Whereas the National Pharmaceutical Pricing Authority NPPA was established by Resolution

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- 2334] ubZ fnYyh] c`gLifrokj] vxLr 17] 2017@Jko.k 26] 1939 No. 2334] NEW DELHI, THURSDAY, AUGUST 17, 2017/SRAVANA 26, 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] 16 vxLr] 2017 dk-vk- 2668¼v½-&;r% jk”Vªh; vkS”k/k ewY; fu/kkZj.k izkf/kdj.k ¼,u-ih-ih-,½ dh LFkkiuk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; ds fnukad 29 vxLr] 1997 ds ladYi la- 33@7@97&ihvkbZ-I }kjk vkS”kf/k;ksa@fofufeZfr ds ewY;ksa dks fu;r@la”kksf/kr] fuxjkuh j[kus vkSj Mh-ih-lh-vks ds dk;kZUo;u dk fujh{k.k djus ds fy, gqbZ Fkh( vkSj tcfd fnukad 30 ebZ] 2013 ds dk0vk0 1394 ¼v½ }kjk Hkkjr ljdkj us vfuok;Z oLrq,a vf/kfu;e] 1955 ¼1955 dk 10½ dh /kkjk 3 vkSj 5 esa iznRr “kfDr;ksa dk iz;ksx djrs gq, Mh-ih-lh-vks] 2013 ds iSjk 4]5]6]7]8]9]10]11]12]13]14]15]16]18]19]20]21]23]24]25] 26]27] 28]29]30 vkSj 32 ds ckjs esa ,u-ih-ih-, dks dsUnzh; ljdkj ds dk;ksZa dks djus dh “kfDr;ka izR;k;ksftr dh gSaA 2- blds vykok tcfd vfuok;Z oLrq,a vf/kfu;e] 1955 dh /kkjk 3 ds varxZr tkjh Mh-ih-lh-vks] 2013 dk y{; ;g lqfuf”pr djuk gS fd lHkh dks vko”;d vkS”kf/k;ka ogu ;ksX; ewY;ksas ij miyC/k gksA tcfd Hkkjr ds ekuuh; mPpre U;k;ky; us ,l,yih la0 3668@2003 ¼Hkkjr la?k cuke ds-,l-xksihukFk ,oa vU;½ esa fnukad 12 uoacj] 2002 ds vius vkns”k }kjk ljdkj dks ;g lqfuf”pr djus dk funs”k fn;k gS fd thou j{kd vkS”kf/k;ka ewY; fu;a=.k ls ckgj uk gksaA 3- blds vykok] tcfd Hkkjr ds ekuuh; mPPkre U;k;ky; us XySDlks bafM;k fyfeVsM cuke Hkkjr la?k ¼2014½ 2 ,llhlh 753 esa vius fu.kZ; esa miHkksDrkvksa ds ykHk ds fy, vf/klwfpr ewY;ksa ds dk;kZZUo;u ij dk;Zokgh djrs gq, lk;ukekbM bafM;k fyfeVsM¼1987½ 2 ,llhlh 722 esa ekuuh; mPPkre U;k;ky; }kjk fn;k x;k] esa egRoiw.kZ /;ku nsus ;ksX; izkjafHkd dFku fn;k ftlesa U;k;ky; us ik;k% ^^2- equkQk[kksjh] Loa; esa gh] ,d cqjkbZ gSA leqnk; ds nqyZHk lalk/kuksa esa equkQk[kksjh] ije vko”;d thou ;kiu gsrq [kkn~; inkFkksZa vkSj thou j{kd vkS’kf/k;ka] ds chp iS”kfpd :Ik esa gSA ;g ,d ,slk [krjk gS ftl ij jksd yxkuk ,oa bls fu;fa=r djuk gksxkA vko”;d oLrq vf/kfu;e] 1955 dk izeq[k mn~ns”; lkj :Ik esa ;gh gSA ;g Lej.k j[kuk gksxk fd vuqPNsn 39¼[k½ jkT; dks leqnk; ds HkkSfrd lalk/kuksa ds LokfeRo ,oa fu;a=.k izkfIr ds izfr drZO; dk O;kns”k nsrk gS fd ;g yksdfgr esa csgrj :Ik esa forfjr djus esa lgk;d gks^^A 5011GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 4- blds vykok] tcfd LokLF; vkSj ifjokj dY;k.k ea=ky; us vius fnukad 06 vDVwcj] 2005 ds dk-vk- 1468 }kjk vfLFk baIykUVksa dks ^vkS’kf/k;ksa^ ds :i esa vf/klwfpr fd;k gS] vr% Mhihlhvks] 2013 lHkh vkS’kf/k;ksa ¼vf/klwfpr midj.kksa lfgr½ ij ykxw gksrk gS vkSj ,uihih, iSjk 20 ds varxZr bu vkS’kf/k;ksa ds ewY;ksa ij fuxjkuh j[kus ds fy, vf/kns”kk/khu gS fd ,slh vkS’kf/k;ksa ¼;kfu vf/klwfpr midj.k½ dh miyC/krk lqfuf”pr gks vkSj ;g Hkh lqfuf”pr gks fd ejhtksa dh dher ij dksbZ vkS’kf/k ¼;kfu vf/klwfpr midj.k½ ds ekeys esa vuSfrd :i ls equkQk[kksjh u dj jgk gksA ;g ns[kk gS fd vfLFk&?kqVuk baIykUVksa esa vU;k;ksfpr] gn ls T;knk vkSj vdkj.k mPp O;olk; ykHk lekfgr gS ftlds ifj.kkeLo:i budh vR;f/kd nke gksrs gSa tks ejhtkas ds [kpksZa dks izHkkfor djrk gS vkSj yk[kksa ejht vFkzksZIykfLV izfdz;k ds fy,] bu vR;f/kd dherksa dk Hkqxrku djus esa vleFkZ gSaA nnZxzLr jgrs gSa vkSj tcfd vFkzksZIykfLV t:jrcan ,sls ejhtksa] funkuhr vkSj vfunkfur nksuksa dh vuqekfur la[;k 1-5 ls 2 djksM+ ds yxHkx gS ftuesa ls ek= 01 yk[k ls vf/kd lEiUu ejht izR;sd o’kZ bldk Hkqxrku djus dh fLFkfr esa gksrs gSa( vkSj tcfd MCY;w ,p vks cqysfVu] 2003] 81] ¼9½ ds vuqlkj vkSLVhvksvFkZjkbfVl o’kZ 2020 rd dh viaxrk dk pkSFkk izeq[k dkj.k gksus dh laHkkouk gS vkSj la[;k ds vuqlkj Hkkjr ds ,sls xfrghu ukxfjdksa dk ,d izeq[k ns”k gksus dh laHkkouk gS( vkSj tcfd ,sls fdlh ifjn`”; dks izR;sd O;fDr ds lkFk&lkFk jk’Vªh; fgr esa jksduk vfuok;Z gSA 5- vkSj ;r% ljdkj dk vfLFk baIykaV~l gsrq mfpr] ;Fkksfpr ,oa ogu;ksX; ewY; iznku djuk ,d ewyHkwr nkf;Ro gS vkSj vr% vuqfpr equkQk[kksjh ,oa csfglkc ewY;ksa dks jksdus ds fy, blesa rRdky gLr{ksi djuk vko”;d gS vkSj tcfd] vU; ckrksa ds lkFk&lkFk Mhihlhvks] 2013 dk iSjkxzkQ 19 ljdkj dks] vlk/kkj.k ifjfLFkfr;ksa esa izkf/kd`r djrk gS