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] c`glifrokj] vizsy 26] 2018@oS'kk[k 6] 1940 No. 1591] NEW DELHI, THURSDAY, APRIL 26, 2018/VAISAKHA 6, 1940 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] 26 vizsy 2018 dk-vk- 1766¼v½-ÑHkkjr 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,] 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 Ø- la- vuqlwfpr fofufezfr dk uke@czkam dk uke izcyrk lkj.kh bdkbz fofuekzrk vksj foi.ku daiuh (1) (2) (3) (4) (5) (6) 93.75 1. fmdyksqsud $ esfkhy lkylhysv $ esafkksy ¼oksfyuh esdl Lizs 15 fexzk- isd esa½ blesa kkfey gs% fmdyksqsud MkbZbfFkyekbu chih 2-32% MCY;w@MCY;w ¼ds cjkcj fmdyksqsud lksfm;e 2% MCY;w@MCY;w½] esfkhy lkylhysv vkbzih 10% MCY;w@MCY;w vksj esafkksy vkbzih 5% MCY;w@MCY;w 15 xzke esllz lu QkekZL;wfVdYl bamlvªht [kqnjk ewy; ¼#-½ 2407 GI/2018 (1)
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 2. fmdyksqsud $ esfkhy lkylhysv $ esafkksy ¼oksfyuh esdl Lizs 30 fexzk- isd esa½ 3. fmdyksqsud $ esfkhy lkylhysv $ esafkksy ¼oksfyuh esdl Lizs 40 fexzk- isd esa½ 4. fmdyksqsud $ esfkhy lkylhysv $ esafkksy ¼oksfyuh esdl Lizs 60 fexzk- isd esa½ 5.,VksjokLVkfVu $,Lizhu $ DyksfiMksxzsy dsilwy 6.,VksjokLVkfVu $,Lizhu $ DyksfiMksxzsy dsilwy 7.,VksjokLVkfVu $,Lizhu $ DyksfiMksxzsy dsilwy 8.,VksjokLVkfVu $,Lizhu $ DyksfiMksxzsy dsilwy blesa kkfey gs% fmdyksqsud MkbZbfFkyekbu chih 2-32% MCY;w@MCY;w ¼ds cjkcj fmdyksqsud lksfm;e 2% MCY;w@MCY;w½] esfkhy lkylhysv vkbzih 10% MCY;w@MCY;w vksj esafkksy vkbzih 5% MCY;w@MCY;w blesa kkfey gs% fmdyksqsud MkbZbfFkyekbu chih 2-32% MCY;w@MCY;w ¼ds cjkcj fmdyksqsud lksfm;e 2% MCY;w@MCY;w½] esfkhy lkylhysv vkbzih 10% MCY;w@MCY;w vksj esafkksy vkbzih 5% MCY;w@MCY;w blesa 'kkfey gs% fmdyksqsud MkbZbfFkyekbu chih 2-32% MCY;w@MCY;w ¼ds cjkcj fmdyksqsud lksfm;e 2% MCY;w@MCY;w½] esfkhy lkylhysv vkbzih 10% MCY;w@MCY;w vksj esafkksy vkbzih 5% MCY;w@MCY;w,VksjokLVkfVu dsfy k;e vkbzih ds cjkcj,vksjoklvkfvu 10 fexzk- ¼xzkuqysl½],Lizhu vkbzih 75 fexzk- ¼bZlh xksyh esa½ DyksfiMksxzsy fclyqsv vkbzih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½,vksjoklvkfvu dsfy k;e vkbzih ds cjkcj,vksjoklvkfvu 20 fexzk- ¼xzkuqysl½],Lizhu vkbzih 75 fexzk- ¼bZlh xksyh esa½ DyksfiMksxzsy fclyqsv vkbzih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½,vksjoklvkfvu dsfy k;e vkbzih ds cjkcj,vksjoklvkfvu 10 fexzk- ¼xzkuqysl½],Lizhu vkbzih 75 fexzk- ¼bZlh xksyh esa½ DyksfiMksxzsy fclyqsv vkbzih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½,vksjoklvkfvu dsfy k;e vkbzih ds cjkcj,vksjoklvkfvu 20 fexzk- ¼xzkuqysl½],Lizhu vkbzih 75 fexzk- ¼bZlh xksyh esa½ DyksfiMksxzsy fclyqsv vkbzih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½ 30 xzke esllz lu QkekZL;wfVdYl bamlvªht 40 xzke esllz lu QkekZL;wfVdYl bamlvªht 60 xzke esllz lu QkekZL;wfVdYl bamlvªht 1 dsilwy esllz thds,e U;w QkekZ@eSllZ dsfmyk gsyfkds;j 1 dsilwy esllz thds,e U;w QkekZ@eSllZ dsfmyk gsyfkds;j 1 dsilwy esllz l;uksdse QkekZL;wfVdYl @ esllz bjht ykbqlkbal 1 dsilwy esllz l;uksdse QkekZL;wfVdYl @ esllz bjht ykbqlkbal 187.50 231.25 318.75 4.12 5.56 4.12 5.56
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] 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 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-@188@56@2018@,q@qk- la- 8¼56½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 26th April, 2018 S. O. 1766(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. Diclofenac + Methyl Salcylate + Menthol (Volini Maxx Spray in 15gm Pack) Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & 15 GM M/Sun Pharmaceuticals Industries 93.75
