1. Dr. Paresh Koli Guide: Dr. Yashashri Shetty
Essential Drug List
Dr. Paresh Koli
Guide: Dr. Yashashri Shetty

2. Approach History & Definition Usefulness Economic Impact
New Procedure in selection
WHO Model List of Essential Medicines
National List of Essential Medicines of India & its Weaknesses
State Essential Medicine lists
Price cap in Essential Medicines
EDL & Rational Drug Use
KEM Pharmacy
Final Words

3. History & Definition
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” 
First meeting held in 1977, the WHO Expert Committee on the Selection of Essential Drugs
“are of utmost importance, and are basic, indispensable and necessary for the health needs of the population” 
1982 – 1999
1999, Combine this description with the affordability concept

4. History & Definition (Cont.)
WHO Secretariat, report to the Executive Board of January 2002
Description of essential medicines - include three components:
Definition. Essential medicines are those that satisfy the priority health care needs of the population.
Selection criteria. disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness.
Purpose. Essential medicines 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 at a price the individual and the community can afford.
“disease prevalence” did not cover the use of preventive medicines and items for family planning and aspect of prevention be added to the “selection criteria” part of the description.
recommended the replacement of “disease prevalence” by “public health relevance” in the section on selection criteria
Many additions

5. History & Definition (Cont.)
WHO Secretariat in its report to the Executive Board (2001) highlighted - need for countries and institutions to develop their own list of essential medicines.
As stated by the Expert Committee at its meeting in 1999
essential drugs - flexible and adaptable to many different situations
exactly which drugs are regarded as essential remains a national responsibility
“disease prevalence” did not cover the use of preventive medicines and items for family planning and aspect of prevention be added to the “selection criteria” part of the description.
recommended the replacement of “disease prevalence” by “public health relevance” in the section on selection criteria, and the addition of “with adequate information” to the section on purpose and “implementation of” to the last sentence.

6. Full description
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. Essential medicines 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. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility.

7. Previous Lists Before WHO
Formulation of national drug lists s in countries such as Sri Lanka and Papua New Guinea,
1960s in Cuba and Peru
1970s in countries such as, Mozambique.
The Scandinavian countries and Tanzania had both adopted lists of essential medicines
Industrialised countries such as Canada and Australia practised selection of medicines
ANTEZANA F, SEUBA X. THIRTY YEARS OF ESSENTIAL MEDICINES: THE CHALLENGE [Internet]. 1st ed. Farmamundi - Servicios Centrales en Valencia; [cited 30 January 2015]. Available from:

8. How it is Useful
Most cost-effective elements in modern health care and their potential health impact is remarkable
In 2013 there were 40 million deaths in developing countries, one-third among children under age five
Ten million will be due to acute respiratory infections, diarrhoeal diseases, tuberculosis, and malaria
All conditions for which safe, inexpensive, essential drugs can be life-saving
Examples
Simple iron-folate preparations can reduce maternal and child mortality from anaemia of pregnancy
Treatment of STDs reduces transmission of the AIDS virus
Treatment of hypertension reduces heart attacks and strokes

9. A global concept Concept of essential medicines is forward-looking
Need to regularly update medicines selections to reflect new therapeutic options and changing therapeutic needs
Need to ensure drug quality
Need for continued development of better medicines, medicines for emerging diseases, and medicines to meet changing resistance patterns

10. Economic Impact
Impact of pharmaceuticals is substantial -- especially in developing countries
Spending on pharmaceuticals
< 1/5th of total public and private health spending in most developed countries
transitional economies - 15 to 30%
developing countries - 25 to 66%

11. New Procedures in 2002
Term “essential medicines” instead of “essential drugs”
More systematic approach to inviting and dealing with applications
More transparent process - including a systematic analysis of the evidence
Opportunities for interested parties to comment on both the application and its review to the Expert Committee
Full involvement of different WHO departments
Full scientific independence as it makes its final recommendations
term “essential medicines” instead of “essential drugs” to reflect the common use of the term “medicines” to describe pharmaceutical preparations used in clinical health care practice

12. New Procedures in 2002
Absolute cost of a medicine will not be a reason to exclude it from the Model List if it meets the stated selection criteria
Cost-effectiveness comparisons must be made among medicines within the same therapeutic group (e.g. for identifying the most cost- effective medicine treatment to prevent mother-to-child transmission of HIV).

13. Essential Medicines Library

14. Information to be included with an application
1. Summary statement of the proposal for inclusion, change or deletion 2. Name of the focal point in WHO submitting or supporting the application (where relevant) 3. Name of the organization(s) consulted and/or supporting the application 4. International Nonproprietary Name (INN, generic name) of the medicine 5. Formulation proposed for inclusion; including adult and paediatric (if appropriate) 6. International availability - sources, of possible manufacturers and trade names 7. Whether listing is requested as an individual medicine or as an example of a therapeutic group 8. Information supporting the public health relevance (epidemiological information on disease burden, assessment of current use, target population) 9. Treatment details (dosage regimen, duration; reference to existing WHO and other clinical guidelines; need for special diagnostics, treatment or monitoring facilities and skills) 10. Summary of comparative effectiveness in a variety of clinical settings 11. Summary of comparative evidence on safety 12. Summary of available data on comparative cost and cost-effectiveness within the pharmacological class or therapeutic group 14. Availability of pharmacopoeial standards (British Pharmacopoeia, International Pharmacopoeia, United States Pharmacopoeia, European Pharmacopeia) 15. Proposed (new/adapted) text that could be included in a revised WHO Model Formulary

15. WHO Model List of Essential Medicines
First published in 1977 & included 204 pharmaceuticals
Updated every 2 years
Since 2007, a separate list for children up to 12 years (WHO Model List of Essential Medicines for Children) has been released
18th edition for adults (30 cat.) and the fourth edition for children were released in April 2013 (with Amendments in Oct 2013)
More than 130 countries have created national essential medicines lists based on the WHO's model list. These lists contain between 334 and 580 medications.

