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रजिस्ट्री सं. डी.एल.- 33004/99

REGD. No. D. L.-33004/99

सी.जी.-डी.एल.-अ.-07012023-241750

CG-DL-E-07012023-241750

xxxGIDHxxx

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असाधारण

EXTRAORDINARY

भाग II—खण्ड 3—उप-खण्ड (ii)

PART II—Section 3—Sub-section (ii)

प्राधिकार से प्रकाशित

PUBLISHED BY AUTHORITY

सं. 83] नई दिल्ली, शुक्रवार, जनवरी 6, 2023/पौष 16, 1944 No. 83] NEW DELHI, FRIDAY, JANUARY 6, 2023/PAUSHA 16, 1944

रसायन और उर्वरक मंत्रालय

(औषध विभाग)

(राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण)

आदेश

नई दिल्ली, 6 जनवरी, 2023

का.आ. 86(अ).—भारत सरकार के रसायन और उर्वरक मंत्रालय द्वारा जारी का.आ. 1394(अ) तारीख 30 मई, 2013 और का.आ. 5249(अ) तारीख 11 नवम्बर, 2022 के साथ पठित औषध (कीमत नियंत्रण) आदेश, 2013 के पैरा 5,11 और 15 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए, राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण (जिसको संक्षिप्त रूप में एनपीपीए कहा जाता है), नीचे की सारणी के स्तंभ (6) में विनिर्दिष्ट खुदरा मूल्य को उक्त सारणी के स्तंभ (3), (4) और (5) में तत्स्थानी प्रविष्टियों में विनिर्दिष्ट प्रबलता, इकाई (यूनिट) और विनिर्माता और विपणन कं पनियों के नाम सहित स्तंभ (2) में की तत्स्थानी प्रविष्टि में से प्रत्येक की, वस्तु एवं सेवा कर, यदि कोई है, को छोड़कर अधिकतम खुदरा मूल्य के रूप में नियत करती है ।

तालिका

135 GI/2023

(1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

तालिका (6) V (4) सुस्पष्ट I इस आदेश में उपरोक्त तालिका के कॉलम (3) और (5) में तत्स्थानी प्रविष्टियों में निर्दिष्ट विनिर्माण और विपणन कं पनियों की स्ट्रेंथ और नाम के साथ, उपरोक्त तालिका के कॉलम (2) में निर्दिष्ट ऐसे फॉमू र्लेशन के खुदरा मूल्य के निर्धारण के परिणामस्वरूप, कॉलम (2), (3) और (5) में तत्स्थानी प्रविष्टियों में यथा निर्दिष्ट उस विनिर्माण और विपणन कं पनियों के लिए निर्दिष्ट स्ट्रेंथ के साथ फॉमू र्लेशन के खुदरा मूल्य को निर्धारित करने वाले कोई मूल्य आदेश यदि इस अधिसूचना से पहले जारी किए गए हो, तो उसे इसका स्थान लिया माना जाएगा।

[पीएन/238/106/2022/एफ /फा.न.8(106)/2022/डी.पी./एनपीपीए-डी.वी.-II]

महावीर सैनी, उप निदेशक MINISTRY OF CHEMICALS AND FERTILIZERS

(Department of Pharmaceuticals)

(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)

ORDER

New Delhi, the 6th January, 2023

S.O. 86(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 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, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;

TABLE

Note:

(a) The manufacturer of above-mentioned formulations i.e., "new drug" under paragraph 2(1)(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.

(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.

(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 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.

(d) 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.

(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.

(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.

(g) Consequent to the fixation of retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.

[PN/238/106/2022/F /F. No. 8(106)/2022/D.P./NPPA-Div.-II]

MAHAVEER SAINI, Dy. Director15 [भाग II—खण्ड ³(ii)] भारत का राजपत्र : असाधारण

नई दिल्ली, 6 जनवरी, 2023

का.आ. 87(अ).—भारत सरकार के रसायन और उर्वरक मंत्रालय द्वारा जारी का0 आ0 1394(अ) तारीख 30 मई, 2013 और का.आ. 5249(अ) तारीख 11 नवम्बर, 2022 के साथ पठित औषध (कीमत नियंत्रण) आदेश, 2013 के पैरा 4, 6, 10, 11, 14, 16, 17 और 18 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए और भारत सरकार में रसायन एवं उर्वरक मंत्रालय (राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण) के का. आ. 1499(अ) दिनांक 30 मार्च, 2022 के आदेष के अधिक्रमण में जहां तक उसका संबंध नीचे की सारणी के विनिर्मिति पैक से है, उन बातों के सिवाय अधिक्रान्त करते हुए जिन्हें ऐसे अधिक्रमण के पूर्व किया गया है या करने का लोप किया गया है, राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण नीचे की सारणी के स्तंभ (5) में विनिर्दिष्ट अधिकतम कीमत को उक्त सारणी के स्तंभ (3) और (4) में क्रमशः तत्स्थानी प्रविष्टियों में विनिर्दिष्ट खुराक रूप एवं प्रबलता और इकाई सहित उस सारणी के स्तंभ (2) में की तत्स्थानी प्रविष्टि में विनिर्दिष्ट अनुसूचित विनिर्मितियों में से प्रत्येक की, वस्तु एवं सेवा कर, यदि कोई है, को छोड़कर अधिकतम कीमत के रूप में नियत करती हैः

