jlk;u vksj mozjd ea=ky;

Transkript

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- 403] ubz fnyyh] eaxyokj] iqjojh 14] 2017@ek?k 25] 1938 No. 403] NEW DELHI, TUESDAY, FEBRUARY 14, 2017/MAGHA 25, 1938 jlk;u vksj mozjd ea=ky; ¼vkS k/k fohkkx½ ¼jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k½ vkns'k ubz fnyyh] 14 Qjojh] 2017 dk-vk- 442¼v½- jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k] 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,] 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 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 gkbmªksdyksjksfkkbtkbm xksyh gkbmªksdyksjksfkkbtkbm -50fexzk- 1 xksyh tksyihmse dsilwy tksyihmse -5 fexzk- 1 dsilwy QsuhVkWbu vksjy fyd;wbm QsuhVkWbu&30fexzk@5 fefy 1 fefy 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 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 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 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=.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 forjd dks tkjh djsaa ¼M-½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izr;sd QqVdj foøsrk 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 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-@173@41/2017@,q@qk- la- 8¼41½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs'kd

3 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 14th February, 2017 S.O. 442(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 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. Hydrochlorothiazide Tablet Hydrochlorothiazide-50mg 1 Tablet Zolpidem Capsule Zolpidem-5mg 1 Capsule Phenytoin Oral Liquid Phenytoin-30mg/5ml 1 ML 0.27 (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.

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (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/173/41/2017/F/F. No. 8(41)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns'k ubz fnyyh] 14 Qjojh] 2017 dk-vk- 443¼v½- jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] 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,] 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 gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bdkbz vf/kdre dher ¼#-½ lsqksvsdlkbe butsd ku ds fy, lsqksvsdlkbe fexzk- izfr ikmmj isd lsqksvsdlkbe butsd ku ds fy, lsqksvsdlkbe fexzk- izfr ikmmj isd DyksjksD;wbu vksjy fyd;wbm DyksjksD;wbu - 50 fexzk-/5fefy 1 fefy DyksjksD;wbu xksyh DyksjksD;wbu- 150 fexzk- 1 xksyh ,lsVhylsyhlkbfyd,lhM xksyh,lsvhylsyhlkbfyd,lhm 75 fexzk- 1 xksyh vkbzlkslksfczm&5&eksuksukbzvªsv xksyh vkbzlkslksfczm&5&eksuksukbzvªsv xksyh 1.82 fexzk- 7. vkbzlkslksfczm&5&eksuksukbzvªsv xksyh vkbzlkslksfczm&5&eksuksukbzvªsv xksyh 2.84 fexzk- 8. fyxuksdsu butsd ku fyxuksdsu - 2% (IV iz;ksx ds fy, iztoszfvo Qzh½ 1 fefy okvj QkWj butsd ku okvj QkWj butsd ku -5 fefy izfr isd okvj QkWj butsd ku okvj QkWj butsd ku -10 fefy izfr isd flizksq~yksdlhu Mªksil flizksq~yksdlhu- 0.3% 1 fefy 1.41

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 uksv % 12. iksfomkwu vk;ksmhu lksyw ku iksfomkwu vk;ksmhu- 10% 1 fefy dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe] vksjy fyd;wbm dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe]- 200 fexzk-$40 fexzk-/5fefy 1 fefy dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe] xksyh 15. dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe] xksyh dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe]- 400 fexzk-$80 fexzk- dks&vªkbeksdlktksy [lyqkesfkksdlktksy$vªhesfkksizkbe]- 800 fexzk-$160 fexzk- 1 xksyh xksyh ,Msukslkbu butsd ku,msukslkbu&3 fexzk-/fefy 1 fefy DyksfeQsu xksyh DyksfeQsu- 100 fexzk- 1 xksyh DyksfeQsu xksyh DyksfeQsu- 50 fexzk- 1 xksyh vkbzlksq~ywjsu bagsys ku vkbzlksq~ywjsu 1 fefy tselhvkokbu butsd ku ds fy, tselhvkokbu- 200 fexzk- izfr ikmmj 21. lkbvkslkbu,jkfcukslkbm butsd ku ds fy, ikmmj lkbvkslkbu,jkfcukslkbm& fexzk- 22. esvªksukbmktksy butsd ku esvªksukbmktksy&500 fexzk-/100fefy 1 fefy flizksq~yksdlhu butsd ku flizksq~yksdlhu&200 fexzk-/100fefy 1 fefy ,ehvksMkjksu butsd ku,ehvksmkjksu&50 fexzk-/fefy 1 fefy QsuksckfoZVksu vksjy fyd;wbm QsuksckfoZVksu&20 fexzk-/5fefy 1 fefy fyxuksdsu$,mªsukykbu butsd ku fyxuksdsu&2%$,mªsukykbu& 1 fefy : (5,elhth@fefy½ 27. lksfm;e ckbzdkckszusv butsd ku lksfm;e ckbzdkckszusv&8.4% 1 fefy lksfm;e ckbzdkckszusv butsd ku lksfm;e ckbzdkckszusv&7.5% 1 fefy lsycwvkeksy bagsys ku lsycwvkeksy&100,elhth@mkst izfr ¼,eMhvkbZ@MhihvkbZ½ Mkst bzlik?kqyk xzkuqysl@gld@ikmmj bzlik?kqyk 1 xzke 0.73 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 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 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=.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 isd izfr isd

