Under the direction of the Hon. Prime Minister Shri Narendra Modi, Union Health Ministry takes various steps towards “Sabko Dawai, Sasti Dawai”. “The National List of Essential Medicines (NLEM) plays a vital role in ensuring access to quality, affordable medicines at all levels of health care. This will boost cost-effective and quality medicines and contribute to a reduction in out-of-pocket healthcare expenditure for the citizens,” said Dr. Mansukh Mandaviya, Union Minister of Health and Family Welfare , when the National Lists of Essential Medicines (NLEM) were launched, 2022,384 medicines were included in this list with the addition of 34 medicines, while 26 from the previous list were deleted. Medicines have been classified into 27 therapeutic categories.
Speaking on the occasion, the Union Health Minister said that “essential medicines” are those which meet priority health care needs, on the basis of efficacy, safety, quality and total cost of treatment. The main objective of NLEM is to stimulate the rational use of medicines by considering the three important aspects, namely cost, safety and effectiveness. It also contributes to the optimal use of resources and the health budget; drug supply policies, health insurance, improving prescribing habits, medical education and UG/PG training, and drug policy development. Medicines are classified according to the level of the health system as- P-Primary; S- Secondary and T- Tertiary, in NLEM.
He further explained that the concept is based on the premise that a limited list of carefully selected drugs will improve the quality of health care, provide cost-effective health care and better drug management. Adding to this, he said, the NLEM is a living document and is revised regularly taking into account changing public health priorities as well as advances in pharmaceutical knowledge.
“The Standing Independent National Medicines Committee (SNCM) was constituted by the Union Department of Health in 2018. The committee, after detailed consultation with experts and stakeholders, revised the NLEM, 2015 and submitted its report on the NLEM, 2022 to the Department of Health and Family Welfare.” He also noted that the process of creating the NLEM depends on scientifically backed feedback from stakeholders and the inclusion/exclusion principle being followed.
Dr Bharati Pravin Pawar, Union Minister of State, highlighted raising awareness of Antimicrobial Resistance (AMR) which “appears as a big challenge for our scientists and our community and we need to sensitize society to RAM” while commending stakeholders for the revised NLEM which moves the country forward in the direction of providing affordable healthcare to its citizens.
The revision of NLEM 2022 was done after constant consultation with stakeholders ranging from academia, industry and public policy experts, etc., and crucial documents like the WHO EML 2021.
The following criteria are followed for inclusion in the NLEM:
- To be helpful in diseases that are a public health problem in India
- Be Licensed/Approved Drugs Controller General (India) (DCGI)
- Have a proven efficacy and safety profile based on scientific evidence
- Be relatively profitable
- Alignment with current treatment guidelines
- Recommended under the national health programs of India. (for example, ivermectin is part of the 2018 Accelerated Lymphatic Filariasis Elimination Plan).
- When more than one drug is available in the same therapeutic class, a medically best-fit class prototype/drug should be included.
- The price of the treatment is considered and not the unit price of a medicine.
- Fixed dose combinations are generally not included
- Vaccines as they become available are included in the universal immunization program (eg rotavirus vaccine).