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

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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- 896] ubz fnyyh] म गलokj] iqjojh 26] 2019@ iqkyxqu 7] 1940 No. 896] NEW DELHI, TUESDAY, FEBRUARY 26, 2019/ PHALGUNA 7, 1940 रस यन और उव रक म लय (औषध वभ ग) (र ट य औषध म य नध रण धकरण) आद श नई द ल, 26 फरवर, 2019 क.आ. 1028(अ) अ). vks k/k fohkkx }kjk vks k/k ¼ewY; fu;a=.k½] 2013 ds isjk 31 ds varxzr ikfjr blesa uhps lkj.kh ds LraHk ¼6½ esa fofufnz V vkns kksa ds }kjk tkjh iqufozyksdu vkns kksa ds lanhkz 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 dk-vk- 701¼v½ rkjh[k 10 ekpz] 2016 ds lkfk ifbr vks k/k ¼dher fu;a=.k½ vkns k] 2013 ds isjk 4,] 6,] 10,] 11,] 14,] 16,] 17 vksj 18 }kjk iznrr kfdr;ksa dk iz;ksx djrs gq, vksj lkj.kh ds LraHk ¼7½ esa fofufnz V Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky;] ¼jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k½ ds vkns kksa ds vf/kdze.k esa] tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezfr 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] 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 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 ij ykxw olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gs% 1281 GI/2019 (1)

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] Ø- la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkbz lkj.kh vf/kdre dher ¼#-½ iqufozyksdu vkns k la-,oa rkjh[k ekstwnk dk- vkla-,oa rkjh[k (1) (2) (3) (4) (5) (6) (7) 1. cqmslksukbm bugsys ku izfr ehvj (v) fnukad ¼,eMhvkbZ½ 100 Mkst,elhth@Mkst 2. cqmslksukbm bugsys ku ¼,eMhvkbZ½ 200,elhth@Mkst 3. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ 4. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ 5. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ bugsys ku ¼,eMhvkbZ½ 100,elhth ¼,½ $ 6,elhth ¼ch½ bugsys ku ¼,eMhvkbZ½ 200,elhth ¼,½ $ 6,elhth ¼ch½ bugsys ku ¼,eMhvkbZ½ 400,elhth ¼,½ $ 6,elhth ¼ch½ 6. cqmslksukbm bugsys ku ¼MhihvkbZ½ 100,elhth@Mkst 7. cqmslksukbm bugsys ku ¼MhihvkbZ½ 200,elhth@Mkst 8. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ 9. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ 10. cqmslksukbm ¼,½ $ QkseksZVsjksy ¼ch½ bugsys ku ¼MhihvkbZ½ 100,elhth ¼,½ $ 6,elhth ¼ch½ bugsys ku ¼MhihvkbZ½ 200,elhth ¼,½ $ 6,elhth ¼ch½ bugsys ku ¼MhihvkbZ½ 400,elhth ¼,½ $ 6,elhth ¼ch½ 11. fv;ksvªksfi;e bugsys ku ¼,eMhvkbZ½ 9,elhth@Mkst 12. fv;ksvªksfi;e bugsys ku ¼MhihvkbZ½ 18,elhth@Mkst 13. MsDlkesFkklksu batsd ku 4 fexzk-@fefy- izfr ehvj Mkst izfr ehvj Mkst (Ø-la- 112) (v) fnukad (Ø-la- 113) 1.77 i /27/ (v) fnukad ihvkbz-i rkjh[k (Ø-la- 118) izfr ehvj (v) fnukad Mkst ii /52/2017- (Ø-la- 119) izfr ehvj ewy; fu/kkzj.k (v) fnukad Mkst rkjh[k (Ø-la- 120) iii. izfr Mkst /54/ (v) fnukad ewy; fu/kkzj.k rkjh[k (Ø-la- 112) izfr Mkst (v) fnukad (Ø-la- 113) izfr Mkst (v) fnukad (Ø-la- 118) izfr Mkst (v) fnukad (Ø-la- 119) izfr Mkst (v) fnukad (Ø-la- 120) izfr ehvj Mkst (v) fnukad (Ø-la- 799) izfr Mkst (v) fnukad (Ø-la- 798) izfr 2 fefyisd 8.75 i /15/2017- ewy; fu/kkzj.k rkjh[k ii /16/2017- ewy; fu/kkzj.k rkjh[k (v) fnukad (Ø-la- 243)

