← Policy & Regulation: Pricing and Tariff Control (all topics)

NPPA/DPCO price control / NLEM

Policy & Regulation · Pricing & tariff control

What it is

The National List of Essential Medicines (NLEM 2022 - 388 medicines) forms Schedule-I of the DPCO, 2013; inclusion makes a molecule subject to an NPPA ceiling price

Ceiling = simple average of prices of brands with 1%+ market share plus 16% retail margin, revised annually by WPI. Non-scheduled drugs may raise MRP only 10% a year, and Para 19 lets NPPA cap any drug or device

Impact on industries

  • Access gain - ceilings fixed for 935 scheduled formulations and retail prices for 3,845 new drugs as of Jul 2026, where only ~35% of the population is insured
  • Revision far below input inflation: the Apr 2026 cycle allowed a WPI increase of just 0.65% against double-digit API cost rises
  • Hits the weakest hardest - small commodity makers with raw material at 55-65% of revenue have no branded mix to absorb the cap, and each NLEM expansion widens control
  • Para 19 caps on stents and knee implants of 65-85% compress device and hospital realisations well beyond the drug list

Industries affected