vlk/kj.k izkf/dkj ls izdkf'kr

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1 jftlvªh laö REGD. NO. D. L /99 vlk/kj.k EXTRAORDINARY Hkkx II [k.m 3 mi&[k.m (ii) PART II Section 3 Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 2454] ubz fnyyh] 'kqøokj] vdrwcj 7] 2016@vkf'ou 15] 1938 No. 2454] NEW DELHI, FRIDAY, OCTOBER 7, 2016/ASVINA 15, 1938 jlk;u vksj mozjd ea=kky; ¼vkS"k/k fohkkx½ ¼jk"Vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k½ vkns'k ubz fnyyh] 7 vdrwcj] 2016 dk0vk03180 (v). jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }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=k.k½ vkns'k] 2013 ds isjk 4, 10, 11, 14, 16, 17 vksj 18 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky;] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ¼laf{kIr :i esa,uihih, gs½] uhps dh lkj.kh ds LraHk ¼5½ es fofufnz"v rrdky izhkkoh vf/kdre dher vksj mdr lkj.kh ds LraHk ¼3½ vksj ¼4½ es dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bzdkbz ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v vuqlwfpr fofufezzfr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds #i esa fu;r djrh gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bzdkbz vf/kdre dher¼#-½ xsfuldyksfoj butsd'ku xsfuldyksfoj-500 fexzk- izfr isd ds fy, ikmmj 2. yqvksdlhvkbu xksyh yqvksdlhvkbu-20 fexzk 1 xksyh vksesizkt+ksy xksyh vksesizkt+ksy-40 fexzk- 1 xksyh izksizkuksyksy dsilwy izksizkuksyksy-40 fexzk- 1 dsilwy ukbvªks ;wjsuvksbu dsilwy ukbvªks ;wjsuvksbu-100 fexzk- 1 dsilwy ,ftFkzksekbflu dsilwy,ftfkzksekbflu-250 fexzk- 1 dsilwy ,ftFkzksekbflu dsilwy,ftfkzksekbflu-500 fexzk- 1 dsilwy bekfvfuc dsilwy bekfvfuc-100 fexzk- 1 dsilwy GI/2016 (1)

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] uksv % ¼d½ ¼[k½ 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 nksuksa :ikarjksa dks csp jgs vuqlwfpr fofufezfr;ksa ds lhkh fofuekzrk] mi;qzdr lkj.kh ds LraHk (5) esa of.kzr vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezfr;ksa dh dher dk v/kkseq[kh iqujh{k.k djsaxsa 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 LFkkuh; dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds isjkxzkq 13(2) ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka ¼x½ vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk (5) esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djksa dks tksm+ ldrs gsa ¼?k½ ¼M-½ ¼p½ ¼N½ ¼t½ vks"k/k ¼ewY; fu;a=k.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=k.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 djsaa 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=k.k½ vkns'k] 2013 ds isjkxzkq 2¼u½ ds vuqlkj vks"k/k ¼ewY; fu;a=k.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 mi;qzdr vuqlwfpr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa fuekzrkvksa dks vks"k/k ¼ewY; fu;a=k.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 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 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.kke Lo#i] vf/kdre vksj [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-@169@37/2016@fo/qk- la0 8¼37½@2016@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 7th October, 2016 S.O. 3180(E ). In exercise of the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 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 formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:

3 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3 TABLE Sl. Name of the Scheduled Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Ganciclovir Powder for Injection Ganciclovir -500 mg Each Pack Fluoxetine Tablet Fluoxetine-20 mg 1 Tablet Omeprazole Tablet Omeprazole-40 mg 1 Tablet Propranolol Capsule Propranolol-40 mg 1 Capsule Nitrofurantoin Capsule Nitrofurantoin-100 mg 1 Capsule Azithromycin Capsule Azithromycin-250 mg 1 Capsule Azithromycin Capsule Azithromycin-500 mg 1 Capsule Imatinib Capsule Imatinib-100 mg 1 Capsule Note : (a) (b) (c) (d) (e) (f) (g) (h) All the existing 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. 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, 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. 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. 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, 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, 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/169/37/2016/F/ F. No. 8(37)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns'k ubz fnyyh] 7 vdvwcj] 2016 dk-vk- 3181¼v½- jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }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=k.k½ vkns'k] 2013 ds isjk 4, 10, 11, 14, 16, 17 vksj 18 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky;] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ds vkns'k dk- vk- 644¼v½] fnukad 2 ekpz] 2016, dks tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezr isdksa ls gs] mu ckrksa ds flok; vf/køkur djrs gq, ftugsa,sls vf/køe.k ds iwoz fd;k x;k gs ;k djus dk yksi fd;k x;k gs] uhps dh lkj.kh ds LraHk ¼5½ es fofufnz"v vf/kdre dher dks mdr lkj.kh ds LraHk ¼3½ vksj ¼4½ es dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bzdkbz ¼;wfuV½ lfgr ml

