In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals

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- 5013] ubZ fnYyh] 'kqØokj] fnlEcj 21] 2018@vxzgk;.k 30] 1940 No. 5013] NEW DELHI, FRIDAY, DECEMBER 21, 2018/AGRAHAYANA 30, 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] 21 fnlEcj] 2018 dk-vk- 6252¼v½-—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 dk0 vk0 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS”k/k ¼dher fu;a=.k½ vkns’k] 2013 ds iSjk 4, 6, 10, 11, 14, 16, 17 vkSj 18 }kjk iznRr ‘kfDr;ksa dk iz;ksx djrs gq, vkSj lkj.kh ds LraHk ¼7½ esa fofufnZ”V Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] (jk”Vªh; vkS”k/k ewY; fu/kkZj.k izkf/kdj.k) 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 dz- vuqlwfpr [kqjkd :i bdkbZ vf/kdre iqufoZyksdu vkns’k ekStwnk dk- vk- la- la- fofufeZfr dk ,oa izcyrk dher la- ,oa rkjh[k ,oa rkjh[k uke ¼#-½ (1) (2) (3) (4) (5) (6) (7) 1. ikWfoMu vk;ksMhu lkys q'ku 10% 1 fefy- 0.87 31015/24/2018- 1461(v) fnukad ewY; fu/kkZj.k dh 02.04.2018 rkjh[k 08.10.2018 (at Sl. No. 662) 7485 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku 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 (5) 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 (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 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 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,axsA [dka- la-@193@61@2018@,Q@Qk- la- 8¼61½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 21st December, 2018 S.O. 6252(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. Name of the Dosage form Unit Ceiling Review Order Existing SO number No. Scheduled & Strength Price number and date and date Formulation (Rs.) (1) (2) (3) (4) (5) (6) (7) 1. Povidone Iodine Solution 10% 1 ml 0.87 31015/24/2018- 1461(E) dated Pricing dated 02.04.2018 08.10.2018 (at Sl. No. 662) 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 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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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/193/61/2018/F /F. No. 8(61)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director vkns’k ubZ fnYyh] 21 fnlEcj] 2018 dk-vk- 6253¼v½-—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 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 dz- vuqlwfpr fofufeZfr dk izcyrk bdkbZ fofuekZrk vkSj foi.ku [kqnjk la- uke@czkaM dk uke daiuh ewY; ¼#-½ (1) (2) (3) (4) (5) (6) 1. VsyfelkVZu $ izR;sd fQYe fyfir fcys;MZ xksyh esa% 1 xksyh eSllZ ;wuhlu 3.21 ,eyksfMfiu $ VsyfelkVZu vkbZih 40 fexzk-] QkekZL;wfVdYl izk- fy- gkbMªksDyksjFkkbtkbM ,eyksfMfiu fclkbysV vkbZih ds cjkcj xksyh ,eyksfMfiu 5 fexzk-] ¼VsyfejkbM&,,e,p½ gkbMªksDyksjFkkbtkbM vkbZih 12-50 xksyh 2. VsyfelkVZu $ izR;sd vfyfir fcys;MZ xksyh esa% 1 xksyh eSllZ ;wuhlu 3.13 esVksizksyksy xksyh VsyfelkVZu vkbZih 40 fexzk-] QkekZL;wfVdYl izk- fy- ¼VsyfejkbM&,eVh 