The National List of Essential Medicines has not kept pace with global revisions. Examine the institutional and administrative reasons for this lag and its implications for healthcare affordability in India.

Q. The National List of Essential Medicines has not kept pace with global revisions. Examine the institutional and administrative reasons for this lag and its implications for healthcare affordability in India. (15 marks, 250-350 words)

The NLEM, first framed in 1996 and last revised in 2022 with 384 medicines across 27 therapeutic categories [1], is the anchor of India's drug price control architecture. Against WHO's 24th Model List (September 2025), covering 523 medicines [2][3], India's list now trails by two global revision cycles — a lag rooted less in science than in institutional design.

Institutional reasons - No statutory revision cycle: WHO revises its Model List biennially through a standing Expert Committee [3]; NLEM revisions have been irregular — 1996, 2003, 2011, 2015, 2022 — with no legally mandated periodicity. - Dependence on an ad hoc expert body: the Standing National Committee on Medicines (SNCM), constituted only in 2018, took four years of stakeholder consultation to deliver NLEM 2022 [1]. - Split mandates: MoHFW selects medicines, while the NPPA fixes ceiling prices under DPCO, 2013 (Schedule-I) [4] — selection and pricing sit in different institutional silos.

Administrative reasons - Evidence-appraisal capacity gaps: reviewing new therapies (immunotherapies, GLP-1 agonists) demands health-technology-assessment capability that is thinly staffed. - Consultation-heavy process: industry representations on price impact lengthen deliberation, since listing automatically triggers price caps. - Weak feedback loop between WHO updates and domestic review triggers — no institutional mechanism converts a WHO revision into a national review.

Implications for affordability - Newer cancer and diabetes medicines added by WHO in 2025 [2] remain outside price control, staying at market prices in a system dominated by out-of-pocket spending. - The gains are real but frozen: NLEM 2022 price fixation yielded roughly ₹3,788 crore in annual patient savings [5] — savings that a stale list cannot extend to newer therapies. - Free dispensation at government hospitals mirrors the list, so exclusions narrow public-facility access for the poor.

The lag is procedural, not scientific. Institutionalising a fixed biennial revision cycle, a permanent secretariat for the SNCM with HTA capacity, and an automatic domestic review triggered by each WHO update would keep the list current — advancing affordable access consistent with Article 21 and SDG 3.8 on universal health coverage.

(~330 words)

Sources: 1. Dr Mansukh Mandaviya launches National List of Essential Medicines (NLEM) 2022 — PIB — 384 medicines, 27 categories, SNCM constituted 2018, revision history 2. WHO updates list of essential medicines to include key cancer, diabetes treatments (5 Sept 2025) — WHO — new cancer and diabetes additions 3. The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list — WHO — 523 medicines; biennial expert-committee revision cycle 4. NPPA fixes ceiling prices of drugs specified in Schedule-I to DPCO, 2013 — PIB — NLEM–DPCO–NPPA pricing linkage 5. Average price reduction under NLEM 2022: estimated annual savings of ~₹3,788 crore to patients — PIB — savings figure