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"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 gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bzdkbz vf/kdre dher¼#-½ fyffk;e xksyh fyffk;e-300 fexzk- 1 xksyh fm;kt+kike butsd'ku fm;kt+kike-5 fexzk-@fefy 1 fefy QsuhVksbu butsd'ku QsuhVksbu-50 fexzk-@fefy 1 fefy ffk;ksisuvksu butsd'ku ffk;ksisuvksu-1 xzke izfr isd ds fy, ikmmj 5. dsvkekbu butsd'ku dsvkekbu-50 fexzk-@fefy 1 fefy dsvkekbu butsd'ku dsvkekbu-10 fexzk-@fefy 1 fefy izksiksqksy butsd'ku izksiksqksy-10 fexzk-@fefy 1 fefy C;wihosdsu butsd'ku C;wihosdsu-0.25% 1 fefy C;wihosdsu butsd'ku C;wihosdsu-0.5% 1 fefy ,fMªukykbu butsd'ku,fmªukykbu-1 fexzk-@fefy 1 fefy fyxuksdsu butsd'ku fyxuksdsu-1% izfr isd fyxuksdsu butsd'ku fyxuksdsu-2% 1 fefy MksDlhlkbdfyu xksyh MksDlhlkbdfyu-100 fexzk- 1 xksyh foufølvhu butsd'ku foufølvhu-1 fexzk-@fefy 1 fefy vksumsulsvªksu vkwjy fyfdom vksumsulsvªksu-2 fexzk-@5 fefy 1 fefy gsyksisjhmksy butsd'ku gsyksisjhmksy-5 fexzk-@fefy 1 fefy MkdkckZt+hu butsd'ku MkdkckZt+hu-500 fexzk- izfr isd ds fy, ikmmj 18. lkbdyksqkslqkekbm lkbdyksqkslqkekbm-500 fexzk- izfr isd butsd'ku ds fy, ikmmj 19. fcy;ksekbflu butsd'ku fcy;ksekbflu-15 ;wfuv izfr isd ds fy, ikmmj 20. ijesffkzu Øhe ijesffkzu-5% 1 xzke izksvkekbu butsd'ku izksvkekbu-10 fexzk-@fefy 1 fefy LVªsIVksekbflu butsd'ku LVªsIVksekbflu-750 fexzk- izfr isd 7.82 ds fy, ikmmj uksv % ¼d½ ¼[k½ 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 nksuksa :ikarjksa dks csp jgs vuqlwfpr fofufezfr;ksa ds lhkh fofuekzrk] mi;qzdr lkj.kh ds LraHk (5) esa of.kzr vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezfr;ksa dh dher dk v/kkseq[kh iqujh{k.k djsaxsa 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 LFkkuh; dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds isjkxzkq 13(2) ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka ¼x½ vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk (5) esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djksa dks tksm+ ldrs gsa ¼?k½ vks"k/k ¼ewY; fu;a=k.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

5 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 5 ¼M-½ ¼p½ ¼N½ ¼t½ dher fu/kkzfjr djsaa fuekzrk vks"k/k ¼ewY; fu;a=k.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 djsaa 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=k.k½ vkns'k] 2013 ds isjkxzkq 2¼u½ ds vuqlkj vks"k/k ¼ewY; fu;a=k.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 mi;qzdr vuqlwfpr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa fuekzrkvksa dks vks"k/k ¼ewY; fu;a=k.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 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 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.kke Lo#i] vf/kdre vksj [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-@169@37/2016@fo/qk- la0 8¼37½@2016@Mhih@,uihih,-&fMoh- II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 7th October, 2016 S.O. 3181(E). In exercise of the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 644(E), dated 2nd March, 2016, 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 strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. Name of the Scheduled Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Lithium Tablet Lithium-300 mg 1 Tablet Diazepam Injection Diazepam-5 mg/ml 1 ml Phenytoin Injection Phenytoin-50mg/ml 1 ml Thiopentone Thiopentone-1gm Each Pack Powder for Injection 5. Ketamine Injection Ketamine-50 mg/ml 1 ml Ketamine Injection Ketamine-10 mg/ml 1 ml Propofol Injection Propofol-10 mg/ml 1 ml Bupivacaine Injection Bupivacaine-0.25% 1 ml Bupivacaine Injection Bupivacaine-0.5% 1 ml 3.64