25½ esVksizksyksy lqLlkbusV vkbZih 23-75 fexzk- ds cjkcj esVksizksyksy VkjVªsV vkbZih 25 fexzk- ¼,DlVsaMsM fjfyt esa½ 3. VsyfelkVZu $ izR;sd vfyfir fcys;MZ xksyh esa% 1 xksyh eSllZ ;wuhlu 3.57 esVksizksyksy xksyh VsyfelkVZu vkbZih 40 fexzk-] QkekZL;wfVdYl izk- fy- ¼VsyfejkbM&,eVh 50½ esVksizksyksy lqLlkbusV vkbZih 47-50 fexzk- ds cjkcj esVksizksyksy VkjVªsV vkbZih 50 fexzk- ¼,DlVsaMsM fjfyt esa½ 4. vksesizktksy $ izR;sd gkMZ tsysVkbu dSIlwy esa% 1 dSIlwy eSllZ ;wuhlu 1.79 MkseisjhMksu dSIlwy vksesizktksy 20 fexzk- ¼buVsfjd fyfir QkekZL;wfVdYl izk- fy- ¼vksts,lvks,u&Mh½ isysVl esa½ MkseisjhMksu vkbZih 10 fexzk- ¼fyfir isysVl esa½ dSIlwy¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 5. ysehoqMkbu $ izR;sd fQYe fyfir xksyh esa% 1 xksyh eSllZ vkSjksfcaMks QkekZ fy- 114.06 VsuksQksohj $ ysehoqMkbu vkbZih 300 fexzk-] MksyqxsVªohj xksyh VsuksQksohj fMlksizkDlhy QqekjsV vkbZih ¼fMyVªk½ 300 fexzk-] MksyqxsVªohj lksfM;e ds cjkcj MksyqxsVªohj 50 fexzk- 6. esVQksfeZu $ izR;sd vfyfir xksyh esa% 1 xksyh eSllZ ,jhl ykbQlkbal 9.04 fi;ksXyhVktksu xksyh esVQksfeZu gkbMªksDyksjkbM vkbZih 1000 fexzk- ¼lLVsaM fjfyt QkWeZ esa½] fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds cjkcj fi;ksXyhVktksu 15 fexzk- 7. DyhuhfMikbu $ izR;sd fQYe fyfir fcys;MZ xksyh esa% 1 xksyh eSllZ lQsVc ykbQ 6.79 esVksizksyksy xksyh DyhuhfMikbu vkbZih 10 fexzk-] lkbal@eSllZ ,tark QkekZ esVksizksyksy lDlhusV vkbZih 23-75 fexzk- fy- ds cjkcj esVksizksyksy VkjVªsV 25 fexzk- ¼izksyksxsM fjfyt QkWeZ esa½ 8. DyhuhfMikbu $ izR;sd fQYe fyfir fcys;MZ xksyh esa% 1 xksyh eSllZ lQsVc ykbQ 8.19 esVksizksyksy xksyh DyhuhfMikbu vkbZih 10 fexzk-] lkbal@eSllZ ,tark QkekZ esVksizksyksy lDlhusV vkbZih 47-50 fexzk- fy- ds cjkcj esVksizksyksy VkjVªsV 50 fexzk- ¼izksyksxsM fjfyt QkWeZ esa½ 9. jkstqokLVkfVu $ izR;sd gkMZ tsysVkbu dSIlwy esa% 1 dSIlwy eSllZ lk;uksdse 17.88 ,fLifju $ DyksfiMksxzsy jkstqokLVkfVu dSfY’k;e vkbZih ds cjkcj QkekZL;wfVdYl fy-@eSllZ dSIlwy jkstqokLVkfVu 20 fexzk- ¼isysVl esa½] ekbØks yScl fy- ,fLifju vkbZih 75 fexzk- ¼,uVsfjd fyfir isysVl esa½ DyksfiMksxzsy ckbZlYQsV vkbZih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼isysVl esa½ 10. jkstqokLVkfVu $ izR;sd gkMZ tsysVkbu dSIlwy esa% 1 dSIlwy eSllZ lk;uksdse 11.46 ,fLifju $ DyksfiMksxzsy jkstqokLVkfVu dSfY’k;e vkbZih ds cjkcj QkekZL;wfVdYl fy-@eSllZ dSIlwy jkstqokLVkfVu 20 fexzk- ¼isysVl esa½] ekbØks yScl fy- ,fLifju vkbZih 75 fexzk- ¼,uVsfjd fyfir isysVl esa½ DyksfiMksxzsy ckbZlYQsV vkbZih ds cjkcj DyksfiMksxzsy 75 fexzk- ¼isysVl esa½ 11. blhVkyksizke $ izR;sd fQYe fyfir xksyh esa% 1 xksyh eSllZ vkbZihlh, 5.88 Dyksuktsike xksyh blhVkyksizke vksDlkysV ds cjkcj yscksjsVjht fy- ¼jslhVk ,yMh½ blhVkyksizke 5 fexzk-] Dyksuktsike vkbZ 0-25 fexzk- 12. XyhesihjkbM $ izR;sd vfyfir xksyh esa% 1 xksyh eSllZ foaMykl ck;ksVsd izk- 6.38 fi;ksXyhVktksu xksyh XyhesihjkbM vkbZih 1 fexzk-] fy-@eSllZ yqfiu