National List of Essential Medicines (NLEM)

Context:

Recently, the Union Health Ministry launched the new National List of Essential Medicines (NLEM), where 384 drugs have been included in this list with addition of 34 drugs, while 26 from the previous list have been dropped.

About National List of Essential Medicines (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.

• The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines.
• They should be available in such a way that an individual or community can afford.

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 prepare their list of essential medicines.
  • Procurement and supply of medicines in the public sector.

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.
  • 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, then it is removed from NLEM.

NLEM in India

• Drugs listed under NLEM — also known as scheduled drugs — will be cheaper because the National Pharmaceutical Pricing Authority (NPPA) caps medicine prices and changes only based on wholesale price index-based inflation.
• The list includes anti-infectives medicines to treat diabetes such as insulin — HIV, tuberculosis, cancer, contraceptives, hormonal medicines and anaesthetics.
• They account for 17-18 percent of the estimated Rs 1.6-trillion domestic pharmaceutical market.
• Companies selling non-scheduled drugs can hike prices by up to 10 per cent every year.
• Typically, once NLEM is released, the department of pharmaceuticals under the ministry of chemicals and fertilisers adds them in the Drug Price Control Order, after which NPPA fixes the price.