In exercise of the powers conferred by paragraphs 4, 5, 6, 10, 11, 14, 15, 16, 17 and 18 of the Drugs

jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. 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- 2705] ubZ fnYyh] c`gLifrokj] flrEcj 21] 2017@Hkknz 30] 1939 No. 2705] NEW DELHI, THURSDAY, SEPTEMBER 21, 2017/BHADRA 30, 1939 jjjjllllkkkk;;;;uuuu vvvvkkkkSSjjSSjj mmmmooooZjZjZjZjdddd eeeea=a=a=a=kkkkyyyy;;;; ¼¼¼¼vvvvkkkk””SS””SSkkkk////kkkk ffffooooHHHHkkkkkkkkxxxx½½½½ ¼¼¼¼jjjjkkkk””””VVVVªªhhªªhh;;;; vvvvkkkk””SS””SSkkkk////kkkk eeeeYYwwYYww;;;; ffffuuuu////kkkkkkkkZjZjZjZj....kkkk iiiizkzkzkzkffff////kkkkddddjjjj....kkkk½½½½ vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 20 flrEcj] 2017 ddddkkkk----vvvvkkkk---- 3333000088888888¼¼¼¼vvvv½½½½----&&&& Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 ebZ] 2013 vkSj dk- vk- 701¼v½ rkjh[k 10 ekp]Z 2016 ds lkFk ifBr vk"Sk/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 4] 5] 6] 10] 11] 14] 15] 16] 17 vkSj 18 }kjk inz Rr 'kfDr;k sa dk i;z kxs djr s g,q ] jk”Vªh; vkS”k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftl s lfa{kIr :i l s ,uihih, dgk tkrk g½S uhp s dh lkj.kh d s LraHk ¼5½ e sa fofufn”ZV vf/kdre dher dk s mDr lkj.kh ds LrHak ¼3½ vkSj ¼4½ e sa Øe’k% rRLFkkuh izfof”V;k sa e sa fofufnZ”V [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHak ¼2½ esa dh rRLFkkuh ifzof”V es a fofufn”ZV vuqlfwpr fofufefZr;ksa esa ls iRz;ds dh] oLr q ,oa lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s :i e sa fu;r djrh gS% llllkkkkjjjj....kkkkhhhh Ø-l-a vuqlfwpr fofufeZfr dk uke [kqjkd :i ,o a icz yrk bdkb Z vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. fjQkcfqVu dSIlyw 150 fexzk- 1 dSIlyw 35.99 2. ¶ydq kus ktkys vksjy fyfDoM 50 fexzk-@5fefy- 1 fefy- 2.28 3. leq kfVªIVu xkys h 25 fexzk- 1 xkys h 30.21 4. leq kfVªIVu xkys h 50 fexzk- 1 xkys h 46.76 5. vk;kgs sDlkys bta Ds ’ku 300 fexzk- vk;ksfMu@fefy 1 fefy- 15.08 6. gis Vs kbfZVl ch bE;uq kXs ykcs fqyu ifzr iSd 4998.20 7. vkbZlkfsu;kftM xkys h 300 fexzk- 1 xkys h 1.08 5811 GI/20172 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uuuukkkkVVssVVss %%%% 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 los k dj] tk s ykx w gkas½ l s vf/kd dher ij vuqlfwpr fofufefZr;ksa d s czkMa Ms ;k tus sfjd ;k nkus k sa :ikarjks a dk s cps jg s vuqlwfpr fofufefZr;ksa ds lHkh fofuekZrk] mi;qDZ r lkj.kh ds LrHak ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,oa lsok dj] tk s ykx w gk½sa l s vf/kd lHkh ,slh fofufeZr;k as dh dher dk v/kkse[q kh iqujh{k.k djxsa As ¼[k½ lHkh ektS wnk fuekZrkvk sa dk s mi;qZDr dfFkr vulq wfpr fofufeZfr;k sa d s vf/kdre [kqnjk dher mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufnZ"V vf/kdre dher oLr q ,o a lsok dj lfgr l s de g S rk]s tgk a dgh Hkh ykx w gk]s vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 13¼2½ d s vulq kj mldks ektS wnk vf/kdre [kqnjk dher dk s cuk, j[kuk gkxs kA ¼x½ vxj fuekZrkvk sa 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 g S ;k ;g n;s g S rk s o s oLrq ,o a lsok dj dk s tkMs + ldrs gASa ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa ds rgr lEcfU/kr fuekZrkvksa dk s mi;DqZ r lkj.kh ds LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;k sa d s iSdksa d s fy, vf/kdre dher fu/kkZfjr djAas 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 l s Hkjdj ,uihih, dk s ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vk”Skf/k fu;a=dk sa vkSj fofuekZrk forjdk sa dks tkjh djAsa ¼M½+ vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds iSjk 24 ¼4½ d s mic/akk sa d s vuqlkj iRz;ds QqVdj fodzsrk 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 g S 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 gks] dks lia znf’kZr djxs kA ¼p½ mi;DqZ r lkj.kh e sa ;Fkk fofufn"ZV [kqnjk ;k icz yrk ;k nksuksa d s lkFk vuqlfwpr fofufeZfr dk dkbs Z ektS nw k fofuekZrk vk”Sk/k eYw ; fu;a=.k vkn’s k] 2013 d s iSjk 2¼;½w ds vuqlkj dkbs Z ub Z vk”Skf/k dk s ykpa djrk g S rk s ,sls ektS wnk fofuekZrk dk s vk”Sk/k ¼eYw ; fu;a=.k½ vkn’s k 2013 dh vulq pw 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 ksnu gsr q vkosnu djuk gkxs kA ¼N½ mi;DqZ r vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvk sa dk s vk"Sk/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;ks a d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn djus dk bPNdq gk s rk s bldh lpw uk ,uihih, dks voxr djk;xs kA bld s lEcU/k eas vxj vuqlfwpr fofufefZr;ks a ds mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq g S rk s cUn dju s dh frfFk l s N% eghu s igys lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s iLz rqr djxs kA ¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e sa n'kk;Z s vf/kdre eYw ; vkSj 'krk±s 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 ds izko/kkuk sa d s v/khu C;kt lfgr vf/kiHzkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼>½ bl vkn's k es a mijkDs r lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufn"ZV ,slh fofufefZr;k sa d s idS k sa dh vf/kdre dher fu;r gksu s ds ifj.kkeLo#i] vf/kdre ;k [kqnjk eYw ; fu/kkfZjr vkn's k ;fn dkbs Z gk]s tk s fd bl vkn's k ls iwo Z tkjh g,q g]S Lor% gh vf/kØe.k gk s tk;xsa As [dk-al-a@181@49@2017@,Q@Qk-l-a 8¼49½@2017Mhih@,uihih,&fMoh-& II] cythr flga ]]]] lgk;d fun's kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 20th September, 2017 S.O. 3088(E).