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The Department of Pharmaceuticals notified amendments to the Drugs (Prices Control) Order, 2013 via S.O. 3516(E) dated 30 June 2026.
Manufacturer liability for overcharging is now capped to the actual quantity of stock overcharged, instead of the entire consignment.
Existing manufacturers can now adopt an NPPA-fixed retail price for a new formulation within 12 months, without seeking separate prior approval, by intimating NPPA on Form-1A.
Records now need to be kept for only the preceding 7 financial years, and separate ceiling prices are allowed for the same drug where therapeutic rationale justifies it.
Parent Act under which DPCO 2013 is issued; Section 3 empowers the Centre to regulate production, supply, distribution and pricing of essential commodities, including drugs
Fixes ceiling prices for scheduled/NLEM drugs; the 2026 notification is its latest amendment, easing compliance while retaining price control
Implements DPCO, fixes/revises ceiling prices for scheduled drugs, monitors overcharging complaints
Only drugs listed in the National List of Essential Medicines (NLEM) — currently NLEM 2022, with 384 medicines — are 'scheduled' under DPCO and carry government-fixed ceiling prices. Non-scheduled drugs may only raise prices by a capped annual percentage. This amendment changes how manufacturers of scheduled drugs get price approval; it does not change which drugs are scheduled.
Simple Analogy: NLEM is the government's 'essential' shopping list; DPCO is the price-tag rule that applies only to items on that list.
GS Paper 3 > Economy > Pharma Regulation & Price Control
Recurring — pharma pricing regulation and NPPA actions surface periodically in current affairs
Drugs (Prices Control) Order, 2013 — issued under the Essential Commodities Act, 1955, fixing ceiling prices for scheduled (NLEM) drugs
National List of Essential Medicines — the list of drugs (384 medicines, NLEM 2022) that are 'scheduled' and price-controlled under DPCO