National list of essential medicines
About:
- The Ministry of Health and Family Welfare published a list called the National List of Essential Medicines (NLEM).
- The National Pharmaceutical Pricing Authority has set a price ceiling that the medications included in the NLEM are sold below (NPPA).
- It was designed in India in accordance with the WHO’s Essential Medicines List (EML).
History:
- In 1996, the Ministry of Health and Family Welfare created and published India’s first National List of Essential Medicines, which included 279 drugs. Later, this list was updated in 2003, 2011, 2015, and 2022.
Purpose:
- Direct the safe and efficient treatment of a population’s priority disease issues.
- Encourage the judicious use of medications.
- Maximise a nation’s available health resources. It can also serve as a reference guide for:
- The preparation of a list of necessary medications by state governments.
- public sector drug supply and drug procurement.
What Prerequisites Must a Medicine Meet in Order to Be Included in NLEM?
- Before a medicine is included in the NLEM, a number of factors are considered. Which are:
- Essentiality: A drug should meet the criteria outlined in the previous definition in order to be considered essential when looking at the population as a whole.
- Changing disease burden: As time goes on, the nation’s illness burden changes. TB may have once been more urgently addressed. The importance of another illness, like Covid-19, could change in the near future. Therefore, when creating the list, the most common disease is taken into account.
- Efficacy and Safety: To be listed, a medicine must have “unequivocal” proof of its effectiveness as well as wider acceptability based on its safety.
- Cost-Effectiveness: When adding the drug in NLEM, the overall cost of the therapy must be taken into account. The ideal metric for this may not be the unit price alone.
- Single-dose medications are taken into consideration for inclusion in NLEM as Fixed Dose Combinations (FDCs). Only FDCs that have a demonstrated advantage in terms of the therapeutic efficacy are included.
- High sales turnover is not seen as a good criterion in and of itself for the NLEM. In essence, it also needs to take into account other elements.
When is a Drug Removed from the NLEM?
- If a drug is outlawed in India, it is removed from the list. Additionally, it is taken out if there are any reports of drug safety issues.
- If a medication has improved efficacy, a favourable safety profile, or a higher cost-effectiveness, it is taken out of the NLEM.
