VIJAYA COLLEGE OF

PHARMACY

Subject : Pharmaceutical Jurisprudence

Name : BANNE RAJU

ROLL NO : 20Y61R0060
Learning objectives

 Introduction to Essential Medicines

 National list of medicines (NLEM)
 Objectives
 Purpose of the National list of Essential Medicines
 NLEM : 2022
 Criteria for inclusion and deletion of Medicines
 Medicines in NLEM 2005,2011, and 2022
 INTRODUCTION TO ESSENTIAL MEDICINES

 Essential medicines are those that satisfy the priority healthcare needs of majority of the population.
 The first country in the world to compose its Essential Medicines List (EML) was Tanzania in 1970.
 Subsequently, the concept of essential medicines was introduced by WHO in 1977.
 In nineties, WHO EML was recognised as important guiding document mainly for the public sector for the
procurement, distribution, rational use and quality assurance of medicines.
 INTRODUCTION TO ESSENTIAL MEDICINES

 It has now been adopted by many countries, non-governmental organizations and international non-profit
supply agencies.
 The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of
the medicines.
 It considers the standard treatment guidelines (STG) keeping in mind the healthcare needs of the majority of the
population.
 Medicines listed in the EML are intended to be available in adequate amounts, in appropriate dosage forms and
strengths with assured quality and the cost that an individual or community can afford.
 Careful selection of a limited range of essential medicines results in a higher quality of care, better
management of medicines and more cost-effective use of health resources.
 National List of Essential Medicines (NLEM)

 The Govt of India, MOHFW is mandated to ensure the

 Quality Healthcare system by assuring availability of safe and efficacious medicines for its population.
 With the aim of Promotional of Rational use of medicines on the basis of Cost, safety and efficacy and to
promote prescription by generic names.
 GOI has been preparing List of Essential medicines in 1966, which comprises of 279 medicines.
National List of Essential Medicines (NLEM)

 To address the issues of :

 Changing disease prevalence
 Treatment modalities
 Introduction of newer medicines
 Identification of Unacceptable Risk-Benefit Profile.
 Therapeutic profile of some medicines.
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 s (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)
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.
Purpose of the National List of Essential
Medicines

 The list of essential medicines should act as guide to formulate hospital drug policies,
procurement and supply of medicines in public sector, medicine cost reimbursement and
medicine donations.
 It helps in monitoring the pricing of medicines.
 This list serves as a reference document for correct dosage form and strength for
prescribing.
 Use of NLEM is expected to improve prescribing practices as well as the health outcomes
NLEM-2022: Highlights

 LATEST VERSION OF NLEM

 The WHO regularly updates its list every two years and the current WHO Model List of
Essential Medicines was released on 2021. India developed its first national list of
essential medicines (NLEM) in 1996. NLEM 2015 was revised and released as the fifth
list in September 2022 (NLEM 2022).
 384 drugs have been included in this list with addition of 34 drugs
 While 26 from the previous list have been dropped
 The medicines have been categorized into 27 therapeutic categories
 NLEM

 National List of Essential Medicines (NLEM) are those that satisfy the priority healthcare
needs, based on: efficacy, safety, quality and the total cost of treatment.
 The purpose of the list is to ensure safety, quality, affordability and accessible of medicines for
the population.
 In India, the essential medicines list is categorized based on medicines at primary, secondary,
and tertiary healthcare levels.
A significant criteria for inclusion in NLEM is
based on

 1. The medicine shall be useful in diseases that is a public health problem in India
 2. The medicine shall be licensed/approved by the Drugs Controller General of India
(DCGI)
 3. It shall have proven efficacy and safety profile based on scientific evidence
 4. It should be comparatively cost effective and aligned with the current treatment
guidelines
 5. The medicine shall be recommended under National Health Programs of India
A significant criteria for inclusion in NLEM is
based on

 6. When more than one medicine are available from the same therapeutic class, one
prototype/medically best suited medicine of that class to be included
 7. The price of total treatments shall be considered and not the unit price of a medicine
 8. The fixed dose combinations are usually not included
 9. In case of vaccines, It is as and when it is included in Universal Immunization Programme
The criteria for deletion from NLEM is based
on:

 1. The medicine has been banned in India

 2. If there are reports of concerns on the safety profile
 3. If medicine with better efficacy or favourable safety profile and better cost-effectiveness is
now available
 4. The disease burden for which medicine is indicated is no longer a national health concern
 5. In case of antimicrobials, if the resistance pattern has rendered an antimicrobial
ineffective
Medicines in NLEM 2011,2015,and 2022
NLEM Flow chart :
NLEM For Antimicrobials drugs

 For the antimicrobial drugs, the World Health Organization (WHO) has
classified anti-microbials as Access, Watch and Reserve group.
 In Indian context, though the committee did not specify as Access, Watch
and Reserve in NLEM 2022, but a similar philosophy of WHO antimicrobial
classification was kept in mind for the list.
NLEM For Anticancer drugs

 For the anticancer drugs, with advancement in treatment and affordability being an issue,
out of 42 non-NLEM Trade Margin Rationalisation (TMR) drugs, there are now four in
NLEM.
 "Four Anti-cancer drugs have been added to the list like Bendamustine Hydrochloride,
Irinotecan HCI Trihydrate, Lenalidomide and Leuprolide acetate, these medicines are
effective in various types of cancers and these are affordable also,"
NLEM For Fixed dose combinations

 For the fixed drug combinations, although, many antibiotic FDCs with
multiple antibiotics, analgesics, vitamins, minerals, etc have been banned,
there are still many combinations in the market with doubtful rationality.
 Though, the committee wish to publish a negative list of such disease, it is
restricting itself as the list will become only example and cannot be
exhaustive.
NLEM: Still under patent drugs

 NLEM 2022 also mentions four drugs which are still under patent, namely

 Delamanid
 Bedaquiline
 Dolutegravir
 Daclatasvir
List of medicines removed from NLEM 2022
(total 26)

 1. Alteplase  9. Erythromycin
 2. Atenolol  10. Ethinylestradiol
 3. Bleaching Powder  11. Ethinylestradiol(A) Norethisterone (B)
 4.Capreomycin  12.Ganciclovir
 5. Cetrimide  13. Kanamycin
 6. Chlorpheniramine  14. Lamivudine (A) + Nevirapine (B) + Stavudine
 7. Diloxanide furoate (C)
 8. Dimercaprol  15.Leflunomide
List of medicines removed from NLEM 2022
(total 26)

 16. Methyldopa
 17. Nicotinamide  22. Ranitidine

 18. Pegylated interferon alfa 2a, Pegylated  23. Rifabutin

interferon alfa 2b  24. Stavudine (A) + Lamivudine (B)
 19. Pentamidine  25. Sucralfate
 20. Prilocaine (A) + Lignocaine (B)  26. White Petrolatum
 21. Procarbazine
Thank you….