Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 4 6 10 11 ...
Date: 2019-06-26 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 Contro

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: This document from the National Pharmaceutical Pricing Authority (NPPA) in India, dated June 26, 2019, concerns the regulation of drug prices. It fixes ceiling prices for scheduled formulations and revises retail prices for certain drugs, in accordance with the Drugs Prices Control Order (DPCO) 2013. Manufacturers must comply with these prices and submit necessary information to the NPPA. Key Points / Main Content: Ceiling Price Fixation: * The NPPA fixes ceiling prices for scheduled formulations as specified in the tables, exclusive of goods and services tax (GST). * Manufacturers selling above the ceiling price plus GST must revise prices downward. * Existing manufacturers with MRP lower than the ceiling price plus GST must maintain their existing MRP. * The ceiling price for a pack is determined as per DPCO 2013 guidelines. Retail Price Revision: * Retail prices are fixed for certain formulations based on strength, unit, manufacturer, and marketing company. * The retail price is applicable only to manufacturers who applied for price fixation/revision by submitting Form I. Manufacturer Responsibilities: * Manufacturers must issue a price list in Form V to the NPPA through IPDMS and provide copies to State Drug Controllers and dealers. * Manufacturers launching new drugs must apply for prior price approval in Form I. * Quarterly returns on production, import, and sale of scheduled formulations must be submitted in Form III via IPDMS. * Manufacturers intending to discontinue production must notify the NPPA six months prior using Form IV. Retailer and Dealer Obligations: * Retailers and dealers must display the price list and supplementary price list in a visible location. Compliance and Penalties: * Non-compliance with ceiling or retail prices and specified conditions will result in liability to deposit the overcharged amount with interest. Supersession of Previous Orders: * Previous price orders fixing ceiling or retail prices for formulations specified in this notification are superseded. Impact Analysis: Manufacturers: * Impact: Must adhere to the fixed ceiling and retail prices, revise existing prices if necessary, and fulfill reporting requirements. * Action Required: Revise prices, submit Form V price list, submit quarterly returns (Form III), seek prior approval for new drugs (Form I), and notify NPPA of discontinuation plans (Form IV). Retailers and Dealers: * Impact: Required to display accurate price lists, ensuring transparency for consumers. * Action Required: Display price lists and supplementary lists provided by manufacturers. Consumers: * Impact: Benefit from regulated drug prices, ensuring affordability and accessibility. * Action Required: Be aware of the ceiling/retail prices to ensure fair pricing at retail locations. National Pharmaceutical Pricing Authority (NPPA): * Impact: Responsible for enforcing price regulations and monitoring manufacturer compliance. * Action Required: Review and process manufacturer submissions, monitor market prices, and take action against non-compliant entities.

Key Entities Referenced

Ministry of Chemicals and Fertilizers: The Indian government ministry that issued the notification through the Department of Pharmaceuticals. Department of Pharmaceuticals: The department under the Ministry of Chemicals and Fertilizers responsible for pharmaceutical policies. National Pharmaceutical Pricing Authority (NPPA): The regulatory body in India responsible for fixing and revising prices of pharmaceutical products. Drugs Prices Control Order, 2013: A legal order issued by the Government of India to regulate the prices of essential drugs. Essential Commodities Act, 1955: An act of the Parliament of India that ensures the supply of essential commodities. New Delhi: Capital of India, place where the order was issued. Ibuprofen Capsule: A scheduled formulation whose ceiling price is being fixed in the order. Tetanus Toxoid Injection: A scheduled formulation whose price is being revised in the order.
