CM19.1-4 | Essential Medicine — Glossary

Central Drugs Standard Control Organisation — India's national medicines regulatory authority under the Directorate General of Health Services, Ministry of Health; responsible for drug approval, manufacturer licensing, and post-market surveillance.

Indian government order that sets maximum retail prices (price ceilings) for medicines included in the NLEM, administered by NPPA; the primary mechanism by which NLEM inclusion translates into affordability.

Medicines that satisfy the priority health care needs of the population, selected on the basis of disease prevalence, evidence of efficacy and safety, and comparative cost-effectiveness (WHO definition).

A medicine that deliberately and fraudulently misrepresents its identity, composition, or source — may contain no active ingredient, wrong ingredient, or dangerous contaminants; a criminal act.

Government-operated generic medicine retail outlet (Pradhan Mantri Bhartiya Janaushadhi Pariyojana) stocking NLEM and other essential generic medicines at prices typically 50–90% below branded equivalents.

A drug requirement calculation method using: population × disease incidence × treatment quantity per episode + safety stock buffer (typically 25%); used when reliable morbidity and standard treatment data are available.

India's current national essential medicines list, containing 384 medicines across 27 therapeutic categories; triggers DPCO price regulation through NPPA and serves as the basis for government procurement and PHC formularies.

India's pharmaceutical price regulatory body under the Ministry of Chemicals and Fertilizers; implements DPCO and sets ceiling prices for NLEM medicines.

A prescriber's preferred drug for a given clinical indication, selected by the prescriber from available alternatives based on comparative efficacy, safety, suitability, and cost — forming the prescriber's personal formulary.

India's national pharmacovigilance programme operated by CDSCO and the Indian Pharmacopoeia Commission; collects and analyses adverse drug reaction reports, including signals from substandard or falsified medicines.

WHO 1985 Nairobi definition: patients receive medicines appropriate to their clinical needs, in doses meeting individual requirements, for an adequate period, and at the lowest cost to the patient and community.

An authorised medicine (approved by the national regulator) that fails to meet its quality specifications — due to manufacturing error, degradation, or improper storage — but is not deliberately misrepresented.

A medicine that has not undergone evaluation or approval by the relevant national regulatory authority for the market in which it is distributed.

The WHO Expert Committee's model list of essential medicines, first established 1977, now in its 28th edition (2023) with 502 medicines in core and complementary lists — used as a reference for national adaptation.

Standardised survey methodology developed by WHO and Health Action International to measure medicine availability and affordability at facility and patient levels, enabling cross-country comparison.