|Year : 2023 | Volume
| Issue : 1 | Page : 1-5
Concept of essential medicines and recent updates
Shreya Gupta, J Kumaravel, Ajay Prakash, Bikash Medhi
Department of Pharmacology, PGIMER, Chandigarh, India
|Date of Submission||21-Feb-2023|
|Date of Acceptance||23-Feb-2023|
|Date of Web Publication||20-Mar-2023|
Department of Pharmacology, PGIMER, PN Chuttani Block (Research Block B), Sector 12, Chandigarh - 160 012
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Gupta S, Kumaravel J, Prakash A, Medhi B. Concept of essential medicines and recent updates. Indian J Pharmacol 2023;55:1-5
| » Introduction|| |
According to the World Health Organization (WHO), essential medications are those that meet the majority of the population's medical needs and are chosen as per their relevance in public health and on the existing evidence of their efficacy, safety, and comparative cost-effectiveness. One of the most important tools for enhancing the quality and equitability of access to health care is the availability of a small number of properly chosen necessary medicines within the framework of operating health systems. In order to assist countries in creating their own lists, the WHO issued its first Model List of Essential Medicines (EML) back in 1977, and the latest one was released in 2021 which is the 22nd EML by WHO. India formulated its own list in 1996, then the same amended in 2003, 2011, then 2015 and the latest list was released in month of September, 2022.
A study was conducted by Narayan et al. in 2015 regarding the comparative analysis of the list of essential medicines of three states (Bihar, Rajasthan and Tamil Nadu) from India. The author highlighted different patterns of EML among the 3 states, with varying number of medications included in the state lists. Since, the availability of drugs, prescription trends, and responsible drug use are all impacted by this, proper implementation of EML across the nation requires in-depth discussion and consultative strategizing to improve uniformity and coherence across the state lists, which would in turn enhance accessibility and affordability of essential medicines.
|Table 1: Comparison of NLEM (2011, 2015 and 2022) between number of drugs in their respective classes with WHO EML 2021,,,|
Click here to view
| » History of EML|| |
The first country to construct its own EML was Tanzania in the year 1970. From 1975, the WHO began assisting its member countries to identify essential medicines catering to their country-specific needs, thereby assuring their availability at the best quality and reasonable cost. In 1977, the first EML was published by the WHO, which included 186 medicines and was formulated as a template for its member nations. In 1978 the Alma Ata conference was held in which essential medicines were recognized as one of the eight key components of primary health care. However, until 1991, the criteria for including medicines in EML were not well defined and were mainly based on recommendations given by the WHO program staff and pharmaceuticals. In 2002, this changed and an evidence-based approach came into being with regard to efficacy, safety, cost-effectiveness, and relevance to public health. Over the past decades, with the increase in disease burden and diversity, the number of drugs in WHO EML kept on increasing and a similar trend can be observed with the NLEM of India as well.,Inclusion of a drug in the NLEM also means that its price gets regulated, as per the directions of the Hon' Supreme Court of India, making essential medicines much more affordable to the public at large.
| » Criteria for Formulating National List of Essential Medicine|| |
The following factors and considered while formulating and updating NLEM:
- Demographic profile of most prevalent communicable/noncommunicable disease burden and likely future trends
- Evolution of pathogens in diseases like dengue, influenza-like H1N1, H5N1 etc.,
- Evolution of drug resistance in diseases posing public health concerns such as TB, HIV, and other sexually transmitted diseases
- Limiting out-of-pocket expenditure on medicines to reduce the financial burden on households
- Balancing cost-effectiveness of included drugs and public health requirements, in terms of disease burden, efficacy, and safety concerns
- Making healthcare accessible, affordable, and acceptable to all sectors of the population, including migrant workers, workers in unorganized sectors, and agriculture-dependent population.
