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- 3268] ubz fnyyh] c`glifrokj] uoecj 23] 2017@vxzgk;.k 2] 1939 No. 3268] NEW DELHI, THURSDAY, NOVEMBER 23, 2017/AGRAHAYANA 2, 1939 jlk;u vksj mozjd ea=ky; ¼ vks k/k fohkkx½ ¼jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k½ vkns k ubz fnyyh] 23 uoecj] 2017 dk-vk-3722¼v½-& 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] 6] 10] 11] 14] 15] 16] 17 vksj 18 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftls laf{kir :i ls,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 dh] 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 (1) (2) (3) (4) (5) 1. vkwdlkfyiykfvu batsd ku 100 fexzk- izfr isd 4055.10 ¼ykblsal ds vuqlkj½ 2.,lhVkbylSyhflfyd,flM bzqjoslsuv@fmlijflcy@bufvªd dksfvm 1 xksyh 0.1625 xksyh 100 fexzk- 3. Tkkikuh bulsqkfyfvl osdlhu4,llhth ls 6,elhth izfr isd 632.95 4. Tkkikuh bulsqkfyfvl osdlhu3,llhth rd izfr isd 482.22 5. eht+yl :csyk osdlhu izfr isd 80.22 ¼0-5 fefy-½ 6. lwjqsdvav Llisa ku QkWj bavªkdpsy izfr fexzk- vkwq 60.69 bulvhyys ku ¼ykblsal ds vuqlkj½ QksLQksfyfiMl 6871 GI/2017 (1)
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 iqujh{k.k djsaxsa ¼[k½ lhkh ekstwnk fuekzrkvksa dks mi;qzdr dffkr vuqlwfpr fofufezfr;ksa ds vf/kdre [kqnjk dher mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher olrq,oa lsok dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 13¼2½ ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka 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 isjk 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk 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 esa ;Fkk fofufnz"v [kqnjk ;k izcyrk ;k nksuksa ds lkfk vuqlwfpr fofufezfr dk dksbz ekstwnk fofuekzrk vks k/k ewy; fu;a=.k vkns k] 2013 ds isjk 2¼;w½ ds vuqlkj dksbz ubz vks kf/k dks ykap djrk gs rks,sls ekstwnk fofuekzrk dh vks k/k ¼ewY; fu;a=.k½ vkns k 2013 dh vuqlwph&ii ds varxzr ;Fkk fofufnz V QkeZ&I esa,uihih, dks,slh ubz vks kf/k ds iwoz ewy; vuqeksnu 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-@182@50@2017@,q@qk- la- 8¼50½@2017@Mhih@,uihih,&fMoh-II] MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 23rd November, 2017 cythr flag] lgk;d funs'kd S.O. 3722(E). In exercise of the powers conferred by paragraphs 4, 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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 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: Sl. No. Name of the Scheduled Formulation TABLE Dosage form & Strength Unit Ceiling Price (1) (2) (3) (4) (5) 1. Oxaliplatin Injection 100mg (as licensed) Each Pack 4055.10 2. Acetylsalicylic acid Effervescent/ Dispersible/ Enteric coated Tablet 100 mg (Rs.) 1 Tablet 0.1625 3. Japanese Encephalitis Vaccine 4mcg to 6mcg Each Pack 632.95 4. Japanese Encephalitis Vaccine up to 3mcg Each Pack 482.22 5. Measles Rubbela Vaccine Each Pack 6. Surfactant Suspension for intratracheal instillation (As liensed) (0.5ml) 80.22 Per mg of Phospholipid60.69 in the pack 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/182/50/2017/F/F. No. 8(50)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director
