Home=20 > India=20 > Food,=20 Drugs, Healthcare, Life Sciences

India: An Overview Of The Clinical = Establishments=20 (Registration And Regulation) Act, 2010

Last Updated: 25 = November=20 2015

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Introduction

The Clinical Establishments (Registration and Regulation) Act, 2010 = ("Act")=20 has been enacted by the Central Government to provide for registration = and=20 regulation of all clinical establishments in the country with a view to=20 prescribing the minimum standards of facilities and services provided by = them.

As per a report submitted by the Government of India, planning = commission=20 namely "Clinical Establishments, Professional Services Regulation and=20 Accreditation of Health Care Infrastructure" for the 11th Five-Year=20 Plan,¹ Health regulation in India encompasses a variety of = factors=20 and issues. These include promulgation of legislation for health = facilities=20 & services, disease control & medical care, human power = (Education,=20 Licensing & Professional Responsibility), Ethics and Patients = Rights,=20 Pharmaceuticals & Medical Devices, Radiation Protection, Poisons = &=20 Hazardous Substances, Occupational Health and Accident Prevention, = Elderly,=20 Disabled & Rehabilitation Family, Women and child Health, Mental = Health,=20 Smoking/Tobacco Control, Social Security & Health Insurance, = Environmental=20 Protection, Nutrition. Hence, the report highlighted for the need for a = central=20 legislation for registration of clinical establishments in the country = and=20 uniform standards need to be developed for the entire country.

Objective of the Act

The Act makes it mandatory for registration of all clinical = establishments,=20 including diagnostic centres and single-doctor clinics across all = recognized=20 systems of medicine both in the public and private sector except those = run by=20 the defence forces. The registering authority facilitates policy = formulation,=20 resource allocation and determines standards of treatment. It can impose = fines=20 for non-compliance of the provision of the Act. The Act lays down = Standard=20 Treatment Guidelines for common disease conditions, for which a core = committee=20 of experts has been formed. Further, the Act makes all clinical = establishments=20 to provide medical care and treatment necessary to stabilize any = individual who=20 comes or is brought to the clinical establishment in an emergency = medical=20 condition, particularly women who come for deliveries and accident = cases.

Implementation of the Act

Vide the notification dated 28 January, 2010 the Act came into force = in four=20 states of India, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, = Sikkim and=20 all Union Territories. Later, Uttar Pradesh, Rajasthan and Jharkhand = have=20 adopted the Act under clause (1) of article 252 of the Constitution. In = 2013,=20 the State of Maharashtra planed a multi-stakeholder committee to = formulate the=20 Maharashtra Clinical Establishment Act to an important step towards=20 standardization of quality and costs in the private medical sector. = Further, the=20 Kerala Clinical Establishments (Registration, Accreditation and = Regulation)=20 Bill, 2009 is awaiting a go-ahead from the Government to be = enforced.

An overview of the Clinical Establishments (Registration and = Regulation)=20 Act

Article 47 of the Constitution lays down a responsibility upon the = State for=20 aiming at improvement in public health and shall consider this = responsibility as=20 among its primary duties in particular, the State shall endeavour to = bring about=20 prohibition of the consumption except for medicinal purposes of = intoxicating=20 drinks and of drugs which are injurious to health.

Hence, with the objective to strive at fulfill this responsibility, = the=20 Government of India enacted the Act with the objective to provide for = the=20 registration and regulation of clinical establishments in India and for = matters=20 connected therewith or incidental thereto.

The Act defines "Clinical Establishment" and bring under the ambit of = clinical establishment all hospitals, maternity home, nursing home, = dispensary,=20 clinic, etc or an institution by whatever name called that offers = services,=20 facilities requiring diagnosis, treatment or care for illness, injury, = etc or a=20 place establishmed as an independent entity pr part of an establishment = in=20 connection with the diagnosis or treatment of certain diseases. It also = includes=20 a clinical establishment which is owned, controlled and managed by = government or=20 a department of the Government, a trust, a corporation registered under = a=20 Central, Provincial or State Act, a local authority and a single = doctor.

