(Tentative Draft)pbhealth.gov.in/Tentative Draft Clinical Establisments Act05nov.pdf(18)...

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Transcript of (Tentative Draft)pbhealth.gov.in/Tentative Draft Clinical Establisments Act05nov.pdf(18)...

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(Tentative Draft)

THE PUNJAB CLINICAL ESTABLISHMENTS

(REGISTRATION,REGULATION& TRANSPARENCY) ACT,2019

An Act to provide for the registration, regulation and transparency of clinical

establishments in the State of Punjab and for matters connected therewith or

incidental thereto.

WHEREAS it is expedient, in the public interest, to provide for registration,

regulation and transparency of clinical establishments registered under this Act with a

view to prescribe minimum standards of facilities and services which may be provided

by them so that mandate of Article 47 of the Constitution for improvement in public

health may be achieved.

Be it enacted by the Legislature of the State of Punjab in the seventieth year of the

Republic of India as follows :

CHAPTER I

PRELIMINARY

1. Short title, application and commencement –

(1) This Act may be called the Punjab Clinical Establishments (Registration,

Regulation& Transparency) Act, 2019.

(2) It shall apply to the whole of the State of Punjab.(3) It shall come into force on such date as the State Government may, by notification in the Official Gazette,

appoint.

Provided that different dates may be appointed for different categories of

clinical establishments and for different recognised systems of medicine.

2.Definitions - In this Act, unless the context otherwise requires,—

(1)"Authority" means the registering authority established under section 7;

(2)“Certificate” means the certificate issued either under section 12 or 17 to

keep or carry on a clinical establishment consequent upon registration;

(3)“clinical laboratory” means an establishment where-

i.biological, pathological, bacteriological, radiological, chemical,

biochemical or other tests, examinations or analysis are done; or

ii.the preparation of cultures, vaccines, serums of other biological

or bacteriological products, in connection with the diagnosis or

treatment of diseases are usually carried on;

(4)"emergency medical condition" means a medical condition manifesting

itself by acute symptoms of sufficient severity (including severe pain) of

such a nature that the absence of immediate medical attention could reasonably

be expected to result in -

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(i)placing the life of the individual or, with respect to a pregnant

women, the life of the woman or her unborn child, in serious

jeopardy; or

(ii)serious impairment to bodily functions; or

(iii)serious dysfunction of any organ or part of a body;

(5) "clinical establishment" means-

(i) a hospital, maternity home, nursing home, dispensary, clinic,

sanatorium or an institution by whatever name called that offers

services, facilities requiring diagnosis, treatment or care for illness,

injury, deformity, abnormality or pregnancy in any recognised system

of medicine established and administered or maintained by any person

or body of persons, whether incorporated or not;or

(ii) a place established as an independent entity or part of an

establishment referred to in sub-clause (i), in connection with the

diagnosis or treatment of diseases where pathological,

bacteriological, genetic, radiological, chemical, biological

investigations or other diagnostic or investigative services with the

aid of laboratory or other medical equipment, are usually carried on,

established and administered or maintained by any person or body of

persons, whether incorporated ornot,and shall include a clinical

establishment owned, controlled or managed by-

(a) the Government or a department of the Government;

(b) a trust, whether public orprivate;

(c) a corporation (including a society) registered under a Central,

Provincial or State Act, whether or not owned by theGovernment;

(d) a local authority;and

(e) a singledoctor,

but does not include 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, the Air Force Act, 1950 and the Navy Act,

1957;

(6)“hospital” means any premises used for the reception of the sick and their

treatment as indoor patient;

(7)“maternity home” means an establishment where women are received or

accommodated for the purpose of antenatal and postnatal care in connection

with child-birth:

(8)“Member” means a member of the State Council for clinical establishments

constituted under section 3;

(9) "notification" means a notification published in the Official Gazette;

(10) “nursing home” means an establishment or premises used or intended to

be used for the reception of and provision of medical care including nursing

care in any form to persons suffering from sickness, injury or infirmity under

direct supervision of duly registered medical practitioner:

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(11)“physical therapy establishment” means a centre where persons are

usually treated by physical means.