—In exercise of the powers conferred by paragraphs 4, 5, 6, 10, 11, 14, 15, 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:¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 TABLE Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Price Formulation (Rs.) (1) (2) (3) (4) (5) 1. Rifabutin Capsule 150mg 1 Capsule 35.99 2. Fluconazole Oral Liquid 50mg/5ml 1 ML 2.28 3. Sumatriptan Tablet 25mg 1 Tablet 30.21 4. Sumatriptan Tablet 50mg 1 Tablet 46.76 5. Iohexol Injection 300mg iodine/ml 1 ML 15.08 6. Hepatitis B immunoglobulin Each Pack 4998.20 7. Isoniazid Tablet 300mg 1 Tablet 1.08 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/181/49/2017/F/F. No. 8(49)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vvvvkkkknnnn’’ss’’sskkkk ub ZfnYyh] 20 flrEcj] 2017 ddddkkkk----vvvvkkkk---- 3333000088889999¼¼¼¼vvvv½½½½----&&&&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 vk"Sk/k ¼dher fu;a=.k½ vkn'sk] 2013 d s iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk inz Rr 'kfDr;k sa dk iz;kxs djr s gq, vkSj Hkkjr ljdkj e sa jlk;u ,o a moZjd ea=ky; ¼jk”Vªh; vk”Sk/k eYw ; fu/kkZj.k izkf/kdj.k½ d s dk-vk- 2060¼v½ fnukda 30 tuw ] 2017 vkSj dk-vk- 2061¼v½ fnukda tuw ] 2017 d s vkn’s k d s vf/kØe.k e sa tgk a rd mldk lca a/k uhp s dh lkj.kh d s fofufefZr idS 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 g S ;k dju s dk ykis fd;k x;k g]S jk”Vªh; vk”Sk/k eYw ; fu/kkZj.k izkf/kdj.k uhp sdh lkj.kh d sLrHak ¼5½ e safofufnZ”V vf/kdre dher dk smDr lkj.kh d sLrHak ¼3½ vkSj ¼4½ e sa Øe’k% rRLFkkuh ifzof”V;k sae sa fofufn”ZV [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh izfof”V esa fofufn”ZV vuqlfwpr fofufefZr;k sa e sa l s iRz;ds dh] oLr q ,o a lsok dj] ;fn dksb Z g]S dks NksMd+ j vf/kdre dher d s :i e sa fu;r djrh g%S llllkkkkjjjj....kkkkhhhh Ø-l-a vuqlfwpr fofufefZr dk uke [kqjkd :i ,o aizcyrk bdkbZ vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. vkbZlkfsu;kftM xkys h 100 fexzk- 1 xkys h 0-62 2. ,fDVuksekbflu Mh bta Ds ”ku d s fy, ikmMj ifzr idS 287-76 0-5 fexzk- 3. bQZ ksLQkekbM bta Ds ”ku d s fy, ikmMj ifzr idS 328-33 1 xzke 4. fouCykfLVu bta Ds ”ku 1 fexzk-@fefy- 1 fefy- 18-62 5. flYoj lYQkMkbfZtu dzhe 1% 1 xzke 0-27 6. ets yl oDS lhu oDS lhu ifzr idS 46-27 ¼0-5 fefy½ uuuukkkkVVssVVss %%%% ¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkjS vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLr q,o a lsok dj] tk sykx wgk½sa l s vf/kd dher ij vuqlfwpr fofufefZr;k sa d s czkaMMs ;k tus fsjd ;k nkus k sa :ikarjk sa dk s cps jg s vulq wfpr fofufefZr;k sa d s lHkh fofuekZrk] mi;DqZ r lkj.kh d s LrHak ¼5½ e sa of.kZr vf/kdre dher ¼/ku oLr q ,o a lsok dj] tk s ykx w gk½sa l s vf/kd lHkh ,slh fofufeZr;k sa dh dher dk v/kkes q[kh iuq jh{k.k djxsa As ¼[k½ lHkh ektS nw k fuekZrkvk sa dk s mi;DqZ r dfFkr vulq wfpr fofufeZfr;ks a d s vf/kdre [knq jk dher mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher oLr q ,o a lsok dj lfgr l sde g Srk]s tgk a dgh Hkh ykx wgk]s vkS"k/k ¼eYw ; fu;a=.k½ vkn'sk] 2013 d siSjkxzkQ 13¼2½ d s vuqlkj mldk s ektS nw k vf/kdre [knq jk dher dk s cuk, j[kuk gkxs kA ¼x½ vxj fuekZrkvks a 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 g S ;k ;g n;s g S rk s o s oLr q ,o a lsok dj dk s tkMs + ldrs gASa ¼?k½ vk"Sk/k ¼eYw ; fu;a=.k½ vkn'sk] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr lEcfU/kr fuekZrkvk sa dk s mi;qDZ r lkj.kh d s LrHak ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;k sa d s idS k sa d s fy, vf/kdre dher fu/kkfZjr djAsa fuekZrk vk"Sk/k ¼eYw ; fu;a=.k½ vkn'sk] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V e sa vf/klpw uk dh rkjh[k l svkbZihMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s ,d eYw ; lpw h tkjh dj sarFkk mldh dkiW h jkT; vk”Skf/k fu;a=dk sa vkSj fofuekZrk forjdk sadk s tkjh djAsa ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkn'sk] 2013 d s ijS k 24 ¼4½ d s mic/akk sa d s vuqlkj izR;ds QqVdj fodzsrk 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 g S 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 dksb Z gk]s dk s lia nz f’kZr djxs kA ¼p½ 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 ektS nw k fuekZrkvk sa }kjk ,d ub Z vk”Skf/k dk s ykpa djrk g S rk s ml s igy s vk”Sk/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjkxzkQ 2¼;½w d s vuqlkj vk”Sk/k ¼eYw ; fu;a=.k½ vkn’sk] 2013 d s rgr lpw h II es a fofufn”ZV Qke Z I d s ek/;e l s ,uihih, e saewY; fu/kkZj.k grs qvkons u djuk gkxs kA ¼N½ mi;DqZ r vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa fuekZrkvk sa dk s vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lpw h II d s QkWe Z III dk s vkbZihMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;DqZ r vuqlfwpr fofufeZfr;k sa d s fuek.Zk 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 blds lEcU/k e sa vxj vuqlfwpr fofufefZr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq g S rk s cUn dju s dh frfFk l s N% eghus igy slpw h II d sQkWe ZIV e sa Hkjdj ,uihih, dk s izLrqr djxs kA ¼Tk½ 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 sizko/kkuk sad s v/khu C;kt lfgr vf/kiHzkkfjr jkf'k dk stek dju s d sfy, nk;h gkxsa As ¼>½ bl vkn'sk e sa mijkDs r lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV ,slh fofufefZr;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/kkfZjr vkn'sk ;fn dkbs Zgk]s tks fd bl vkn'sk l s iwo Ztkjh gq, g]S Lor% gh vf/kØe.k gk s tk;xsa As [dk-a l-a@181@49@2017@,Q@Qk- l-a 8¼49½@2017@Mhih@,uihih,&fMoh-&II] cythr flga ]]]] lgk;d fun'skd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 ORDER New Delhi, the 20th September, 2017 S.O. 3089(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. 