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L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (ii) PART II—Section 3—Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 1924] ubZ fnYyh] cq/okj] twu 26] 2019@vk"kk<++ 5] 1941 No. 1924] NEW DELHI, WEDNESDAY, JUNE 26, 2019/ ASHADHA 5, 1941 jlk;u vkSj moZjd ea=ky; ¼vkS"k/k foHkkx½ ¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ vkns'k ub Z fnYyh] 26 tuw ] 2019 dk-vk-2136¼v½-&Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 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] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk iznRr 'kfDr;ksa dk i;z kxs djr s g,q ] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftl s laf{kIr :i l s ,uihih, dgk tkrk g½S uhp s dh lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher dk s mDr lkj.kh d s LrHa k 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 LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV vuqlwfpr fofufeZfr;ksa e sa l s iRz ;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s :i e sa fu;r djrh gS% lkj.kh Ø-l-a vuqlwfpr fofufeZfr dk uke [kqjkd :i ,o a icz yrk bdkb Z vf/kdre dher ¼#-½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ 1- vkbcZ iw zkQs us dSIlyw 200 fexzk- 1 lkWQV~ 2-62 tys fsVu dSIlyw uksV % ¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gk½sa l s vf/kd dher ij vuqlwfpr fofufeZfr;k sa d s czkMa Ms ;k tsufsjd ;k nkus ksa :ikra jk sa dk s cps jgs vuqlwfpr fofufefZr;k sa d s lHkh fofuekZrk] mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gks½a l s vf/kd lHkh ,slh fofufeZr;k sa dh dher dk v/kkes q[kh iuq jh{k.k djsaxsA 3119 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼[k½ lHkh ekStnw k fuekZrkvk sa dks mi;qZDr dfFkr vulq wfpr fofufefZr;k sa d s vf/kdre [knq jk dher mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher oLr q ,o a lsok dj lfgr l s de gS rk]s tgk a dgh Hkh ykx w gk]s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 13¼2½ d s vuqlkj mldk s ekStnw k vf/kdre [knq jk dher dk s cuk, j[kuk gkxs kA ¼x½ vxj fuekZrkvksa u s mi;qZDr lkj.kh d s LrHa k 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 oLr q ,o a lsok dj dk s tkMs + ldr s gSAa ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvk sa dk s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlwfpr fofufeZfr;ks a d s iSdk sa d s fy, vf/kdre dher fu/kkZfjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z 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=dksa vkSj fofuekZrk forjdksa dk s tkjh djsaA ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 ¼4½ d s mic/a kk sa d s vuqlkj iRz ;ds QVq dj foØsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke“kZ 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 ¼p½ mi;qZDr lkj.kh e sa ;Fkk fofufn"ZV [knq jk ;k icz yrk ;k nksuka s d s lkFk vuqlwfpr fofufeZfr dk dkbs Z ekStnw k fofuekZrk vkS"k/k eYw ; fu;=.a k vkns“k] 2013 d s iSjk 2¼;½w d s vuqlkj dkbs Z ubZ vkS"kf/k dk s ykpa djrk gS rk s ,l ss ekStnw k fofuekZrk dks vkS"k/k ¼eYw ; fu;a=.k½ vkns“k 2013 dh vulpqw h&II d s varxZr ;Fkk fofufn"ZV Qke&Z I e sa ,uihih, dk s ,slh ub Z vkS"kf/k d s eYw ; iwo Z vueq kns u gsr q vkons u djuk gkxs kA ¼N½ mi;DqZ r vuqlfwpr fofufefZr;ks a dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvksa 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 djsxkA mi;qZDr vuqlwfpr fofufeZfr;k sa d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNdq gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e sa vxj vuqlwfpr fofufefZr;ksa 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 ¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh e sa n'kk;Z s vf/kdre ewY; 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 d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek dju s d s fy, nk;h gksaxsA ¼>½ bl vkn's k e sa mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV ,slh fofufeZfr;k sa d s iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre ;k [knq jk eYw ; fu/kkZfjr 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 sA [dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II ] izlus thr nkl] lgk;d fun's kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 26th June, 2019 S.O. 2136(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 goods and services 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. Ibuprofen Capsule 200mg 1 soft gelatin 2.62 Capsule¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 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 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/200/68/2019/F/F. No. 8(68)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Assistant Director vkns'k ub Z fnYyh] 26 tuw ] 2019 dk-vk- 2137¼v½-&vkS"k/k foHkkx }kjk vkS"k/k ¼ewY; fu;a=.k½] 2013 d s iSjk 31 d s varxZr ikfjr ble sa uhp s lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV vkns“kk s d s }kjk tkjh iuq foyZ kds u vkns“kk s d s lna Hk Z e sa fn; s x, funsZ“kk sa d s dk;kUZo;u e sa vkSj Hkkjr ljdkj ds 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 vkns“k] 2013 d s iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk inz Rr “kfDr;k sa dk i;z ksx djr s g,q vkSj lkj.kh d s LrHa k ¼7½ e sa fofufn"ZV Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] ¼jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k½ d s vkns“kk sa d s vf/kØe.k e]sa tgk¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufefZr iSdk sa l s gS] mu ckrk sa d s flok;] vf/kØkUr djr s g,q ftUg sa ,sl s vf/kØe.k d s iow Z fd;k x;k gS ;k dju s dk ykis fd;k x;k g]S jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s laf{kIr :Ik es a ,uihih, dgk tkrk gS½ uhp s dh lkj.kh d s LrHa k ¼5½ esa fofufn"ZV vf/kdre dher dk s mDr lkj.kh d s LrHa k ¼3½ vkSj ¼4½ e sa Øe“k% rRLFkkuh ifzof"V;k sa e sa fofufn"ZV [kqjkd :Ik ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufn"ZV vuqlfwpr fofufeZfr;ks a esa l s iRz ;ds ij ykx w oLrq ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s :Ik e sa fu;r djrh gS%4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] lkj.kh Ø- vuqlwfpr [kqjkd :Ik ,o a bdkb Z vf/kdre iuq foyZ kds u vkns“k l-a ekStnw k dk- vk- l-a ,o a l-a fofufeZfr dk icz yrk dher ,o a rkjh[k rkjh[k uke ¼#-½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ ¼7½ 1- fVVul bta Ds “ku ifzr