Comparison Between Latest National Essential Medicine List and Latest WHO Essential Medicine List

Introduction

Essential medicines, as defined by the World Health Organization (WHO), are the medicines that satisfy the priority healthcare needs of the population.¹ The first ‘Essential Medicines List’ (EML) was published in 1977, and the WHO Model Lists of Essential Medicines are updated every two years by the Expert Committee on Selection and Use of Essential Medicines.² Since its inception, the WHO EML has been revised periodically to incorporate new scientific evidence, address emerging health challenges, and reflect changes in treatment practices. The EML is updated every two years, with the latest revision being the 23rd edition released in 2023.³ This regular updating process ensures that the list remains relevant and continues to guide countries in the selection of essential medicines.

Similarly, the development of the National Essential List of Medicines (NELM) allows countries to adapt the WHO EML recommendations to their specific health contexts. In India, the NELM was first introduced in 1996 with the publication of the first list.⁴ Since then, the Indian NELM has undergone several revisions to address changing health priorities and the availability of new treatments. Key revisions occurred in 2003, 2011, 2015 and 2019 with the most recent update being the 2022 edition.⁵ These updates reflect ongoing efforts to align the national list with global standards, while considering local health needs and resource constraints.

The WHO EML and the Indian NELM both play pivotal roles in guiding medicine procurement and ensuring the availability of essential treatments. However, variations between the two lists can highlight differences in priority setting, medicine access, and healthcare quality. Other factors such as disease prevalence, evidence on efficacy and safety and comparative cost effectiveness are also considered.⁶ Comparing the WHO EML with the Indian NELM offers valuable insights into how national policies align with international standards and identifies potential areas for improvement in medicine management and healthcare delivery.

This article aimed to provide a detailed comparison of the WHO EML and the Indian NELM, examining their current practices and implications for public health. By exploring these lists, we seek to identify best practices and opportunities for enhancing the effectiveness of essential medicine management both globally and locally.

Materials and Methods

Study Design

This study employed a comparative analysis approach to evaluate and contrast the WHO Essential Medicines List (EML) and the Indian National Essential Medicines List (NELM). The analysis focused on its content, and coverage of both lists to identify similarities and differences.

Data Collection

WHO EML Data

The most recent edition of the WHO EML, the 23rd list published in 2023, was accessed via the WHO website.³ Previous editions of the WHO EML were also reviewed to understand the evolution of the list over time.

Indian NELM Data

The Indian National Essential Medicines List was reviewed in its 2022 edition, the most recent update.⁵

Comparison Criteria

Content Analysis

• Medications listed in both the WHO EML and Indian NELM were categorized and compared based on therapeutic categories, indications, and drug classes.

• The scope of medicines covered by both lists was analysed to determine the extent of alignment and gaps in treatment options.

Data Analysis

• Quantitative analysis: Manual analysis was conducted to compare the number of medicines listed, the overlap between the WHO EML 2023 and Indian NELM 2022.

• Qualitative analysis: Descriptive analysis was used to evaluate the rationale behind the inclusion and exclusion of specific medicines, as well as to assess the implications of these decisions for public health and healthcare delivery.

Results

Content Analysis

After analysing WHO and NLEM essential medicine list, the following results were obtained. WHO essential medicine list 2023 had 502 medicines and NLEM 2022 had 384.

Infectious diseases (174, 33%), followed by cardiovascular system (100, 19%), antineoplastic immunomodulators (86,16%), central nervous system (62, 12%), immunological and vaccines (30, 6%), hormones and endocrines (29, 6%), respiratory system (21, 4%), GIT (20, 4%) were allocated to the essential medicines list in descending order in the latest WHO essential medicines list 2023, which is graphically illustrated in Figure 1.

Infectious diseases (108, 33%), followed by cardiovascular system (54, 17%), antineoplastic immunomodulators (63, 19%), central nervous system (37, 11%), immunological and vaccines (18, 6%), hormones and endocrines (24, 7%), respiratory system (14, 4%), GIT (7, 2%) were allocated to the essential medicines list in descending order in the latest NLEM 2022 essential medicines list, which is graphically illustrated in Figure 2.

The medications included in both the lists were compared and the differences were noted as below.

