PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1075

( 1075 )

Regd. No. NW/CH-22

Regd. No. CHD/0092/2018-2020

EXTRAORDINARY

Published by Authority

CHANDIGARH, FRIDAY, AUGUST 28, 2020

(BHADRA 6, 1942 SAKA)

PUNJAB VIDHAN SABHA SECRETARIAT

NOTIFICATION

The 28th August, 2020

No. 18-PLA-2020/62.- The Punjab Clinical Establishments (Registration

and Regulation) Bill, 2020 is hereby published for general information under

the proviso to rule 121 of the Rules of Procedure and Conduct of Business in

the Punjab Vidhan Sabha (Punjab Legislative Assembly):-

Bill No.18-PLA-2020

THE PUNJAB CLINICAL ESTABLISHMENTS (REGISTRATION

AND REGULATION) BILL, 2020

A

BILL

to provide for the registration and regulation of clinical establishments in

the State of Punjab and for matters connected therewith or incidental thereto.

BE it enacted by the Legislature of the State of Punjab in the Seventy-

first Year of the Republic of India as follows:-

CHAPTER I

PRELIMINARY

1.

(1)

This Act may be called the Punjab Clinical Establishments

(Registration and Regulation) Act, 2020.

Short title,

application

and

Commencement

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(2)

It shall apply to the entire State of Punjab.

(3)

It shall come into force on such date as the State Government may,

by notification, appoint:

Provided that different dates may be appointed for different

categories and capacities of clinical establishments and for different recognised

systems of medicine.

2.

In this Act, unless the context otherwise requires,—

(a)

“clinical establishment" means,-

(i)

a hospital, maternity home, nursing home, dispensary, clinic,

sanatorium or an institution, by whatever name called, that

offers services and facilities providing diagnosis, treatment

or care for illness, injury, deformity, abnormality or pregnancy

in any recognized 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 a

clinical 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 or not, 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 or private;

(c)

a corporation (including a society) registered under a

Central, Provincial or State Act, whether or not owned

by the Government;

(d)

a local authority; and

(e)

a single doctor,

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

Definitions.

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Act, 1950 and the Navy Act, 1957;

(b)

"District Register of Clinical Establishments" means the

register maintained by the concerned District Registration

Authority;

(c) "District Registration Authority" means the District

Registration Authority for Clinical Establishments established

under section 9 of this Act;

(d)

"notification" means a notification published in the Official

Gazette;

(e)

"prescribed" means prescribed by rules made under this Act;

(f)

“Punjab State Appellate Authority " means the Punjab State

Appellate Authority for Clinical Establishments established

under section 34 of this Act;

(g)

“Punjab State Council” means the Punjab State Council for

Clinical Establishments established under section 3 of this

Act;

(h)

“Punjab State Master Register” means the Punjab State

Master Register of Clinical Establishments maintained by the

Punjab State Council, and compiled and updated by the State

Registrar of Clinical Establishments on behalf of the said

Council;

(i)

“qualified medical practitioner” means a medical practitioner

registered in the State of Punjab with the statutory

State Council or the statutory National Council constituted

or established for the registration of medical practitioners in

any recognised system of medicine;

(j)

“qualified nurse” means a nurse registered in the State of

Punjab with the statutory State Council or the statutory

National Council constituted or established for the registration

of nurses;

(k)

“qualified para-medical person” means a person holding a

qualification recognised by the State Government from a

recognised institution wherein there is no statutory State or

National Council or body for the registration of such manpower;

(l)

"recognised system of medicine" means Allopathy, Yoga,

Naturopathy, Ayurveda, Homoeopathy, Siddha and Unani

System of medicines or any other system of medicine as

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may be recognised by the State Government;

(m) “registration” means registration of clinical establishments

under this Act by the State Registration Authority or the

concerned District Registration Authority, as the case may

be, and the expression registration or registered shall be

construed accordingly;

(n)

“service provider” means a qualified medical practitioner,

qualified nurse, qualified para-medical person, social worker

or other appropriately trained and qualified person with

specific skills relevant to particular health care services,

including the management of clinical establishment, and any

reference to service provider shall mean the same unless

specifically stated otherwise;

(o)

“service recipient” means a person who seeks, accesses or

receives any treatment or health care, as an outpatient or

inpatient, from any clinical establishment or service provider;

(p)

“standards” means such conditions, as the State Government

may prescribe for the registration and regulation of clinical

establishments;

(q)

“State Government” means the Government of the State of

Punjab in the Department of Health and Family Welfare;

(r)

“State Register of Clinical Establishments” means the register

maintained by the State Registration Authority; and

(s)

“State Registration Authority” means the State Registration

Authority for Clinical Establishments established under section

7 of this Act.

