Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 4 6 10 11 ...
Date: 2017-03-30 Category: Extra Ordinary State: Union Government Country: India

In exercise of the powers conferred by paragraphs 4 6 10 11 14 16 17 and 18 of the Drugs Prices Control Order 2013

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, fixes the ceiling prices for various scheduled formulations, effective April 1, 2017. It outlines the responsibilities of manufacturers, retailers, and dealers regarding price revisions, display of price lists, and compliance with the Drugs Prices Control Order, 2013. The order also specifies procedures for new drug launches and discontinuation of production. Key Points / Main Content: Price Fixation: - Ceiling prices for scheduled formulations are fixed as specified in the table, exclusive of local taxes. - The ceiling prices include the Wholesale Price Index (WPI) of 1.97186 for 2016 over 2015. - Existing manufacturers with MRP lower than the ceiling price may revise their MRP based on the WPI for 2016, subject to the ceiling price plus applicable local taxes. Responsibilities of Manufacturers: - Manufacturers selling formulations above the ceiling price must revise prices downward. - Manufacturers may add local taxes if they have actually paid or are liable to pay them to the government. - Manufacturers must determine the ceiling price for a pack of scheduled formulation according to DPCO, 2013 guidelines. - A price list in Form V must be issued to NPPA through IPDMS, with copies to the State Drug Controller and dealers. - For new drug launches, manufacturers must apply for prior price approval to the NPPA in Form I. - Quarterly returns on production, import, and sale must be furnished to the NPPA in Form III. - Intent to discontinue production must be communicated to the NPPA in Form IV six months prior to discontinuation. Responsibilities of Retailers and Dealers: - Retailers and dealers must display the price list and supplementary price list conspicuously on their premises. Compliance: - Non-compliance with ceiling prices and specified notes will result in liability to deposit the overcharged amount with interest. - Previous price orders fixing ceiling or retail prices are superseded by this notification. Impact Analysis: Manufacturers: Impact: Ceiling prices are set for their formulations, requiring potential price adjustments. They must adhere to compliance and reporting requirements. Action Required: Revise prices as necessary, ensure accurate price displays, submit required forms to NPPA, and comply with DPCO, 2013. Retailers and Dealers: Impact: They are required to display the updated price lists to ensure transparency for customers. Action Required: Display the manufacturer-provided price list and supplementary lists in a conspicuous location. Consumers: Impact: Benefit from regulated drug prices, ensuring affordability and transparency. Action Required: Be aware of the ceiling prices of scheduled formulations. National Pharmaceutical Pricing Authority (NPPA): Impact: Responsible for enforcing the order, reviewing manufacturer submissions, and ensuring compliance with pricing regulations. Action Required: Enforce the order, review submissions, and take action against non-compliant manufacturers.

Key Entities Referenced

Drugs Prices Control Order, 2013: A legal order in India that regulates the prices of drugs. Ministry of Chemicals and Fertilizers: A ministry in the Government of India. National Pharmaceutical Pricing Authority: A regulatory agency in India that fixes and revises drug prices. New Delhi: The capital of India, where the order was issued. Essential Commodities Act, 1955: An act of the Parliament of India to ensure the supply of certain commodities. Wholesale Price Index: The Wholesale Price Index (WPI) is an index that measures and tracks the changes in the price of goods at the wholesale level. Department of Pharmaceuticals: A department of the Indian government responsible for the regulation and development of the pharmaceutical industry. State Drug Controller: The Drug Controller is responsible for the regulation of pharmaceutical products within a specific state.