3 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k tsavkekblhu batsd ku 40 fexzk-@fefy- izfr 2 fefyisd /21/2017- ewy; fu/kkzj.k rkjh[k (v) fnukad (Ø-la- 353) uksv % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbz vksj vf/klwfpr dh xbz vf/kdre dher ¼oLrq,oa lsok 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 ¼oLrq,oa lsok dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezr;ksa dh dher dk v/kkseq[kh la kks/ku djsaxsa ¼[k½ mi;qzdr lkj.kh ¼oLrq,oa lsok dj] tks ykxw gs] ;fn dksbz gs½ ds LraHk ¼5½ esa fofufnz V vf/kdre ewy; dh vis{kk de [kqnjk ewy; okyh Åij of.kzr vuqlwfpr fofufezfr;ksa ds lhkh ekstwnk fofuekzrk Mhihlhvks] 2013 ds isjk 13¼2½ ds vuqlkj olrq,oa lsok dj ds dk;kzuo;u ij mrikn kqyd vksj djksa ds varj ds dkj.k vf/kdre [kqnjk ewy; esa gqbz o`f) ds vykok ekstwnk vf/kdre [kqnjk ewy; dks fujarj cuk, j[ksaxsa 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 olrq,oa lsok dj 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 djsa rfkk mldh dkwih jkt; vks kf/k fu;a=dksa vksj fofuekzrk forjdksa 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 2¼;w½ 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

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] ¼Tk½ fofuekzrk ;k foi.ku deiuh] mijksdr dffkr lkj.kh esa n'kkz;s vf/kdre ewy; vksj 'krks± dk ikyu ugha djrh gsa rks os vko';d olrq, vf/kfu;e] 1955 ds lkfk ifbr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizhkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsa ¼>½ bl vkns'k 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 ;k [kqnjk ewy; fu/kkzfjr vkns'k ;fn dksbz gks] tks fd bl vkns'k ls iwoz tkjh gq, gs] Lor% gh vf/køe.k gks tk;saxsa [dka- la-@195@63@2019@,q@qk- la- 8¼63½@2019@Mhih@,uihih,&fMoh-II] izlsuthr nkl] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (National Pharmaceutical Pricing Authority) ORDER New Delhi, the 26th February, 2019 S.O. 1028(E). In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and 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(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table regarding formulation specified as 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/revises the price as specified in column (5) of the table herein below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation(s) 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.) Review Order number and date Existing SO number and date (1) (2) (3) (4) (5) (6) (7) 1. Budesonide Inhalation (MDI) 100 mcg / dose 2. Budesonide Inhalation (MDI) 200 mcg / dose 3. Budesonide (A)+ Formoterol (B) 4. Budesonide (A)+ Formoterol (B) 5. Budesonide (A)+ Formoterol (B) Inhalation (MDI) 100 mcg (A) + 6 mcg (B) Inhalation (MDI) 200 mcg (A) + 6 mcg (B) Inhalation (MDI) 400 mcg (A) + 6 mcg (B) 6. Budesonide Inhalation (DPI) 100 mcg/dose Per Metered Dose (E) dated (at Sl. No. 112) Per Metered (E) dated Dose Per Metered Dose 1.77 i /27/2016- PI.I dated (at Sl. No. 113) 1461(E) dated (at Sl. No. 118) Per Metered Dose 2.51 ii /52/2017- Pricing dated (E) dated (at Sl. No. 119) Per Metered (E) dated Dose iii /54/2017- Pricing (at Sl. No. 120) Per Dose 1.87 dated (E) dated (at Sl. No. 112)

