What are essential medicines?
“Essential medicines” are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment.
- NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge.
- The NLEM was first formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.
- The independent Standing National Committee on Medicines (SNCM) was constituted by Union Health Ministry in 2018.
- The Committee after detailed consultation with experts and stakeholders has revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Ministry of Health & Family Welfare.
- The concept is based on the premise that a limited list of carefully selected medicines will improve quality of health care, provide cost-effective health care and better management of medicines.
- The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy.
- It also helps in optimum utilization of healthcare resources and budget; drug procurement policies, health insurance; improving prescribing habits; medical education and training for UG/PG; and drafting pharmaceutical policies.
- In NLEM, the medicines are categorized based on level of healthcare system as-
- P- Primary.
- S- Secondary.
- T- Tertiary.
- Several factors influence the decision to include a drug in the NLEM. Exactly how essential the medicine is is key.
- But that is not all. As per the 2015 regulations, “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.”
- A changing disease burden also impacted the decision-making process. Other factors include efficacy, safety and cost-effectiveness.
- A drug is removed from NLEM if another medicine performs better in terms of these above-mentioned factors.
- 384 drugs have been included in this list with addition of 34 drugs, while 26 from the previous list have been dropped. The medicines have been categorized into 27 therapeutic categories
Criteria for NLEM-
The following criteria are followed for inclusion in NLEM:
- Be useful in diseases which is a public health problem in India.
- Be licensed/ approved Drugs Controller General (India) (DCGI).
- Have proven efficacy and safety profile based on scientific evidence.
- Be comparatively cost effective.
- Be aligned with the current treatment guidelines.
- Recommended under National Health Programs of India. (e.g. Ivermectin part of Accelerated Plan for Elimination of Lymphatic Filariasis 2018).
- When more than one medicine is available from the same therapeutic class, one prototype/ medically best suited medicine of that class to be included.
- Price of total treatment is considered and not the unit price of a medicine.
- Fixed dose combinations are usually not included.
- Vaccines as and when are included in Universal Immunization Program (e.g. Rotavirus vaccine).