2060(E)and S.O.2061(E) dated 30th June, 2017 respectively 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 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 from & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. No. Name of the Dosage form & Unit Ceiling Price (Rs.) Scheduled Strength Formulation (1) (2) (3) (4) (5) 1. Isoniazid Tablet 100mg 1 Tablet 0.62 2. Actinomycin D Powder for Injection Each Pack 287.76 0.5mg 3. Ifosfamide Powder for Injection Each Pack 328.33 1g 4. Vinblastine Injection 1mg/ml 1 ML 18.62 5. Silver Sulphadiazine Cream 1% 1 GM 0.27 6. Measles vaccine Vaccine Each Pack (0.5ml) 46.27 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) 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/181/49/2017/F/F. No. 8(49)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 20 flrEcj] 2017 ddddkkkk----vvvvkkkk---- 3333000099990000¼¼¼¼vvvv½½½½----&&&&;r% vkS’k/k foHkkx ¼ftl s ckn esa Mhvkis h ds :i e sa lna fHkZr fd;k gS½ u s vfuok; Z vkS’kf/k dh l'a kkfs/kr jk"Vªh; lpw h] 2015 ¼tl s ckn e sa ,u,yb,Z e d s :i e sa lna fHkZr fd;k gS½ d s vk/kkj ij fnukad 10-03-2016 d s dk-vk- 701¼v½ d s }kjk vkS"k/k ewY; fu;a=.k vkn's k] 2013 ¼ftl s ckn e sa Mhihlhvk s d s :i e sa lna fHkZr fd;k g½S dh vuqlpw h I d s vk/kkj ij l'a kk/s ku fd;k gSA vkSj 02- tcfd vuqlfwpr fofufeZfr;k sa dh lpw h d s l'a kk/s ku gkus s ij Mhihlhvk]s 2013 d s iSjk 17 esa l'kk/s ku dh rkjh[k l s lkB fnuk sa dh vof/k d s Hkhrj Mhihlhvk]s 2013 d s mic/a kk sa d s vuqlkj r; gkus s okyh vuqlpw h&I es a tkMs +h xb Z fofufefZr;k sa ¼;kuh nokb;k½a dh vf/kdre dherk sa dk fu/kkZj.k vko';d gSA vkSj 03- tcfd jk’Vªh; vkS’k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftl s ckn e sa ,uihih, d s :i e sa lna fHkZr fd;k gS½ u s ekp]Z 2016 e sa vf/kdre ewY; fu/kkZj.k dh ifzØ;k 'k:q dh FkhA bl lca /a k e]sa ,uihih, u s fnukda 04-04-2016 d s dk;kyZ ; Kkiu ¼;kfu vk,s e½ 19¼697½@2016@Mh II@,uihih, }kjk vuqlwfpr fofufeZfr;k sa dh ,d lpw h viykMs dh Fkh ftld s fy, eYw ; fu/kkZj.k d s fy, vifs{kr MkVk vk/kkfjr lna Hk Z foi.ku miyc/k ugh a FkkA rniq jkra dfFkr lpw h l'a kkfs/kr dh xb Z vkSj bl s fnukda 28-04-2016] 13-05-2016] 10-01-2017 vkSj 08-07-2017 dk s iuq % inz f'kZr fd;k x;kA mi;qZDr vk,s e dh izfr;k a MªXl eSU;Qq SDpjl Z ,lksfl;'s kUl dk s ;g vuqjk/s k djr s Hkts h xb Z Fkh fd o s foi.ku vk/kkfjr MkVk izLrqr dj sa vkSj tcfd ,uihih, u s vkS"k/k foHkkx dk s Mhihlhvk]s 2013 dk s la'ksf/kr dju s dk Hkh l>q ko fn;k Fkk rkfd tgk a foi.ku vk/kkfjr vkda M +s vf/kdre eYw ; fu/kkZj.k d s fy, miyC/k ugh a gS a vkSj ,slh vuqlwfpr fofufefZr;k sa d s fy, jkT; lLa Fkkxr [kjhn ewY; miyC/k g]Sa mudk eYw ; fu/kkZj.k gsr q lqfo/kk vuqlkj fopkj fd;k tk ldsA vkSj 04- tcfd fofuekZrkvks a vkSj vkf/kdkfjd vkda M +s lxa gz dju s okyh ,tsalh tSl s ,vkbvZ kslhMh ,MCY;,w lh,l l s miyC/k djkb Z xb Z tkudkjh d s vk/kkj ij dfri; vuqlwfpr fofufeZfr;k sa ds lca /a k e sa tgka foi.ku vk/kkfjr dher sa miyC/k Fkh] ,uihih, u s ,slh vuqlwfpr fofufefZr;k sa dh vf/kdre dher r; dj nh gAS ,uihih, u s vc rd miyC/k vkda M+k sa d s vk/kkj ij 785 fofufefZr;k sa dh vfd/kre dherk sa dk s r; dj fy;k gSA gkykfad] izklfaxd vkSj fo’oluh; foi.ku vk/kkfjr MVs k izkIr dju s d s db Z i;z klks a d s ckn Hkh] ,uihih, vko';d foi.ku MVs k dh deh d s fy, 'k"sk vuqlfwpr fofufefZr;k sa dh vf/kdre dherks a dk fu/kkZj.k ugh a dj ik;k gSA vkSj 05- tcfd ;g Mhihlhvk]s 2013 d s vuqlwph I d s rgr vf/klwfpr lHkh nokvk sa dh vf/kdre dherksa dk s l”a kkfs/kr dju s d s fy, ,uihih, d s fy, tufgrks a dh j{kk d s fy,] eYw ; fu/kkZj.k d s oSdfYid rjhdksa dk s viukuk vfuok; Z gS] rkfd ,Va hV~;cw jdyq kfsll] ,Va heSjfy;y] bE;uq kys kWftdy] ,faVQxa y] ,Va kb;fse;k] ,Va hLikLekfsMd vkfn fpfdRlh; J.s kh dh vko';d nokb;k sa d s miHkksDrkvks a dk s mi;qDr vkSj mfpr vf/kdre dherk sa dk ykHk lqfuf'pr fd;k tk ldAs vkSj 06- tcfd ,uihih, u s dnsa z ljdkj vkSj jkT;k sa vkSj jkT; fpfdRlk lsok fu;e d s rgr fofHkUu ljdkjh [kjhn ,tfsal;k sa l s tkudkjh ekaxh] D;ksafd vuqlfwpr fofufeZfr;ks a dh vf/kdre dher r; djuk vko';d gSA rnuqlkj] ,vkbvZ kslhMh,MCY;,w lh,l dh QkekVZ ªds fjikVs Z e sa izklafxd foi.ku vk/kkfjr vkda M+ks a d s vHkko e sa fnukda 19-09-2017 dk s ,uihih, e sa vk;ksftr izkf/kdj.k dh cBS d e sa r; fd;k x;k gS rkfd 'k"sk vuqlfwpr fofufeZfr;ksa dh vf/kdre dher] fofHkUu ljdkjh [kjhn ,tfsal;ks a dh [kjhn eYw ;k sa d s vk/kkj ij r; dh tk,A vkSj¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 07- vc 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 vkn's k] 2013 d s iSjk 19 }kjk inz Rr 'kfDr;k sa dk i;z ksx djr s g,q tk s ekuuh; mPp U;k;ky; vkSj Hkkjr d s ekuuh; mPpre U;k;ky; }kjk cjdjkj j[kk x;k gS vkSj Hkkjr ljdkj e sa jlk;u ,o a moZjd