4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] vkns k ubz fnyyh] 23 uoecj] 2017 dk-vk-3723 ¼v½-& 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] 6] 10] 11] 14] 16] 17 vksj 18 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq, vksj Hkkjr ljdkj esa jlk;u,oa mozjd ea=ky; ¼jk"Vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k½ ds dk- vk- 2060¼v½ fnukad 30 twu] 2017 vksj dk- vk- 2061¼v½ fnukad 30 twu] 2017 ¼dz- la- 10 vksj 11½ ds vkns k ds vf/kdze.k esa tgka rd mldk laca/k uhps dh lkj.kh ds fofufezfr isd 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 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 dh] 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 bdkb vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. Lsoks ywjku bugsys'u 1 fefy- 24-12 2.,lhVkbylSyhflfyd,flM Xksyh 325 fexzk- 1 xksyh 0-50 3. MslQsfjZvkWDlkekbu batsd ku ds fy, ikmmj izfr isd 145-91 500 xzke 4. vkwdlkfyiykfvu batsd ku 50 fexzk- ¼ykblsal ds vuqlkj½ izfr isd 2303-01 5. QsVksesukMk;ksu ¼foVkfeu ds1½ btsd ku 10 fexzk-@fefy- 1 fefy- 43-45 6. XywVkjkYMsgkbM lksyq'ku 2 % 1 fefy- 0-05868 7.,aVh&Mh beequksxykscqfyu batsd ku 300,elhth izfr isd 1936-82 8. chlhth osdlhu izfr Mkst 4-32 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 iqujh{k.k djsaxsa ¼[k½ lhkh ekstwnk fuekzrkvksa dks mi;qzdr dffkr vuqlwfpr fofufezfr;ksa ds vf/kdre [kqnjk dher mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher olrq,oa lsok dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 13¼2½ ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka 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 isjk 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk 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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 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-@182@50@2017@,q@qk- la- 8¼50½@2017@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 23rd November, 2017 S. O. 3723(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. SO 2060(E) & S.O. 2061(E) dated 30 th 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 Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Sevoflurane Inhalation 1 ml 24.12 2. Acetylsalicylic acid Tablet 325mg 1 Tablet 0.50 3. Desferrioxamine Powder for Injection 500mg Each pack 145.91 4. Oxaliplatin Injection 50mg Each Pack 2303.01 (as licensed) 5. Phytomenadione Injection 10mg/ml 1 ML 43.45 (Vitamin K1) 6. Glutaraldehyde Solution 2% 1 ML 0.05868 7. Anti-D immunoglobulin Injection 300mcg Each Pack 1936.82 8. BCG vaccine Each Dose 4.32
6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 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 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/182/50/2017/F/F. No. 8(50)/2017/D.P./NPPA-Div.-II ] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 23 uoacj] 2017 dk-vk- 3724¼v½- ;r% vks"k/k fohkkx ¼ftls ckn esa Mhvksih ds :i esa lanfhkzr fd;k gs½ us vfuok;z vks"kf/k dh la kksf/kr jk"vªh; lwph] 2015 ¼tls ckn esa,u,ybz,e ds :i esa lanfhkzr fd;k gs½ ds vk/kkj ij fnukad 10-03-2016 ds dk-vk- 701¼v½ ds }kjk vks"k/k ewy; fu;a=.k vkns k] 2013 ¼ftls ckn esa Mhihlhvks ds :i esa lanfhkzr fd;k gs½ dh vuqlwph I ds vk/kkj ij la kks/ku fd;k gsa vksj 02- tcfd vuqlwfpr fofufezfr;ksa dh lwph ds la kks/ku gksus ij Mhihlhvks] 2013 ds isjk 17 esa la kks/ku dh rkjh[k ls lkb fnuksa dh vof/k ds Hkhrj Mhihlhvks] 2013 ds mica/kksa ds vuqlkj r; gksus okyh vuqlwph&i esa tksm+h xbz fofufezfr;ksa ¼;kuh nokb;ka½ dh vf/kdre dherksa dk fu/kkzj.k vko ;d gsa vksj 03- tcfd jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftls ckn esa,uihih, ds :i esa lanfhkzr fd;k gs½ us ekpz] 2016 esa vf/kdre ewy; fu/kkzj.k dh izfdz;k kq: dh FkhA bl laca/k esa],uihih, us fnukad 04-04-2016 ds dk;kzy; Kkiu ¼;kfu vks,e½ 19¼697½@2016@Mh II@,uihih, }kjk vuqlwfpr fofufezfr;ksa dh,d lwph viyksm dh Fkh ftlds fy, ewy; fu/kkzj.k ds fy, visf{kr MkVk vk/kkfjr lanhkz foi.ku miyc/k ugha FkkA rnqijkar dffkr lwph la kksf/kr dh xbz vksj bls fnukad 28-04-2016] 13-05-2016] 10-01-2017 vksj 08-07-2017 dks iqu% iznf kzr fd;k x;ka mi;qzdr vks,e dh izfr;ka MªXl esu;qqsdpjlz
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7,lksfl;s kul dks ;g vuqjks/k djrs Hksth xbz Fkh fd os foi.ku vk/kkfjr MkVk izlrqr djsa vksj tcfd,uihih, us vks"k/k fohkkx dks Mhihlhvks] 2013 dks la kksf/kr djus dk Hkh lq>ko fn;k Fkk rkfd tgka foi.ku vk/kkfjr vkadm+s vf/kdre ewy; fu/kkzj.k ds fy, miyc/k ugha gsa vksj,slh vuqlwfpr fofufezfr;ksa ds fy, jkt; lalfkkxr [kjhn ewy; miyc/k gsa] mudk ewy; fu/kkzj.k gsrq lqfo/kk vuqlkj fopkj fd;k tk ldsa vksj 04- tcfd fofuekzrkvksa vksj vkf/kdkfjd vkadm+s laxzg djus okyh,tsalh tsls,vkbzvkslhmh,mcy;w,lh,l ls miyc/k djkbz xbz tkudkjh ds vk/kkj ij dfri; vuqlwfpr fofufezfr;ksa ds laca/k esa tgka foi.ku vk/kkfjr dhersa miyc/k Fkh],uihih, us,slh vuqlwfpr fofufezfr;ksa dh vf/kdre dher r; dj nh gsa,uihih, us vc rd miyc/k vkadm+ksa ds vk/kkj ij 821 fofufezfr;ksa dh vfd/kre dherksa dks r; dj fy;k gsa gkykafd] izklafxd vksj fo oluh; foi.ku vk/kkfjr MsVk izkir djus ds dbz iz;klksa ds ckn Hkh],uihih, vko ;d foi.ku MsVk dh deh ds fy, ks k vuqlwfpr fofufezfr;ksa dh vf/kdre dherksa dk fu/kkzj.k ugha dj ik;k gsa vksj 05- tcfd ;g Mhihlhvks] 2013 ds vuqlwph I ds rgr vf/klwfpr lhkh nokvksa dh vf/kdre dherksa dks la kksf/kr djus ds fy,,uihih, ds fy, tufgrksa dh j{kk ds fy,] ewy; fu/kkzj.k ds osdfyid rjhdksa dks viukuk vfuok;z gs] rkfd g``n; rfkk jdrokfgdkvksa laca/kh] jdr mriknksa vksj IykTek mi kh kzd vkfn fpfdrlh; Js.kh dh vko ;d nokb;ksa ds mihkksdrkvksa dks mi;qdr vksj mfpr vf/kdre dherksa dk ykhk lqfuf pr fd;k tk ldsa vksj 06- tcfd,uihih, us dsanz ljdkj vksj jkt;ksa vksj jkt; fpfdrlk lsok fu;e ds rgr fofhkuu ljdkjh [kjhn,tsafl;ksa ls tkudkjh ekaxh] D;ksafd vuqlwfpr fofufezfr;ksa dh vf/kdre dher r; djuk vko ;d gsa rnuqlkj],vkbzvkslhmh,mcy;w,lh,l dh QkekZVªsd fjiksvz esa izklafxd foi.ku vk/kkfjr vkadm+ksa ds vhkko esa fnukad 19-09-2017 dks,uihih, esa vk;ksftr izkf/kdj.k dh csbd esa r; fd;k x;k gs rkfd ks k vuqlwfpr fofufezfr;ksa dh vf/kdre dher] fofhkuu ljdkjh [kjhn,tsafl;ksa dh [kjhn ewy;ksa ds vk/kkj ij r; dh tk,a vksj 07- vc 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 19 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq, tks ekuuh; mpp U;k;ky; vksj Hkkjr ds ekuuh; mppre U;k;ky; }kjk cjdjkj j[kk x;k 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 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 dh] 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 bdkb vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. eksjfqu,lvkj xksyh 30 fexzk- 1 xksyh 4.94 2.,YVsIysl batsd ku ds fy, ikmmj 20 fexzk- izfr isd 17235.00 3.,YVsIysl batsd ku ds fy, ikmmj 50 fexzk- izfr isd 35985.00 4. tkmksosukv batsd ku 529 fexzk-@fefy- 1 fefy- 98.90 5. gseksmk;fyfll ywm ykblsal ds vuqlkj 1 fefy- 0.03695 6. QwjkslsekbM vksjy fyfdom 10 fexzk-@fefy- 1 fefy- 0.29 7. Xywdkst batsd ku 50% 1 fefy- 0.44 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 iqujh{k.k djsaxsa