(12) "prescribed" means prescribed by rules made under this Act;

(13)“qualified medical practitioner” means a medical practitioner registered

in the state of Punjab with the statutory state council or the statutory National

Council under a Law for the registration of medical practitioners in the

concerned system of medicine;

(14) “qualified midwife” means a midwife registered in the state of Punjab

with the statutory state council or the statutory National Council under a Law

for the registration of midwives;

(15) “qualified nurse” means a nurse registered in the state of Punjab with the

statutory state council or the statutory National Council under a Law for the

registration of nurses.

(16)“qualified para-medical person” means a person holding a recognised

qualification recognised by the State Government, from a recognised institution

wherein there is no statutory state or National Council under a Law for the

registration of such manpower.

(17)"recognised system of medicine" means Allopathy, Yoga,

Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani System of medicines

or any other system of medicine as may be recognised by the State

Government;

(18) “registered clinical establishment” means a clinical establishment

registered or deemed to be registered under this Act.

(19) "register" means the register maintained by the Authority, containing

the details of clinical establishments registered;

(20)"registration" means to register under section 8 and the expression

registration or registered shall be construed accordingly;

(21) "rules" means rules made by the State Government under section 48 of

this Act;

(22)"State Council" means the State Council for clinical establishments

established under section 3;

(23)"Schedule" means the Schedule appended to this Act;

(24) “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;

(25) “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;

(26)"standards" means the standards with regard to the services, skills and

other aspects declared by the clinical establishment under section 9, for the

registration of the clinical establishments;

(27)"State Government" means the Government of Punjab in the Department of

Health and Family Welfare.

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CHAPTER II

THE STATE COUNCIL FOR CLINICAL ESTABLISHMENTS

3. Establishment of State Council -

(1)With effect from such date as the State Government may, by

notification appoint in this behalf, there shall be established for the

purposes of this Act, a Council to be called the State Council forclinical

establishments.

(2)The State Council shall consist of -

(a)Administrative Secretary overall incharge of the Department of Health

and Family Welfare or his nominee who shall be an officer not below the

rank of Secretary to the State Government - Chairperson;

(b)Director - Health Services of the State Government-Member Secretary;

(c) Director – Health & Family Welfare of the State Government - Registrar

(d) Directors of different recognised systems of medicine of the State

Governmentincluding but not limited to Director-Ayurveda and Director-

Homeopathy - Members;

(e) One representative each to be elected by the executive committee of-

i)State Medical Council of India;

ii)State Dental Council;

iii) State Nursing Council;

iv) State Pharmacy Council; ........Members

(f)One representative each to be elected as Member by the respective

executive committeesor governing councils of the apex professional bodies

concerning recognised systems of medicine; - Members

(g) One representative of the State branch of the Indian Medical

Association - Member

(h) One representative from the field of paramedical systems to be

nominated by the State Government; - Member

(i) Two representatives from amongst the State level consumer groups or

reputed non-government organisations working in the field of health to be

nominated by the State Government.- Members

(3) The nominated Members shall hold office for a term of three years, but

shall be eligible for re-nomination for maximum of one additional term not

exceeding three years.

(4) The elected Members, as the case may be, shall hold office for three years,

but shall be eligible for re-election:

Provided that the person nominated or elected, as the case may be, shall hold

office for so long as he holds the appointment of the office or the position by

virtue of which he was nominated or elected to the State Council.

(5)The State Council shall perform the following functions, namely -

(a)compiling and updating the State Register of clinical establishments;

(b)sending monthly returns for updating the National Register;

(c)representing the State in the National Council;

(d)hearing of an appeal against the orders of the registration authority;

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(e)publication on annual basis, a report regarding the status of

implementation of the Act; and

(f)shall have power to constitute any Sub Committee to perform any of its

roles and functions;

(6) A person shall be disqualified for being appointed as a Member of the State

Council ifhe -

(a)has been convicted and sentenced to imprisonment for an offence

which, in the opinion of the State Government, involves moral turpitude;or

(b)is an undischarged insolvent;or

(c).is of unsound mind and stands so declared by a competent court;or

(d)has been removed or dismissed from the service of the Government or a

Corporation owned or controlled by the Government;or

(e)has, in the opinion of the State Government, such financial or other

interest in the Council as is likely to affect prejudicially the discharge by

him of his functions as amember.

