National List of Essential Medicines: All that you need to know about it

The National List of Essential Medicines (NLEM) is a list released by the National Pharmaceuticals Pricing Authority (NPPA), fixing a ceiling on the prices of essential medicines so that they are affordable and widely available to everyone.

In India, it was framed on the lines of the Essential Medicines List (EML) released by the World Health Organisation (WHO). EML was first published in 1977 and had 186 medicines.

The Ministry of Health and Family Welfare released the first NLEM in 1996. It contained 279 medicines. The list was subsequently revised in 2003 and had 354 medicines.

In 2011, the list was again revised and had 348 medicines. In 2015, the last time the list was revised, it contained 851 medicines. It was decided that it would be revised every three years. The NPPA was promulgated in 2012 to fix the price ceiling.

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

“Every medicine may be necessary or even critical for specific disease conditions for which it is indicated. But in the context of NLEM, a medicine may be essential considering the population at large and should fit into the definition mentioned earlier,” the regulations in 2015 read.

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 NLEM guidelines state that 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.

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.

“If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available,” it is removed from NLEM.

Another criterion for deletion is the change in the country’s disease burden.