CHAPTER II

PUNJAB STATE COUNCIL FOR CLINICAL ESTABLISHMENTS

3.

(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 Punjab State Council to be called the Punjab State Council for

Clinical Establishments.

(2)

The Punjab State Council shall consist of the following, namely:-

(a)

Administrative Secretary, Department of Health : Chairperson

and Family Welfare, Punjab;

Establishment

of the Punjab

State Council.

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(b)

Director Health and Family Welfare, Punjab;

: Member-

Secretary

(c)

Director Health Services (Family Welfare),

: Member

Punjab;

(d)

Director Health Services (Social Insurance),

: Member

Punjab;

(e)

Directors of different recognised systems of

:Members

medicine of the State Government, including

but not limited to the Director, Ayurveda, Punjab

and the Head of Homoeopathic Department,

Punjab;

(f)

President of the Punjab Medical Council;

: Member

(g)

President of the Punjab Dental Council;

: Member

(h)

Registrar of the Punjab Nurses Registration

: Member

Council;

(i)

Registrar of the Punjab State Pharmacy

: Member

Council;

(j)

one representative to be elected by the

: Member

executive of the Board of Ayurvedic and

Unani Systems of Medicine, Punjab;

(k)

one representative of the State Branch of the

: Member

Indian Medical Association;

(l)

one representative from the field of

: Member

paramedical systems to be nominated by the

State Government;

(m) two representatives from amongst the State

: Members

level consumer groups or reputed Non

Governmental Organisations working in the

field of healthcare to be nominated

by the State Government; and

(n)

one Law Officer to be nominated by the

: Member

State Government.

(3)

The nominated and elected Members shall hold office for a term

of three years, but shall be eligible for re-nomination for a maximum of one

additional term not exceeding three years:

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Provided that the person so nominated or elected, as the case may

be, shall hold office for as long as he or she holds the appointment of the

office or the position by virtue of which he or she was nominated or elected to

the Council.

(4)

The Punjab State Council may, subject to the previous approval of

the State Government, make bye laws fixing a quorum and regulating its own

procedure and the conduct of business to be transacted by it.

(5)

The Punjab State Council shall meet at least once in three months.

(6)

The functions of the Punjab State Council may be exercised not

withstanding any vacancy therein.

4.

The Punjab State Council shall have the following functions and

powers, namely: –

(a)

maintain the Punjab State Master Register;

(b)

sending monthly returns for updating the National Register

as may be required by the Central Government or the National

Council established under the Clinical Establishments

(Registration and Regulation) Act, 2010 (Central Act No. 23

of 2010);

(c)

representing the State of Punjab in the National Council as

may be required by the Central Government or the National

Council established under the Clinical Establishments

(Registration and Regulation) Act, 2010 (Central Act No. 23

of 2010);

(d)

publication, on an annual basis, of report regarding the status

of implementation of this Act;

(e)

constituting any Committee to perform any of its roles and

functions;

(f)

issuing such directions, including furnishing returns, statistics

and other information for the proper functioning of clinical

establishments, and any such directions, as may be issued

from time to time, shall be binding;

(g)

associating with itself, any person or body whose assistance

or advice it may require in carrying out its functions under

any of the provisions of this Act; and

(h)

any other functions, as may be determined by the State

Government, from time to time.

Functions and

powers of the

Punjab State

Council.

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5.

A person shall be disqualified from being appointed as a Member of the

Punjab State Council, if, he,-

(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 any other statutory body of the Government;

or

(e)

has, in the opinion of the State Government, such financial or

other interest in the Punjab State Council as is likely to affect

prejudicially the discharge by him of his functions or duties as

a Member.

CHAPTER III

REGISTRATION AND STANDARDS FOR CLINICAL

ESTABLISHMENTS

6.

(1)

The Director Health and Family Welfare, Punjab shall be the State

Registrar of Clinical Establishments.

(2)

It shall be the responsibility of the State Registrar of Clinical

Establishments to compile and update the Punjab State Master Register on

behalf of the Punjab State Council.

7.

(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 State Registration Authority to be called the State Registration

Authority for Clinical Establishments.

(2)

The State Registration Authority shall consist of the following,

namely: –

(i)

Director, Health and Family Welfare,

: Chairperson

Punjab;

(ii)

one Deputy Director, office of Director, : Member

Health and Family Welfare, Punjab to be

nominated by the State Government;

Disqualification

of a Member of

the Punjab State

Council.

State Registrar

of Clinical

Establishments.

State

Registration

Authority.

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(iii)

one Law Officer to be nominated by the : Member

State Government; and

(iv)

Nodal Officer in the office of Director

: Member

Health and Family Welfare, Punjab,

for this Act.

8.