4.Classification of clinical establishments - (1) Clinical establishments shall be classified into such categories, as may be

prescribed by the State Government from time to time.

(2) Different standards may be prescribed by the State Government for

particular categories of clinical establishments.

5. Power to seek advice or assistance - The State Council may associate with itself,

any person or body whose assistance or advice it may require in carrying out its

functions under any of the provisions of thisAct

CHAPTER III

REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS

6. State Registrar for clinical establishments - (1) The Director, Health & Family

Welfare, Government of Punjabshall perform the role of the State Registrar of clinical

establishments on behalf of the State Council.

(2) It shall be the responsibility of the State Registrar of clinical establishments to

compile and update the State register of clinical establishments on behalf of the State

Council.

7. Authority for registration & license -(1) The Registering authorities for

clinical establishment with 50-100 beds will be civil surgeons of respective

district.

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(2) Registering authority is for clinical establishments with more than 100 beds

will be Director Health Services, Punjab.

8. Registration andlicense for clinical establishments -No person shall keep or

carry on a clinical establishment without being dulyregistered by the registering

authority in respect thereof and except under and inaccordance 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.

9. Conditions for registration and license-(1) The licensing authority, if satisfied

that the applicant and the clinicalestablishment has fulfilled such standards as may

be prescribed, shall register theclinical establishment and shall grant a license in

respect of the clinical establishmentin 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 by the government.

(3) Every license granted under sub-section (1) shall be subject to the

followingterms 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

clinicalestablishment is not being used for unsocial or immoral purpose or both;

(c) that the clinical establishment shall not resort to any unethical or unfairtrade

practices including unfair pricing for different services;

(d) that such measures shall be taken to keep the clinical establishment insuch

satisfactory, sanitary and hygienic condition as may be prescribed;

(e) that such information is to be displayed and in such manner as may

beprescribed;

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(f) that such reports in such form containing such particulars and suchnecessary

documents shall be submitted to such authorities at such intervalsor on demand, as

may be prescribed;

(g) that such medical and other reports, records and documents shall be

madeavailable to the licensing authority or the service recipient or

hisrepresentative on demand, as may be prescribed;

(h) that report shall be submitted to the licensing authority as soon as aperson who

has been received or accommodated or both in the clinicalestablishment is found to

be suffering from any such infectious ordangerous disease or other condition as

may be notified;

(i) that every case of a victim of accident, injury, or trauma, received

oraccommodated or both thereto shall be reported to the police stationwithin the

jurisdiction of which such clinical establishment is locatedafter providing

immediate medical treatment;

(j) that every clinical establishment shall take steps to stabilize the victims of road

traffic accident, persons suffering from suddencalamities, acid attack victims and

rape victims irrespective of their abilityto bear the treatment cost at the relevant

time:

Provided that the clinical establishment shall have the right to recoverthe cost from

the service recipients or his representatives in due course oftime;

(k) that there should be no delay in releasing the Dead Body of patients orservice

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 Cellfor

lodging of any complaint regarding treatment, improper billing, deficitin service,

attending staffs’ behaviour etc. and for redressal thereof;

(m) that every clinical establishment shall set up a proper Help Desk to

maintainregular and proper communication with the service recipients or

theirrepresentatives regarding treatment, recipient’s condition, regular billingetc.

and for their proper counseling;

(n) that every clinical establishment shall immediately after coming into forceof

this Act, implement e-Prescription, maintain Electronic MedicalRecords and

provide a set of all medical records and treatment detailsalong with the discharge

summary at the time of discharge of the servicerecipient;