सहित (5) सहित18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (2) (5) V विक्रे ता

(4) सुस्पष्ट II I के निर्माता अनु II III का वह

II IV गई उनका जाएगा [कां.सं./238/106/2022/एफ/फा.सं . 8(106)/2022/डी.पी./एनपीपीए-डी.वी.-II ]

महावीर सैनी, उप निदेशक

ORDER

New Delhi, the 6th January, 2023

S.O. 87(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) No. S.O. 1499(E) dated 30th March, 2022 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

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 (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/238/106/2022/F/ F. No. 8(106)/2022/D.P./NPPA-Div.-II]

MAHAVEER SAINI, Dy. Director22 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]

नई दिल्ली, 6 जनवरी, 2023

.—भारत सरकार के रसायन और उर्वरक मंत्रालय द्वारा जारी का0 आ0 1394(अ) तारीख 30 मई, 2013 और का. आ. 5249(अ) तारीख 11 नवम्बर, 2022 के साथ पठित औषध (कीमत नियंत्रण) आदेश, 2013 के पैरा 4, 6, 10, 11, 14, 16, 17 और 18 द्वारा प्रदत्त शक्तियों का प्रयोग करते हुए तथा भारत सरकार के रसायन एवं उर्वरक मंत्रालय, राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण; जिसको संक्षिप्त रूप में एनपीपीए कहा जाता है), नीचे की सारणी के स्तंभ (5) में विनिर्दिष्ट अधिकतम कीमत को उक्त सारणी के स्तंभ (3) और (4) में क्रमशः तत्स्थानी प्रविष्टियों में विनिर्दिष्ट खुराक रूप एवं प्रबलता और इकाई सहित उस सारणी के स्तंभ (2) में की तत्स्थानी प्रविष्टि में विनिर्दिष्ट अनुसूचित विनिर्मितियों में से प्रत्येक की, वस्तु एवं सेवा कर, यदि कोई है, को छोड़कर अधिकतम कीमत के रूप में नियत करती हैः

(5) (2) (5) V (4) II I अनु II III23 [भाग II—खण्ड ³(ii)] भारत का राजपत्र : असाधारण II IV उनका जाएगा [कां. सं./238/106/2022/एफ/फा. सं. 8(106)/2022/डीपी/एनपीपीए-डिवी.-II]

महावीर सैनी, उप निदेशक

ORDER

New Delhi, the 6th January, 2023

S.O. 88(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, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices 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

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 (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/238/106/2022/F /F. No. 8(106)/2022/D.P./NPPA-Div.-II]

MAHAVEER SAINI, Dy. Director नई दिल्ली, 6 जनवरी, 2023 राष्ट्रीय औषध मूल्य निर्धारण प्राधिकरण की अधिसूचना का.आ. 5938(अ), दिनांक 19 दिसम्बर, 2022 जो अधिकतम मूल्य से संबंधित है भारत के आसाधरण राजपत्र में तालिका के क्रम सं. 1, 7 - 10, 12, 22, 23, 26 - 28, 30, 48, 50, 53, 55, 57 - 64, 66, 74, 82, 89, 92, 102 और 105 नीचे दी गई तालिका के कॉलम (5) में उल्लिखित तालिका के हिंदी और अंग्रेजी दोनों संस्करणों में, नीचे दी गई तालिका के कॉलम (6) में प्रविष्टियों के रूप में पढ़ा जाए:

दिसम्बर, ²⁰²² [कां. सं./238/106/2022/एफ फा. सं. 8(106)/2022/डीपी/एनपीपीए-डिवी-II]

महावीर सैनी, निदेशक

CORRIGENDUM

New Delhi, the 6th January, 2023

S.O. 89(E).—In the National Pharmaceutical Pricing Authority's notification S.O. 5938(E), dated 19th December, 2022 relating to fixation of ceiling price, published in the Gazette of India, Extraordinary, the Entry at Sl. No. 1, 7 – 10, 12, 22, 23, 26 – 28, 30, 48, 50, 53, 55, 57 – 64, 66, 74, 82, 89, 92, 102 & 105 of the Table, both in Hindi & English version as mentioned in column (5) of the table below, be read as entries in column (6) of the table below:

TABLE

All the notes and other contents mentioned in the original order S.O. 5938(E), dated 19th December, 2022 shall remain same.

[PN/238/106/2022/F /F. No. 8(106)/2022/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.