalf? (a) may make such inquiries, as he deems necessary in
order to ascertain whether the place or the establishment is being used as a
clinical establishment; (b) may make such examination of place or establishment
and inspect any equipment, sample, article or document found therein and seize
and take out there from any such equipment, sample, article or document, as he
deems necessary for the purpose of examination, analysis, investigation or
evidence and retain them in such manner and for such period as may be
prescribed; (c) may, if there is any reasonable cause to suspect
that anyone is carrying on a clinical establishment without registration and
license, enter and search in the manner prescribed with or without the
assistance of a police officer not below the rank of Sub-Inspector, at any
reasonable time, and
the clinical establishment, shall offer reasonable facilities for inspection or
inquiry and be entitled to be represented thereat: Provided
that no such person shall enter the clinical establishment without giving
notice in writing of his intention to do so. (2)
No
person shall obstruct an officer authorized under sub-section (1) in the
exercise of any power conferred by that sub-section or make any false or
reckless statement in answer to a question put by such officer in exercise of
the power conferred on him under clause (a) of that sub-section. (3) Save as in this Act otherwise expressly provided,
provision of the Code of Criminal Procedure, 1973 (2 of 1974) relating to
search, seizure, summon, investigation and prosecution shall apply, as far as
may be, to all action taken by the Officer authorized under sub-section (1). The
licensing authority may charge such fees for registration and license for
different categories of clinical establishments, as may be prescribed: Provided
that the State Government may, if it considers necessary to do so in the public
interest, by order, subject to such terms and conditions as may be specified
therein, exempt clinical establishment from payment wholly of any such fee or
reduce the amount of any such fee payable by any clinical establishment as may
be prescribed. (1) Any person, aggrieved by? (i) the failure of the licensing authority in
communicating the allowing or rejection of application for registration and
license to clinical establishment after the expiry of prescribed period; or (ii) an order of the licensing authority refusing to
allow registration or to grant or renew a license; or (iii) canceling or suspending a license; or (iv) an improvement notice; or (v) prohibition order; may, prefer an appeal to such authority not below
the rank of Special Secretary, Department of Health & Family Welfare of the
State Government being the Appellate authority as may be prescribed. (2) Every appeal under sub-section (1) shall be made in
such manner, in such form within such period from the date of the order and be
accompanied by such fee as may be prescribed: Provided
that the Appellate authority may entertain an appeal preferred after the expiry
of the prescribed period if it is satisfied that the appellant was prevented by
sufficient cause from preferring the appeal in time. (3) The decision of the Appellate authority shall be
final and binding. (4) No civil court shall have any jurisdiction to
entertain any suit or other proceedings challenging the decision of the
licensing authority refusing to allow registration of the clinical
establishment or to grant or renew a license or canceling or suspending a
license or issuing a prohibition order or, an improvement notice under sections
13, 14, 20, 21 and section 23 as well as the decision of the Appellate
authority. (1) Whoever carries on a clinical establishment without
registration and license shall be liable to a penalty which may extend to one
lakh rupees, along with a further penalty of one thousand rupees for each day
of operation of the clinical establishment without license subject to maximum
of ten lakh rupees. (2) Whoever knowingly serves in a clinical
establishment which is not duly registered and licensed under this Act, shall
be liable to a penalty which may extend to twenty-five thousand rupees. (1) Whoever wilfully disobeys any direction lawfully
given by any person or authority empowered under this Act to give such
direction, or obstructs any person or authority in the discharge of any functions
which such person or authority is required or empowered under this Act to
discharge, shall be liable to a penalty which may extend to five lakh rupees. (2) Whoever being required by or under this Act to
supply any information wilfully withholds such information or gives information
which he knows to be false or which he does not believe to be true, shall be
liable to a penalty which may extend to one lakh rupees. (3) Whoever being required by or under this Act to
maintain and supply records, reports, registers and other documents wilfully
tampers, destroys, falsifies such documents shall be liable to a penalty which
may extend to five lakh rupees. (1) Whoever contravenes any provision of this Act or
