Regulations , Standards & Codes “CLINICAL ESTABLISHMENT ACT” I.P.H.S and UCPMP by Dr. Mira Shiva MD National Consultation on ‘Expanding Access and Using the Law to Ensure Sexual and Reproductive Health Rights’ was held in December’ 2015. The consultation brought together experts, activists, lawyers, health workers and students from all corners in the country, in building the understanding on the issues and the emerging challenges. Human Rights Law Network http://hrln.org

1. Using Law to Ensure Reproductive and Sexual
Health Rights
Regulations , Standards & Codes
“CLINICAL ESTABLISHMENT ACT”
I.P.H.S and UCPMP
Dr. Mira Shiva MD
Initiative for Health & Equity in Society
Consumer Representative in National Council for CEA
Organised by
Human Rights Law Network (HRLN)
At
Jaipur
5-6th Dec 2015
Address: Initiative for Health & Equity in Society
A-60 Hauz Khas, New Delhi 110016
E-mail: mirashiva@gmail.com
PH 919810582028,01126512385

2. Regulations , Standards
Guidelines and Codes

3. Acts
Clinical Establishment Act .
Mental Health Act .
Medical Council of India Act
Consumer Protection Act
Maternity Benefits Act
PCPNDT Act
MTP Act

4. Standards
Only for Public Sector
Indian Public Health Standards
for
Sub centre
Primary Health Centre (PHC)
Community Health Centre (CHC)
Sub District hospital
District Hospital

5. National Guidelines
National Guidelines for
Biomedical Research in Human
Subjects
National Guidelines for Stem
Cell research &
Therapy(DBT,ICMR) 2006
National Guideline for
Biomedical Research
(DBT,ICMR 20140

6. Codes
Baby Food Code
Infant Milk Substitutes
Regulation of Marketing Act
1995, amended 2003.
Uniform Code for
Pharmaceutical Marketing
Practices 2015

7. Exploitatation & Profit Making
Mega Imaging Path Lab Centre Yusuf Sarai
functioning for several years .Lab
reports signed by Dr Anu Kundra MD
Pathologist.
She had left centre 3 years earlier.
Lab reports being given when equipment
for the tests did not exist .
Medical Treatment given on the basis of
lab reports

8. Clinical Establishments
(Registration & Regulation)Act
2010
“The Supervision and Regulation
of the Quality of services
provided by the health care
delivery system to the people by
both public & private sectors has
remained a contentious and
unresolved issue .”

9. “The Private sector health care
delivery system in India has
remained largely unregulated &
uncontrolled . Problems range from
inadequate and uncontrolled
treatment , excessive use of
higher technologies , and wasting
of scarce resources to serious
problems of medical Malractice and
Negligence .”

10. CEA Rules 2012 Section 9(ii)
“The Clinical Establishments
Act shall charge the rates for
each type of procedures and
services within the range of
rates determined & issued by
the central Government from
time to time , in consultation
with the State govts .”

11. Exploitatation & Profit Making
Mega Imaging Path Lab Centre Yusuf
Sarai functioning for several
years .Lab reports signed by Dr
Anu Kundra MD Pathologist.
She had left centre 3 years
earlier.
Lab reports being given when
equipment for the tests did not
exist .
Medical Treatment given on the
basis of lab reports

12. Clinical Establishment Act
Present Health Context
- Health Budget 1.2%
- 80% Out of Pocket Expenditure Out Patient, 60%
in patient
- Increasing privatization, commercialization,
corporatization of Medical Care
- According to NSSO Medical Care 2nd commonest
cause of rural indebtedness
- Erosion of concept of Comprehensive Health
Care
- Alma Ata Charter
- Importance of Determinants of Health
- Social Sector Budget cuts

13. - Focus on Currative Care rather than preventive
promotive
- Shift from Universal Health – Universal Health Care -
Terteriary Care
•Increasing costs of medical care, Diagnostics,
Medicines, Medical Devices
•Exploitation in the name of medicine by overcharging,
substandard care, exploitative care, increasing
Caesarian, increasing Hysterectomy
• Not following standard treatment Guidelines (STG)
•Result emergence of antibiotic resistance, Adverse
reaction, Complications, Hospital Infections
• Sterilization deaths, Bilaspur
• Maternal deaths in Umed Hospital, Jodhpur