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 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 forjd dks tkjh djsaa ¼M-½ vks k/k ¼ewY; fu;a=.k½ vkns k] 2013 ds 24 (4) 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 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 bl vkns k ls iwoz tkjh gq, gsa] Lor% gh vf/køe.k gks tk;saxsa [dka- la-@173@41/2017@,q@qk- la- 8¼41½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 14th February, 2017 S.O. 443(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:

7 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 TABLE Sl. No. Name of the Scheduled Formulation Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Cefotaxime Powder for Injection Cefotaxime-500mg Each Pack Cefotaxime Powder for Injection Cefotaxime-250mg Each Pack Chloroquine Oral liquid Chloroquine-50mg/5ml 1 ML Chloroquine Tablet Chloroquine-150mg 1 Tablet Acetylsalicylic Acid Tablet Acetylsalicylic Acid-75mg 1 Tablet Isosorbide-5-mononitrate Tablet Isosorbide-5-mononitrate-10mg 1 Tablet Isosorbide-5-mononitrate Tablet Isosorbide-5-mononitrate-20mg 1 Tablet Lignocaine Injection Lignocaine-2% (Preservative free for 1 ML 0.90 IV use) 9. Water for Injection Water for Injection Each Pack 2.09 (5ml) 10. Water for Injection Water for Injection Each Pack 2.17 (10ml) 11. Ciprofloxacin Drops Ciprofloxacin-0.3% 1 ML Povidone Iodine Solution Povidone Iodine-10% 1 Tablet Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Tablet 14. Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Oral Liquid 15. Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Tablet Co-trimoxazole [Sulphamethoxazole + Trimethoprim]-400mg+80mg Co-trimoxazole [Sulphamethoxazole+ Trimethoprim]-200mg+40mg/5ml Co-trimoxazole [Sulphamethoxazole + Trimethoprim]-800mg+160mg 1 Tablet ML Tablet Adenosine Injection Adenosine-3mg/ml 1 ML Clomiphene Tablet Clomiphene-100mg 1 Tablet Clomiphene Tablet Clomiphene-50mg 1 Tablet Isoflurane Inhalation Isoflurane 1 ML Gemcitabine Powder for Gemcitabine-200mg Each Pack Injection 21. Cytosine arabinoside Powder for Cytosine arabinoside-1000mg Each Pack Injection 22. Metronidazole Injection Metronidazole-500mg/100ml 1 ML Ciprofloxacin Injection Ciprofloxacin-200mg/100ml 1 ML Amiodarone Injection Amiodarone-50mg/ml 1 ML Phenobarbitone Oral Liquid Phenobarbitone-20mg/5ml 1 ML Lignocaine + Adrenaline Lignocaine-2% + Adrenaline- 1 ML 0.85 Injection 1:200000(5mcg/ml) 27. Sodium bicarbonate Injection Sodium bicarbonate-8.4% 1 ML Sodium bicarbonate Injection Sodium bicarbonate-7.5% 1 ML Salbutamol Inhalation Salbutamol-100mcg/dose Per Dose 0.37 (MDI/DPI) 30. Ispaghula Granules/ Husk/ Powder Ispaghula 1GM 0.73

8 8 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 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/173/41/2017/F/F. No. 8(41)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns'k ubz fnyyh] 14 Qjojh] 2017 dk-vk- 444¼v½- vks"k/k fohkkx }kjk tkjh iqufozyksdu vkns'k la /72/2016-ihvkbZ-I fnukad ij fn;s x;s vkns'k esa vafdr funsz'kksa ds dk;kzuo;u gsrq vksj jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] 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, 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 dze k% vkns'k dk- vk- 1951¼v½] fnukad 2 twu] 2016] dh lkj.kh esa myysf[kr Øe la- 9 esa] tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezr isd ls gs] mu ckrksa ds flok; vf/køkur djrs gq,

9 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 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 bdkbz 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 uksv % lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bdkbz vf/kdre dher ¼#-½ izksizkuksyksy xksyh izksizkuksyksy- 40 fexzk 1 xksyh 2.56 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=.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 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 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 (4) 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 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

10 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 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-@173@41/2017@,q@qk- la- 8¼41½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 14th February, 2017 S.O. 444(E). In implementation of directions given in line with review order issued vide letter No /72/2016-PI.I dated passed by the Department of Pharmaceuticals and 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. 1951(E), dated 2nd June, 2016 regarding formulation pack mentioned in the table at Sl. No. 9 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 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: Sl. No. Note : Name of the Scheduled Formulation TABLE Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Propranolol Tablet Propranolol-40mg 1 Tablet 2.56 (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.