The State Registration Authority shall perform the following

functions, namely:-

(i)

registration of clinical establishments with one hundred or

more beds;

(ii)

publish, in a manner, as may be prescribed,-

(a)

a list of provisionally registered clinical establishments

with one hundred or more beds;

(b)

a list of clinical establishments, with one hundred or more

beds, who submit evidence for permanent registration;

and

(c)

a list of expired registrations;

(iii)

enter and search unregistered clinical establishments with one

hundred or more beds after due notice, as may be prescribed;

(iv)

inspection and inquiry of the registered clinical establishments

with one hundred or more beds through a multi-member

inspection team in such manner, as may be prescribed;

(v)

recover penalties;

(vi)

compile and maintain the State Register of Clinical

Establishments;

(vii) establish a Grievance Redressal Cell for any grievances

or complaints related to the clinical establishments with one

hundred or more beds, in such manner, as may be prescribed;

(viii) any other work related to the registration of clinical

establishments with one hundred or more beds; and

(ix)

such other functions, as may be determined by the State

Government from time to time.

9.

(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 District Registration Authority for each district to be called the

District Registration Authority for Clinical Establishments.

Functions of the

State Registra-

tion Authority.

District

Registration

Authority.

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(2)

Each District Registration Authority shall consist of the following,

namely:–

(i)

Civil Surgeon of the respective district;

: Chairperson

(ii)

District Family Welfare Officer of the

: Member

respective district;

(iii)

one representative of the District Attorney

: Member

of the respective district; and

(iv)

District Nodal Officer in the office of Civil

: Member

Surgeon of the respective district, for this

Ordinance.

10.

Each District Registration Authority shall perform the following functions,

namely:-

(i)

registration of all clinical establishments of the respective

district, except the clinical establishments having one hundred

or more beds;

(ii)

publish, in a manner, as may be prescribed,-

(a)

a list of clinical establishments registered by it

provisionally;

(b)

a list of clinical establishments, who submit evidence

for permanent registration; and

(c)

a list of expired registrations;

(iii)

enter and search any unregistered clinical establishment of

the respective district, except the clinical establishment having

one hundred or more beds after due notice, as may be

prescribed;

(iv)

inspection and inquiry of the clinical establishments registered

under it through a multi-member inspection team in such

manner, as may be prescribed;

(v)

recover penalties;

(vi)

compile and maintain the District Register of Clinical

Establishments of the respective District;

(vii) establish a Grievance Redressal Cell in the respective district

for any grievances or complaints related to the clinical

establishments, in such manner, as may be prescribed;

Functions of

the District

Registration

Authority.

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(viii) any other work related to the registration of clinical

establishments to be registered by it; and

(ix)

such other functions, as may be determined by the State

Government from time to time.

11.

No person shall keep or carry on a clinical establishment without being

duly registered by the concerned registration authority in respect thereof and

except under and in accordance with the terms of registration granted thereof.

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 any 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 service including consultation, treatment, diagnosis,

or nursing care.

12.

(1) Clinical establishments shall be classified into such categories, as

may be prescribed from time to time.

(2)

Different standards may be prescribed for various categories of

clinical establishments.

13.

(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 concerned registration authority for the purposes

of registration in respect of a clinical establishment. The concerned registration

authority shall make provisions for submission of applications also and

registration thereto.

(2)

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

particulars and be accompanied by such declarations and documents of the

clinical establishment and the standards of services and skills being provided

by it, as may be prescribed.

(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 concerned registration authority not later than

thirty days after such change with a 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.

Registration

certificates for

clinical estab-

lishments.

Application for

provisional

certificate of

registration.

Classification of

clinical estab-

lish-ments.

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14.

The concerned registration authority shall, within a period of thirty

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.

15.

(1)

The concerned registration authority shall not conduct any inquiry

prior to the grant of provisional registration.

(2)

Notwithstanding the grant of the provisional certificate of

registration, the concerned registration authority shall, within the prescribed

period from the grant of provisional registration, cause to be published in such

manner, as may be prescribed, all particulars of the clinical establishment so

registered provisionally.

16.

Subject to the provisions of section 18, every provisional registration

shall be valid for a period of six months from the date of issue of the certificate

of provisional registration.

17.

(1)

Only in unavoidable or special circumstances, the provisional

registration may be extended for such period, in such manner and subject to

the payment of such fees, as may be prescribed.

(2)

The application for extension of provisional registration shall be

made thirty days before the expiry of the validity of the certificate of provisional

registration and in case the application for extension is made after the expiry

of the provisional registration, the concerned registration authority shall allow

the extension of provisional registration upon the payment of such enhanced

fees, as may be prescribed.

18.

