vlk/kj.k izkf/dkj ls izdkf'kr jlk;u vksj mozjd ea=ky;

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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- 222] ubz fnyyh] eaxyokj] tuojh 24] 2017@ek?k 4] 1938 No. 222] NEW DELHI, TUESDAY, JANUARY 24, 2017/MAGHA 4, 1938 jlk;u vksj mozjd ea=ky; ¼vkS vks k/k k/k fohkkx½ ¼jk jk Vªh; vks k k/k ewy; fu/kkzj.k izkf/kdj.k½ vkns k ubz fnyyh] 24 tuojh] 2017 dk-vk- 247¼v½. jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k] 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,] uhps dh lkj.kh ds LraHk ¼5½ esa 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 bdkbz ¼;wfuV½ lfgr ml 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 gs% lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bdkbz vf/kdre dher ¼#-½ lsvªhthu dsilwy lsvªhthu -10 fexzk- 1 dsilwy QsuhVkWbu dsilwy QsuhVkWbu fexzk. 1 dsilwy QsuhVkWbu bzvkj dsilwy QsuhVkWbu -300 fexzk- 1 dsilwy lsfqdlhe dsilwy lsfqdlhe fexzk- 1 dsilwy thmksoqmhu dsilwy thmksoqmhu fexzk- 1 dsilwy izksdkckzthu xksyh izksdkckzthu - 50 fexzk- 1 xksyh fcvkesfkklksu tsy fcvkesfkklksu % 1 xzke vksesizktksy xksyh Vksesizktksy -10 fexzk- 1 xksyh GI/2017 (1)

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] uksv % 9. QsuhVkWbu vksjy fyd;wbm QsuhVkWbu&125 fexzk-@5 fefy 1 fefy ikwohmkwu vk;ksmhu lkwyq ku ikwohmkwu vk;ksmhu&4% 1 fefy vksesizktksy butsd ku ds fy, ikmmj vksesizktksy&20 fexzk- 1 xzke 1.14 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 ¼5½ 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 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 dgha 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 LFkkuh; djksa dks tksm+ ldrs gsa 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 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/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'kr 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 2¼u½ 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 ¼t½ 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 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-@172@40/2016@,q@qk- la- 8¼40½@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 24th January, 2017 S.O. 247(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

3 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 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: Note : TABLE Sl. No. Name of the Scheduled Formulation Strength Unit Ceiling Price (1) (2) (3) (4) (5) 1 Cetirizine capsule Cetirizine-10mg 1 Capsule Phenytoin Capsule Phenytoin-300mg 1 Capsule Phenytoin ER Capsule Phenytoin-300mg 1 Capsule Cefixime Capsule Cefixime-200 mg 1 Capsule Zidovudine Capsule Zidovudine-300mg 1 Capsule Procarbazine Tablet Procarbazine-50mg 1 Tablet Betamethasone Gel Betamethasone-0.05% 1 GM Omeprazole Tablet Omeprazole-10mg 1 Tablet Phenytoin Oral Liquid Phenytoin-125mg/5ml 1 ML Povidone Iodine Solution Povidone Iodine-4% 1 ML Omeprazole Powder for Injection Omeprazole-20mg 1 GM 1.14 (Rs.) (a) (b) (c) (d) (e) (f) (g) (h) 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. 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 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, 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.

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (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/172/40/2016/F. No. 8(40)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt Director vkns k ubz fnyyh] 24 tuojh] 2017 dk-vk- 248¼v½. jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] 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,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky;] 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 esa fofufnz"v rrdky izhkkoh vf/kdre dher vksj mdr lkj.kh ds LraHk ¼3½ vksj ¼4½ esa dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bdkbz ¼;wfuV½ lfgr ml 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 gs % dz-la- vuqlwfpr fofufezfr dk uke lkj.kh izcyrk bdkbz vf/kdre dher ¼#-½ isjkflvkeksy butsd'ku isjkflvkeksy 150 fexzk-@fefy izfr isd ¼2 fefy½ MsDlkesFkklksu butsd'ku MsDlkesFkklksu - 4 fexzk-@fefy izfr isd ¼30 fefy½ MsDlkesFkklksu butsd'ku MsDlkesFkklksu - 4 fexzk-@fefy izfr isd ¼20 fefy½ MsDlkesFkklksu butsd'ku MsDlkesFkklksu - 4 fexzk-@fefy izfr isd ¼10 fefy½ MsDlkesFkklksu butsd'ku MsDlkesFkklksu - 4 fexzk-@fefy izfr isd ¼2 fefy½ ,YcsuMktksy vksjy fyd;wbm,ycsumktksy-200 fexzk-@5 fefy 1 fefy tsavkekblhu butsd'ku tsavkekblhu - 40 fexzk-@fefy izfr isd ¼30 fefy½ tsavkekblhu butsd'ku tsavkekblhu - 40 fexzk-@fefy izfr isd ¼20 fefy½ tsavkekblhu butsd'ku tsavkekblhu - 40 fexzk-@fefy izfr isd ¼10 fefy½ tsavkekblhu butsd'ku tsavkekblhu - 40 fexzk-@fefy izfr isd ¼2 fefy½ fjqseihlhu vksjy fyd;wbm 12. LVªsiVksekblhu butsd'ku ds fy, ikmmj fjqseihlhu fexzk-@5 fefy 1 fefy 0.34 LVªsiVksekblhu - 1 xzke izfr isd DyksVªhektksy isljh DyksVªhektksy -100 fexzk- izfr isljh ft+mksoqmkbu$ ft+mksoqmkbu&300 fexzk-$ 1 xksyh ysfeoqmkbu$ usfojkikbu ysfeoqmkbu&150 fexzk-$ usfojkikbu - xksyh 200 fexzk- 15. ijesfkjhu yks ku ijesfkjhu -1% 1 xzke vksesizktksy dsilwy vksesizktksy - 10 fexzk- 1 dsilwy ckblkdksmkby lqiksftvªh ckblkdksmkby-5 fexzk- izfr lqiksftvªh esfkhyjxksesvªkbu xksyh esfkhyjxksesvªkbu&0-125 fexzk- 1 xksyh QsuhVkWbu dsilwy QsuhVkWbu&100 fexzk- 1 dsilwy 1.41