8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ¼[k½ lhkh ekstwnk fuekzrkvksa dks mi;qzdr dffkr vuqlwfpr fofufezfr;ksa ds vf/kdre [kqnjk dher mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher olrq,oa lsok dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 13¼2½ ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka 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 isjk 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk 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 esa ;Fkk fofufnz"v [kqnjk ;k izcyrk ;k nksuksa ds lkfk vuqlwfpr fofufezfr dk dksbz ekstwnk fofuekzrk vks k/k ewy; fu;a=.k vkns k] 2013 ds isjk 2¼;w½ ds vuqlkj dksbz ubz vks kf/k dks ykap djrk gs rks,sls ekstwnk fofuekzrk dh vks k/k ¼ewY; fu;a=.k½ vkns k 2013 dh vuqlwph&ii ds varxzr ;Fkk fofufnz V QkeZ&I esa,uihih, dks,slh ubz vks kf/k ds iwoz ewy; vuqeksnu 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-@182@50@2017@,q@qk- la- 8¼50½@2017@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 23rd November, 2017 S.O. 3724(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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 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 821 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 therapeutic category of cardiovascular, blood products and plasma substitutes 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 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, 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. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Morphine SR Tablet 30 mg 1 Tablet 4.94 2. Alteplase Powder for Injection 20 mg Each Pack 17235.00 3. Alteplase Powder for Injection 50 mg Each Pack 35985.00 4. Gadobenate Injection 529 mg/ml 1 ML 98.90 5. Haemodialysis fluid As license 1 ML 0.03695 6. Furosemide Oral liquid 10 mg/ml 1 ML 0.29 7. Glucose Injection 50% 1 ml 0.44 Note: (a) (b) 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. 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.
10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (c) (d) (e) (f) (g) (h) (i) 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. 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. 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. 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. 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. 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. 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/182/50/2017/F/F. No. 8(50)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 23 uoecj] 2017 dk-vk- 3725¼v½-&;r% vks k/k fohkkx ¼ftls ckn esa Mhvksih ds :i esa lanfhkzr fd;k gs½ us vfuok;z vks kf/k dh la kksf/kr jk Vªh; lwph] 2015 ¼tls ckn esa,u,ybz,e ds :i esa lanfhkzr fd;k gs½ ds vk/kkj ij fnukad 10-03-2016 ds dk-vk- 701¼v½ ds }kjk vks k/k ewy; fu;a=.k vkns k] 2013 ¼ftls ckn esa Mhihlhvks ds :i esa lanfhkzr fd;k gs½ dh vuqlwph I ds vk/kkj ij la kks/ku fd;k gsa vksj 02- tcfd vuqlwfpr fofufezfr;ksa dh lwph ds la kks/ku gksus ij Mhihlhvks] 2013 ds isjk 17 esa la kks/ku dh rkjh[k ls lkb fnuksa dh vof/k ds Hkhrj