ea=ky; ¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ d s dk- vk- 2061¼v½ fnukda 30 tuw ] 2017 vkSj dk- vk- 2060¼v½ vkSj 2061¼v½ fnukda 30 tuw ] 2017 d s vkn's k d s vf/kØe.k e sa tgk a rd mldk lca /a 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 iow Z fd;k x;k gS ;k djus dk ykis fd;k x;k gS] jk"Vªh; vkS”k/k ewY; fu/kkZj.k izkf/kdj.k uhp s dh lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher dks mDr lkj.kh ds LrHa k ¼3½ vkSj ¼4½ e sa Øe'k% rRLFkkuh izfof"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 izfof"V e sa fofufn"ZV vuqlwfpr fofufefZr;k sa e sa ls 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 d-zl-a vuqlwfpr fofufeZfr dk uke [kqjkd :i ,o a icz yrk bdkb Z vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. DyksDlklhfyu bta Ds 'ku d s fy, ikmMj 250 ifzr iSd 4.03 fexzk- 2. xzhlsvkQs yq fou xkys h 125 fexzk- 1 xkys h 0.74 3. fMykDs lkukbM Qqjk,s V xkys h 500 fexzk- 1 xkys h 0.96 4. fXyljhu vksjy fyfDoM 1 fefy- 0.13599 5. DyksjgsDlhMkbu lkYs ;'w ku 5% ¼dkWuluVªVs QkWj 1 fefy- 0.14194 fMy'q ku½ 6. gkbMªkts u isjksDlkbM lkYs ;'w ku 6% 1 fefy- 0.03634 7. eus hVkys bta Ds 'ku 10% 1 fefy- 0.14626 8. MkblkbDZ ykes kbu xkys h 10 fexzk- 1 xkys h 0.09955 9. ,Va h&fVVusl bE;uq kXs ykcs fqyu ifzr iSd 748.06 10. fMIFkhfj;k ,Va hVkWfDlu 10000 vkb;Z w ifzr iSd 1189.22 11. ik;jhMksDlkbu xkys h 10 fexzk- 1 xkys h 0.10491 12. foVkfeu , dSIlyw 50000 vkb;Z w 1 dSIlyw 0.50 13. ,LdkfscdZ ,flM ¼foVkfeu lh½ xkys h 100 fexzk- 1 xkys h 0.17603 uksV % ¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLrq ,o a lsok dj] tk s ykx w gks½a l s vf/kd dher ij vuqlfwpr fofufefZr;k sa d s czkMa Ms ;k tus fsjd ;k nkus k sa :ikarjk sa dk s cps jg s vuqlfwpr fofufeZfr;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 gk½sa l s vf/kd lHkh ,slh fofufeZr;k sa dh dher dk v/kkes q[kh iuq jh{k.k djsaxsA ¼[k½ lHkh ekStnw k fuekZrkvks a dks mi;DqZ r dfFkr vuqlfwpr fofufeZfr;ks a d s vf/kdre [knq jk dher mi;DqZ r 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 vkns'k] 2013 d s iSjkxzkQ 13¼2½ d s vuqlkj mldk s ekStnw k vf/kdre [knq jk dher dk s cuk, j[kuk gksxkA ¼x½ vxj fuekZrkvks a u s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dks 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 ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 11 esa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvks a dk s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufeZfr;k sa d s iSdk sa ds fy, vf/kdre dher fu/kkZfjr djAsa fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V es a vf/klpw uk dh rkjh[k ls vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vkS"kf/k fu;a=dk sa vkSj fofuekZrk forjdksa dk s tkjh djsAa8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjk 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'k Z d s bPNdq fdlh O;fDr ds 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 djsxkA ¼p½ mi;DqZ r lkj.kh d s LrHa k 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 fuekZrkvks a }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 ds iSjkxzkQ 2¼;½w d s vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s rgr lpw h II esa 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;qZDr vuqlwfpr fofufeZfr;ks a 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 fjiksV Z izLrqr djxs kA mi;qZDr vuqlwfpr fofufefZr;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, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufeZfr;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 es a 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 gS a rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuks a d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dks tek dju s d s fy, nk;h gkxsa sA ¼>½ bl vkn's k es a mijkDs r lkj.kh ds LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V esa fofufn"ZV ,slh fofufeZfr;k sa ds iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre ;k [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 g]S Lor% gh vf/kØe.k gk s tk;xsa As [dk-a l-a@181@49@2017@,Q@ Qk- l-a 8¼49½@2017@Mhih@,uihih,&fMoh-&II] cythr flga ]]]] lgk;d fun's kd ORDER New Delhi, the 20th September, 2017 S.O. 3090(E).—Whereas, the Department of Pharmaceuticals (hereinafter referred as DOP) has amended Schedule I of the Drugs Price Control Order (hereinafter referred as DPCO) 2013 vide S.O. 701(E) dated 10.03.2016 based on revised National List of Essential Medicine (hereinafter referred as NLEM) 2015; and 02. Whereas on amendment of the list of scheduled formulations, paragraph 17 of the DPCO 2013 requires fixation of the ceiling prices of formulations (i.e. medicines) added in the Schedule I to be fixed as per the provisions of the DPCO, 2013 within a period of sixty days from the date of amendment; and 03. Whereas the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) initiated the process of the ceiling price fixation in March 2016. In this connection, NPPA vide Office Memorandum (i.e. OM) 19(697)/2016/Div II/NPPA dated 4.4.2016 had uploaded a list of the scheduled formulations for which reference market based data required for price fixation was not available. The said list was subsequently amended and displayed again vide OMs dated 28.4.2016, 13.5.2016, 