14. Corruption
-demand for bribes, oiling of palms for hospital admission
- Death certificate for release of Body
-Increasing Medical Touts for Kidney Transplants
-Payment of Commission to doctors
-For prescribing lab test from specific Diagnostic labs
Specific costly brand
-Drugs of specific Pharma company for specific Chemist
For referral to specialists
-Medical Care – commodifications, growth of medical market
Increasing Capital investment in medical care market for
profits
- Hospital chains
- Pharmacy chains
- Diagnostic Labs

15. - Speculation, Growth in capital
intensive Medical Care Model
- Increasing Medical Tourism –
Heart surgery, Hip replacement
- Reproductive Tourism, Surrogacy
Cosmetic Surgery

16. Growth of medical industrial complex
- Clinical Trials – Pharma sponsors
- Private Medical Insurance
- Medical Device Industries
- Pharmaceutical industry
- Diagnostic
-Medical Device Industry
Public Private Partnership
Public payment / liability
Private profits
Public state support of private insurance
Dismantling of Institutions
NNMB – National Nutrition Medical Bureau

17. Unresolved Issues
•Shortages of qualified trained doctors, Nurses, specialists –
concerns about meeting
•Inadequate Health budget for medical equipment, medicines,
incubators, ventilators, Beds
•Role of Para medicals
•Physiotherapists
•Chemists prescribing medicines in absence of prescribing
doctors
•High costs of medical consultation
•Medicines given influenced by Commission offered by Pharma
companies
•Status of unqualified inadequately trained practioners, in absence
of health care facilities and personnel close down? Punish?

18. Concerns
•In absence of adequate Health Budget Government health institutions being
unable to meet standard
•Smaller private institution being unable to meet standards, including mission
hospitals
•Continued exploitation of patients by certain commercial corporate private
medical institution
•Wiping out of smaller institutions as corporate hospitals chains and speculation
in medical care investment seen as business opportunity
•Increase in costly high tech capital intensive medical care in the name of high
standards
•Implementation and monitoring of CEA requires adequate budget personnel
Medical Council of India Act } have failed to protect and give justice to
Consumer Protection Act } aggrieved patients
Failure of Medical Council of India and Consumer Protection Act to protect
patients and their rights

19. •Increasing commercialization privatization of medical
education
•Pharmacy, Dental, Nursing education
•Sales of medical admission seats eg. Vyapam scam
•Misuse of Mental Health Act – false certificates to
incarcerate sane women, elderly parents in Mental
Asylum
•National Guideline for Stem Cell research (Therapy
deleted)
•ICMR DBT (earlier National Guideline for Stem Cell
included Research & Therapy)
•In CEA Patients Rights not included
•No provision of Grievance Redressal System

20. Clinical Establishments Act, 2010
• For Registration and Regulation of the clinical establishments (except those
of Armed Forces) with a view to prescribe minimum standards of facilities
and services so that mandate of article 47 can be fulfilled
• The Parliament legislated the Clinical Establishment Act (Registration &
Regulation) in pursuance of the resolutions passed by the legislatues of
the states of Arunachal Pradesh, Himachal Pradesh, Sikkim and Mizoram
under clause (1) article of 252 of the constitution.
• Act passed by Parliament : 17th August 2010
• Act Notified on 1st March, 2012.
• National Council notified: 19th March, 2012
• Central Rules notified : 23rd May, 2012

21. Applicability
• States - Arunachal Pradesh, Himachal
Pradesh, Mizoram and Sikkim and 6 Union
Territories
• States who have adopted the Act - Uttar
Pradesh, Uttarakhand Rajasthan, Bihar and
Jharkhand
• Such other States who may adopt this Act under
clause (1) of article 252 of the Constitution.

22. Definition: Clinical Establishment
(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
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 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 or not,

23. Cont.…
and shall include a clinical establishment owned,
controlled or managed by
(a)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

24. Salient Features & Benefits
• Coverage - All clinical establishments - including diagnostic
centres and single doctor clinics, across all recognized systems
of medicine in both public and private sector.
(exception: establishments of the Armed Forces)
• Registry: Digital registry at National, State & District level to
aid in policy formulation and resource allocation
 Standard Application Form
Application for registration by post, in person or online
Website www.clinicalestablishments.nic.in functional
 Implementation by District Registering Authority under
Chairpersonship of District collector. The authority has power
to inspect, grant, suspend and cancel registration
Appeal goes to the State Council