Mhihlhvks] 2013 ds mica/kksa ds vuqlkj r; gksus okyh vuqlwph&i esa tksm+h xbz fofufezfr;ksa ¼;kuh nokb;ka½ dh vf/kdre dherksa dk fu/kkzj.k vko ;d gsa vksj 03- tcfd jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftls ckn esa,uihih, ds :i esa lanfhkzr fd;k gs½ us ekpz] 2016 esa vf/kdre ewy; fu/kkzj.k dh izfdz;k kq: dh FkhA bl laca/k esa],uihih, us fnukad 04-04-2016 ds dk;kzy; Kkiu ¼;kfu vks,e½ 19¼697½@2016@Mh II@,uihih, }kjk vuqlwfpr fofufezfr;ksa dh,d lwph viyksm dh Fkh ftlds fy, ewy; fu/kkzj.k ds fy, visf{kr MkVk vk/kkfjr lanhkz foi.ku miyc/k ugha FkkA rnqijkar dffkr lwph la kksf/kr dh xbz vksj bls fnukad 28-04-2016] 13-05-2016] 10-01-2017 vksj 08-07-2017 dks iqu% iznf kzr fd;k x;ka mi;qzdr vks,e dh izfr;ka MªXl esu;qqsdpjlz,lksfl;s kul dks ;g vuqjks/k djrs Hksth xbz Fkh fd os foi.ku vk/kkfjr MkVk izlrqr djsa vksj tcfd,uihih, us vks k/k fohkkx dks Mhihlhvks] 2013 dks la kksf/kr djus dk Hkh lq>ko fn;k Fkk rkfd tgka foi.ku vk/kkfjr vkadm+s vf/kdre ewy; fu/kkzj.k ds fy, miyc/k ugha gsa vksj,slh vuqlwfpr fofufezfr;ksa ds fy, jkt; lalfkkxr [kjhn ewy; miyc/k gsa] mudk ewy; fu/kkzj.k gsrq lqfo/kk vuqlkj fopkj fd;k tk ldsa vksj 04- tcfd fofuekzrkvksa vksj vkf/kdkfjd vkadm+s laxzg djus okyh,tsalh tsls,vkbzvkslhmh,mcy;w,lh,l ls miyc/k djkbz xbz tkudkjh ds vk/kkj ij dfri; vuqlwfpr fofufezfr;ksa ds laca/k esa tgka foi.ku vk/kkfjr dhersa miyc/k Fkh],uihih, us,slh vuqlwfpr fofufezfr;ksa dh vf/kdre dher r; dj nh gsa,uihih, us vc rd miyc/k vkadm+ksa ds vk/kkj ij 821 fofufezfr;ksa dh vfd/kre dherksa dks r; dj fy;k gsa gkykafd] izklafxd vksj fo oluh; foi.ku vk/kkfjr MsVk izkir
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 djus ds dbz iz;klksa ds ckn Hkh],uihih, vko ;d foi.ku MsVk dh deh ds fy, ks k vuqlwfpr fofufezfr;ksa dh vf/kdre dherksa dk fu/kkzj.k ugha dj ik;k gsa vksj 05- tcfd ;g Mhihlhvks] 2013 ds vuqlwph I ds rgr vf/klwfpr lhkh nokvksa dh vf/kdre dherksa dks la kksf/kr djus ds fy,,uihih, ds fy, tufgrksa dh j{kk ds fy,] ewy; fu/kkzj.k ds osdfyid rjhdksa dks viukuk vfuok;z gs] rkfd g``n; rfkk jdrokfgdkvksa laca/kh] jdr mriknksa vksj IykTek mi kh"kzd vkfn fpfdrlh; Js.kh dh vko ;d nokb;ksa ds mihkksdrkvksa dks mi;qdr vksj mfpr vf/kdre dherksa dk ykhk lqfuf pr fd;k tk ldsa vksj 06- tcfd,uihih, us dsanz ljdkj vksj jkt;ksa vksj jkt; fpfdrlk lsok fu;e ds rgr fofhkuu ljdkjh [kjhn,tsafl;ksa ls tkudkjh ekaxh] D;ksafd vuqlwfpr fofufezfr;ksa dh vf/kdre dher r; djuk vko ;d gsa rnuqlkj],vkbzvkslhmh,mcy;w,lh,l dh QkekZVªsd fjiksvz esa izklafxd foi.ku vk/kkfjr vkadm+ksa ds vhkko esa fnukad 19-09-2017 dks,uihih, esa vk;ksftr izkf/kdj.k dh csbd esa r; fd;k x;k gs rkfd ks k vuqlwfpr fofufezfr;ksa dh vf/kdre dher] fofhkuu ljdkjh [kjhn,tsafl;ksa dh [kjhn ewy;ksa ds vk/kkj ij r; dh tk,a vksj 07- vc 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 19 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq, tks ekuuh; mpp U;k;ky; vksj Hkkjr ds ekuuh; mppre U;k;ky; }kjk cjdjkj j[kk x;k gs vksj Hkkjr ljdkj esa jlk;u,oa mozjd ea=ky; ¼jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k½ ds dk- vk- 2061¼v½ fnukad 30 twu] 2017 vksj dk- vk- 2060¼v½ vksj 2061¼v½ fnukad 30 twu] 2017 ds vkns k ds vf/kdze.k esa tgka rd mldk laca/k uhps dh lkj.kh ds fofufezfr isd 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 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 