Qualitative Analysis (Comparing WHO EML and Indian NELM)

The WHO EML establishes a global standard for essential medicines that should be accessible within all health systems. It divides medicines into two categories: Core (essential for fundamental healthcare) and Complementary (requiring specialized care or monitoring). This list reflects global disease trends and encompasses treatments for communicable diseases, non-communicable diseases (NCDs), reproductive health, and mental health. The NLEM is specifically designed to cater to India’s healthcare requirements and disease burdens. While it aligns with the WHO’s fundamental framework, it also includes medications that target diseases prevalent in India, such as tuberculosis, leprosy, and malaria. The NLEM addresses local priorities including affordability, healthcare costs, and the accessibility of generic medications. Both lists emphasize the inclusion of medicines vital for tackling significant health challenges, including infectious diseases (e.g., HIV, tuberculosis, malaria) and NCDs like diabetes, hypertension, and cancer. Both the WHO and NLEM prioritize medicines that demonstrate proven safety, efficacy, and quality. The promotion of generic alternatives is crucial for enhancing accessibility and affordability, especially in resource-limited settings. The further safety and efficacy is strictly monitored by pharmacovigilance authorities in India. The Central Drugs Standard Control Organization (CDSCO) releases reports of quality and also safety, efficacy and steps that can be taken to ensure better outcome. A fundamental aspect of both lists is their focus on cost-effective therapies, ensuring that essential medi cines remain affordable for the population. In India, the price of essential medicines is regulated by the National Pharmaceutical Pricing Authority based on yearly change in wholesale price index.

Similarities and differences in Drug Categories Between WHO EML (2023) and Indian NLEM (2022)

Here an attempt was made to compare the medication classes used in the treatment of major prevalent diseases/ problems in India.

Anti-Infective Medicines

The WHO EML emphasizes antibiotic stewardship, employing the AWARE (Access, Watch, Reserve) framework to combat antimicrobial resistance (AMR).⁷ This system encourages appropriate antibiotic use, categorizing them based on their usage frequency to prevent overuse of stronger antibiotics. Indian NLEM does not mention about AWARE classification, but has been discussed in the meeting. Classifying the drugs based on aware classifications could help clinicians to use antibiotics appropriately and also to combat microbial resistance. WHO list mentions first line uses of most antibiotics for readers or for clinicians’ purpose, but Indian NLEM does not mention them. Both lists focus on various infectious diseases in common, such as tuberculosis, HIV, malaria, leprosy, hepatitis {B,C}, parasitic diseases and fungal diseases. WHO list includes diseases such as trypanosomiasis, Ebola virus, which are prevalent in other parts of the world but not common in India. In the same context, our list includes diseases such as filariasis and schistosomiasis which are not included in the WHO list. While addressing antimicrobial resistance, the NLEM places a greater emphasis on local concerns, particularly tuberculosis, malaria and leprosy. Tuberculosis is an important infectious disease, with India contributing to 28% of global burden. Hence both lists emphasize on effective treatment of tuberculosis.

After Standing National Committee on Medicines (SNCM) meeting, Indian NLEM recently included newer anti-TB drugs, such as Bedaquiline and Delamanid in line with WHO list.^8,9 Both these drugs are especially helpful in combating multi-drug resistant (MDR) and extensively drug resistant (XDR) TB. The present National tuberculosis elimination programme includes both of these drugs. WHO list mentions various f ixed drug combinations (FDC) used in tuberculosis whereas in Indian NLEM, first line drugs are mentioned as monotherapy format only. This is not complying with the National Tuberculosis Elimination Programme (NTBEP) which emphasizes clinicians to use combined therapy to prevent resistance.¹⁰

HIV infection is a significant global issue. Therefore, both lists give equal importance to various FDCs used in HIV infection. In the new Indian NLEM list, there is an inclusion of Tenofovir, Lamivudine, and Dolutegravir (FDC). Dolutegravir-based regimen has fewer side effects and is less toxic. It has also demonstrated superior efficacy in suppressing viral load and acts as a barrier to the development of resistance. Therefore, it is added as a first-line regimen along with Tenofovir, Lamivudine for people living with HIV, aged more than 10 years, weighing more than 30 kgs. The 11^th WHO list mentions Cotrimoxazole while the Indian NLEM does not mention it for treating opportunistic infections in HIV, such as Pneumocystis jiroveci. Cotrimoxazole is the first line drug in HIV opportunistic infection, especially for Pneumocystis jiroveci. This does not comply with National AIDS Control Organisation (NACO) guidelines. Most of the other drugs for treating opportunistic infections in HIV have been added in both the lists.