Where the categories of clinical establishments in respect of which

standards have been notified by the State Government, provisional registration

shall not be granted or extended beyond,-

(i)

the period of two years from the date of notification of the

standards in case of clinical establishments which came into

existence before the commencement of this Act;

(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 Act but before the notification

of the standards; and

(iii)

the period of six months from the date of notification of

standards for clinical establishments which come into existence

after the standards have been notified.

Provisional

certificate.

Extension of

provisional

registration.

Validity of

provisional

registration.

Time limit for

Provisional

registration.

No inquiry

prior to grant

of provisional

registration.

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19.

Application for permanent registration by a clinical establishment

shall be made to the concerned registration authority in such form and be

accompanied by such fees, as may be prescribed.

20.

The clinical establishment shall submit evidence of having complied

with the prescribed minimum standards in such manner, as may be prescribed.

21.

(1)

No permanent registration shall be granted in respect of a clinical

establishment, unless it has, -

(a)

provided such minimum standards of accommodation, as may

be prescribed;

(b)

engaged such minimum number of service providers and other

categories of employees with such qualification(s), as may

be prescribed;

(c)

made arrangements for such minimum standards of facilities

and services including emergency care and referral services,

as may be prescribed;

(d)

installed such equipment and machineries, as may be

prescribed;

(e)

made such arrangements for the disposal of Bio-Medical

Waste as prescribed under the Bio-Medical Waste

Management Rules, 2016 made by the Government of India,

Ministry of Environment, Forest and Climate Change;

(f)

made provisions for the maintenance of such records and

registers in such form and containing such particulars, as may

be prescribed; and

(g)

fulfilled such other condition(s), as may be prescribed.

(2)

Every registration granted under sub-section (1) shall be subject to

the following terms and conditions, namely:-

(a)

conditions laid down in sub-section (1) are continuously

complied with;

(b)

necessary precautions are observed so as to ensure that the

clinical establishment is not being used for any unsocial or

immoral purpose;

(c)

the clinical establishment does not resort to any unethical

practice whatsoever;

(d)

all such measures are taken to keep the clinical establishment

in such satisfactory, sanitary and hygienic condition, as may

be prescribed;

Application

for premanent

registration.

Verification of

application.

Conditions for

premanent

registration.

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(e)

all such information is displayed in such manner, as may be

prescribed;

(f)

all such reports in such form containing such particulars and

such necessary documents are submitted to such authorities

at such intervals or on demand, as may be prescribed;

(g)

such medical and other reports, records and documents are

made available to the registration authority or the service

recipient or his representative on demand, as may be

prescribed;

(h)

a report is submitted to the concerned authority immediately

in case a person, who has been received in 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 have been notified by the State Government,

especially those covered under the Epidemic Diseases Act,

1897;

(i)

every clinical establishment maintains a Public Grievance

Redressal Mechanism for lodging of any complaint regarding

treatment, improper billing, deficiency in service, attending

staff's behaviour etc. and for timely assured redressal thereof;

(j)

every clinical establishment sets up a proper Help Desk to

maintain regular and proper communication with the service

recipients or their representatives regarding treatment being

provided, recipient’s condition, regular billing etc. and their

proper counseling;

(k)

every clinical establishment immediately after coming into

force of this Act, maintains comprehensive medical records

and provides a set of all medical records and treatment details

along with the discharge summary at the time of discharge of

the service recipient;

(l)

every clinical establishment having more than one hundred

beds may endeavour to set up a Fair Price Medicine Shop

and a Fair Price Diagnostic Centre;

(m) no person is 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/gender, physical or mental disability,

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occupation, religion, sect, language, caste, political or other

opinion or affiliation, actual or perceived health status and

disease condition like Human Immunodeficiency Virus (HIV)

infection or Acquired Immunodeficiency Syndrome (AIDS)

or such other diseases like Covid-19 and other emerging and

as yet unknown infectious diseases, as may be prescribed, or

such other arbitrary grounds;

(n)

the clinical establishment actively participates in the

implementation of all National and State Health Programmes

including the prevention of spread of communicable diseases

in such manner as the State Government may specify from

time to time and furnish periodical reports related thereto as

per prescribed formats to the authorities concerned;

(o)

the clinical establishment at all times, ensures compliance

with all the applicable laws including any rules, regulations,

instructions, guidelines, notifications, circulars and by-laws;

(p)

the clinical establishment provides treatment within the staff

and facilities available, to provide first aid to all the victims of

road traffic accidents, rail accidents, air accidents, explosions,

natural disasters and calamities who come or are brought to

the clinical establishment. After providing the first aid and

making all possible available efforts to stabilize such patients,

the clinical establishment shall be at liberty to refer them to

an appropriate Government hospital or medical college; and

(q)

such other terms and conditions, as may be prescribed.