iSd 10-61 31015@46@2018- eYw ; 1485¼v½ fnukda VkWDlkWbM ¼0-5 fefy-½ fu/kkZj.k rkjh[k 19-03- 29-03-2019 2019 ¼Ø-l-a 795½ 2- fVVul bta Ds “ku ifzr iSd 22-94 31015@46@2018- eYw ; 1485¼v½ fnukda VkWDlkWbM ¼5 fefy-½ fu/kkZj.k rkjh[k 19-03- 29-03-2019 2019 ¼Ø-l-a 796½ uksV % ¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gk½sa l s vf/kd dher ij vuqlwfpr fofufeZfr;k sa d s czkMa Ms ;k tsufsjd ;k nkus ksa :ikra jk sa dk s cps jgs vuqlwfpr fofufefZr;k sa d s lHkh fofuekZrk] mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gks½a l s vf/kd lHkh ,slh fofufeZfr;k sa dh dher dk v/kkse[q kh l“a kk/s ku djsxa sA ¼[k½ mi;qZDr lkj.kh ¼/ku oLr q ,o a lsok dj] tk s ykx w gS] ;fn dkbs Z gS½ d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre eYw ; dh vi{s kk de [knq jk ewY; okyh Åij of.kZr vuqlwfpr fofufefZr;ks a d s lHkh ekStnw k fofuekZrk Mhihlhvk]s 2013 d s iSjk 13¼2½ d s vuqlkj oLr q ,o a lsok dj d s dk;kUZ o;u ij mRikn “kYq d vkSj djk sa d s varj d s dkj.k vf/kdre [knq jk ewY; e sa gbq Z of`)+ d s vykok ekStnw k vf/kdre [knq jk ewY; dk s fujarj cuk, j[kxsa sA ¼x½ vxj fuekZrkvksa u s mi;qZDr lkj.kh d s LrHa k 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 oLr q ,o a lsok dj dk s tkMs + ldr s gSAa ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvk sa dk s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlwfpr fofufeZfr;ks a d s iSdk sa d s fy, vf/kdre dher fu/kkZfjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z 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=dksa vkSj fofuekZrk forjdksa dk s tkjh djsaA ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 ¼4½ d s mic/a kk sa d s vuqlkj iRz ;ds QVq dj foØsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke“kZ 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 ¼p½ mi;DqZ r lkj.kh ds LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vuqlfwpr fofufeZfr;ks a 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 2¼;½w d s vuqlkj vkS"k/k ¼ewY; fu;a=.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, e sa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA ¼N½ mi;DqZ r vuqlfwpr fofufefZr;ks a 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 d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjiksV Z izLrqr djxs kA mi;qZDr vuqlwfpr fofufeZfr;k sa d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNdq gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e sa vxj vuqlwfpr fofufefZr;ksa 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 ¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh e sa n'kk;Z s vf/kdre ewY; 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 d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek dju s d s fy, nk;h gksaxsA ¼>½ fufeZr fdlh Hkh vU; iSd vkdkj ds fy, fuekZrk vf/kdre dher r; dju s d s fy, fof/kor iez k.khd`r izklfaxd cktkj MsVk d s lkFk viuh fofufefZr ds fy, fof“k"V ewY; vueq kns u ds fy, ,uihih, l s lia d Z djxs kA ¼.k½ bl vkn's k e sa mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V es a fofufn"ZV ,slh fofufeZfr;k as d s iSdk sa dh vf/kdre dher fu;r gksu s d s ifj.kkeLo:i] vf/kdre ;k [kqnjk eYw ; fu/kkZfjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k l s iwo Z tkjh gq, gS] Lor% gh vf/kØe.k gk s tk;xsa sA [dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II] izlus thr nkl] lgk;d fun's kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 ORDER New Delhi, the 26th June, 2019 S.O.2137(E).