This document provides an overview of essential drugs and the National List of Essential Medicines (NLEM) in India. It discusses the history and definition of essential drugs as developed by the WHO. Key points covered include the selection criteria and purpose of essential drug lists, as well as the development and features of India's national list. The inclusion and deletion criteria for the NLEM are presented. The importance and impact of essential drug lists at the national and state level in India is also summarized.

1. ESSENTIAL
DRUGS
DR. ANAGHA SHENDE
GUIDE: DR. SHIRISH JOSHI

2. OVERVIEW
 History
 Expert committee report, April 2002
 Definition of essential drugs
 WHO Model list of essential medicines
 Importance of WHO list
 Introduction to NLEM
 Features of NLEM 2015
 Inclusion and deletion criteria of medicines in NLEM 2015
 Purpose of NLEM
 State lists
 Price cap in essential medicines
 EML and Rational use of medicines
 KEM Pharmacy
 Conclusion
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3. HISTORY
 1975, the World Health Assembly requested the Director-
General to advise Member States on “the selection and
procurement, at reasonable cost, of essential drugs of
established quality corresponding to their national health
needs”
 1st WHO model list of essential drugs- 1977 contained
208 medicines.
 It stated that essential drugs were “of utmost
importance, basic, indispensable and necessary for the
health and needs of the population”.
 Revised every 2 years
 2007, a separate list for children up to 12 years
WHO Essential Medicines http://www.who.int/medicines/services/essmedicines_def/en/Accessed on 15/12/16
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4. FULL DESCRIPTION OF ESSENTIAL
DRUGS (EXPERT COMMITTEE
REPORT, APRIL 2002)
 Description of essential medicines - include three
components:
1. Definition. Essential medicines are those that satisfy the
priority health care needs of the population.
2. Selection criteria: public health relevance, evidence on
efficacy and safety, and comparative cost-effectiveness.
3. Purpose: intended to be available within the context of
functioning health systems at all times in adequate
amounts, in the appropriate dosage forms, with assured
quality & adequate information, and at a price the
individual and the community can afford.
WHO Expert committee report http://www.who.int/medicines/services/essmedicines_def/en/ Accessed on 14/12/16.
WHO Essential Medicines http://www.who.int/topics/essential_medicines/en/ Accessed on 16/12/16
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5. NEW PROCEDURES IN 2002
 Term “essential medicines” instead of “essential drugs”
 ATC(Anatomical Therapeutic Chemical) classification of
drugs
 More transparent process, systematic analysis of the
evidence
 Full involvement of different WHO departments
 Absolute cost of a medicine not be a reason to exclude it
from the Model List if it meets the stated selection criteria
 Cost-effectiveness comparisons made among medicines
within the same therapeutic group
 Interested parties could comment on the application and
its review to the Expert Committee
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WHO Expert committee report http://www.who.int/medicines/services/essmedicines_def/en/ Accessed on 14/12/16.

6. DEFINITION
 Essential medicines are those that satisfy the priority
health care needs of the population. They are selected
with due regard to public health relevance, evidence on
efficacy and safety, and comparative cost-effectiveness.
They are intended to be available within the context of
functioning health systems at all times in adequate
amounts, in the appropriate dosage forms, with assured
quality and adequate information, and at a price the
individual and the community can afford.
 Implementation of the concept of essential medicines -
flexible and adaptable
 Which medicines regarded as essential- national
responsibility
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WHO Essential Medicines http://www.who.int/medicines/services/essmedicines_def/en/Accessed on 15/12/16

