NLEM meaning: India's essential medicines list What the list is, who prepares it, the P, S and T levels, and why it decides which medicines have a ceiling price.

The National List of Essential Medicines (NLEM) is the Union Health Ministry's list of medicines that satisfy the priority health care needs of the population, graded by level of care, and its 2022 edition is the First Schedule of the Drugs (Prices Control) Order, 2013. The list names each medicine with its dosage forms and strengths, and marks whether it is meant for primary, secondary or tertiary care. Because the same list sits inside the price control order, a medicine on it is one whose price the government caps.

What is the NLEM?

A national reference list of medicines, revised from time to time. The PIB release of 13 Sep 2022 says the list was first formulated in 1996 and revised in 2003, 2011 and 2015 before the 2022 edition. NLEM 2022, as published on the CDSCO website, is arranged in 27 sections, from medicines used in anaesthesia to medicines for COVID-19 management, and each entry carries a "Level of Healthcare" column. The release explains: "In NLEM, the medicines are categorized based on level of healthcare system as- P- Primary; S- Secondary and T- Tertiary."

The same release lists the inclusion criteria. A medicine should be useful in a disease that is a public health problem in India, be licensed or approved by the Drugs Controller General (India), have a proven efficacy and safety profile based on scientific evidence, and be comparatively cost effective.

Where does the definition come from?

From the Health Ministry. At the launch, the PIB release records, the Union Health Minister "stated that the 'essential medicines' are those that satisfy the priority health care needs, based on efficacy, safety, quality and total cost of the treatment." The release adds that "The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy." The list itself was revised by the Standing National Committee on Medicines, which the Ministry constituted in 2018, and the Government "accepted the recommendations of the Committee and adopted the list".

The price link comes from a second document. Paragraph 2(t) of the Drugs (Prices Control) Order, 2013 defines the National List of Essential Medicines as the list "published by the Ministry of Health and Family Welfare as updated or revised from time to time and included in the first schedule of this order". Paragraph 2(zb) then defines a "scheduled formulation" as "any formulation, included in the First Schedule whether referred to by generic versions or brand name". Our entry on the DPCO explains what a ceiling price means.

What it means for a small clinic

For most OPDs the NLEM matters in two places. The first is price. If Sunrise Clinic, a sample single-doctor clinic, keeps a few medicines at the desk, the ones that appear in Schedule I are scheduled formulations, and the National Pharmaceutical Pricing Authority (NPPA) fixes their ceiling prices. NPPA's website publishes a therapeutic category wise ceiling price list and runs the Pharma Sahi Daam app for checking medicine prices. When a patient says the price on a strip has changed, that list is where the desk checks.

The second is prescribing. The list names medicines by their generic names, and the 2002 conduct regulations ask doctors to prescribe by generic name; our post on generic name prescription rules covers the wording in force. The NLEM itself is a list of medicines with levels of care. It does not tell a doctor what to prescribe for a given patient, and this entry does not either.

Does the NLEM apply to a single-doctor clinic?

The list does not impose duties on anyone by itself. Its force comes through the price control order: once a medicine is in Schedule I, the order's rules on ceiling prices, price lists and sale prices apply to the manufacturers and sellers of that medicine, whatever the size of the business. A clinic that does not sell medicines is affected only as a prescriber whose patients buy at capped prices.