any rule made there under resulting in such minor deficiencies, that do not
pose any imminent danger to the health and safety of any patient or public and
can be rectified within a reasonable time, shall be liable to a penalty which
may extend to fifty thousand rupees. (2) Whoever contravenes any provision of this Act or
any rule made there under resulting in such major deficiencies, that pose an
imminent danger to the health and safety of any member of the public or patient
and which cannot be rectified within a reasonable time, shall be liable to a
penalty which may extend to ten lakh rupees. Explanation.-- For the purpose of this section "minor
deficiencies and major deficiencies" shall have such meaning as may be
prescribed. Whoever
contravenes any provision of this Act or any rule made there under shall, if no
penalty is provided elsewhere, be liable to a penalty which may extend to fifty
thousand rupees for the first contravention and one lakh rupees for any
subsequent contravention. (1) Where a person committing contravention of any of
the provisions of this Act or of any rule made there under is a company, every
person who, at the time the contravention was committed, was in charge of, and
was responsible to the company for the conduct of the business of the company,
as well as the company, shall be deemed to be guilty of the contravention and
shall be liable to penalty: Provided
that nothing contained in this sub-section shall render any such person liable
to any penalty if he proves that the contravention was committed without his
knowledge or that he had exercised all due diligence to prevent the commission
of such contravention. (2) Notwithstanding anything contained in sub-section
(1), where a contravention of any of the provisions of this Act or of any rule
made there under has been committed by a company and it is proved that the
contravention has taken place with the consent or connivance of, or is
attributable to any neglect on the part of, any director, manager, secretary or
other officer of the company, such director, manager, secretary or other
officer shall also be deemed to be guilty of that contravention and shall be
liable to penalty. Explanation.-- For the purposes of this section,-- (a) "company" includes a firm or society; and (b) "director" in relation to a firm means a
partner in the firm. (1) While adjudging the quantum of penalty under this
Chapter, the Adjudicating Authority or the Commission, as the case may be,
shall have due regard to the following:-- (a) the amount of gain or unfair advantage, wherever
quantifiable, made as a result of the contravention; (b) the amount of loss caused or likely to be caused to
any person as a result of the contravention; (c) the repetitive nature of the contravention; (d) whether the contravention is without his knowledge;
and (e) any other relevant factor. (2) The penalties which may be imposed for
contravention of any provision of this Act or any rule made there under shall
be without prejudice to the power of the licensing authority to suspend or
cancel the license. (1) Without prejudice to the other provisions of this
Chapter, if any clinical establishment whether by itself or by any other person
on it's behalf, while providing services causes injury to the service recipient
or his death, due to negligence or any deficiency in providing service, it
shall be lawful for the Commission, on substantiation of charges, to direct it
to pay compensation to the victim or the legal representative of the victim, a
sum? (a) which may extend to three lakh rupees in case of
simple injury; (b) which may extend to five lakh rupees in case of
grievous injury; and (c) which shall not be less than ten lakh rupees in
case of death: Provided
that the compensation shall be paid at the earliest and in no case later than
six months from the date of occurrence of the incident: Provided
further that in case of death, an interim relief shall be paid to the next of
the kin within thirty days of the incident. (2) Where any person is held guilty of a contravention
leading to grievous injury or death, the Commission may cause the name and
place of residence of the person held guilty, the offence and the penalty
imposed to be published at the offender's expense in such newspapers or in such
other manner as the Commission may direct and the expenses of such publication
shall constitute the cost and the same shall be recoverable in the same manner
as fine. (3) The Commission may also order for cancellation of
license, closure of the clinical establishment, forfeiture of establishment and
property in case of grievous injury or death of the service recipient. (1) Notwithstanding anything contained in this Act, if
any person? (a) violates the conditions of registration and license
under this Act, he shall be liable for imprisonment which may extend to three
years; or (b) causes death or injury of patient or service
recipients due to negligence, shall be liable to punishment as provided in the
Indian Penal Code, 1860 (45 of 1860). (2) The prosecution, trial etc. for the purpose of
