dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½

Transkript

1 a REGD. NO. D. L /99 EXTRAORDINARY II (ii) PART II Section 3 Sub-section (ii) PUBLISHED BY AUTHORITY 1180] No. 1180] NEW DELHI, THURSDAY, APRIL 27, 2017/VAISAKHA 7, 1939 ubz fnyyh] 27 vizsy] 2017 dk-vk- 1333¼v½-&Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 ebz] 2013 vksj dk0 vk0 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,] 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 es a Øe k% rrlfkkuh izfof V;ksa es a fofufnz V [kqjkd :i,oa izcyrk vksj bdkbz lfgr ml lkj.kh ds LraHk ¼2½ es a dh rrlfkkuh izfof V esa fofufnz V vuqlwfpr fofufezfr;ksa es a ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i es 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. व नक म इस न इ ज क शन क ल ए प उडर 250लमग र. प रल प क इट प स इड क प स 50लमग र. 1 क प स न र ड र न इन इ ज क शन 2लमग र. /लमल. 1लमल ब ड स न इड न क क स प प र 100एमस ज /ड ज 1 ड ज ब ड स न इड न क क स प प र 50एमस ज /ड ज 1 ड ज एलमन स लसल क एलसड स प प लजट र 500लमग र. ररट शन इन म 1 स प प लजट र आईस स रब इड-5-म न न ईट र ट एसआर क प स 60लमग र. 1 क प स आईस स रब इड-5-म न न ईट र ट एसआर क प स 30लमग र. 1 क प स GI/2017 (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 LFkkuh; dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufezfr;ksa ds czkamsm ;k tsusfjd ;k nksuks a :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 LFkkuh; 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 es a fofufnz"v vf/kdre dher LFkkuh; 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 es a of.kzr vf/kdre dher ij ljdkj dks oklro es a Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djks a dks tksm+ ldrs gsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 11 esa fn, x, izko/kkuks a ds rgr lecfu/kr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼5½ es a 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 es a vf/klwpuk dh rkjh[k ls vkbzihmh,e,l ds ek/;e ls Hkjdj,uihih, dks,d ewy; lwph tkjh djsaa rfkk mldh dkwih jkt; vks kf/k fu;a=dksa vksj fofuekzrk forjd dks tkjh djsaa ¼M+½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kks a 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 es a 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=k.k½ vkns'k] 2013 ds isjkxzkq 2¼;w½ ds vuqlkj vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II es a 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 es a 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 es a 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 es a mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v es a 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;s axsa [dka-la-@176@44@2017@,q@qk- la- 8¼44½@2017@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 27th April, 2017 S.O. 1333(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 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 prices as specified in column (5) of the table herein below as ceiling price exclusive of local 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 Formulatio Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Vancomycin Powder for Injection 250mg Each Pack

3 II (ii) 3 Note : 2. Etoposide Capsule 50mg 1 Capsule Noradrenaline Injection 2mg/ml 1ML Budesonide Nasal Spray 100mcg/dose 1 Dose Budesonide Nasal Spray 50mcg/dose 1 Dose aminosalicylic Acid Suppository 500mg 1 Suppository Retention Enema 7. Isosorbide-5-mononitrate SR Capsule 60mg 1 Capsule Isosorbide-5-mononitrate SR Capsule 30mg 1 Capsule 3.32 (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 local taxes 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 local taxes 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 local taxes 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 local taxes 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 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/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director ubz fnyyh] 27 vizsy] 2017 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- 1040¼v½ fnukad 01 vizsy] 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] 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 fofufn 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] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gs%

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. स न क व न म एन ट स रम-स ब / ल क व ड प व न ट इ ज क शन 10 लमल. प क ह प ररन इ ज क शन 1000 आईय /लमल. 1 लमल लल सर इ ट र ईन ट र ट इ ज क शन 5 लमग र./लमल. 1 लमल ड ईग क स न इ ज क शन 0.25 लमग र./लमल. 1 लमल ह रम न ररल जजग आईय ड व न रज स प टर क 52 लमग र. म 1 आईय ड 3, uksv % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbz vksj vf/klwfpr dh xbz vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufezfr;ksa ds czkamsm ;k tsusfjd ;k nksuks a :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 LFkkuh; 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 es a fofufnz"v vf/kdre dher LFkkuh; 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 es a of.kzr vf/kdre dher ij ljdkj dks oklro es a Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djks a dks tksm+ ldrs gsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 11 esa fn, x, izko/kkuks a ds rgr lecfu/kr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼5½ es a 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 es a vf/klwpuk dh rkjh[k ls vkbzihmh,e,l ds ek/;e ls Hkjdj,uihih, dks,d ewy; lwph tkjh djsaa rfkk mldh dkwih jkt; vks kf/k fu;a=dksa vksj fofuekzrk forjd dks tkjh djsaa ¼M+½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kks a 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 es a 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=k.k½ vkns'k] 2013 ds isjkxzkq 2¼;w½ ds vuqlkj vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II es a 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 es a 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 es a 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 es a mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v es a 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;s axsa [dka-la-@176@44@2017@,q@qk- la- 8¼44½@2017@Mhih@,uihih,&fMoh-II ] ORDER New Delhi, the 27th April, 2017 cythr flag] lgk;d funs'kd S.O. 1334(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)