16. The Interagency List of Essential Medicines for Reproductive Health
Lack of consistency between various United Nations agencies UNFPA/UNAIDS/WHO lists
36 "discrepancy medicines" which figured on one list but not on another
Published in 2006
Presents the current international consensus on rational selection of essential reproductive health medicines

17. National List of Essential Medicines of India
By GOI and MOHFW
First National Essential Drugs List in 1996
Revised in 2003 as the National List of Essential Medicines (NLEM)
new section on medicines for HIV-AIDS
new anti-cancer drugs
71 added and 3 removed in 2003 (compared to 1996)
Changes in categories of drugs
Allopurinol from NSAID to drugs to treat gout

18. NLEM 2011
The National List of Essential Medicines of India (NLEMI 2011) was revised recently by MOHFW & GOI, in June 2011, nearly eight years after the previous list, on the directions of the Supreme Court of India
Preparation for the list started as early as 16 September 2009
Published in 2011
348 drugs in total (deleted is 47 and 43 added compared to 2003)
Added new drugs indicated for Rx (cefixime, cetirizine) & removed older drugs (tetracycline)
Revision of NLEM was also based on the two important national reference documents i.e., Indian Pharmacopeia 2010 and National Formulary of India, 4th Edition, 2010.

19. Weaknesses in NLEM 2011 Improper selection of medicines
‘Ether' as a general anesthetic – no longer used
Pyridoxine as antianemic – idiopathic sideroblastic anemia (rare disorder)
 Including medicines of the same class which have no major advantages in efficacy and safety
omeprazole and ranitidine - pantoprazole and famotidine
cisplatin - oxaliplatin 
Non-alignment of the NLEMI with the National Health Programs and the National Formulary of India
Non-inclusion of pediatric formulations (Indian Academy of Pediatrics List of Essential Medicines for Children of India – in collaboration with WHO, 134 medicines)
Errors of medicine formulation strengths & Incomplete medicine information 
National diarrheal disease control program (as per IMNCI*) Dispersible zinc tablets 20 mg Zinc syrup 20 mg/5ml
IMNCI guidelines for pneumonia Amoxycillin - tablet 150 mg and syrup 125mg/5ml Amoxycillin powder for suspension (125mg/5ml) Capsules 250 mg and 500 mg
Cetirizine Syrup 5 mg/ml (NLEM), 5 mg/5ml or 1 mg/ml (correct)
Ondansetron Syrup 2 mg/ml, 2 mg/5ml
(ORS) for which the strength is mentioned as ‘As per IP’. As there are many types of ORS (low osmolality, rice based and high osmolality), the exact constituents should be specified
Gitanjali B, Manikandan S. National list of essential medicines of India: The way forward. Journal of Postgraduate Medicine. 2012;58(1):68.

20. State lists
THE ESSENTIAL MEDICINES LIST, Government of NCT of Delhi (8th edition with 152 medicines)
Gujarat - Essential Drugs List
Primary Health Care (PHC, Sub Centres and Others)-(249)
Secondary Health Care (CHC & T.B. Hospitals)-(366)
Tertiary Health Care (Districts, Sub-Districts & Medical Colleges)-(538)
Chhattisgarh, Rajasthan, Madhya Pradesh, Uttarakhand, Orissa, Meghalaya
No list for Maharashtra
 Delhi.gov.in. THE ESSENTIAL MEDICINES LIST Government of NCT of Delhi 2013 [Internet] [cited 30 January 2015]. Available from:
Gmscl.gujarat.gov.in. Essential Drugs List [Internet] [cited 30 January 2015]. Available from:

21. Future Lists
WHO - 20th Expert Committee on the Selection and Use of Essential Medicines
WHO Headquarters, Geneva, April 2015
India
New list after NLEM 2011
Meeting in Nov. 2014

22. Price cap in Essential Medicines
National Pharmaceutical Pricing Policy (NPPP) in 2012 
Drugs Price Control Order (DPCO) 2013
mechanism for price fixing, the issue is still under the scrutiny of the Supreme Court
National Pharmaceutical Pricing Authority (NPPA)
All NLEM under price cap (60% of total sales)
Ceiling price of an essential drug will be the simple average of all brands with a market share of at least 1 per cent.

23. EDL & Rational Drug Use
Essential drug list – Twelve core interventions to promote more rational use of medicines
Study in China
National Essential Medicine System (NEMS) is a new policy in China launched in 2009
average number of drugs per prescription decreased from 3.64 to 3.46
percentage of prescriptions including antibiotics decreased from to 58.48%
Song Y e. The impact of China’s national essential medicine system on improvi... - PubMed - NCBI [Internet]. Ncbi.nlm.nih.gov [cited 29 January 2015]. Available from:

24. Other Countries
In Palestinian Ministry of Health introduced an essential medicines list
Analysis of prescription patterns between 1997 and 2003
Effective in improving prescribing indicators of appropriate use of medicines
average number of medicines prescribed per clinic visit decreased,
percentage of all medicines prescribed that were antibiotics and injections
percentage of all medicines included in the essential medicines list being prescribed increased by about 5%
Hutchings J, Neroutsos K, Donnelly K. Making the List: The Role of Essential Medicines Lists In Reproductive Health. IPSRH. 2010;36(04):

25. KEM Pharmacy List of drugs for free 157 drugs 105 Tabs 22 mixtures
19 ointment, power, lotion, liniment
11 ENT preparation
Out of stock
New list

26. Final Words Revision of list like WHO Making drugs available
KEM pharmacy
Price control – Help patients

27. Thank You