sub-section (1) shall be as per the provision contained under the Code of
Criminal Procedure, 1973 (2 of 1974). (1) For the purposes of adjudication under this
Chapter, District Magistrate or an officer not below the rank of Additional
District Magistrate of the district where the alleged offence is committed
shall be notified by the State Government as the Adjudicating authority for
adjudication in the manner as may be prescribed: Provided
that for the district of Kolkata an officer not below the rank of Joint
Secretary to the State Government as may be appointed by notification by the
State Government shall be the Adjudicating authority. Explanation.-- For the purposes of this section, the word
"Kolkata" shall have the same meaning as defined in clause (9) of section
2 of the Kolkata Municipal Corporation Act, 1980 (West Ben. Act LIX of 1980). (2) The Adjudicating authority, on receipt of a
complaint from the licensing authority that any person has committed a
contravention under sections 27, 28, sub-section (1) of section 29, and section
30 of this Act, shall, after giving the person a reasonable opportunity for
making representation in the matter, and if, on such inquiry, he is satisfied
that the person has committed the contravention of provisions of this Act or the
rules or the regulations made there under, impose such penalty as he thinks fit
in accordance with the provisions of this Act. (3) The Adjudicating Authority shall have the powers of
a civil court and? (a) all proceedings before him shall be deemed to be
judicial proceeding within the meaning of sections 193 and 228 of the Indian
Penal Code, 1860; (b) shall be deemed to be a court for the purposes of
sections 345 and 346 of the Code of Criminal Procedure, 1973. (4) While adjudicating the quantum of penalty under
this Chapter, the Adjudicating authority shall have due regard to the
guidelines specified in section 32. (1) The State Government shall constitute a West Bengal
Clinical Establishment Regulatory Commission to exercise the powers and perform
the functions conferred on the commission under this Act for the purpose of
regulation and supervision of the functioning and activities of the clinical
establishments licensed under this Act for ensuring accountability and
transparency in dealing with patients by clinical establishments in providing
patient care services, to advise the Government on measures be adopted for
enhancing and augmenting the performance of clinical establishments in the
State. (2) The West Bengal Clinical Establishment Regulatory
Commission shall consist of? (a) a Chairperson, appointed by the State Government,
who is or has been a High Court Judge or any officer who has held the office of
Chief Secretary, Additional Chief Secretary in the State Government or any
officer who has held equivalent post in the Government of India: Provided
that a retired High Court Judge, if appointed as Chairperson, may pursue his
professional work; (b)
a
Vice -Chairperson who is a person of eminence to be appointed by the State
Government; (c) members not exceeding eleven in number, to be
appointed by the State Government, selected from the fields of medicine
including diagnostics, public health, academia, social services, law, finance,
public administration, nursing and consumer interests. (1) The Chairperson, the Vice Chairperson and the
members shall hold the office of the Commission during the pleasure of the
State Government. (2) If a casual vacancy occurs in the Office of any of
the members of the Commission, whether by reason of his death, resignation or
inability to discharge his functions owing to illness or any other incapacity,
such vacancy shall be filled up by the State Government by making a fresh
appointment. (1) The Commission shall? (i)
monitor
the functioning of clinical establishments; (ii)
regulate
and supervise functions of clinical establishments as prescribed; (iii) examine and consider complaints, filed manually or
electronically through an online system in matters related to patient care
service, deviations from declared fees and charges, refusal of supply of copy
of medical records and allied matters, alleged irrational and unethical trade
practice alleged before the Commission by aggrieved patient parties against clinical
establishments and after issue of notice and hearing both parties, adjudicate,
compensate and pass such other orders, as deemed appropriate: Provided
that any complaint of medical negligence against medical professionals will be
dealt with by respective State Medical Councils: Provided
further that the Commission for the purpose of adjudicating disputes and appeal
under this Act, shall have a quorum of the Chairperson and not less than two
other members; (iv) make regulations with regard to fixing of rates or
charges for indoor patient department and outdoor patient department treatment
including diagnostics and also to ensure compliance with fixed rates and
charges by clinical establishments; (v) enforce transparency in dealing with patients by
the clinical establishments; (vi) tender advice and make suggestions regarding