fy- fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds cjkcj fi;ksXyhVktksu 15 fexzk- 13. XyhesihjkbM $ izR;sd vfyfir xksyh esa% 1 xksyh eSllZ foaMykl ck;ksVsd izk- 8.20 fi;ksXyhVktksu xksyh XyhesihjkbM vkbZih 2 fexzk-] fy-@eSllZ yqfiu fy- fi;ksXyhVktksu gkbMªksDyksjkbM vkbZih ds cjkcj fi;ksXyhVktksu 15 fexzk- 14. fMDyksQsud $ izR;sd ,uVsfjd fyfir xksyh esa% 1 xksyh eSllZ ,dEl MªXl ,aM 5.00 lsjkfV;ksiks,VhMkl fMDyksQsud lksfM;e vkbZih 50 fexzk-] QkekZL;wfVdYl fy-@eSllZ xksyh ¼fMDyksVky ,l½ lsjkfV;ksiks,VhMkl vkbZih 10 fexzk- ds Cyw Øksl yscksjsVjht izk- cjkcj 20000 ,utkbeh ,DVhohVh ;wfuVl fy- vkWQ lsjkfV;ksiks,VhMkl 15. ,eksDlhflYyhu $ izR;sd dkWEchiSd esa% 1 fefy- eSllZ efyd ykbQ 3.28 DykoqysuV ,flM ¼d½ ou cksVy vkWQ ,eksDlhflYyhu ,aM lkbaflt fy-@eSllZ lLisa’ku iksVsf’k;e DykoqysuV vksjy lLisa’ku oksdgkMZV fy- vkbZih izR;sd 5 fefy- vkWQ fjdalfVVwM lLisa’ku esa% ,eksDlhflYyhu VªhgkbMªsV vkbZih ds cjkcj ,eksDlhflYyhu 400 fexzk-] iksVsf’k;e DykoqysuV fMyqfVM vkbZih ds6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] cjkcj DykoqysuV ,flM 57 fexzk-] ¼[k½ ou ok;y vkWQ LVhfjy okWVj QkWj batsD’ku vkbZih izR;sd ok;y esa% LVhfjy okWVj QkWj batsD’ku vkbZih 30 fefy- 16. isjkflVkeksy $ izR;sd vfyfir xksyh esa% 1 xksyh eSllZ lselu yscksjsVjht 2.70 QsuhysQjhu $ dSQhu isjkflVkeksy vkbZih 500 fexzk-] izk-fy-@eSllZ xYQk $ fMQsugkMªkekbu QsuhysQjhu gkbMªksDyksjkbM vkbZih 5 yscksjsVjht fy- xksyh fexzk-] ¼useks&dksYM&,u,Q½ dSQhu ¼,ugkbMªkst½ vkbZih 30 fexzk-] fMQsugkMªkekbu gkbMªksDyksjkbM vkbZih 25 fexzk- 17. MsDykVklohj $ izR;sd fQYe fyfir xksyh esa% 1 xksyh eSllZ eSllZ ukVdks QkekZ 556.442 lksQkscqohj xksyh MsDykVklohj fMgkbMªksDyksjkbM ds cjkcj fy-@eSllZ ,izktj MsDykVklohj 60 fexzk-] gsYFkds;j izk- fy- lksQkscqohj 400 fexzk- 18. dksyhu lSfyflysV dksyhu lSfyflysV lksyq’ku ch-ih- ds 1 xzke eSllZ xzqi QkekZL;wfVdYl 4.29 lksyq’ku $ cjkcj dksyhu lSfyflysV 8-7% fy-@eSllZ gsVsjks gsYFkds;j csutkydksfu;e MCY;w@MCY;w] fy- DyksjkbM lksyq’ku $ csutkydksfu;e DyksjkbM lksyq’ku vkbZih fyXuksdsu 0001% MCY;w@MCY;w] gkbMªksDyksjkbM tsy fyXuksdsu gkbMªksDyksjkbM vkbZih 2-0 ¼myQzh tsy½ 19. izR;sd fefy- esa% 20 fefy- eSllZ Vªksbdk 71.43 cqfiokdkbu $ QsaVfuy cqfiokdkbu gkbMªksDyksjkbM vkbZih 1-00 ok;y QkekZL;wfVdYl fy- batSD’ku fexzk- ds cjkcj bugkbMªkst cqfiokdkbu gkbMªksDyksjkbM 0-948 fexzk-] QsaVfuy lkbVªsV vkbZih ds cjkcj QsaVfuy 2-0 ,elhth 20. izR;sd fefy- esa% 20 fefy- eSllZ Vªksbdk 75.89 cqfiokdkbu $ QsaVfuy cqfiokdkbu gkbMªksDyksjkbM vkbZih 1-25 ok;y QkekZL;wfVdYl fy- batSD’ku fexzk- ds cjkcj bugkbMªkst cqfiokdkbu gkbMªksDyksjkbM 1-185 fexzk-] QsaVfuy lkbVªsV vkbZih ds cjkcj QsaVfuy 2-0 ,elhth 21. fMIFkhfj;k VksDlkW;M $ izR;sd iSd esa% 0-5 fefy- eSllZ isusfl;k ck;ksVsd fy- 340.15 VsVul VksDlkW;M $ fMIFkhfj;k VksDlkW;M 20 ,y,Q ¼30 fuf”Ø; MCY;w&ch vkbZ;w½] ijVqLlhl cYd $ fgc VsVul VksDlkW;M 7-5 ,y,Q ¼30 vkbZ;w½] ¼ihvkjih&VhVh½ ¼fgc fuf”Ø; MCY;w&ch ijVqLlhl cYd 10 ihvkjih dutxVhM