WEST BENGAL CLINICAL ESTABLISHMENTS
(REGISTRATION AND REGULATION) ACT, 2010 THE WEST BENGAL
CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 [Act No. 26 of 2010] [5th October, 2010] An Act to provide for
the registration and regulation of clinical establishments of the State and for
matters connected therewith or incidental thereto. Whereas
it is expedient, in the public interest, to provide for registration and
regulation of clinical establishments and to prescribe the minimum standards of
facilities and services to be provided by them; It
is hereby enacted in the Sixty-first Year of the Republic of India, by the
Legislature of West Bengal, as follows:- (1) This Act may be called the West Bengal Clinical
Establishments (Registration and Regulation) Act, 2010. (2) It extends to the whole of the State of West
Bengal. (3) It shall come into force on such date as the State
Government may, by notification in the Official Gazette, appoint. (4) It shall apply to all clinical establishments other
than- (a) any clinical establishment maintained by, or under
the control of, the State Government, Central Government or local
Self-Government or any local authority; or (b) any clinical establishment or asylum established or
licensed under the Mental Health Act, 1987 (14 of 1987.); or (c) the clinical establishments owned, controlled or
managed by the Armed Forces. Explanation.-For
the purpose of this clause "Armed Forces" means the forces
constituted under the Army Act, 1950 (46 of 1950.), the Air Force Act, 1950 (45
of 1950.) and the Navy Act, 1957 (62 of 1957.). In
this Act, unless there is anything repugnant in the subject or the context,- (a) "adjudicating authority" means the
authority appointed under section 34; (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; (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 purpose 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) (j) "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; (k) "notification" means a notification
published in the Official Gazette; (l) "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; (m) "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; (n) "prescribed" means prescribed by rules
made under this Act; (o) "prohibition order" means an order issued
under section 21; (p) "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; (q) "registration" means registration done
under this Act; (r) "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; (s) "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, Homeopathic and Board of Indian Medicine or any such
Council, Board or any other statutory body recognized by the Government of West
Bengal; (t) "registered nurse" or 'registered
midwife' means a nurse or midwife registered under the Bengal Nurses Act, 1934
(Ben. Act X of 1934); (u) "Tribunal" means the West Bengal Clinical
Establishments Tribunal constituted under section 35; (v) "rules" means rules made under this Act; (w) "section" means the section of this Act; (x) "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, and any reference to "service provider" shall
mean the same unless specifically stated otherwise; (y) "service recipient" means person who
seeks, accesses or receives any health care, as outpatient or inpatient, from
any clinical establish (z) ent or service provider, including for profit and
not for profit; (aa) "standards" means the requirements that
the State Government may prescribe under section 7 for the registration of
clinical establishments; (bb) "State Government" means the State Government
of West Bengal; (cc) '"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. 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 establishment 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
establishment situated within the district of Kolkata. Explanation.-For
the purpose of this section the word 'Kolkata' shall have 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 therefor. Explanation I.-For the purpose of this section
'person' includes a body, group or association of individuals, an 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 purpose 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 duplicate in respect of the clinical establishment in such form 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 qualifications 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 machinaries 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 lisensing
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; (j) 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 Immune Deficiency Syndrome (AIDS) or such other
diseases as may be prescribed or such other arbitrary grounds; (k) 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; (1) that the clinical establishment shall actively
participate in the implementation of all national and State Health Programmes
including prevention of spread of communicable disceass in such manner as the
State Government may specify from time to time and furnish periodical reports
thereon to the authorities concerned; and (l) 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 he 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 the licensing authority rejects an application for registration and
license or renewal of registration and license, he shall record his 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 subsections (1) and (2) of section 12; or (c) that the applicant is trying to obtain the license
in contravention to subsection (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 antisocial 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 fee
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 every one 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 licence, the licencing authority shall allow renewal of registration and licence
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 (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 Tribunal; or (d) that the person entrusted with the management of
the clinical establishment has contravened any of the provisions of this Act or
rules made thereunder, the lincensing 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 the 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 provisons of this Act or the rules made
thereunder, he may, without prejudice to any other action that he may take
against such clinical establishment, cancel its registration and licence. (1) If- (a) any clinical establishment is convicted of any