measures to be adopted under this Act, for improving patient care services and
redressal of grievances; (vii) undertake planned or surprise inspections to
examine and ascertain strict compliance by clinical establishments with
provisions of this Act; (viii) hear appeals arising from orders and decisions
passed by the Adjudicating Authority in the Districts; (ix) have the powers to award such compensation as
deemed appropriate not exceeding fifty lakh rupees, including interim
compensation; (x) ensure that only properly trained medical and
para-medical personnel like doctors, nurses, technicians, pharmacists are
employed by the clinical establishment. (1) The West Bengal Clinical Establishment Regulatory
Commission may hold a meeting at least once in a month. (2) If due to any reason, the Chairperson is unable to
attend any meeting of the Commission, the Vice-Chairperson and in his absence,
any other member chosen by the members present at the meeting shall preside at
the meeting. (3) Save as otherwise provided under this Act, all
matters under the consideration of the West Bengal Clinical Establishment Regulatory
Commission at any meeting shall be decided by majority of votes of the members
present. If there is an equality of votes, the Chairperson or in his absence
the person presiding shall have and exercise a casting vote. (4) A monthly report may be submitted by the Commission
to the State Government regarding its activities. (5) The Commission may associate with itself, in such
manner and for such purposes as may be determined by regulations, any person
whose assistance or advice it may desire in carrying out any of the provisions
of this Act. (6) A person associated with the Commission under
sub-section (5) for any purpose shall have a right to take part in the
discussion relevant for that purpose but shall have no right to vote and shall
not be a member for any other purposes. Orders
and decisions of the West Bengal Clinical Establishment Regulatory Commission
shall be authenticated by the signature of the Chairperson, the
Vice-Chairperson or any other member authorised by the Commission in this
behalf, and all other instruments issued by the Commission shall be
authenticated by the signature of any other member authorised in like manner on
this behalf. Orders
and decisions of the Adjudicating Authority in the Districts shall be
appealable before the West Bengal Clinical Establishment Regulatory Commission
within a period of fifteen days from the date of passing the order and
accompanied by fixed fees of one hundred rupees: Provided
that the Commission may admit the appeal after the expiry of such period if it
is satisfied that the aggrieved parties were prevented by sufficient cause from
filing it within appropriate time. (1) The salary, allowances payable to and other terms
and condition of service of the Chairperson, the Vice-Chairperson and members
of the West Bengal Clinical Establishment Regulatory Commission shall be such,
as may be prescribed: Provided
that the salary, allowances and other terms and conditions of service of
Chairperson, the Vice-Chairperson and the members, shall not be varied to their
disadvantage after appointment. (2) Notwithstanding anything contained in sub-section
(1), the Chairperson, the Vice-Chairperson or any Member of the commission may
relinquish his office by giving in writing to the State Government a notice of
not less than three months. (1) The West Bengal Clinical Establishment Regulatory
Commission, with the approval of the State Government, appoint officers and
such other employees as may be considered by it for the due discharge of its
functions. (2) The salaries and allowances payable to, and other
terms and conditions of service of, the officers and other employees shall be
such as may be prescribed. (3) The Commission may, with the approval of the State
Government, appoint consultants required to assist it in the discharge of its
functions on such terms and conditions as may be specified, by regulations. (1) The West Bengal Clinical Establishment Regulatory Commission
shall not be bound by the procedure laid down by the Code of Civil Procedure,
1908 (5 of 1908) but shall be guided by the principles of natural justice and,
subject to the other provisions of this Act and the rules made there under, the
Commission shall have powers to regulate its own procedure including the place
at which it shall have its sittings. (2) The Commission shall, for the purposes of
discharging its functions under this Act, have the same powers as are vested in
a civil court under the Code of Civil Procedure, 1908, in respect of the
following matters, namely:-- (a) summoning and enforcing the attendance of any
person and examining him on oath; (b) requiring the discovery and production of any
document or other electronic records or other material object producible as
evidence; (c) receiving evidence on affidavits; (d) requisitioning of any public record; (e) issuing commission for the examination of witnesses