vkbZvks;w ¼4 vkbZ;w½] fon dSfj;j izksVhu fgc ¼ihvkjih&VhVh½ ¼fgc ihvkjih VsVul VksDlkW;M½ $ dutxVhM fon dSfj;j izksVhu VsVul ,Y;wfefu;e lkexzh ¼, VksDlkW;M½ 10 ;wth] 13½ ¼,Y;wfefu;e QkWLQsV tsy ds :i esa½ ,Y;wfefu;e lkexzh ¼, 13$½ ¼,Y;wfefu;e fFk;ksekjly 0-025 QkWLQsV tsy ds :i esa½ 0-25 fexzk-] fexzk- ¼bth Qksj½ fFk;ksekjly 0-025 fexzk- 22. QkWeksZVsjksy Q~;wejsV $ izR;sd 2 fefy- bugsys’ku lLisa’ku esa% 2 fefy- eSllZ ,dEl MªXl ,aM 36.04 cqMslksukbM bugsys’ku QkWeksZVsjksy Q~;wejsV fMgkbMªsV vkbZih ds QkekZL;wfVdYl fy-@eSllZ lLisa’ku ¼LekVZwyl½ cjkcj QkWeksZVsjksy Q~;wejsV 20 ,elhth] XysuekdZ QkekZL;wfVdYl cqMslksukbM vkbZih 0-5 fexzk- bu ,u fy- blksVksfud lksyq’ku 23. QkWeksZVsjksy Q~;wejsV $ izR;sd 2 fefy- bugsys’ku lLisa’ku esa% 2 fefy- eSllZ ,dEl MªXl ,aM 42.12 cqMslksukbM bugsys’ku QkWeksZVsjksy Q~;wejsV fMgkbMªsV vkbZih ds QkekZL;wfVdYl fy-@eSllZ lLisa’ku ¼LekVZwyl½ cjkcj QkWeksZVsjksy Q~;wejsV 20 ,elhth] XysuekdZ QkekZL;wfVdYl cqMslksukbM vkbZih 1 fexzk- bu ,u fy- blksVksfud lksyq’ku¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 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 (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] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsaA ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA ¼M-½ mi;qZDr 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-@193@61@2018@,Q@Qk- la- 8¼61½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 21st December, 2018 S.O. 6253(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 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, 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; TABLE Sl. Name of the Strength Unit Manufacturer & Retail No. Formulation / Marketing Company Price Brand Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Telmisartan + Each film coated bilayered tablet 1 Tablet M/s Unison 3.21 Amlodipine + contains: Pharmaceuticals Pvt. Hydrochlorthaiazide Telmisartan IP 40mg, Ltd. Tablets Amlodipine Besylate IP eq. to (Telmiride – AMH) Amlodipine 5mg, Hydrochlorthaiazide IP 12.50mg Tablets8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 2. Telmisartan + Each uncoated bilayered tablet 1 Tablet M/s Unison 3.13 Metoprolol Tablet contains: Pharmaceuticals Pvt. (Telmiride – MT 25) Telmisartan IP 40mg, Ltd. Metoprolol Succinate IP 23.75mg, eq. to Metoprolol Tartrate IP 25mg (as Extended Release) 3. Telmisartan + Each uncoated bilayered tablet 1 Tablet M/s Unison 3.57 Metoprolol Tablet contains: Pharmaceuticals Pvt. (Telmiride – MT 50) Telmisartan IP 40mg, Ltd. Metoprolol Succinate IP 47.50mg, eq. to Metoprolol Tartrate IP 50mg (as Extended Release) 4. Omeprazole + Each hard gelatin capsule contains: 1 Capsule M/s Unison 1.79 Domperidone Omeprazole 20mg (As enteric coated Pharmaceuticals Pvt. Capsule (OZSON-D) pellets) + Ltd. Domperidone IP 10mg (As coated pellets) Capsule 5. (Diltra Tablets) Each film coated tablet