25. Cont’d
 Provisional and Permanent registration
 Every clinical establishment has to be registered. Norms
required to be met prior to registration include
(a) minimum standards of facilities and services; and
(b) minimum qualifications for the personnel.
(c) Provision and maintenance of records and reports
(d) Any other condition that may be prescribed
 National Council for clinical establishments through multi
stakeholder participation and consultative process would
classify clinical establishments into different categories and
determine minimum standards and their periodic review,
determine the statistics to be collected and compile and
publish national register

26. Cont’d
 Mandatory for every clinical establishment to provide treatment
“with in the staff and facilities available” to stabilize the emergency
medical condition.
 Details of charges, facilities available would be prominently
displayed by each establishment at a conspicuous place at each
establishment
 Electronic medical records and EHR
• Clinical Establishments shall charge the rates for procedures and
services with in the range of rates determined by the Central
Government from time to time in consultation with the State
Governments.
• Compliance to Standard Treatment guidelines as may be issued by
Central/State Govt. to be ensured by CEs.
• Penalties: Monetary/ suspension or cancel of registration

27. Benefits
• Comprehensive Digital Registry of clinical establishments
– Policy formulation
– Better surveillance, response and management of outbreak & public health emergencies
– Engagement with private providers
 Uniform standards for a category
 Transparency: process of registration & data in public domain.
 Multi stakeholder participation in institutional mechanisms
(National & State Councils, District Registration Authority)
 Effective Regulation of providers.
 Improved quality of health care and patient safety
 Deterrent against quackery
 Better management of Emergency medical conditions
 Details of charges, facilities available would be prominently
displayed at a conspicuous place at each establishment

28. Steps taken for
implementation of the
Clinical Establishment
Act 2010

29.  Dedicated website
(www.clinicalestablishments.nic.in)
 Online registration functional in the States of
Jharkhand, Himachal Pradesh and UT of Daman
and Diu and Chandigarh.
 Nodal Officers in the states
 Draft State Rules were circulated for guidance
 Secretariat for National Council set up
 Budget for implementation through NRHM
 Work initiated for standards of EMR and HER

30. Website
Ensure transparency through online system of registration and
information in the public domain

31. Nat. Council for Clinical
Establishments
Preparatory work
 Existing standards reviewed to identify the gaps.
 Indian Public Health Standards (IPHS) revised
 Revised two Bureau of Indian Standards (BIS) documents
for upto 30 bedded Hospitals and upto 100 bedded Hospitals.
 Developed Guidelines on Daycare Centers and Wellness
Centers
Developed and finalized
 Application form for provisional registration,
 Certificate of Provisional Registration,
 information to be displayed by the Clinical establishments

32. Cont.d
 A survey of clinical establishments in 61 districts in
the implementing states
Subcommittees of National Council
 Categorization and Classification of Clinical
Establishments
 Development of StandardTemplate of Minimum
Standards
 Developing Minimum Standards
 Information and Statistics to be collected from
Clinical establishments
 Defining the range of rates of procedures and
services

33. Progress
Mandate Status
States repealing existing
legislations and enacting own acts
on lines of CEA, 2010
Maharashtra, & Goa are in the
process of repealing existing
legislation & enacting one on the
lines of CEA with modifications.
States enacting legislations where
there was no legislations
Kerala, Gujarat, Punjab, Haryana &
Meghalaya are in the process of
enacting legislation on the lines of
central act with modifications
Notification of State rules Notified by – Arunachal Pradesh,
Himachal Pradesh, Bihar,
Jharkhand, Sikkim, Andaman &
Nicobar Islands, Daman, Diu,
Dadar Nagar Haveli, Puducherry,
Uttarakhand

34. Cont…
Mandate Status
Notification of State / UT
council
Notified by – Arunachal Pradesh, Himachal
Pradesh, Bihar, Jharkhand, Rajasthan, Sikkim,
Andaman & Nicobar Islands, Lakshwadeep,
Daman, Diu, Dadar Nagar Haveli, Puducherry,
Uttarakhand
Notification of District
Registration Authorities
Notified by - Arunachal Pradesh, Himachal
Pradesh, Bihar, Jharkhand, Sikkim, Andaman
& Nicobar Islands, Daman, Diu, Dadar Nagar
Haveli, Puducherry. Rajasthan, Uttarakhand
Provisional Registration Online registration in Himachal Pradesh,
Jharkhand and UT of Andaman & Nicobar
Islands, Daman & Diu.
Offline registration in Sikkim Arunachal
Pradesh & Lakshadweep.