fofufn V vuqlwfpr fofufezfr;ksa esa ls izr;sd dh] 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 bdkb vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. fyxuksdsu ¼,½ $ batsd ku 1% ¼,½$ 1%200000 ¼5 1 fefy- 0-41,Mªsukykbu ¼ch½,elhth@fefy-½ ¼ch½ 2. dsfy k;e XywdksusV batsd ku 100 fexzk-@fefy- 1 fefy- 0-50 3. MsDlVªku&40 batsd ku 10 % 1 fefy- 0-38 4. dksxqys'ku QSDVj IX batsd ku ds fy, ikmmj 600 vkbz;w izfr isd 11180-00 5. fmxksdlhu vksjy fyfdom 0-05 fexzk-@fefy 1 fefy- 0-29 6. iksvsf k;e ijesaxusv følvy QkWj VkWfidy 1 xzke 0-40 lksyq ku 7. fiyksdkjfiu MªksIl 4% 1 fefy- 10-60 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 iqujh{k.k djsaxsa
12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ¼[k½ lhkh ekstwnk fuekzrkvksa dks mi;qzdr dffkr vuqlwfpr fofufezfr;ksa ds vf/kdre [kqnjk dher mi;qzdr lkj.kh ds LraHk ¼5½ esa fofufnz"v vf/kdre dher olrq,oa lsok dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 13¼2½ ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka 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 isjk 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk 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-@182@50@2017@,q@qk- la- 8¼50½@2017@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 23rd November, 2017 S.O. 3725(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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 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 821 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 therapeutic category of cardiovascular, blood products and plasma substitutes 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 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, 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 30 th 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. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Lignocaine (A) + Adrenaline (B) Injection 1% (A) + 1:200000 1 ML 0.41 (5 mcg/ml) (B) 2. Calcium gluconate Injection 100 mg/ml 1 ML 0.50 3. Dextran-40 Injection 10% 1 ML 0.38 4. Coagulation factor IX Powder for Injection 600 IU Each Pack 11,180.00 5. Digoxin Oral liquid 0.05 mg/ml 1 ML 0.29 6. Potassium permanganate Crystals for topical solution 1 gm 0.40 7. Pilocarpine Drops 4% 1 ML 10.60 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
14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 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 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/182/50/2017/F/F. No. 8(50)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 23 uoecj] 2017 dk- vk-3726¼v½-& 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 dzla- vuqlwfpr fofufezfr dk uke@czkam dk uke lkj.kh izcyrk bdkbz fofuekzrk vksj foi.ku daiuh [kqnjk ewy; ¼#-½ (1) (2) (3) (4) (5) (6) 1. lksqkslcqohj,am osyikrklohj 2. lksqkslcqohj,am osyikrklohj 3. lksqkslcqohj,am osyikrklohj izr;sd fqye fyfir xksyh esa % lksqkslcqohj 400 fexzk-] osyikrklohj 100 fexzkizr;sd fqye fyfir xksyh esa % lksqkslcqohj 400 fexzk-] osyikrklohj 100 fexzkizr;sd fqye fyfir xksyh esa % lksqkslcqohj 400 fexzk-] osyikrklohj 28 xksyh esllz gsvªks yscl fy- @esllz,cckksv bafm;k fy- 28 xksyh esllz gsvªks yscl fy- @esllz dsfmyk gsyfkds;j fy- 28 xksyh esllz ukvdks QkekZ fy- @ esllz lu 15625.00 15625.00 15625.00