—In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and 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(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table regarding formulation specified as 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/revises 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(s) 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. Name of the Dosage form Unit Ceiling Review Order number Existing SO No. Scheduled & Strength Price and date number and date Formulation (Rs.) (1) (2) (3) (4) (5) (6) (7) 1. Tetanus Toxoid Injection Each Pack 10.61 31015/46/2018-Pricing 1485(E) dated (0.5ML) dated 19.03.2019 29.03.2019 (at Sl. No. 795) 2. Tetanus Toxoid Injection Each Pack 22.94 31015/46/2018-Pricing 1485(E) dated (5ML) dated 19.03.2019 29.03.2019 (at Sl. No. 796) 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 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.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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) For any other pack size manufactured, the manufacturer shall approach NPPA for specific price approval for its formulations along with the relevant market data duly authenticated for fixation of the ceiling price. (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/200/68/2019/F/F. No. 8(68)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Assistant Director vkns'k ub Z fnYyh] 26 tuw ] 2019 dk-vk- 2138¼v½-&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 5] 11 vkSj 15 }kjk inz Rr 'kfDr;k sa dk i;z kxs djrs g,q ] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk g½S] uhp s dh lkj.kh d s LrHa k ¼6½ e as fofufn"ZV [knq jk ewY; dk s mDr lkj.kh d s LrHa k ¼3½] ¼4½] vkSj ¼5½ e as rRLFkkuh ifzof"V;ksa e sa fofufn"ZV icz yrk] bdkb Z ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;k sa d s uke lfgr LrHa k ¼2½ e sa dh rRLFkkuh izfof"V es a l s iRz ;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre [knq jk ewY; d s :i e sa fu;r djrh gSA lkj.kh dz- vuqlwfpr fofufeZfr izcyrk bdkbZ fofuekZrk vkSj foi.ku [kqnjk la- dk uke@czkaM dk daiuh ewY; uke ¼#-½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ 1- VSØkfsyel vkWuVesaV iRz ;ds xzke vkWuVesVa e sa “kkfey gS% eSll Z ,fyuk gYs Fkd;s j 30-89 ¼ekbfZyel 0-1% VSØkfsyel vkbiZ h 1 xzke ¼10 xzke iSd½ 1 xzke izk- fy-@eSll Z ek;yu 10 xzke½ QkekZL;wfVdYl izk- fy- 2- VSØkfsyel vkWuVesaV iRz ;ds xzke vkWuVesVa e sa “kkfey gS% eSll Z ,fyuk gYs Fkd;s j 30-89 ¼ekbfZyel 0-1% VSØkfsyel vkbiZ h 1 xzke ¼20 xzke iSd½ 1 xzke izk- fy-@eSll Z ek;yu 20 xzke½ QkekZL;wfVdYl izk- fy- 3- ,eksDlhflyhu $ iRz ;ds 5 fefy- fjdkWuLVhVMw lLi“sa ku e%sa 3-28 ikVs fs“k;e Dykoyq kuVs ,eksDlhflyhu fVªgkbMVªs vkbiZ h d s eSll Z cDzw l ycs ksjVs jht lLi“sa ku cjkcj ,ekDs lhflyhu 400 fexzk-] 1 fefy- fy-@eSll Z bVa kl ikVs fs“k;e Dykoyq