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

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- 899] ubz fnyyh] c`glifrokj] ekpz 30] 2017@ ps=k 9] 1939 No. 899] NEW DELHI, THURSDAY, MARCH 30, 2017/CHAITRA 9, 1939 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] 30 ekpz] 2017 dk-vk vk-1008¼v½ 1008¼v½-&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 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 es a dh Øe k% rrlfkkuh izfof V;ksa esa fofufnz V [kqjkd :i,oa izcyrk vksj bdkbz lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof V esa fofufnz V vuqlwfpr fofufezfr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gs% lkj.kh dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½ 1. म ड ल क स ल 100 म. 1 क स ल स ल स सन ओरल ल ड 250 म./5 म ल. 1 म ल प यर जन म इड ओरल ल ड 250 म./5 म ल. 1 म ल ग न स ल व र क स ल 250 म. 1 क स ल एब क व र (ए) + ल म व ड न (ब ) ग ल 60 म.(ए) + 30 म.(ब ) 1 ग ल ल म व ड न (ए)+ न वर प इन (ब )+ ट व डन ड परस बल ग ल 30 म.(ए) ग ल 4.68 (स ) म.(ब ) + 6 म.(स ) 7. ल पन वर (ए) + रट न वर (ब ) ग ल 100 म.(ए) + 25 म.(ब ) 1 ग ल प ग ल ट ड इ टरफ र न अ फ 2 ब इ ज शन 120 एमस ज त प क 13, प ग ल ट ड इ टरफ र न अ फ 2 ए इ ज शन 180 एमस ज त प क 7, GI/2017 (1)

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 10. आट म थर (ए) + य म फ न (ब ) ओरल ल ड 80 म.(ए) +480 म./5 म ल.(ब ) 1 म ल डन स ल न ग ल 40 म. 1 ग ल स इ ल प रन इ ज शन 50 म./ म ल. 1 म ल ज़ ल नक ए सड इ ज शन क लए प उडर 4 म. त प क 3, लव ड प (ए) + क बड प (ब ) स आर ग ल 200 म.(ए) + 50 म. (ब ) 1 ग ल व रफ रन ग ल 3 म. 1 ग ल व रफ रन ग ल 2 म. 1 ग ल ह इ क ट स न ग ल 10 म. 1 ग ल ह इ क ट स न ग ल 5 म. 1 ग ल ल व न ज ल ग ल 0.75 म. 1 ग ल ए ट -र ब ज इ य न ल ब लन इ ज शन 300 आईय / म ल. 1 म ल uksv % ¼d½ vf/kdre ewy; fnukad ls ykxw gsa ¼vf/kdre ewy;ksa esa 2015 dh vis{kk o kz 2016 ds fy, izfr kr dh Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ dh nj kkfey gsa½a 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 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 ¼x½ 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 ¼/ku LFkkuh; dj lfgr½ ls de gs] tgka dgh Hkh ykxw gks] vks k/k ¼ewY; fu;a=.k½ vkns k] 2013 ds isjkxzkq 16(2) ds vuqlkj o kz 2016 ds fy, izfr kr dh nj ls Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ ds vk/kkj ij viuh fofufezfr;ksa dk ekstwnk vf/kdre [kqnjk ewy; ¼,evkjih½ dks la kksf/kr dj ldrs gsa tks vf/kdre [kqnjk dher ¼/ku LFkkuh; dj] tks ykxw gksa] ;fn dksbz gsa½ ds v/khu gksxha ¼?k½ 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 ¼M+½ 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 ¼p½ 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 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 ¼N½ 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 ¼t½ 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 ¼>½ 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.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-@175@43@2017@,q@qk- la0 8¼43½@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 30th March, 2017 S.O (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 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any, in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: Sl. No. Note: Name of the Scheduled Formulation TABLE Dosage form & Strength Unit Ceiling Price (Rs.) 1. Tramadol Capsule 100mg 1 Capsule Ciprofloxacin Oral Liquid 250mg/5ml 1 ML Pyrazinamide Oral Liquid 250mg/5ml 1 ML Ganciclovir Capsule 250mg 1 Capsule Abacavir (A) + Lamivudine (B) Tablet 60mg (A) + 30mg (B) 1 Tablet Lamivudine (A)+ Nevirapine (B) Dispersible Tablet 30mg (A) + 1 Tablet Stavudine (C) 50mg (B) + 6mg (C) 7. Lopinavir (A) + Ritonavir (B) Tablet 100mg (A) + 25mg (B) 1 Tablet Pegylated interferon alfa 2b Injection 120mcg Each Pack 13, Pegylated interferon alfa 2a Injection 180mcg Each Pack 7, Artemether (A) + Lumefantrine Oral Liquid 80mg (A) +480mg 1ML 3.82 (B) (B) /5ml 11. Prednisolone Tablet 40mg 1 Tablet Cyclosporine Injection 50mg/ml 1 ML Zoledronic Acid Powder for Injection 4mg Each Pack 3, Levodopa (A) + Carbidopa (B) CR Tablet 200mg (A) + 50mg 1 Tablet 3.89 (B) 15. Warfarin Tablet 3mg 1 Tablet Warfarin Tablet 2mg 1 Tablet Hydrocortisone Tablet 10mg 1 Tablet Hydrocortisone Tablet 5mg 1 Tablet Levonorgestrel Tablet 0.75mg 1 Tablet Anti-rabies immunoglobulin Injection 300 IU/ml 1 ML (a) (b) (c) (d) The ceiling prices are applicable with effect from (ceiling prices are inclusive of Wholesale Price Index for the year 2016 over 2015). 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), may revise the existing M.R.P. of their formulations, on the basis of % for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). 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.