contains: 1 Tablet M/s Aurobindo Pharma 114.06 Lamivudine + Lamivudine IP 300mg, Limited Tenofovir + Tenofovir Disoproxil Fumarate IP Dolugetravir Tablets 300mg Dolugetravir Sodium eq. to Dolutegravir 50mg 6. Metformin + Each uncoated tablet contains: 1 Tablet M/s Eris Lifesciences 9.04 Pioglitazone Tablet Metformin Hydrochloride IP Ltd. 1000mg (in sustained release form), Pioglitazone Hydrochloride IP eq. to Pioglitazone 15mg 7. Clinidipine + Each Film coated bilayered tablet 1 Tablet M/s Safetab Life 6.79 Metoprolol Tablet contains: Science / M/s Ajanta Clinidipine IP 10mg, Pharma Limited Metoprolol Succinate IP 23.75mg eq. to Metoprolol tartrate 25mg (In prolonged release form) 8. Clinidipine + Each Film coated bilayered tablet 1 Tablet M/s Safetab Life 8.19 Metoprolol Tablet contains: Science / M/s Ajanta Clinidipine IP 10mg, Pharma Limited Metoprolol Succinate IP 47.50mg eq. to Metoprolol tartrate 50mg (In prolonged release form) 9. Rosuvastatin + Each Hard Gelatine Capsule 1 Capsule M/s Synokem 17.88 Aspirin + contains: Pharmaceuticals Ltd. / Clopidogrel Capsule Rosuvastatin Calcium IP eq. to M/s Micro Labs Rosuvastation 20mg (As pellets) Limited Aspirin IP 75mg (As enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 10. Rosuvastatin + Each Hard Gelatine Capsule 1 Capsule M/s Synokem 11.46 Aspirin + contains: Pharmaceuticals Ltd. / Clopidogrel Capsule Rosuvastatin Calcium IP eq. to M/s Micro Labs Rosuvastation 10mg (As pellets) Limited Aspirin IP 75mg (As enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets)¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 11. Escitalopram + Each film coated tablet contains: 1 Tablet M/s IPCA Laboratories 5.88 Clonazepam Tablet Escitalopram Oxalate eq. to Ltd. (Recita LD) Escitalopram 5mg, Clonazepam IP 0.25mg 12. Glimepiride + Each uncoated tablet contains: 1 Tablet M/s Windlas Biotech 6.38 Pioglitazone Tablet Glimepiride IP 1mg Pvt. Ltd. / M/s Lupin Pioglitazone Hydrochloride IP eq. to Limited Pioglitazone 15mg 13. Glimepiride + Each uncoated tablet contains: 1 Tablet M/s Windlas Biotech 8.20 Pioglitazone Tablet Glimepiride IP 2mg Pvt. Ltd. / M/s Lupin Pioglitazone Hydrochloride IP eq. to Limited Pioglitazone 15mg 14. Diclofenac + Each enteric coated Tablet Contains: 1 Tablet M/s Akums Drugs & 5.00 Serratiopeotidase Diclofenac Sodium IP 50mg, Pharmaceuticals Ltd. / Tablets Serratiopeotidase IP 10mg eq. to M/s Blue Cross (Diclotal S) 20000 enzyme activity units of Laboratories Pvt. Ltd. Serratiopeptidase. 15. Amoxycillin + Each combipack contains: 1 ml M/s Malik Life 3.28 Clavulanic Acid (a) One bottle of Amoxycillin & Sciences Ltd. / M/s Suspension Potassium Clavunate Oral Wockhardt Limited Suspension L.P. Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulante Diluted IP eq. to Clavulnic Acid 57mg (b) One vial of Sterile water for Injection IP Each vail contains: Sterile water for injection IP 30ml 16. Paracetamol + Each uncoated tablet contains: 1 Tablet M/s Samson 2.70 Phenylephrine + Paracetamol IP 500mg, Laboratories Pvt. Ltd. / Caffeine + Phenylephrine Hydrochloride IP M/s Galpha Diphenhydramine 5mg, Laboratories Limited Tablet (NEMO- Caffeine (Anhydrous) IP 30mg, KOLD-NF) Diphenhydramine Hydrochloride IP 25mg 17. Daclatasvir + Each film coated tablet contains: 1 Tablet M/s Natco Pharma Ltd. 556.442 Sofosbuvir Tablet Daclatasvir Dihydrochloride eq. to / M/s Aprazer Daclatasvir 60mg, Healthcare Pvt. Ltd. Sofosbuvir 400mg 18. Choline Salicylate Choline Salicylate Solution B.P. eq. 1 GM M/s Group 4.29 Solution + to Choline Salicylate 8.7% w/w, Pharmaceuticals Benzalkonium Benzalkonium Chloride Solution IP Limited / M/s Hetero Chloride Solution + 0001% w/w, Healthcare Ltd. Lignocaine Lignocaine Hydrochloride IP 2.0% Hydrochloride Gel w/w (ULFREE Gel) 19. Bupivacaine + Each ml Contains: 20 ML M/s Troikaa 71.43 Fentanyl Injection Bupivacaine Hydrochloride IP Vial Pharmaceuticals Ltd. 1.00mg eq. to anyhydrous Bupivacaine Hydrochloride 0.948mg, Fentanyl Citrate IP eq. to Fentanyl 2.0mcg10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 20. Bupivacaine + Each ml Contains: 20 ML M/s Troikaa 75.89 Fentanyl Injection Bupivacaine Hydrochloride IP Vial Pharmaceuticals Ltd. 1.25mg eq. to anyhydrous Bupivacaine Hydrochloride 1.185mg, Fentanyl Citrate IP eq. to Fentanyl 2.0mcg 21. Diphtheria Toxoid + Each pack contains: 0.5 ML M/s Panacea Biotech 340.15 Tetanus Toxoid + Diphtheria Toxoid 20Lf (30 IU), Ltd. Inactivated w-B. Tetanus Toxoid 7.5Lf (60 IU), pertussis bulk + Inactivated w-B. pertussis bulk 10 Hib (PRP- TT) (Hib IOU (4 IU), PRP Conjugated Hib (PRP- TT) (Hib PRP Conjugated with carrier protein with carrier protein Tetanus Toxoid) Tetanus Toxoid) + 10 ug, Aluminium content Aluminium content (A13+) (as (A13+) (as Aluminium Phosphate Gel) 0.25mg, Aluminium Thiomersal 0.025mg, Phosphate Gel) + Thiomersal 0.025mg, (Easy Four) 22. Formoterol Fumarate Each 2ml Inhalation suspension 2 ML M/s Akums Drugs & 36.04 + contains: Pharmaceuticals Ltd. / Budesonide Formoterol Fumarate Dihydrate IP M/s Glenmark Inhalation eq. to Formoterol Fumarate 20mcg, Pharmaceuticals Suspension Budesonide IP 0.5mg in an Isotonic Limited (Smartules) Solution 23. Formoterol Fumarate Each 2ml Inhalation suspension 2 ML M/s Akums Drugs & 42.12 + contains: Pharmaceuticals Ltd. / Budesonide Formoterol Fumarate Dihydrate IP M/s Glenmark Inhalation eq. to Formoterol Fumarate 20mcg, Pharmaceuticals Suspension Budesonide IP 1.0mg in an Isotonic Limited (Smartules) Solution 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 / 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.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 (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/193/61/2018/F/F. No. 8(61)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.