7. WHO MODEL LIST OF ESSENTIAL
MEDICINES
 1st list by WHO in 1977.
 Revised every 2 years
 Current version- 19th WHO Essential Medicines List
- 5th WHO Essential Medicines List for children
 Both updated in April 2015(36 added to adult and 16 to children
list)
 Contents not mandatory -indicative list
 Provide guidance for 4 levels involved in selecting medicines:
 registration
 development of national lists
 development of lists in the hospital and medical environment
 medical prescription
http://www.who.int/medicines/publications/essentialmedicines/en/
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8.  Core list: minimum
drug needs for a basic
health care system,
listing the most cost-
effective drugs for
priority conditions
(selected on the basis
of burden of disease
and potential for safe
and cost-effective
treatment).
• Complementary list:
essential drugs for
priority diseases
which are cost-
effective but not
necessarily affordable
or for which
specialised health
care facilities may be
needed
8
http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf Accessed on 15/12/16.
 The WHO Model EML is a model product, model
process and public health tool
 The WHO Model List consists of:-

9. IMPORTANCE OF THE WHO LIST
 Forms the basis of national drugs policy
 Procurement and supply of medicines in the public
sector, schemes that reimburse medicine costs,
medicine donations, and local medicine production
 International organizations, including UNICEF, UNHCR
and UNFPA, NGOs and international non-profit supply
agencies, adopt the essential medicines concept &
base their medicine supply system mainly on the Model
List.
 Powerful tool to promote health equity
http://www.who.int/medicines/services/essmedicines_def/en/aaAccessed on 15/12/16
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10. INTERAGENCY LIST OF ESSENTIAL
MEDICINES FOR REPRODUCTIVE
HEALTH
 2006, WHO and UNFPA published the Interagency List
of Essential Medicines for Reproductive Health- subset
of the 14th Model List
 Contained 148 medicines, revised in 2009, 2011
 Only list devoted to products in a specific field of public
health
 Key tool to:
 guide country decisions regarding reproductive health
essential medicines
 guide international bulk procurement and support a core
list
IInteragency list of essential medicines for reproductive health, 2006. Document no. WHO/PSM/PAR/2006.1 -
WHO/RHR/2006.1.Geneva: World Health Organization;
2006.http://www.who.int/medicines/publications/essentialmedicines/WHO/PSM/PAR/2006%20I_Rev.pdf. [Ref
list]
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11.  Currently, 156 of the 193 WHO Member States have official essential
medicines lists, of which 127 have been updated in the past five years
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12. INTRODUCTION TO NLEM
 In 1978, the World Health Assembly passed a resolution
urging the Member States to establish national lists of
essential medicines and adequate procurement systems.
 By MOHFW, GOI, 1st list 1996- 279 medicines
 Revision in 2003, 2011, 2015
 The NLEM 2015 has been prepared adhering to the
basic principles of Efficacy, Safety, Cost-Effectiveness;
consideration of diseases as public health problems in
India. The list could be called as a Best-Fit List.
http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16
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13. FEATURES OF NLEM 2015
 NLEM 2011- 348 medicines. 106 medicines -added
70 medicines -deleted
NLEM 2015- 376 medicines.
 Coronary stents included in NLEM- to increase affordability
 Medicines used in dementia and neonatal care added
 Any medicine/ vaccine, under a National Health Programme will
be deemed to have been included in NLEM.
 Vaccines/ immunoglobulins/ sera in NLEM, irrespective of
variation in source, composition and strength, all the products of
the same vaccines/ immunoglobulins/ sera approved by the
licensing authority are considered included.
http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16
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14.  Essentiality considered in terms dosage form and strength
also.
 Oral solid dosage form (tablet/capsule)- two aspects
considered
1) dosage form that is commonly available
2) dosage form that is mentioned in Indian Pharmacopoeia
 Formulations developed through innovation/ novel drug
delivery systems considered as included only if specified in
the list against any medicine.
 Active moieties, without mentioning the salt
 Active moiety available as different isomers/ analogues/
derivatives, considered as separate entities, and inclusion of
one does not imply inclusion of all isomers/ analogues/
derivatives.
http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16
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15.  Fixed Dose Combinations (FDCs) not included unless,
combination has unequivocally proven advantage over
individual ingredients administered separately, in terms
of increasing efficacy, reducing adverse effects and/or
improving compliance.
 Over 50 representations- pharmaceutical industries,
NGOs, associations/bodies, ministries- their viewpoints
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http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16