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 7. Budesonide Inhalation (DPI) 200 mcg/dose 8. Budesonide (A)+ Formoterol (B) 9. Budesonide (A)+ Formoterol (B) 10. Budesonide (A)+ Formoterol (B) Inhalation (DPI) 100 mcg (A) + 6 mcg (B) Inhalation (DPI) 200 mcg (A) + 6 mcg (B) Inhalation (DPI) 400 mcg (A) + 6 mcg (B) 11. Tiotropium Inhalation (MDI) 9 mcg/dose 12. Tiotropium Inhalation (DPI) 18 mcg/dose 13. Dexamethasone Injection 4mg/ml 14. Gentamicin Injection 40mg/ml Per Dose (E) dated (at Sl. No. 113) Per Dose (E) dated (at Sl. No. 118) Per Dose (E) dated (at Sl. No. 119) Per Dose (E) dated Per Metered Dose (at Sl. No. 120) (E) dated (at Sl. No. 799) Per Dose (E) dated (at Sl. No. 798) Per 2ML Pack 8.75 i /15/2017- Pricing dated ii /16/2017- Pricing dated Per 2ML Pack /21/2017- Pricing dated (E) dated (at Sl. No. 243) 1461(E) dated (at Sl. No. 353) 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 goods and services tax 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 goods and services tax 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 goods and services tax 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 goods and services tax 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, 1955.

6 6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (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/195/63/2019/F/F.No. 8(63)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Asstt. Director vkns k ubz fnyyh] 26 Qjojh] 2019 dk- vk- 1029¼v½-&vkS"k/k fohkkx }kjk vks k/k ¼ewY; fu;a=.k½] 2013 ds isjk 31 ds varxzr ikfjr blesa uhps lkj.kh ds LraHk ¼6½ esa fofufnz"v vkns'kksa ds }kjk tkjh iqufozyksdu vkns'kksa ds lanhkz esa fn;s x, funsz'kksa ds dk;kzuo;u esa vksj 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 5 11 vksj 15 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] lkj.kh ds LraHk ¼7½ esa fofufnz"v Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky;] ¼jk"Vªh; vks"k/k ewy; fu/kkzj.k izkf/kdj.k½ ds vkns'kksa ds vf/køe.k esa] tgk rd mldk lecu/k uhps dh lkj.kh ds fofufezfr 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] 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 ¼5½ eas fofufnz"v [kqnjk ewy; dks mdr lkj.kh ds LraHk ¼3½] ¼4½] vksj ¼8½ eas rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk] bdkbz ¼;wfuV½ vksj fofuekzrk vksj foi.ku deifu;ksa ds uke lfgr LraHk ¼2½ esa dh rrlfkkuh izfof"v esa ls izr;sd dh] olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre [kqnjk ewy; ds :i esa fu;r djrh gsa Ø- la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk lkj.kh bdkbz vf/kdre dher ¼#-½ iqufozyksdu vkns k la-,oa rkjh[k ekstwnk dkvk- la-,oa rkjh[k