10.1.2017 and 8.7.2017. Copies of the aforesaid OMs were also sent to Drugs Manufacturers Associations requesting for submission of market based data and whereas NPPA had also suggested the Department of Pharmaceuticals to amend DPCO 2013 so as to facilitate consideration of the State Institutional Procurement Price for such scheduled formulations where market based data are not available to facilitate ceiling price fixation; and 04. Whereas on the basis of inputs from the manufacturer and official data collection agency viz AIOCD AWACS in respect of certain scheduled formulations where market based prices could be traced, NPPA has fixed the ceiling prices of such scheduled formulations. NPPA has so far fixed the ceiling prices of 785 formulations on the basis of available data. However, even after a number of attempts made to obtain the relevant and reliable market based data, NPPA has not been able to fix the ceiling prices of remaining scheduled formulation for the want of requisite market data; and 05. Whereas, it is obligatory on the part of the NPPA to revise the ceiling prices of all the drugs notified under the Schedule I of DPCO, 2013 so as to ensure the benefit of fair and reasonable ceiling prices to the consumers of such essential medicines falling in therapetutic category of Antituberculosis ,Antimalarial, Immunologicals,¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 Antifungal, Antianaemia, Antispasmodic etc. to protect public interest, there is a necessity to adopt alternative methods of price fixation; and 06. Whereas NPPA also sought information from the various Government Procurement Agencies under Central Government and States and State Medical Services Corporation, as it is necessary to fix ceiling prices of scheduled formulations. Accordingly, in the absence of the relevant market based data in the Pharmatrac report of AIOCD-AWACS, it has been decided in the Authority Meeting held in the NPPA on 19/9/2017 to fix the ceiling prices of remaining scheduled formulations on the basis of procurement prices; and 07. Now, in exercise of the powers conferred by paragraphs 19 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, which has been upheld by the Honourable High Court and also Hon’ble Supreme court of India 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. 2060(E) and SO 2061(E) dated 30th June, 2017, 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. Name of the Scheduled Dosage form & Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Cloxacillin Powder for Injection250mg Each Pack 4.03 2. Griseofulvin Tablet 125mg 1 Tablet 0.74 3. Diloxanide furoate Tablet 500mg 1 Tablet 0.96 4. Glycerin Oral Liquid 1 ML 0.13599 5. Chlorhexidine Solution 5% (Concentrate for 1 ML 0.14194 dilution) 6. Hydrogen peroxide Solution 6% 1 ML 0.03634 7. Mannitol Injection 10% 1 ML 0.14626 8. Dicyclomine Tablet 10mg 1 Tablet 0.09955 9. Anti-tetanus immunoglobulin Each Pack 748.06 10. Diphtheria antitoxin 10000 IU Each Pack 1189.22 11. Pyridoxine Tablet 10mg 1 Tablet 0.10491 12. Vitamin A Capsule 50000 IU 1 Capsule 0.50 13. Ascorbic Acid (Vitamin C) Tablet 100mg 1 Tablet 0.17603 Not e: (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.10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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/181/49/2017/F/F. No. 8(49)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 20 flrEcj] 2017 ddddkkkk----vvvvkkkk---- 3333000099991111¼¼¼¼vvvv½½½½----&&&&;r% vkS’k/k foHkkx ¼ftl s ckn esa Mhvkis h ds :i e sa lna fHkZr fd;k gS½ u s vfuok; Z vkS’kf/k dh l'kkfs/kr jk"Vªh; lpw h] 2015 ¼ftl s ckn e sa ,u,yb,Z e d s :i esa lna fHkZr fd;k gS½ d s vk/kkj ij fnukad 10-03-2016 d s dk-vk- 701¼v½ d s }kjk vkS"k/k ewY; fu;a=.k vkn's k] 2013 ¼ftl s ckn e sa Mhihlhvk s d s :i e sa lna fHkZr fd;k gS½ dh vuqlpw h I d s vk/kkj ij l'a kk/s ku fd;k gSA vkSj 02- tcfd vuqlfwpr fofufeZfr;k sa dh lpw h d s l'a kk/s ku gkus s ij Mhihlhvk]s 2013 d s iSjk 17 esa l'a kk/s ku dh rkjh[k l s lkB fnuks a dh vof/k d s Hkhrj Mhihlhvk]s 2013 d s mic/a kk sa d s vuqlkj r; gkus s okyh vuqlpw h&I es a tkMs +h xb Z fofufeZfr;k sa ¼;kuh nokb;k½a dh vf/kdre dherk sa dk fu/kkZj.k vko';d gSA vkSj 03- tcfd jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftl s ckn e sa ,uihih, d s :i e sa lna fHkZr fd;k gS½ u s ekp]Z 2016 e sa vf/kdre ewY; fu/kkZj.k dh ifzØ;k 'k:q dh FkhA bl lca /a k e]sa ,uihih, u s fnukda 04-04-2016 d s dk;kyZ ; Kkiu ¼;kfu vk,s e½ 19¼697½@2016@Mh II@,uihih, }kjk vuqlwfpr fofufeZfr;k sa dh ,d lpw h viykMs dh Fkh ftld s fy, eYw ; fu/kkZj.k d s fy, vifs{kr MkVk vk/kkfjr lna Hk Z foi.ku miyc/k ugh a FkkA rniq jkra dfFkr lpw h l'a kkfs/kr dh xb Z vkSj bl s fnukda 28-04-2016] 13-05-2016] 10-01-2017 vkSj 08-07-2017 dk s iuq % inz f'kZr fd;k x;kA mi;qZDr vk,s e dh izfr;k a MªXl eSU;Qq SDpjl Z ,lksfl;'s kUl dk s ;g vuqjk/s k djr s Hkts h xb Z Fkh fd o s foi.ku vk/kkfjr MkVk izLrqr dj sa vkSj tcfd ,uihih, u s vkS"k/k foHkkx dk s Mhihlhvk]s 2013 dk s l'a kksf/kr dju s dk Hkh l>q ko fn;k Fkk rkfd tgk a foi.ku vk/kkfjr vkda M +s vf/kdre eYw ; fu/kkZj.k d s fy, miyC/k ugh a gS a vkSj ,slh vuqlwfpr fofufefZr;k sa d s fy, jkT; lLa Fkkxr [kjhn ewY; miyC/k g]Sa