fd og ;fn tu fgr esa vko”;d le>sa rks fdlh vof/k gsrq ftruh og mi;qDr le>s] fdlh vkS”kf/k ¼;kfu vf/klwfpr midj.k½ dk vf/kdre ewY; ;k [kqnjk ewY; fu;r dj ldrh gS( vkSj tcfd ?kqVuk jksi.k ds ekeys esa mijksDr ewY;kadu ds vk/kkj ij ;g vlk/kkj.k fLFkfr ikbZ xbZ gSA 6- vkSj tcfd ,u-ih-ih-, }kjk 10 tqykbZ] 2014 dks Mhihlhvks] 2013 ds iSjk 19 ds varxZr tkjh dfri; vkS’kf/k;ksa ds fy, tkjh dh xbZ ewY; fu;r djus laca/kh vf/klwpuk,a ekuuh; mPp U;k;ky;] cacbZ }kjk vius fu.kZ; vkSj vkns”k ¼Hkkjrh; vkS’k/k ,yk;al cuke Hkkjr la?k½ 2014 ds MCY;wih¼lh½ la[;k 2700 esa 26 flracj] 2016 ds }kjk ifjiqf’V dh gSa ftlesa vU; ckrksa ds lkFk ekuuh; mPp U;k;ky; us ik;k fd% ^^20-----------tc ,slh vlQyrk ds ckjs esa tu LokLF; ds {ks= esa] vkS’k/khd Hkwfedk ds lanHkZ esa fopkj fd;k tkrk gS] tks ,d lkekftd vf/kdkj gS] rks ljdkj dk gLr{ksi vko”;d gks tkrk gS fo”ks’k :i ls tc foLQksVd ewY; vkS’kf/k;ksa dks voguh; cuk nsrs gSa vkSj vf/kdka”k dh igqap ls ckgj gks tkrs gSa vkSj LokLF; laca/kh ns[kHkky ij gksus okys O;; ds vFkksZa esa vR;f/kd foRrh; Hkkj Mky nsrk gSa------^^ vkSj tcfd Hkkjrh; vkS’k/kh; ,yk;al }kjk mijksDr dfFkr fu.kZ; dks pqukSrh nsus okyh ,l,yih ¼lh½ 30089@2016 dks Hkkjr ds ekuuh; mPp U;k;ky; }kjk 24 vDVwcj] 2016 dks [kkfjt dj fn;k tkrk gSA 7- vkSj tcfd ,uihih, us vfLFk ?kqVuk jksi.k dh c<+rh ykxr vkSj vR;kf/kd O;olk; ykHk ds ekeys ij i.k/kkfj;ksa ds lkFk gq, foLr`r ijke”kZ fd;k vkSj ?kqVuk jksi.k ds cktkj esa ^O;olk; ykHk^ ds fo”ys’k.k dks] ikjnf”kZrk ds fy, vkSj turk dh lwpuk ds vf/kdkj dks /;ku j[krs gq,] ifCyd Mksesu ij viyksM fd;k FkkA 8- ;r% ,uihih, us 10 vxLr] 2017 dks vk;ksftr cSBd esa tks 14 vxLr] 2017 dks tkjh jgha] ftlesa jksxh vkSj gSYFkds;j lqiqnZxh iz.kkyh ds chp lwpuk fo’kerk ds dkj.k ,d vlQy vkSj foLQksVdkRed foi.ku ds orZeku vlk/kkj.k ifjfLFkfr;ksa ds varxZr vfLFk ?kqVuk jksi.k ds ewY; fu/kkZj.k esa lHkh laxr fodYiksa vkSj lHkh miyC/krk lwpuk@vkadM+ksa@erksa ij foLr`r] fopkj&foe”kZ vkSj fof/k :i ls tkap djus ds i”pkr~ fu.kZ; fy;k x;k gS fd vfLFk ?kqVuksa ds baIykUVksa dk vf/kdre ewY; fu;r djus ds fy, vfr O;oLkk; ykHk ij fu;a=.k djuk vko”;d gS tks tufgr ds laj{k.k djus gsrq laxr ykHkksa lfgr tks baIykUV ds vius ewyHkwr ewY; ij vk/kkfjr mfpr ,oa vkSfpR;iw.kZ gSA 9- vc] vr% fnukad 30 ebZ] 2013 ds dk-vk- la- 1394¼v½ }kjk Mhihlhvks] 2013 ds iSjk 19 ds varxZr Hkkjr ljdkj esa jlk;u ,oa moZjd ea=ky; dks izR;k;ksftr “kfDr;ksa dk iz;ksx djrs gq, ,uihih, bl ckr ls larq’V gksrs gq, fd mijksDr ;Fkk of.kZr vlk/kkj.k ifjfLFkfr;ksa dks /;ku esa j[krs gq, ik;k gS fd tufgr esa ,slk djuk vR;Ur vko”;d le>k fd jkti= vf/klwpuk dh rkjh[k 16 vxLr] 2017 ls fuEukuqlkj ;Fkk fofufnZ’V] fVIi.k lfgr ?kqVuk izfrLFkkiu iz.kkyh ds fy, vfLFk ?kqVuk baIykUVksa dk vf/kdre ewY;] ,rn~}kjk] fu;r ,oa vf/klwfpr fd;k tkrk gS%&¹Hkkx IIμ[k.M 3 (ii)º Hkkjr dk jkti=k % vlk/kj.k 3 lkj.kh dz vfLFk ?kqVuk baIykUV vax ?kqVuk baIykUV dk bdkbZ vf/kdre ewY; la- iz.kkyh vkdkj@lkexzh ¼la[;k esa½ ¼#0 esa½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ izkFkfed 1- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk fVVsfu;e vykS; ¼lHkh 1 38]740 izfrLFkkiu iz.kkyh }kjk Qheksjy vax :ikUrj½ fyfir 2- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk vksfDlfMftM ftdksZfu;e 1 38]740 izfrLFkkiu iz.kkyh }kjk Qheksjy vax ¼vks,DltsMvkj½ vykS; ¼lHkh :ikUrj½ fyfir 3- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk gkbZ&¶ySDl 1 25]860 izfrLFkkiu iz.kkyh }kjk Qheksjy vax 4- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk dksckYV dzksfe;e 1 24]090 izfrLFkkiu iz.kkyh }kjk Qheksjy vax ¼lhvkslhvkj½ vykS; ¼lHkh :ikUrj½ fyfir vkSj dz- la- 1] 2 ,oa 3 ls fHkUu 5- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk VhVkfu;e vykS; ¼vkSj lHkh 1 24]280 izfrLFkkiu iz.kkyh }kjk Vhfcvy ?kVd ;k :ikUrj½ fyfir Vhfcvy Vªs 6- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk vksfDlfMftM ftdksZfu;e 1 24]280 izfrLFkkiu iz.kkyh }kjk Vhfcvy ?kVd ;k ¼vks,DltsMvkj½ vykS; Vhfcvy Vªs fyfir 7- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk dksckYV dzksfe;e 1 16]990 izfrLFkkiu iz.kkyh }kjk Vhfcvy ?kVd ;k ¼lhvkslhvkj½ vykS; fyfir Vhfcvy Vªs vkSj dz- la- 5 ,oa 6 ls fHkUu 8- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 9]550 izfrLFkkiu iz.kkyh }kjk