Ceiling price fixation of 13 scheduled formulations and revision of ceiling price of 7 formulations based on review orders

8209 GI/202 4 (1) EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY No. 5089 ] NEW DELHI, THURSDAY , DEC EMBER 19, 2024 /AGRAHAYANA 28, 194 6 CG-DL-E-19122024-259537 (1) (2) (3) (4) (5) 400mcg ( ए) + 6mcg 200mcg ( ए) + 6mcg MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals ) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 19th December , 2024 S.O. 5497 (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. 1548 (E) dated 26th March, 202 4 in so fa r 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 speci fied 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 & streng th 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 Anti-rabies immunoglobulin Injection 150 IU/ml 1 ML 3107.59 2 Anti-rabies immunoglobulin Injection 300 IU/ml 1 ML 109.56 3 Measles vaccine As licensed Each Vial of 0.5ml 50.20 4 Anti-tetanus immunoglobulin As licensed ( 250IU ) 1 Vial 1244.79 5 Anti-tetanus immunoglobulin As licensed ( 500IU ) 1 Vial 1875.75 6 Anti-tetanus immunoglobulin As licensed ( 1000IU ) 1 Vial 2684.19 7 BCG vaccine As licensed Each dose (0.10 ML) 8.01 8 Measles Rubella vaccine As licensed Each Vial of 0.5ml 71.19 9 Amphotericin B Liposomal Injection 50mg/ vial 1 Vial 6648.23 10 Amphotericin B Lipid Injection 50mg/ vial 1 Vial 1887.75 11 Water for injection Injection Each Pack (10 ml) 2.42 12 Budesonide (A) + Formoterol (B) Inhalation (MDI) 400mcg (A) + 6mcg (B) Per Metered dose 3.37 13 Budesonide (A) + Formoterol (B) Inhalation (MDI) 200mcg (A) + 6mcg (B) Per Metered dose 2.96 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 existin g 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 p aragraph 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 manufactu rer 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 pri ce 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 ma nufacturer 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 or der(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/260/128/2024/F /F. No. 8(128)/2024/D.P./NPPA/Div. -II] MAHAVEER SAINI , Dy. Director 0.00551% (1) (2) (3) (4) (5) (6) (7) (8) 04.10.2024 1547( अ) 26.03.2024 (पी) 1 जम.ली. 4.61 4.65 31015/ 38/2023 04.10.2024 1547( अ) 26.03.2024 04.10.2024 1547( अ) 26.03.2024 2-5 % 1 ग्राम/जम.ली. 1.13 1.08 31015/ 46/2023 04.10.2024 1547( अ) 26.03.2024 04.10.2024 1547( अ) 26.03.2024 04.10.2024 1547( अ) 26.03.2024 04.10.2024 और 31015/ 15/2023 27.05.2024 1547( अ) 26.03.2024 ORDER New Delhi, the 19th December , 2024 S.O. 5498(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, 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 Go vernment 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 @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 applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry in column (2) o f 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. Thiamine Injection 100mg/ml 1 ml 22.59 26.70 31015/45/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 652 ) 2. Clarithromycin Oral liquid 125mg/ 5ml 1 ml 4.61 4.65 31015/38/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 151 ) 3. Lignocaine Injection 2% 1 ml 1.04 1.14 31015/46/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 405 ) 4 Lignocaine Topical forms 2-5% 1 GM/ML 1.13 1.08 31015/46/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 404 ) 5 Clarithromycin Tablet 250 mg 1 tablet 23.89 24.06 31015/86/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 149 ) 6 Ascorbic acid (Vitamin C) Tablet 500 mg 1 tablet 1.48 1.54 31015/68/2023 - Pricing dated 04.10.2024 1547(E) dated 26.03.2024 (Sl. No. 55) 7 Atorvastatin Tablet 10 mg 1 tablet 4.94 4.97 31015/86/2023 - Pricing dated 04.10.2024 and 31015/15/2023 - Pricing dated 27.05.2024 1547(E) dated 26.03.2024 (Sl. No. 59) 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 fo rmulations 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 pri ce 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 th ey 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 paragra ph 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 manufactu rer, 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 specifie d 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 o f 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 produ ction 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/260/128/2024/F /F. No. 8(128)/2024/D.P./NPPA/Div. -II] MAHAVEER SAINI , Dy. Director Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.