NOTIFICATION In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-01072026-273983 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 3381] NEW DELHI, TUESDAY, JUNE 30, 2026/ ASHADHA 9, 1948 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) NOTIFICATION New Delhi, the 30th June, 2026 S.O. 3516(E). In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby makes the following Order further to amend the Drugs (Prices Control) Order, 2013, namely:— 1. (1) This Order may be called the Drugs (Prices Control) Amendment Order, 2026. (2) It shall come into force on the date of its publication in the Official Gazette. 2. In the Drugs (Prices Control) Order, 2013,— (a) in paragraph 11, for sub-paragraph (3), following sub-paragraph shall be substituted, namely:— "(3) Notwithstanding anything contained in sub-paragraphs (1) and (2), in the case of any drug for which a ceiling price or retail price has been fixed, the Government may fix and notify separate ceiling price or retail price on an application made by the manufacturer or otherwise, for such drug with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack, namely, liquid, gaseous or any other form, in the unit dosage, as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same drug."; (b) in paragraph 14, in sub-paragraph (2), the following proviso shall be inserted, namely:- "Provided that, in respect of scheduled formulations produced or available in the market before the date of notification of the ceiling price, where the manufacturer demonstrates compliance with the provisions of paragraph 24 and such other guidelines as may be issued by the Government from time to time, the liability of the manufacturer for overcharging shall be restricted to the quantity of stock traded through the distributor or retailer found to have effected such overcharging.”; (c) in paragraph 15, (i) in sub-paragraph (2), the following provisos shall be inserted, namely:- "Provided that any other existing manufacturer launching the same new drug within twelve months of retail price fixation of such new drug under this paragraph shall not be required to apply: Provided further that such manufacturer launching the new drug shall intimate the details of launch in Form-IA within one month of the launch."; (ii) for sub-paragraph (5), the following sub-paragraph shall be substituted, namely:- “(5) Where existing manufacturer of scheduled formulation fails to adhere to sub-paragraph (2), such manufacturer shall be liable to deposit the overcharged amount over and above such price fixed and notified by the Government, if any, along with interest thereon from the date of launch of the new drug, in addition to the penalty."; (iii) for sub-paragraph (6), the following sub-paragraph shall be substituted, namely:— "(6) No existing manufacturer of a scheduled formulation shall launch such a new drug at a price higher than the latest retail price (plus local taxes as applicable) fixed by the Government for such new drug during the preceding twelve months and in case such a manufacturer is found to sell such a new drug at a price higher than the retail price (plus local taxes as applicable) fixed by the Government, such manufacturer of the new drug shall be liable to deposit the overcharged amount along with interest from the date of overcharge, in addition to the penalty."; (d) in paragraph 24, — (i) in sub-paragraph (1), after the proviso, the following proviso shall be inserted, namely:- "Provided further that where a manufacturer produces documentary evidence, upon demand, demonstrating sufficient effort at disseminating the revision in price to all stakeholders including through — (i) circulation of the revised Market Retail Price list to dealers and retailers immediately and in any case not later than two weeks of the date of such notification, for display to consumers; (ii) advertisement in at least two national newspapers immediately and in any case not later than two weeks of the date of such notification, informing dealers, retailers, and consumers about the price reduction; (iii) issuing a revised or supplementary price list in Forms V or VI to dealers, retailers, reflecting the revised prices; (iv) creating a dedicated Drugs (Prices Control) Order Matters section on the homepage of the company and upload details of the revised price notification and Market Retail Price; and (v) submitting batch-wise production details and stock position of the scheduled formulations held by the company and distributors at the time of the price revision; the overcharged amount for such manufacturer shall be calculated solely on the stock handled by each retailer, distributor, or stockist found selling the formulation above the ceiling price (plus local taxes as applicable) pertaining to that batch."; (ii) for sub-paragraph (3), the following sub-paragraph shall be substituted, namely:— "(3) Every manufacturer shall issue a price list and supplementary price list, if required, in Form V or Form-VI to the State Drugs Controllers and the Government indicating reference to such price fixation or revision as covered by the order or Gazette notification issued by the Government, from time to time."; (e) for paragraph 29, the following shall be inserted, namely: — "29. Maintenance of records and production thereof for inspection.- Every manufacturer shall maintain records, in good order, for a period of not less than seven financial years immediately preceding the current financial year, relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the Government, and the Government shall have the power to call for any record and to inspect such records at the premises of the manufacturer: Provided that where any proceeding has been initiated or pending in respect of the manufacturer under this Order, such records shall be maintained in good order till the final disposal of such proceedings."; (f) in Schedule-II, after Form-I, the following form shall be inserted, namely:- "Form - IA PROFORMA FOR INTIMATION OF LAUNCH OF NEW DRUGS [See paragraph 15 (2)] 1. Name of the Formulation: 2. Name and address of the Manufacturer/Importer: 3. Name and address of the Marketing Company, if any: 4. Composition as per label claimed and approved by Drug Control Authorities: 5. Date of commencement/launch of production/import: 6. Type of formulation: 7. Size of Packs: 8. Therapeutic category/ use of the formulation: 9. Launch price (in Rs. Per unit excluding taxes): 10. Latest price notified by the government and date of notification (in Rs. Per unit excluding taxes): The information furnished above is correct and true to the best of my knowledge and belief. Place: Date: Authorized Signatory: Name: Designation: .". [F. No. 31026/16/2026-Pricing] AWADHESH KUMAR CHOUDHARY, Senior Economic Advisor Note: The Drugs (Prices Control) Order, 2013 was published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (ii), vide notification number S.O. 1221 (E), dated the 15th May, 2013 and subsequently amended vide notifications numbers: (i) S.O. 686(E), dated the 9th March, 2015; (ii) S.O. 1233(E), dated the 8th May, 2015; (iii) S.O. 701(E), dated the 10th March, 2016; (iv) S.O. 1192(E), dated the 22nd March, 2016; (v) S.O. 4100(E), dated the 21st December, 2016; (vi) S.O. 39(E), dated the 3rd January, 2019; (vii) S.O. 508(E), dated the 1st February, 2021; (viii) S.O. 2899(E), dated the 20thJuly, 2021; (ix) S.O. 3249(E), dated the 12th August, 2021; (x) S.O. 5249(E), dated the 11th November, 2022; (xi) S.O. 2165(E), dated the 11th May, 2023; and (xii) S.O. 2324(E), dated the 25th May, 2023. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.