Medications to treat Hepatitis B and C, such as Daclatasvir, Tenofovir-Alafenamide Fumarate have been added recently to Indian NLEM considering their high efficacy. WHO list contains the FDCs of Sofosbuvir. However, the cost of marketing in India may have been a barrier for their inclusion. In India, the availability of essential medicines is distributed in primary, secondary and tertiary care centers. Considering the cost of transportation and economic issues, there might be difficulty in ensuring access to these medications for all patients. For example, Inj. Ceftriaxone and Cefotaxime are categorised under secondary and tertiary setup only. These antibiotics are very helpful in treating many bacterial infections. Therefore, such common medications should be made available in primary healthcare setup also. By including the drugs in primary healthcare setup, there will be minimization of transport cost to the patient, proper utilization of healthcare resources at the nearest, minimization of out of pocket expenditure and reduced OPD/IPD burden at tertiary care centres.

Anticancer Drugs

In a recent global survey, the highly preferred anticancer drugs were studied. These anticancer drugs covered most prevalent cancers across the globe including India. Notably, all of these anticancer drugs are included in both the lists. This indicates that both WHO EML and Indian EML increasingly emphasize oncological drugs, listing wider essential chemotherapy and biologic agents. WHO list clearly mentions the indications of chemotherapeutic drugs, while the Indian NLEM does not mention them. While also focusing on cancer, the NLEM highlights cost-effective treatments available in India, including generic versions of drugs like Methotrexate and Cisplatin. Out of the 42 non - NLEM Trade Margin Rationalism (TMR) drugs, four have now been included in NLEM 2022.⁸ These newly added anticancer medications are: Bendamustine hydrochloride, Irinotecan HCl trihydrate, Lenalidomide, and Leuprolide acetate. These drugs will now fall under the purview of the National Pharmaceutical Pricing Authority, making them more affordable to cancer population.¹² The main drawbacks among anticancer drugs are cost and availability, as many are expensive and may not be accessible to patients from all economic backgrounds. The NLEM takes into account both the cost as well as efficacy of drugs that can be considered for addressing most common cancers in the population.

Cardiovascular Medicines

The WHO EML clearly explains the regimens and formulations categorising them according to various conditions such as hypertension, heart failure, arrythmias. In the WHO, medications like ACE inhibitors are listed under both antihypertensives and medicines used for heart failure. Whilst in Indian NLEM, ACE inhibitors are only listed under the heading of ‘Treatment of Hypertension’ but not for the treatment of heart failure. ACE inhibitors are considered first line drugs for heart failure and should have been mentioned. Beta blocker such as Metaprolol is listed under the treatment of angina but not under the treatment of heart failure. This confusion can be avoided by classifying and repeating the drugs under the useful indications. The WHO list includes a few medications that are not part of the Indian NLEM (For example, Hydralazine for severe pregnancy-induced hypertension). This is because better alternatives, such as Methyldopa, are included in the Indian list instead. The Indian NLEM features widely used cardiovascular drugs such as Amlodipine, Losartan, and Hydrochlorothiazide, reflecting the high incidence of hypertension in India. It prioritizes treatments for ischemic heart disease and heart failure, focusing on affordable generics like Clopidogrel. The new list contains Enalapril and Ramipril which are efficacious drugs in hypertension with cardiological protection.¹³

Mental Health and Neurological Disorders

Both the lists include antidepressants, antipsychotics, mood disorders and psychoactive substance abuse treating drugs. Substance use is prevalent across the world with opioids being the major contributors.¹⁴ Drugs in the treatment of opioid use such as Buprenorphine and Buprenorphine-Naloxone combinations are listed in the new version of NLEM. According to the recent research, tobacco use is increasing in India with a prevalence of 34% in the age group of 20-60 years.¹⁵ Tobacco use is increasingly common among patients with psychiatric diseases. The earlier Global Adult Tobacco Survey, from 2016, also had supported these findings, reporting a tobacco use prevalence of 28.6%.¹⁶ New NLEM 2022 has focused on the treatment of Nicotine replacement therapy for tobacco use disorder. Bupropion and Varenicline are also first line drugs which are missing from NLEM 2022 and could have been added.¹⁷

Antidiabetic Medications

Diabetes has been a historical burden for years, with increasing incidence. Recently, in line with WHO 2023 list, Insulin Glargine and Teneligliptin were added to the Indian NLEM 2022. Teneligliptin is considered a first line therapy in diabetes.¹⁸ Teneligliptin is a special gliptin due to its cost-effectiveness and its proven efficacy in reducing HbA1c, fasting plasma glucose (FPG), and postprandial glucose (PPG). It is associated with fewer glucose fluctuations and a lower incidence of hypoglycaemia.¹⁹ Indian NLEM presently contains four insulin analogues, NPH (Neutral Protamine Hagedorn), Soluble, Glargine, Premixed insulin at all healthcare levels. This is an important development in the Indian care of diabetic population. Effective glycaemic control is very important for preventing long term complications in diabetes. Hence the new list of NLEM has given importance to both injectables as well as oral medications.