or documents; (f) reviewing its decisions, directions and orders; (g) dismissing an application for default or deciding
it ex-parte; (h) award compensation as per provisions under sections
33 and 38 of this Act; (i) any other matter which may be prescribed. (3)
The
appellant may either appear in person or authorise one or more legal practitioners
or any of its officers to represent his case before the Commission. (4)
The
provisions of the Limitation Act, 1963 (36 of 1963), shall, except as otherwise
provided in this Act, apply to an appeal made to the Commission. (5)
The
Commission shall have the powers to pass such interim order in any proceedings,
hearing or matter before the Commission, as that Commission may consider
appropriate. (6) While adjudicating the quantum of penalty under
this Chapter, the Commission shall have due regard to the guidelines specified
in section 32. (1) Where an order made under this Act by the
Commission is not complied with the Commission may order the property of the
clinical establishment, not complying with such order to be attached. (2) No attachment made under sub-section (1) shall
remain in force for more than three months at the end of which, if the
non-compliance continues, the property attached may be sold and out of the
proceeds thereof, the Commission may pay the compensation awarded by it to the
complainant or service recipient and shall pay the balance if any, to the
clinical establishment thereof. No
civil court shall have jurisdiction to entertain any suit or proceeding in
respect of any matter which an Adjudicating Authority or the West Bengal
Clinical Establishment Regulatory Commission is empowered by or under this Act
to determine and no injunction shall be granted by any court or other authority
in respect of any action taken or to be taken in pursuance of any power
conferred by or under this Act. The
State Government may, after due appropriation made by Legislature of the State
in this behalf, make to the Commission grants and loans of such sums of money
as the Government may consider necessary. (1) There shall be constituted a Fund to be called the
West Bengal Clinical Establishment Regulatory Commission Fund and there shall
be credited thereto? (a) any grants and loans made to the Commission by the
State Government under section 47; (b) all proceeds of the attachment received by the
Commission under sub-section (2) of section 45; (c) all sums received by the Commission from such other
sources as may be decided upon by the State Government. (2) The Fund shall be applied for meeting? (a) the salary, allowances and other remuneration of
Chairperson, the Vice-Chairperson, Members, Officers and other employees of the
Commission; (b) the expenses of the Commission in discharge of its
functions; (c) the expenses on objects and for purposes authorized
by this Act; (d) the payment of compensation out of the sale
proceeds under sub-section (2) of section 45. (3) The State Government may, in consultation with the
Comptroller and Auditor General of India, notify the manner of applying Fund
for meeting the expenses specified in clause (b) or clause (c) of sub-section
(2). (1) The West Bengal Clinical Establishment Regulatory
Commission shall maintain proper accounts and other relevant records and
prepare annual statement of accounts in such form as may be notified by the
State Government in consultation with the Comptroller and Auditor General of
India. (2) The accounts of the Commission shall be audited by
the Comptroller and Auditor General of India at such intervals as may be
specified by him and any expenditure incurred in connection with such audit
shall be payable by the Commission to the Comptroller and Auditor General of
India. (3) The Comptroller and Auditor General of India and
any person appointed by him in connection with the audit of the accounts of the
Commission under this Act shall have the same rights and privileges and
authority in connection with audit as the Comptroller and Auditor General of
India generally has in connection with the audit of Government accounts and, in
particular, shall have the right to demand the production of books, accounts,
connected vouchers and other documents and papers and to inspect any of the
offices of the Commission. (4) The accounts of the Commission, as certified by the
Comptroller and Auditor General of India or any other person appointed by him
in this behalf, together with the audit report thereon shall be forwarded
annually to the State Government and the Government shall cause the same to be
laid, as soon as may be after it is received, before the State Legislature. (1) The Commission shall prepare once in every year in
such form and at such time as may be notified, an annual report giving a
summary of its activities during the previous year and copies of the report
shall be forwarded to the State Government. (2) A copy of the report received under sub-section (1)
shall be laid, as soon as may be after it is received, before the State
Legislature. The
Commission shall prepare, in such form and at such time in each financial year
