The document discusses essential medicines lists, noting that the World Health Organization first published an essential medicines list in 1977 which is updated every 5 years, and that countries like India also publish their own national essential medicines lists. It provides details on the history and revisions of India's National List of Essential Medicines, the criteria for including and excluding medicines from the list, and examples of common types of medicines included in essential medicines lists.
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Pharmacotherapeutics chapter 1 topic3 (EML).pptx
1. FACULTY OF PHARMACEUTICAL SCIENCE
PHARMACOTHERAPEUTICS ER20-24T
Chapter 1: Pharmacotherapeutics
Topic 3. Essential Medicines lists
Presented by- Ms. ALKA
Assistant Professor
FACULTY OF PHARMACEUTICAL SCIENCE
RAMA UNIVERSITY UTTAR PRADESH
KANPUR, INDIA
2023-2024
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Essential Medicines List
Essential Medicines (EM) are those that satisfy the healthcare needs of most of the population
and therefore should always be available in appropriate amounts and in appropriate dosage
forms.
History of EML
The first country in the World to compose its Essential Medicine List (EML) was Tanzania
in 1970.
WHO published the first EML in 1977, which has been updated successively every 5 years in
view of changing world scenario regarding the medical needs and availability of new and
better drugs. The first EML for Children was published in 2007 by WHO.
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In India, The Government of India, Ministry of Health & Family Welfare (MOHFW) is
mandated to ensure a quality healthcare system by assuring the availability of safe and
efficacious medicines for its population. MOHFW publishes the National List of Essential
Medicines (NLEM)
Ministry of Health and Family Welfare, Government of India hence prepared and released
the first National List of Essential Medicines of India in 1996 consisting of 279
medicines. This list was subsequently revised in 2003 and had 354 medicines. Later in 2011,
the list was revised and had 348 medicines. Till 2021, 399 medicines (including 4 medical
devices) are regulated under Revised Schedule – I based on the NLEM, 2015.
National List of Essential Medicines (NLEM)
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Sr. no NLE
M
No. of medicines
1. 1996 279
2. 2003 354
3. 2011 348
4. 2015 376
5. 2021 399
6. 2022 384 medicines (34 medicines have been added and 26
medicines have been deleted from NLEM, 2015)
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Salient features of the Latest NLEM 2015
1. There were 348 medicines listed in NLEM 2011. A total of 106 Medicines has been added,
and 70 medicines have been deleted to prepare NLEM 2015 which now contains a total of
376 medicines.
2. Medicines in NLEM are listed with reference to the levels of healthcare, namely, Primary
(P), Secondary (S) and Tertiary (T). There are 209 medicine formulations listed for all levels
of health care (P, S, T), 115 medicine formulations for secondary and tertiary levels (S, T)
and 79 medicine formulations for the tertiary level (T).
List of Sections of NLEM 2015
There are Total 30 Sections in NLEM 2015 (In NLEM 2011, there were 27 sections)
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Consideration
for Framing the
NLEM 2015
Public Health
Relevance
Clinical Efficacy
and Safety
Cost-effectiveness
Patient Accessibility
and Equity
Rational Drug
Use
Global and Regional
Guidelines
Healthcare
Infrastructure
Stakeholder
Engagement
Local Production
and Supply
Regular Review and
Update
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Selection criteria of Essential medicines
1. Be licensed/ approved in the country by the Drugs Controller General of India.
2. Be useful in disease which is a public health problem in India.
3. Have proven efficacy and safety profile.
4. Be comparatively cost-effective.
5. Be aligned with the current treatment guidelines for the disease.
6. Be stable under storage conditions.
7. While comparing more than one medicine of the same therapeutic class, prefer prototype or
best-suited medicine.
8. Considered the total treatment price not the unit price of a medicine.
9. Medicine in NLEM will be based on the P/S/T level of healthcare.
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Criteria for exclusion of medicine from NLEM
1. A medicine has been banned in India.
2. If any safety concerns are reported.
3. The criteria of safety, efficacy, and cost-effectiveness of any medicine were not fulfilled.
4. The disease burden for which medicine is indicated is no longer a national health concern.
5. In the case of antimicrobials, if the resistance pattern has rendered a medicine ineffective.
List of Essential Medicines: The list of essential medicines can vary by country and is
typically compiled and updated by national health authorities or international organizations
like the World Health Organization (WHO). These lists include medications that are
considered essential for addressing the most important health needs in each region or
globally. some examples of essential medicines include:
