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- 70] ubz fnyyh] 'kqøokj] iqjojh 23] 208@ QkYxqu 4] 939 No. 70] NEW DELHI, FRIDAY, FEBRUARY 23, 208/ PHALGUNA 4, 939 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] 23 Qjojh] 208 dk- vk- 793¼v½ ¼v½. Hkkjr ljdkj ds jlk;u vksj mozjd ea=ky; }kjk tkjh dk0 vk0 394¼v½ rkjh[k 30 ebz] 203 vksj dk0 vk0 70¼v½ rkjh[k 0 ekpz] 206 ds lkfk ifbr vks"k/k ¼dher fu;a=.k½ vkns'k] 203 ds isjk 5, vksj 5 }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 fofufezfr dk uke@czkam dk uke izcyrk bdkbz fofuekzrk vksj foi.ku daiuh [kqnjk ewy; ¼#-½ () (2) (3) (4) (5) (6).,EyksfMikbu izr;sd fqye fyfir xksyh esa% xksyh esllz okihds;j QkekZ 2.0 $okylkjvu xksyh,eyksfmikbu ckbzlysv ds cjkcj ¼osysefod 80,,e½,EyksfMikbu ;w,lih 5 fexzk-] 2.,EyksfMikbu $ okylkjvu xksyh ¼osysefod 60,,e½ okylkjvu ;w,lih 80 fexzk- xksyh izr;sd fqye fyfir xksyh esa%,eyksfmikbu ckbzlysv ds cjkcj,eyksfmikbu ;w,lih 5 fexzk-] okylkjvu ;w,lih 60 fexzk- xksyh xksyh esllz okihds;j QkekZ izk@esllz,ysfecd GI/208 ()

2 2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 3. ifdyvsdlsy ¼izksVhu ckmum ikfvzdyl½ butsdvscy QkWj llisa ku ¼ukcVksDlksy½ 4. VsyfelkZVu $ DyksjFkkfyMksu xksyh 5. XyhehfijkbM esvqkwfezu$oksxyhckwl xksyh ¼fVªoksxks 2@0-3½ 6. bvksfjdksdlhc $ isjkflvkeksy xksyh 7. lksqkslcqohj $ osyivklohj xksyh 8.,sVksjokLVkfVu $ DyksfiMksxzsy dsilwy 9.,sVksjokLVkfVu $ DyksfiMksxzsy dsilwy 0. jkslqoklvkfvu $,Lizhu$ DyksfiMksxzsy dsilwy. QSjl,LdkWcsZV $ Qksfyd,flM llisa ku izr;sd ok;y esa% ifdyvsdlsy 00 fexzk- batsd ku izr;sd vfyfir ok;ys;mz xksyh esa% VsyfelkZVu vkbzih 40 fexzk-] DyksjFkkfyMksu vkbzih 6-25 fexzk- izr;sd vfyfir ok;ys;mz xksyh esa% XyhehfijkbM vkbzih 2 fexzk-] esvqkwfezu gkbmªksdyksjkbm vkbzih 500 fexzk- ¼,lvkj QkWeZ esa½ oksxyhckwl vkbzih 0-3 fexzkizr;sd fqye fyfir xksyh esa% bvksfjdksdlhc vkbzih 60 fexzk-] isjkflvkeksy vkbzih 325 fexzkizr;sd fqye fyfir xksyh esa% lksqkslcqohj vkbz,p 400 fexzk-] osyivklohj vkbz,p 00 fexzkizr;sd gkmz tsykfvu dsilwy esa%,svksjoklvkfvu dsfy k;e vkbzih ds cjkcj,svksjoklvkfvu 0 fexzk- ¼fiysVl esa½] DyksfiMksxzsy izr;sd gkmz tsysvkbu dsilwy esa%,svksjoklvkfvu dsfy k;e vkbzih ds cjkcj,svksjoklvkfvu 20 fexzk- ¼fiysVl esa½] DyksfiMksxzsy izr;sd gkmz tsysvkbu dsilwy esa% jkslqoklvkfvu dsfy k;e vkbzih ds cjkcj jkslqoklvkfvu 20 fexzk- ¼fiysVl esa½],lizhu vkbzih 75 fexzk- ¼buVsfjd fyfir fiysvl esa½] DyksfiMksxzsy izr;ds 5 fe vkwq llisa ku esa% QSjl,LdkWcsZV ds cjkcj bysesuvy vk;ju 30 fexzk-] Qksfyd,flM vkbzih 550,elhth bu, fqysomz lh:ih csl 2. cksjvstksfec batsd ku izr;sd ok;y esa% cksjvstksfec vkbzih 3-5 batsd ku 3. VsusfyXyhfIVu $ esvqkwfezu,plh,y xksyh 4. VsusfyXyhfIVu $ esvqkwfezu,plh,y xksyh izr;ds vfyfir ok;ys;mz xksyh esa% VsusfyXyhfIVu gkbzmªksczksekbm gkbmªsv ds cjkcj VsusfyXyhfIVu 20 fexzk-] esvqkwfezu,plh,y 500 fexzk- ¼,lvkj½ izr;ds vfyfir ok;ys;mz xksyh esa% VsusfyXyhfIVu gkbzmªksczksekbm gkbmªsv ds cjkcj VsusfyXyhfIVu 20 fexzk-] esvqkwfezu,plh,y 000 fexzk- ¼,lvkj½ okw;y esllz isusfl;k ek;yu QkekZL;wfVdYl izk- xksyh esllz,del esudkbam QkekZ xksyh esllz foamykl xksyh esllz jkosuhksy gsyfkds;j gsyfkds;j izk- 28 xksyh esllz gsvsjks VksjsaV dsilwy esllz dsilwy esllz dsilwy esllz bavkl fe esllz buksok dsivsc izk@esllz bavkl okw;y esllz bavkl xksyh esllz foamykl bafm;k xksyh esllz foamykl bafm;k

3 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 uksv % ¼d½ mi;qzdr nh xbz fofufnz"v QkWewZys'ku ds fofuekzrk vfkkzr tks ÞubZ Mªxß Mhihlhvks] 203 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 (6) 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] 203 ds isjkxzkq 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] 203 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?k½vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 203 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 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] 203 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] 955 ds lkfk ifbr Mhihlhvks] 203 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-@87@55/208,q Qk- la- 8¼55½@208@Mhih@,uihih,&fMoh&II] MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICALS PRICING AUTHORITY) ORDER New Delhi, the 23 rd February, 208 cythr falag] lgk;d funs kd S.O. 793(E). In exercise of the powers conferred by paragraphs 5, and 5 of the Drugs (Prices Control) Order, 203, read with S.O. 394(E) dated the 30 th May, 203 and S. O. 70(E) dated 0 th March, 206 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.) () (2) (3) (4) (5) (6). Amlodipine +, Valsartan Tablet (Valembic 80 AM) Each film coated tablet Amlodipine Besylate eq. to Amlodipine USP 5mg, Tablet M/s Vapicare pharma Pvt. Ltd. / M/s Alembic Amlodipine +, Valsartan Tablet (Valembic 60 AM) Valsartan USP 80mg Tablet Each film coated tablet Amlodipine Besylate eq. to Amlodipine USP 5mg, Valsartan USP 60mg Tablet Tablet M/s Vapicare pharma Pvt. Ltd. / M/s Alembic 3.24

4 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 3. Paclitaxel (Protein Bound Particles) for Injectable Suspension (Nabtoxol) 4. Telmisartan + Chlorthalidone Tablet 5. Glimepiride + Metformin + Voglibose Tablet (TRIVOGO 2/0.3 Mg) 6. Etoricoxib + Paracetamol Tablet 7. Sofosbuvir + Velpatasvir Tablets 8. Atorvastatin + 9. Atorvastatin + 0. Rosuvastatin + Aspirin +. Ferrous Ascorbate + Folic Acid Suspension Each vial Paclitaxel 00mg Human albumin Telmisartan IP 40mg, Chlorthalidone IP 6.25mg Glimepiride IP 2mg, Metformin Hydrochloride IP 500mg (As SR form) Voglibose IP 0.3mg Each film coated tablet Etoricoxib IP 60mg, Paracetamol IP 325mg Each film coated tablet Sofosbuvir IH 400mg, Velpatasvir IH 00mg Each hard gelatine capsule Atorvastatin Calcium IP eq. to Atorvastatin 0mg (As Pellets) Clopidogrel 75mg (As Pellets) Each hard gelatine capsule Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As Pellets) Clopidogrel 75mg (As Pellets) Each hard gelatine capsule Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As pellets) Aspirin IP 75mg (As enteric coated pellets) Clopidogrel 75mg (As pellets) Each 5ml of suspension Ferrous Ascorbate eq. to elemental Iron 30mg, Folic Acid IP 550mcg In a flavoured Syrupy base. 2. Bortezomib Injection Each vial Bortezomib IP 3.5mg Injection 3. Teneligliptin + Metformin HCl Tablet 4. Teneligliptin + Metformin HCl Tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg (SR) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 000mg (SR) Vial M/s Panacea Biotec Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. Tablet M/s Akums Drugs & M/s Mankind Pharma Tablet M/s Windlas Biotech / M/s Alembic Pharmaceuticals Ltd. Tablet M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd. 28 s Tablets M/s Hetero Labs Ltd. / M/s Torrent Pharmaceuticals Ltd. M/s Emcure M/s Emcure Pharmaceuticals Ltd../ M/s Intas ML M/s Innova Captab Pvt. Ltd. / M/s Intas Vial M/s Intas Tablet M/s Windlas Biotech and marketed by M/s Abbott India Tablet M/s Windlas Biotech and marketed by M/s Abbott India Note: (a) The manufacturer of above mentioned formulations i.e. new drug under paragraph 2(u) of the DPCO, 203 shall fix the retail price as specified in column (6) of the table hereinabove.

5 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (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 of the DPCO, 203. The manufacturer shall issue a price list in Form V from date of Notification as per paragraph 24 of the DPCO, 203 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 203, 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 / marketeer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 203 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, 203 read with the Essential Commodities Act, 955. (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/87/55/208/F.No. 8(55)/208/DP/NPPA/Div-II] BALJIT SINGH, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-0064 and Published by the Controller of Publications, Delhi-0054.

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

vlk/kj.k izkf/dkj ls izdkf'kr jlk;u vksj mozjd ea=ky; jftlvªh laö Mhö,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II [k.m 3 mi&[k.m (ii) PART II Section 3 Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 1591] ubz fnyyh]