In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals

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- 570] ubZ fnYyh] eaxyokj] iQjojh 13] 2018@ek?k 24] 1939 No. 570] NEW DELHI, TUESDAY, FEBRUARY 13, 2018/MAGHA 24, 1939 jjjjllllkkkk;;;;uuuu vvvvkkkkSSjjSSjj mmmmooooZjZjZjZjdddd eeeea=a=a=a=kkkkyyyy;;;; ¼vvvvkkkk””SS””SSkkkk////kkkk ffffooooHHHHkkkkkkkkxxxx½ ¼jjjjkkkk””””VVVVªªhhªªhh;;;; vvvvkkkk””SS””SSkkkk////kkkk eeeeYYwwYYww ;;;; ffffuuuu////kkkkkkkkZjZjZjZj....kkkk iiiizkzkzkzkffff////kkkkddddjjjj....kkkk½ vvvvkkkknnnn’’ss’’ss kkkk ub Z fnYyh] 13 Qjojh] 2018 ddddkkkk---- vvvvkkkk---- 666655550000¼¼¼¼vvvv½½½½.—vk"Sk/k foHkkx }kjk vk”Sk/k ¼eYw ; fu;a=.k½ vkn’s k] 2013 d s iSjk 31 d s varxZr ikfjr bles a uhp s lkj.kh d s LraHk ¼6½ esa fofufn”ZV vkn’s kk sa d s }kjk tkjh iuq foZykds u vkn’s kks a d s lna Hk Z e sa fn; s x, fun’sZ kk as d s dk;kUZo;u e as vkSj Hkkjr ljdkj d s jlk;u vkSj mojZ d 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 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk inz Rr ‘kfDr;ks a dk i;z kxs djr s g,q vkSj lkj.kh d s LrHak ¼7½ e sa fofufn”ZV Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; ¼jk”Vªh; vkS”k/k ewY; fu/kkZj.k izkf/kdj.k½] d s vkn’s kk sa ds vf/kdez .k e]sa tgk¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufeZfr idS ksa l s g]S 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/kkjZ .k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½ uhp s dh lkj.kh d s LrHak ¼5½ e sa fofufnZ”V vf/kdre dher dk s mDr lkj.kh d s LrHak ¼3½ vkSj ¼4½ e sa Øe’k% rRLFkkuh izfof”V;k sa esa fofufnZ”V [kqjkd :i ,o a icz yrk vkSj bdkbZ lfgr ml lkj.kh d s LrHak ¼2½ e sa dh rRLFkkuh ifzof”V e sa fofufn”ZV vuqlwfpr fofufeZfr;k sa esa ls iRz;ds ij ykx w oLr q ,o a lsok dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre dher d s :i e sa fu;r djrh g%S lkj.kh Øz- vuqlfwpr fofufefZr dk [kqjkd :i ,o a bdkbZ vf/kdre iuq foZykds u vkn’s k l-a ,o a ektS nw k dk- vk- l-a ,o a l-a uke izcyrk dher ¼#-½ rkjh[k rkjh[k ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ ¼7½ 1- Dykes hQus xkys h 50 fexzk- 1 xkys h 7-56 31015@36@2017& 2058¼v½ fnukda 30- eYw ; fu/kkjZ .k fnukda 24-08- 06-2017 2017 ¼Ø- l-a 146½ 2- Dykes hQus xkys h 100 fexzk 1 xkys h 11-08 31015@36@2017& 2058 ¼v½ fnukda eYw ; fu/kkjZ .k fnukda 30-6-2017 872 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 24-08-2017 ¼Ø- l-a 147½ 3- ,Mhukslkbu bta Ds ’ku 3 1 89-34 31015@12@2017& 2058 ¼v½ fnukda fexzk-@fefy- fefy- eYw ; fu/kkjZ .k fnukda 30-6-2017 28-09-2017 ¼Ø- l-a 15½ ,Ma 31015@39@2017& eYw ; fu/kkZj.k fnukda 24-08-2017 4- ikfsoMkus vk;kfsMu lY;’q ku 10% 1 0-76 31015@34@2017& 2058 ¼v½ fnukda fefy- eYw ; fu/kkjZ .k fnukda 30-06-2017 28-09-2017 ¼Ø- l-a 490½ ,Ma 31015@20@2017& eYw ; fu/kkjZ .k fnukda 28-09-2017 5- feFkkbyizhMukslkys kus bta Ds ’ku 40 1 48-97 31015@26@2017& 2058 ¼v½ fnukda fexzk-@fefy- fefy- eYw ; fu/kkjZ .k fnukda 28-07-2017 30-10-2017 ¼Ø- l-a 23½ 6- lkfsM;e oYizk,s V lhvkj