fofuekzrk vksj foi.ku daiuh (1) (2) (3) (4) (5) (6) (7) (8) 1. csdyksqsu izr;sd 5 fefy- esa% /45/2018- esllz vksjy csdyksqsu vkbzih 5 fefy- ewy; fu/kkzj.k lksyq kau fexzk- fnukad uksv % 5638(v) fnukad (Ø-la- 18) lu QkekZL;wfVdYl bamlvªht fyfevsm / esllz QkekZ yscksjsvjht fy- ¼d½ mi;qzdr nh xbz fofufnz"v QkWewZys'ku ds fofuekzrk vfkkzr tks ÞubZ Mªxß Mhihlhvks] 2013 ds isjkxzkq 2¼;w½ ds rgr mi;qzdr nh xbz lkj.kh ds LraHk ¼5½ esa fofufnz"v [kqnjk ewy; fu/kkzfjr djsaxsa 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 olrq,oa lsok dj 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 ¼5½ 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 djsa rfkk mldh dkiwh jkt; vks"kf/k fu;a=dksa vksj fofuekzrk forjdksa dks tkjh djsaa lu

7 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ 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 ¼M-½ mi;qzdr xsj vf/kdre dher ¼[kqnjk ewy;½ dsoy mi;qzdr fuekzrk@foi.ku ds fy, ykxw gs tslk fd mi;qzdr tsusjfd@leku lajpuk okyk dksbz Hkh czkam@ lacaf/kr fofufezfr;ksa dh izcyrk rfkk ljdkj }kjk fu/kkzfjr ykxw os/kkfud vko';drkvksa dh iwfrz ds v/khu izklafxd fof/k;ksa@fu;eksa ds vurxzr dsunzh;@jkt; ykblsflax vkwfkksfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykblsal eatwjh ds rgr lacaf/kr fofufezr fuekzrk@foi.ku deifu;ka tks vuqikyu djrh gsa ¼p½ 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 [dka-la-@195@63@2019@,q@qk- la- 8¼63½@2019@Mhih@,uihih,&fMoh-II] ORDER New Delhi, the 26th February, 2019 izlsuthr nkl] lgk;d funs'kd S. O. 1029(E). In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and 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, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (5) of the table herein below as the retail price, exclusive of goods and services tax, 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, as specified in the corresponding entries in columns (3), (4) and (8) thereof; Sl. No. Name of the Formulation Dosage form & Strength TABLE Unit Retail Price (Rs.) Review Order number and date Existing SO number & date Manufacturer & Marketing Company (1) (2) (3) (4) (5) (6) (7) (8) 1. Baclofen Oral Each 5 ml Solution Baclofen IP 5 mg 1 ML /45/2018- Pricing dated (E) dated (at Sl. No. 18) M/s. Sun Pharmaceuticals Industries M/s. Sun Pharma Laboratories Ltd Note: (a) The manufacturer 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 (5) of the table hereinabove. (b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (5) of the above said table.

8 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 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. (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 / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, subject to fulfilment 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) 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, [PN/195/63/2019/F/F. No. 8(63)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Asstt. Director vkns k ubz fnyyh] 26 Qjojh] 2019 dk- vk- 