mudk eYw ; fu/kkZj.k gsr q lqfo/kk vuqlkj fopkj fd;k tk ldsA vkSj 04- tcfd fofuekZrkvks a vkSj vkf/kdkfjd vkda M +s lxa gz dju s okyh ,tsalh tSl s ,vkbvZ kslhMh ,MCY;,w lh,l l s miyC/k djkb Z xb Z tkudkjh d s vk/kkj ij dfri; vuqlwfpr fofufeZfr;k sa ds lca /a k e sa tgka foi.ku vk/kkfjr dher sa miyC/k Fkh] ,uihih, u s ,slh vuqlwfpr fofufefZr;k sa dh vf/kdre dher r; dj nh gAS ,uihih, u s vc rd miyC/k vkda M+k sa d s vk/kkj ij 785 fofufeZfr;k sa dh vf/kdre dherk sa dk s r; dj fy;k gSA gkykfad] izklfaxd vkSj fo”oluh; foi.ku vk/kkfjr MVs k izkIr dju s d s db Z i;z klks a d s ckn Hkh] ,uihih, vko';d foi.ku MVs k dh deh d s fy, 'k"sk vuqlfwpr fofufefZr;k sa dh vf/kdre dherks a dk fu/kkZj.k ugh a dj ik;k gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 vkSj 05- tcfd ;g Mhihlhvk]s 2013 d s vuqlwph I d s rgr vf/klwfpr lHkh nokvk sa dh vf/kdre dherk sa dk s l'a kkfs/kr dju s d s fy, ,uihih, d s fy, tufgrks a dh j{kk d s fy,] eYw ; fu/kkZj.k d s oSdfYid rjhdksa dk s viukuk vfuok; Z gS] rkfd ,Va hV~;cw jdyq kfsll] ,Va heSjfy;y] bE;uq kys kWftdy] ,faVQxa y] ,Va kb;fse;k] ,Va hLikLekfsMd vkfn fpfdRlh; J.s kh dh vko';d nokb;k sa d s miHkksDrkvks a dk s mi;qDr vkSj mfpr vf/kdre dherk sa dk ykHk lqfuf'pr fd;k tk ldAs vkSj 06- tcfd ,uihih, u s dnsa z ljdkj vkSj jkT;k sa vkSj jkT; fpfdRlk lsok fu;e d s rgr fofHkUu ljdkjh [kjhn ,tfsal;k sa l s tkudkjh ekaxh] D;ksafd vuqlfwpr fofufeZfr;ks a dh vf/kdre dher r; djuk vko”;d gSA rnuqlkj] ,vkbvZ kslhMh,MCY;,w lh,l dh QkekVZ ªds fjikVs Z e sa izklafxd foi.ku vk/kkfjr vkda Mk+s a d s vHkko e sa fnukda 19-09-2017 dk s ,uihih, e sa vk;ksftr izkf/kdj.k dh cBS d e sa r; fd;k x;k gS rkfd 'k"sk vuqlfwpr fofufeZfr;ksa dh vf/kdre dher] fofHkUu ljdkjh [kjhn ,tfsal;ks a dh [kjhn eYw ;k sa d s vk/kkj ij r; dh tk,A vkSj 07- vc 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 19 }kjk inz Rr 'kfDr;k sa dk i;z ksx djr s g,q tk s ekuuh; mPp U;k;ky; vkSj Hkkjr d s ekuuh; mPpre U;k;ky; }kjk cjdjkj j[kk x;k 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] jk’Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k 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 izfof"V;ks a es a fofufn"ZV [kqjkd :i ,o a icz yrk vkSj bdkb Z lfgr ml lkj.kh ds LraHk ¼2½ e sa dh rRLFkkuh ifzof"V esa fofufn"ZV vuqlfwpr fofufeZfr;ksa e sa l s iRz ;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs +dj vf/kdre dher d s :i esa fu;r djrh gS%- lkj.kh d-z vuqlwfpr fofufeZfr dk uke [kqjkd :i ,o a icz yrk bdkb Z vf/kdre l-a dher ¼#-½ (1) (2) (3) (4) (5) 1- vkfVZluq Vs ¼,½$lYQkMksfDlu xkys h 100 fexzk- ¼,½$ 1 xkys h ¼750 fexzk-$37-5 dkEs ch iSd 26.77 &ikfjeFs kkekbu ¼ch½ fexzk-½ ¼ch½ 2- vkfVZluq Vs ¼,½$lYQkMksfDlu xkys h 150 fexzk- ¼,½$ 2 xkys h ¼500 fexzk-$25 dkEs ch iSd 36.34 &ikfjeFs kkekbu ¼ch½ fexzk-½ ¼ch½ 3- vkfVZluq Vs ¼,½$lYQkMksfDlu xkys h 200 fexzk- ¼,½$ 2 xkys h ¼750 fexzk-$ 37-5 dkEs ch iSd 33.13 &ikfjeFs kkekbu ¼ch½ fexzk-½ ¼ch½ 4- vkfVZluq Vs ¼,½$lYQkMksfDlu xkys h 25 fexzk- ¼,½$ 1 xkys h ¼250 fexzk-$12-5 dkEs ch iSd 17.84 &ikfjeFs kkekbu ¼ch½ fexzk-½ ¼ch½ 5- ,flVkbylyS hflfyd ,flM xkys h 350 fexzk- 1 xkys h 0.28 6- Qsjkvs l lkYV ¼,½$Qkfsyd ¼ch½ vksjy fyfDoM 20 fexzk- ,yes us Vy vk;ju 1 fefy- 0.12074 ¼,½$100 ,elhth@fefy- ¼ch½ 7- Qsjkvs l lkYV ¼,½$Qkfsyd ¼ch½ xkys h 100 fexzk- ,yes us Vy vk;ju ¼,½$500 1 xkys h 0.09821 ,elhth ¼ch½ 8- Qsjkvs l lkYV ¼,½$Qkfsyd ¼ch½ xkys h 45 fexzk- ,yes us Vy vk;ju ¼,½$400 1 xkys h 0.12755 ,elhth ¼ch½ 9- OgkbV iVs ªkys kVe tys h 100% 1 xzke 0.0843 10- MkblkbDZ ykes kbu vksjy lkYs ;w'ku 10 fexzk@5 fefy- 1 fefy- 0.15089 11- foVkfeu , vksjy fyfDoM 100000 vkb;Z @w fefy- 1 fefy- 0.47 uksV % ¼d½ ljdkj }kjk bl idz kj fu;r dh xb Z vkSj vf/klfwpr dh xb Z vf/kdre dher ¼/ku oLrq ,o a lsok dj] tk s ykx w gks½a l s vf/kd dher ij vuqlfwpr fofufefZr;k sa d s czkMa Ms ;k tus fsjd ;k nkus k sa :ikra jks a dk s cps jg s vuqlfwpr fofufeZfr;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 gk½sa l s vf/kd lHkh ,slh fofufeZr;k sa dh dher dk v/kkes q[kh iuq jh{k.k djsaxsA12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼[k½ lHkh ekStnw k fuekZrkvks a dks mi;DqZ r dfFkr vuqlfwpr fofufeZfr;ks a d s vf/kdre [knq jk dher mi;DqZ r 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 vkns'k] 2013 d s iSjkxzkQ 13¼2½ d s vuqlkj mldk s ekStnw k vf/kdre [knq jk dher dk s cuk, j[kuk gksxkA ¼x½ vxj fuekZrkvks a u s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dks 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 ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 11 esa fn, x, izko/kkuks a d s rgr lEcfU/kr fuekZrkvks a dk s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufn"ZV vf/kdre dher d s vk/kkj ij vuqlfwpr fofufeZfr;k sa d s iSdk sa ds fy, vf/kdre dher fu/kkZfjr djAsa fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V es a vf/klpw uk dh rkjh[k ls vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s ,d eYw ; lwph tkjh djs a rFkk mldh dkWih jkT; vkS”kf/k fu;=a dk sa vkSj fofuekZrk forjdksa dk s tkjh djsAa ¼M½+ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjk 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'k Z d s bPNdq fdlh O;fDr ds 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 djsxkA ¼p½ mi;DqZ r lkj.kh d s LrHa k 