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 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 inpatient or an outpatient and the inpatients 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 inpatients 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 inpatients
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 establshment 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, his
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 therefrom 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 establshment 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) cancelling 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 and 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 cancelling 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 fifty
thousand rupees, alongwith a further penalty of five hundred rupees for each
day of operation of the clinical establishment without license subject to
maximum of two 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 two 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 fifty thousand rupees. (3) Whoever being required by or under this Act to
maintain and supply records, reports, registers and other documents wilfully
tamper, destroy, falsify such documents shall be liable to a penalty which may
extend to two lakh rupees. (1) Whoever contravenes any provision of this Act or
any rule made thereunder 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 thereunder 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 five 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 thereunder shall, if no
penalty is provided elsewhere, be liable to a penalty which may extend to ten
thousand rupees for the first contravention and fifty thousand rupees for any
subsequent contravention. (1) Where a person committing contravention of any of the
provisions of this Act or of any rule made thereunder 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 thereunder 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 Tribunal, 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 cause 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 thereunder 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 Tribunal, on substantiation of charges, to direct it to pay
compensation to the victim or the legal representative of the victim, a sum- (a) not less than five lakh rupees in case of death; (b) not exceeding three lakh rupees in case of grievous
injury; and (c) not exceeding one lakh rupees, in all other cases
of injury: 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 Tribunal 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 Tribunal
may direct and the expenses of such publication shall be deemed to be part of
the cost attending the conviction and shall be recoverable in the same manner
as a fine. (3) The Tribunal 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) For the purposes of adjudication under this
Chapter, 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, subsection
(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 thereunder, 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 proceedings within the meaning of sections 193 and 228 of the Indian
Penal Code, 1860 (45 of 1860.); (b) shall be deemed to be a court for the purposes of
sections 345 and 346 of the Code of Criminal Procedure, 1973 (2 of 1974). (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 may constitute by notification
for the purposes of this Act, a Tribunal for the State to be known as the West
Bengal Clinical Establishment Tribunal (hereinafter referred to as the
Tribunal). (2) The Tribunal shall consist of not more than three
Members, including the Chairperson. (3) The Chairperson and members of the Tribunal shall
be appointed by the State Government. (1) The Chairperson and the Members of the Tribunal
shall be persons of ability, integrity and standing who have adequate knowledge
of, and have shown capacity in, dealing with problems relating to health
administration, finance, economics, law or management, ethics or public health
Acts. (2) Notwithstanding anything contained in sub-section
(1), the State Government may appoint any person as the Chairperson from
amongst persons who is, or has been, a Judge of a High Court: Provided
that no appointment under this sub-section shall be made except after
consultation with the Chief Justice of that High Court. (3) The Chairperson or any other Member of the Tribunal
shall not hold any other office. (1) The Chairperson or other member shall hold office
for a term of not more than three years from the date on which he enters upon
his office: Provided
that the Chairperson or other member of the Tribunal shall not be eligible for
reappointment in the same capacity as the Chairperson or a member in that
Tribunal in which he had earlier held office as such: Provided
further that no Chairperson or member shall hold office as such after he has
attended the age of sixty-five years. (2) The salary, allowances payable to and other terms
and conditions of service of the Chairperson and members shall be such, as may
be prescribed: Provided
that the salary, allowances and other terms and conditions of service of the
Chairperson and the members, shall not be varied to their disadvantage after
appointment. (3) Notwithstanding anything contained in sub-section
(1), the Chairperson or any Member may- (a) relinquish his office by giving in writing to the
State Government a notice of not less than three months; or (b) be removed from his office in accordance with the
provisions of section 38. (1) The Chairperson or Member shall not be removed from
office except in accordance with the provision of this section. (2) The State Government may, by order, remove from
office the Chairperson or any Member if he- (a) has been adjudged an insolvent; or (b) has been convicted of an offence which, in the
opinion of the State Government, involves moral turpitude; or (c) has become physically or mentally incapable of
acting as a Member; or (d) has acquired such financial or other interest as is
likely to affect prejudicially his functions as a Member; or (e) has so abused his position as to render his
continuance in office prejudicial to the public interest; or (f) has been guilty of proved misbehaviour. (3) No member or Chairperson shall be removed under
clauses (d) and (e) of subsection (2) unless he has been given a reasonable