laf/k ;kstu lrg ;k bulVZ 9- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 4]090 izfrLFkkiu iz.kkyh }kjk isVyk 10- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk iksfyfFkysu ;k dzkslfyadM 1 12]960 izfrLFkkiu iz.kkyh }kjk ,slk vax tks ,dy iksfyfFkysu ;k mPp bdkbZ ds :i esa Vhfcvy Vªs dzkslfyadM iksfyfFkysu ;k vkSj bulVZ gks dksbZ vU; lkexzh 11- izkFkfed ?kqVuk fdlh Hkh uke@fof”k’Vrk Vhfcvy% esVkfyd bulVZ% 1 26]546 izfrLFkkiu iz.kkyh }kjk,slk vax tks ,dy iksfyfFkysu ;k dzkslfyadM bdkbZ ds :i esa Vhfcvy Vªs iksfyfFkysu ;k mPp vkSj bulVZ gks dzkslfyadM iksfyfFkysu ;k dksbZ vU; lkexzh iqu% LFkkiu 12- iqu% ?kqVuk izfrLFkkiu fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 62]770 iz.kkyh }kjk Qheksjy vax 13- iqu% ?kqVuk izfrLFkkiu fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 31]220 iz.kkyh }kjk Vhfcvy ?kVd ;k Vhfcvy Vªs 14- iqu% ?kqVuk izfrLFkkiu fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 15]870 iz.kkyh }kjk laf/k ;kstu lrg ;k bulVZ 15- iqu% ?kqVuk izfrLFkkiu fdlh Hkh uke@fof”k’Vrk dksbZ Hkh lkexzh 1 4]090 iz.kkyh }kjk isVyk4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV% ¼d½ mi;qZDr rkfydk ds LrHak ¼6½ es a fofufnZ”V vf/kdre ewY; Hkkjr ds jkti= ¼vlk/kkj.k½ esa bl vf/klwpuk ds izdk’ku gksus dh rkjh[k ls ykxw gksaxs vkSj O;olk; pSuy esa fczdh ds fy, miyC/k ?kqVuk baIykaVl ds lHkh LVkWd ij Hkh ykxw gksaxsA ¼[k½ lHkh fofuekZrkvksa dks ykxw Js.kh ds varxZr vkSj lhesaV;ksX;] vlhesaV;ksX;] fyax fo’ks”k ;k ;fwulsDl ij /;ku fn, fcuk bles a of.kZr vf/kdre ewY;ksa dk vuqikyu vkSj dk;kZUo;u djsaxsA rFkkfi fcuk lhesaV baIykUVksa ds fofuekZrk i`Fkd vf/kdre ewY; ;k [kqnjk ewY; ds fu;r djus gsrq lefFkZr nLrkostksa lfgr ,uihih, ls laidZ dj ldrk gSA ¼x½ dSalj@V~;wej vkfn ds fy, fo’ks”k vksFkksZisfMd ?kqVuk baIykUV iqu% ltZjh ds ewY;ksa dks viuk,axsA rFkkfi] ,sls baIykUVksa dk vk;kr ewY; ;fn vf/kdre ewY; ls vf/kd gksrk gS] rks fofuekZrk bl vf/klwpuk ds tkjh gksus ls 45 fnuksa rd] Hkkjr esa ykap gq, ,sls baIykUV ds igys cSp ds vk;kr ewY; ij vf/kdre 30 izfr’kr dk dqy ykHk tksM+ ldr s gSa vkSj vf/kdre ewY; vkSj [kqnjk ewY; vf/klwpuk ds fy, ,uihih, dks ‘kh?kz vkosnu djuk iM+sxkA ¼?k½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼?ku oLrq ,oa los k dj] tks ykxw gksa½ ls vf/kd dher ij ?kqVuk baIykUV ds czkaMsM ;k xSj&czkaMsM ;k nksuks a :ikarjks a dks csp jgs ?kqVuk baIykUV~l ds lHkh fofuekZrk] mi;ZqDr lkj.kh d s LrHak ¼6½ es a of.kZr vf/kdre dher ¼?ku] oLrq ,oa lsok dj] tks ykxw gksa½ ;fn dksbZ gS ls vf/kd lHkh ,sls ?kqVuk baIykUVl dh dher dks v/kkseq[kh la’kksf/kr djsaxsA ¼M+½ lHkh ?kqVuk baIykUV~l fuekZrkvksa@foi.kudrkZvksa dks vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ”V vf/kdre dher oLrq ,oa lsok dj lfgr ls de gS] rks tgka dgha Hkh ykxw gks] vkS”k/k ewY; fu;a=.k vkns’k] 2013 ds iSjkxzkQ 13¼2½ ds vuqlkj ekStwnk vf/kdre [kqnjk ewY; dks cuk, j[kuk gksxkA ¼p½ fofuekZrk us bl vkns’k ds iSjk ¼9½ esa mi;qZDr lkj.kh ds LrHak ¼6½ es a fofufnZ”V vf/kdre dher ij ljdkj dks okLro es a ,sls djksa dk Hkqxrku fd;k gS ;k ;g ns; gSa rks os oLrq ,oa lsok dj tksM+ ldrs gSa vkSj vU; dksbZ izHkkj ugha tksM+ ldrsA ¼N½ Mhihlhvks] 2013 ds varxZr mica/kksa ds vuqlkj mijksDr lkj.kh ds LraHk ¼6½ esa fofufnZ”V vf/kdre ewY; ds vuqlkj lacaf/kr fofuekZrk@vk;krdrkZ }kjk baIykUV ds fdlh idS ds fy, vf/kdre ewY; rd cuk, j[kuk gksxkA ¼t½ blesa mijksDr lkj.kh esa of.kZr vf/kdre eYw ; lHkh ?kVdksa vkSj miHkksT;ksa lfgr gSa] tks ?kqVuk baIykUV ds iz;ksx esa gkrs s gSa vkSj ejht ds ‘kjhj es a gh jgrs gSAa ¼>½ Mhihlhvks] 2013 ds iSjk 24 ds rgr vuqlwph&II esa ;Fkkfu/kkZfjr QkeZ&V varxZr] vf/klwpuk dh rkjh[k ls vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lpw h tkjh djsxk rFkk mldh dkWih lHkh jkT; vkS”k/k fu;a=dksa vkSj lHkh vius forjdksa@Mhyjksa@vksFkksZisfMd LokLF; lqfo/kk laLFkkuksa dks izfr izLrqr djsxkA ¼´½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjk 24 ¼4½ ds vuqlkj izR;ds forjd] Mhyj vkSj laLFkkua s ,ls s ifjlj] tgka dkjckj dk s bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igpqa vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij fofuekZrk@vk;krdrkZ }kjk nh xbZ ewY; lwph vkSj iwjd ewY; lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA ¼V½ tgka dgha