| » Benefits of National List of Essential Medicine|| |
NLEMs serves many purposes and is an integral part of various health care initiatives launched by the Government of India, such as Jan Aushadhi Yojana, AMRIT Pharmacies, Ayushman Bharat, and the National Health Mission. This helps ensure rational, effective, and, most importantly, safe use of medicines, especially for the treatment of priority illnesses, by optimizing the available resources of India. Further, the National EML actually serves as the guidance document for the State governments for the preparation of their respective lists. It also aids in formulating the Standard Treatment Guidelines and in preparing various hospital formularies. NLEM also plays an important role in procuring and supplying the required medicines in both public and private sector hospitals, and in cases of reimbursement by employers and insurance agencies. The drugs included in the NLEM are part of the “must know” curriculum in the training of health-care professionals, including doctors, dentists, nurses, physiotherapists, optometrists, and pharmacists.
| » National List of Essential Medicine 2022|| |
- The first national list of India was released in the year 1996. After this, the list was revised in 2003, 2011, and 2015. The NLEM 2022 was released on September 13, 2022. While NLEM 2015 contained 376 medicines, NLEM 2022 contained 384 medicines. Thirty-four medicines have been added from the last list and 26 medicines were deleted. Out of the included medicines, 342 belong to one therapeutic category, 41 medicines appear in two therapeutic categories, 11 medicines appear in three therapeutic categories, and 4 medicines appear in four categories
- In NLEM, medicines are divided by health-care setups into primary (P), secondary (S), and tertiary (T) health-care facilities. Thirty-five such medicines, which were initially used mainly in tertiary care setups only, have now also been included under secondary setups
- Based on the national list, the respective state governments modify their lists as well. Further, all government and private hospitals are supposed to formulate their individual lists for their formulary as per the state and national EMLs, giving special consideration to any disease which may be more prevalent or endemic in the particular area
- Furthermore, the need for novel drug delivery systems and formulations has been recognized and was included in NLEM 2022
- Only those fixed drug combinations have been included, which have proven advantages over individual drugs with respect to their efficacy, safety, and compliance
- The antimicrobials included in the NLEM have been done so taking into consideration the AWaRe (Access, Watch and Reserve) classification of antimicrobial agents included in WHO Essential Medicine List of 2019. Out of the 19 antibiotics included in the 'Access' subgroup of the WHO EML 2019, 16 have been included in NLEM 2022. Similarly, out of the 12 antimicrobials included in the Watch category, 11 drugs are included, and out of the 7 antimicrobials included in the Reserve (Aware) category, 1 agent is listed in NLEM 2022.,,
- Few medicines were also added for the new section for the treatment of COVID-19 such as dexamethasone, enoxaparin, methylprednisolone, paracetamol, and oxygen.
| » Inclusion of Coronary Stents in National List of Essential Medicine 2022|| |
As per the Ministry of Health and Family Welfare's notification dated November 10, 2022, the recommendation put forth by the Standing National Committee on Medicines on the inclusion of coronary stents in NLEM was accepted, as per the following categories:
- Bare metal stents
- Drug-eluting stents (DES), also including metallic DES and Bioresorbable Vascular Scaffold/Biodegradable stents.
This move was based on the recommendations of the expert committee, with the aim to fix the pricing of coronary stents by the National Pharmaceutical Pricing Authority.
| » References|| |
National List of Essential Medicines (NLEM): Ministry of Health and Family Welfare: GOI. Ministry of Health and Family Welfare | GOI. (n.d.); 2022. Available from: https://main.mohfw.gov.in/newshighlights-104
. [Last retrieved on 2023 Feb 02].
Narayan V, Chokshi M, Hasan H. A comparative review of the list of essential medicines of three Indian states: Findings and implications. Int J Med Public Health 2015;5:71-6. [Full text]
Laing R, Waning B, Gray A, Ford N, 't Hoen E. 25 years of the WHO essential medicines lists: Progress and challenges. Lancet 2003;361:1723-9.
National List of Essential Medicines (NLEM): Ministry of Health and Family Welfare: GOI. Ministry of Health and Family Welfare | GOI. (n.d.); 2015. Available from: https://main.mohfw.gov.in/newshighlights-104
. [Last retrieved on 2023 Feb 04].
National List of Essential Medicines (NLEM): Ministry of Health and Family Welfare: GOI. Ministry of Health and Family Welfare | GOI. (n.d.); 2011. Available from: https://main.mohfw.gov.in/newshighlights-104
. [Last retrieved on 2023 Feb 04].
[Table 1], [Table 2], [Table 3]