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 fuekZrkvks a }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 ¼eYw ; 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;qZDr vuqlwfpr fofufeZfr;ks a 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 fjiksV Z izLrqr djxs kA mi;qZDr vuqlwfpr fofufefZr;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, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufeZfr;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 es a 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 gS a rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuks a d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dks tek dju s d s fy, nk;h gkxsa sA ¼>½ bl vkn's k es a mijkDs r lkj.kh ds LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V esa fofufn"ZV ,slh fofufeZfr;k sa ds iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo#i] vf/kdre ;k [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 g]S Lor% gh vf/kØe.k gk s tk;xsa As [dk-a l-a@181@49@2017@,Q@ Qk- l-a 8¼49½@2017@Mhih@,uihih,&fMoh-&II] cythr flga ]]]] lgk;d fun's kd ORDER New Delhi, the 20th September, 2017 S.O. 3091(E).—Whereas, the Department of Pharmaceuticals (hereinafter referred as DOP) has amended Schedule I of the Drugs Price Control Order (hereinafter referred as DPCO) 2013 vide S.O. 701(E) dated 10.03.2016 based on revised National List of Essential Medicine (hereinafter referred as NLEM) 2015; and 02. Whereas on amendment of the list of scheduled formulations, paragraph 17 of the DPCO 2013 requires fixation of the ceiling prices of formulations (i.e. medicines) added in the Schedule I to be fixed as per the provisions of the DPCO, 2013 within a period of sixty days from the date of amendment; and 03. Whereas the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) initiated the process of the ceiling price fixation in March 2016. In this connection, NPPA vide Office Memorandum (i.e. OM) 19(697)/2016/Div II/NPPA dated 4.4.2016 had uploaded a list of the scheduled formulations for which reference market based data required for price fixation was not available. The said list was subsequently amended and displayed again vide OMs dated 28.4.2016, 13.5.2016, 10.1.2017 and 8.7.2017. Copies of the aforesaid OMs were also sent to Drugs Manufacturers Associations requesting for submission of market based data and whereas NPPA had also suggested the Department of Pharmaceuticals to amend DPCO 2013 so as to facilitate consideration of the State Institutional Procurement Price for such scheduled formulations where market based data are not available to facilitate ceiling price fixation;¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 and 04. Whereas on the basis of inputs from the manufacturer and official data collection agency viz AIOCD AWACS in respect of certain scheduled formulations where market based prices could be traced, NPPA has fixed the ceiling prices of such scheduled formulations. NPPA has so far fixed the ceiling prices of 785 formulations on the basis of available data. However, even after a number of attempts made to obtain the relevant and reliable market based data, NPPA has not been able to fix the ceiling prices of remaining scheduled formulation for the want of requisite market data; and 05. Whereas, it is obligatory on the part of the NPPA to revise the ceiling prices of all the drugs notified under the Schedule I of DPCO, 2013 so as to ensure the benefit of fair and reasonable ceiling prices to the consumers of such essential medicines falling in therapetutic category of Antituberculosis ,Antimalarial, Immunologicals, Antifungal, Antianaemia, Antispasmodic etc. to protect public interest, there is a necessity to adopt alternative methods of price fixation; and 06. Whereas NPPA also sought information from the various Government Procurement Agencies under Central Government and States and State Medical Services Corporation, as it is necessary to fix ceiling prices of scheduled formulations. Accordingly, in the absence of the relevant market based data in the Pharmatrac report of AIOCD- AWACS, it has been decided in the Authority Meeting held in the NPPA on 19/9/2017 to fix the ceiling prices of remaining scheduled formulations on the basis of procurement prices; and 07. Now, in exercise of the powers conferred by paragraphs 19 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, which has been upheld by the Honourable High Court and also Hon’ble Supreme court of India, 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. Name of the Scheduled Dosage form & Strength Unit Ceiling No. Formulation Price (Rs.) (1) (2) (3) (4) (5) 1. Artesunate (A) + Sulphadoxine - Tablet 100 mg (A) + 1 Tablet (750 mg + Combi pack 26.77 Pyrimethamine (B) 37.5 mg) (B) 2. Artesunate (A) + Sulphadoxine - Tablet 150 mg (A) + 2 Tablet (500 mg + Combi pack 36.34 Pyrimethamine (B) 25 mg) (B) 3. Artesunate (A) + Sulphadoxine - Tablet 200 mg (A) + 2 Tablet (750 mg + Combi pack 33.13 Pyrimethamine (B) 37.5 mg) (B) 4. Artesunate (A) + Sulphadoxine - Tablet 25 mg (A) + 1 Tablet (250 mg + Combi pack 17.84 Pyrimethamine (B) 12.5 mg) (B) 5. Acetylsalicylic acid Tablet 350mg 1 Tablet 0.28 