laLFkku tSls vLirky@uflZax gksEl@fDyfud ?kqVuk baIykUVksa dk iz;ksx ,oa vksFkksZisfMd lftZdy izfdz;kvksa dk fu”iknu djrs gq, lh/ks :i es a ejhtks a dk fcy rS;kj djrs gS]a mUgs a bles a mijksDr esa vf/klwfpr vf/kdre ewY;ksa dk vuqikyu djuk blesa mijksDr ¼´½ lfgr Mhihlhvks] 2013 ds ykxw mica/kksa dk vuqikyu djuk visf{kr gksxkA ¼B½ dksbZ Hkh LokLF; lqfo/kk laLFkku tSls vLirky@uflZax&gksEl@fDyfud ?kqVuk baIykUVksa dk iz;ksx djrs gq, vksFkksZisfMd lftZdy izfdz;kvksa dk fu”iknu djrk gS vkSj ;fn ejht fdlh vU; r`rh; ikVhZ L=ksr l s ,ls k baIykUV izkIr djus dk bPNdq g S rks og ejht dks blls ?kqVuk bIaykUV [kjhnus dk vkxzg ugha dj ldrkA ¼M½ lHkh fofuekZrkvksa dks baIykUV ds lHkh czkaMksa dh miyC/krk fujarj lqfuf’pr djuh gksxh vkSj ;g Hkh lqfuf’pr djuk gS fd u, ,evkjih eqfnzr gksus ds dkj.k vkiwfrZ Ja`[kyk e as dksbZ ck/kk mRiUu ugh a gqbZ gSA ¼.k½ laLFkku tSls vLirky@uflZax gksEl@Dyhfud }kjk ?kqVuk baIykUV dk iz;ksx djrs] gq, fo’ks”k vkSj i`Fkd :i ls ejhtksa ;k muds izfrfuf/k;ksa dks muds vuqekfur@izksQksekZ buoksbl rS;kj djrs le; blds czkaM uke] fofuekZrk@vk;krdrkZ csp uacj dk uke vkSj vU; fooj.k ;fn dksbZ gksa ds lfgr ?kqVuk baIykUV vxa okj dh ykxr dk mYys[k djuk gksxkA ¼r½ bl vkns’k ds iz;kstukFkZ ^fofuekZrk^ ls vfHkizk;% fdlh ,sls O;fDr ls gS tks vkS”kf/k;ksa dk fofuekZ.k ;k vk;kr ;k foi.ku djrk gks ;kfu vf/klwfpr midj.kksa tSls ?kqVuk bIaykUVk sa dk ns’k esa forj.k ;k fodz; djrk gSA ¼Fk½ dksbZ Hkh O;fDr tks vkS”k/k ,oa dksLesfVDl vf/kfu;e] 1945 vkSj fu;ekoyh ds varxZr Lo;a vius uke ls tkjh QkeZ 41 esa fcuk ita hdj.k izek.k&i= ¼vkjlh½ j[krs gq, izR;{k :i ls ?kqVuk baIykUV vk;kr djrk gS vkSj bls vkS”k/k ,oa dksLesfVDl] vf/kfu;e] 1945 vkSj fu;ekoyh ds¹Hkkx IIμ[k.M 3 (ii)º Hkkjr dk jkti=k % vlk/kj.k 5 varxZr tkjh QkeZ 41 es a fdlh vU; vkjlh j[kus okys O;fDr }kjk QkeZ 9 e sa fn, x, opu ij tkjh gq, QkeZ 10 ykbllsa ds vra xZr iz;kstu djrk g S tks blds varxZr vkS”k/k ,oa dksLesfVDl vf/kfu;e] 1945 ,oa fu;ekoyh ds varxZr tkjh gqvk gS] bl vkns’k ds iz;kstukFkZ ^forjd^ ds :i esa ekuk tk,xkA bu forjdksa dks Hkkjr esa mRikn ykap djus ls igys fo’ks”k vf/kdre ewY; ysus ds fy, ;k izkIr djus ds fy, ,uihih, ls laidZ djuk vko’;d gksxkA ¼n½ dksbZ Hkh fofuekZrk ;k laLFkku ;k O;fDr vf/kdre ewY; ;k blesa Åij fofufnZ”V fVIi.kksa dk vuqikyu ugha djrk rks mls vko’;d oLrq,a vf/kfu;e] 1955 ds lkFk ifBr vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds mica/kksa ds varxZr ml ij C;kt lfgr vf/kHkkfjr jkf’k ds tek djus gsrq nk;h gksxkA ¼/k½ bl vkns’k ds iSjk 9 esa ;Fkk fofufnZ”V vf/kdre ewY; esa O;olk; ykHk ‘kkfey gSa] tks vy?a kuh; gS vkSj dksbZ Hkh vfrfjDr izHkkj bl ewY; vf/klwpuk esa blds Åij fofufnZ”V] dqy feykdj vf/kdre ewY;] tks Hkh gks] eky ,oa lsok dj] ;fn dksbZ gS] Hkqxrku fd, ;k Hkqxrku ;kXs; ds vykok miHkksDrk@ejht ls olyw k ugh a tk,xkA forjd@LVkfdLV vkSj vLirkyksa@uflZax gksEl@fDyfud ds fy, vf/kdre O;olk; ykHk vuqer% lkj.kh dh dze la[;k 4] 7] 8] 9] 10 vkSj 11 ij izkFkfed ?kqVuk izfrLFkkiu iz.kkyh ds fy, dze’k% vf/kdre dher dk 16 izfr’kr vkSj 8 izfr’kr gSA forjd@LVkfdLV vkSj vLirkyksa@uflZax gksEl@fDyfud ds fy, vf/kdre O;olk; ykHk vuqer% lkj.kh dh dze la[;k 1] 2] 3] 5] 6] 12] 13] 14 vkSj 15 ij izkFkfed ?kqVuk izfrLFkkiu iz.kkyh vkSj iqu% ?kqVuk izfrLFkkiu iz.kkyh ij dze’k% vf/kdre dher dk 12 izfr’kr vkSj 4 izfr’kr gSA forjd@LVkfdLV vkSj vLirkyksa@uflZax gksEl@fDyfud ds fy, vf/kdre O;olk; ykHk dSalj@V~;wej gsrq fo’ks”k vksFkksZisfMd ?kqVuk baIykUVksa ds fy, dze’k% laxf.kr vf/kdre ewY; dk 16 ifzr’kr vkSj 8 izfr’kr gS ftldk vf/kdre ewY; vk;kr ewY; ?ku 30 izfr’kr ekurs gq, uksV ¼x½ ds vuqlkj lax.kuk dh xbZ gSA ¼u½ ftl ekeys esa fofuekZrk fdlh laLFkku dks] fdlh forjd dh vUrxzLZ rrk ds fcuk ?kqVuk baIykUV lh/ks gh vkiwfrZ@fodz; djrk gS rc vLirky@uflZax gksEl@fDyfud~l ds fy, vf/kdre O;olk; ykHk 16 izfr’kr rd izfrcaf/kr gksxkA ¼i½ uksV ¼/k½ vkSj ¼u½ esa fofufnZ”V vf/kd O;olk; ykHk] fdlh Hkh :i esa gks] la;qDr vkSj i`Fkd :i ls] ysus&nsuksa esa varxzZLr O;fDr@laLFkku@fofuekZrkvksa@vk;krdksa@ forj.kdrkZvksa@vLirkyksa }kjk ^mYya?ku^ ds :i esa ekuk tk,xk vkSj vfuok;Z oLrq,a vf/kfu;e] 1955 ds varxZr Mhihlhvks] 2013 ds mica/kksa ds mYya?ku gsrq vfHk;kstu lfgr mi;qDr dkjZokbZ djus dk nk;h gksxkA 10- blesa Åij fu;r dh xbZ vf/kdre dher bl vf/klwpuk dh rkjh[k ls rks ,d o”kZ dh vof/k ds fy, j[kh tk;sxhA ;fn fdlh vU; vf/klwpuk }kjk la’kksf/kr ugha gksrk gSA [dka-la-@180@48@2017@Qk- la0 8¼48½@2017@Mhih@,uihih,-&fMoh-II] HkwisUnz flag] v/;{k MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICALS PRICING AUTHORITY) ORDER New Delhi, the 16th August, 2017 S.O.2668 (E).