(o) that every clinical establishment shall strictly follow the fixed rates andcharges

including the Package Rates for investigation, bed charges,operation theatre

procedures, Intensive Care, ventilation, implants,consultation and similar tests and

procedures, and any additional treatmentor procedure shall not attract additional

charges over and above suchfixed rates and charges including the Package Rates;

(p) that every clinical establishment shall provide proper estimates fortreatments

not covered in fixed rates and charges including the PackageRates, to the service

recipients or representative of service recipientsduring initiation or due course of

treatment, and final bills shall notexceed estimates by a certain percentage, as may

be prescribed by theGovernment;

(q) that every clinical establishment shall strictly discourage repetitivelaboratory

tests for any service recipient, unless essential;

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(r) that every clinical establishment having more than 100 beds may

endeavoursetting up Fair Price Medicine Shop and Fair Price Diagnostic Centre;

(s) that any clinical establishment which has received land or other facilityfrom the

Government during initiation and in course of continuance oftheir projects shall be

responsible to provide completely free treatment to20 percent of Outdoor Patient

Department patients and 10 percent ofIndoor Patient Department patients in such

manner as may be prescribed:

Provided that clinical establishments, owned and managed by corporateentities that

have not availed such benefits, may endeavour to providecompletely free treatment

to 20 percent of Outdoor Patient Departmentpatients and 10 percent of Indoor

Patient Department patients as part oftheir Corporate Social Responsibility;

(t) that every clinical establishment shall mandatorily obtain express consentof the

patient party for continuation of ventilation support to the patientafter brain death;

(u) that no person shall be subject to any discrimination in any form ormanner, by

the clinical establishment in access to facilities, goods, careand 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 anddisease condition like Human Immunodeficiency Virus

(HIV) infectionor Acquired Immunodeficiency Syndrome (AIDS) or such other

diseasesas may be prescribed or such other arbitrary grounds;

(v) that no person shall be denied, under any circumstances, including inabilityto

pay the requisite fee or charges, such emergency life-saving medicaltreatment and

critical care by the clinical establishment as may beprescribed:

Provided that the clinical establishment has the right to recover thecost from the

service recipient or his representative in due course oftime;

(w) that the clinical establishment shall actively participate in theimplementation

of all National and State Health Progammes includingprevention of spread of

communicable diseases in such manner as theState Government may specify from

time to time and furnish periodicalreports thereon to the authorities concerned; and

(x)that the clinical establishment shall at all times, ensure compliance with all the

applicable laws including any rules, regulations, instructions, guidelines,

notifications, circulars, by-laws etc.

(y) any other terms and conditions which may be prescribed.

(4) Every license granted under sub-section (1) shall, unless suspended or

cancelledearlier under this Act, remain in force and be valid for such period with

effect fromthe date on which it is granted as may be prescribed.

CHAPTER IV

PROCEDURE FOR REGISTRATION

10. Application for registration (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 registering authority for the purposes of registration in

respect of a clinical establishment under section 5 and for the grant of a

certificate thereof subject to the provision of section 6 or for the renewal of the

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registration. The registering authority shall make provisions for submission of

online applications also and registration thereto.

(2)Every application made under sub-section (1) shall contain such particulars

and shall be accompanied by such declarations and documents of the clinical

establishment and the standards of services and skills being provided by it

along with the charges and other declarations required under the provisions of

the rules framed under this Act.

(3)Any change in address or other particulars mentioned under sub-section (2)

shall be communicated by the applicant or the person carrying on the clinical

establishment to the 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 registration by

means of misrepresentation of facts, fraudulent practices, falsifying documents,

or using unfair means.

11.Grant or rejection- On receipt of application made under sub-section (1) of section 7, the

registration authority shall, if it is satisfied after causing such inquires 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

granting or rejecting the application as per procedure prescribed. If application

is rejected, reasons for rejection will be specified.

12.Provisional certificate - The authority shall, within a period of 10 days from

the date of receipt of such application, grant to the applicant a certificate of

provisional registration in such form and containing such particulars and such

information, as may be prescribed.

13.Inquiry prior to granting the provisional registration. –

(1) The Authority shall not conduct any inquiry prior to the grant of

provisional registration.

