National List of Essential Medicines

The National List of Essential Medicines identifies medicines that meet the priority health-care needs of most people in India. It seeks to improve their availability, affordability and rational use throughout the health system. The list is periodically revised as disease patterns, evidence and treatment practices change.

Basis for selecting medicines

Selection reflects national health needs rather than the commercial popularity of a medicine.

• A medicine must address diseases of public-health relevance in India.
• Selection considers evidence of efficacy, safety and comparative cost-effectiveness.
• The medicine must be suitable for use within India's health-care system, with appropriate dosage forms and strengths.

Role in health-care delivery

The NLEM provides a common reference for governments, health facilities and medical professionals.

• It guides public procurement, stocking and supply of priority medicines at appropriate levels of care.
• It supports rational prescribing and the preparation of treatment guidelines, formularies and professional training.
• The NLEM 2022 contains 384 medicines, classified according to their use at primary, secondary or tertiary levels of care.

Role in pharmaceutical price control

The NLEM identifies medicines warranting priority, but it does not itself fix their prices. Price control follows when listed medicines are incorporated into Schedule I of the Drugs (Prices Control) Order, 2013 as scheduled formulations.

• The National Pharmaceutical Pricing Authority fixes or revises the ceiling prices of scheduled formulations according to the method prescribed under the DPCO.
• The ceiling price is based on the simple average price to retailer of brands and generic versions having at least 1 per cent market share, with the prescribed retailer margin added.
• Manufacturers of a scheduled formulation cannot charge more than the applicable ceiling price, apart from permitted local taxes.
• Price ceilings promote affordability, but effective access also requires public procurement, reliable supply and quality assurance.