Fixation of Ceiling price of 1 formulation and extended of 5 medical devices and Oxygen Concentrator approved in 110 Authority meeting

रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 ससीी..जजीी..--डडीी..एएलल..--अअ..--2299003322002233--224444776633 xxxGIDHxxx CCGG--DDLL--EE--2299003322002233--224444776633 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 1465] नई ददल्ली, िुधर्ार, मार् व29, 2023/र्त्रै 8, 1945 No. 1465] NEW DELHI, WEDNESDAY, MARCH 29, 2023/CHAITRA 8, 1945 रसायन और उर्रव क मत्रं ालय (औषध जर्भाग) (राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण) आदेि नई ददल्ली, 29 मार्,व 2023 का.आ. 1518(अ).—डीपीसीओ 2013 के पैरा 19 के अनसु ार िारी पांर् जर्दकत्सा उपकरण, अर्ातव ् (i) पल्स ऑक्सीमीटर, (ii) ब्लड प्रेिर मॉनीटररंग मिीन, (iii) नेब्युलाइज़र, (iv) जडजिटल र्मावमीटर और (v) ग्लूकोमीटर के जलय े ‘व्यापार मार्िवन युजिकरण दजृ िकोण’ स े उत्पाद की जिक्री के पहल े बिंद ु (जर्तरक को मूल्य) के आधार पर अजधकतम मल्ू य को जनधावररत करने स े संिंजधत ददनांक 13 िुलाई 2021 के का. आ. 2808(अ), 31 िनर्री, 2022 के का.आ. 401 (अ), 29 िुलाई, 2022 के का.आ. 3534 (अ) और 30 ददसंिर 2022 के का.आ. 6176 (अ) के माध्यम स े राष्ट्रीय औषध मूल्य जनधावरण प्राजधकरण, औषध जर्भाग, रसायन और उर्वरक मंत्रालय, भारत सरकार द्वारा अजधसूर्ना िारी की गई ह।ै उपरोि अजधसूर्नाओं के क्रम म,ें पांर् जर्दकत्सा उपकरण, नामतः(i) पल्स ऑक्सीमीटर, (ii) ब्लड प्रिे र मॉनीटररंग मिीन,

(iii) नेब्युलाइज़र, (iv) जडजिटल र्मावमीटर और (v) ग्लूकोमीटर के जलय े ‘व्यापार मार्िवन यजु िकरण दजृ िकोण’ स े उत्पाद की जिक्री के पहले बिंद ु(जर्तरक को मल्ू य) के आधार पर अजधकतम कीमत ें जनधावररत करन े संिंधी 31 मार् व 2023 तक की अजधसूर्ना को 30 िून 2023 तक अर्र्ा अगले आदेि तक, िो भी पहल े हो, िढा ददया गया ह।ै 2128 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

2. ददनांक 13 िुलाई 2021 के का. आ. 2808 (अ) की रटप्पणया ं (ख) स े (ड) तक इस आदिे के िारी रहने की अर्जध के दौरान लाग ू रहगें ी। [पीएन/242/110/2023/एफ/फा. स.ं 8(110)/2023/डीपी/एनपीपीए/जडर्.II] रािेि कुमार टी, उप जनदेिक MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY)

ORDER New Delhi, the 29th March, 2023 S.O. 1518(E).—The National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India vide S.O. 2808(E) dated 13th July 2021, S.O. 401 (E) dated 31st January 2022, S.O. 3534(E) dated 29th July 2022 and S.O. 6176(E) dated 30th December 2022 issued notifications under Para 19 of the DPCO, 2013 regarding capping the trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer, at the first point of sale of the product (price to distributor) for fixation of Maximum Retail Price of these products. In continuation to the above notifications, capping the trade margin of five medical devices, namely, (i) Pulse Oximeter,

(ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at the first point of sale (price to distributor) up to 31st March 2023 is further extended up to 30th June 2023 or till further order, whichever is earlier.

2. The Notes (b) to (m) of the Notification S.O. 2808 (E) dated 13th July 2021 shall remain in force during the currency of this order. [PN/242/110/2023/F/ F. No. 8(110)/2023/DP/NPPA/Div.II] RAJESH KUMAR T, Dy. Director आदेि नई ददल्ली, 29 मार्,व 2023 का.आ. 1519(अ).—डीपीसीओ, 2013 के पैरा 19 के तहत िारी ऑक्सीिन सांद्र्क (कांसेंरेटसव) के जलए ‘व्यापार मार्िवन युजिकरण दजृ िकोण’ स े उत्पाद जिक्री के पहले बिंद ु (जर्तरक को मूल्य) के आधार पर अजधकतम खुदरा मल्ू य को जनयत/संिोजधत करन े स े संिंजधत ददनांक 3 िनू , 2021 के का.आ. 2161(अ), ददनांक 30 नर्ंिर, 2021 के का.आ.