kuVs fMyfqVM vkbiZ h d s QkekZL;wfVdYl fy- cjkcj Dykoyq kuVs ,flM 57 fexzk- 4- eVs kis zkys kys $ iRz ;ds fQYe fyfir xkys h e%sa 5-58 ,eykfsMikbu xkys h eVs kis zkys kys lqlhuVs vkbiZ h 23-75 fexzk- eSll Z foMa ykl ck;kVs ds d s cjkcj eVs kis zkys kys VkjVªVs 25 fexkz-] 1 xkys h fy-@eSll Z ,CckWV ¼izkys kWxM fjfyt QkWe Z e½sa] gYs Fkd;j izk fy- ,eykfsMikbu fclkbyVs vkbiZ h d s cjkcj ,eykfsMikbu 5 fexzk- 5- ,VksjokLVkfVu $ iRz ;ds gkM Z tys fsVu dSIlyw e%sa 16-73 DyksfiMkxs zys dSIlyw ,VksjokLVkfVu dSfY“k;e vkbiZ h d s eSll Z lk;ukds es cjkcj ,VksjokLVkfVu 20 fexzk ¼iys Vs l 1 dSIlyw QkekZL;wfVdYl fy- e½sa] @eSll Z lhiyk fy- DyksfiMkxs zys ckblYQVs vkbiZ h d s cjkcj DyksfiMkxs zys 75 fexzk- ¼iys Vs l e½sa 6- ,VksjokLVkfVu $ iRz ;ds fQYe fyfir xkys h e%sa 1 xkys h 9-18 foVkfeu Mh3 xkys h ,VksjokLVkfVu dSfY“k;e vkbiZ h d s eSll Z lu Qkek Z cjkcj ,VksjokLVkfVu 10 fexzk-] ycs ksjVs jht fy- foVkfeu Mh3 ¼dkWyds SfYlQsjkWy½ vkbiZ h 1000 vkb;Z w¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 7- ,VksjokLVkfVu $ iRz ;ds fQYe fyfir xkys h e%sa 1 xkys h 16-12 foVkfeu Mh3 xkys h ,VksjokLVkfVu dSfY“k;e vkbiZ h d s eSll Z lu Qkek Z cjkcj ,VksjokLVkfVu 20 fexzk-] ycs ksjVs jht fy- foVkfeu Mh3 ¼dkWyds SfYlQsjkWy½ vkbiZ h 1000 vkb;Z w 8- vkys eslkVuZ iRz ;ds fQYe fyfir xkys h e%sa 1 xkys h 9-65 $eMs ksDlksfey $ vkys eslkVuZ eMs ksDlkfsey vkbiZ h 20 fexzk- eSll Z lu Qkek Z ,eykfsMikbu $ ,eykfsMikbu fclkbyVs d s cjkcj ycs ksjVs jht fy- DyksjFkkyhMkus xkys h ,eykfsMikbu 5 fexzk-] DyksjFkkyhMkus vkbiZ h 12-5 fexzk- 9- vkys eslkVuZ iRz ;ds fQYe fyfir xkys h e%sa 15-83 $eMs ksDlksfey $ vkys eslkVuZ eMs ksDlkfsey vkbiZ h 40 fexzk- eSll Z lu Qkek Z ,eykfsMikbu $ ,eykfsMikbu fclkbyVs d s cjkcj 1 xkys h ycs ksjVs jht fy- DyksjFkkyhMkus xkys h ,eykfsMikbu 5 fexzk-] DyksjFkkyhMkus vkbiZ h 12-5 fexzk- 10- jkts qokLVkfVu $ iRz ;ds gkM Z tys fsVu dSIlyw e%sa 11-15 ,fLifju $ jkts qokLVkfVu dSfY“k;e vkbiZ h d s cjkcj DyksfiMkxs zys dSIlyw jkts qokLVkfVu 10 fexzk-¼fQYe fyfir eSll Z ,dEl MªXl ,Ma xkys h e½sa] QkekZL;wfVdYl fy- ,fLifju vkbiZ h 75 fexzk- ¼,fLifju 1 dSIlyw @eSll Z buVkl xsLVªksjsflLVsVa xkys h½] QkekZL;wfVdYl fy- DyksfiMkxs zys ckblYQVs vkbiZ h d s cjkcj DyksfiMkxs zys 75 fexzk- ¼fQYe fyfir xkys h e½sa 11- jkts qokLVkfVu $ iRz ;ds gkM Z tys fsVu dSIlyw e%sa 16-82 ,fLifju $ jkts qokLVkfVu dSfY“k;e vkbiZ h d s cjkcj DyksfiMkxs zys dSIlyw jkts qokLVkfVu 20 fexzk-¼fQYe fyfir eSll Z ,dEl MªXl ,Ma xkys h e½sa] QkekZL;wfVdYl fy- ,fLifju vkbiZ h 75 fexzk- ¼,fLifju 1 dSIlyw @eSll Z buVkl xsLVªksjsflLVsVa xkys h½] QkekZL;wfVdYl fy- DyksfiMkxs zys ckblYQVs vkbiZ h d s cjkcj DyksfiMkxs zys 75 fexzk- ¼fQYe fyfir xkys h e½sa 12- iSjkflVkekys $ iRz ;ds 5 fefy- lLi“sa ku es%a eSll Z fr:ifr esfMd;s j 0-63 eQs us fed ,flM iSjkflVkekys vkbiZ h 250 fexzk-] 1 fefy- fy-@eSll Z bVa kl lLi“sa ku eQs us fed ,flM vkbiZ h 100 fexzk- QkekZL;wfVdYl fy- 13- DyksfiMkxs zys iRz ;ds fQYe fyfir xkys h e%sa 1 xkys h 3-48 $,fLifju xkys h DyksfiMkxs zys ckbZlYQVs vkbiZ h d s cjkcj eSll Z lu Qkek Z DyksfiMkxs zys 75 fexzk-] ycs ksjVs jht fy- ,fLifju vkbiZ h ¼,faVªd fyfir e½sa 75 fexzk- 14- DyksfiMkxs zys iRz ;ds