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 10. Adrenaline Injection Adrenaline -1 mg/ml 1 ml Lignocaine Injection Lignocaine-1% Each Pack Lignocaine Injection Lignocaine-2% 1 ml Doxycycline Tablet Doxcycline-100 mg 1 Tablet Vincristine Injection Vincristine-1 mg/ml 1 ml Ondansetron Oral Liquid Ondansetron-2 mg/5ml 1 ml Haloperidol Injection Haloperidol-5 mg/ml 1 ml Dacarbazine Dacarbazine-500 mg Each Pack Powder for Injection 18. Cyclophosphamide Cyclophosphamide-500 mg Each Pack Powder for Injection 19. Bleomycin Bleomycin-15 units Each Pack Powder for Injection 20. Permethrin Cream Permethrin-5% 1 Gram Protamine Injection Protamine-10mg/ml 1 ml Streptomycin Streptomycin-750 mg Each Pack 7.82 Powder for Injection Note : (a) (b) (c) (d) (e) (f) (g) (h) All the existing 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. 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, 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. 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. 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, 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, 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/169/37/2016/F/F. No. 8(37)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns'k ubz fnyyh] 7 vdvwcj] 2016 dk-vk- 3182(v). jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }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=k.k½ vkns'k] 2013 ds isjk 4, 10, 11, 14, 16, 17 vksj 18 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky;] jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k ds vkns'k dk- vk- 1561¼v½] fnukad 27 vizsy] 2016

7 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 7 dh lkj.kh esa myysf[kr Øe la- 10] dks tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezr 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 dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bzdkbz ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v vuqlwfpr fofufezr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds #i esa fu;r djrh gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bzdkbz vf/kdre dher¼#-½ esvªksfumkt+ksy vksjy fyfdom esvªksfumkt+ksy-200 fexzk-@5 fefy 1 fefy 0.27 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 nksuksa :ikarjksa dks csp jgs vuqlwfpr fofufezfr;ksa ds lhkh fofuekzrk] mi;qzdr lkj.kh ds LraHk (5) 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 esa fofufnz"v vf/kdre dher LFkkuh; dj lfgr ls de gs rks] tgka dgh Hkh ykxw gks] vks"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds isjkxzkq 13(2) ds vuqlkj mldks ekstwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxka ¼x½ vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk (5) esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djksa dks tksm+ ldrs gsa ¼?k½ ¼M-½ ¼p½ ¼N½ ¼t½ vks"k/k ¼ewY; fu;a=k.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=k.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 djsaa 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=k.k½ vkns'k] 2013 ds isjkxzkq 2¼u½ ds vuqlkj vks"k/k ¼ewY; fu;a=k.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 mi;qzdr vuqlwfpr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa fuekzrkvksa dks vks"k/k ¼ewY; fu;a=k.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 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 bl vkns'k esa mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v,slh fofufezr;ksa ds isdksa dh vf/kdre dher fu;r gksus ds ifj.kke Lo#i] vf/kdre vksj [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-@169@37/2016@fo/qk- la0 8¼37½@2016@Mhih@,uihih,-&fMoh-&II] cythr flag] lgk;d funs'kd

8 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ORDER New Delhi, the 7th October, 2016 S.O. 3182(E). In exercise of the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 1561(E), dated 27th April, 2016 regarding formulation pack mentioned in the table at Sl. No. 10, in so far as it relates to formulation pack mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes 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 strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. Name of the Scheduled Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Metronidazole Oral Liquid Metronidazole-200 mg/5 ml. 1 ml Note : (a) (b) (c) (d) (e) (f) (g) (h) All the existing 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. 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, 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. 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. 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, 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, 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/169/37/2016/F/F. No. 8(37)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director