— Whereas the National Pharmaceutical Pricing Authority (NPPA) was established by Resolution No. 33/7/97-PI.I dated 29th August 1997 of the Government of India in the Ministry of Chemicals and Fertilizers to fix/revise, monitor prices of drugs/formulations and oversee the implementation of the Drugs (Prices Control) Order (DPCO); and whereas the Government of India by S.O. 1394(E) dated 30th May 2013 in exercise of the powers conferred by Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has delegated the powersin respect of paragraphs 4,5,6,7,8,9,10,11,12,13,14,15,16,18,19,20, 21,23,24,25,26,27,28,29,30 and 32 of the DPCO, 2013 to the NPPA to exercise the functions of the Central Government; 02. And whereas the aim of the DPCO, 2013 issued under section 3 of Essential Commodities Act, 1955, is to ensure that essential drugs are available to all at affordable prices. Whereas the Hon’ble Supreme Court of India by order dated 12th November 2002 in SLP no. 3668/2003 (Union of India vs. K.S.Gopinath& others) directed the Government to ensure that lifesaving drugs do not fall out of price control; 03. And whereas the Hon’ble Supreme Court of India in its judgment in Glaxo India Limited vs. UOI reported in (2014) 2 SCC 753, while dealing with the implementation of notified prices of drugs for the benefit of consumers, referred to the prefatory statement made by the Hon’ble Supreme Court in Cynamide India Limited (1987) 2 SCC 722 as worth noticing, wherein the Court observed:6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] “2. Profiteering, by itself, is evil. Profiteering in the scarce resources of the community, much needed life-sustaining foodstuffs and life-saving drugs is diabolic. It is a menace which has to be fettered and curbed. One of the principal objectives of the Essential Commodities Act, 1955 is precisely that. It must be remembered that Article 39(b) enjoins a duty on the State towards securing ‘that the ownership and control of the material resources of the community are so distributed as best to subserve the common good” 04. And whereas Ministry of Health and Family Welfare vide its S.O. 1468 dated 6th October, 2005, has notified the orthopedic implants as ‘drugs’, the DPCO, 2013, is applicable to all notified drugs (including notified devices) and NPPA is mandated to monitor the prices of these drugs under paragraph 20, so as to ensure availability of such drugs (i.e. notified devices) and also ensure that no unethical profiteering is happening in case of any drugs (i.e. notified devices) at the cost of patients. It is noticed that orthopedic-knee implants are having unjustified, unreasonable and irrational high trade margins leading to their exorbitant prices which affects the out of pocket expenses of patients and lakhs of patients are not able to pay for arthroplasty procedures because of these exorbitant prices and suffering in pain; and whereas the estimates of such patients requiring arthroplasty intervention, both diagnosed and undiagnosed, is about 1.5 to 2 crores out of which only about 1 lakh plus well off patients are in a position to pay for it every year and whereas ‘osteoarthritis is likely to become fourth leading cause of disability by year 2020’ as per the W.H.O Bulletin,2003 ,81,(9) and India is likely to be one of the leading countries of such immobilized citizens in terms of numbers; and whereas preventing such a scenario is essential in individual as well as national interest; 05. And whereas the Government is under constitutional obligation to provide fair, reasonable and affordable price for orthopedic implants and therefore its immediate intervention is imperative to check unethical profiteering and exploitive pricing at the cost of the patients in an unregulated market; and whereas Paragraph 19 of the DPCO, 2013 inter-alia authorizes the Government, in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug (i.e. notified devices) for such period, as it deems fit; and whereas based on the above assessment the extra-ordinary situation in the case of knee implants does exist; 06. And whereas price fixation notifications issued for certain drugs under paragraph 19 of the DPCO, 2013 by the NPPA on 10th July 2014 have been upheld by the Hon’ble High Court of Bombay in its judgment and order dated 26th September 2016 in W.P.