(2) Notwithstanding the grant of the provisional certificate of registration, the

Authority shall, within a prescribed period from the grant of provisional

registration, cause to be published within period of 45 days, as may be

prescribed, all particulars of the clinical establishment so registered.

14.Validity of provisional registration :- Every provisional registration shall be

valid for a period of 6 months from the date of issue of the certificate of

provisional registration. Only in unavoidable/special circumstances it could be

extended up to 2 years.

15.Display of certificate of registration:- The certificate shall be affixed in a

conspicuous place in clinical establishment in such manner so as to be visible to

everyone visiting such establishment.

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16.Duplicate certificate- In case the certificate is lost, destroyed, mutilated or

damaged, the authority shall issue a duplicate certificate on the request of the

clinical establishment and on the payment of such fees as may be prescribed.

17. Permanent Registration - On expiry of the prescribed period the certificate of

permanent registration shall be issued as per procedure laid down in the rules

framed under this Act.

18.Certificate to be non-transferable -

(1)The certificate of registration shall be non-transferable.

(2)In the event of change of ownership or management, or change of category,

or location, or on withdrawing some facility provided, the clinical

establishment shall inform the authority of such change in such manner as may

be prescribed.

(3)In the event of ceasing to function as a clinical establishment, the certificate

in respect of such clinical establishment shall be surrendered to the authority

19.Publication of expiry of registration:- The Authority shall cause to be

published within such time and in such manner, as may be prescribed, the names

of clinical establishment whose registration has expired.

20.Extension of provisional registration:- The application for extension of

provisional registration shall be made thirty days before the expiry of the validity

of the certificate of provisional registration with prescribed fees. In case the

application for extension is made after the expiry of the provisional registration the

authority shall allow extension of registration on payment of such enhanced fees,

as may be prescribed.

21.Time limit for Provisional Registration:- Where the clinical establishment in

respect of which standards have been notified by the State Government provisional

registration shall not be granted or renewed beyond-

(i) the period of two years from the date of notification of the standards in case

of clinical establishment which came into existence before the commencement

of this Bill;

(ii) the period of two years from the date of notification of the standards for

clinical establishments which come into existence after the commencement of

this Bill but before the notification of the standards; and

(iii) the period of six months from the date of notification of standards for

clinical establishments which come into existence after standards have been

notified.

22.Application for permanent registration:- Application for permanent

registration by a clinical establishment shall be made to the authority in such form

and be accompanied by such fees, as may be prescribed.

23.Verification of application :- The clinical establishment shall submit evidence

of having complied with the prescribed minimum standards in such manner, as

may be prescribed.

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24.Display of information for filling objections:- As soon as the clinical

establishment submits the required evidence of having complied with the

prescribed minimum standards, the authority shall cause to be displayed for

information of the public at large and for filing objections, if any, in such manner,

as may be prescribed, all evidence submitted by the for clinical establishment of

having compiled with the prescribed minimum standards for a period of thirty days

before processing for grant of permanent registration.

25.Communication of objections :- If objections are received referred to in the

preceding section, such objections shall be communicated to the clinical

establishment for response within a period of forty-five days.

26.Standards for Permanent Registration:- Permanent registration shall be

granted only when a clinical establishment fulfils the prescribed standards for

registration by the State Government.

27.Allowing or disallowing of registration:- The authority shall pass an order

immediately after the expiry of the prescribed period and within the next 30 days

thereafter either:-

(a) allowing the application for permanent registration; or

(b) disallowing the application.

Provided that the authority shall record its reasons, if it disallows an

application, for permanent registration.

28.Certificate of permanent registration:-

(1) The authority shall, if it, allows an application of the clinical establishment,

issue a certificate of permanent registration in such form and containing such

particulars as may be prescribed.

(2) The certificate shall be valid for a period of 5 years the date of issue.

(3) The application for permanent registration shall be made within six months

before the expiry of the validity of the certificate of permanent and, in case

the application of renewal is not submitted within the stipulated period, the

authority may allow renewal of registration on payment of such enhanced

fees and penalties as may be prescribed.