9 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 9 vkns'k ubz fnyyh] 7 vdvwcj] 2016 dk- vk- 3183(v)-jk"Vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }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=k.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=kky;] 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 dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk] bzdkbz ¼;wfuV½ vksj fufezr vksj foi.ku deifu;ksa lfgr Øe'k% LraHk ¼2½ esa dh rrlfkkuh izfof"v esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre [kqnjk ewy; ds #i esa fu;r djrh gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk izcyrk bzdkbz fufezr vksj foi.ku [kqnjk ewy; uke@czkam dk uke }kjk Øe'k% ¼#-½ DyksfiMksxjsy$ izr;sd gkmz t+sysfvu 1 dsilwy esllz lk;uksdse jksl;woklvsfvu dsilwy dsilwy esa % QkWekZL;wfVdYl DyksfiMksxjsy ck;lyqsv fyfevsm vksj DyksfiMksxjsy-75 fexzk- esllz buv~kl ds cjkcj esa ¼isysV~l esa½ QkWekZL;wfVdYl jksl;woklvsfvu dsfy'k;e fyfevsm jksl;woklvsfvu-10 fexzkds cjkcj esa ¼isysV~l esa½ 2. DyksfiMksxjsy$ izr;sd gkmz t+sysfvu 1 dsilwy esllz lk;uksdse jksl;woklvsfvu dsilwy dsilwy esa % QkWekZL;wfVdYl DyksfiMksxjsy ck;lyqsv fyfevsm vksj DyksfiMksxjsy-75 fexzk- esllz buv~kl ds cjkcj esa ¼isysV~l esa½ QkWekZL;wfVdYl jksl;woklvsfvu dsfy'k;e fyfevsm jksl;woklvsfvu-5 fexzkds cjkcj esa ¼isysV~l esa½ 3. dksydsfy'kqsjksy Mªksi izr;sd fefy esa % 1 fefy esllz jsivkdksl czsv,am 4.33 ¼vkjfcfoV&3 QksVZ½ dksydsfy'kqsjksy-800 vkbz;w deiuh fyfevsm ¼foVkfeu Mh3½ isysvscy csl 4. ls VkftMkbe$ izr;sd ok;y esa % 1 ok;y esllz dsfmyk VstkscsdVe butsd'ku ls VkftMkbe isvkgkbmªsv gsyfkds;j fyfevsm ¼tk;Vkt+&Vh½ ls VkftMkbe-1 xzke ds cjkcj ¼LVªkby lksfm;e dkckszusv cqfjax,stsuv ds leku tksm+h xbz½ VstkscsdVe lksfm;e VstkscsdVe-125 fexzk- ds cjkcj ¼bUtsD'ku ds fy, ikuh 10 fefy LVªkby iwfrz lfgr½ 5. fxfyfeizkbm$ izr;sd vfyfir ck;ys;mz 1 xksyh esllz foamykl ck;ksvsd 9.45 esvqksfezu,plh,y xksyh esa % fyfevsm vksj xksyh fxfyfeizkbm-4 fexzk- esllz,ydse ¼Xywdksfjy,e 4 QksVZ½ esvqksfezu,plh,y-1000 fexzk- yscksjsvªht+ fyfevsm ¼lLVsUM fjfyt+ QkWeZ esa½

