Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5 11 and 1...
Date: 2020-12-11 Category: Extra Ordinary State: Union Government Country: India

In exercise of the powers conferred by paragraphs 5 11 and 15 of the Drugs Prices Control Order

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: This document, issued by the National Pharmaceutical Pricing Authority (NPPA) on December 11, 2020, fixes the retail prices of specific drug formulations as per the Drugs Prices Control Order (DPCO) 2013. It specifies retail prices exclusive of GST for the formulations listed in the table. Manufacturers and retailers must comply with the DPCO 2013 guidelines, including issuing price lists and displaying them conspicuously. Key Points / Main Content: Price Fixation: * The NPPA fixes the retail price for specific formulations listed in the table, excluding goods and services tax. * The retail price is specified in column 6 of the table and applies to the corresponding formulation in column 2, with details in columns 3, 4, and 5. Manufacturer Responsibilities: * Manufacturers of new drugs must fix the retail price as specified in column 6 of the table. * Manufacturers may add goods and services tax only if they have paid it or it is payable to the Government. * Retail price for a pack must align with column 6 as per paragraph 11 of the DPCO, 2013. * A price list in Form V must be issued from the date of notification per paragraph 24 of the DPCO, 2013, to NPPA via IPDMS, with copies to the State Drug Controller and dealers. Retailer Responsibilities: * Retailers and dealers must display the price list and supplementary price list conspicuously as furnished by the manufacturer. Applicability and Compliance: * The retail price applies only to manufacturers/marketers who applied via Form I for price fixation/revision under DPCO, 2013. * Compliance is subject to fulfilling all statutory requirements, including manufacturing license/permission from the Competent Authority. * Non-compliance results in liability to deposit the overcharged amount with interest under the DPCO, 2013, and the Essential Commodities Act, 1955. * Price orders issued before this notification's date are superseded. Impact Analysis: Manufacturers: * Impact: Must adhere to the fixed retail prices for specified formulations and comply with DPCO 2013 guidelines. * Action Required: Fix prices accordingly, issue price lists, and ensure compliance with all statutory requirements. Retailers/Dealers: * Impact: Must sell formulations at or below the fixed retail price and display price lists conspicuously. * Action Required: Display updated price lists and ensure adherence to the set prices. Consumers: * Impact: Can purchase essential drugs at regulated prices, ensuring affordability. * Action Required: Be aware of the fixed prices and report any overcharging. National Pharmaceutical Pricing Authority (NPPA): * Impact: Responsible for enforcing the price regulations and ensuring compliance. * Action Required: Monitor manufacturer and retailer compliance, address grievances, and update price lists as needed.

Key Entities Referenced

