jlk;u vksj mozjd ea=ky; vkns k lkj.kh

Transkript

1 jftlvªh laö REGD. NO. D. L /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- 302] ubz fnyyh] eaxyokj] tuojh 23] 2018@ek?k 3] 1939 No. 302] NEW DELHI, TUESDAY, JANUARY 23, 2018/MAGHA 3, 1939 jlk;u vksj mozjd ea=ky; ¼vkS"k/k fohkkx½ ¼jk Vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k½ vkns k ubz fnyyh] 23 tuojh] 2018 dk-vk vk-352¼v½ 352¼v½- vks"k/k fohkkx }kjk vks k/k ¼ewY; fu;a=.k½] 2013 ds isjk 31 ds varxzr ikfjr blesa uhps lkj.kh ds LraHk ¼6½ esa fofufnz V vkns kksa ds }kjk tkjh iqufozyksdu vkns kksa ds lanhkz esa fn;s x, funsz kksa ds dk;kzuo;u esa vksj Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky; }kjk tkjh dk vk 1394¼v½] rkjh[k 30 ebz] 2013 vksj dk- vk- 701¼v½] rkjh[k 10 ekpz] 2016 ds lkfk ifbr vks k/k ¼dher fu;a=.k½ vkns k] 2013 ds isjk 4,] 10,] 11,] 14,] 16,] 17 vksj 18 }kjk iznrr kfdr;ksa dk iz;ksx djrs gq, vksj lkj.kh ds LraHk ¼7½ esa fofufnz V Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky;] ¼jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k½ ds vkns kksa ds vf/køe.k esa] tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezfr isdksa ls gs] mu ckrksa ds flok;] vf/køkur djrs gq, ftugsa,sls vf/køe.k ds iwoz fd;k x;k gs ;k djus dk yksi fd;k x;k gs] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftldks laf{kir :i esa,uihih, dgk tkrk gs½ uhps dh lkj.kh ds LraHk ¼5½ esa fofufnz V vf/kdre dher dks mdr lkj.kh ds LraHk ¼3½ vksj ¼4½ esa Øe k% rrlfkkuh izfof V;ksa esa fofufnz V [kqjkd :i,oa izcyrk vksj bdkbz lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof V esa fofufnz V vuqlwfpr fofufezfr;ksa esa ls izr;sd ij ykxw olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gs% lkj.kh dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½ iqufozyksdu vkns k la-,oa rkjh[k ekstwnk dk- vk- la-,oa rkjh[k (1) (2) (3) (4) (5) (6) (7) 1- esvªksfumktksy batsd ku 500 fexzk-@ @22@ ¼v½ fnukad fefy- fefy- ewy; fu/kkzj.k dh fnukad ¼Ø-la- 398½ 466 GI/2018 (1)