The National Council for Clinical Establishment

The Act lays down establishment for the a Council Body called The = National=20 Council for Clinical Establishment which is responsible primarily for = setting up=20 standards for ensuring proper healthcare by the clinical establishment = and=20 develop the minimum standards and their periodic review.

Clinical Establishments and procedure for registration of the = Clinical=20 Establishment

Section 11 of the Act mandates that no person shall run a clinical=20 establishment unless it has been duly registered in accordance with the=20 provisions of the Act.

In September 2014, the Government of India, the Ministry of Health = and Family=20 Welfare² issued the Application format for Permanent = Registration of=20 Clinical Establishments which requires the applicant to provide = information such=20 as, among others, establishment details, types of service, system of = medicine,=20 etc.

Minimum Standards to be followed by Clinical Establishments

Further, Section 12 of the Act lays down that for the registration = and=20 continuation of a Clinical Establishment, such clinical establishment = shall=20 fulfill the conditions namely,

the minimum standards of facilities = and=20 services
the minimum requirement of = personnel
provisions for maintenance of records = and=20 reporting
such other conditions as may be=20 prescribed.

The minimum standards for hospitals are implemented on the basis of = level of=20 care provided by such hospitals.

Recently in September 2014, the National Council for Clinical = Establishments=20 under the Chairmanship of Director General of Health Services, = Government of=20 India in consultation with various stakeholders has prepared following = draft=20 Documents with the objective of implementation of the Clinical = Establishments=20 Act³:

Application format for Permanent = Registration of=20 Clinical Establishments
Minimum Standards
Formats for Collection of information = and=20 Statistics
Template for Display of Rates
Standard Treatment Guidelines of = Ayurveda=20 Accordingly, the draft document issued by the Government this = September4=20 divided hospitals into 4 levels of hospitals, namely -

Accordingly, the draft document issued by the Government this=20 September⁴ divided hospitals into 4 levels of hospitals, = namely -

Hospital Level 1-

Hospital Level 1 are the primary healthcare services provided by = qualified=20 doctors. It includes services such as General Medicine, Pediatrics, = First aid to=20 emergency patient and Out Patient Services, Obstetrics & Gynecology=20 Non-surgical and Minor Surgery and have a bed strength of not more than = 30 which=20 can be provided through trained and qualified manpower with = support/supervision=20 of registered medical practitioners with the required support systems = for this=20 level of care.

Hospital Level 2-

This level includes services of Surgery and Anesthesia in addition to = the=20 services provided at level 1 through registered medical practitioner = under=20 supervision and with support of specialists. It will also have other = support=20 systems required for these services like pharmacy, laboratory, = diagnostic=20 facility, etc.

Hospital Level 3-

This level includes all the services provided at level 1 and 2 and in = addition the following as well such as Multi-specialty clinical care = with=20 distinct departments, General Dentistry, Intensive Care Unit,. Tertiary=20 healthcare services can be provided through specialists. It will also = have other=20 support systems required for these services like pharmacy, Laboratory, = and=20 Imaging facility.

Hospital Level 4 =96

This level will include all the services provided at level 3. It will = however=20 have the distinction of being teaching/ training institution and it will = have=20 multiple superspecialties. Tertiary healthcare services that can be = provided=20 through specialists. It shall have other support systems required for = these=20 services. It shall also include the requirements of MCI/other = registering=20 body.

Template for Display of Rates

The Hospitals are required to follow a particular template for = display of the=20 various rates related to PD, Investigation /diagnostic, emergencies, etc = which=20 is detailed in the draft documents issued by the Ministry.

Conclusion

To conclude with, India is already outshining itself in the global = strata of=20 pharmaceutical market. It is apparently a boon above that for the fact = that=20 India is expected to witness a tremendous improvement in its public = health as=20 the Government is showing enthusiastic approach towards striving at the=20 objective of the Clinical Establishments (Registration and Regulation) = Act,=20 2010. With the implementation of the diligently drafted standards = through this=20 Act, it is expected that in the coming years each and every clinical=20 establishment in India will be systematized and stringently compelled = equipped=20 with all the basic minimum standard of medical care and hence, the = scenario of=20 healthcare section in India is expected to grow through a tremendously=20 appreciable revolution.