opportunity of being heard in the matter. (1) The Tribunal may, 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 Tribunal 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 Tribunal shall discharge the following
functions namely:- (a) to decide any dispute between proprietors of
clinical establishment and service recipient in relation to- (i) services as provided by clinical establishment; (ii) bills as charged by clinical establishment, and to
award reasonable amount of compensation payable by the clinical establishment
to the service recipients: Provided
that any complaint of medical negligence against medical professionals will be
dealt with by respective State Medical Councils; (b) to decide whether the charges for services and
investigations by clinical establishment are fair and reasonable in case where
there is any dispute between the clinical establishment and the service
recipient or his representative: Provided
that dispute between Insurance agency and clinical establishment regarding
charges or rates of services investigations shall not be decided by the
Tribunal. (2)
The
Tribunal shall hear the appeal preferred by the aggrieved clinical
establishment against the order of penalty made by the Adjudicating authority
under sub-section (2) of section 34. (3) Every appeal under sub-section (2) 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 Tribunal may admit the appeal after the expiry of such period if it is
satisfied that the aggrieved clinical establishment was prevented by sufficient
cause from filing it in appropriate time. (4) The Tribunal shall adjudicate any complaint made by
the aggrieved party against any clinical establishment regarding- (a) alleged irrational and unethical trade practice;
and (b) alleged contravention of any provision of this Act
or any rule made thereunder resulting in major deficiencies that may pose any
imminent danger to the health and safety of any patient or public, under
subsection (2) of section 29. (1) The Tribunal 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 thereunder, the Tribunal shall have powers to
regulate its own procedure including the place at which it shall have its
sittings. (2) The Tribunal 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 objective 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 exparte; (h) any other matter which may be prescribed. (3) Every proceedings before the Tribunal shall be
deemed to be judicial proceedings within the meaning of sections 193 and 228 of
the Indian Penal Code, 1860 (45 of 1860.) and the Tribunal shall be deemed to
be a civil court for the purposes of sections 345 and 346 of the Code of
Criminal Procedure, 1973 (2 of 1974). (4) 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 Tribunal. (5) 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 Tribunal. (6) The Tribunal shall have the powers to pass such
interim order in any proceedings, hearing or matter before the Tribunal, as
that Tribunal may consider appropriate. (7) While adjudicating the quantum of penalty under
this Chapter, the Tribunal shall have due regard to the guidelines specified in
section 32. Any
person aggrieved by any decision or order of the Tribunal may file an appeal to
the High Court within sixty days from the date of communication of the decision
or order of the tribunal to him on any question of fact or law arising out of
such order: Provided
that the High Court may, if it is satisfied that the appellant was prevented by
sufficient cause from filing the appeal within the said period, allow it to be
filed within a further period not exceeding sixty days. (1) Where an order made under this Act by the Tribunal
is not complied with, the Tribunal 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 Tribunal 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 Tribunal 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 a State in
this behalf, make to the Tribunal grants and loans of such sums of money as
that Government may consider necessary. (1) There shall be constituted a Fund to be called the
State Clinical Establishment Tribunal Fund and there shall be credited thereto- (a) any grants and loans made to the Tribunal by the
State Government under section 45; (b) all proceeds of the attachment received by the Tribunal
under sub-section (2) of section 43; (c) all sums received by the Tribunal 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,
Members, Secretary, officers and other employees of the Tribunal; (b) the expenses of the Tribunal in discharge of its
functions under section 40; (c) the expenses on objects and for purposes authorized
by this Act; (d) the payment of compensation out of the sell
proceeds under sub-section (2) of section 43. (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 cluase (b) or clause (c) of sub-section
(2). (1) The Tribunal 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 Tribunal 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 Tribunal 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
Tribunal 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 Tribunal. (4) The accounts of the Tribunal, 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 that Government shall cause the same to be
laid, as soon as may be after it is received, before the State Legislature. (1) The Tribunal shall prepare once 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
Tribunal 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 Tribunal and forward the same to the State
Government. The
Tribunal may, with the previous approval of the State Government, by
notification, make regulations not inconsistent with this Act and the rules
made thereunder to provide for all matters for which provision is necessary or
expedient for the purpose of giving effect to the provisions of this Act. (1) In the discharge of its functions, the Tribunal
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) No suit, prosecution or other legal proceedings
whatsoever shall lie against any authority or any officer authorized in this
behalf in respect of anything, which is in good faith done or intended to be
done in pursuance of the provisions of this Act or any rule made thereunder. (2) No suit or other legal proceedings shall lie
against the State Government in respect of any loss or damage caused or likely
to be caused by anything which is in good faith done or intended to be done in
pursuance of the provisions of this Act or any rule made thereunder. Any
