The Ministry of Chemicals and Fertilizers (MoC&F) on June 30, 2026, notified the Drugs (Prices Control) Amendment Order, 2026 to amend the Drugs (Prices Control) Order, 2013.
The following has been stated:-
•The Drugs (Prices Control) Amendment Order, 2026 amends the Drugs (Prices Control) Order, 2013 and comes into force upon its publication in the Official Gazette.
•It empowers the Government to fix separate ceiling or retail prices for the same drug based on therapeutic rationale, packaging, pack size, dosage compliance, or content.
•The amendment relaxes certain requirements for existing manufacturers launching the same new drug within 12 months while strengthening provisions on recovery of overcharged amounts and penalties for non-compliance.
•It also introduces detailed obligations for manufacturers to promptly communicate revised prices, maintain transparency, and limits overcharging liability where prescribed compliance measures are demonstrated.
•Additionally, manufacturers are required to maintain sales and related records for at least seven financial years (or longer if proceedings are pending) and produce them for Government inspection.
It shall come into force on July 01, 2026.
The detailed notification is given in the document below.
[Notification No.: S.O. 3516(E)]