xkys h 300 1 xkys h 5-71 31015@68@2017& 2058¼v½ fnukda fexzk eYw ; fu/kkZj.kh fnukda 30-06-2017 28-11-2017 ¼Ø- l-a 556½ ,Ma 31015@69@2017& eYw ; fu/kkjZ .k fnukda 28-11-2017 7- lkfsM;e oYizk,s V lhvkj xkys h 500 1 xkys h 8-85 31015@68@2017& 2058¼v½ fnukda fexzk eYw ; fu/kkjZ .k fnukda 30-06-2017 28-11-2017 ¼Ø- l-a 555½ ,Ma 31015@69@2017& eYw ; fu/kkjZ .k fnukda 28-11-2017 8- vkbZlkslkfscMZ 5 xkys h 20 fexzk 1 xkys h 2-98 31015@31@2017& 2058¼v½ fnukda ekus kus kbVZ ªVs eYw ; fu/kkjZ .k 30-06-2017 fnukda 28-11-2017 ¼Ø- l-a 314½ ,Ma 31015@39@2017& eYw ; fu/kkjZ .k fnukda 24-8-2017 9- fyXukds us VkWfidy QkeW Zl 1 xzk- 0-98 31015@44@2017& 2058¼v½ fnukda 2-5% vkSj 1 eYw ; fu/kkjZ .k 30-06-2017 fefy- fnukda 28-11-2017 ¼Ø- l-a 354½ 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 lsok dj] tk s ykx w gksa½ l s vf/kd dher ij vuqlfwpr fofufefZr;k sa d s czkMa Ms ;k tus sfjd ;k nksuk sa :ikarjk sa dk s cps jg s vuqlfwpr fofufeZfr;k as d s lHkh fofuekZrk] mi;DqZ r lkj.kh d s 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 sa dh dher dk v/kkse[q kh l’a kk/sku djxsa As ¼[k½ mi;DqZ r lkj.kh ¼/ku oLr q ,o a lsok dj] tk s ykx w gS] ;fn dkbs Z gS½ d s LrHak ¼5½ e as fofufn”ZV vf/kdre eYw ; dh vi{s kk de [kqnjk eYw ; okyh Åij of.kZr vuqlfwpr fofufefZr;ksa ds lHkh ektS wnk fofuekZrk Mhihlhvk]s 2013 d s iSjk 13¼2½ d s vuqlkj oLr q ,o a los k dj d s dk;kUZo;u ij mRikn ‘kYq d vkSj djk sa d s varj ds dkj.k vf/kdre [kqnjk eYw ; e sa gbq Z of`) d s vykok ektS nw k vf/kdre [kqnjk eYw ; dk s fujarj cuk, j[kxsa As ¼x½ vxj fuekZrkvksa u s mi;qDZ r lkj.kh d s LrHak ¼5½ esa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k ;g n;s g S rks o s oLr q ,o a lsok dj dk s tkMs + ldrs gASa¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 ¼?k½ vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr lEcfU/kr fuekZrkvks a dk s mi;DqZ r lkj.kh d s LrHak ¼5½ e sa fofufnZ"V vf/kdre dher d s vk/kkj ij vuqlfwpr fofufefZr;ksa d s iSdk sa d s fy, vf/kdre dher fu/kkfZjr djAas fuekZrk vk"Sk/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, dks ,d eYw ; lpw h tkjh dj sa rFkk mldh dkWih jkT; vk”Skf/k fu;a=dk sa vkSj fofuekZrk forjdk sa dk s tkjh djAsa ¼M½+ vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s 24 ¼4½ d s mic/akk sa d s vuqlkj iRz;ds QVq dj 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 ds 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 znf’kZr djxs kA ¼p½ mi;DqZ r lkj.kh ds LrHak ¼5½ esa fofufnZ"V vf/kdre dher d s fy, fofufn"ZV vuqlwfpr fofufefZr;k sa d s fofufnZ"V fofHkUu rjhd s vkSj icz yrk ls fHkUu vxj ektS wnk fuekZrkvk sa }kjk ,d ub Z vk"Skf/k dk s ykpa djrk g S rk s ml s igy s vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 2¼;½w d s vulq kj vk"Sk/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds rgr lpw h II e sa fofufn"ZV Qke Z I ds ek/;e l s ,uihih, e sa eYw ; fu/kkZj.k gsr q vkons u djuk gkxs kA ¼N½ mi;DqZ r vuqlfwpr fofufeZfr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k