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (e) (f) (g) (h) (i) (j) 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, 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/175/43/2017/F/F. No. 8(43)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 30 ekpz] 2017 dk- vk- 1009¼v½ ¼v½-&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 [kqjkd :i,oa izcyrk vksj bdkbz lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa fofufnz"v vuqlwfpr fofufezfr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds #i esa fu;r djrh gsa lkj.kh dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½ 1. ल क न इ ज शन 5% क स थ 7.5% ल क ज 1 म ल म ड ल इ ज शन 50 म./ म ल. (20 म ल.प क) 1 म ल म ड ल इ ज शन 50 म./ म ल. (2 म ल. प क तक) 1 म ल म शयम स फ ट इ ज शन 500 म./ म ल. 1 म ल ज ट म इ सन इ ज शन 10 म./ म ल. 1 म ल ड पस न ग ल 100 म. 1 ग ल एल- ऐ प रज इन स इ ज शन क लए प उडर 5000 क य त प क डन स ल न इ ज शन 20 म./2 म ल. 1 म ल म ट ल म इड इ ज शन 5 म./ म ल. 1 म ल. 1.35

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (10 म ल. प क) 10. म ट ल म इड इ ज शन 5 म./ म ल. (2 म ल. प क) 1 म ल uksv % 11. म ल म इन ड य ईज य ट इ ज शन 76% ड य /व 1 म ल म ल म इन ड य ईज य ट इ ज शन 60% ड य /व 1 म ल ए मन स ल स लक ए सड ग ल 400 म. 1 ग ल ए ट -र ब ज इ य न ल ब लन इ ज शन 150 आईय / म ल. 1 म ल स स न इल क लन इ ज शन 50 म./ म ल. 1 म ल ऑ स ट सन इ ज शन 10 आईय / म ल. 1 म ल ¼d½ vf/kdre ewy; fnukad ls ykxw gsa ¼vf/kdre ewy;ksa esa 2015 dh vis{kk o kz 2016 ds fy, izfr kr dh Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ dh nj kkfey gsa½a 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 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 ¼x½ 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 ¼/ku LFkkuh; dj lfgr½ ls de gs] tgka dgh Hkh ykxw gks] vks k/k ¼ewY; fu;a=.k½ vkns k] 2013 ds isjkxzkq 16¼2½ ds vuqlkj o kz 2016 ds fy, izfr kr dh nj ls Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ ds vk/kkj ij viuh fofufezfr;ksa dk ekstwnk vf/kdre [kqnjk ewy; ¼,evkjih½ dks la kksf/kr dj ldrs gsa tks vf/kdre [kqnjk dher ¼/ku LFkkuh; dj] tks ykxw gksa] ;fn dksbz gsa½ ds v/khu gksxha ¼?k½ 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 ¼M+½ 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 ¼p½ 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 ¼N½ 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 ¼t½ 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 ¼>½ 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.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 bl vkns k ls iwoz tkjh gq, gsa] Lor% gh vf/køe.k gks tk;saxsa [dka-la-@175@43@2017@,q@qk- la0 8¼43½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs kd