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] uksv % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbz vksj vf/klwfpr dh xbz vf/kdre dher ¼/ku olrq,oa lsok dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufezfr;ksa ds czkamsm ;k tsusfjd ;k nksuksa :ikarjksa dks csp jgs vuqlwfpr fofufezfr;ksa ds lhkh fofuekzrk] mi;qzdr lkj.kh ds LraHk ¼5½ esa of.kzr vf/kdre dher ¼/ku olrq,oa lsok dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezr;ksa dh dher dk v/kkseq[kh la kks/ku djsaxsa ¼[k½ mi;qzdr lkj.kh ¼/ku olrq,oa lsok dj] tks ykxw gs] ;fn dksbz gs½ ds LraHk ¼5½ esa fofufnz V vf/kdre ewy; dh vis{kk de [kqnjk ewy; okyh Åij of.kzr vuqlwfpr fofufezfr;ksa ds lhkh ekstwnk fofuekzrk Mhihlhvks] 2013 ds isjk 13¼2½ ds vuqlkj olrq,oa lsok dj ds dk;kzuo;u ij mrikn kqyd vksj djksa ds varj ds dkj.k vf/kdre [kqnjk ewy; esa gqbz o`f) ds vykok ekstwnk vf/kdre [kqnjk ewy; dks fujarj cuk, j[ksaxsa ¼x½ vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk ¼5½ esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os olrq,oa lsok dj dks tksm+ ldrs gsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 11 esa fn, x, izko/kkuksa ds rgr lecfu/kr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher ds vk/kkj ij vuqlwfpr fofufezfr;ksa ds isdksa ds fy, vf/kdre dher fu/kkzfjr djsaa fuekzrk vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 24 ds rgr QkWeZ&V esa vf/klwpuk dh rkjh[k ls vkbzihmh,e,l ds ek/;e ls Hkjdj,uihih, dks,d ewy; lwph tkjh djsa rfkk mldh dkwih jkt; vks kf/k fu;a=dksa vksj fofuekzrk forjdksa dks tkjh djsaa ¼M+½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj foøsrk vksj forjd fofuekzrk }kjk fn, x, :i esa,sls ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gs fd mlls ijke kz ds bpnqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn` ; Hkkx ij dher lwph vksj iwjd lwph] ;fn dksbz gks] dks laiznf kzr djsxka ¼p½ mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher ds fy, fofufnz"v vuqlwfpr fofufezfr;ksa ds fofufnz"v fofhkuu rjhds vksj izcyrk ls fhkuu vxj ekstwnk fuekzrkvksa }kjk,d ubz vks"kf/k dks ykap djrk gs rks mls igys vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 2¼;w½ ds vuqlkj vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnz"v QkeZ I ds ek/;e ls,uihih, esa ewy; fu/kkzj.k gsrq vkosnu djuk gksxka ¼N½ mi;qzdr vuqlwfpr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa fuekzrkvksa dks vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds lwph II ds QkWeZ III dks vkbzihmh,e,l ds ek/;e ls Hkjdj,uihih, dks gj frekgh dh fjiksvz izlrqr djsxka mi;qzdr vuqlwfpr fofufezfr;ksa ds fuekz.k dks dksbz fuekzrk mriknu cun djus dk bpnqd gks rks bldh lwpuk,uihih, dks voxr djk;sxka blds lecu/k esa vxj vuqlwfpr fofufezfr;ksa ds mriknu vksj vk;kr dks cun djus dk bpnqd gs rks cun djus dh frffk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj,uihih, dks izlrqr djsxka ¼Tk½ fofuekzrk ;k foi.ku deiuh] mijksdr dffkr lkj.kh esa n'kkz;s vf/kdre ewy; vksj 'krks± dk ikyu ugha djrh gsa rks os vko';d olrq, vf/kfu;e] 1955 ds lkfk ifbr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizhkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsa ¼>½ bl vkns'k esa mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v,slh fofufezfr;ksa ds isdksa dh vf/kdre dher fu;r gksus ds ifj.kkelo:i] vf/kdre ;k [kqnjk ewy; fu/kkzfjr vkns'k ;fn dksbz gks] tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh vf/køe.k gks tk;saxsa [dka-la-@185@53@2018@एफ@qk- la- 8¼53½@2018@Mhih@,uihih,&fMoh--II] cythr flag] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 23rd January, 2018 S.O. 352(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, 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

3 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 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. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) Review Order number and date Existing SO number and date (1) (2) (3) (4) (5) (6) (7) 1. Metronidazole Injection 500mg/100ml 1 ML /22/2017- Pricing dated 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, (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, 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, (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, (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/185/53/2018/F/F. No. 8(53)/2018/D.P./NPPA-Div.-II] vkns k ubz fnyyh] 23 tuojh] (E) dated (at Sl. No. 398) BALJIT SINGH, Assistant Director dk- vk- 353¼v½. Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 ebz] 2013 vksj dk- vk- 701¼v½ rkjh[k 10 ekpz] 2016 ds lkfk ifbr vks"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds isjk 5, 11 vksj 15 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftldks laf{kir :i esa,uihih, dgk tkrk gs½] uhps dh lkj.kh ds LraHk ¼6½ eas fofufnz"v [kqnjk ewy; dks mdr lkj.kh ds LraHk ¼3½] ¼4½] vksj ¼5½ eas rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk] bdkbz ¼;wfuV½ vksj fofuekzrk vksj foi.ku deifu;ksa ds uke lfgr LraHk ¼2½ esa dh rrlfkkuh izfof"v esa ls izr;sd dh] olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre [kqnjk ewy; ds :i esa fu;r djrh gsa