fQYe fyfir xkys h e%sa 1 xkys h 3-55 $,fLifju xkys h DyksfiMkxs zys ckbZlYQVs vkbiZ h d s cjkcj eSll Z lu Qkek Z DyksfiMkxs zys 75 fexzk-] ycs ksjVs jht fy- ,fLifju vkbiZ h ¼,faVªd fyfir e½sa 150 fexzk- uksV % ¼d½ mi;DqZ r nh xb Z fofufn"ZV QkWeywZ 's ku d s fofuekZrk vFkkZr tk s Þub Z Mxª ß Mhihlhvk]s 2013 d s iSjkxzkQ 2¼;½w d s rgr mi;qZDr nh xb Z lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk eYw ; fu/kkZfjr djxsa sA ¼[k½ vxj fuekZrkvk sa u s mi;qZDr lkj.kh d s LrHa k ¼6½ 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 oLr q ,o a lsok dj dk s tkMs + ldr s gSAa ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr fuekZrkvksa dk s mi;qZDr lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk eYw ; d s vk/kkj ij vuqlwfpr fofufeZfr;k sa d s iSdk sa d s fy, [knq jk eYw ; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY;8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 24 d s rgr QkWe Z V esa vf/klpw uk dh rkjh[k l s ,d eYw ; lpw h ,uihih, dk s vkbiZ hMh,e,l d s ek/;e l s tkjh djs a rFkk mldh dkih jkT; vkS"kf/k fu;a=dk sa vkSj fofuekZrk forjdk sa dk s tkjh djsaA ¼?k½vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s 24 ¼4½ d s mic/a kk sa ds vuqlkj iRz ;ds QVq dj foØsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjckj 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 ¼M-½ mi;DqZ r xSj vf/kdre dher ¼[knq jk eYw ;½ dsoy mi;DqZ r fuekZrk@foi.ku d s fy, ykx w gS tSlk fd mUgkusa s vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fu/kkZj.k@l'a kks/ku d s fy, QkWe Z I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkfZjr lHkh ykx w oS/kkfud vko';drkvks a dh ifwr Z d s v/khu izklfaxd fof/k;k@sa fu;eks a d s vUrxZr tSlk fd dUsnzh;@jkT; ykblfslxa vkWFkksfjVh d s l{ke izkf/kdkjh }kjk eUs;Qw sDpfjxa ykblsal eta jw h d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuiq kyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ks a vkSj fofufn"ZV 'krks± dk ikyu ugh a djrh gS a rk s o s vko';d oLrq,¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼N½ bl vkn's k es a mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV fofufeZfr;k sa d s iSdk sa dh [kqnjk eYw ; fu;r gkus s d s ifj.kkeLo#i] vkn's k tk s fd bl vkn's k l s iow Z tkjh gq, g]S Lor% gh fujLr gk s tk;saxsA [dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-II] izlus thr nkl] lgk;d fun's kd ORDER New Delhi, the 26th June, 2019 S.O.2138(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. Tacrolimus Each gm of Ointment contains: M/s Alina Healthcare 30.89 Ointment Tacrolimus IP 1mg (10gm pack) Pvt. Ltd. / M/s Mylan 1gm (MYLIMUS 0.1% Pharmaceuticals Private 10gm) Limited 2. Tacrolimus Each gm of Ointment contains: M/s Alina Healthcare 30.89 Ointment Tacrolimus IP 1mg (20gm pack) Pvt. Ltd. / M/s Mylan 1gm (MYLIMUS 0.1% Pharmaceuticals Private 20gm) Limited 3. Amoxycillin + Each 5ml of reconstituted suspension 3.28 Potassium contains: M/s Brooks Clavulanate Amoxycillin Trihydarte IP eq. to Laboratories Ltd. / M/s 1 ML Suspension Amoxycillin 400mg, Intas Pharmaceuticals Potassium Clavulanate Diluted IP eq. Limited to Clavulanic acid 57mg 4. Metoprolol+ Each