Fixation of Retail Prices for New Drug Formulations under Drugs (Prices Control) Order, 2013

Notification/Circular No.: S.O. 3709(E) dated July 8, 2026
Applicable Act/Rule: Drugs (Prices Control) Order, 2013
Applicable Section/Rule: Paragraphs 5, 11 and 15

National Pharmaceutical Pricing Authority (NPPA), in exercise of powers under paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013 read with S.O. 1394(E) dated 30.05.2013, S.O. 5249(E) dated 11.11.2022 and S.O. 3516(E) dated 30.06.2026, has fixed the retail price (exclusive of Goods and Services Tax, if any) for 39 formulations/brand names, specifying for each the strength, unit, and name of the manufacturer and marketing company. The formulations covered include combinations such as Amlodipine/Telmisartan/Metoprolol Succinate, Amoxicillin/Potassium Clavulanate, Atorvastatin/Ezetimibe, Atorvastatin/Clopidogrel, Empagliflozin/Sitagliptin/Metformin, Tenecteplase Injection, Imatinib Oral Solution, and others, with retail prices ranging from Rs. 2.80 to Rs. 60,238.27 per unit.

Notes specify: manufacturers of “new drug” formulations under paragraph 2(1)(u) of the DPCO, 2013 shall not fix retail prices exceeding the notified price; other existing manufacturers launching the same new drug within twelve months of publication may market at the notified price subject to filing Form-IA on IPDMS 2.0 within one month of launch; GST may be added only if actually paid or payable to Government; manufacturers shall issue price lists in Form-V under paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and to State Drug Controllers and dealers; retailers and distributors shall display the price list per paragraph 24(4) of the DPCO, 2013; and non-compliant manufacturers/marketing companies shall be liable to deposit the overcharged amount with interest under the DPCO, 2013 read with the Essential Commodities Act, 1955.

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