11 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 (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/173/41/2017/F/F. No. 8(41)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns'k ubz fnyyh] 14 Qjojh] 2017 dk-vk- 445¼v½- jk"vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k] 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 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 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 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 uke@czkam dk uke izcyrk bdkbz fofuekzrk vksj foi.ku daiuh dze k% (1) (2) (3) (4) (5) (6) lkbcysdl,e 30,Dlvkj xksyh 2. lkbcysdl,e 40 xksyh izr;sd vfyfir ck;ys;mz xksyh esa% esvqksfezu,plh,y 500 fexzk- ¼,DlVsafMM fjyht esa½ XyhdyktkbM 30 fexzk- izr;sd vfyfir xksyh esa% XyhdyktkbM 40 fexzkesvqksfezu,plh,y 500 fexzk- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- [kqnjk ewy; ¼#-½ 45.40

12 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 3. lkbcysdl,e 60,Dlvkj xksyh 4. lkbcysdl,e 80 xksyh 5. lkbcysdl,eoh 80-2 ¼0-2@500@80½ xksyh 6. lkbcysdl,eoh 80-3 ¼0-3@500@80½ xksyh uksv % izr;sd vfyfir ck;ys;mz xksyh esa% XyhdyktkbM 60 fexzk- ¼,DlVsafMM fjyht esa½ esvqksfezu,plh,y 500 fexzk- ¼,DlVsafMM fjyht esa½ izr;sd vfyfir xksyh esa% XyhdyktkbM 80 fexzkesvqksfezu,plh,y 500 fexzkizr;sd vfyfir xksyh esa% esvqksfezu,plh,y 500 fexzk- XyhdyktkbM 80 fexzkoksxyhcksl 0-2 fexzkizr;sd vfyfir xksyh esa% esvqksfezu,plh,y 500 fexzk- XyhdyktkbM 80 fexzkoksxyhcksl 0-3 fexzk- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- 10 xksfy;ka esllz bfjl ykbq lkbaflt izk- fy- ¼d½ mi;qzdr nh xbz fofufn"v QkWewZys'ku ds fofuekzrk vfkkzr tks ÞubZ Mªxß Mhihlhvks] 2013 ds isjkxzkq 2¼u½ 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 (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 gsaa ¼x½ vks"k/k ¼ewY; fu;a=.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=.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 ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) 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 of.kzr [kqnjk ewy; tsusfjd@leku fej.k ds fdlh czkam@fofuzfefr;ksa dh izcyrk ij mi;qzdr of.kzr fofuekzrk@foi.kudrkz ij ykxw gs tks ljdkj }kjk fu/kkzfjr lhkh ykxw os/kkfud vko';drkvksa dh iwfrz ds v/khu izklafxd fof/k;ksa@fu;eksa ds vurxzr tslk fd dsunzh;@jkt; ykblsflax vkwfkksfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykblsal eatwjh ds rgr tks bldk vuqikyu djrh gsaa ¼p½ mi;qzdr fofufezfr;ksa dh mriknu@vk;kr vksj fcøh ds lecu/k esa 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 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

13 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 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 esa mijksdr lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v fofufezfr;ksa ds isdksa dh [kqnjk ewy; fu;r gksus ds ifj.kkelo#i] vkns'k tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh fujlr gks tk;saxsa [dka- la-@173@41/2017@,q@qk- la- 8¼41½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 14th February, 2017 S.O. 445(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 Strength Unit Manufacturer & Marketing Company respectively Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 1. Cyblex M 30 XR tablet Each uncoated bilayered tablet contains: Metformin HCL 500mg (as extended release) Gliclazide 30mg 10 Tablets M/s Eris Life Sciences Pvt. Ltd Cyblex M 40 tablet Each uncoated tablet contains: Gliclazide 40mg Metformin HCl 500mg 3. Cyblex M 60 XR tablet Each uncoated bilayered tablet contains: Gliclazide 60mg (as extended release) Metformin HCl 500mg (as extended release) 4. Cyblex M 80 tablet Each uncoated tablet contains: Gliclazide 80mg Metformin HCl 500mg 10 Tablets 10 Tablets 10 Tablets M/s Eris Life Sciences Pvt. Ltd M/s Eris Life Sciences Pvt. Ltd M/s Eris Life Sciences Pvt. Ltd

14 14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 5. Cyblex MV 80.2 (0.2/500/80) tablet 6. Cyblex MV 80.3 (0.3/500/80) tablet Each uncoated tablet contains: Metformin HCL 500mg Gliclazide 80mg Voglibose 0.2mg Each uncoated tablet contains: Metformin HCL 500mg Gliclazide 80mg Voglibose 0.3mg 10 Tablets 10 Tablets M/s Eris Life Sciences Pvt. Ltd M/s Eris Life Sciences Pvt. Ltd 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 price list in Form V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS. (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 prices are applicable only to the manufacturer / marketeer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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. (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/173/41/2017/F/F. No. 8(41)/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