as may be notified, its budget for the next financial year, showing the
estimated receipts and expenditure of that Commission and forward the same to
the State Government. The
Commission may, with the previous approval of the State Government, by
notification, make regulations not inconsistent with this Act and the rules
made there under to provide for all matters for which provision is necessary or
expedient for the purpose of giving effect to the provisions of this Act and
patient care at the clinical establishments. (1) In the discharge of its functions, the Commission
shall be guided by such directions in matters of policy involving public
interest as the State Government may give to it in writing. (2) If any question arises as to whether any such
direction relates to a matter of policy involving public interest, the decision
of the State Government thereon shall be final. (1) Anything which is done in good faith or intended to
be done by any authority or any officer in this behalf in respect of anything
done under this Act, the authority or the officer, as the case may be, shall be
protected from prosecution, suit or any other legal proceeding. (2) If any loss or damage is caused or likely to be
caused by anything which is in good faith done or intended to be done by the
State Government in pursuance of the provisions of this Act or any rules made
there under, the State Government shall be protected from prosecution, suit or
any other legal proceeding. Any
fees received or fines paid under this Act and rules framed there under shall
be credited to the Consolidated Fund of the State. Without
prejudice to the foregoing provisions of this Act, the licensing authority
shall have the power to issue such directions, including furnishing returns,
statistics and other information for the proper functioning of clinical
establishments and such directions shall be binding. Every
employee of the adjudicating authority, licensing authority and appellate
authority including Commission, when acting or purporting to act in pursuance
of any of the provisions of this Act shall be deemed to be public servants
within the meaning of section 21 of the Indian Penal Code, 1860 (45 of 1860). (1) If any difficulty arises in giving effect to the
provisions of this Act, the State Government may, by order published in the
Official Gazette, make such provisions not inconsistent with the provisions of
this Act as may appear to it to be necessary or expedient for removal of the
difficulty: Provided
that no such order shall be made after the expiry of a period of two years from
the date of commencement of this Act. (2) Every order made under this section shall, as soon
as it is made, be laid before the State Legislative Assembly. (1) The State Government may, by notification, make
rules for carrying out all or any of the provisions of this Act. (2) All rules made under this Act shall be laid for not
less than fourteen days before the State Legislature as soon as possible after
they are made and shall be subject to such modification as the State
Legislature may make during the session in which they are so laid. Any
modification of the said rules made by the State Legislature shall be published
in the Official Gazette, and shall, unless some later date is appointed by the
State Government, come into force on the date of such publication. The
provisions of this Act shall have effect notwithstanding anything inconsistent
therewith contained in any other law for the time being in force and to extent
of such inconsistency that other law shall be deemed to have no effect. The
provision of the West Bengal Medicare Service Persons and Medicare Service Institutions
(Prevention of Violence and Damage to Property) Act, 2009 (West Ben. Act XI of
2009), shall be applicable to prohibit violence against medicare service
persons and damage to property in medicare service institutions. (1) The West Bengal Clinical Establishments
(Registration and Regulation) Act, 2010 (West Ben. Act XXVI of 2010), is hereby
repealed. (2) Notwithstanding such repeal, anything done,
including any rule, notification, inspection, order or notice made or issued or
any license, permission, authorization or exemption granted or any document or
instrument executed or any direction given under the repealed Act shall,
insofar as it is not inconsistent with the provisions of this Act, be deemed to
have been done or taken under the corresponding provisions of this Act. (3) Notwithstanding anything contained in this Act, any
proceeding pending in any court at the commencement of this Act may be
continued in that court as if this Act has not been passed. (4) Notwithstanding anything contained in sub-section
(2), the clinical establishment for which license was granted before the
commencement of this Act shall be governed by the provisions of repealed Act
till the expiry of the terms of existing license.
WEST BENGAL CLINICAL ESTABLISHMENTS
(REGISTRATION, REGULATION AND TRANSPARENCY) ACT, 2017
Preamble - WEST BENGAL CLINICAL
ESTABLISHMENTS (REGISTRATION, REGULATION AND TRANSPARENCY) ACT, 2017PREAMBLE