About clinical establishment act and National List of Essential Medicine.

1. CLINICAL
ESTABLISHMENT ACT
DR VANDANA VERMA,
ASSOS. PROF,
DEPT. OF COMMUNITY
MEDICINE,

2. Introduction
• The Clinical Establishments Act was passed by
Parliament of India on 17th August2010
• The Ministry of Health and Family Welfare has notified the
National Council for Clinical Establishments and the Clinical
Establishments (Central Government) Rules, 2012 under this
Act vide Gazette notifications dated 19th March, 2012 and
23rd May, 2012 respectively.
• NSSO estimates, as much as 40% of the private care is likely
being provided by informal unqualified providers.

3. Objectives of the Act
 To prevent quackery by unqualified practitioners by
introducing registration system, which is mandatory.
 To establish digital registry of Clinical Establishments at
National, State and District level.
 To improve quality of health care through standardization of
healthcare facilities by prescribing minimum standards of
facilities and services for all categories of health care
establishments.

4. Definition
• Clinical establishments defined as health care/
establishments by any name, engaged in diagnosis,
treatment or care of injury, illness, pregnancy, disability,
or abnormality in any recognised sysytem of medicine
established and adminstrated.

5. Clinical Establishment..
• 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
(Exception: establishments of the Armed Forces)

9. Authority
National Council for clinical establishments
• DGHS, Ex-officio, Chairperson
4 elected representatives, out of which
• Medical Council of India (one representative),
• Dental Council of India (one representative),
• Nursing Council of India (one representative),
• Pharmacy Council of India(one representative),
• Indian Medicines representing the Ayurveda,Siddha,Unani
(three elected representatives),
• Central Council of Homoeopathy (one elected
representative) ,

10. At State Level
• State shall set up, District Registering Authority
 District collector - Chairperson
 District Health Ofiicer - Converner
 Three Members

11. Powers & Responsibilities: DRA
a) Grant/Renew provisional (within 10 days)/permanent registration.
b) May issue a notice to Clinical Establishment to show cause
within 3 months, if condition(s) of registration are not met.
c) To enter and search unregistered CE (after due notice),
inspection and inquiry of registered Clinical establishments
e) May cancel registration (after giving reasonable opportunity) and
giving reasons. After cancelling registration, immediately restrain
Clinical Establishment if imminent danger to the health and safety
of patients
f) Recover penalties.
g) Maintain District register of Clinical establishments.

12. Minimum required standards
• Clinic / Polyclinic only Consultation ( level
1A)
1. Space :
2.Human Resource:
One Doctor – MBBS / BDS registered in any MCI
One Support staff – registered in any nursing council
Common area Consultation area
Reception Waiting Room
35 sqft 35 sqft 70 sqft

14. Essential Equipment
Equipment Minimum specification Number
Stethoscope 1
Thermometer Digital 1
Torch (flash lights) 1
Sphygmomanometer(B
.P. Apparatus)
Digital 1
Weighing
machine(Optiona
l)
Adult 1

15. Emergency Equipment
Equipment Minimum specification Number
Resuscitation
Equipment Ambu
Bag/Air Way
Adult
Pediatri
c
1
1
Oxygen
Concentrator/
Cylinder .
Portable 1
Fire Extinguisher 1

16. Emergency Drugs
Name of the Drug No of ampule
Inj Adrenaline 2 A
Inj Hydrocortisone 1 vial
Inj Atropine 1 Ampoule
Inj Avil 1 Ampoule
Inj Phenargan 1 Ampoule
Inj. Deryphyline 1 Ampoule
Inj. Frusemide 1 Ampoule
Inj. Metoclopramide 1 Ampoule

17. Emergency Drugs
Name of the Drug No of ampule
Inj. Dexamethasone 2 A
Inj. Diazepam 1 vial
Inj. Dicyclomine Hydrochloride 1 Ampoule
Inj. 5% dextrose infusion 1 Vac
Inj. Normal saline 1 Vac

18. Penalties under the Act
Offences penalties
FIRST ATTEMPT SECOND
ATTEMPT
SUBSEQUENT
ATTEMPT
Running Clinical
Establishment
without registration
50,000 2,00,000 5,00,000
Contravention of
any other provision
of the Act
10,000 50,000 5,00,000
Whoever knowingly
serves in an
unregistered
Clinical
Establishment
25,000
Minor deficiencies
which do not pose
imminent danger
10,000

20. ESSENTIAL MEDICINE LIST

21. DEFINITION
Essential medicines are those that satisfy the priority health care needs
of the population at all time.

22. Essential medicines are selected with due regard to:
1. Disease prevalence
2. Public health relevance
3. Evidence on efficacy and safety
4. Comparative cost-effectiveness

23. HISTORYOFTHE WHO MODELLIST OF ESSENTIAL MEDICINES
• Tanzania was the first country in the world to compose Essential
Medicine List
• 1977 First Model list published by WHO, ± 200 active substances
• List is revised every two years by WHO Expert Committee
• 21st WHO model EML published in June 2019, is proof that the
concept is still valid after nearly 43 years and continues to have
many advantages when it is used appropriately and in conjunction
with standard treatment guidelines.

24. NATIONAL LIST OF ESSENTIAL MEDICINES INDIA (NLEM)
• Introduced & controlled by Ministry of Health & Family Welfare
(MOHFW), GOI
• First NLEM 1996 (Revised in 2003)
• NLEM 2011 (348 Drugs)
• NLEM 2015 [376 Drugs (106 added & 70 deleted)]
• Category of Drugs (On basis of health care and disease burden)
• P→ Primary (206)
• S → Secondary (115)
• T → Tertiary (79)(106 additions and 70 deletions)
• Medicines deleted from NLEM-2003 (47 Drugs)

25. CRITERIA FOR INCLUSION OFA MEDICINE IN NLEM 2015
• The medicine should be approved/licensed in India.
• The medicine should be useful in disease which is a public health
problem in India.
• The medicine should have proven efficacy and safety profile
based on valid scientific evidence.
• The medicine should be cost effective.
• The medicine should be aligned with the current treatment
guidelines for the disease.
• The medicine should be stable under the storage conditions in India.

26. WHAT IS CORE LIST AND
COMPLEMENTARY
LIST?
• Core list –
• List of minimum medicine needs for a basic health care system, listing the
most efficacious , safe and cost effective medicines for priority conditions.
• Complementary list –
• Essential medicines for priority diseases , for which specialised diagnostic or
monitoring facilities and or specialist medical care and or specialist training are
needed.

27. PURPOSE OF
NLEM
• Guides safe and effective treatment of priority disease conditions.
• Promote the rational use of medicines
• Optimize the available health resources of a country
• NLEM-a guiding document for
• State governments to prepare their list of essential medicines
• Procurement and supply of medicines in the public sector
• Reimbursement of cost of medicines by organizations to its
employees
• Reimbursement by insurance companies identifying the ‘MUST
KNOW’ domain for the teaching and training of health care
professionals

28. TAKE HOME
MESSAGE
• E – Efficacy
• S – Safety and suitability
• S - Storage and stability
• E - Ease of administration (dosage form)
• N - Need of population
• T - Total cost
• I - Irrational combination to be avoided
• A- Availability,Affordability
• L - Listing regularly (updating)

29. MCQ
1.Which Clinical establishments not covered under the Act ?
a) Clinic owned by single doctor.
b) Clinics owned, controlled or managed by the Armed
Forces.
c) Government medical college.
d) Corporation / municipality – dispensaries

30. 2.According to National Sample Survey 60th
round % of the private care is likely being
provided by informal unqualified providers?
a) 20%
b) 30%
c) 40%
d) 50%