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] lkj.kh dzla- vuqlwfpr fofufezfr dk izcyrk bdkbz fofuekzrk vksj [kqnjk uke@czkam dk uke foi.ku daiuh ewy; ¼#-½ (1) (2) (3) (4) (5) (6) 1. vkwyeslkvzu esmkwdlkfey$,eyksfmfiu$ gkbmªksdyksjksffk;ktkbm xksyh 2. vkwyeslkvzu esmkwdlkfey$,eyksfmikbu$ gkbmªksdyksjksffk;ktkbm xksyh 3. fv;ksvªksfi;e czksekbm$qkwekszvsjksy Q~;wekjsV$fdDyslksukbM ikmmj QkWj bugsys ku 4. vkbzlkslksckzbm fmfuvªsv$gkbmªkykftu,plh,y xksyh ¼lksjfcVªsV,p,Q½ 5. vkwyeslkvzu esmkwdlkfey$,eyksfmfiu$ xksyh vkwyeslkvzu esmkwdlkfey vkbz ih 40 fexzk ],EyksfMfiu ckbzlkbysv vkbzih ds cjkcj,eyksfmfiu 5 fexzkgkbmªksdyksjksffk;ktkbm vkbzih 12-5 fexzk- vkwyeslkvzu esmkwdlkfey vkbz ih 20 fexzk ],EyksfMfiu ckbzlkbysv vkbzih ds cjkcj,eyksfmfiu 5 fexzkgkbmªksdyksjksffk;ktkbm vkbzih 12-5 fexzk- izr;sd dsilwy esa% fv;ksvªksfi;e ¼fV;ksVªksfi;e czksekbm eksuksgkbmªsv½ 18,elhth] QkWeksZVsjksy Q~;wekjsV MkbgkbMªsV 12,elhth fddyslksukbm 400,elhth fmywfvm vkbzlkslkfczm fmfuvªsv ds cjkcj vkbzlkslksfczm fmfuvªsv 20 fexzk- gkbmªkykftu gkbmªksdyksjkbm 37-5 fexzk- vkwyeslkvzu esmkwdlkfey vkbz ih 40 fexzk ],EyksfMfiu ckbzlkbysv vkbzih ds cjkcj,eyksfmfiu 5 fexzk- 1 xksyh esllz,del MªXl,aM QkekZL;wfVdYl tqosuvl gsyfkds;j fy- 1 xksyh esllz,del MªXl,aM QkekZL;wfVdYl fyesllz tqosuvl gsyfkds;j fy dsilwy esllz yqfiu fy xksyh esllz foamykl ck;ksvsd fy-@esllz vccksv gsyfkds;j izkfy- 1 xksyh esllz lk;uksdse QkekZL;wfVdYl tqosuvl gsyfkds;j fy uksv % ¼d½ mi;qzdr nh xbz fofufnz"v QkWewZys'ku ds fofuekzrk vfkkzr tks ÞubZ Mªxß Mhihlhvks] 2013 ds isjkxzkq 2¼;w½ ds rgr mi;qzdr nh xbz lkj.kh ds LraHk ¼6½ esa fofufnz"v [kqnjk ewy; fu/kkzfjr djsaxsa ¼[k½ vxj fofuekzrk us rd dh vof/k ds laca/k esa mi;qzdr lkj.kh ds LraHk ¼6½ esa of.kzr QqVdj dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; dj tksm+ ldrs gsaa ¼x½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 11 esa fn, x, izko/kkuksa ds rgr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼6½ esa fofufnz"v [kqnjk ewy; ds vk/kkj ij vuqlwfpr fofufezfr;ksa ds isdksa ds fy, [kqnjk ewy; fu/kkzfjr djsaa fuekzrk vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls,d ewy; lwph,uihih, dks vkbzihmh,e,l ds ek/;e ls tkjh djsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izr;sd QqVdj foøsrk vksj forjd fofuekzrk }kjk fn, x, :i esa,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gs fd mlls ijke kz ds bpnqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn` ; Hkkx ij dher lwph vksj iwjd lwph] ;fn dksbz gks] dks laiznf kzr djsxka ¼M-½ mi;qzdr xsj vf/kdre dher ¼[kqnjk ewy;½ dsoy mi;qzdr fuekzrk@foi.ku ds fy, ykxw gs tslk fd mugksaus vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewy; fu/kkzj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fu/kkzfjr lhkh ykxw os/kkfud vko';drkvksa dh iwfrz