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(cid:1)ामाडोल कै(cid:9)सूल 100 िम(cid:13)ा. 1 कै(cid:9)सूल 9.08 2. िस(cid:15)ो(cid:16)लॉ(cid:18)सािसन ओरल िल(cid:21)(cid:22)ड 250 िम(cid:13)ा./5िमिल. 1 िमिल. 0.59 3. पायरािजनामाइड ओरल िल(cid:21)(cid:22)ड 250 िम(cid:13)ा./5िमिल. 1 िमिल. 0.56 4. गेनिस(cid:18)लोवीर कै(cid:9)सूल 250 िम(cid:13)ा. 1 कै(cid:9)सूल 109.09 5. एबाकावीर (ए) + लैमीवुडीन (बी) गोली 60 िम(cid:13)ा.(ए) + 30 िम(cid:13)ा.(बी) 1 गोली 19.00 6. लैमीवुडीन (ए)+ नेिवरापाइन (बी)+ टेवुिडन िड परसीबल गोली 30 िम(cid:13)ा.(ए) + 50 1 गोली 4.68 (सी) िम(cid:13)ा.(बी) + 6 िम(cid:13)ा.(सी) 7. लोिपनािवर (ए) + $रटोनिवर (बी) गोली 100 िम(cid:13)ा.(ए) + 25 िम(cid:13)ा.(बी) 1 गोली 22.25 8. पेगीलेटेड इंटरफेरॉन अ)फा 2 बी इंजे(cid:18)शन 120 एमसीजी (cid:15)ित पैक 13,784.92 9. पेगीलेटेड इंटरफेरॉन अ)फा 2 ए इंजे(cid:18)शन 180 एमसीजी (cid:15)ित पैक 7,486.68 1808 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 10. आट.मेथर (ए) +)यूमेफ1$(cid:1)न (बी) ओरल िल(cid:21)(cid:22)ड 80 िम(cid:13)ा.(ए) +480 1िमिल. 3.82 िम(cid:13)ा./5िमिल.(बी) 11. (cid:15)ेडनीसोलोन गोली 40 िम(cid:13)ा. 1 गोली 2.66 12. साइ(cid:18)लो पो$रन इंजे(cid:18)शन 50 िम(cid:13)ा./िमिल. 1 िमिल. 244.75 13. ज़ोलै3ोिनक एिसड इंजे(cid:18)शन के िलए पाउडर 4 िम(cid:13)ा. (cid:15)ित पैक 3,812.10 14. िलवोडोपा (ए) + का6बडोपा (बी) सीआर गोली 200 िम(cid:13)ा.(ए) + 50 1 गोली 3.89 िम(cid:13)ा. (बी) 15. वारफ$रन गोली 3 िम(cid:13)ा. 1 गोली 2.95 16. वारफ$रन गोली 2 िम(cid:13)ा. 1 गोली 2.52 17. हाइ3ोकोट8सोन गोली 10 िम(cid:13)ा. 1 गोली 5.34 18. हाइ3ोकोट8सोन गोली 5 िम(cid:13)ा. 1 गोली 2.75 19. लेवोनोज. (cid:1)ेल गोली 0.75 िम(cid:13)ा. 1 गोली 21.78 20. एंटी-रेबीज इ9युनो:लोबुिलन इंज(cid:18)े शन 300 आईयू/िमिल. 1 िमिल. 88.75 uuuukkkkVVssVVss %%%% ¼d½ vf/kdre eYw ; fnukda 01-04-2017 l s ykxw gS a ¼vf/kdre eYw ;ksa e sa 2015 dh vi{s kk o”k Z 2016 ds fy, 1-97186 ifzr’kr dh Fkkds eYw ; lpw dkad ¼MCY;iw hvkb½Z dh nj ‘kkfey gS½aA ¼[k½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku LFkkuh; dj] tk s ykx w gk½sa l s vf/kd dher ij vulq fwpr fofufefZr;ksa ds czkMa Ms ;k tus sfjd ;k nkus ksa :ikra jk sa dk s cps jg s vuqlfwpr fofufeZfr;k sa d s lHkh fofuekZrk] mi;DqZ r lkj.kh d s LrHak ¼5½ esa of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tk s ykxw gk½sa ls vf/kd lHkh ,slh fofufefZr;k sa dh dher dk v/kkes [q kh iuq jh{k.k djxsa As ¼x½ lHkh ekStnw k fuekZrkvksa dk s mi;qZDr dfFkr vuqlfwpr fofufefZr;k sa d s vf/kdre [knq jk dher mi;qDZ r lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher ¼/ku LFkkuh; dj lfgr½ ls de gS] tgka dgh Hkh ykxw gk]s vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 ds iSjkxzkQ 16(2) ds vuqlkj o”kZ 2016 d s fy, 1-97186 ifzr’kr dh nj ls Fkksd eYw ; lpw dkad ¼MCY;iw hvkb½Z ds vk/kkj ij viuh fofufefZr;ksa dk ekStnw k vf/kdre [knq jk eYw ; ¼,evkjih½ dk s l’a kkfs/kr dj ldr s gS a tk s vf/kdre [knq jk dher ¼/ku LFkkuh; dj] tk s ykx w gk]sa ;fn dkbs Z gS½a d s v/khu gksxhA ¼?k½ vxj fuekZrkvksa u s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k ;g n;s gS rk s o s LFkkuh; djk sa dk s tkMs + ldr s gSA ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr lEcfU/kr fuekZrkvk sa dk s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;ksa d s iSdk sa d s fy, vf/kdre dher fu/kkfZjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 ds rgr QkWeZ V e sa vf/klpw uk dh rkjh[k l s vkbiZ hMh,e,l d s ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dk sa vkSj fofuekZrk forjd dk s tkjh djAsa ¼p½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds 24 ¼4½ ds mic/akksa ds vuqlkj iRz;ds QVq dj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke’k Z d s bPNdq fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn’` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f’kZr djxs kA ¼N½ mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vuqlfwpr fofufefZr;k sa d s