35. Cont…
Mandate Status
Categorization & Classification of
Clinical Establishments
Completed and approved by
National Council
Standard Format for Minimum
standard
Completed and approved by
National Council
Development of Minimum
Standards for Clinical
Establishments
Developed draft for 34 specialties/
super-specialties and major
categories of allopathic CE and 7
categories of AYUSH uploaded on
website for
comments/suggestions.
Information & Statistics to be
provided by Clinical
Establishments
Formats Drafted
1. OPD Form
2. IPD Form
3. Lab and Imaging
Fixing of rates & charges Separate sub – committee
engaged in process

36. Cont…
Mandate Status
Standard Treatment Guidelines
(STG’s)
STG’s for 20 medical domains
developed and AYURVEDA
uploaded on the website
Providing technical assistance and
financial resources
MOHFW, GOI providing technical
assistance to the States for the
implementation through continuous
communication, meetings and visits
to the States and UT’s
Provision of budget for
implementation of the Act & Rules
by the States/UT has been made
through State PIPs from NRHM.
Sensitization & Advocacy and
Training workshops
Stakeholders consultation and
awareness meetings held at
various levels. Recently at
Jharkhand

37. Standard Treatment Guidelines
1. Cardiovascular Diseases
Part - 1
2. Critical Care
3. Gastroenterological
Diseases
4. Obstetrics and Gynaecology
5. Haemodialysis
6. Ophthalmology
7. ENT
8. Orthopaedics
9. Medicine (Respiratory)
10. Medicine (Non Respiratory
Medical Conditions)
11. Paediatrics & Paediatrics
Surgery
12. General Surgery
13. Interventional Radiology
14. Oncology
15. OrganTransplant - Liver
16. Urology
17. Laboratory Medicine
18. G. I. Surgery
19. Neurology
20 Endocrinology

38. Cont…
Mandate Status
Comments invited on Draft Documents
(in pipeline)
i) . Minimum Standards
ii).Application format Permanent
Registration
iii). Information & Statistics to be collected
from Clinical Establishments
iv).Template of Display of Rate
v). StandardTreatment Guidelines of
Ayurveda
Comments invited from
1. Members of public through
websites for 1 month and 7
days
2. State Governments
3. NationalCouncil and
respective Subcommittees
Comments compiled and
discussed with respective
specialities / superspecialities ---
Drafts being finalized for
approval
Attempts by allied health personnels like
medical technologists, medical
microbiology, medical biochemistry to
work as independent practitioners
not agreed

39. States implementing the Act
 Arunachal Pradesh
 Himachal Pradesh
 Mizoram
 Sikkim
 Uttar Pradesh
 Rajasthan
 Jharkhand
 Chhattisgarh (State Act)

40. CEA Covers
Recognized system of medicine :
 Allopathy
 Homoeopathy
 Ayurveda, Siddha and Unani
 Naturopathy
 Yoga
 Any other system of medicine recognized by GOI
Definition of a clinical establishment –hospital,
maternity home, nursing home, dispensary, clinic,
sanatorium, laboratories, radio-imaging centres

41. CEA Covers
Owned, controlled or managed by:
1. The Government or a department of the
Government
2. A trust, whether public or private
3. A corporation (including a society) registered
under a Central, Provincial or State Act, whether
or not owned by the Government or local
authority
4. A single doctor
Only exception - establishments run by the
Armed forces.

42. Some positive features
 StandardTreatment Guidelines
 Charges by hospitals will have to be within the range
decided by the government, after following consultative
process with stakeholders including representatives from
doctors.
 Clinical establishments will have to display charges for
some of the typical main items like consulting charges,
room charges etc.
 Electronic record maintenance
 Minimum standards for Clinical Establishments

43. Clause 12- Condition for
registration
 For registration and continuation, every clinical
establishment shall fulfill the following
conditions, namely:—
 (i) the minimum standards of facilities and services
as may be prescribed
 (ii) the minimum requirement of personnel as may
be prescribed;
 (iii) provisions for maintenance of records and
reporting as may be prescribed;
 (iv) such other conditions as may be prescribed.