In exercise of powers under section 3 of the Essential Commodities Act, 1955, the Central Government makes the Drugs (Prices Control) Amendment Order, 2026, further amending the Drugs (Prices Control) Order, 2013, effective from the date of publication in the Official Gazette.

Key amendments:

1. Paragraph 11(3) is substituted to allow the Government to fix separate ceiling/retail prices for drugs with specified therapeutic rationale based on packaging, pack size, dosage, or content.
2. Paragraph 14(2) inserts a proviso limiting a manufacturer’s overcharging liability to stock traded through the offending distributor/retailer, where compliance with paragraph 24 is demonstrated.
3. Paragraph 15 is amended to exempt an existing manufacturer launching the same new drug within 12 months of price fixation from re-applying (subject to intimation in new Form-IA within one month), and revises sub-paragraphs (5) and (6) to impose deposit-with-interest liability, in addition to penalty, for non-compliance or overcharging on new drug launches.
4. Paragraph 24(1) inserts a proviso allowing overcharge calculation to be restricted to specific offending stock where the manufacturer demonstrates adequate price-revision dissemination (dealer circulars, newspaper advertisements, revised price lists, website disclosure, and stock reporting, within prescribed timelines).
5. Paragraph 24(3) is substituted to require price lists in Form V/VI to be issued to State Drugs Controllers and the Government.
6. Paragraph 29 is substituted to require manufacturers to maintain sales records for at least seven preceding financial years, subject to Government inspection. A new Form-IA (Proforma for Intimation of Launch of New Drugs) is inserted in Schedule-II after Form-I.

The principal Order (S.O. 1221(E), dated 15.05.2013) has been amended twelve times previously (2015–2023). This Order applies to manufacturers, importers, distributors, retailers, and stockists of scheduled drug formulations under the Drugs (Prices Control) Order, 2013.