29.Cancellation of registration and certificate

(1) If, at any time after any clinical establishment has been registered and the

registering authority on receiving a complaint and on getting such complaint

duly investigated in the manner prescribed, is satisfied,—

a. that the conditions of the registration are not being complied with; or

b. that any of the grounds which would have entitled the registering

authority to refuse the application for registration; or

c. that the person entrusted with the management of the clinical

establishment has violated any of the directions including

improvement notice of the registering authority; 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 there under,

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the registering authority, may issue a show cause notice as to why its

registration under this Act should not be cancelled for the reasons to

be mentioned in the notice, if clinical establishment has not complied

with the improvement notice contained in section 16.

(2) If after giving a reasonable opportunity of being heard to the clinical

establishment, the registering authority is satisfied that there has been a breach

of any of the provisions of this Act or the rules made there under, the authority

may, without prejudice to any other action that the authority may take against

such clinical establishment, cancel its registration.

30.Inspection of registered health care facility –

(1) Inspection would be mandatory before the issue of permanent registration

certificate.

(2)The registration authority or officers authorised by it shall have the right to

cause an inspection of, or inquiry in respect of any registered clinical

establishment, its building, laboratories and equipment and also of the work

conducted or done by the health care facility, to be made by such multimember

inspection team comprising of at least three members of high stature and

integrity, as may be prescribed and to cause an inquiry to be made in respect of

any other matter connected with the clinical establishment and that the clinical

establishment shall be entitled to be represented there at provided that such

enquiry can be conducted only after a complaint for breach of the declarations

or terms and conditions, is received by the authority making such an enquiry.

(3) (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.

Videography should be compulsory during inspection.

31.Improvement notices

(1) If the registration Authority has reasonable ground by way of the receipt of

any complaint, for believing that any clinical establishment has failed to

comply with any provision of this Act or the rules, the Authority 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 Act or 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

more than one month) as may be specified in the notice.

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32.Power to enter- The registration authority or officers authorised by it may, if

there is any reason to suspect that anyone is carrying on a clinical establishment

without registration, enter and search in the manner prescribed, 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 the approval letter from competent

authority.

33.Levy of fee by State Government:-

The State Government may charge fees for registration and licencing of clinical

establishments, as may be prescribed.

34.Appeal and revocation

(1)Any person, aggrieved by– (i) the failure of the registration authority in

communicating the allowing or rejection of application for registration to

clinical establishment within the prescribed period; or

(ii) an order of the registration authority refusing to allow registration or to

grant or renew of a registration certificate; or

(iii) cancelling or suspending a registration certificate; or

(iv) an improvement notice; or

(v) prohibition order;

(vi) or any other

may, prefer an appeal to State Council as prescribed under the rules .

(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 State Council 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)Cancellation of registration can be revoked by the State Council after

considering the appeal for same.

(4)The decision of the State Council shall be final and binding.

CHAPTER V

REGISTER OF CLINICAL ESTABLISHMENTS

35.Register of clinical establishments -

(1) The authority shall within a period of two years from its establishment,

compile, publish and maintain in digital format a register of clinical

establishments, registered by it and it shall enter the particulars of the

certificate so issued in a register to be maintained.

36.Maintenance of State Register of clinical establishments-

(1) The State Council shall maintain in digital and in such 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 of Punjab.

(2) The State Council on behalf of the State Government shall supply in digital

format to the Central Government, a copy of the State Register of clinical

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establishment and shall inform the Central Government all additions to and

other amendments in such register made, for a particular month by the 15th day

of the following month.

CHAPTER VI

PENALTIES

37.Penalty - Whosoever contravenes any provision of this Act shall, be punishable

for the first, second or any subsequent offence as prescribed under rules.

38.Monetary penalty for non-registration- (1)Whoever carries on a clinical

establishment without registration shall, on first contravention, be liable to a

monetary penalty up to 50 thousand rupees, for second contravention with a

monetary penalty which may extended to 2 lakh rupees and subsequent

contravention with a monetary penalty which may extended to 5 lakh rupees and

would also invite disciplinary action as prescribed.