4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 2. Diclofenac + Methyl Salcylate + Menthol (Volini Maxx Spray in 30gm Pack) 3. Diclofenac + Methyl Salcylate + Menthol (Volini Maxx Spray in 40gm Pack) 4. Diclofenac + Methyl Salcylate + Menthol (Volini Maxx Spray in 60gm Pack) 5. Atorvastatin + Aspirin + Clopidogrel capsule 6. Atorvastatin + Aspirin + Clopidogrel capsule 7. Atorvastatin + Aspirin + Clopidogrel capsule 8. Atorvastatin + Aspirin + Clopidogrel capsule Menthol IP 5% w/w Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & Menthol IP 5% w/w Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & Menthol IP 5% w/w Diclofenac Diethylamine BP 2.32% w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salcylate IP 10% w/w & Menthol IP 5% w/w Each hard gelatin capsule Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As granules) Aspirin IP 75mg (As EC tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as two film coated tablets) Each hard gelatin capsule Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As granules) Aspirin IP 75mg (As EC tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as to film coated tablets) Each hard gelatin capsule Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As granules) Aspirin IP 75mg (As EC tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as two film coated tablets) Each hard gelatin capsule Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As granules) Aspirin IP 75mg (As EC tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as two film coated tablets) 30 GM M/Sun Pharmaceuticals Industries 40 GM M/Sun Pharmaceuticals Industries 60 GM M/Sun Pharmaceuticals Industries 1 Capsule M/s GKM New Pharma / M/s Cadila Healthcare 1 Capsule M/s GKM New Pharma / M/s Cadila Healthcare 1 Capsule M/s Synokem Pharmaceuticals / M/s Eris Lifesciences Limited 1 Capsule M/s Synokem Pharmaceuticals / M/s Eris Lifesciences Limited 187.50 231.25 318.75 4.12 5.56 4.12 5.56 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 (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, 2013. 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.
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (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 / marketeer 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, 1955. (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. vkns k ubz fnyyh] 26 vizsy] 2018 [PN/188/56/2018/F/F. No. 8(56)/2018/D.P./NPPA-Div.-II ] BALJIT SINGH, Assistant Director dk- vk- 1767¼v½- 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,] 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 Ø- la- vuqlwfpr fofufezfr dk uke@czkam dk uke izcyrk lkj.kh bdkbz fofuekzrk vksj foi.ku daiuh [kqnjk ewy; ¼#-½ (1) (2) (3) (4) (5) (6) 11.70 1. jkstqoklvkfvu $,Lizhu $ DyksfiMksxzsy dsilwy ¼vkj 2 Vªhvks 10½ 2. jkstqoklvkfvu $,Lizhu $ DyksfiMksxzsy dsilwy ¼vkj 2 Vªhvks 20½ jkstqoklvkfvu dsfy k;e vkbzih ds cjkcj jkstqoklvkfvu 10 fexzk- ¼fQYe fyfir xksyh esa½],lizhu vkbzih 75 fexzk- ¼xSlVªks jsfllvsav xksyh esa½ DyksfiMksxzsy fclyqsv ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½ jkstqoklvkfvu dsfy k;e vkbzih ds cjkcj jkstqoklvkfvu 20 fexzk- ¼fQYe fyfir xksyh esa½],lizhu vkbzih 75 fexzk- ¼xSlVªks jsfllvsav xksyh esa½ DyksfiMksxzsy fclyqsv ds cjkcj DyksfiMksxzsy 75 fexzk- ¼izR;sd fqye fyfir xksyh esa½ 1 dsilwy esllz,del MªXl,aM QkekZL;wfVdYl @ esllz,ccksv gsyfkds;j izk- 1 dsilwy esllz,del MªXl,aM QkekZL;wfVdYl @ esllz,ccksv gsyfkds;j izk- 18.00
6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 3.,VksjokLVkfVu $ DyksfiMksxzsy dsilwy ¼LVkVksj lhoh½ 4.,eksDlhlhfyu $ Dykoqyfud llisa ku 5. isdfyvkdlsy batsd ku ¼uc&,YVkDlsy 100 fexzk-½ 6.,fLlVkyksizke $ Dyksuktsike xksyh ¼ltsVkyks Iyl 5½ 7. VsusfyfXyifVu $ esvqksfezu xksyh ¼VsjZLVy,e½ 8. XyhesijkbM esvqksfezu xksyh ¼Xyhfetu&,e 2 QksVZ½ 9. XyhesijkbM esvqksfezu xksyh ¼Xyhfetu&,e 1 QksVZ½ 10. esvksizksyksy $,EyksfMfiu xksyh ¼,eihvkjvks,y&,e 25@5½ 11. VsyfelkVZu $ DyksjFkkfyMksu xksyh ¼VsyfejkbM&lh,p 6-25½ 12. VsyfelkVZu $ DyksjFkkfyMksu xksyh 13. Qsjl $ Qksfyd,flM $ bysesuvy xksyh ¼VksuksQksfyd&,DlVh½,VksjokLVkfVu dsfy k;e vkbzih ds cjkcj,vksjoklvkfvu 10 fexzk- ¼fQYe fyfir xksyh esa½] DyksfiMksxzsy fclyqsv ds cjkcj DyksfiMksxzsy 75 fexzk- ¼2 fqye fyfir 37-5 fexzk- izr;sd xksyh esa½ ¼d½ izr;sd 5 fe izr;sd 5 fefydalvhvwfvm llisa ku esa%,eksdlhlhfyu VªhgkbMªsV vkbzih ds cjkcj,eksdlhlhfyu 400 fexzk-] iksvsf k;e Dykoqykfud fmyqfvm vkbzih ds cjkcj Dykoqykfud,flM 57 fexzk- ¼[k½ ou ok;y vkwq I;wjhQkbM okvj vkbzih izr;sd ok;y esa% I;wjhqQkbM okvj vkbzih 30 fefyizr;ds ok;y esa% isdfyvkdlsy vkbzih 100 fexzkg~;qeu vkbzih izr;sd fqye fyfir xksyh esa%,fllvkyksizke vkwdlkysv ds cjkcj,fllvkyksizke 5 fexzk-] Dyksuktsike vkbzih 0-5 fexzkizr;sd vfyfir fcys;mz xksyh esa% VsusfyfXyifVu gkbmªksczksekbm gkbmªsv ds cjkcj VsusfyfXyfVu 20 fexzk-] esvqksfezu,plh,y 500 fexzk- ¼,lvkj½ izr;sd vfyfir fcys;mz xksyh esa% XyhesijkbM vkbzih 2 fexzk-] esvqksfezu gkbmªksdyksjkbm 1000 fexzk- ¼,lvkj½ izr;sd vfyfir fcys;mz xksyh esa% XyhesijkbM vkbzih 1 fexzk-] esvqksfezu gkbmªksdyksjkbm 1000 fexzk- ¼,lvkj½ izr;sd fyfir fcys;mz xksyh esa% esvksizksyksy lqlkbusv bzvkj 25 fexzk-],eyksfmfiu fclkbysv 5 fexzkfcys;mz xksyh izr;sd fyfir fcys;mz xksyh esa% VsyfelkVZu vkbzih 40 fexzk-] DyksjFkkfyMksu vkbzih 6-25 fexzkxksyh izr;sd fyfir fcys;mz xksyh esa% VsyfelkVZu vkbzih 40 fexzk-] DyksjFkkfyMksu vkbzih 12-5 fexzkxksyh izr;sd fqye fyfir xksyh esa% Qsjl,LdkscsZV ds cjkcj bysesuvy vk;ju 100 fexzk-] Qksfyd,flM 1-5 fexzk-] bysesuvy ftad 22-5 fexzk- xksyh 1 dsilwy esllz foamykl ck;ksvsd @esllz,ccksv gsyfkds;j izk- 1 fe esllz,del MªXl,aM QkekZL;wfVdYl @ esllz vkbzihlh, yscksjsvjht 1 ok;y esllz chvk MªXl @ esllz,ydse yscksjsvjht 1 xksyh esllz VªhLVkj QkWewZys kul izk- @ esllz,ccksv gsyfkds;j izk- 1 xksyh esllz lk;uksdse QkekZL;wfVdYl @ esllz,afkse ck;ksqkekz izk- 1 xksyh esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz foamykl ck;ksvsd izk- @esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz foamykl ck;ksvsd izk- @esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz jkosuhksy gsyfkds;j izk- @esllz ;wuhlu QkekZL;wfVdYl izk- 8.394 2.91 11115.39 14. oksxyhcksl $ izr;sd vfyfir fcys;mz xksyh esa% 1 xksyh esllz foamykl ck;ksvsd 3.21 3.83 9.62 3.88 3.53 1.96 2.68 3.21 3.52
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 XyhesijkbM esvqksfezu xksyh ¼oksxyhlksu th,e 1½ 15. oksxyhcksl $ XyhesijkbM esvqksfezu xksyh ¼oksxyhlksu th,e 2½ oksxyhcksl 0-2 fexzk-] XyhesijkbM 1 fexzk-] esvqksfezu gkbmªksdyksjkbm 500 fexzkxksyh ¼,lvkj½ izr;sd vfyfir fcys;mz xksyh esa% oksxyhcksl 0-2 fexzk-] XyhesijkbM 2 fexzk-] esvqksfezu gkbmªksdyksjkbm 500 fexzk- xksyh ¼,lvkj½ 16. MksDlks:fcflu batsd ku izr;sd fe esa% MksDlks:fcflu gkbmªksdyksjkbm 2 fexzk- ¼isxhysfVM fyikslksey½ okvj QkWj batsd ku 17. XyhfeihjkbM $esvqksfezu xksyh ¼XykbdksesV thih 3 QkWVZ½ 18. jkstqoklvkfvu $,Lizhu $ DyksfiMksxzsy dsilwy ¼jDlVksj xksym 10½ 19. jkstqoklvkfvu $,Lizhu $ DyksfiMksxzsy dsilwy ¼jDlVksj xksym 20½ 20. isdfyvsdlsy ¼izksVhu ckmam ikfvzdyl½ QkWj batsdvscy llisa ku 21. XyhfeihjkbM $esvqksfezu xksyh ¼XyhekbZ,e 0-5 fexzk-½ 22. XyhDyktkbM esvqksfezu xksyh ¼XyhtsLV,e½ 23. MksDlks:fcflu gkbmªksdyksjkbm fyikslkseky batsd ku ¼2 fexzk-@fe½ ¼20 fexzk-@ok;y½ 24. VsusfyfXyiVhu $ eksvqksfezu xksyh 25. jkstqoklvkfvu $,Lizhu dsilwy ¼jkstMs, 20½ izr;sd fqye fyfir xksyh esa% XyhesihjkbM vkbzih 3 fexzk-] esvqksfezu gkbmªksdyksjkbm vkbzih 1000 fexzk- ¼,lvkj½ jkstqoklvkfvu dsfy k;e vkbzih 10 fexzk- ¼iSysVl esa½],lizhu 75 fexzk- ¼,UVªhd isysvl esa½ DyksfiMksxzsy fclyqsv vkbzih 75 fexzk- ¼ isysvl esa½ jkstqoklvkfvu dsfy k;e vkbzih 20 fexzk- ¼iSysVl esa½],lizhu 75 fexzk- ¼,UVªhd isysvl esa½ DyksfiMksxzsy fclyqsv vkbzih 75 fexzk- ¼ isysvl esa½ izr;sd ok;y esa% isdfyvsdlsy vkbzih 100 fexzkg~;qeu,yoqfeu vkbzih 900 fexzk- izr;sd vfyfir fcys;mz xksyh esa% XyhesihjkbM vkbzih 0-5 fexzk-] esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk- ¼b vkj½ izr;sd fyfir xksyh esa% XyhDyktkbM vkbzih 80 fexzk-] esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk- izr;sd fe esa% MksDlks:fcflu gkbmªksdyksjkbm vkbzih 2 fexzk- ¼isxhysfVM fyikslksey½ okvj QkWj batsd ku izr;sd vfyfir fcys;mz xksyh esa% VsusfyfXyifVu gkbmªksczksekbm gkbmªsm ds cjkcj VsusfyXyhfVu 20 fexzk-] esvqksfezu,plh,y 1000 fexzk- ¼bZvkj½ jkstqoklvkfvu dsfy k;e vkbzih ds cjkcj jkstqoklvkfvu 20 fexzk- ¼iSysVl esa½],lizhu 75 fexzk- ¼,UVªhd isysvl esa½ izk- @esllz ;wuhlu QkekZL;wfVdYl izk- 1 xksyh esllz foamykl ck;ksvsd izk- @esllz ;wuhlu QkekZL;wfVdYl izk- 1 fe esllz esllz usvdks QkekZ @esllz vkjihth ykbq lkbal 1 xksyh esllz,lsav QkekZ@eSllZ ;w,loh izk- 1 dsilwy esllz lk;uksdse QkekZL;wfVdYl @ esllz vkbzihlh, yscksjsvjht 1 dsilwy esllz lk;uksdse QkekZL;wfVdYl @ esllz vkbzihlh, yscksjsvjht 1 ok;y esllz,ed;ksj QkekZL;wfVdYl 3.57 694.29 8.37 11.70 18.00 11115.39 1 xksyh esllz I;ksj,aM D;ksj gsyfkds;j izk- @esllz MkW- jsm~mht yscksjsvjht 2.22 1 xksyh esllz QkekZQscfjdksu 4.88 1 fe esllz usvdks QkekZ @ esllz dsfmyk gsyfkds;j 1 xksyh esllz XysuekdZ QkekZL;wfVdYl @ esllz dks; QkekZL;wfVdYl izk- 1 dsilwy esllz lk;uksdse QkekZL;wfVdYl @ esllz ;w,loh izk- 694.29 10.87 7.80
8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 26. esvqksfezu $ XyhesihjkbM xksyh ¼Xywdksjkby &,e 0-5½ 27.,EkksDlhlhfyu $ Dykoqykfud MªkbZ flji ¼VªheksDl lhoh QkWVZ½ izr;sd vfyfir fcys;mz xksyh esa% esvqksfezu gkbmªksdyksjkbm vkbzih 500 fexzk-¼izksykwxsm fjfyt QkWeZ esa½] XyhesihjkbM vkbzih 0-5 fexzk izr;sd 5 fe vkwq fj&dalvhvwfvm llisa ku esa%,eksdlhlhfyu VªhgkbMªsV vkbzih ds cjkcj,eksdlhlhfyu 400 fexzk-] iksvsf k;e Dykoqykfud fmyqfvm vkbzih ds cjkcj Dykoqykfud,flM 57 fexzk- 1 xksyh esllz,ydse yscksjsvjht 1 fe esllz efyd ykbq lkbal izk- @esllz ekizk yscksjsvjht izk- 2.22 2.91 uksv % 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 djsaa 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 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-@188@56@2018@,q@qk- la- 8¼56½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 26th April, 2018 S. O. 1767(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;
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 Sl. No. Name of the Formulation / Brand Name TABLE Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 1. Rosuvastatin + Aspirin + Clopidogrel Capsule (R2 Trio 10) 1 Capsule M/s Akums Drugs & Pharmaceuticals / M/s Abbott Healthcare Pvt. 11.70 2. Rosuvastatin + Aspirin + Clopidogrel Capsule (R2 Trio 20) 3. Atorvastatin + Clopidogrel Capsule (Stator CV) 4. Amoxycillin + Clavulnic Suspension 5. Paclitaxel Injection (Nab-Altaxel 100mg) Each hard gelatine capsule Rosuvastatin Calcium IP eq. to Rosuvastation 10mg (As film coated tablet) Aspirin IP 75mg (As gastro resistant tab) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As film coated tablet) Each hard gelatine capsule Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As film coated tablet) Aspirin IP 75mg (As gastro resistant tab) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As film coated tablet) Each hard gelatine capsule Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As film coated tablet) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As 2 film coated 37.5mg each tablet) (a) Each 5ml of constituted suspension Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulante Diluted IP eq. to Clavulnic Acid 57mg (b) One vial of purified water IP Each vail Purified water IP 30ml Each vial Paclitaxel IP 100mg Human Albumin IPm q.s. 1 Capsule M/s Akums Drugs & Pharmaceuticals / M/s Abbott Healthcare Pvt. 1 Capsule M/s Windlas Biotech Limited / M/s Abbott Healthcare Pvt. 1 ML M/s Akums Drugs & Pharmaceuticals / M/s IPCA Laboratories Limited 1 Vial M/s Beta Drugs Limited / M/s Alkem Laboratories Limited 18.00 8.394 2.91 11115.39 6. Escitalopram + Clonazepam Tablet (Szetalo Plus 5) 7. Teneligliptin + Metformin Tablet (Terostil M) 8. Glimepride + Metformin Tablet (Glimison-M2 Forte) 9. Glimepride + Metformin Tablet (Glimison-M1 Each film coated tablet Escitalopram Oxalate eq. to Escitalopram 5mg, Clonazepam IP 0.5mg Each uncoated bilayered tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg (SR) Each uncoated Bilayered tablet Glimepride IP 2mg, Metformin Hydrochloride (SR) 1000mg Each uncoated Bilayered tablet Glimepride IP 1mg, 1 Tablet M/s Tristar Formulations Pvt. / M/s Abbott Healthcare Pvt. 1 Tablet M/s Synokem Pharmaceuticals / M/s Anthem BioPharma Pvt. 1 Tablet M/s Unison Pharmaceuticals Pvt. 1 Tablet M/s Unison Pharmaceuticals Pvt. 3.83 9.62 3.88 3.53
10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] Forte) 10. Metoprolol + Amlodipine Tablet (MPROL-AM 25/5) 11. Telmisartan + Chlorthalidone Tablet (Telmiride CH 6.25) Metformin Hydrochloride (SR) 1000mg Each film coated bilayered tablet Metoprolol Succinate ER 25mg Amlodipine Besylate 5mg bilayered Tablets Each uncoated bilayered tablet Telmisartan IP 40mg, Chlorthalidone IP 6.25mg Tablets 1 Tablet M/s Unison Pharmaceuticals Pvt. 1 Tablet M/s Windlabs Biotech Pvt. / M/s Unison Pharmaceuticals Pvt. 1.96 2.68 12. Telmisartan + Chlorthalidone Tablet 13. Ferrous + Folic Acid + Elemental Tablet (Tonofolic XT) 14. Voglibose + Glimepride + Metformin Tablet (Voglyson GM1) 15. Voglibose + Glimepride + Metformin Tablet (Voglyson GM2) 16. Doxorubicin Injection 17. Glimiepiride + Metformin Tablet (GLYCOMET GP 3 Forte) 18. Rosuvastation + Aspirin + Clopidogrel Capsule (Rxtor Gold 10) 19. Rosuvastation + Aspirin + Clopidogrel Capsule (Rxtor Gold 20) 20. Paclitaxel (Protein bound Particles) for Injectable Suspension 21. Glimepiride + Metformin Tablet (Glimy M 0.5mg) Telmiride CH 12.50 Tablet Each uncoated bilayered tablet Telmisartan IP 40mg + Chlorthalidone IP 12.50mg Tablets Each film coated tablets Ferrous Ascorbate eq. to elemental Iron 100mg + Folic Acid 1.5mg + Elemental Zinc 22.5mg Tablets Each uncoated bilayered tablet Voglibose 0.2mg, Glimepride 1mg & Metformin Hydrochloride 500mg Tablets(SR) Each uncoated bilayered tablet Voglibose 0.2mg, Glimepride 2mg & Metformin Hydrochloride 500mg Tablets(SR) Each ml Doxorubicin Hydrochloride 2mg (Pegylated Liposomal) Water for Injection Each film coated tablet Glimiepiride IP 3mg, Metformin Hydrochloride IP 1000mg (SR) Each hard gelatine capsule Rosuvastation Calcium IP 10mg (As pellets), Aspirin 75mg (as enteric coated pellets) & Clopidogrel Bisulphate IP 75mg (as pellets) Each hard gelatine capsule Rosuvastation Calcium IP 20mg (As pellets), Aspirin 75mg (as enteric coated pellets) & Clopidogrel Bisulphate IP 75mg (as pellets) Each vial Paclitaxel IP 100mg Human Albumin IP 900mg Each uncoated bilayered Tablet Glimepiride IP 0.5mg Metformin Hydrochloride IP 500mg(ER) 1 Tablet M/s Windlabs Biotech Pvt. / M/s Unison Pharmaceuticals Pvt. 1 Tablet M/s Ravenbhel Healthcare Pvt. ltd. / M/s Unison Pharmaceuticals Pvt. 1 Tablet M/s Windlabs Biotech Pvt. / M/s Unison Pharmaceuticals Pvt. 1 Tablet M/s Windlabs Biotech Pvt. / M/s Unison Pharmaceuticals Pvt. 1 ML M/s Natco Pharma Limited / M/s RPG Life Sciences 1 Tablet M/s Accent Pharma / M/s USV Private Limited 1 Capsule M/s Synokem Pharmaceuticals Limited / M/s IPCA Laboratories Limited 1 Capsule M/s Synokem Pharmaceuticals Limited / M/s IPCA Laboratories Limited 1 Vial M/s Emcure Pharmaceuticals 1 Tablet M/s Pure & Cure Healthcare Pvt. / M/s Dr. Reddy s Laboratories Limited 3.21 3.52 3.21 3.57 694.29 8.37 11.70 18.00 11115.39 22. Gliclazide + Each uncoated tablet 1 Tablet M/s Pharmafabrikon 4.88 2.22