1030¼v½-&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,] 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 rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk] bdkbz ¼;wfuV½ vksj fofuekzrk vksj foi.ku deifu;ksa ds uke lfgr LraHk ¼2½ esa dh rrlfkkuh izfof"v esa ls izr;sd dh] olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre [kqnjk ewy; ds :i esa fu;r djrh gsa lkj.kh dzla- vuqlwfpr izcyrk bdkbz fofuekzrk vksj foi.ku [kqnjk fofufezfr dk daiuh ewy; ¼#-½ uke@czkam dk uke (1) (2) (3) (4) (5) (6) 1. izr;sd fqye fyfir esa% 5.88 bzlhvkyksizke vkwdlkysv esllz I;ksj,oa D;ksj bzlhvkyksizke $ vkbzih ds cjkcj gsyfkds;j izk- fy- Dyksuktsike bzlhvkyksizke 5 fu;ksesd ¼,afMQzs&,y,l½ Dyksuktsike vkbzih 0-25 QkekZL;wfVdYl izk- fyfexzk-

9 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 2. isjkflvkeksy $,lsdyksqsud 3. felksizkslvksy 4. esqsukfed,flm $ isjkflvkeksy 5. VªkLVqtqekc batsd ku 6. DyhuhfMikbu $ VsyfelkVZu $ DyksjFkkyhMksu 7. esvqksfezu $ XyhDyktkbM 8. esvqksfezu $ XyhDyktkbM 9. VsyfelkVZu $ esvksizksyksy ¼VsyehykbQ&,e 25½ 10. VsyfelkVZu $ esvksizksyksy ¼VsyehykbQ&,e 50½ 11. izksizkuksyksy $ Q~yqukfjtkbu izr;sd vfyfir esa% isjkflvkeksy vkbzih 325 fexzk-],lsdyksqsud vkbzih 100 fexzkizr;sd vfyfir esa% felksizkslvksy 25,elhth izr;sd vfyfir esa% esqsukfed,flm vkbzih 500 fexzk-] isjkflvkeksy vkbzih 325 fexzkizr;sd yk;ksfqfytm ok;y esa% VªkLVqtqekc 150 fexzkizr;sd fqye fyfir esa% DyhuhfMikbu vkbzih 10 fexzk- VsyfelkVZu vkbzih 40 fexzk-] DyksjFkkyhMksu vkbzih 6-25 fexzkizr;sd vfyfir ckbys;mz esa% esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk- ¼,DlMsaM fjfyt QkWeZ esa½ XyhDyktkbM vkbzih 80 fexzk- ¼ekWMhQkbM fjfyt QkWeZ esa½ izr;sd vfyfir ckbys;mz esa% esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk- ¼,DlMsaM fjfyt QkWeZ esa½ XyhDyktkbM vkbzih 60 fexzk- ¼ekWMhQkbM fjfyt QkWeZ esa½ izr;sd fqye fyfir ckbys;mz esa% VsyfelkVZu vkbzih 40 fexzk-] esvksizksyksy lqlhusv vkbzih fexzk- ds cjkcj esvksizksyksy VkjVªsV ¼,DlVsafMM fjfyt QkWeZ esa½ 25 fexzkizr;sd fqye fyfir ckbys;mz esa% VsyfelkVZu vkbzih 40 fexzk-] esvksizksyksy lqlhusv vkbzih fexzk- ds cjkcj esvksizksyksy VkjVªsV ¼,DlVsafMM fjfyt QkWeZ esa½ 50 fexzkizr;sd gkmz tsysfvu dsilwy esa% esllz dsiysv bafm;k izkfy- esllz,des QkWewZys ku izk- fy-@esllz tk;ml gsyfkds;j fy- esllz,del MªXl,aM QkekZL;wfVdYl gsyfkds;j izk- fy- 1 okw;y esllz dsfmyk gsyfkds;j fy-@esllz XysuekdZ QkekZL;wfVdYl fyesllz foamykl Ckk;ksVsd izk- fy-@esllz,ed;ksj QkekZL;wfVdYl fy- 1 dsilwy esllz,uqkj vkwxszfudl izk- fy-@esllz yqfiu fy- esllz,uqkj vkwxszfudl izk- fy-@esllz yqfiu fy- esllz jkosuhksy gsyfkds;j izk- fu;ksesd QkekZL;wfVdYl ¼izk-½ fy- esllz jkosuhksy gsyfkds;j izk- fu;ksesd QkekZL;wfVdYl ¼izk-½ fy- esllz buuksok dsivc fy-@esllz fliyk fy