16. LEVELS OF HEALTHCARE
IN NLEM
 Medicines in NLEM are listed with reference to the levels
of healthcare, i.e., Primary (P), Secondary (S) and
Tertiary (T) as the treatment facilities, training,
experience and availability of health care personnel differ
at these levels.
 209 medicine formulations- all levels of health care (P, S,
T),
 115 medicine formulations- secondary and tertiary levels
(S, T)
 79 medicine formulations- the tertiary level (T).
 Formulations of certain medicines are listed at different
levels but as item, they are counted as one.
http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16
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17. INCLUSION CRITERIA OF
MEDICINE IN NLEM 2015
 Medicine has to be licensed and approved in the country
by DCGI
 Useful in disease which is a public health problem in
India
 Proven efficacy and safety profile based on valid
scientific evidence
 Comparatively cost effective
 Aligned with current treatment guidelines for the disease
 Stable under storage conditions in India
 Total treatment price considered, not the unit price of
medicine
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http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16

18. CRITERIA FOR DELETION OF
MEDICINE IN NLEM 2015
 Medicine banned in India
 Reports of concerns on the safety profile
 Medicine with better efficacy or safety profile and better
cost effectiveness is available
 Disease burden for which medicine is indicated is no
longer a national health concern
 In case of antimicrobials, resistance pattern has
rendered the medicine ineffective
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http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16

19. PURPOSE OF NLEM
 Guide safe and effective treatment of priority disease
conditions of a population
 Promote the rational use of medicines
 Optimize the available health resources of a country
 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
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http://cdsco.nic.in/WriteReadData/NLEM-2015/Recommendations.pdf Accessed on 15/12/16