National Pharmaceutical Pricing Authority: A government regulatory agency in India that controls the prices of pharmaceutical drugs. Drugs Prices Control Order, 2013: An order issued by the Government of India to regulate the prices of drugs. Ministry of Chemicals and Fertilizers: A ministry in the Government of India responsible for the chemical and fertilizer industries. Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India, focusing on the pharmaceutical sector. New Delhi: The capital city of India, where the order was issued. Essential Commodities Act, 1955: An act of the Parliament of India that ensures the supply of essential commodities. Ofloxacin: An antibiotic drug, the price of which is being regulated by this order. Dexamethasone: A corticosteroid drug, the price of which is being regulated by this order.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-11122020-223654 xxxGIDHxxx CG-DL-E-11122020-223654 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.ं 3951] नई ददल्ली, िुक्रर्ार, ददसम्ब र 11, 2020/अग्रहायण 20, 1942 No. 3951] NEW DELHI, FRIDAY, DECEMBER 11, 2020/AGRAHAYANA 20, 1942 रसायन और उर्रव क मत्रं ालय (औषध जर्भाग) (राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण) आदेि नई ददल्ली, 11 ददसम्बर, 2020 का. आ. 4498 (अ).—भारत सरकार के रसायन और उर्वरक मंत्रालय द्वारा िारी का. आ. 1394 (अ) तारीख 30 मई, 2013 और का. आ. 701(अ) तारीख 10मार्,व 2016 के साथ पठित औषध (कीमत जनयंत्रण) आदेि, 2013 के पैरा 5,11 और 15 द्वारा प्रदत्त िजियों का प्रयोग करते हुए, राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण(जिसको संजिप्त रूप म ें एनपीपीए कहा िाता ह)ै नीर्े की सारणी के स्ट्तंभ(6) में जर्जनर्दष्टव खुदरा मल्ू य को उि सारणी के स्ट्तंभ(3),(4) और (5) म ें तत्सस्ट्थानी प्रजर्जष्टयों म ें जर्जनर्दष्टव प्रबलता, इकाई (यूजनट) और जर्जनमावता और जर्पणन कंपजनयों के नाम सजहत स्ट्तंभ(2) म ें की तत्सस्ट्थानी प्रजर्जष्ट म ें से प्रत्सयेक की,र्स्ट्त ु एर् ं सेर्ा कर, यदद कोई ह,ै को छोड़कर अजधकतम खुदरा मल्ू य के रूप म ें जनयत करती ह ै 6056 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] सारणी क्र.स.ं जर्जनर्मजव त का प्रबलता इकाई जर्जनमातव ा और जर्पणन खदु रा नाम/ब्ाडं का नाम कंपनी मल्ू य (रु.) (1) (2) (3) (4) (5) (6) 1. घटक: 4.25 ओफ़्लॉक्साजसन आईपी 0.3% ओफ़्लॉक्साजसन + मैससव स्ट्काइमैप हल्े थकेयर डेक्सामेथासोन डब्ल/ूर्ी, 1 जमली प्रा. जल. / मैससव ग्लेंजस्ट्मथ सोजडयम फॉस्ट्फेट आई डेक्सामेथासोन सोजडयम लैब्स प्रा. जलजमटेड / ईयर ड्रॉप्स फॉस्ट्फेट आईपी 0.1% डब्ल/ूर्ी, 2. घटक: 4.25 ओफ़्लॉक्साजसन + ओफ़्लॉक्साजसन आईपी 0.3% डेक्सामेथासोन डब्ल/ूर्ी, मैससव स्ट्काइमैप हल्े थकेयर 1 जमली सोजडयम फॉस्ट्फेट आई प्रा. जलजमटेड डेक्सामेथासोन सोजडयम / ईयर ड्रॉप्स फॉस्ट्फेट आईपी 0.1% डब्ल/ूर्ी 3. प्रत्सयेक अजलजपत र्बाने योग्य 3.82 गोली म:ें एस्ट्कॉर्बवक एजसड आईपी 100 जमलीग्राम, मैससव अकुम ड्रग्स एंड एस्ट्कॉर्बवक एजसड सोजडयम एस्ट्कॉबेट आईपी फामावस्ट्यूठटकल्स जलजमटेड (जर्टाजमन सी) + जिंक 1 गोली 450 जमलीग्राम, एस्ट्कॉर्बवक / मैससव एबोट हल्े थकेयर र्बाने योग्य गोली प्राइर्ेट जलजमटेड एजसड 400 जमलीग्राम के बराबर, जिंक साइरेट यूएसपी मौजलक जिंक 5 जमलीग्राम के बराबर, नोट: (क) उपयुवि दी गई जर्जनर्दष्टव फॉमूवलेिन के जर्जनमावता अथावत िो “नई ड्रग” डीपीसीओ, 2013 के पैराग्राफ 2(य)ू के तहत उपयुवि दी गई सारणी के स्ट्तंभ (6) म ें जर्जनर्दष्टव खुदरा मल्ू य जनधावठरत करेंगे। (ख) अगर जनमावताओं न ेउपयुवि सारणी के स्ट्तंभ (6) म ें र्र्णवत अजधकतम कीमत पर सरकार को र्ास्ट्तर् म ें भुगतान दकया ह ै या यह दये ह ैतो र् े र्स्ट्त ु एर् ं सर्े ा कर को िोड़ सकते ह।