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 Metformin Tablet (Glizest M) 23. Doxorubicin Hydrochloride liposomal Injection. (2mg/ml)(20mg/vial ) 10ml 24. Teneligliptin + Metformin Tablet 25. Rosuvastatin + Aspirin Capsules (Roseday A 20) 26. Metformin + Glimepiride Tablet (Glucoryl M 0.5) 27. Amoxycillin + Clavulanic Dry Syrup (Trimox CV Forte) Gliclazide IP 80mg, Metformin Hydrochloride IP 500mg Each ml Doxorubicin Hydrochloride IP 2mg (As pegylated liposomal) Water for Injection Each uncoated bilayered tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 1000mg (ER) Each hard gelatine capsule Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As pellets), Aspirin IP 75mg (As Enteric Coated pellets IP), Each uncoated bilayer tablet Metformin Hydrochloride IP 500mg (As prolonged Release form), Glimepiride IP 0.5mg Each 5ml of re-constituted Suspension Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulanic Diluted IP eq. to Clavulanic Acid 57mg 1 ML M/s Natco Pharma Limited / M/s Cadila Healthcare Limited 1 Tablet M/s Glenmark Pharmaceuticals / M/s Koye Pharmaceuticals Private Limited 1 Capsule M/s Synokem Pharmaceuticals / M/s USV Private Limited 1 Tablet M/s Alkem Laboratories 1 ML M/s Malik Life Sciences Pvt. / M/s Mapra Laboratories Pvt. 694.29 10.87 7.80 2.22 2.91 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 (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, 2013. 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 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, 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, 1955. (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/188/56/2018/F/F. No. 8(56)/2018/D.P./NPPA-Div.-II ] BALJIT SINGH, Assistant Director
12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] vkns k ubz fnyyh] 26 vizsy] 2018 dk-vk- 1768 ¼v½-&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 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% lkj.kh dzla- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkb vf/kdre dher ¼#-½ iqufozyksdu vkns k la-,oa rkjh[k ekstwnk dk- vk- la-,oa rkjh[k (1) (2) (3) (4) (5) (6) (7) 1- QsuhVkWu vksjy fyd;wbzm 30 fexzk-@5 fe 1 fe 0-29 31015@38@2017- ewy; fu/kkzj.k dh fnukad 09-02-2018 1461¼v½ fnukad 02-04-2018 ¼Ø-la- 646½ uksv % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbz vksj vf/klwfpr dh xbz vf/kdre dher ¼/ku olrq,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 ¼5½ esa of.kzr vf/kdre dher ¼/ku olrq,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 ¼/ku olrq,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 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 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 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 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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 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 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-@188@56@2018@,q@qk- la0 8¼56½@2018@Mhih@,uihih,&fMoh-II ] cythr flag] lgk;d funs'kd ORDER New Delhi, 26th April, 2018 S.O.1768 (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 in 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. Phenytoin Oral Liquid 30mg/5 ml 1 ML 0.29 31015/38/2017-Pricing dated 09.02.2018 1461(E) dated 02.04.2018 (at Sl. No. 646) 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, 2013. (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