10 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] dsilwy 12. izksizkuksyksy $ Q~yqukfjtkbu dsilwy 13. ysoksuksxszlvªsy 14. QksjeksVsjkWy $ cqmslksukbm jslfijkvksj llisa ku ¼cqMsVªkWy 0-5½ 15. QksjeksVsjkWy $ cqmslksukbm jslfijkvksj llisa ku ¼cqMsVªkWy 1½ 16. esvqksfezu $ XyhesihjkM ¼xsfeuksj 0-5½ 17. Dykscktke llisa ku 18. fmdyksqsusd $ DyksjtksDlktksu ¼ekbvkslikl&,Q½ 19. Dyksuktsike vksjy fmlbuvhxzsfvax flvªil ¼esytki vksmh,l 0-5½ 20. Dyksuktsike vksjy fmlbuvhxzsfvax flvªil ¼esytki vksmh,l 1½ izksizkuksyksy gkbmªksdyksjkbm vkbz 40 fexzk- ¼,lvkj isysvl esa½] Q~yqukfjtkbu fmgkbmªksdyksjkbm chih ds cjkcj Q~yqukfjtkbu 5 fexzk- ¼isysVl esa½ izr;sd gkmz ftysfvu dsilwy esa% izksizkuksyksy gkbmªksdyksjkbm vkbz 40 fexzk- ¼,lvkj isysvl esa½] Q~yqukfjtkbu fmgkbmªksdyksjkbm chih ds cjkcj Q~yqukfjtkbu 10 fexzk- ¼isysVl esa½ izr;sd vfyfir esa% ysoksuksxszlvªsy vkbzih 1-5 fexzk- izr;ds fefy- jsliwy esa% QksjeksVsjkWy QqekjsV fmgkbmªsv ds cjkcj QksjeksVsjkWy QqekjsV 20,elhth] cqmslksukbm vkbzih 0-5 fexzkizr;ds fefy- jsliwy esa% QksjeksVsjkWy QqekjsV fmgkbmªsv ds cjkcj QksjeksVsjkWy QqekjsV 20,elhth] cqmslksukbm vkbzih 1 fexzkizr;ds vfyfir ckbys;mz esa% esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk-] ¼izkykssx fjfyt QkWeZ esa½ XyhesihjkM vkbzih 0-5 fexzkizr;sd fefy- llisa ku esa% Dykscktke vkbzih 2-5 fexzkizr;sd fqye fyfir esa% fmdyksqsusd iksvsf k;e chih 50 fexzk-] DyksjtksDlktksu ;w,lih 500 fexzk- izr;sd vksjy fmlbuvhxzsfvax flvªil esa% Dyksuktsike vkbzih 0-5 fexzk- izr;sd vksjy fmlbuvhxzsfvax flvªil esa% Dyksuktsike vkbzih 1 fexzk- 1 dsilwy izfr 2 fefyisd izfr 2 fefyisd 1 fefy- 1 vksjy fmlbuvhxzsfvax flvªi 1 vksjy fmlbuvhxzsfvax flvªi esllz buuksok dsivc fy-@esllz fliyk fy- esllz ekbzyu yscksjsvjht fy-@esllz ekbzyu QkekZL;wfVdYl izk- fy- esllz,dlk isjsavjyl fy-@esllz esdyksm~l QkekZL;wfVdYl fy- esllz,dlk isjsavjyl fy-@esllz esdyksm~l QkekZL;wfVdYl fy- esllz esdykwml QkekZL;wfVdYl fy- esllz buvkl QkekZL;wfVdYl fyesllz th-,l- QkeZcqVksj izk- fy-@esllz fou&esmhds;j izk- fy- esllz fte yscksjsvjht fy-@esllz,ydse yscksjsvjht fy- esllz fte yscksjsvjht fy-@esllz,ydse yscksjsvjht fy

11 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k Dyksuktsike vksjy fmlbuvhxzsfvax flvªil ¼esytki vksmh,l 2½ uksv % izr;sd vksjy fmlbuvhxzsfvax flvªil esa% Dyksuktsike vkbzih 2 fexzk- 1 vksjy fmlbuvhxzsfvax flvªi esllz fte yscksjsvjht fy-@esllz,ydse yscksjsvjht fy ¼d½ mi;qzdr nh xbz fofufnz"v QkWewZys'ku ds fofuekzrk vfkkzr tks ÞubZ Mªxß Mhihlhvks] 2013 ds isjkxzkq 2¼;w½ ds rgr mi;qzdr nh xbz lkj.kh ds LraHk ¼6½ esa fofufnz"v [kqnjk ewy; fu/kkzfjr djsaxsa ¼[k½ vxj fuekzrkvksa us mi;qzdr lkj.kh ds LraHk ¼6½ esa of.kzr vf/kdre dher ij ljdkj dks oklro esa Hkqxrku fd;k gs ;k ;g ns; gs rks os olrq,oa lsok dj 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 djsa rfkk mldh dkih jkt; vks"kf/k fu;a=dksa vksj fofuekzrk forjdksa dks tkjh djsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kksa ds vuqlkj izr;sd QqVdj fodzsrk vksj forjd fofuekzrk }kjk fn, x, :i esa,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gs fd mlls ijke'kz ds bpnqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`'; Hkkx ij dher lwph vksj iwjd lwph] ;fn dksbz gks] dks laiznf'kzr djsxka ¼M-½ mi;qzdr xsj vf/kdre dher ¼[kqnjk ewy;½ dsoy mi;qzdr fuekzrk@foi.ku ds fy, ykxw gs tslk fd mugksaus vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewy; fu/kkzj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fu/kkzfjr lhkh ykxw os/kkfud vko';drkvksa dh iwfrz ds v/khu izklafxd fof/k;ksa@fu;eksa ds vurxzr tslk fd dsunzh;@jkt; ykblsflax vkwfkksfjvh ds l{ke izkf/kdkjh }kjk esu;wqsdpfjax ykblsal eatwjh ds rgr lacaf/kr fofufezr fuekzrk@foi.ku deifu;ka tks vuqikyu djrh gsa ¼p½ 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 ¼N½ 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-@195@63@2019@,q@qk- la- 8¼63½@2019@Mhih@,uihih,&fMoh-&II] ORDER New Delhi, the 26th February, 2019 izlsuthr nkl] lgk;d funs'kd S. O. 1030(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 goods and services tax, 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, as specified in the corresponding entries in columns (3), (4) and (5) thereof; Sl. No. Name of the Formulation / Brand Name TABLE Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 1. Each film coated tablet M/s. Pure & Cure 5.88 Escitalopram + Healthcare Pvt. Ltd. / Clonazepam Escitalopram Oxalate IP eq. to M/s. Neomac Tablet (Andefre- Escitalopram 5mg, Pharmaceuticals Pvt. LS) Clonazepam IP 0.25mg Ltd.

12 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 2. Paracetamol + Aceclofenac Tablet Each uncoated tablet Paracetamol IP 325mg, Aceclofenac IP 100mg. 3. Misoprostol Tablet Each uncoated tablets Misoprostol 25mcg 4. Mefenamic Acid + Paracetamol Tablet 5. Trastuzumab Injection 6. Cilnidipine + Telmisartan + Chlorthalidone Tablet 7. Metformin + Gliclazide Tablet 8. Metformin + Gliclazide Tablet 9. Telmisartan + Metoprolol Tablet (TELMELIFE M25) 10. Telmisartan + Metoprolol Tablet (TELMELIFE M50) 11. Propranolol + Flunarizine Capsule 12. Propranolol + Flunarizine Capsule Each uncoated tablets Mefenamic Acid IP 500mg, Paracetamol IP 325mg Each Lyophilized Vial Trastuzumab 150mg Each film coated tablet Cilnidipine IP 10mg, Telmisartan IP 40mg Chlorthalidone IP 6.25mg Each uncoated bilayered tablet Metformin Hydrochloride IP 500mg (in extended release form) Gliclazide IP 80mg (as modified release form) Each uncoated bilayered tablet Metformin Hydrochloride IP 500mg (in extended release form) Gliclazide IP 60mg (as modified release form) Each film coated bilayered tablet Telmisartan IP 40mg, Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (as extended release form) 25mg Each film coated bilayered tablet Telmisartan IP 40mg, Metoprolol Succinate IP 47.5mg eq. to Metoprolol Tartrate (as extended release form) 50mg Each hard gelatine capsule Propranolol Hydrochloride IP 40mg (as SR pellets), Flunarizine Dihydrochloride BP eq. to Flunarizine 5mg (as pellets) Each hard gelatine capsule Propranolol Hydrochloride IP 40mg (as SR pellets), Flunarizine Dihydrochloride M/s. Caplet India Private M/s. Acme Formulation Pvt. Ltd. / M/s. Zydus Healthcare M/s. Akums Drugs & Pharmaceuticals Ltd. / M/s. Abbott Healthcare Pvt. Ltd. 1 Vial M/s. Cadila Healthcare / M/s. Glenmark Pharmaceuticals M/s. Windlas Biotech Pvt. Ltd. /M/s. Emcure Pharmaceuticals 1 Capsule 1 Capsule M/s. Anphar Organics Pvt. Ltd. / M/s. Lupin M/s. Anphar Organics Pvt. Ltd. / M/s. Lupin M/s. Ravenbhel Healthcare Pvt. Ltd. / M/s. Neomac Pharmaceuticals (P) Ltd. M/s. Ravenbhel Healthcare Pvt. Ltd. / M/s. Neomac Pharmaceuticals (P) Ltd. M/s. Innova Captab Ltd. / M/s. Cipla M/s. Innova Captab Ltd. / M/s. Cipla

13 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k Levonorgestrel Tablet 14. Formoterol + Budesonide Respirator suspension (Budetrol 0.5) 15. Formoterol + Budesonide Respirator suspension (Budetrol 1) 16. Metformin + Glimepiride Tablet (Geminor 0.5) 17. Clobazam Suspension 18. Diclofenac + Chlorzoxazone Tablet (MYOSPAS-F ) 19. Clonazepam Orally disintegrating Strips (Melzap ODS 0.5) 20. Clonazepam Orally disintegrating Strips (Melzap ODS 1) 21. Clonazepam Orally disintegrating Strips (Melzap ODS 2) Note: BP eq. to Flunarizine 10mg (as pellets) Each uncoated tablet Levonorgestrel IP 1.5mg Each ml respule Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate 20mcg, Budesonide IP 0.5mg Each ml respule Formoterol Fumarate Dihydrate IP eq. to Formoterol Fumarate 20mcg, Budesonide IP 1mg Each uncoated bilayered tablet Metformin Hydrochloride IP 500mg, (as Prolonged release form) Glimepiride IP 0.5mg Each ml suspension Clobazam IP 2.5mg Each film coated tablet Diclofenac Potassium BP 50mg Chlorzoxazone USP 500mg Each Orally disintegrating Strips Clonazepam IP 0.5mg Each Orally disintegrating Strips Clonazepam IP 1mg Each Orally disintegrating Strips Clonazepam IP 2mg Each 2 ML Pack Each 2 ML Pack 1 ML 1 Orally disintegrating Strip 1 Orally disintegrating Strip 1 Orally disintegrating Strip M/s. Mylan Laboratories / M/s. Mylan Pharmaceutical Private M/s. Axa Parenterals Ltd. / M/s. Macleods Pharmaceutical M/s. Axa Parenterals Ltd. / M/s. Macleods Pharmaceutical M/s. Macleods Pharmaceutical M/s. Intas Pharmaceutical M/s. G. S. Pharmbutor Pvt. Ltd. /M/s. Win- Medicare Pvt. Ltd. M/s. ZIM Laboratories / M/s. Alkem Laboratories Ltd. M/s. ZIM Laboratories / M/s. Alkem Laboratories Ltd. M/s. ZIM Laboratories / M/s. Alkem Laboratories Ltd. (a) The manufacturer 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 manufacturer may add goods and services tax 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 manufacturer 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 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

14 14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment 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 manufacturer/marketing companies. (f) 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, (g) 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/195/63/2019/F/F. No. 8(63)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, 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