ैं (ग) औषध (मूल्य जनयंत्रण) आदेि, 2013 के परै ाग्राफ 11 म ें ददए गए प्रार्धानों के तहत जनमावताओं को उपयिुव सारणी के स्ट्तंभ (6) म ें जर्जनर्दष्टव खुदरा मूल्य के आधार पर अनुसूजर्त जर्जनर्मवजतयों के पैकों के जलए खुदरा मूल्य जनधावठरत करें। जनमावता औषध (मल्ू य जनयंत्रण) आदेि, 2013 के परै ाग्राफ 24 के तहत फॉमवट म ें अजधसूर्ना की तारीख स े एक मल्ू य सूर्ी एनपीपीए को आईपीडीएमएस के माध्यम स े िारी करें तथा उसकी काप ी राज्य औषजध जनयंत्रकों और जर्जनमावता जर्तरकों को िारी करें। (घ) औषध (मल्ू य जनयंत्रण) आदेि, 2013 के 24 (4) के उपबंधों के अनुसार प्रत्सयेक फुटकर जर्क्रेता और जर्तरक जर्जनमावता द्वारा ददए गए रूप म ें ऐस े पठरसर, िहां कारबार को इस प्रकार दकया िा रहा ह ै दक उससे परामिव के इच्छुक दकसी व्यजि[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 के जलए पहुर्ं आसान हो, र्हां उसके दकसी सहिदष्ृ य भाग पर कीमत सूर्ी और परू क सूर्ी, यदद कोई हो, को संप्रदर्षवत करेगा। (ड.) उपयुवि गैर अजधकतम कीमत (खुदरा मूल्य) केर्ल उपयिुव जनमावता/जर्पणन के जलए लागू ह ै िैसा दक उन्होंन े औषध (मूल्य जनयंत्रण) आदेि, 2013 के तहत अनुबद्ध मल्ू य जनधावरण/संिोधन के जलए फॉमवट पर िमा दकया गया था और सरकार द्वारा जनधावठरत सभी लागू र्धै ाजनक आर्श्यकताओं की पूर्तव के अधीन प्रासंजगक जर्जधयों/जनयमों के अन्तगवत िैसा दक केन्रीय/राज्य लाइसेजसंग ऑथोठरटी के सिम प्राजधकारी द्वारा मेन्यूफेक्र्ररंग लाइसेंस मंिूरी के तहत संबंजधत जर्जनर्मवत जनमावता/जर्पणन कम्पजनया ं िो अनुपालन करती ह।ै (र्) जर्जनमावता या जर्पणन कम्पनी, उपरोि जर्जनर्मवजतयों और जर्जनर्दष्टव ितों का पालन नहीं करती ह ैं तो र् े आर्श्यक र्स्ट्तुए ँ अजधजनयम, 1955 के साथ पठित डीपीसीओ, 2013 के प्रार्धानों के अधीन ब्याि सजहत अजधप्रभाठरत राजि को िमा करने के जलए दायी होंगे। (छ) इस आदेि म ें उपरोि सारणी के स्ट्तंभ (2) म ें की तत्सस्ट्थानी प्रजर्जष्ट म ें जर्जनर्दष्टव जर्जनर्मवजतयों के पैकों की खुदरा मल्ू य जनयत होने के पठरणामस्ट्र्रुप, आदेि िो दक इस आदेि स े पूर् व िारी हुए ह,ै स्ट्र्तः ही जनरस्ट्त हो िायेंगे। [पीएन/213/81/2020/एफ/फा.न.8(81)/2020/डी.पी./एनपीपीए-डी.र्ी.-II] प्रसेनिीत दास, सहायक जनदेिक MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi,the 11th December, 2020 S.O. 4498(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. 701(E) dated 10th March, 2016 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 Sl. Name of the Strength Unit Manufacturer & Retail No. Formulation / Marketing Company Price Brand Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Ofloxacin + Composition: M/s Skymap 4.25 Dexamethasone Ofloxacin IP 0.3% w/v, Healthcare Pvt. Ltd. / 1 ml Sodium Phosphate Dexamethasone Sodium Phosphate IP M/s Glensmith Labs Eye /Ear Drops 0.1% w/v, Pvt. Ltd. 2. Ofloxacin + Composition: 4.25 Dexamethasone Ofloxacin IP 0.3% w/v, M/s Skymap 1 ml Sodium Phosphate Dexamethasone Sodium Phosphate IP Healthcare Pvt. Ltd. Eye /Ear Drops 0.1% w/v, 3. Each uncoated Chewable Tablet 3.82 Contains: M/s Akums Drugs & Ascorbic Acid Ascorbic Acid IP 100mg, Pharmaceuticals Ltd. / (Vitamin C) + Zinc Sodium Ascorbate IP 450mg eq. to 1 Tablet M/s Abbott Chewable Tablet Ascorbic Acid 400mg, Healthcare Pvt. Ltd. Zinc Citrate USP eq. to Elemental Zinc 5mg.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Note: (a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(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 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/213/81/2020/F/F. No. 8(81)/2020/D.P./NPPA-Div.-II] PRASENJIT DAS, Assistant 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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