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ORDER New Delhi, the 30th March, 2017 S.O. 1009(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 dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: Table Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) 1. Lignocaine Injection 5% with 7.5% Glucose 1 ML Tramadol Injection 50mg/ml 1 ML 1.18 (20ML Pack) 3. Tramadol Injection 50mg/ml 1 ML 9.91 (upto 2ML Pack) 4. Magnesium Sulphate Injection 500mg/ml 1 ML Gentamicin Injection 10mg/ml 1 ML Dapsone Tablet 100mg 1 Tablet L-Asparaginase Powder for Injection 5000KU Each Pack Prednisolone Injection 20mg/2ml 1 ML Metoclopramide Injection 5mg/ml 1 ML 1.35 (10 ML Pack) 10. Metoclopramide Injection 5mg/ml 1 ML 2.22 (2 ML Pack) 11. Meglumine Diatrizoate Injection 76%w/v 1 ML Meglumine Diatrizoate Injection 60%w/v 1 ML aminosalicylic Acid Tablet 400mg 1 Tablet Anti-rabies immunoglobulin Injection 150 IU/ml 1 ML Succinyl Choline Injection 50mg/ml 1 ML Oxytocin Injection 10 IU/ml 1 ML Note: (a) The ceiling prices are applicable with effect from (ceiling prices are inclusive of Wholesale Price Index for the year 2016 over 2015). (b) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus 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. (c) 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), may revise the existing M.R.P. of their formulations, on the basis of % for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). (d) 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. (e) 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.

7 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 (f) 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. (g) 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, (h) 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. (i) 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, (j) 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/175/43/2017/F/ F. No. 8(43)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 30 ekpz] 2017 dk-vk vk- 1010¼v½-& vks"k/k fohkkx }kjk ikfjr dze k% fnukad ds i= la @18@2016-ihvkbZ-I (ट लमस क स ल 0.5 म. और 1 म.), fnukad ds i= la @58@2016-ihvkbZ-I (फ न ट इन ग ल 100 म.), fnukad ds i= la @29@2016-ihvkbZ-I (ए ज़ म इ सन ग ल 500 म. और 250 म.), fnukad ds i= la @26@2016-ihvkbZ-I ( रफ म प सन क स ल 150 म, 300 म, 450 म. और रफ म प सन सरप 100 म./5 म ल.) vksj fnukad ds i= la @85@2016-ihvkbZ-I (ईम ट नब म सल ट ग ल 100 म.), vks k/k fohkkx }kjk tkjh iqufozyksdu vkns'k esa fn;s x, funsz'kksa ds dk;kzuo;u esa vksj 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- 1404¼v½] fnukad 12 vizsy] 2016 ij Øe la- 64 vksj 65 (ट लमस- क स ल 0.5 म. और 1 म.), dk- vk- 1819¼v½] fnukad 18 ebz] 2016 ij Øe la- 6 (फ न ट इन- ग ल 100 म.), dk- vk- 1686¼v½] fnukad 9 ebz] 2016 ij Øe la- 4 vksj 5 (ए ज़ म इ सन- ग ल 500 म.और 250 म.), dk- vk- 2730¼v½] fnukad 17 vxlr] 2016 ij Øe la- 9] 10 vksj 11 ( रफ म प सन- क स ल 150 म, 300 म, 450 म.), dk- vk- 248¼v½] fnukad 24 tuojh] 2017 ij Øe la- 11 ( रफ म प सन - ओरल ल ड 100 म./5 म ल.), dk- vk- 2730¼v½] fnukad 17 vxlr] 2016 ij Øe la- 13 (ईम ट नब म सल ट - ग ल 100 म.), tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezfr isd ls gs] mu ckrksa ds flok; vf/køkur djrs gq, ftugsa,sls vf/køe.k ds iwoz fd;k x;k gs ;k djus dk yksi fd;k x;k gs] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnz V vf/kdre dher dks mdr lkj.kh ds LraHk ¼3½ vksj ¼4½ esa Øe k% rrlfkkuh izfof V;ksa esa fofufnz V [kqjkd :i,oa izcyrk vksj bdkbz lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof V esa fofufnz V vuqlwfpr fofufezfr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds #i esa fu;r djrh gsa lkj.kh dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz vf/kdre dher ¼#-½ 1. ट लमस क स ल 0.5 म. 1 क स ल ट लमस क स ल 1 म. 1 क स ल फ न ट इन ग ल 100 म. 1 ग ल 1.47