Others

Both the WHO and Indian Essential Medicines Lists give equal importance to the treatment of maternal and child health, as well as to antiseptics, blood products, endocrine drugs, immunologicals, and ophthalmic medicines.

Discussion

India, despite being the world’s largest producer of generic medicines, continues to face significant challenges in ensuring equitable access and affordability of essential medicines for its population. A major concern is the infrequent updating of the National List of Essential Medicines (NLEM), which leads to gaps in procurement, price control, and patient access.20 This results in suboptimal availability of essential medicines in public health facilities, ranging from just 17% to 51% across major states- with frequent stock-outs that can last weeks, forcing patients to turn to the private sector where medicines are often unaffordable. Out-of pocket (OOP) spending on medicines remains a leading cause of impoverishment, accounting for up to 63.7% of household health expenditures in some states.^21,22

India’s disease profile has shifted since the 1990s, with a dual burden now evident: non-communicable diseases (NCDs) such as diabetes, cardiovascular diseases, and cancers are rising sharply, while communicable diseases remain prevalent.^23,24 This dual burden strains the healthcare system and highlights the need for the NLEM to prioritize both NCDs and traditional infectious diseases, as well as malnutrition. While the decline in some infectious diseases can be attributed to robust health programs and newer antibiotics, malnutrition persists as a significant problem, requiring inclusion of therapeutic foods and supplements in essential lists.

Availability of essential medicines is hampered by systemic barriers such as inefficient procurement and distribution systems, governance issues, inconsistent prescription practices, and lack of adherence to essential drug guidelines. The public sector, which is the main source of free medicines for low-income populations, is particularly affected, driving patients to the private sector where costs are higher and affordability is a challenge. Policy shortcomings, including inadequate pricing regulations and fragmented supply chains, further exacerbate these issues.²¹

Specific gaps in the NLEM include limited pharmacological options for obesity, despite its rising prevalence as a risk factor for diabetes and hypertension. Drugs like Orlistat and Semaglutide, though approved and available privately, are not widely included or accessible in public facilities. There is also a lack of standardized treatment algorithms for obesity management at the primary care level.²⁵

For diabetes, while NLEM and Indian Public Health Standards (IPHS) include core drugs like metformin and basic insulins, they lack several newer, guideline recommended agents such as DPP-4 inhibitors, SGLT2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, and glinides, despite their endorsement in national guidelines. Glucagon, vital for hypoglycemia management, is only available at the highest level of care.²⁶

Hypertension management is similarly constrained. Although NLEM covers some core drug classes, it lacks f ixed-dose combinations (FDCs) for hypertension, which are recommended by the WHO and widely used in the private sector for better adherence and outcomes. The absence of FDCs and limited drug choices at primary care levels hinder optimal therapy, especially for patients with comorbidities or resistant hypertension.²⁷

In oncology, the NLEM does not include several newer therapies such as Enzalutamide, Trastuzumab, Osimertinib, Atezolizumab, and Nivolumab, which are essential for modern cancer care. Among antiinfectives, important antibiotics according to the aware classification, and drugs for opportunistic infections in HIV, are also missing.

To address these challenges, the NLEM must be updated regularly to reflect current epidemiological trends, prioritize both NCDs and communicable diseases, and include newer, evidence-based therapies. Strengthening procurement, distribution, and regulatory frameworks, along with ensuring rational use and affordability, is essential for improving access and reducing the financial burden on India’s population.

Conclusion

In our study, we conclude that the new NLEM with few drawbacks still covers most medications which are helpful and is in line with the WHO list. Despite efficient procurement prices and a robust generic manufacturing sector, India’s essential medicines are often unavailable or unaffordable for large segments of the population, especially for chronic and life-threatening diseases. Addressing these challenges requires regular updates to the NLEM, strengthening of public procurement and supply chains, strict adherence to prescription guidelines, and targeted policy interventions to ensure equitable access and affordability for all. As discussed, essential lists need to include FDCs for hypertension and diabetes. Aware strategy should be implemented to combat microbial resistance. Inclusion of treatment for malnutrition in all healthcare setups can be an important milestone. Alignment of anticancer drugs with WHO list for treatment of various cancers is also required. The goal is to ensure that India’s list remains evidence-based, cost-effective, and responsive to public health needs.

Conflict of Interest

Nil