(2) Whoever knowingly serves in a clinical establishment which is not duly

registeredunder this Act, shall be liable to a monetary penalty which may

extend to 25 thousand rupees for first contravention, 1 lakh rupees for second

contravention and 2.5 lakh rupees for third contravention.

(3) For the purpose of adjudging under sub-sections (1) and (2), the registering

authority shall hold an inquiry in the prescribed manner after giving any

person concerned a reasonable opportunity of being heard for the purpose of

imposing any monetary penalty.

(4) While holding an inquiry the registering authority shall have power to

summon and enforce the attendance of any person acquainted with the facts

and circumstances of the case to give evidence or to produce any document

which in the opinion of the authority, may be useful for or relevant to the

subject matter of the inquiry and if, on such inquiry, it is satisfied that the

person has failed to comply with the provisions specified in sub-sections (1)

and (2), it may by order impose the monetary penalty as prescribed to be

deposited within thirty days of the order in the account.

(5) While determining the quantum of monetary penalty, the registering

authority shall take into account the category, size and type of the clinical

establishment and local conditions of the area in which the clinical

establishment is situated, subject to the provisions of rules framed there under.

(6) Any person aggrieved by the decision of the registering authority may

prefer an appeal to the Competent Authority as provided under rules.

(7) The manner and levels of filing the appeal shall be such as may be

prescribed.

(8) Punjab Medical Council or the concerned Registering Council would be

informed the name of the doctor or healthcare person who has committed more

than 3 offences .

39.Disobedience of direction, obstruction and refusal of information:– (1)

Whoever wilfully disobeys any direction lawfully given registering authority or

by any person empowered under this Act to give such direction, or obstructs any

person or authority in the discharge of any functions which such person or

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authority is required or empowered under this Act to discharge, shall be liable to a

monetary penalty as prescribed under rules .

(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

monetary penalty as prescribed under rules.

(3) For the purpose of adjudging the registering authority shall hold an inquiry

in the prescribed manner after giving any person concerned a reasonable

opportunity of being heard for the purpose of imposing any monetary penalty.

(4) While holding an inquiry the registering authority shall have power to

summon and enforce the attendance of any person acquainted with the facts

and circumstances of the case to give evidence or to produce any document

which in the opinion of the authority, may be useful for or relevant to the

subject matter of the inquiry and if, on such inquiry, it is satisfied that the

person has failed to comply with the provisions specified in sub-sections (1)

and (2), it may by order impose the monetary penalty as specified under those

subsections to be deposited within thirty days of the order in the account.

(5) While determining the quantum of monetary penalty, the registering

authority shall take into account the category, size and type of the clinical

establishment and local conditions of the area in which the clinical

establishment is situated, subject to the provisions of rules framed there under.

(6) Any person aggrieved by the decision of the registering authority may

prefer an appeal to the Competent Authority as per provisions of the rules.

(7) The manner of filing the appeal referred to in subsection (6) shall be such as

may be prescribed.

(8) The monetary penalty levied under sections 22 and 23 shall be credited to

such account as the State Council may by order specify in this behalf.

40.Penalty for minor deficiencies- Whoever contravenes any provision of this

Act or any rule made there under resulting in deficiencies that do not pose

any imminent danger to the health and safety of any patient and can be rectified

within a reasonable time, shall be punishable and liable to a penalty as prescribed

i.e 10 thousand rupees for first contravention, 50 thousand rupees for second

contravention and 1 lakh rupees for third contravention.

41.Contravention by companies- (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 fine as prescribed Provided that nothing

contained in this sub-section shall render any such person liable to any

punishment 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

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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 fine as

prescribed.

Explanation.—For the purpose of this section,—

(a) "company" means a body corporate and includes a firm or other

association of individuals; and

(b) "director", in relation to a firm, means a partner in the firm.