14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] of the Drugs (Prices Control) Order, 2013. 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, 2013. (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. (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/188/56/2018/F/ F. No. 8(56)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director vkns k ubz fnyyh] 26 vizsy] 2018 dk-vk- 1769¼v½-&vkS k/k fohkkx }kjk vks k/k ¼ewY; fu;a=.k½ vkns k] 2013 ds isjk 6 ds varxzr jlk;u,oa mozjd ea=ky; }kjk tkjh dk-vk- 3723¼v½ fnukad 23-11-2017 ds rgr,vkbzvkslhmh&,mcy;w,lh,l dh QkesZfVd fjiksvz ds vk/kkj ij chlhth osdlhu dh vf/kdre dher fu;r fd;k FkkA dk-vk- 1461¼v½ fnukad 02-04-2018 ds rgr MCY;wihvkbZ vk/kkj ij vf/kdre ewy; dks ifj kksf/kr fd;k FkkA 02- tcfd,uihih, us viuh osclkbv ij elksnk vf/kdre ewy; x.kuk dh odzlhv viyksm dh Fkh vksj esllz lsje balvhv~;wv vkwq bafm;k izk- us viuk vh;kosnu lksaik Fkk ftlesa nkok fd;k x;k fd%& (i) isjk 6 ds rgr deh 2014 esa 45-64 izfr kr dh lhek rd dh xbz rfkk ewy; esa fxjkov 20-24- izfr kr dsoy chlhth Vhdk esa dh xbz tksfd vo;ogk;z gs vksj (ii) bl ekeys esa deh ykxw ugha gs] D;ksafd izr;sd Vhdk dk vyx fpfdrlh; mi;ksx gs vksj deh ds ekinam dks mi&fpfdrlh; xzqi ds fy, ykxw ugha fd;k tk ldrka 03- tcfd fnukad 22-11-2017 dh csbd esa izkf/kdj.k us uksv fd;k fd ^^esllz lsje us chlhth Vhdk ds yxkrkj fxjrs gq,,dkf/kdkj ewy; ij vkosnu nk;j fd;k gs vksj dgk gs fd mrikn esa deh vo;ogk;z gsa esllz lsje balvhv~;wv vkwq bafm;k izk- us blds fo:) izfrfuf/kro fd;k gs] gkaykfd Mhihlhvks] 2013 ds isjk 06 ds vuqlkj elksnk vf/kdre dher dh deh ds :i esa izkf/kdj.k us chlhth osdlhu dk 4-32 izfr [kqjkd vf/kdre dher dks vf/klwfpr djus dk fu.kz; fy;k gsa tc dhkh mudk vkosnu isjk 19 ds rgr izkir gksxk rc mu ij,uihih, }kjk fopkj fd;k tk,xka^^ 04- tcfd esllz lsje balvhv~;wv vkwq bafm;k izk- us Mhihlhvks] 2013 ds isjk 19 ds rgr la kksf/kr dher dks c<+kus ds fy, vkosnu fn;k gsa 05- tcfd,uihih, us viuh 188oha izkf/kdj.k dh csbd tks fd 23-04-2018 dks vk;ksftr dh xbz Fkh esa fu.kz; fy;k fd Mhihlhvks] 2013 ds isjk 19 ds rgr vf/kdre ewy; fu;r@la kksf/kr fd, cxsj vkosnd dh f kdk;r dks lqfuf pr djus ds fy,,dkf/kdkj flfkfr ds QyLo:i cktkj esa vks k/k dh miyc/krk lqfuf pr dh tk,a 06- 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 19 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] jk Vªh; vks k/k ewy; fu/kkzj.k izkf/kdj.k ¼ftls laf{kir :i ls,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
¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 15 bdkbz lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof V esa fofufnz V vuqlwfpr fofufezfr;ksa esa ls izr;sd dh] olrq,oa lsok dj] ;fn dksbz gs] dks NksM+dj vf/kdre dher ds :i esa fu;r@la kksf/kr djrh gs% lkj.kh dz-la- vuqlwfpr fofufezfr dk uke [kqjkd :i,oa izcyrk bdkb vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. chlhth osdlhu izfr Mkst 5.59 uksv % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbz vksj vf/klwfpr dh xbz vf/kdre dher ¼/ku olrq,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 ¼5½ esa of.kzr vf/kdre dher ¼/ku olrq,oa lsok dj] tks ykxw gksa½ ls vf/kd lhkh,slh fofufezr;ksa dh dher dk v/kkseq[kh iqujh{k.k 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 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; vkskf/k fu;a=dksa vksj fofuekzrk forjdksa dks tkjh djsaa ¼?k½ vks"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds isjk 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 ¼M+½ mi;qzdr lkj.kh esa ;Fkk fofufnz"v [kqnjk ;k izcyrk ;k nksuksa ds lkfk vuqlwfpr fofufezfr dk dksbz ekstwnk fofuekzrk vks k/k ewy; fu;a=.k vkns k] 2013 ds isjk 2¼;w½ ds vuqlkj dksbz ubz vks kf/k dks ykap djrk gs rks,sls ekstwnk fofuekzrk dh vks k/k ¼ewY; fu;a=.k½ vkns k 2013 dh vuqlwph&ii ds varxzr ;Fkk fofufnz V QkeZ&I esa,uihih, dks,slh ubz vks kf/k ds iwoz ewy; vuqeksnu gsrq vkosnu djuk gksxka ¼p½ 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 ¼N½ 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 ¼Tk½ ;g vf/klwpuk tkjh gksus dh frffk ls,d o kz ds fy, eku; gksxha 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-@188@56@2018@,q@qk- la- 8¼56½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 26th April, 2018 S.O.1769(E). Whereas the National Pharmaceutical Pricing Authority(NPPA), Department of Pharmaceuticals, Ministry of Chemical and Fertilizers had fixed the ceiling price under paragraph 6 of the Drug (Prices Control) order 2013 of BCG Vaccine vide S.O. 3723(E) dated 23.11.2017 based on the Pharmatrac report of AIOCD AWACS. The ceiling prices were revised on the basis of WPI vide SO 1461(E) dated 2.4.2018.
16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] 02. Whereas NPPA had uploaded the worksheet of draft ceiling price calculation on the website of NPPA and M/s Serum Institute of India Pvt Limited had submitted its representation, wherein it was claimed that (i) reduction under para 6 has been carried out to the extent of 45.64% in 2014 and another further downward reduction of 20.024% in price would only render manufacturing of BCG vaccine unviable; and (ii) the reduction is not applicable in this case as each vaccine has distinct therapeutic usage and criteria of reduction based on sub-therapeutic group cannot be applied to vaccines. 03. Whereas the Authority in the meeting dated 22.11.2017, whereby the Authority noted M/s Serum has filed the application for repeat monopoly reduction in the ceiling price of BCG Vaccine and stated that the product will become unviable on reduction. M/s Serum Institute of India Ltd has represented against it. However, as the reduction applied in the draft ceiling price as per para 6 of the DPCO 2013, the Authority decided to notify the uploaded ceiling price of BCG vaccine at Rs. 4.32 per dose. As and when their detail application in para 19 is received, it will considered by the NPPA. 04. Whereas M/s Serum Institute of India Pvt Limited has submitted its application under para 19 of the DPCO 2013 for revising the price upward. 05. Whereas the NPPA in its 188th Authority meeting held on 23.4.2018, decided that ceiling price may be fixed/revised under para 19 of the DPCO 2013 without applying reduction under monopolistic condition to address the grievance of the applicant as well as to ensure sufficient availability of the drug In the market. 06. Now, in exercise of the powers conferred by paragraphs 19 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, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes/revises the prices 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 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. Name of the Scheduled Formulation Dosage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. BCG Vaccine Each dose 5.59 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) 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. (c) 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, 2013. 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) 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, 2013. (f) 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. (g) 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.