8 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] uksv % 4. ए ज़ म इ सन ग ल 500 म. 1 ग ल ए ज़ म इ सन ग ल 250 म. 1 ग ल रफ म प सन क स ल 150 म 1 क स ल रफ म प सन क स ल 300 म 1 क स ल रफ म प सन क स ल 450 म. 1 क स ल रफ म प सन ओरल ल ड 100 म./5 म ल. 1 म ल ईम ट नब ग ल 100 म. 1 ग ल ¼d½ vf/kdre ewy; fnukad ls ykxw gsa ¼vf/kdre ewy;ksa esa 2015 dh vis{kk o kz 2016 ds fy, izfr kr dh Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ dh nj kkfey gsa½a 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 ¼5½ esa of.kzr vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezr;ksa dh dher dk v/kkseq[kh iqujh{k.k djsaxsa ¼x½ 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 ¼/ku LFkkuh; dj lfgr½ ls de gs] tgka dgh Hkh ykxw gks] vks k/k ¼ewY; fu;a=.k½ vkns k] 2013 ds isjkxzkq 16¼2½ ds vuqlkj o kz 2016 ds fy, izfr kr dh nj ls Fkksd ewy; lwpdkad ¼MCY;wihvkbZ½ ds vk/kkj ij viuh fofufezfr;ksa dk ekstwnk vf/kdre [kqnjk ewy; ¼,evkjih½ dks la kksf/kr dj ldrs gsa tks vf/kdre [kqnjk dher ¼/ku LFkkuh; dj] tks ykxw gksa] ;fn dksbz gsa½ ds v/khu gksxha ¼?k½ 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 gsaa ¼M+½ 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 ¼p½ 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 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 ¼N½ 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 ¼t½ 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 ¼>½ 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.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-@175@43@2017@,q@qk- la- 8¼43½@2017@Mhih@,uihih,-&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 30th March, 2017 S.O.1010(E). In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide letters no /18/2016-PI.I dated (Tacrolimus Capsule 0.5mg & 1mg), 31015/58/2016-PI.I dated (Phenytoin Tablet 100mg), 31015/29/2016-PI.I dated (Azithromycin Tablet 500mg & 250mg), 31015/26/2016-PI.I dated (Rifampicin Capsule 150mg, 300mg, 450mg &

9 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 Rifampicin Syrup 100mg/5ml) & 31015/85/2016-PI.I dated (Imatinib Mesylate Tablet 100mg) respectively 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. 1404(E), dated 12 th April, 2016 at Sl. No. 64 & 65 (Tacrolimus Capsule 0.5mg & 1mg), S.O. 1819(E) dated 18 th May, 2016 at Sl. No. 6 (Phenytoin Tablet 100mg), S.O. 1686(E) dated 9 th May, 2016 at Sl. No. 4 & 5 (Azithromycin Tablet 500mg & 250mg), S.O. 2730(E) dated 17 th August, 2016 at Sl. No. 9, 10 & 11 (Rifampicin Capsule 150mg, 300mg & 450mg), S.O. 248(E) dated 24 th January, 2017 at Sl. No. 11 (Rifampicin Oral Liquid 100mg/5ml) & S.O. 2730(E) dated 17 th August, 2016 at Sl. No. 13 (Imatinib Mesylate Tablet 100mg) respectively regarding formulation pack mentioned in the table 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 dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: Note: TABLE Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) 1. Tacrolimus Capsule 0.5mg 1 Capsule Tacrolimus Capsule 1mg 1 Capsule Phenytoin Tablet 100mg 1 Tablet Azithromycin Tablet 500mg 1 Tablet Azithromycin Tablet 250mg 1 Tablet Rifampicin Capsule 150mg 1 Capsule Rifampicin Capsule 300mg 1 Capsule Rifampicin Capsule 450mg 1 Capsule Rifampicin Oral Liquid 100mg/5ml 1 ML Imatinib Tablet 100mg 1 Tablet (a) (b) (c) (d) (e) (f) (g) (h) The ceiling prices are applicable with effect from (ceiling prices are inclusive of Wholesale Price Index for the year 2016 over 2015). 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), may revise the existing M.R.P. of their formulations, on the basis of % for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, subject to ceiling price (plus local taxes as applicable, if any). 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

10 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (i) (j) 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/175/43/2017/F/F. No. 8(43)/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