Footnotes

1.=20 planningcommission.nic.in/aboutus/committee/.../wg11_hclinic.pdf

2.=20 http://clinicalestablishments.nic.in/En/1070-draftminimum-standards.aspx

3. Available at the official website of Ministry of Health and Family = Welfare=20 http://clinicalestablishments.nic.in/En/1070-draft-minimum-s= tandards.aspx

4.=20 http://clinicalestablishments.nic.in/En/1070-draftminimum-standards.aspx

The content of this article is intended to provide a general = guide to the=20 subject matter. Specialist advice should be sought about your specific=20 circumstances.

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} document.getElementById("navbar_navigation_holder").style.display =3D = "none"; document.getElementById("navbargroup").style.display =3D "none"; } else { if (testelement("toplevelnav")){ document.getElementById ("toplevelnav").style.display =3D ""; } document.getElementById("navbar_navigation_holder").style.display =3D = ""; document.getElementById("navbargroup").style.display =3D ""; =20 } reloadpage() } function reloadpage(){ //alert("now") //checkwindowsize() var wd =3D 0 var max_width =3D 0 var client_width =3D 0=20 client_width =3D document.body.clientWidth if (client_width > 900){ max_width =3D 1028 } else if (client_width < 880){ max_width =3D 880 } else { max_width =3D client_width } wd =3D Math.min(client_width, max_width) if (wd <=3D 300) { wd =3D 300 } var divWidth =3D (wd + 'px'); document.getElementById ("totalpagecontainercentre").style.width =3D = divWidth ; document.getElementById ("header").style.width =3D divWidth ; =20 if (testelement("addblock1")){ document.getElementById ("addblock1").style.display =3D ""; =20 switch (true){ case (wd < 970):=20 document.getElementById ("addblock2").style.display =3D "none" document.getElementById ("addblock3").style.display =3D ""=20 break; case ( wd > 1200):=20 document.getElementById ("addblock2").style.display =3D "" document.getElementById ("addblock3").style.display =3D "" =20 break; default :=20 document.getElementById ("addblock2").style.display =3D "" =20 document.getElementById ("addblock3").style.display =3D "none" =20 } } =20 if (testelement("default_main_area")) { divWidth =3D wd + 'px'; =20 switch (true){ case (wd > 716 && wd < 979):=20 =09 divWidth =3D wd + 'px'; document.getElementById ("slidescontainer").style.display =3D ""; document.getElementById ("right_navigation").style.display =3D = 'none'; document.getElementById ("default_main_area").style.width =3D = divWidth ; =09 divWidth =3D '716px;'; setupslider(716, divWidth) document.getElementById ("main_slider").style.width =3D divWidth document.getElementById("slider1").style.width =3D divWidth document.getElementById("paginate-slider1").style.width =3D divWidth =09 document.getElementById ("main_middle").style.display =3D ""; =09 break; case (wd > 500 && wd < 716):=20 divWidth =3D wd + 'px'; document.getElementById ("slidescontainer").style.display =3D = "none"; document.getElementById ("right_navigation").style.display =3D = 'none'; document.getElementById ("main_middle").style.display =3D ""; document.getElementById ("default_main_area").style.width =3D = divWidth ; document.getElementById ("main_slider").style.width =3D divWidth =09 divWidth =3D Math.floor(wd * 0.50); ddivWidth =3D divWidth + 'px'; document.getElementById ("main_middle").style.display =3D ""; document.getElementById ("main_middle").style.width =3D ddivWidth=20 ddivWidth =3D (wd - divWidth - 30); ddivWidth =3D ddivWidth + 'px'; document.getElementById ("main_left").style.width =3D ddivWidth =09 break; case (wd < 500):=20 divWidth =3D wd + 'px'; document.getElementById ("default_main_area").style.width =3D = divWidth ; document.getElementById ("main_slider").style.width =3D divWidth document.getElementById ("slidescontainer").style.display =3D = "none"; document.getElementById ("right_navigation").style.display =3D = 'none'; document.getElementById ("main_middle").style.display =3D "none"; ddivWidth =3D wd + 'px'; document.getElementById ("main_left").style.width =3D ddivWidth break; =20 default :=20 document.getElementById ("slidescontainer").style.display =3D ""; document.getElementById ("right_navigation").style.display =3D ""; document.getElementById ("default_main_area").style.width =3D = divWidth ; document.getElementById ("right_navigation").style.width =3D = '280px'; =20 wd =3D wd - 310 divWidth =3D wd + 'px'; setupslider(wd, divWidth) document.getElementById ("main_slider").style.width =3D divWidth document.getElementById("paginate-slider1").style.width =3D divWidth document.getElementById("slider1").style.width =3D divWidth document.getElementById("divslider1").style.width =3D divWidth document.getElementById("divslider2").style.width =3D divWidth document.getElementById("divslider3").style.width =3D divWidth document.getElementById("divslider4").style.width =3D divWidth document.getElementById("imgslider1").style.width =3D divWidth document.getElementById("imgslider2").style.width =3D divWidth document.getElementById("imgslider3").style.width =3D divWidth document.getElementById("imgslider4").style.width =3D divWidth =09 document.getElementById ("main_middle").style.display =3D ""; divWidth =3D Math.floor(wd * 0.37); if (divWidth < 290) { divWidth =3D 290 ddivWidth =3D '290px'; } else { ddivWidth =3D divWidth + 'px'; } document.getElementById ("main_middle").style.width =3D ddivWidth=20 =20 ddivWidth =3D (wd - divWidth - 30); ddivWidth =3D ddivWidth + 'px'; document.getElementById ("main_left").style.width =3D ddivWidth } } =20 if (testelement("main_literal")) { divWidth =3D wd + 'px'; document.getElementById ("main_literal").style.width =3D = divWidth =20 } if (testelement("sconsole")) { document.getElementById("sconsole").innerHTML =3D = document.body.clientWidth;=0D } if (testelement("main_article")) { if (wd > 605){ wd =3D (wd - 305) divWidth =3D wd + 'px'; document.getElementById ("main_article").style.width =3D divWidth document.getElementById ("main_article_right").style.width =3D = '300px'; if (testelement("authorcontanctblock")){ document.getElementById ("authorcontanctblock").style.display =3D = ""; =09 } }else { divWidth =3D wd + 'px'; document.getElementById ("main_article").style.width =3D divWidth document.getElementById ("main_article_right").style.width =3D = '300px'; =09 if (testelement("authorcontanctblock")){ document.getElementById ("authorcontanctblock").style.display =3D = "none"; =09 } } =09 } =20 if (testelement("officeleft")) { wd =3D (wd - 265) divWidth =3D wd + 'px'; document.getElementById ("officeright").style.width =3D divWidth } if (testelement("kahmiddle")) { wd =3D (wd - 260) divWidth =3D wd + 'px'; document.getElementById ("kahmiddle").style.width =3D divWidth } =20 } function setupslider(wd, divWidth){ document.getElementById ("main_slider").style.width =3D divWidth document.getElementById("paginate-slider1").style.width =3D divWidth =09 document.getElementById("slider1").style.width =3D divWidth document.getElementById("divslider1").style.width =3D divWidth document.getElementById("divslider2").style.width =3D divWidth document.getElementById("divslider3").style.width =3D divWidth document.getElementById("divslider4").style.width =3D divWidth document.getElementById("imgslider1").style.width =3D divWidth document.getElementById("imgslider2").style.width =3D divWidth document.getElementById("imgslider3").style.width =3D divWidth