22.

Permanent registration shall be granted only when a clinical

establishment fulfils the prescribed standards for registration by the State

Government.

23.

The concerned registration authority shall pass an order immediately

after the expiry of the prescribed period and within the next thirty days thereafter

either:-

(a)

allowing the application for permanent registration; or

(b)

disallowing the application:

Provided that the concerned registration authority shall record

its reasons in writing, if it disallows an application for permanent

registration.

Standards for

permanent

registration.

Allowing or

disallowing

of registra-

tion.

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24.

(1)

The concerned registration 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 five years from the

date of issue.

(3)

The application for renewal of permanent registration shall be made

within three months before the expiry of the validity of the certificate of

permanent registration in such form and alongwith such fees, as may be

prescribed.

(4)

In case the application of renewal referred in sub-section (3) is not

submitted within the stipulated period, the concerned registration authority

may allow renewal of permanent registration on payment of such enhanced

fees and penalties, as may be prescribed.

25.

The certificate of provisional or permanent registration shall be

affixed in a conspicuous place in the clinical establishment in such manner so

as to be visible to everyone visiting such establishment.

26.

In case the certificate of provisional or permanent registration is

lost, destroyed, mutilated or damaged, the concerned registration authority

shall issue a duplicate certificate on the request of the clinical establishment

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

27.

(1)

The certificate of provisional or permanent registration shall be

non-transferable.

(2)

In the event of change of ownership or management, or change of

category, or location, or upon the withdrawal or addition of some facility

provided, the clinical establishment shall inform the concerned registration

authority of such change in such manner, as may be prescribed and such

clinical establishment shall apply afresh for the grant of certificate of registration

alongwith such fees, as may be prescribed.

(3)

In the event of ceasing to function as a clinical establishment, the

certificate of registration in respect of such clinical establishment shall be

surrendered to the concerned registration authority.

28.

The concerned registration authority shall cause to be published

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

clinical establishments whose registration has expired.

29.

(1)

If, at any time after any clinical establishment has been registered

and the concerned registration authority on receiving a complaint and on getting

such complaint duly investigated in the manner prescribed, is satisfied,—

Certificate of

permanent

registration and

its renewal.

Duplicate

certificate.

Display of

certificate of

registration.

Certficate to

be non-

transferable.

Publication of

expiry of

registration.

Cancellation

or Suspen-

sion of

registration.

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1090

(a)

that the conditions of the registration are not being complied

with; or

(b)

that there exists any of the grounds which would have entitled

the concerned registration 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 any

notice of improvement from the concerned registration

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 thereunder; or

(e)

that the clinical establishment has not complied with the

improvement notice issued under section 31 of this Act,

the concerned registration authority, may issue a show cause notice as to why

its registration under this Act should not be cancelled or suspended for the

reasons to be mentioned in the notice.

(2)

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

establishment, the concerned registration authority is satisfied that there has

been a breach of any of the provisions of this Act or the rules made thereunder,

it may, by an order, without prejudice to any other action that it may take

against such clinical establishment, cancel or suspend its registration.

30.

(1)

Inspection by the concerned registration authority or a multi-member

inspection team referred to in sub-section (2) shall be mandatory before the

issuance of certificate of permanent registration.

(2)

The concerned registration authority or a multi-member inspection

team authorised by it, which shall comprise of at least three members of

impeccable integrity, 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 clinical

establishment, in such manner as may be prescribed and to cause an inquiry to

be made in respect of any other matter connected with the clinical establishment

and such clinical establishment shall be entitled to be represented thereat:

Provided that such inquiry can be conducted only after a complaint for

breach of the declarations or terms and conditions, is received by the concerned

registration authority.

(3)

Every inspection team authorized under this section shall conduct

Inspection of

clincal estab-

lishment.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

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1091

the inspection and submit a report to the concerned registration authority within

seven days of completion of such inspection in such manner, as may be

prescribed.

(4)

The inspection team conducting the inspection shall record its

observation or inspection note in the inspection book to be kept at the clinical

establishment for this purpose.

31.

If the concerned 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 made thereunder,

the concerned registration authority may, after ascertaining the opinion of the

concerned clinical establishment thereon, by an improvement notice served

on that clinical establishment,-

(a)

state the grounds for believing that the clinical establishment

has failed to comply with any provision of this Act or the

rules made thereunder;

(b)

specify the matters which constitute the clinical

establishment’s failure to comply;

(c)

specify the measures which, in the opinion of the concerned

registration authority, the clinical establishment must take, in

order to ensure 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.

32.

