National List of Essential Medicines (NLEM)?
- About: National List of Essential Medicines is a list of medicines released by the Ministry of Health and Family Welfare to make them affordable and widely available to everyone. Essential medicines are those that satisfy the priority health care needs of the population.
- Background: In India, it was framed on the lines of the National Essential Medicines List (EML) released by the World Health Organization (WHO). EML was first published in 1977.
- The Ministry of Health and Family Welfare released the first National List of Essential Medicines in 1996. It contained 279 medicines. The list was subsequently revised in 2003, 2011 and 2015.
- The National Pharmaceutical Pricing Authority (NPPA) was promulgated in 2012 to fix the price ceiling.
- National List of Essential Medicines 2022 was prepared after constant consultations with several stakeholders and referring crucial documents like WHO EML 2021.
- Objective: National List of Essential Medicines primary aim is to promote rational use of medicines considering three important aspects — cost, safety and efficacy so as to improve quality of healthcare, provide cost-effective healthcare and better management of medicines.
- Mechanism: Once National List of Essential Medicines is released, the department of pharmaceuticals under the ministry of chemicals and fertilizers adds them in the Drug Price Control Order, after which the NPPA fixes the price ceiling for all the medicines in the list.
National List of Essential Medicines 2022: Key Highlights
- National List of Essential Medicines features a total of 384 medicines with the addition of 34 new medicines and dropped 26 old ones from the previous list.
- National List of Essential Medicines has classified the medicines under 27 therapeutic categories.
- The new list also includes four drugs that are still under patent.
- Bedaquiline and Delamind used in the treatment of multiple drug-resistant tuberculosis.
- Dolutegravir used to treat human immunodeficiency virus (HIV) infection.
- Daclatasvir used in treating viral infections such as Hepatitis C.
- None of the COVID drugs were included in the list as the committee in charge was of the view that the clinical trials to check the efficacy of the drugs were not yet conclusive.
- The list also featured several antibiotics, anti-cancer drugs, endocrine medicines, contraceptives and cardiovascular medicines.
National List of Essential Medicines: Significance
- Affordable health care: Drugs listed under National List of Essential Medicines — also known as scheduled drugs — will be cheaper because the NPPA caps medicine prices and changes only based on WPI inflation.
- Reduces Out of Pocket Expenditure: The list ensures accessibility of affordable quality medicines at all levels of healthcare and contribute towards reduction in Out-of-Pocket Expenditure on healthcare for the citizens.
- In Uttar Pradesh for example, out-of-pocket health expenditure accounts for 71.3 per cent of the state’s total health expenditure. For India, the figure was 48.2 per cent.
National List of Essential Medicines: Criteria for Inclusion and Deletion of a Medicine
Criteria for Inclusion
Criteria for Deletion
|1. The medicine shall be useful in diseases that is a public health problem in India
2. The medicine shall be licensed/ approved by the Drugs Controller General India (DCGI)
3. It shall have proven efficacy and safety profile based on scientific evidence
4. It should be comparatively cost effective and aligned with the current treatment guidelines
5. The medicine shall be recommended under National Health Programs of India
6. When more than one medicine are available from the same therapeutic class, one prototype/ medically best suited medicine of that class to be included
7. The price of total treatment shall be considered and not the unit price of a medicine
8. The fixed dose combinations are usually not included
9. In case of vaccines, it is as and when it is included in Universal Immunization Programme
|1. The medicine has been banned in India
2. If there are reports of concerns on the safety profile
3. If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available
4. The disease burden for which medicine is indicated is no longer a national health concern
5. In case of antimicrobials, if the resistance pattern has rendered an antimicrobial ineffective