(C) No. 2700 of 2014 (Indian Pharmaceutical Alliance vs. Union of India) wherein the Hon’ble High Court, inter-alia, observed: “20. …… when such failure is considered in the context of role the pharmaceuticals playin the area of public health, which is a social right, the Government intervention becomes necessary especially when exploitive pricing makes medicines un-affordable and beyond the reach of most and also puts huge financial burden in terms of out of pocket expenditure on healthcare….” And whereas SLP (C) 30089/2016 filed by Indian Pharmaceutical Alliance challenging the aforesaid judgment and order has been dismissed on 24th October, 2016 by the Hon’ble Supreme Court of India; 07. And whereas NPPA carried out an exhaustive stakeholder’s consultation on the issue of exorbitant cost of orthopedic knee implants and excessive trade margins and analysis of ‘trade margins’ in the market of knee implants was uploaded in public domain for the sake of transparency and in the spirit of people’s right to information. 08.Whereas, the NPPA in its Authority meeting held on August 10, 2017 which continued on August 14, 2017 after duly examining in detail, deliberating and considering all available information/data/viewpoints and all relevant options for price fixation of orthopedic knee implants, under present extraordinary circumstances of a failed and exploitative market because of information asymmetry between the patient and healthcare delivery system has decided that it is necessary to control the excessive trade margins for fixing ceiling price of orthopedic knee implants which is fair and reasonable based on its intrinsic value of the implants with rational margins to protect public interest. 9. Now, therefore, in the exercise of the powers delegated by Government of India in the Ministry of Chemicals and Fertilizers under paragraph 19 of the DPCO, 2013 by S.O. No. 1394(E) dated 30th May, 2013, the NPPA, having been satisfied that in view of extraordinary circumstances as explained above, finds that it is urgently necessary to do so in public interest, hereby fixes and notifies the ceiling prices of orthopedic knee implants for knee replacement system, along with the notes, as specified herein below to be effective from August16, 2017, the date of its gazette notification:¹Hkkx IIμ[k.M 3 (ii)º Hkkjr dk jkti=k % vlk/kj.k 7 TABLE Sl. Orthopedic knee Component Feature/Material of the knee Units Ceiling No. Implant system implant (In Price Number) (In Rs.) (1) (2) (3) (4) (5) (6) PRIMARY 1. Primary knee Femoral component by Titanium alloy (all variants) coated 1 38,740 replacement system whatsoever name/specification 2. Primary knee Femoral component by Oxidized zirconium (OxZr) alloy 1 38,740 replacement system whatsoever name/specification (all variants) 3 Primary knee Femoral component by Hi-flex 1 25,860 replacement system whatsoever name/specification 4 Primary Knee Femoral component by Cobalt chromium (CoCr) alloy (all 1 24,090 replacement system whatsoever name/specification variants)& other than at serial no 1,2 and 3 5 Primary knee Tibial component or Tibial tray Titanium alloy (& it’s all variants) 1 24,280 replacement system by whatsoever coated name/specification 6 Primary knee Tibial component or Tibial tray Oxidized zirconium (OxZr) alloy 1 24,280 replacement system by whatsoever name/specification 7 Primary knee Tibial component or Tibial tray Cobalt chromium (CoCr) alloy & 1 16,990 replacement system by whatsoever other than at Serial no 5 and 6 name/specification 8 Primary knee Articulating surface or Insert by Any Material 1 9,550 replacement system whatsoever