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Core Purpose

Order issued by the National Pharmaceutical Pricing Authority fixing the ceiling prices for specific scheduled formulations under the Drugs (Prices Control) Order, 2013.

Detailed Summary

The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), National Pharmaceutical Pricing Authority (NPPA), issued Order S.O. 2027(E) on 6th May, 2025, exercising powers under paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022. This order supersedes S.O. 1487(E) dated 27th March, 2025, concerning the formulations listed, except for actions taken prior to supersession. The NPPA fixed the ceiling prices (exclusive of Goods and Services Tax) for the following scheduled formulations: 5-amino salicylic Acid (Mesalazine/Mesalamine) Suppository 500 mg at Rs. 17.74 per Suppository, Retention Enema (Foam) at Rs. 17.00 per GM, and Retention Enema (Liquid) at Rs. 2.16 per ML; Surfactant Suspension for intratracheal instillation at Rs. 80.37 per mg of Phospholipids; Betamethasone valerate Lotion 0.05% at Rs. 0.67 per ML, and Gel 0.05% at Rs. 0.48 per GM; Efavirenz Capsule 600 mg at Rs. 56.66 per Capsule; Rifampicin Tablet 300 mg at Rs. 3.70 per Tablet; and Ibuprofen Capsule 400 mg at Rs. 1.33 per Capsule. Manufacturers must revise prices downward if exceeding the ceiling price plus applicable GST. Existing manufacturers with lower MRP must maintain it per paragraph 13(2) of DPCO, 2013. Ceiling price calculation is per paragraph 11 of DPCO, 2013. Manufacturers are required to issue a price list (Form-V) from the notification date to NPPA (via IPDMS), State Drug Controller, and dealers per paragraph 24 of DPCO, 2013. Retailers and dealers must display the price list per paragraph 24(4). Existing manufacturers launching new drugs (paragraph 2(1)(u)) must seek prior price approval (Form I, Schedule-II). Quarterly returns (Form-III, Schedule-II) on production/import and sale must be furnished via IPDMS. Discontinuation requires six months' prior notice (Form-IV, Schedule-II). Non-compliance incurs liability to deposit the overcharged amount 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 Previous price orders for these formulations are superseded.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-06052025-262936 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 1983] NEW DELHI, TUESDAY, MAY 6, 2025/VAISAKHA 16, 1947 2981 GI/2025 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th May, 2025 S. O. 2027(E). 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 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India 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. 1487(E) dated 27th March, 2025 in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the price as specified in column (5) 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. No. | Medicines | Dosage form and strength | Unit | Ceiling Price | | | | | | (Rs.) | +=====+===================================+============================+================+================+ | (1) | (2) | (3) | (4) | (5) | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 1. | 5-amino salicylic Acid | Suppository 500 mg | 1 Suppository | 17.74 | | | (Mesalazine/Mesalamine) | | | | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 2. | 5-amino salicylic Acid | Retention Enema (Foam) | 1 GM | 17.00 | | | (Mesalazine/Mesalamine) | | | | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 3. | 5-amino salicylic Acid | Retention Enema (Liquid) | 1 ML | 2.16 | | | (Mesalazine/Mesalamine) | | | | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 4. | Surfactant | Suspension for | Per mg of | 80.37 | | | | intratracheal instillation | Phospholipids | | | | | (As licensed) | in the pack | | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 5. | Betamethasone valerate | Lotion 0.05% | 1 ML | 0.67 | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 6. | Betamethasone valerate | Gel 0.05% | 1 GM | 0.48 | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 7. | Efavirenz | Capsule 600 mg | 1 Capsule | 56.66 | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 8. | Rifampicin | Tablet 300 mg | 1 Tablet | 3.70 | +-----+-----------------------------------+----------------------------+----------------+----------------+ | 9. | Ibuprofen | Capsule 400 mg | 1 Capsule | 1.33 | +-----+-----------------------------------+----------------------------+----------------+----------------+ Note: (a) All manufacturers of scheduled formulation, 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 (5) 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 (5) 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 (5) 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 (5) 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 price of such formulation 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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