What is the National List of Essential Medicines?

National Pharmaceuticals Pricing Authority (NPPA) - a government regulatory agency that controls the prices of medicines in India - comes out with a list every three years. Through the National List of Essential Medicines or NLEM, the regulator fixes a cap on the prices of essential medicines so that they are affordable and widely available to everyone.

When was NLEM first released in India?

The Ministry of Health and Family Welfare released the first NLEM in 1996. It contained 279 medicines. The subsequent revised list came in 2003 which 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.

And on Tuesday, the government came out with a fresh list. It added 34 and removed 26 drugs from the NLEM.  Several antibiotics, anti-diabetes and anti-infectives have been included in the list. 

How are medicines included in the NLEM?

Several factors are looked at before including a drug in the NLEM. According to the regulations, the drug must be critical and essential for curing a disease.

Also, disease burden is considered an essential factor. At one point, TB might be more important to tackle. At the next moment, another disease like Covid-19 may become more important.

Efficacy and Safety

The medicine must have “unequivocal” evidence of efficacy and wider acceptance based on its safety to be included in the list. 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 and Turnover

The single dose medicines are considered for inclusion in NLEM. FDCs are only included if they have a proven advantage concerning the therapeutic effect. Also, the decision must not be taken solely based on high sales turnover.

When is a medicine dropped 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 a better, more cost-effective medicine is available in the market, it can be replaced on the list. Another criterion for deletion is the change in the country’s disease burden.