name/specification 9 Primary knee Patella by whatsoever Any Material 1 4,090 replacement system name/specification 10 Primary knee Component having Tibial tray Polyethylene or crosslinked 1 12,960 replacement system and Insert combined as single polyethylene or highly crosslinked unit by whatsoever polyethylene or any other material name/specification 11 Primary knee Components having Tibial Tray Tibial: Metallic 1 26,546 replacement system and Insert combined as single Insert: Polyethylene or Cross- unit by whatsoever name called linked polyethylene or highly cross- linked Polyethylene or any other material REVISION 12 Revision Knee Femoral Component by Any material 1 62,770 Replacement system whatsoever name/specification 13 Revision Knee Tibial component or Tibial Any material 1 31,220 Replacement system Tray by whatsoever name/specification 14 Revision Knee Articulating surface or Insert by Any material 1 15,870 Replacement system whatsoever name/specification 15 Revision Knee Patella by whatsoever Any material 1 4,090 Replacement system name/specification Note: a) The ceiling prices specified in column (6) of the above table shall be applicable from the date of publication of this notification in the Gazette of India Extraordinary and shall also be applicable to all the stocks of knee implants available for sale in the trade channel. b) All manufacturers shall comply and implement the ceiling prices mentioned hereinabove under the applicable category and serial number irrespective of being cementable, uncementable, gender specific or unisex. The8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] manufacturer of uncemented implants, however, may approach NPPA with supporting documents, for fixation of separate ceiling price or retail price. c) Special orthopedic knee implants for cancer/tumor etc will follow the prices of revision surgery. However, if the import prices are higher than the ceiling price of such implants, manufacturers may add a total margin of maximum 30 percent over the import price of the first batch of such implant launched in India as the ceiling price for 45 days from the issue of this notification and apply to NPPA for a retail price notification at the earliest. d) All manufacturers of knee Implants, selling branded or non-branded or both versions of implants at prices higher than the ceiling price (plus goods and services tax as applicable) so fixed and notified by the Government, shall revise the price of all such implants downward not exceeding the ceiling price specified in column (6) in the above Table, plus goods and services tax as applicable and paid, if any. e) All manufacturers/marketers of knee implants having MRP lower than the ceiling price specified in column (6) 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. f) The manufacturers may add goods and services tax and no other charges in the calculation of MRP, if they have actually paid such taxes or if it is payable to the Government on the ceiling price specified in column (6) of the above said Table in paragraph (9) of this order. g) The ceiling price for a pack of implant shall be arrived at by the concerned manufacturer/importer in accordance with the ceiling price specified in column (6) of the above Table as per the provisions under DPCO, 2013. h) The Ceiling prices mentioned in Table hereinabove are inclusive of all components and consumables, which are used in the knee implant procedure and remain in the body of the patient i) The manufacturers under Paragraph 24 of DPCO, 2013 shall issue price list in Form–V as prescribed in Schedule II of the DPCO, 2013 to the NPPA online through Integrated Pharmaceutical Database Management System (IPDMS) along with a hard copy and submit a copy immediately to all State Drug Controllers and all its distributors/dealers/orthopedic healthcare institutions. j) In accordance with paragraph 24(4) of DPCO 2013, every distributor, dealer and institution shall display price list and the supplementary price list, if any, as furnished by the manufacturer/importer, 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. k) Wherever institutions such as