National List of Essential Medicines (India) 2022

Tanzania was the first country to compose its own country specific EML in 1970.?WHO published first model list of essential medicines in 1977 which contained 186 medicines.

In India, 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.

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

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.

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.

This not necessarily means that if a particular drug is not included in the list of essential medicines, it is not necessary in therapeutics. Non-inclusion of such drugs in the list of essential medicines does not undermine their importance in therapeutics.

Medicine which is critical for a specific condition may not be listed in the list of essential medicines if the disease condition for which it is indicated has low prevalence or is rare.

#india #pharma #pharmacovigilance #regulatoryaffairs #pharmaceutical #medicine #pharmd