fofufn"ZV fofHkUu rjhd s vkSj icz yrk l s fHkUu vxj ekStnw k fuekZrkvk sa }kjk ,d ub Z vkS"kf/k dk s ykpa djrk gS rk s ml s igy s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 2¼u½ d s vulq kj vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds rgr lpw h II e sa fofufn"ZV Qke Z I ds ek/;e l s ,uihih, e sa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA ¼t½ mi;DqZ r vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvks a dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lpw h II d s QkWe Z III dk s vkbiZ hMh,e,l ds ek/;e l s Hkjdj ,uihih, dks gj frekgh dh fjikVs Z izLrqr djxs kA mi;DqZ r vuqlfwpr fofufefZr;ksa ds fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufefZr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA ¼>½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e sa n'kk;Z s vf/kdre eYw ; vkSj 'krks± dk ikyu ugh a djrh g Sa rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa ds v/khu C;kt lfgr vf/kiHzkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼.k½ bl vkn's k e sa mijkDs r lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufnZ"V ,slh fofufefZr;k sa d s iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre vkSj [knq jk eYw ; fu/kkfZjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k l s iwo Z tkjh g,q gS] Lor% gh vf/kØe.k gk s tk;xsa As [dk-al-a@175@43@2017@,Q@Qk- l0a 8¼43½@2017@Mhih@,uihih,-&fMoh-II] cythr flga ]]]] lgk;d fun's kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 30th March, 2017 S.O. 1008 (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 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 prices as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any, in respect of the Scheduled formulations 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. Name of the Scheduled Dosage form & Strength Unit Ceiling Price Formulation (Rs.) (1) (2) (3) (4) (5) 1. Tramadol Capsule 100mg 1 Capsule 9.08 2. Ciprofloxacin Oral Liquid 250mg/5ml 1 ML 0.59 3. Pyrazinamide Oral Liquid 250mg/5ml 1 ML 0.56 4. Ganciclovir Capsule 250mg 1 Capsule 109.09 5. Abacavir (A) + Lamivudine (B) Tablet 60mg (A) + 30mg (B) 1 Tablet 19.00 6. Lamivudine (A)+ Nevirapine (B) Dispersible Tablet 30mg (A) + 1 Tablet 4.68 + Stavudine (C) 50mg (B) + 6mg (C) 7. Lopinavir (A) + Ritonavir (B) Tablet 100mg (A) + 25mg (B) 1 Tablet 22.25 8. Pegylated interferon alfa 2b Injection 120mcg Each Pack 13,784.92 9. Pegylated interferon alfa 2a Injection 180mcg Each Pack 7,486.68 10. Artemether (A) + Lumefantrine Oral Liquid 80mg (A) +480mg 1ML 3.82 (B) (B) /5ml 11. Prednisolone Tablet 40mg 1 Tablet 2.66 12. Cyclosporine Injection 50mg/ml 1 ML 244.75 13. Zoledronic Acid Powder for Injection 4mg Each Pack 3,812.10 14. Levodopa (A) + Carbidopa (B) CR Tablet 200mg (A) + 50mg 1 Tablet 3.89 (B) 15. Warfarin Tablet 3mg 1 Tablet 2.95 16. Warfarin Tablet 2mg 1 Tablet 2.52 17. Hydrocortisone Tablet 10mg 1 Tablet 5.34 18. Hydrocortisone Tablet 5mg 1 Tablet 2.75 19. Levonorgestrel Tablet 0.75mg 1 Tablet 21.78 20. Anti-rabies immunoglobulin Injection 300 IU/ml 1 ML 88.75 Note: (a) The ceiling prices are applicable with effect from 01.4.2017 (ceiling prices are inclusive of Wholesale Price Index (WPI) @1.97186% for the year 2016 over 2015). (b) 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 local taxes 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 local taxes as applicable, if any. (c) 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 local taxes as applicable, if any), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 1.97186% for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). (d) The manufacturers may add local taxes 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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (e) 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. (f) 