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 ds v/khu izklafxd fof/k;ksa@fu;eksa ds vurxzr tslk fd dsunzh;@jkt; ykblsflax vkwfkksfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykblsal eatwjh ds rgr lacaf/kr fofufezr fuekzrk@foi.ku deifu;ka tks vuqikyu djrh gsa ¼p½ mi;qzdr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa lecfu/kr fuekzrkvksa dks vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds vuqlwph II ds QkWeZ III dks vkbzihmh,e,l ds ek/;e ls Hkjdj,uihih, dks gj frekgh dh fjiksvz izlrqr djsxka mi;qzdr fofufezfr;ksa ds fuekz.k dks dksbz fuekzrk mriknu cun djus dk bpnqd gks rks bldh lwpuk,uihih, dks voxr djk;sxka blds lecu/k esa vxj fofufezfr;ksa ds mriknu vksj vk;kr dks cun djus dk bpnqd gs rks cun djus dh frffk ls de ls de N% eghus igys lwph II ds QkWeZ IV esa Hkjdj,uihih, dks izlrqr djsxka ¼N½ fofuekzrk ;k foi.ku deiuh] mijksdr fofufezfr;ksa vksj fofufnz"v 'krks± dk ikyu ugha djrh gsa rks os vko';d olrq, vf/kfu;e] 1955 ds lkfk ifbr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizhkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsa ¼t½ bl vkns'k esa mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v fofufezfr;ksa ds isdksa dh [kqnjk ewy; fu;r gksus ds ifj.kkelo#i] vkns'k tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh fujlr gks tk;saxsa [dka-la-@185@53/2018@,q@qk- la- 8¼53½@2018@Mhih@,uihih,&fMoh.-II] ORDER New Delhi, the 23rd January, 2018 cythr flag] lgk;d funs'kd S. O. 353(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 30 th May, 2013 and S. O. 701(E) dated 10 th 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; Sl. No. Name of the Scheduled Formulation / Brand Name TABLE Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (7) 1. Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide Tablet Olmesartan Medoxomil IP 40mg Amlodipine Besylate IP eq. to Amlodipine 5mg 1 Tablet M/s Akums Drugs and Pharmaceutical Ltd. / M/s Zuventus Healthcare Limited Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide Tablet 3. Tiotropium Bromide + Formoterol Fumarate + Ciclesonide Powder for Inhalation 4. Isosobide Dinitrate + Hydralazine HCl tablet (Sorbitrate HF) 5. Olmesartan Medoxomil + Amlodipine + Tablet Hydrochlorothiazide IP 12.5mg Olmesartan Medoxomil IP 20mg Amlodipine Besylate IP eq. to Amlodipine 5mg Hydrochlorothiazide IP 12.5mg Each capsule contains: Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg Formoterol Fumarate Dihydrate 12mcg Ciclesonide 400mcg Diluted Isosorbide Dinitrate eq. to Isosorbide Dinitrate 20mg Hydralazine Hydrochloride 37.5mg Olmesartan Medoxomil IP 40mg Amlodipine Besylate IP eq. to Amlodipine 5mg 1 Tablet M/s Akums Drugs and Pharmaceutical Ltd. / M/s Zuventus Healthcare Limited Capsule M/s Lupin Ltd Tablet M/s Windlas Biotech Ltd. / M/s Abbott Healthcaere Pvt. Ltd. 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Zuventus Healthcare Limited

6 6 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, 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, (h) 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/185/53/2018/F/F. No. 8(53)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi and Published by the Controller of Publications, Delhi