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Core Purpose

Order issued by the National Pharmaceutical Pricing Authority fixing/revising the ceiling price for Iohexol Injection 300mg iodine/ML and providing related directions under the Drugs (Prices Control) Order, 2013.

Detailed Summary

The National Pharmaceutical Pricing Authority, under the Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), issued Order S.O. 2026(E) on 6th May, 2025. This order is in implementation of review directions from the Department of Pharmaceuticals under para 31 of the Drugs (Prices Control) Order, 2013, and in exercise of powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the same Order, read with S.O. 1394(E) dated 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022. It supersedes the Order S.O. 1489(E) dated 27.3.2025 (Sl. No. 384 in that order). The order fixes/revises the ceiling price for the scheduled formulation Iohexol Injection 300mg iodine/ML, considering a WPI impact of 1.74028% for 2025. The previous ceiling price under NLEM, 2022 was Rs. 17.19 per ML, which is now revised to Rs. 19.74 per ML, exclusive of Goods and Services Tax. This revision is based on Review Order numbers 31015/54/2023-Pricing and 31015/55/2023-Pricing dated 27.12.2024. The order mandates manufacturers to revise downward prices exceeding the new ceiling plus GST and maintain existing lower MRPs per paragraph 13(2) of DPCO, 2013. Manufacturers can add GST if paid/payable. The ceiling price for packs is to be calculated per paragraph 11 of DPCO, 2013, and a price list in Form-V must be issued from the notification date per paragraph 24 of DPCO, 2013, submitted to NPPA via IPDMS and copies to State Drug Controller and dealers. Retailers/dealers must display the price lists per paragraph 24(4) of DPCO, 2013. Existing manufacturers launching new drugs (paragraph 2(1)(u) DPCO, 2013) must seek prior price approval from NPPA in Form I (Schedule-II DPCO, 2013). Quarterly returns on production/import/sale (Form-III, Schedule-II DPCO, 2013) must be furnished via IPDMS. Discontinuation information (Form-IV, Schedule-II DPCO, 2013) is required six months prior. Non-compliance incurs liability to deposit overcharged amounts with interest under DPCO, 2013 read with the Essential Commodities Act, 1955. Previous price orders for these formulations are superseded.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-06052025-262933 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 1982] NEW DELHI, TUESDAY, MAY 6, 2025/VAISAKHA 16, 1947 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th May, 2025 S.O. 2026(E).β€”In implementation of directions of review order issued by the Department of Pharmaceuticals (DOP) under para 31 of Drugs (Prices Control) Order, 2013 vide order specified in column (7) of the table below and in exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. and date specified in the Column (8) of the table, the National Pharmaceutical Pricing Authority, hereby fixes/revises the price including WPI impact @1.74028% for the year 2025 as specified in column (6) of the table herein below as ceiling price exclusive of Goods and Services Tax applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE +-----+-----------+-------------------------+------+-------------------------+-----------------------------+---------------------------+-------------------------+ | Sl. | Medicines | Dosage | Unit | Ceiling | Revised Ceiling | Review Order | Existing | | No. | | form & | | Price | price based on | number and date | SO number | | | | Strength | | under | Review Order & | | and date | | | | | | NLEM, | considering WPI | | | | | | | | 2022 | @1.74028% (Rs.) | | | | | | | | (Rs.) | | | | +=====+===========+=========================+======+=========================+=============================+===========================+=========================+ | (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | +-----+-----------+-------------------------+------+-------------------------+-----------------------------+---------------------------+-------------------------+ | | | | | | | 31015/54/2023- | 1489(E) | | | | Injection | | | | Pricing and | dated | | 1. | Iohexol | 300mg | 1 ML | 17.19 | 19.74 | 31015/55/2023- | 27.3.2025 | | | | iodine/ML | | | | Pricing dated | (Sl. No. | | | | | | | | 27.12.2024 | 384) | +-----+-----------+-------------------------+------+-------------------------+-----------------------------+---------------------------+-------------------------+ Note: (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (6) in the above table plus Goods and Services Tax as applicable, if any. (b) All the existing manufacturers of above-mentioned scheduled formulations having MRP lower than the ceiling price specified in column (6) in the above table plus Goods and Services Tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (c) The manufacturers may add Goods and Services Tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (6) of the above said table. (d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (6) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form-V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2(1)(u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (i) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/264/132/2025/F/F. No. 8(132)/2025/D.P./NPPA-Div.-II] MAHAVEER SAINI, Dy. Director 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.

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