(1)

If,-

(a)

any clinical establishment is convicted of an offence under

this Act; or

(b) the clinical establishment is being kept or carried on without a

valid certificate of registration; or

(c) the registration of the clinical establishment is cancelled or

suspended; or

(d)

the concerned registration authority is satisfied that an

imminent danger to the health and safety of any member of

the public or patient exists with respect to that clinical

establishment,

Prohibition

order.

Improvement

notice.

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1092

the concerned registration authority may, after giving such 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;

and/or

(ii)

a prohibition on the use of the premises or equipment for the

purposes of the service delivery by the clinical establishment.

(2) Every order made under sub-section (1) shall take immediate effect:

Provided that the concerned registration authority, after issuance

of prohibition order shall take such steps, to restrain immediately the clinical

establishment from carrying on health care related services, as may be

prescribed.

33.

The concerned registration authority or such officers as may be

authorised by it, may, if there is any reason to suspect that anyone is carrying

on a clinical establishment without due 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

an authority letter from the concerned registration authority.

CHAPTER IV

PUNJAB STATE APPELLATE AUTHORITY

34.

(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, the Punjab State Appellate Authority to be called the Punjab State

Appellate Authority for Clinical Establishments.

(2)

The Punjab State Appellate Authority shall consist of the following,

namely:-

(i)

Administrative Secretary, Department of

: Chairperson

Health and Family Welfare, Punjab;

(ii)

Director Health Services (Family Welfare), : Member

Punjab; and

(iii)

one Law Officer to be nominated by the

: Member

State Government.

Power to enter.

Punjab State

Appellate

Authority.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1093

35.

The Punjab State Appellate Authority shall,-

(i)

be the appellate authority to hear appeals against the orders

of the State Registration Authority and the District Registration

Authority; and

(ii)

perform such other functions, as may be determined by the

State Government.

36.

(1)

Any person, aggrieved by,–

(i)

the failure of the concerned registration authority in

communicating the allowing or disallowing of an application

for registration to a clinical establishment within the prescribed

period; or

(ii)

an order of the concerned registration authority refusing to

allow registration or extend or renew a registration certificate;

or

(iii)

an order of cancellation or suspension of a registration

certificate; or

(iv)

an improvement notice; or

(v)

prohibition order;

(vi)

or any other order of the concerned registration authority,

may, prefer an appeal to the Punjab State Appellate Authority.

(2)

Every appeal under sub-section (1) shall be made in such manner,

in such form, within such period and shall be accompanied by such fee, as

may be prescribed:

Provided that the Punjab State Appellate Authority may entertain

an appeal referred to in sub-section (1) 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 may be revoked by the Punjab State

Appellate Authority after considering the appeal.

(4)

The decision of the Punjab State Appellate Authority shall be final

and binding.

CHAPTER V

REGISTERS OF CLINICAL ESTABLISHMENTS

37.

(1)

The concerned District Registration Authority shall maintain in such

form and containing such particulars, as may be prescribed, a register to be

known as the District Register of Clinical Establishments in respect of all the

Functions of

Punjab State

Appellate

Authority.

Appeal and

revocation.

District Register

of Clinical

Establishments.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1094

clinical establishments of that District, except the clinical establishments having

one hundred or more beds.

(2)

The concerned District Registration 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 enter the

particulars of the certificates so issued in a register to be maintained for such

purpose.

38.

(1)

The State Registration Authority shall maintain in such form and

containing such particulars, as may be prescribed, a register to be known as

the State Register of Clinical Establishments in respect of the clinical

establishments having one hundred or more beds.

(2)

The State Registration 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 enter the particulars of the

certificates so issued in a register to be maintained for such purpose.

39.

(1)

The Punjab State Council shall maintain in such form and containing

such particulars, as may be prescribed, a register to be known as the Punjab

State Master Register of Clinical Establishments in respect of all the clinical

establishments registered in the State of Punjab.

(2)

It shall be the responsibility of the State Registrar of Clinical

Establishments to compile and update the Punjab State Master Register on

behalf of the Punjab State Council.

(3)

The Punjab State Master Register would be subsequently digitized

within two years.

(4)

The Punjab State Council on behalf of the State Government shall

supply to the Central Government, a copy of the Punjab State Master Register

and inform the Central Government of all additions to and other amendments

in the said register, for a particular month by the 15thday of the following

month.

CHAPTER VI

PENALTIES

40.

Whosoever contravenes any provision of this Act shall, if no penalty

is provided elsewhere, be punishable in accordance with the rules made under

this Act.

State Register of

Clinical

Establishments.

Punjab State

Master Register..

Penalty.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

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1095

41.

(1)

Whosoever carries on a clinical establishment without registration

shall, on first contravention, be liable to a monetary penalty which may extend

to fifty thousand rupees, for second contravention with a monetary penalty

which may extend to two lakh rupees and for any subsequent contravention

with a monetary penalty which may extend to five lakh rupees and may also

invite disciplinary action, as may be prescribed.