fees received or fines paid under this Act and rules framed thereunder 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 Tribunal shall be deemed to, when acting or purporting to
act in pursuance of any of the provisions of this Act, 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) In particular, and without prejudice to the
generality of the foregoing power, such rules may provide for all or any of the
following matters, namely:- (a) the standards which an applicant and a clinical establishment
shall fulfil for registration and license under sub-section (1) of section 7; (b) the form in which a license shall be granted under
sub-section (1) of section 7; (c) the minimum standard of accommodation which shall
be provided under clause (a) of sub-section (2) of section 7; (d) the minimum number and norms in respect of health
service providers and other persons under clause (b) of sub-section (2) of
section 7; (e) the minimum qualification in respect of health
service providers and other persons under clause (b) of sub-section (2) of
section 7; (f) the minimum standard of services including
emergency care, and referral services which are to be provided under clause (c)
of sub-section (2) of section 7; (g) the equipments and machineries which are to be provided
under clause (d) of sub-section (2) of section 7; (h) the arrangements for disposal of biomedical wastes
which are to be provided under clause (e) of sub-section (2) of section 7; (i) the records and registers, the format and the
particulars which are to be maintained under clause (f) of sub-section (2) of
section 7; (j) any other terms and conditions subject to which the
license shall be granted under clause (g) of sub-section (2) of section 7; (k) the measures which shall be taken to keep the
clinical establishment in the satisfactory sanitary and hygienic condition
under clause (d) of subsection (3) of section 7; (l) the conditions which are satisfactory sanitary and
hygienic under clause (d) of sub-section (3) of section 7; (m) the information which are to be displayed under
clause (e) of sub-section (3) of section 7; (n) the manner in which the information are to be
displayed under clause (e) of sub-section (3) of section 7; (o) the reports, their format, the particulars
containing therein, and the necessary documents which are to be submitted under
clause (f) of sub-section (3) of section 7; (p) the authorities to whom the reports are to be
submitted under clause (f) of sub-section (3) of section 7; (q) the interval at which the reports are to be
submitted under clause (f) of sub-section (3) of section 7; (r) the medical and other reports, records and
documents which are to be made available under clause (g) of sub-section (3) of
section 7; (s) the grounds of discrimination and the diseases
under clause (j) of subsection (3) of section 7; (t) the emergency medical treatment, first-aid and
critical care to be provided under clause (k) of sub-section (3) of section 7; (u) any other terms and conditions subject to which the
license shall be granted under clause (m) of sub-section (3) of section 7; (v) the period for which registration and license shall
be valid under subsection (4) of section 7; (w) the circumstances in which the State Government may
relax all or any of the terms and conditions under section 8; (x) the form and particulars to be contained in the
register to be maintained under sub-section (1) of section 9; (y) the format and manner of supply to the State
Registrar the entry made in the register of clinical establishments under
sub-section (2) of section 9; (z) the form and particulars to be contained in the
register to be maintained under section 10; (aa) the categories into which the clinical
establishment shall be classified under sub-section (1) of section 11; (bb) the different standards for classification of
clinical establishments under sub-section (2) of section 11; (cc) the proforma of application and the fees to be paid
for registration and license under sub-section (1) of section 12; (dd) the particulars and the accompanied evidence under
sub-section (2) of section 12; (ee) the criteria and time period to be followed before
passing an order under section 13; (ff) the manner by which the copy of order to be sent to
the applicant under section 13; (gg) the fees to be paid by the clinical establishment
to get a copy of license under section 17; (hh) the enhanced fees to be charged for renewal after
expiry of registration and license under sub-section (1) of section 19; (ii) the terms and conditions for renewal after expiry
of registration and license under sub-section (1) of section 19; (jj) the period from the date of receipt of application
under sub-section (2) of section 19; (kk) the manner by which the copy of order to be served
under clause (a) of sub-section (2) of section 21; (ll) the manner of inspection and submission of report
under clause (a) of sub-section (2) of section 22; (mm)
the
manner of seizure and period of retention under clause (b) of subsection (1)
and the manner of entry and search under clause (c) of subsection (1) of
section 24; (nn) the fees to be charged by the licensing authority
for different categories of clinical establishments under section 25; (oo) (the terms and conditions for exemption of fees
payable by any clinical establishment under proviso of section 25; (pp) the authority to Act as Appellate authority under
sub-section (1) of section 26; (qq) ) the manner and the period within which an appeal
may be preferred to the Appellate authority under sub-section (2) of section
26; (rr) (ar) the form and the fees to be paid for an appeal
under sub-section (2) of section 26; (ss) the meaning of minor and major deficiencies under
section 29; (tt) the manner for adjudication under sub-section (1)
of section 34; (uu) the manner of lodging appeal by anyone to the
Tribunal under sub-section (3) of section 40; (vv) any other matter in respect of powers of the
Tribunal under clause (h) of sub-section (2) of section 41; (ww) any other matter which is required to be or may be
prescribed by the State Government. (3) 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. (1) The West Bengal Clinical Establishments Act, 1950
(West Ben. Act LVI of 1950) 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 had 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.
Preamble - WEST BENGAL CLINICAL
ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010PREAMBLE
Section 45 - Grants and loans by State
Government