4909(अ), 30 मई, 2022 के का.आ. 2465(अ), 30 िून, 2022 के का.आ. 2983 (अ) और 30 ददसंिर, 2022 के का.आ.

6177(अ) के माध्यम स े राष्ट्रीय औषध मल्ू य जनधावरण प्राजधकरण, औषध जर्भाग, रसायन और उर्वरक मंत्रालय, भारत सरकार के द्वारा अजधसूर्ना िारी की गई ह।ै उपरोि अजधसर्ू नाओं के क्रम म,ें ऑक्सीिन सांद्र्क (कांसेंरेटसव) के व्यापार मार्िवन युजिकरण दजृ िकोण स े उत्पाद की जिक्री के पहल े बिदं (ु जर्तरक को मल्ू य) के आधार पर अजधकतम कीमत ें जनयत करने संिंधी 31 मार् व 2023 तक की अजधसूर्ना को 30 िून 2023 तक अर्र्ा अगले आदिे तक, िो भी पहल े हो, िढा ददया गया ह।ै

2. ददनांक 3 िून 2021 के का.आ. 2161(अ) की रटप्पजणयां (ख) स े (न) तक इस आदेि के िारी होने की अर्जध के दौरान लाग ू रहगें ी। [पीएन/242/110/2023/एफ/फा. स.ं 8(110)/2023/डीपी/एनपीपीए/जडर्.II] रािेि कुमार टी, उप जनदेिक[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3

ORDER New Delhi, the 29th March, 2023 S.O. 1519(E).—The National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India vide S.O. 2161 (E) dated 3rd June 2021, S.O. 4909 (E) dated 30th November 2021, S.O. 2465 (E) dated 30th May 2022, S.O.2983(E) dated 30th June 2022 and S.O. 6177 (E) dated 30th December 2022 issued notifications under Para 19 of the DPCO, 2013 regarding capping the trade margin of Oxygen Concentrators at the first point of sale (price to distributor) for fixation of Maximum Retail Price of the product. In continuation to the above notifications, capping the trade margin of Oxygen Concentrator at the first point of sale (price to distributor) up to 31st March 2023 is further extended up to 30th June 2023 or till further order, whichever is earlier.

2. The Notes (b) to (n) of the Notification S.O. 2161(E) dated 3rd June 2021 shall remain in force during the currency of this order. [PN/242/110/2023/F/ F. No. 8(110)/2023/DP/NPPA/Div.II] RAJESH KUMAR T, Dy. Director आदेि नई ददल्ली, 29 मार्,व 2023 का.आ. 1520(अ).— नवम्बर 4, 6, 10, 11, 14, 16, फ़रवरी अधिक्रमण एसओ दिन ांक के अनुस र

(1) (2) (3) (4) (5) (6) gkeksZu fjfyftax blesa 52 fexzk- 1 vkbZ;wMh vkbZ;wMh yos ksuksxsZLVªsy 'kkfey 3456.44 3659.68 1 gS [पीएन/242/110/2023/एफ/फा. सं. 8(110)/2023/डीपी/एनपीपीए/जडर्.II] रािेि कुमार टी, उप जनदिे क सधित

(6) सधित4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

(2)

(6) V

(4) धवक्रेता सस्ु पष्ट

(1) II I के धनमााता अनु II III का वि II IV गई उनका जाएगा

ORDER New Delhi, the 29th March, 2023 S.O. 1520(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 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. 879(E) dated 24th February, 2023 in so far as it relates to formulation pack 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 (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:[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5 TABLE Ceiling Price (Rs) as per Ceiling Price Sl. Name of the Scheduled Dosage form and Unit S.O. 879(E) dt (Rs.) No. Formulation strength 24/02/2023

(1) (2) (3) (4) (5) (6) Hormone Releasing IUD Contains 52 mg of 1 IUD 1 Levonorgestrel 3456.44 3659.68 [PN/242/110/2023/F/ F. No. 8(110)/2023/DP/NPPA/Div.II] RAJESH KUMAR T, Dy. Director

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 (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/VI 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.

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