document.getElementById("imgslider4").style.width =3D divWidth //have width need to constrain height: var y =3D (wd / 940) //decimal change value var newy =3D Math.floor(350 * y)=20 newy =3D newy + 'px'; document.getElementById("slider1").style.height =3D newy document.getElementById("imgslider1").style.height =3D newy document.getElementById("imgslider2").style.height =3D newy document.getElementById("imgslider3").style.height =3D newy document.getElementById("imgslider4").style.height =3D newy } function checkwindowsize() { var winW =3D 1160, winH =3D 800; if (document.body && document.body.offsetWidth) { winW =3D document.body.offsetWidth; winH =3D document.body.offsetHeight; } if (document.compatMode=3D=3D'CSS1Compat' && document.documentElement && document.documentElement.offsetWidth ) { winW =3D document.documentElement.offsetWidth; winH =3D document.documentElement.offsetHeight; } if (window.innerWidth && window.innerHeight) { winW =3D window.innerWidth; winH =3D window.innerHeight; } //alert (winW) if (winW < 1000){ parent.resizeTo (1160, 800) } } function testelement(theVal) { if (document.getElementById(theVal) !=3D null) { return true; } else { return false; }=20 } function incfont(){ var ifontsize ifontsize =3D readCookie("fontsize") if (ifontsize =3D=3D null){ ifontsize =3D 80 createCookie("fontsize", ifontsize, 365) =09 } ifontsize =3D parseInt(ifontsize) + 5 =09 createCookie("fontsize", ifontsize, 365) var s =3D ""; s =3D ifontsize + "%"; document.body.style.fontSize=3D s; =20 document.getElementById("btnDec").title =3D "Decrease Font Size by 5%, = current size:" + s; =20 document.getElementById("btnInc").title =3D "Increase Font Size by 5%, = current size:" + s; =20 } function decfont(){ var ifontsize ifontsize =3D readCookie("fontsize") if (ifontsize =3D=3D null){ ifontsize =3D 80 createCookie("fontsize", ifontsize, 365) } ifontsize =3D parseInt(ifontsize) - 5 =09 createCookie("fontsize", ifontsize, 365) var s =3D ""; s =3D ifontsize + "%"; document.body.style.fontSize=3D s; =20 document.getElementById("btnDec").title =3D "Decrease Font Size by 5%, = current size:" + s; =20 document.getElementById("btnInc").title =3D "Increase Font Size by 5%, = current size:" + s; =20 =09 } function createCookie(name,value,days) { if (days) { var date =3D new Date(); date.setTime(date.getTime()+(days*24*60*60*1000)); var expires =3D "; expires=3D"+date.toGMTString(); } else var expires =3D ""; document.cookie =3D name+"=3D"+value+expires+"; path=3D/"; } function readCookie(name) { var nameEQ =3D name + "=3D"; var ca =3D document.cookie.split(';'); for(var i=3D0;i < ca.length;i++) { var c =3D ca[i]; while (c.charAt(0)=3D=3D' ') c =3D c.substring(1,c.length); if (c.indexOf(nameEQ) =3D=3D 0) return = c.substring(nameEQ.length,c.length); } return null; } function eraseCookie(name) { createCookie(name,"",-1); } function checkfontcookie(){ var ifontsize ifontsize =3D readCookie("fontsize") if (ifontsize =3D=3D null){ ifontsize =3D 90 createCookie("fontsize", ifontsize, 365) } var s =3D ""; s =3D ifontsize + "%"; document.body.style.fontSize=3D s; =20 } function checkprivacycookie(){ var iprivacy iprivacy =3D readCookie("privacy") if (iprivacy =3D=3D null){ iprivacy =3D 0 //createCookie("fontsize", ifontsize, 365) } if (iprivacy =3D=3D 0){ document.getElementById("privacy").style.display=3D'block'; document.getElementById("privacy").style.visibility=3D'visible'; } =09 } function writeprivacycookie(){ document.getElementById("privacy").style.display=3D'none'; document.getElementById("privacy").style.visibility=3D'hidden'; createCookie("privacy", 1, 365) } checkfontcookie() checkprivacycookie() window.onresize =3D pageresize;=20 // ]]> ------=_NextPart_000_0000_01D1F342.01F32C80--