(2) Whosoever knowingly serves in a clinical establishment which is

not duly registered under this Act shall, on first contravention, be liable to a

monetary penalty which may extend to twenty-five thousand rupees, for

second contravention with a monetary penalty which may extend to one lakh

rupees and for any subsequent contravention with a monetary penalty which

may extend to two lakh and fifty thousand rupees.

(3)

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

concerned registration authority shall hold an inquiry in the prescribed manner

after giving the person concerned a reasonable opportunity of being heard

for the purpose of imposing any monetary penalty.

(4)

While holding an inquiry, the concerned registration authority shall

have the 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 concerned registration authority, may be

useful for or relevant to the subject matter of the inquiry and if, upon 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 in the said sub-sections to be deposited within thirty days of the

order in the account referred to in sub-section (8) of section 42.

(5)

While determining the quantum of monetary penalty, the

concerned registration 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.

(6)

Any person aggrieved by the decision of the concerned registration

authority may prefer an appeal to the Punjab State Appellate Authority within

such period, as may be prescribed.

(7)

The manner of filing the appeal referred to in sub-section (6) shall

be such, as may be prescribed.

(8)

The Punjab Medical Council or the concerned Registration Council

or body shall be informed about the name of the doctor or service provider

who has committed more than three offences.

Monetary

penalty for non-

registration.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

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42.

(1)

Whosoever wilfully disobeys any direction lawfully issued by the

concerned registration authority or by any person empowered under this Act

to give such direction, or obstructs any person or authority in the discharge of

any duty or functions which such person or authority is required or empowered

under this Act to discharge, shall be liable to such monetary penalty, as may

be prescribed.

(2)

Whosoever being required by or under this Act to supply any

information, wilfully withholds such information or wilfully provides such

information which he knows to be false or which he does not believe to be

true, shall be liable to such monetary penalty, as may be prescribed.

(3)

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

concerned registration authority shall hold an inquiry in the prescribed manner

after giving the concerned person a reasonable opportunity of being heard for

the purpose of imposing any monetary penalty.

(4)

While holding an inquiry, the concerned registration authority shall

have the 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 concerned registration 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 referred to in the said sub-sections to be deposited within

thirty days of the order in the account referred to in sub-section (8).

(5)

While determining the quantum of monetary penalty, the concerned

registration 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.

(6)

Any person aggrieved by the decision of the concerned registration

authority may prefer an appeal to the Punjab State Appellate Authority within

such period, as may be prescribed.

(7)

The manner of filing the appeal referred to in sub-section (6) shall

be such, as may be prescribed.

(8)

All monetary penalties levied under this Act shall be credited to

such account as the State Government may by order specify in this regard.

43.

Whosoever contravenes any provision of this Act or any rule

made thereunder resulting in deficiencies that do not pose any imminent

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

Disobedience of

direction,

obstruction and

refusal of

information.

Penalty for

minor deficien-

cies.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1097

reasonable time, shall be liable for such punishment, as may be prescribed

alongwith monetary penalty which may extend upto ten thousand rupees for

first contravention, upto fifty thousand rupees for second contravention and

upto one lakh rupees for any subsequent contravention.

44.

(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 itself, shall be deemed to be guilty of such contravention

and shall be liable to pay such monetary penalty, as may be 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 thereunder

has been committed by a company and it is proved that such 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 such contravention and shall be liable to pay such

monetary penalty, as may be 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.

45.

(1)

Where an offence under this Act has been committed by any

Department of Punjab Government within such period, as may be prescribed

after the commencement of this Act, the concerned service provider employed

or engaged by such Department shall be deemed to be guilty of such offence

and shall be liable to be proceeded against and punished according to the

provisions of this Act and the rules made thereunder:

Provided that nothing contained in this section shall render such

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

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

prevent the commission of such offence.

Contravention

by companies.

Offences by

Government

Departments.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1098

(2)

Notwithstanding anything contained in sub-section (1), whereby

an offence under this Act has been committed by a Department of Punjab

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 according to

the provisions of this Act and the rules made thereunder.

46.

Whosoever fails to pay any fine, the Punjab State Council may

prepare a certificate signed by an officer duly authorised by it specifying the

amount of 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

business and the said Collector, upon receipt of such certificate, shall proceed

to recover from such person the amount specified thereunder, as if it were an

arrear of land revenue.

47.

There shall be such grievance redressal mechanism, as may be

prescribed, whereby any member of the public may file a complaint regarding

non-compliance with any provision of this Act.

CHAPTER VII

MISCELLANEOUS

48.

