National List of Essential Medicines (NLEM)

National List of Essential Medicines 

About NLEM

The National List of Essential Medicines (NLEM) is a list released by the Ministry of Health and Family Welfare.

The medicines listed in the NLEM are sold below a price ceiling fixed by the National Pharmaceutical Pricing Authority (NPPA).

In India, it was framed on the lines of the Essential Medicines List (EML) released by the WHO.

History

The Ministry of Health and Family Welfare 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, 2011, 2015 and 2022.

Purpose

• Guide safe and effective treatment of priority disease conditions of a population.
• Promote the rational use of medicines.
• Optimize the available health resources of a country. It can also be a guiding document for:
• State governments to prepare their list of essential medicines
• Procurement and supply of medicines in the public sector.

What Are The Criteria For a Medicine To Be Included In NLEM

Several factors are looked at before including a drug in the NLEM. These are:

Essentiality: A medicine may be essential considering the population at large and should fit into the definition mentioned earlier.

Changing disease burden: With time, the disease burden keeps changing in the country. At one point, TB might be more important to tackle. At the next moment, another disease like Covid-19 may become more important. 

So, the prevalent disease is considered while preparing the list.

Efficacy and Safety: The medicine must have "unequivocal" evidence of efficacy and wider acceptance based on its safety to be included in the list.

Cost-Effectiveness: The total price of the treatment must be considered while including the drug in NLEM. Only unit price may not be the best benchmark for this.

Fixed Dose Combinations (FDCs): The single-dose medicines are considered for inclusion in NLEM. FDCs are only included if they have a proven advantage concerning the therapeutic effect.

FDC - fixed-dose combination (FDC) is a medicine that includes two or more active ingredients combined in a single dosage form

Turnover: High sales turnover alone is not considered a good benchmark for inclusion in the NLEM. Other factors are also required to be essentially considered for it.

When Is a Medicine Deleted From NLEM

A drug is deleted from the list if it gets banned in India. Also, it is removed if reports of concerns about drug safety emerge

What Is An Essential Medicine List (EML)

The list is made with consideration of disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines.

Such medicines should be available in such a way that an individual or community can afford them.

The WHO EML is updated every two years by the Expert Committee on Selection and Use of Essential Medicines.

History

The first country in the world to compose its EML was Tanzania in 1970. Then in 1975, the World Health Assembly (WHA) requested WHO to assist member states in selecting and procuring essential medicines, assuring good quality at a reasonable cost.

Subsequently, the first WHO model list of essential medicines was published in the year 1977 which contained 186 medicines.

It stated that essential medicines were “of utmost importance, basic, indispensable and necessary for the health and needs of the population” and the criteria for selection were based on efficacy, safety, quality and total cost.

What Are Cardio Vascular Diseases (CVDs)

About

CVDs are a group of disorders of the heart and blood vessels and include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions.

Global Scenario

CVDs are the leading cause of death globally, taking an estimated 17.9 million lives in 2019 according to WHO.

More than four out of five CVD deaths are WHO due to heart attacks and strokes, and one third of these deaths occur prematurely in people under 70 years of age.

Indian Scenario

As per WHO, India reported 63% of total deaths in 2016 due to NCDs, of which 27% were attributed to CVDs.

CVDs also account for 45% of deaths in the 40–69-year age group.

Risk Factors:

The most important behavioral risk factors of heart disease and stroke are unhealthy diet, physical inactivity, tobacco use and alcohol consumption.

The effects of behavioral risk factors may show up in individuals as intermediate risk factors such as raised blood pressure, raised blood glucose, raised blood lipids, and obesity.

Indian Initiative

National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) is being implemented under the National Health Mission (NHM).

Affordable Medicines and Reliable Implants for Treatment (AMRIT) Deendayal outlets have been opened at 159 Institutions/Hospitals with an objective to make available Cancer and Cardiovascular Diseases drugs and implants at discounted prices to the patients.

Jan Aushadhi stores are set up by the Department of Pharmaceuticals to provide generic medicines at affordable prices.

ST-Elevation Myocardial Infarction (STEMI) Project: The Maharashtra government launched the STEMI programme recognised by NHM in 2021 to enable rapid diagnosis of heart disease.

ST-Elevation Myocardial Infarction (STEMI) is a condition wherein one of the heart’s major arteries, supplying oxygen-rich blood to the heart muscle, gets completely blocked.