6. Ferrous salt (A) + Folic acid (B) Oral liqiud 20mg elemental iron (A) + 1 ML 0.12074 100mcg (B)/ml 7. Ferrous salt (A) + Folic acid (B) Tablet 100 mg elemental iron (A) + 500 1 Tablet 0.09821 mcg (B) 8. Ferrous salt (A) + Folic acid (B) Tablet 45mg elemental iron (A) + 400 1 Tablet 0.12755 mcg (B) 9. White Petrolatum Jelly 100% 1 GM 0.0843 10. Dicyclomine Oral Solution 10mg/5ml 1 ML 0.15089 11. Vitamin A Oral liquid 100000 IU/ml 1 ML 0.47 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, 2013.14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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/181/49/2017/F/F. No. 8(49)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 20 flrEcj] 2017 dk-vk- 3092¼v½-&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 vk"Sk/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 djr s g,q ] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s laf{kIr :i e sa ,uihih, dgk tkrk gS½] uhp s dh lkj.kh d s LrHa k ¼6½ eas fofufn"ZV [knq jk eYw ; dks mDr lkj.kh d s LrHa k ¼3½] ¼4½] vkSj ¼5½ e as rRLFkkuh ifzof"V;k sa esa fofufn"ZV icz yrk] bdkb Z ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;k sa ds uke lfgr LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V esa 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 Ø- vuqlwfpr fofufeZfr dk izcyrk bdkbZ fofuekZrk vkSj [kqnjk ewY; la- uke@czkaM dk uke foi.ku daiuh ¼#-½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ 1- jcs ht g;~ eq u eksuksDyksuy jcs ht g;~ eq u ekus ksDykus y ifzr iSd eSll Z lhje baLVhVMw 8055.68 ,Va hckWMh ¼vkjMh,u,½ ,Va hckWMh 100 vkb;Z @w 2-5 vkWQ bfaM;k izk- fy- ¼jcs hf'kYM½ fefy- iRz ;ds fefy- e%sa jcs ht g;~ eq u ekus ksDykus y ,Va hckWMh ¼vkjMh,u,½ 40 vkbZ;w 2- jcs ht g;~ eq u eksuksDyksuy jcs ht g;~ eq u ekus ksDykus y ifzr iSd eSll Z lhje baLVhVMw 20139.20 ,Va hckWMh ¼vkjMh,u,½ ,Va hckWMh 250 vkb;Z @w 2-5 vkWQ bfaM;k izk- fy- ¼jcs hf'kYM½ fefy- iRz ;ds fefy- e%sa jcs ht g;~ eq u ekus ksDykus y ,Va hckWMh ¼vkjMh,u,½ 100 vkb;Z w¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 15 uksV % ¼d½ mi;qZDr nh xb Z fofufn"ZV QkWewZy's ku d s fofuekZrk vFkkZr tk s ^^ub Z Mªxß 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/kkfZjr djsaxAs 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 es a fn, x, izko/kkuk sa d s rgr fuekZrkvks a dk s mi;qZDr lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk ewY; ds vk/kkj ij vuqlfwpr fofufefZr;k sa d s iSdk sa d s fy, [knq jk eYw ; fu/kkZfjr djsaA 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 ,d eYw ; lpw h ,uihih, dk s vkbiZ hMh,e,l d s ek/;e l s tkjh djAsa ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's 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 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;qZDr xSj vf/kdre dher ¼[knq jk eYw ;½ dsoy mi;qZDr fuekZrk@foi.ku d s fy, ykx w g S tSlk fd mUgkusa s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fu/kkZj.k@l'a kk/s 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';drkvk as dh ifwr Z d s v/khu izklafxd fof/k;ksa@fu;eks a d s vUrxZr tSlk fd dUsnzh;@jkT; ykblfslxa vkWFkkfsjVh d s l{ke izkf/kdkjh }kjk eUs ;Qw Ds pfjxa ykblsal eta wjh d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuiq kyu djrh gSA ¼p½ mi;qZDr fofufeZfr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa lEcfU/kr fuekZrkvk sa dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s vuqlwph II d s QkWeZ III dks vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dks gj frekgh dh fjiksV Z izLrqr djxs kA mi;qZDr fofufefZr;k sa ds 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 fofufeZfr;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 de l s de N% eghu s igy s lpw h II d s QkWe Z IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;k sa vkSj fofufn"ZV '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/kkuksa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dks tek dju s d s fy, nk;h gksaxAs [dk-a l-a@181@49@2017@,Q@ Qk- l-a 8¼49½@2017@Mhih@,uihih,&fMoh-&II] cythr flga ]]]] lgk;d fun's kd ORDER New Delhi, the 20th September, 2017 S.O. 3092(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 Scheduled Strength Unit Manufacturer & Retail No. Formulation / Brand Marketing Price (Rs.) Name Company (1) (2) (3) (4) (5) (6) 1. Rabies Human Monoclonal Rabies Human Monoclonal Each M/s. Serum 8,055.68 Antibody (rDNA) Antibody 100IU/2.5ml Pack Institute of India (Rabishield) Each ml contains: Pvt. Ltd. Rabies Human Monoclonal Antibody (rDNA) 40IU 2. Rabies Human Monoclonal Rabies Human Monoclonal Each M/s. Serum 20,139.20 Antibody (rDNA) Antibody 250IU/2.5ml Pack Institute of India (Rabishield) Each ml contains: Pvt. Ltd. Rabies Human Monoclonal Antibody (rDNA) 100IU16 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 / marketeer 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) The concerned manufacturer of above said formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Manufacturer, in case intending to discontinue above said formulations, shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) 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. [PN/181/49/2017/F/F. No. 8(49)/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.