Govt revises NLEM, 34 new drugs added & 26 dropped

Medicines listed in NLEM are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment

Generic medicines

New Delhi: The Union ministry of health and family welfare (MHFW) on Tuesday announced the revised National Lists of Essential Medicines (NLEM) 2022, containing 384 drugs. The list has got 34 new drugs, while 26 from the previous list have been dropped. The medicines have been categorized into 27 therapeutic categories.

Releasing the NLEM-2022, Union minister for health and family welfare Mansukh Mandaviya said the Ministry is taking various steps under the vision of Prime Minister Narendra Modi towards ‘Sabko Dawai, Sasti Dawai’. “The NLEM plays an important role in ensuring accessibility of affordable quality medicines at all levels of healthcare. This will give a boost to cost-effective, quality medicines and contribute towards reduction in out of pocket expenditure on healthcare for the citizens,” the minister added.

What is NLEM?

NLEM is a list released by the National Pharmaceuticals Pricing Authority (NPPA), fixing a ceiling on the prices of essential medicines so that they are affordable and widely available to everyone. Medicines listed in NLEM are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment.

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 utilisation 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 and T- Tertiary.

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The concept of NLEM is based on the premise that a limited list of carefully selected medicines will improve quality of healthcare, provide cost-effective healthcare and better management of medicines. It is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. NLEM was first formulated in 1996 and it was revised thrice earlier in 2003, 2011 and 2015.

NLEM finalised in consultation with stakeholders

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 MHFW. The Government of India has accepted the recommendations of the Committee and adopted the list.

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The drugs which are included in the list needs to be useful in diseases which is a public health problem in India, be licensed/approved Drugs Controller General of India (DCGI) and have proven efficacy and safety profile based on scientific evidence.

What happens when a drug is removed?

NLEM delete a drug from the list if it gets banned in India. Removal is done over the reports of safety concern. If medicine with better efficacy or favourable safety profile and better cost-effectiveness is now available, the NLEM has to be revised. Another criterion for deletion is the change in the country’s disease burden.

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