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k VsVul VkWDlkbM butsd'ku 21. VsVul VkWDlkbM butsd'ku 22. esfkhyizsmuhlksyksu butsd'ku & izfr isd ¼5 fefy½ & izfr isd ¼0-5 fefy½ 5.53 esfkhyizsmuhlksyksu&40 fexzk-@fefy 1 fefy 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 ¼5½ 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 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=.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 LFkkuh; djksa dks tksm+ ldrs gsa 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 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/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 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 2¼u½ 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 ¼t½ 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 tsavkekblhu butsd ku 40 fexzk-@fefy] MsDlkesFkklksu butsd ku]4 fexzk-@fefy] isjkflvkeksy butsd ku]150 fexzk-@fefy vksj VsVul VkWDlkbM butsd ku ds laca/k esa] vu; fdlh isd vkdkj ds fy, fuekzrk viuh fofufezfr;ksa ds fo'ks k ewy; vuqeksnu gsrq,uihih, dks laidz djsxka ¼.k½ 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 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-@172@40@2016@,q@qk- la- 8¼40½@2016@Mhih@,uihih,-&fMoh-- I I] cythr flag] lgk;d funs'kd

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ORDER New Delhi, the 24th January, 2017 S.O. 248(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. 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: Sl. No. Note: Name of the Scheduled Formulation TABLE Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1 Paracetamol Injection Paracetamol-150mg/ml Each Pack (2ml) Dexamethasone Injection Dexamethasone-4mg/ml Each Pack (30ml) Dexamethasone Injection Dexamethasone-4mg/ml Each Pack (20ml) Dexamethasone Injection Dexamethasone-4mg/ml Each Pack (10ml) Dexamethasone Injection Dexamethasone-4mg/ml Each Pack (2ml) Albendazole Oral Liquid Albendazole-200mg/5ml 1 ML Gentamicin Injection Gentamicin-40mg/ml Each Pack (30ml) 8 Gentamicin Injection Gentamicin-40mg/ml Each Pack (20ml) Gentamicin Injection Gentamicin-40mg/ml Each Pack (10ml) Gentamicin Injection Gentamicin-40mg/ml Each Pack (2ml) Rifampicin Oral Liquid Rifampicin-100mg/5ml 1 ML Streptomycin Powder for Injection Streptomycin-1gm Each Pack Clotrimazole Pessary Clotrimazole-100mg Each Pessary Zidovudine + Lamivudine + Nevirapine Tablet Zidovudine + Lamivudine + Nevirapine -(300mg + 150mg + 200mg) Tablet Permethrin Lotion Permethrin-1% 1 GM Omeprazole Capsule Omeprazole-10mg 1 Capsule Bisacodyl Suppository Bisacodyl-5mg Per Suppository Methylergometrine Tablet Methylergometrine-0.125mg 1 Tablet Phenytoin Capsule Phenytoin-100mg capsule 1 capsule Tetanus Toxoid injection - Each pack (5ml) Tetanus Toxoid injection - Each pack (0.5ml) Methylprednisolone injection Methylprednisolone-40mg/ml 1 ML (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.

7 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 (b) (c) (d) (e) (f) (g) (h) (i) (j) 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 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, 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, In respect of Gentamycin injection 40mg/ml, Dexamethasone injection 4mg/ml, Paracetamol injection 150mg/ml and Tetanus toxoid injection, for any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulations. 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/172/40/2016/F. No. 8(40)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi and Published by the Controller of Publications, Delhi

bulvhyys ku ¼ykblsal ds vuqlkj½ QksLQksfyfiMl

bulvhyys ku ¼ykblsal ds vuqlkj½ QksLQksfyfiMl 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]