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. (g) 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. (h) 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. (i) 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. (j) 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/175/43/2017/F/F. No. 8(43)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 30 ekp]Z 2017 ddddkkkk---- vvvvkkkk---- 1111000000009999¼¼¼¼vvvv½½½½-&jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk- vk- 701¼v½ rkjh[k 10 ekp]Z 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk inz Rr 'kfDr;k sa dk i;z kxs djr s g,q ] rFkk Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k ikzf/kdj.k ds vkn's k dk- vk- 644¼v½] fnukda 2 ekp]Z 2016] dk s tgk¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufeZr iSdksa l s gS] mu ckrk sa d s flok; vf/kØkUr djr s g,q ftUgsa ,sl s vf/kØe.k ds iwo Z fd;k x;k gS ;k dju s dk ykis fd;k x;k gS] uhps dh lkj.kh ds LrHak ¼5½ esa fofufn"ZV rRdky izHkkoh vf/kdre dher vkSj mDr lkj.kh d s LrHak ¼3½ vkSj ¼4½ e sa dh Øe'k% rRLFkkuh ifzof"V;k sa e sa fofufnZ"V [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHak ¼2½ es a dh rRLFkkuh ifzof"V e sa fofufnZ"V vuqlfwpr fofufefZr;k sa esa l s iRz;ds dh] LFkkuh; dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s #i e sa fu;r djrh gSA llllkkkkjjjj....kkkkhhhh dz-la- vuqlwfpr fofufeZfr dk uke [kqjkd :i ,oa izcyrk bdkbZ vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. िल;ोकेन इंजे(cid:18)शन 5% के साथ 7.5% :लूकोज 1 िमिल. 3.48 2. (cid:1)ामाडोल इंजे(cid:18)शन 50 िम(cid:13)ा./ िमिल. 1 िमिल. 1.18 (20 िमिल.पैक) 3. (cid:1)ामाडोल इंजे(cid:18)शन 50 िम(cid:13)ा./ िमिल. 1 िमिल. 9.91 (2 िमिल. पैक तक) 4. मै;ीिशयम स)फेट इंजे(cid:18)शन 500 िम(cid:13)ा./िमिल. 1 िमिल. 4.52 5. ज<टामाइिसन इंजे(cid:18)शन 10 िम(cid:13)ा./िमिल. 1 िमिल. 3.00 6. डैपसोन गोली 100 िम(cid:13)ा. 1 गोली 0.21414 7. एल- ऐ पैरजाइनेस इंजे(cid:18)शन के िलए पाउडर 5000 केयू (cid:15)ित पकै 980.41 8. (cid:15)ेडनीसोलोन इंजे(cid:18)शन 20 िम(cid:13)ा./2 िमिल. 1 िमिल. 3.39 9. मेटो(cid:18)लो(cid:15)माइड इंजे(cid:18)शन 5 िम(cid:13)ा./िमिल. 1 िमिल. 1.35¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (10 िमिल. पैक) 10. मेटो(cid:18)लो(cid:15)माइड इंजे(cid:18)शन 5 िम(cid:13)ा./िमिल. 1 िमिल. 2.22 (2 िमिल. पैक) 11. मे:लुमाइन डाय(cid:1)ाईजोयेट इंजे(cid:18)शन 76% ड?)यू/वी 1 िमिल. 9.03 12. मे:लुमाइन डाय(cid:1)ाईजोयेट इंजे(cid:18)शन 60% ड?)यू/वी 1 िमिल. 7.82 13. 5-एिमनोसिे लिसिलक एिसड गोली 400 िम(cid:13)ा. 1 गोली 7.07 14. एंटी-रेबीज इ9युनो:लोबुिलन इंजे(cid:18)शन 150 आईयू/िमिल. 1 िमिल. 2517.40 15. स(cid:18)सीनाइल कोिलन इंजे(cid:18)शन 50 िम(cid:13)ा./िमिल. 1 िमिल. 4.58 16. ऑ(cid:18)सीटोिसन इंजे(cid:18)शन 10 आईयू/िमिल. 1 िमिल. 37.27 uuuukkkkVVssVVss %%%% ¼d½ vf/kdre eYw ; fnukda 01-04-2017 l s ykxw gS a ¼vf/kdre eYw ;ksa e sa 2015 dh vi{s kk o”k Z 2016 ds fy, 1-97186 ifzr’kr dh Fkkds eYw ; lpw dkad ¼MCY;iw hvkb½Z dh nj ‘kkfey gS½aA ¼[k½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku LFkkuh; dj] tk s ykx w gk½sa l s vf/kd dher ij vulq fwpr fofufefZr;ksa d s czkMa Ms ;k tus fsjd ;k nkus k sa :ikra jk sa dks cps jg s vuqlfwpr fofufefZr;ksa d s lHkh fofuekZrk] mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tk s ykxw gk½sa ls vf/kd lHkh ,slh fofufefZr;k sa dh dher dk v/kkes [q kh iuq jh{k.k djxsa As ¼x½ lHkh ekStnw k fuekZrkvksa dk s mi;qZDr dfFkr vuqlfwpr fofufefZr;k sa d s vf/kdre [knq jk dher mi;qDZ r lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher ¼/ku LFkkuh; dj lfgr½ l s de gS] tgk a dgh Hkh ykx w gk]s vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 16¼2½ d s vuqlkj o”kZ 2016 d s fy, 1-97186 ifzr’kr dh nj l s Fkkds eYw ; lpw dkda ¼MCY;iw hvkb½Z d s vk/kkj ij viuh fofufefZr;k sa dk ekStnw k vf/kdre [knq jk eYw ; ¼,evkjih½ dk s l’a kkfs/kr dj ldr s gS a tk s vf/kdre [knq jk dher ¼/ku LFkkuh; dj] tk s ykx w gk]sa ;fn dkbs Z gS½a d s v/khu gksxhA ¼?k½ vxj fuekZrkvksa u s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k ;g n;s gS rk s o s LFkkuh; djk sa dk s tkMs + ldr s gSA ¼M½+ vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr lEcfU/kr fuekZrkvk sa dk s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;ksa d s iSdk sa d s fy, vf/kdre dher fu/kkfZjr djAsa fuekZrk vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 24 ds rgr QkWeZ V e sa vf/klpw uk dh rkjh[k l s vkbiZ hMh,e,l d s ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dk sa vkSj fofuekZrk forjd dk s tkjh djAsa ¼p½ vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s 24 (4) ds mic/akksa ds vuqlkj iRz;ds QVq dj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i es a ,sls ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke’k Z d s bPNdq fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn’` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f’kZr djxs kA ¼N½ mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher d s fy, fofufn”ZV vuqlfwpr fofufefZr;k sa d s fofufn”ZV fofHkUu rjhd s vkSj icz yrk l s fHkUu vxj ekStnw k fuekZrkvk sa }kjk ,d ub Z vkS”kf/k dk s ykpa djrk gS rk s ml s igy s vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 2¼u½ d s vulq kj vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 ds rgr lpw h II e sa fofufn”ZV Qke Z I ds ek/;e l s ,uihih, e sa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA ¼t½ mi;DqZ r vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvks a dk s vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s lpw h II d s QkWe Z III dk s vkbiZ hMh,e,l ds ek/;e l s Hkjdj ,uihih, dks gj frekgh dh fjikVs Z izLrqr djxs kA mi;DqZ r vuqlfwpr fofufefZr;ksa ds fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufefZr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA ¼>½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e sa n’kk;Z s vf/kdre eYw ; vkSj ‘krks± dk ikyu ugh a djrh g Sa rk s o s vko’;d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa ds v/khu C;kt lfgr vf/kiHzkkfjr jkf’k dk s tek dju s d s fy, nk;h gkxsa As ¼.k½ bl vkn’s k e sa mijkDs r lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof”V e sa fofufnZ”V ,slh fofufefZr;k sa d s iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre vkSj [knq jk eYw ; fu/kkfZjr vkn’s k ;fn dkbs Z gk]s tk s bl vkn’s k l s iwo Z tkjh g,q gS]a Lor% gh vf/kØe.k gk s tk;xsa As [dk-al-a@175@43@2017@,Q@Qk- l0a 8¼43½@2017@Mhih@,uihih,-&fMoh&II] cythr flga ] lgk;d fun’s kd6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ORDER New Delhi, the 30th March, 2017 S.O. 1009(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 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, 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. 644(E), dated 2nd March, 2016, 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, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled formulations 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. Name of the Scheduled Dosage form & Strength Unit Ceiling Formulation Price (Rs.) (1) (2) (3) (4) (5) 1. Lignocaine Injection 5% with 7.5% Glucose 1 ML 3.48 2. Tramadol Injection 50mg/ml 1 ML 1.18 (20ML Pack) 3. Tramadol Injection 50mg/ml 1 ML 9.91 (upto 2ML Pack) 4. Magnesium Sulphate Injection 500mg/ml 1 ML 4.52 5. Gentamicin Injection 10mg/ml 1 ML 3.00 6. Dapsone Tablet 100mg 1 Tablet 0.21414 7. L-Asparaginase Powder for Injection 5000KU Each Pack 980.41 8. Prednisolone Injection 20mg/2ml 1 ML 3.39 9. Metoclopramide Injection 5mg/ml 1 ML 1.35 (10 ML Pack) 10. Metoclopramide Injection 5mg/ml 1 ML 2.22 (2 ML Pack) 11. Meglumine Diatrizoate Injection 76%w/v 1 ML 9.03 12. Meglumine Diatrizoate Injection 60%w/v 1 ML 7.82 13. 