42.Offences by Government Departments-

(1) Where an offence under this Act has been committed by any Department of

Government within a prescribed period after the commencement of this Act,

the concerned service provider employed or engaged by such Department of

Government shall be deemed to be guilty of the offence and shall be liable to

be proceeded against and punished accordingly.

Provided that nothing contained in this section shall render such service

provider liable to any punishment if he or she proves that the offence was

committed without his knowledge or that he exercised all due diligence to

prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where an offence

under this Act has been committed by a Department of Government and it is

proved that the offence has been committed by a service provider with the

consent or connivance of, or is attributable to any neglect on the part of any

officer, such officer shall also be deemed to be guilty of that offence and shall

be liable to be proceeded against and punished accordingly.

43.Recovery of fine -Whoever fails to pay any fine imposed by the State Council,

the State Council may prepare a certificate signed by an officer authorised by it

specifying the fine due from such person and send it to the Collector of the District

in which such person owns any property or resides or carries on his or her business

and the said Collector, on receipt of such certificate, shall proceed to recover

from such person the amount specified there under, as if it were an arrear of land

revenue.

44.Grievance redressal – (1) There shall be a grievance redressal mechanism as

prescribed, where any member of the public may file a complaint regarding non-

compliance with this Act.

(2) If any complaint filed against a clinical establishment is found to be fictitious,

the complainant shall be liable to a monetary penalty as prescribed under the rules.

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CHAPTER VII

MISCELLANEOUS

45.Protection of action taken in good faith. - (1) No suit,

prosecutionorotherlegalproceedingsshalllieagainstanyauthority or any Member of the

State Council or any officer authorised 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 madethereunder.

(2) No suit or other legal proceedings shall lie against any officer of 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.

46. Furnishing of returns, etc. - Every clinical establishment shall, within such time

or within such extended time, as may be prescribed in that behalf, furnish to the

Authority or the State Council, such returns or the statistics and other information in such

manner, as may be prescribed by the State Government, from time totime.

47.Power to give directions - Without prejudice to the foregoing provisions of this Act,

the 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 bebinding.

48. Employees of the Authority and State Council, to be public servants. -

EveryemployeeoftheAuthorityand the State Council 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 PenalCode.

49.Power to remove difficulties. - (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 thedifficulty:

Provided that no such order shall be made after the expiry of a period of two years from

the date of commencement of thisAct.

(2) Every order made under this section shall, as soon as may be after it is made, be

laid before the State Legislature.

50.Power of State Government to make rules -

(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

proforma and the fee to be paid for registration under sub-section (1) of section

10;

b)the form and details of application under subsection (3) of section 10;

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c)the particulars and information contained in certificate of provisional

registration under section 12;

d)the manner of publication of all particulars of the clinical establishments

proposed to be registered under sub-section (2) of section 13;

e)the fees to be paid for issuance of a duplicate certificate;

f)the change of ownership or management to be informed by the clinical

establishment to the Authority under sub-section (2) of section 18;

g)the manner in which the Authority shall publish the names of the clinical

establishment whose registration has expired;

h)the enhanced fees to be charged for renewal after expiry of the registration;

i)the manner of submitting evidence of the clinical establishments having

complied with the standards declared by the clinical establishment in the

registration application;

j)the manner of displaying information of the clinical establishments;

k)the expiry of period;

l)the form and particulars of the certificate of registration;

m)the period within which an appeal shall be preferred;

n)the circumstances manner of entry and search of clinical establishment;

o)the fees to be charged by the State Government or the State Council

fromclinical establishment;

p)the manner and the period within which an appeal may be preferred to the

State Council;

q)the form and the fee to be paid for an appeal;

r)the form and the manner in which the register is to be maintained;

s)the manner of holding an inquiry by any of the Authority;

t)the types and categories of clinical establishment ;

u)Provisions of emergency treatment by certain categories ofclinical

establishment , irrespective of charges not being paid.

v)norms for prescription of drugs.

w)any other matter which is required to be or may be prescribed by the State

Council.

51.Laying of rules - Rules made by the State Government under the

provisions of this Act shall be laid, as soon as may be after it is made, before

the House of the State Legislature.