5 II (ii) 5 No. S.O. 1040(E), dated 1 st April, 2017, 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 local 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) 6. Snake venom antiserum - Injection 10 ML Pack Soluble/liquid polyvalent 7. Heparin Injection 1000 IU/ml 1 ML Glyceryl Trinitrate Injection 5 mg/ml 1 ML Digoxin Injection 0.25 mg/ml 1 ML Hormone Releasing IUD Contains 52 mg of Levonorgestrel 1 IUD 3, 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 local taxes 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 local taxes 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 local taxes 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 local taxes 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/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II] BALJIT SINGH,Assistant Director

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] vkns k ubz fnyyh] 27 vizsy] 2017 dk- vk ¼v½- Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 ebz] 2013 vksj dk0 vk0 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,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky;] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftldks laf{kir :i es a,uihih, dgk tkrk gs½] uhps dh lkj.kh ds LraHk ¼6½ ea s fofufnz"v [kqnjk ewy; dks mdr lkj.kh ds LraHk ¼3½] ¼4½] vksj ¼5½ ea s Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk] bdkbz ¼;wfuV½ vksj fofuekzrk vksj foi.ku deifu;ksa ds uke lfgr Øe'k% LraHk ¼2½ es a dh rrlfkkuh izfof"v es a ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre [kqnjk ewy; ds #i es a fu;r djrh gsa lkj.kh dz-la- vuqlwfpr fofufezfr dk uke@czkam dk uke izcyrk bdkbz fofuekzrk vksj foi.ku daiuh dze k% [kqnjk ewy; ¼#-½ (1) (2) (3) (4) (5) (6) 1- isjkflvkeksy llvsam fjfyt 1000 fexzk- xksyh izr;sd vfyfir ck;ys;mz xksyh es a% isjkflvkeksy 300 fexzk ¼bEehMsV fjfyt es a½ isjkflvkeksy 700 fexzk ¼llVsUM fjyht es a½ 2- bumjky 20 fexzk- xksyh izr;sd vfyfir xksyh esa: izksizkuksyksy,plh,y 20 fexzk- 1 xksyh esllz fyudksu QkekZL;wfVdYl fy- vksj esllz dsfmyk gsyfkds;j fy- 1 xksyh esllz,ccksv gsyfkds;j izkfy uksv % ¼d½ mi;qzdr nh xbz fofufn"v QkWew Zys'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 fuekzrkvksa us mi;qzdr lkj.kh ds LraHk ¼6½ es a of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djks a dks tksm+ ldrs gsaa ¼x½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjkxzkq 11 es a fn, x, izko/kkuks a ds rgr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼6½ es a 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 es a 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 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk 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 ds v/khu izklafxd fof/k;ks a@fu;eks a ds vurxzr tslk fd dsunzh;@jkt; ykblsflax vkwfkksfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykbls al 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 es a lecfu/kr 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 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 es a vxj 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 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 es a mijksdr lkj.kh ds LraHk ¼2½ es a dh rrlfkkuh izfof"v esa fofufnz"v fofufezfr;ksa ds isdksa dh [kqnjk ewy; fu;r gksus ds ifj.kkelo#i,sls vkns'k tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh fujlr gks tk;saxsa [dka-la-@176@44@2017@,q@qk- la0 8¼44½@2017@Mhih@,uihih,&fMoh&II] cythr flag] lgk;d funs'kd

7 II (ii) 7 ORDER New Delhi, the 27th April, 2017 S.O. 1335(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 local taxes, 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 respectively, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. No. Name of the Scheduled Formulation / Brand Name Note: (a) The manufacturers 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 manufacturers may add local taxes 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 manufacturers 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 manufacturers 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. Strength Unit Manufacturer & Marketing Company respectively (1) (2) (3) (4) (5) (6) 1. Paracetamol sustained 3.28 release 1000mg tablet Each uncoated bilayered tablet contains: Paracetamol 300mg (as immediate release) Paracetamol 700mg (as sustained release) 2. Inderal 20mg tablet Each uncoated tablet contains: Propranolol HCL 20mg 1 Tablet M/s Lincoln Pharmaceuticals Ltd./ M/s Cadila Healthcare Ltd. 1 Tablet M/s Abbott Healthcare Pvt. Ltd. (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 manufacturers/marketeers 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 fulfillment 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 manufacturers/marketing companies. (f) The concerned manufacturers 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. Manufacturers, 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. Retail Price (Rs.) 2.03

8 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (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 retail price of the aforesaid formulations as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand(s) superseded. [PN/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II ] BALJIT SINGH, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi and Published by the Controller of Publications, Delhi