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.
GS II: Health
Dimensions of the Article:
- What is NLEM?
- How are drugs eliminated and added to the list?
- What is the purpose of having a list?
What is NLEM?
- As per the World Health Organisation (WHO), Essential Medicines are those that satisfy the priority health care needs of the population.
- Ministry of Health and Family Welfare hence prepared and released the first National List of Essential Medicines of India in 1996 consisting of 279 medicines and was revised thrice in 2003, 2011 and 2015, before 2022.
- The NLEM independent Standing National Committee on Medicines (SNCM) was constituted by the Union Health Ministry in 2018.
- After detailed consultation with experts and stakeholders, the committee revised the NLEM, 2015 and submitted its report on NLEM, 2022 to the Health Ministry.
- The list is made with consideration to disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines.
- Such medicines are intended to be available in adequate amounts, in appropriate dosage forms and strengths with assured quality.
- They should be available in such a way that an individual or community can afford.
- The medicines listed in the NLEM are sold below a price ceiling fixed by the National Pharmaceutical Pricing Authority (NPPA).
How are drugs eliminated and added to the list?
Medicine is added to NLEM:
- The drugs have to be useful in treating diseases which are a public health problem in India.
- They have to be licensed/approved by the Drugs Controller General (DCGI), have proven efficacy, a safety profile based on scientific evidence, comparatively cost effective, and aligned with the current treatment guidelines.
- They have to be recommended under the National Health Programs of India (for instance, ivermectin is part of the Accelerated Plan for Elimination of Lymphatic Filariasis, 2018).
- When more than one medicine is available from the same therapeutic class, a prototype that is the best suited medicine of that class is included.
- Besides this, the price of the total treatment is considered and not the unit price of a medicine. Fixed dose combinations are usually not included.
Medicine is deleted from NLEM:
- If it is banned in India;
- If there are reports of concerns on the safety profile
- If a medicine with better efficacy and is cheaper is available.
- If the disease, for which a particular medicine is recommended, is no longer a national health concern, the drug is taken off the list.
- Additionally, in case of antimicrobials — if the resistance pattern has rendered an antimicrobial ineffective, it is removed from the NLEM.
What is the purpose of having a list?
- The primary purpose of the NLEM is to promote rational use of medicines considering three important aspects which are cost, safety and efficacy.
- It also helps in optimum utilisation of healthcare resources and budget, drug procurement policies, health insurance, improving prescribing habits, medical education and training and drafting pharmaceutical policies.
- In NLEM, the medicines are categorised based on the level of the healthcare system as primary, secondary and tertiary.
- The 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.
-Source: The Hindu