film coated tablet contains: 5.58 + Amlodipine Tablet Metoprolol Succinate IP 23.75mg eq. M/s Windlas Biotech to Metoprolol Tartrate 25mg, (as 1 Tablet Limited / M/s Abbott prolonged release form), Healthcare Pvt. Ltd. Amlodipine Besylate IP eq. to¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 Amlodipine 5mg. 5. Atorvastatin + Each hard gelatine capsule contains: 16.73 Clopidogrel Capsule Atorvastatin Calcium IP eq. to M/s Synokem Atorvastatin 20mg (As Pellets), 1 Capsule Pharmaceuticals Ltd. / Clopidogrel Bisulphate IP eq. to M/s Cipla Limited Clopidogrel 75mg (As Pellets) 6. Atorvastatin + Each film coated tablet contains: 9.18 Vitamin D3 Tablet Atorvastatin Calcium IP eq. to M/s Sun Pharma Atorvastatin 10mg 1 Tablet Laboratories Limited Vitamin D3 (Cholecalciferol) IP 1000 IU 7. Atorvastatin + Each film coated tablet contains: 16.12 Vitamin D3 Tablet Atorvastatin Calcium IP eq. to M/s Sun Pharma Atorvastatin 20mg 1 Tablet Laboratories Limited Vitamin D3 (Cholecalciferol) IP 1000 IU 8. Olmesartan Each film coated tablet contains: 9.65 Medoxomil + Olmesartan Medoxomil IP 20mg M/s Sun Pharma Amlodipine + Amlodipine Besylate IP eq. to 1 Tablet Laboratories Limited Chlorthalidone Amlodipine 5mg Tablet Chlorthalidone IP 12.5mg 9. Olmesartan Each film coated tablet contains: 15.83 Medoxomil + Olmesartan Medoxomil IP 40mg, M/s Sun Pharma Amlodipine + Amlodipine Besylate IP eq. to 1 Tablet Laboratories Limited Chlorthalidone Amlodipine 5mg Tablet Chlorthalidone IP 12.5mg 10. Rosuvastatin + Each hard gelatin capsule contains: 11.15 Aspirin + Rosuvastatin Calcium IP eq. to Clopidogrel Capsule Rosuvastatin 10mg (As Film coated M/s Akums Drugs & Tablet), Pharmaceuticals Aspirin IP 75mg (As Aspirin Gastro – 1 Capsule Limited / M/s Intas resistant Tablets) Pharmaceuticals Clopidogrel Bisulphate IP eq. to Limited Clopidogrel 75mg (As film coated tablet) 11. Rosuvastatin + Each hard gelatin capsule contains: 16.82 Aspirin + Rosuvastatin Calcium IP eq. to Clopidogrel Capsule Rosuvastatin 20mg (As Film coated M/s Akums Drugs & Tablet), Pharmaceuticals Aspirin IP 75mg (As Aspirin Gastro – 1 Capsule Limited / M/s Intas resistant Tablets) Pharmaceuticals Clopidogrel Bisulphate IP eq. to Limited Clopidogrel 75mg (As film coated tablet) 12. Paracetamol + Each 5ml Suspension contains: M/s Tirupati Medicare 0.63 Mefenamic Acid Paracetamol IP 250mg Limited / M/s Intas 1 ML Suspension Mefenamic Acid IP 100mg Pharmaceuticals Limited 13. Clopidogrel + Each film coated tablet contains: 3.48 Aspirin Tablet Clopidogrel Bisulphate IP eq. to M/s Sun Pharma 1 Tablet Clopidogrel 75mg Laboratories Limited Aspirin IP (As enteric coated) 75mg 14.. Clopidogrel + Each film coated tablet contains: M/s Sun Pharma 3.55 Aspirin Tablet Clopidogrel Bisulphate IP eq. to 1 Tablet Laboratories Limited Clopidogrel 75mg10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Aspirin IP (As enteric coated) 150mg 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/200/68/2019/F/F. No. 8(68)/2019/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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