20. STATE LISTS
 The expenditure pattern on medicines of the State
Government shows wide-ranging differences across
states (2% in Punjab, 17% in Kerala, 2001-2002)
 Tamil Nadu- first state to develop the EML- 1994
 Delhi is the initiator in developing a comprehensive
policy(Delhi State Drug Policy) in 1994
 For state government health facilities -standard
guidelines (STGs). The armed forces medical college
(AFMC) expanded STGs.
 Current- CPA(Central Procurement Agency) Essential
Medicines List 2016
Sharma S, Kh R, Chaudhury RR. Attitude and opinion towards essential medicine formulary. Indian journal of
pharmacology. 2010 May 1;42(3):150.
http://delhi.gov.in/wps/wcm/connect/abdb54804c877076b665b7dd63b32208/EML2016_draft.pdf?MOD=AJPE
RES&lmod=296430078 Accessed on 15/12/16
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21.  Gujarat Essential Drug List 2016-17:
 Primary Health Care(PHC, Subcentres and others)-244
 Secondary Health Care(CHC and TB Hospitals)-369
 Tertiary Health Care(Districts, Subdistricts and Medical
colleges)-556
 Chattisgarh, Rajasthan, Bihar, Orrisa, Meghalaya,
Uttarakhand among states with EML.
 No Essential drug list for Maharashtra
https://gmscl.gujarat.gov.in/essential-drug-list.htm Accessed on 15/12/16
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22. DRUG (PRICE CONTROL) POLICY
 Based on Hathi Committee Report, 1975
recommendations, the Government announced
Drug (Price Control) Policy, 1979.
 Some of the key objectives of the Policy were:
• to ensure adequate availability of drugs
• to provide drugs at affordable prices
• to ensure the quality of drugs and check medicines
from being adulterated
• to achieve self-sufficiency in production and self-
reliance in drug technology.
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23. PRICE CAP IN ESSENTIAL MEDICINES
 GOI promulgated the NPPP, 2012- all medicines with
specified dosage and strength in NLEM under price control
 Accordingly, DPCO, 2013 issued by Department of
Pharmaceuticals under Ministry of Chemicals and Fertilizers
for fixing the ceiling price of medicines included in NLEM
 Maximum retail price (MRP) <= ceiling price (plus local taxes
as applicable) as notified by the Government for respective
medicines.
 As per DPCO, 2013 ceiling prices- average retail price of the
medicine, produced by all those companies engaged in its
production with a market share of ≥ 1% of the total market
turnover, and adding 16% margin to retailer
Bandameedi R, Mohammed S. A Case Study on National List of Essential Medicines (NLEM) in India and WHO EML
2015-Overview. Pharmaceutical Regulatory Affairs: Open Access. 2016 Feb 24;2016.
http://www.nppaindia.nic.in/DPCO2013.pdf Accessed on 15/12/16
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24. ECONOMIC IMPACT
 Spending on pharmaceuticals:
 <1/5 of total public and private health spending-
developed countries
 15 to 30% of health spending-transitional economies
 25 to 66% -developing countries
 1996 and 2000- savings of 30% on its annual medicines
bill.
 Savings used to procure more medicines- improvement
of more than 80% in the availability of medicines at
health facilities.
 1997 to 2002- >80% of prescriptions by doctors- drugs
from EML, patients received 70–95% of the medicines
prescribed
http://www.who.int/medicines/services/essmedicines_def/en/Accessed on15/12/16
SNOW J, PATH I. The interagency list of essential medicines for reproductive health.
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25. OTHER COUNTRIES
 In 1977, a few months before WHO published the first EML,
Mozambique had already created its national pharmacopeia; a
list consisting of 430 essential medicines. The country has
managed to increase local access to medicines from 10% of
the population in 1975 to 80% in 2007.
 Srilanka created a medicines list for purchase by the state
health care system in 1959. In addition, the Ceylon Hospitals
Formulary was published providing information for the use of
these medicines.
 In 1960, Peru created a list of basic medicines in an attempt to
address at least the most pressing pharmaceutical needs of
the population. 1971-Basic Medicines Program- 1st national list
of essential medicines.
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26. EDL AND RATIONAL USE OF
MEDICINES
 The rational use of drugs requires that patients receive
medications appropriate to their clinical needs, in doses that meet
their own individual requirements for an adequate period of time,
and at the lowest cost to them and their community.
WHO conference of experts Nairobi, 1985
 Worldwide more than 50% of all medicines are prescribed,
dispensed, or sold inappropriately, while 50% of patients fail to
take them correctly
 Selection of essential medicines- improvement of the quality of
health care- appropriate use
 An analysis of prescription patterns between 1997 and 2003 -the
average number of medicines prescribed per clinic visit
decreased, as did the percentage of all medicines prescribed that
were antibiotics and injections; the percentage of all medicines
included in the essential medicines list being prescribed increased
by about 5%.
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27. KEM PHARMACY
 248 of the total 376 medicines included in NLEM is
available in KEM pharmacy.
 No medicines available for neonatal care (sec-24)
 No form of insulin and thyroid medicines
 No medicines used in dementia(donepezil)
 No levodopa+carbidopa for parkinsonism
 No medicines to treat gout(allopurinol, colchicine)
 <50% medicines available for TB, migraine,
antidotes, topical dermatological medicines,
ophthalmological medicines, psychotherapeutic
medicines and vitamins and minerals.
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28. FUTURE LISTS
 The 21st Expert Committee meeting will take place
at WHO Headquarters, Geneva, in March 2017
 The Expert Committee will revise and update the
WHO Model List of Essential Medicines (EML) and
Model List of Essential Medicines for Children
(EMLc).
http://www.who.int/selection_medicines/committees/en/
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29. CONCLUSION
A global concept
The concept of essential medicines is forward-looking.
It incorporates the need to regularly update medicines
selections to reflect new therapeutic options and changing
therapeutic needs; the need to ensure drug quality; and the
need for continued development of better medicines,
medicines for emerging diseases, and medicines to meet
changing resistance patterns.
Once thought of as relevant only in resource-constrained
settings, the WHO Model Lists are now seen as equally
relevant to high-, middle- and low-income countries,
particularly with the inclusion of new, highly effective and
expensive medicines in more recent years.
http://www.who.int/medicines/services/essmedicines_def/en/
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30. THANK YOU.
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