CM19.1-4 | CM19.1-4 | Essential Medicine List, Primary Care Requirements and Counterfeit Prevention — Summary & Reflection

KEY TAKEAWAYS

Essential medicines satisfy the priority health care needs of a population and are selected on the basis of disease prevalence, efficacy, safety, and cost-effectiveness. The WHO Model List of Essential Medicines (28th edition, 2023: 502 medicines in core + complementary lists) was established in 1977 and is the reference for national adaptation. India's NLEM 2022 contains 384 medicines across 27 therapeutic categories and is the basis for DPCO price regulation, government health scheme formularies, and PHC procurement. Rational drug use — the right medicine, right dose, right duration, right patient, lowest cost — is operationalised through the P-drug concept and seven-step prescribing process. WHO distinguishes three categories of poor-quality medicines: substandard (authorised, fails quality standards), unregistered/unlicensed (not approved), and falsified (deliberate misrepresentation). Prevention requires CDSCO regulation, pharmacovigilance through PvPI, track-and-trace systems, and facility-level inspection. Medicine requirements at PHC are calculated using the morbidity method (population × incidence × treatment quantity + 25% buffer) or the consumption method. NLEM inclusion triggers DPCO price ceilings; WHO/HAI availability and rational use indicators measure programme performance.

REFLECT

India's NLEM 2022 does not include several newer, high-cost medicines — including some targeted cancer therapies and novel antidiabetics — that are available in higher-income countries. Consider: what ethical framework should govern the inclusion or exclusion of an expensive medicine from the NLEM? How should a PHC medical officer balance prescribing from the NLEM (affordable, evidence-based) against a patient's request for a branded product advertised on television? Reflect on the 'last mile' problem: NLEM lists are necessary but not sufficient — what additional interventions would you propose to a district CMO to close the gap between what is on the list and what is actually available in a tribal PHC?