eas fuekZrkvk as 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 vuqlwfpr fofufefZr;k as d s fuek.Z k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNqd gks rk s bldh lpw uk ,uihih, dks voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufefZr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn dju s dh frfFk l s N% eghu s igy s lpw h II d s QkWe Z IV esa Hkjdj ,uihih, dk s izLrqr djxs kA 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 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 e sa mijkDs r lkj.kh d s LrHak ¼2½ es a dh rRLFkkuh ifzof"V e sa fofufnZ"V ,slh fofufefZr;k sa d s iSdk sa dh vf/kdre dher fu;r gkus s d s ifj.kkeLo:i] vf/kdre ;k [kqnjk ewY; fu/kkfZjr vkn's k ;fn dkbs Z gk]s tks 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@186@54/2018 ,Q Qk- l-a 8¼54½@2018@Mhih@,uihih,&fMoh&II] cythr falga ]]]] lgk;d fun’s kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICALS PRICING AUTHORITY) ORDER New Delhi, the 13th February, 2018 S.O. 650(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 in 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 Existing SO number and No. Scheduled Strength Price number and date date Formulation (Rs.) (1) (2) (3) (4) (5) (6) (7) 1. Clomiphene Tablet 50mg 1 Tablet 7.56 31015/36/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 146) 24.8.2017 2. Clomiphene Tablet 100mg 1 Tablet 11.08 31015/36/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 147) 24.8.20174 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 3. Adenosine Injection 3mg/ml 1 ML 89.34 31015/12/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 15) 28.9.2017 & 31015/39/2017- Pricing dated 24.8.2017 4. Povidone Iodine Solution 10% 1 ML 0.76 31015/34/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 490) 28.9.2017 & 31015/20/2017- Pricing dated 28.9.2017 5. Methylprednisolone Injection 40mg/ml 1 ML 48.97 31015/26/2017- 2400(E) dated 28.7.2017 (at Pricing dated Sl. No. 23) 30.10.2017 6. Sodium Valproate CR Tablets 300mg 1 Tablet 5.71 31015/68/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 556) 28.11.2017 & 31015/69/2017- Pricing dated 28.11.2017 7. Sodium Valproate CR Tablets 500mg 1 Tablet 8.85 31015/68/2017- 2058(E) dated 30.6.2017 (at Pricing dated Sl. No. 555) 28.11.2017 & 31015/69/2017- Pricing dated 28.11.2017 8. Isosorbide 5 Tablet 20 mg 1 Tablet 2.98 31015/31/2017- 2058(E) dated 30.6.2017 (at Mononitrate Pricing dated Sl. No. 314) 28.11.2017 & 31015/39/2017- Pricing dated 24.08.2017 9. Lignocaine Topical Forms 2- 1 gm or 0.98 31015/44/2017- 2058(E) dated 30.6.2017 (at 5% 1 ml Pricing dated Sl. No. 354) 28.11.2017 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, 2013.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (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 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/186/54/2018/F.No. 8(54)/2018/DP/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.