10 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 6. Vsdjksfyel dsilwy izr;sd gkmz t+sysfvu 1 dsilwy esllz isusf'k;k ck;ksvsd ¼Vsdjksel 0.25½ dsilwy esa % fyfevsm vksj Vsdjksfyel-0.25 fexzk- esllz dsfmyk gsyfkds;j fyfevsm 7. izksizkuksyksy$ izr;sd gkmz t+sysfvu 1 xksyh esllz buksok dsivsc 8.53 y;wukfjtkbu dsilwy dsilwy esa % vksj esllz fyqksmz ¼fexjkfQu&ih½ izksizkuksyksy,plh,y-40 fexzk- gsyfkds;j fyfevsm ¼lLVsUM fjfyt+ isysv~l esa½ y;wukfjtkbu MkbZgkbMªksDyksjkbM y;wukfjtkbu-10 fexzk- ds cjkcj ¼isysV~l esa½ uksv % ¼d½ ¼[k½ ¼x½ ¼?k½ ¼M-½ ¼p½ ¼N½ fofuzekrk mi;qzdr nh xbz fofufn"v QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds isjkxzkq 2¼u½ ds rgr mi;qzdr nh xbz lkj.kh ds LraHk ¼6½ es fofufnz"v [kqnjk ewy; fu/kkzfjr djsaxsa vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk (6) esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os LFkkuh; djksa dks tksm+ ldrs gsa vks"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds isjkxzkq 11 esa fn, x, izko/kkuksa ds rgr fuekzrkvksa dks mi;qzdr lkj.kh ds LraHk ¼6½ esa fofufnz"v [kqnjk ewy; ds vk/kkj ij vuqlwfpr fofufezfr;ksa ds isdksa ds fy, [kqnjk ewy; fu/kkzfjr djsaa fuekzrk vks"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds isjkxzkq 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls,d ewy; lwph,uihih, dks vkbzihmh,e,l ds ek/;e ls tkjh djsaa mi;qzdr xsj vf/kdr dher ¼[kqnjk ewy;½ dsoy mi;qzdr fuekzrk@foi.ku ds fy, ykxw gs tslk fd mugksaus vks"k/k ¼ewY; fu;a=k.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;ksa@fu;eksa ds vurxzr tsls fd dsunzh;@jkt; ykblsflax vkwffkfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykblsal eatwjh ds rgr lacaf/kr fofufezr fuekzrk@foi.ku deifu;ka tks vuqikyu djrh gsa mi;qzdr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa lecfu/kr fuekzrkvksa dks vks"k/k ¼ewY; fu;a=k.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 esa 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 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 bl vkns'k esa mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v fofufezr;ksa ds isdksa dh [kqnjk ewy; fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh fujlr gks tk;saxsa [dka-la-@169@37/2016@fo@qk- la0 8¼37½@2016@Mhih@,uihih,-&fMoh-&II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 7th October, 2016 S.O. 3183(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 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 price as specified in column (6) of the table herein below as the retail

11 ¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 11 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; Sl. No. Name of the Scheduled Formulation / Brand Name TABLE Strength Unit Manufacturer & Marketing Company respectively Clopidogrel + Rosuvastatin Capsule 2. Clopidogrel + Rosuvastatin Capsule 3. Cholecalciferol Drops (Arbivit-3 Forte) 4. Ceftazidime + Tazobactam Injection (Zytaz-T) 5. Glimepiride + Metformin HCl Tablet (Glucoryl M4 Forte) 6. Tacrolimus Capsule (Tacromus 0.25) 7. Propranolol + Flunarizine Capsule (Migrafin-P) Each hard gelatin capsule contains: Clopidogrel Bisulphate eq. to Clopidogrel-75 mg. (as pellets) Rosuvastatin Calcium eq. to Rosuvastatin-10 mg. (as pellets) Each hard gelatin capsule contains: Clopidogrel Bisulphate eq. to Clopidogrel-75 mg. (as pellets) Rosuvastatin Calcium eq. to Rosuvastatin-5 mg. (as pellets) Each ml contains Cholecalciferol-800 IU (Vitamin D3) Palatable base Each vial contains: Ceftazidime Petahydrate eq. to Ceftazidime-1gm (added sterile sodium carbonate as buffering agent) Tazobactam Sodium eq. to Tazobactam-125 mg. (supplied with 10ml sterile water for injection) Each uncoated bilayered tablet contains: Glimepiride-4 mg Metformin HCl 1000mg (as sustained release form) Each hard gelatin capsule contains: Tacrolimus 0.25 mg. Each hard gelatin capsule contains: Propranolol HCl-40 mg. (as sustained release pellets) Flunarizine Dihydrochloride eq. to Flunarizine 10mg (as pellets) 1 Capsule M/s Synokem Pharmaceuticals Ltd. & M/s Intas Pharmaceuticals Ltd. 1 Capsule M/s Synokem Pharmaceuticals Ltd. & M/s Intas Pharmaceuticals Ltd. 1 ml M/s Raptakos, Brett & Co. Ltd. 1 Vial M/s Cadila Healthcare Ltd. 1 Tablet M/s Windlas Biotech Ltd. & M/s Alkem Laboratories Ltd. 1 Capsule M/s Panacea Biotec Ltd. & M/s Cadila Healthcare Ltd. 1 Capsule M/s Innova Captab & M/s Leeford Healthcare Ltd. Retail Price (Rs.)

12 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 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) (c) (d) (e) (f) (g) 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. 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. 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. 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. 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, 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 / marketeer prior to the above said date of notification, stand(s) superseded. [PN/169/37/2016/F/F. No. 8(37)/2016/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

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Detaljer

vlk/kj.k izkf/dkj ls izdkf'kr

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

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