The National List of Essential Medicines (NLEM) for India is developed based on disease burden and priority health concerns to guide treatment, promote rational medicine use, and optimize health resources, with the first list created in 1996 and revised lists issued in 2003 and 2015; the NLEM categorizes medicines by treatment levels and therapeutic areas, and provides criteria for inclusion based on approval, efficacy, safety, cost-effectiveness, and guidelines as well as criteria for deletion if a medicine is banned, raises safety concerns, or if a better treatment exists.

1. National Lists of Essential
Medicines (NLEM)
Sudipta Roy
Associate Professor
East Point College of Pharmacy

2. Objectives.
• The WHO EML is a model list. The decision about which
medicines are essential remains a national
responsibility based on the country's disease burden ,
priority health concerns, affordability concerns etc.
• 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.The list was subsequently revised in 2003
and had 354 medicines (including 4 medical devices i.e.
Cardiac stents , drug eluting stents , condoms and intra
uterine devices) , are regulated under Revised Schedule
-I based on National List of Essential Medicines , 2015.
(NLEM, 2015)

3. Purpose of the National List of
Essential Medicines.
• The NLEM may multiple uses. It can :
• Guide safe and effective treatment of priority disease conditions
of a population.
• Promote the rational use of medicines
• Optimize the available health resources of country , it can also be
a guiding document for :
• 1. State governments to prepare their list of essential medicines.
• 2. Procurement and supply of medicines in the public sector.
• 3. Reimbursement of cost of medicines by organizations to its
employees.
• 4. Reimbursement by insurance companies.
• 5. Identifying the 'Must Know' domainn for the teaching and
training of health care professional.

4. Salient Features of NLEM 2011
• The medicines have been categorized according to therapeutic
area. Therefore it is possible that a medicine with more than one
indication appears in more than one category.
• The issue of mentioning the strength of the medicine dose was
delberated. The committee took the considered view that the
srtength should be mentioned in the NLEM. For essentiality of
requirement the have been categorised as follows - P , S, and T
denote essentiality at Primary, Secondary and Tertiary levels
respectively while P, S, T (U in NLEM 2003) indicates essentiality
at all levels. A total of 348 medicines (excluding repititions) are
present in NLEM 2011, 181 medicines fall under the category of P,
S, and T , 106 medicines fall under the category of S, T while 61
medicines are categorized as T only. In comparison to NLEM 2003,
number of medicines deleted is 47 and 43 medicines have been
added.

5. Core Committee Meetings
• a. The first meeting was held at CDSCO, FDA
Bhawan on July 22, 2010
• b. The second meeting was held CDSCO, FDA
Bhawan on January 4, 2011.
• The third meeting was held at CDSCO , FDA Bhawan
on 31st Jan, 2011.

6. National Consultation Meetings.
• The first consultation meet was held on September
16, 2009 at Department of Pharmacology , AIIMS ,
New Delhi.
• The second National consultation meet was held on
December 3-4 , 2010 at Department of
Pharmacology , AIIMS, New Delhi.
• Other Deliberations :
• A dedicated session on National Essential Medicine
List was organized during 42nd Annual Conference
of Indian Pharmacological Society, on 11th
December , 2009 at Swabhumi, Kolkata.

7. Criteria for Inclusion of Medicine
in NLEM 2015.
• The criteria are as follows
• 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.
• When more than one medicine are available from the same therapeutic class,
preferably one prototype/medically best suited medicine of that class to be included
after due deliberation and careful evaluation of their relative safety, efficacy, cost-
effectiveness.
• Price of total treatment to be considered and not the unit price of a medicine .
• Fixed Dose Combinations (FDCs) are generally not included unless the combination
has unequivocally proven advantage over individual ingredients administered
separtely , in terms of increasing efficacy , reducing adverse effects and or improving
compliance.

8. • The listing of medicine in NlEM is based according
to the level of Health care, i.e. Primary (P) ,
Secondary (S) , and Tertiary (T) because the
treatment facilities, training , experience , and
availability of health care personnel differ at these
levels.

9. • Criteria for deletion of a medicine from NLEM 2015 :
• The medicine has been banned in India.
• There are reports of concerns on the safety profile of a
medicine.
• A medicine with better efficacy or favourable safety
profiles and better cost-effectiveness is now available.
• The disease burden for which a medicine is indicated is
no longer a national health concern in India.
• In case of antimicrobials if the pattern has rendered a
medicine ineffective in Inian context.

10. Questions and Answers.
• Explain National List of Essential Medicines (NLEM).
• What are criteria for deletion of a medicine from
NLEM 2015?
• Give the purpose of the National List of Essential
Medicines?
• What are the objetives of the National
Pharmaceutical Pricing Authority?