hospitals/nursing homes/clinics performing orthopedic surgical procedures using knee implants are billing directly to the patients, they shall be required to comply with the ceiling prices notified hereinabove and follow the applicable provisions of the DPCO, 2013 including (j) herein above. l) No healthcare institutions such as hospitals/nursing-homes/clinics performing orthopedic surgical procedures using knee implants shall solicit any patient to purchase knee implants from it, in case, the patient is interested in procuring such implant from any other third-party sources. m) All the manufacturers will continue to ensure the availability of all the brands of implants and ensure that no disruption is caused in the supply chain because of printing new MRPs. n) Institutions such as hospitals/nursing homes/clinics utilizing knee implants shall specifically and separately mention the cost of the knee implant component-wise along with its brand name, name of the manufacturer/importer/batch no./specifications and other details, if any, in their estimate/performa invoice/final-billing, etc. to the patients or their representatives. o) The 'manufacturer' for the purpose of this order means any person who manufactures or imports or market drugs i.e. notified devices such as knee implants for distribution or sale in the country. p) Any person who imports knee implants directly without having registration certificate (RC) in Form 41 issued under Drugs and Cosmetics Act, 1945 and Rules, thereunder in its own name and does it under Form 10 license issued on the undertaking given in Form 9 by another person having RC in Form 41, issued under Drugs and Cosmetics Act, 1945 and Rules, thereunder, shall be construed as ‘distributor’ for the purpose of this order under the DPCO, 2013. Such distributors will need to approach NPPA to get special ceiling price before the product launch in India. q) Any manufacturer or institution or person 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. r) The ceiling prices as specified in para 9 of the order are inclusive of trade margin which is sacrosanct and no additional charge, whatsoever, over and above the ceiling price specified hereinabove, in the price notification¹Hkkx IIμ[k.M 3 (ii)º Hkkjr dk jkti=k % vlk/kj.k 9 shall be charged from the consumer/patient except applicable goods and services tax, if any, paid or payable. The maximum trade margin permissible for distributor/stockist and hospitals/nursing homes/clinics is 16 percent and 8 percent of ceiling price respectively for primary knee replacement system at serial no 4,7,8, 9, 10 and 11 of the Table. The maximum trade margin permissible for distributor/stockist and hospitals/nursing homes/clinics is 12 percent and 4 percent of ceiling price respectively for primary knee replacement system and revision knee replacement system at serial no 1,2,3,5,6,12,13,14 and 15 of Table.The maximum trade margin permissible for distributor/stockist and hospitals/nursing homes/clinics is 16 percent and 8 percent of computed ceiling price respectively for Special orthopedic knee implants for cancer/tumor whose ceiling price has been computed as per note (c) considering import price plus 30 percent. s) Where, the manufacturer supply/sell knee implant directly to the orthopedic healthcare institutions, without involvement of any distributor, then the maximum trade margin for hospitals/nursing homes/clinics shall be restricted at16 percent. t) Trade margin in excess of specified in note (r) and (s), in whatsoever form, shall be construed as ‘violation’ by the ‘person/institutions/manufacturers/importers/ distributors/hospitals’ involved in the transactions, jointly and severally, and shall be liable to appropriate action including prosecution, for violation of the provisions of the DPCO, 2013 under the Essential Commodities Act, 1955. 10. The ceiling prices fixed hereinabove shall be maintained for a period of one year from the date of this notification, unless revised by another gazette notification. [PN/180/48/2017/F.No 8(48)/2017/DP/NPPA/Div II] BHUPENDRA SINGH, Chairman 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.