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Core Purpose

Order fixing/revising the ceiling price of a Scheduled formulation under the Drugs (Prices Control) Order, 2013 issued by the National Pharmaceutical Pricing Authority.

Detailed Summary

This order, S.O. 3868(E) dated 10th September 2024, issued by the National Pharmaceutical Pricing Authority (NPPA) under the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, implements a review order under para 31 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) and, in exercise of powers under paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the DPCO, 2013 read with S.O. 1394(E) dated 30th May 2013 and S.O. 5249(E) dated 11th November 2022, supersedes the earlier order S.O. 1547(E) dated 26th March 2024 (Sl. No. 134); it revises the ceiling price of Chloroquine Tablet 150 mg (per tablet), incorporating a Wholesale Price Index (WPI) impact of 0.00551% for the year 2024, from the existing ceiling price of Rs. 1.17 (exclusive of GST) to a revised ceiling price of Rs. 1.33, pursuant to Review Order No. 31015/30/2023-Pricing dated 28th May 2024, and sets out compliance notes under the DPCO, 2013 including paragraph 13(2) on MRP maintenance, paragraph 24 on Form-V price lists via IPDMS, paragraph 2(1)(u) on new drug approvals, Schedule-II Form-III/Form-IV returns, and liability for overcharging under the Essential Commodities Act, 1955; the order is issued under file number PN/258/126/2024/F.No. 8(126)/2024/D.P./NPPA-Div.-II and signed by Mahaveer Saini, Deputy Director.

Full Text

5803 GI/202 4 (1) EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 3536] NEW DELHI, TUES DAY , SEPTEMBER 10, 2024 /BHADRA 19, 194 6 CG-DL-E-10092024-257045 2022 क े 0.00551% (1) (2) (3) (4) (5) (6) (7) (8) 28.05.2024 1547( अ) 26.03.2024 MINISTRY OF CHEMICALS AND FERTILIZERS Department of Pharmaceuticals NATIONAL PHARMACEUTICAL PRI CING AUTHORITY ORDER New Delhi, the 10th September , 2024 S.O. 3868(E).— 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 i n exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, rea d with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the G overnment of India in the Mi nistry 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 Nation al Pharmaceutical Pricing Authority, hereby fixes/revises the price including WPI impact @0.00551% for the year 2024 as specified in column (6) of the table herein below as ceiling price exclusive of Goods and Services Tax appli cable, 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 & Strength Unit Ceiling Price under NLEM, (Rs.) Revised Ceiling price based on Review Order & considering WPI @0.00551% (Rs.) Review Order number and date Existing SO number and date (1) (2) (3) (4) (5) (6) (7) (8) 1. Chloroquine Tablet 150 mg 1 Tablet 1.17 1.33 31015/ 30/2023 - Pricing dated 28.05.2024 1547(E) dated 26.03.2024 (Sl. No. 134) Note: (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations a t 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 tabl e 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 ap plicable, if a ny, 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 2 4 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 acces sible 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 manufactur er 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 ab ove said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / i mport and sale of scheduled formulations in Form -III of Schedule -II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue productio n of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuati on 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 E ssential Commodities Act, 1955. (i) Consequent to the issue of ceiling prices of such formulations as specif ied 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 dat e of notification, stand(s) superseded. [PN/258/126/2024/F / F. No . 8(126)/2024/D.P./NPPA -Div.-II] MAHAVEER SAINI , Dy. Director Uploaded by Dte. of Printing at Government of India Press, Rin g Road, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.

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