5-aminosalicylic Acid Tablet 400mg 1 Tablet 7.07 14. Anti-rabies immunoglobulin Injection 150 IU/ml 1 ML 2517.40 15. Succinyl Choline Injection 50mg/ml 1 ML 4.58 16. Oxytocin Injection 10 IU/ml 1 ML 37.27 Note: (a) The ceiling prices are applicable with effect from 01.4.2017 (ceiling prices are inclusive of Wholesale Price Index (WPI) @1.97186% for the year 2016 over 2015). (b) 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 local taxes 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 local taxes as applicable, if any. (c) 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 local taxes as applicable, if any), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 1.97186% for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). (d) The manufacturers may add local taxes 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. (e) 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.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 (f) 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. (g) 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. (h) 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. (i) 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. (j) 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/175/43/2017/F/ F. No. 8(43)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 30 ekp]Z 2017 ddddkkkk----vvvvkkkk---- 1111000011110000¼¼¼¼vvvv½½½½----&&&& vkS"k/k foHkkx }kjk ikfjr dez ’k% fnukda 30-08-2016 d s i= l-a 31015@18@2016-ihvkb-ZI (टै(cid:3)ॉिलमस कै(cid:11)सूल 0.5 िम(cid:13)ा. और 1 िम(cid:13)ा.) , fnukda 06-10-2016 d s i= l-a 31015@58@2016-ihvkb-ZI (फेनीटोइन गोली 100 िम(cid:13)ा.), fnukda 30-08-2016 d s i= l-a 31015@29@2016-ihvkb-ZI (एिज़(cid:18)ोमाइिसन गोली 500 िम(cid:13)ा. और 250 िम(cid:13)ा.), fnukda 30-08-2016 d s i= l-a 31015@26@2016-ihvkb-ZI ((cid:24)रफामिपिसन कै(cid:11)सूल 150 िम(cid:13)ा, 300 िम(cid:13)ा, 450 िम(cid:13)ा. और (cid:24)रफामिपिसन िसरप 100 िम(cid:13)ा./5िमिल.) vkSj fnukda 15-11-2016 ds i= la- 31015@85@2016-ihvkb-ZI (ईमे(cid:24)टिनब मेिसलेट गोली 100 िम(cid:13)ा.), vkS”k/k foHkkx }kjk tkjh iuq foyZ kds u vkn's k e sa fn; s x, fun'sZ kk sa ds dk;kZUo;u e sa vkSj HHHHkkkkkkkkjjjjrrrr lllljjjjddddkkkkjjjj dddd ssss jlk;u vkSj moZjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk0 vk0 701¼v½ rkjh[k 10 ekp]Z 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 4, 10, 11, 14, 16, 17 vkSj 18 }kjk inz Rr 'kfDr;k sa dk i;z kxs djr s g,q ] rFkk Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k d s dez ’k% vkn's k dk- vk- 1404¼v½] fnukda 12 vizSy] 2016 ij Øe l-a 64 vkSj 65 (टै(cid:3)ॉिलमस- कै(cid:11)सूल 0.5िम(cid:13)ा. और 1 िम(cid:13)ा.), dk- vk- 1819¼v½] fnukda 18 eb]Z 2016 ij Øe l-a 6 (फेनीटोइन- गोली 100 िम(cid:13)ा. ), dk- vk- 1686¼v½] fnukda 9 eb]Z 2016 ij Øe l-a 4 vkSj 5 (एिज़(cid:18)ोमाइिसन- गोली 500 िम(cid:13)ा.और 250 िम(cid:13)ा.), dk- vk- 2730¼v½] fnukda 17 vxLr] 2016 ij Øe l-a 9] 10 vkSj 11 ((cid:24)रफामिपिसन- कै(cid:11)सूल 150 िम(cid:13)ा, 300 िम(cid:13)ा, 450 िम(cid:13)ा.), dk- vk- 248¼v½] fnukda 24 tuojh] 2017 ij Øe l-a 11 ((cid:24)रफामिपिसन - ओरल िल!"ड 100 िम(cid:13)ा./5िमिल.), dk- vk- 2730¼v½] fnukda 17 vxLr] 2016 ij Øe l-a 13 (ईमे(cid:24)टिनब मेिसलेट - गोली 100 िम(cid:13)ा.), tgk¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufeZfr iSd l s gS] mu ckrk sa d s flok; vf/kØkUr djr s g,q ftUg sa ,sl s vf/kØe.k d s iwo Z fd;k x;k gS ;k dju s dk ykis fd;k x;k gS] uhp s dh lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher dk s mDr lkj.kh d s LrHak ¼3½ vkSj ¼4½ e sa Øe’k% rRLFkkuh ifzof”V;k sa e sa fofufn”ZV [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof”V esa fofufnZ”V vuqlfwpr fofufefZr;k sa e sa l s izR;ds dh] LFkkuh; dj] ;fn dkbs Z gS] dks NkMs d+ j vf/kdre dher d s #i e sa fu;r djrh gSA lkj.kh dz-la- vuqlwfpr fofufeZfr dk uke [kqjkd :i ,oa izcyrk bdkbZ vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. टैBॉिलमस कै(cid:9)सूल 0.5 िम(cid:13)ा. 