(1)

No suit, prosecution or other legal proceedings shall lie against

any authority or any Member of the Punjab State Council or any officer duly

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 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.

49.

Every clinical establishment shall, within such time or within such

extended time, as may be prescribed in that behalf, furnish to the concerned

registration authority or the Punjab State Council, such returns or the statistical

and other information in such manner, as may be prescribed.

50.

Without prejudice to the foregoing provisions of this Act, the Punjab

State Council shall have the power to issue such directions, including furnishing

returns, statistical and other information for the proper functioning of clinical

establishments and such directions shall be binding.

Recovery of

fine.

Grievance

redressal.

Protection of

action taken in

good faith.

Furnishing of

returns etc.

Power to give

directions.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

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1099

51.

The employees of the registration authorities, the Punjab State

Council and the Punjab State Appellate Authority shall be deemed to, when

acting or purporting to act in pursuance of any of the provisions of this Act, be

public servants as per the provisions of section 21 of the Indian Penal Code.

52.

(1)

If any difficulty arises in giving effect to the provisions of this Act,

the State Government may, by order so 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 may be after

it is made, be laid before the State Legislature.

53.

(1)

The State Government may, by notification in the Official Gazette,

make rules for carrying out the purposes of this Act.

(2)

Every rule made under this section, shall be laid, as soon as may

be, after it is made, before the House of the State Legislature while it is in

session for a total period of ten days, which may be comprised in one session

or in two or more successive sessions and if, before the expiry of the session

in which it is so laid or the successive sessions as aforesaid, the House agrees

in making any modification in the rule or the House agrees that the rule should

not be made, the rule shall thereafter, have effect only in such modified form

or be of no effect, as the case may be. However, any such modification or

annulment shall be without prejudice to the validity of anything previously

done or omitted to be done under that rule.

54.

(1)

The Punjab Clinical Establishments (Registration and Regulation)

Ordinance, 2020 (Punjab Ordinance No. 2 of 2020), is hereby repealed.

(2)

Notwithstanding such repeal, anything done or any action taken

under the Ordinance referred to in sub-section (1), shall be deemed to have

been done or taken under the corresponding provisions of this Act.

Employees of

the registration

authorities etc.,

to be public

servants.

Power to

remove

difficulties.

Power of State

Government to

make rules.

Repeal and

saving.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1100

STATEMENT OF OBJECTS AND REASONS

Providing quality healthcare to the people by the clinical

establishments of both the public and private sectors is among the top priority

of the State Government and assumes more importance in the present emergent

situation arising due to the COVID 19. There was no comprehensive Act

enacted in the State of Punjab to Register & Regulate the Clinical

Establishments and to prescribe minimum standards of facilities and services

to be provided by the clinical establishments. Hence Government of Punjab

Promulgated an Ordinance namely the Punjab Clinical Establishments

(Registration & Regulation) Ordinance 2020.

The Punjab Clinical Establishments (Registration & Regulation)

Ordinance 2020 aims to bring the clinical establishments under a regulatory

mechanism so as to ensure that there is more transparency in their functioning,

check patients disadvantage, to categorise and classify the clinical

establishments, lay down various norms and standards of the facilities and

services, staff norms, record maintenance, reporting etc & supporting the

state during times of natural disasters, calamities & wide spread pandemics &

epidemics. So there is need to present the Punjab Clinical Establishments

(Registration and Regulation) Bill, 2020 in the Punjab Vidhan Sabha Session

to replace the Ordinance.

Hence, the Punjab Clinical Establishments (Registration and

Regulation) Bill, 2020.

BALBIR SINGH SIDHU,

Health and Family Welfare Minister,

Punjab.

PUNJAB GOVT. GAZ. (EXTRA), AUGUST 28, 2020

(BHDR 6, 1942 SAKA)

1101

FINANCIAL MEMORANDUM

The proposed Act is going to be first of its kind in the State. It is

difficult to make an estimate of expected revenue and expenditure. However,

the financial receipts under this proposed act would be from registration fees,

fees for issue of duplicate certificates, penalties and there shall be no other

financial implication.

______________

MEMORANDUM REGARDING DELEGATED LEGISLATION

Section 53 of Punjab Clinical Establishments (Registration &

Regulation) Bill 2020 empowers the State Government to make rules to carry

out the purposes of this Act. The powers sought are necessary for the proper

implementation of the Act and are normal in nature.

______________

The Governor has, in pursuance of clause (1) and (3) of Article

207 of the Constitution of India, recommended to the Punjab Legislative

Assembly, the introduction and consideration of the Bill.

______________

CHANDIGARH

SHASHI LAKHANPAL MISHRA,

THE 28th AUGUST, 2020

SECRETARY.

2091/8-2020/Pb. Govt. Press, S.A.S. Nagar