1 कै(cid:9)सूल 20.92 2. टैBॉिलमस कै(cid:9)सूल 1 िम(cid:13)ा. 1 कै(cid:9)सूल 36.96 3. फेनीटोइन गोली 100 िम(cid:13)ा. 1 गोली 1.478 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 4. एिज़Cोमाइिसन गोली 500 िम(cid:13)ा. 1 गोली 18.82 5. एिज़Cोमाइिसन गोली 250 िम(cid:13)ा. 1 गोली 9.28 6. $रफामिपिसन कै(cid:9)सूल 150 िम(cid:13)ा 1 कै(cid:9)सूल 1.90 7. $रफामिपिसन कै(cid:9)सूल 300 िम(cid:13)ा 1 कै(cid:9)सूल 3.60 8. $रफामिपिसन कै(cid:9)सूल 450 िम(cid:13)ा. 1 कै(cid:9)सूल 4.67 9. $रफामिपिसन ओरल िल(cid:21)(cid:22)ड 100 िम(cid:13)ा./5िमिल. 1 िमिल. 0.37 10. ईमे$टिनब गोली 100 िम(cid:13)ा. 1 गोली 75.15 uuuukkkkVVssVVss %%%% ¼d½ vf/kdre eYw ; fnukda 01-04-2017 l s ykxw gS a ¼vf/kdre eYw ;ksa e sa 2015 dh vi{s kk o”k Z 2016 ds fy, 1-97186 ifzr’kr dh Fkkds eYw ; lpw dkad ¼MCY;iw hvkb½Z dh nj ‘kkfey gS½aA ¼[k½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku LFkkuh; dj] tk s ykx w gk½sa l s vf/kd dher ij vulq fwpr fofufefZr;ksa d s czkMa Ms ;k tus fsjd ;k nkus k sa :ikra jk sa dks cps jg s vuqlfwpr fofufefZr;ksa d s lHkh fofuekZrk] mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tk s ykxw gk½sa ls vf/kd lHkh ,slh fofufeZr;k sa dh dher dk v/kkes [q kh iuq jh{k.k djxsa As ¼x½ lHkh ekStnw k fuekZrkvksa dk s mi;qZDr dfFkr vuqlfwpr fofufefZr;k sa d s vf/kdre [knq jk dher mi;qDZ r lkj.kh d s LrHak ¼5½ e sa fofufn”ZV vf/kdre dher ¼/ku LFkkuh; dj lfgr½ l s de gS] tgk a dgh Hkh ykx w gk]s vkS”k/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 16¼2½ d s vuqlkj o”kZ 2016 d s fy, 1-97186 ifzr’kr dh nj l s Fkkds eYw ; lpw dkda ¼MCY;iw hvkb½Z d s vk/kkj ij viuh fofufefZr;k sa dk ekStnw k vf/kdre [knq jk eYw ; ¼,evkjih½ dk s l’a kkfs/kr dj ldr s gS a tk s vf/kdre [knq jk dher ¼/ku LFkkuh; dj] tk s ykx w gk]sa ;fn dkbs Z gS½a d s v/khu gksxhA ¼?k½ vxj fuekZrkvksa u s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k ;g n;s gS rk s o s LFkkuh; djk sa dk s tkMs + ldr s gSAa ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr lEcfU/kr fuekZrkvk sa dk s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;ksa d s iSdk sa d s fy, vf/kdre dher fu/kkfZjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V esa vf/klpw uk dh rkjh[k ls vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh djAsa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dk sa vkSj fofuekZrk forjd dk s tkjh djAsa ¼p½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds 24 ¼4½ ds mic/akksa ds vuqlkj iRz;ds QVq dj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke’k Z d s bPNdq fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn’` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f’kZr djxs kA ¼N½ mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vuqlfwpr fofufefZr;k sa d s fofufn"ZV fofHkUu rjhd s vkSj icz yrk l s fHkUu vxj ekStnw k fuekZrkvk sa }kjk ,d ub Z vkS"kf/k dk s ykpa djrk gS rk s ml s igy s vkS"k/k ¼eYw ; fu;a=k.k½ vkn's k] 2013 d s iSjkxzkQ 2¼u½ ds vulq kj vkS"k/k ¼eYw ; fu;a=k.k½ vkn's k] 2013 d s rgr lpw h II e sa fofufn"ZV Qke Z I d s ek/;e l s ,uihih, esa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA ¼t½ mi;DqZ r vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvk sa dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lpw h II d s QkWe Z III dk s vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;DqZ r vuqlfwpr fofufefZr;k sa d s fuek.Z k dk s dksb Z fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufefZr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV esa Hkjdj ,uihih, dk s izLrqr djxs kA ¼>½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e sa n'kk;Z s vf/kdre eYw ; vkSj 'krks± dk ikyu ugh a djrh g Sa rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa ds v/khu C;kt lfgr vf/kiHzkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼.k½ bl vkn's k e sa mijkDs r lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufnZ"V ,slh fofufefZr;k sa d s iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre vkSj [knq jk eYw ; fu/kkfZjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k l s iwo Z tkjh g,q gS] Lor% gh vf/kØe.k gk s tk;xsa As [dk-al-a@175@43@2017@,Q@Qk- l-a 8¼43½@2017@Mhih@,uihih,-&fMoh-II] cythr flga ]]]] lgk;d fun's kd ORDER New Delhi, the 30th March, 2017 S.O.1010(E).—In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide letters no. 31015/18/2016-PI.I dated 30.8.2016 (Tacrolimus Capsule 0.5mg & 1mg), 31015/58/2016-PI.I dated 06.10.2016 (Phenytoin Tablet 100mg), 31015/29/2016-PI.I dated 30.8.2016 (Azithromycin Tablet 500mg & 250mg), 31015/26/2016-PI.I dated 30.8.2016 (Rifampicin Capsule 150mg, 300mg, 450mg &¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 Rifampicin Syrup 100mg/5ml) & 31015/85/2016-PI.I dated 15.11.2016 (Imatinib Mesylate Tablet 100mg) respectively passed by the Department of Pharmaceuticals and in exercise of the powers conferred by paragraphs 4, 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. 701(E) dated 10th March, 2016 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) No. S.O. 1404(E), dated 12th April, 2016 at Sl. No. 64 & 65 (Tacrolimus Capsule 0.5mg & 1mg), S.O. 1819(E) dated 18th May, 2016 at Sl. No. 6 (Phenytoin Tablet 100mg), S.O. 1686(E) dated 9th May, 2016 at Sl. No. 4 & 5 (Azithromycin Tablet 500mg & 250mg), S.O. 2730(E) dated 17th August, 2016 at Sl. No. 9, 10 & 11 (Rifampicin Capsule 150mg, 300mg & 450mg), S.O. 248(E) dated 24th January, 2017 at Sl. No. 11 (Rifampicin Oral Liquid 100mg/5ml) & S.O. 2730(E) dated 17th August, 2016 at Sl. No. 13 (Imatinib Mesylate Tablet 100mg) respectively regarding formulation pack mentioned in the table 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, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local 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 Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Price Formulation (Rs.) (1) (2) (3) (4) (5) 1. Tacrolimus Capsule 0.5mg 1 Capsule 20.92 2. Tacrolimus Capsule 1mg 1 Capsule 36.96 3. Phenytoin Tablet 100mg 1 Tablet 1.47 4. Azithromycin Tablet 500mg 1 Tablet 18.82 5. Azithromycin Tablet 250mg 1 Tablet 9.28 6. Rifampicin Capsule 150mg 1 Capsule 1.90 7. Rifampicin Capsule 300mg 1 Capsule 3.60 8. Rifampicin Capsule 450mg 1 Capsule 4.67 9. Rifampicin Oral Liquid 100mg/5ml 1 ML 0.37 10. Imatinib Tablet 100mg 1 Tablet 75.15 Note: (a) The ceiling prices are applicable with effect from 01.4.2017 (ceiling prices are inclusive of Wholesale Price Index (WPI) @1.97186% for the year 2016 over 2015). (b) 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 local taxes 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 local taxes as applicable, if any. (c) 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 local taxes as applicable, if any), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 1.97186% for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). (d) The manufacturers may add local taxes 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. (e) 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. (f) 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. (g) 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. (h) 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 furnish10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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. (i) 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. (j) 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/175/43/2017/F/F. No. 8(43)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, 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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