In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals

jftLVªh löa 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- 356] ubZ fnYyh] lkseokj] iQjojh 17] 2014@ek?k 28] 1935 No. 356] NEW DELHI, MONDAY, FEBRUARY 17, 2014/MAGHA 28, 1935 jlk;u vkSj moZjd ea=ky; ¼vk"Sk/k foHkkx½ ¼jk"Vªh; vk"Sk/k eYw ; fu/kkjZ .k ikzf/kdj.k½ vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1421¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k ¼dher fu;=a .k½ vkns'k] 2013 ds iSjk 4] 11 vkSj 14 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k la- dk-vk- 1554¼v½ fnukad 14 twu] 2013 dks vf/kØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre dher ds :i e as fu;r djrh g S A lkj.kh Ø- la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ vf/kdre dher ¼#-½ 1 2 3 4 5 1- ijs kflVkekys flji 125 fexzk-@5 fefy 1 fefy 0-32 uksV % ¼d½ mi;qZDr lkj.kh ds LraHk ¼5½ esa vf/kdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vf/kdre dher ls vf/kd LFkkuh; dj] tgka dgha Hkh ykxw gks] ds vuqlkj vukf/kd vf/kd [kqnjk dher dks la'kksf/kr djsxk A ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V 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 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A 647 GI/2014 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼?k½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 13¼2½ ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA ¼Ä½ mi;DZq r lkj.kh d s LrHa k ¼5½ e as fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vulq fwpr fofufefZr;k as d s fofufn"ZV fofHkUu rjhds vkjS icz yrk l s fHkUu vxj ektS nw k fuekrZ kvk as }kjk ,d ub Z vk"Skf/k dk s ykpa djrk g S rk s ml s igy s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼p½ mi;DZq r vulq fwpr fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lpw h II ds QkWeZ III e as Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k as d s 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e as n'kk;Z s vf/kdre eYw ; vkjS 'krk± s dk ikyu ugh a djrh g S rk s o s 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 ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 17th February, 2014 S.O. 421(E).—In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority No. S.O. 1554 (E), dated 14th June, 2013, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof : TABLE Sl. Name of the Schedule Formulation Strength Unit Ceiling Price (Rs.) No. (1) (2) (3) (4) (5) 1. Paracetamol Syrup 125 mg/5ml 1 ml 0.32 Note : (a) The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013. (b) The manufacturers may add local taxes only if they have paid actually to the Government on the ceiling price mentioned in the column (5) of the above table. (c) The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the DPCO, 2013.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 (d) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (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 DPCO, 2013 then 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 formulation shall furnish quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/DP/NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1422¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k ¼dher fu;=a .k½ vkns'k] 2013 ds iSjk 4] 11 vkSj 14 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k la- dk-vk- 3367¼v½ fnukda 5 uoEcj] 2013 dk s vf/kØe.k djr s gq,] uhp s dh lkj.kh d s LrHa k ¼5½ e as fofufnZ"V vf/kdre dher dk s mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre dher ds :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ vf/kdre dher ¼#-½ 1 2 3 4 5 1- fMxkDs lhu bUtDs 'ku 0-25 fexzk-@fefy 1 fefy 3-74 uksV % ¼d½ mi;qZDr lkj.kh ds LraHk ¼5½ esa vf/kdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vf/kdre dher ls vf/kd LFkkuh; dj] tgka dgha Hkh ykxw gks] ds vuqlkj vukf/kd vf/kd [kqnjk dher dks la'kksf/kr djsxk A ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V 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 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 13¼2½ ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼Ä½ mi;DZq r lkj.kh d s LrHa k ¼5½ e as fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vulq fwpr fofufefZr;k as d s fofufn"ZV fofHkUu rjhds vkjS icz yrk l s fHkUu vxj ektS nw k fuekrZ kvk as }kjk ,d ub Z vk"Skf/k dk s ykpa djrk g S rk s ml s igy s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼p½ mi;DZq r vulq fwpr fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lpw h II ds QkWeZ III e as Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k as d s 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e as n'kk;Z s vf/kdre eYw ; vkjS 'krk± s dk ikyu ugh a djrh g aS rk s o s 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 ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 422(E).—In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority No. S.O. 3367 (E), dated 5th November, 2013, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof : TABLE Sl. Name of the Schedule Formulation Strength Unit Ceiling Price (Rs.) No. (1) (2) (3) (4) (5) 1. Digoxin Injection 0.25 mg/ml 1 ml 3.74 Note : (a) The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013. (b) The manufacturers may add local taxes only if they have paid actually to the Government on the ceiling price mentioned in the column (5) of the above table. (c) The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (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 DPCO, 2013 then 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, 2013.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (f) The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/DP/NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1423¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k ¼dher fu;=a .k½ vkns'k] 2013 ds iSjk 4] 11 vkSj 14 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k la- dk- vk- 3330¼v½ fnukad 5 uoEcj]2013 dks vf/kØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre dher ds :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ vf/kdre dher ¼#-½ 1 2 3 4 5 1- DyksfVªekTkksy islkfjt 100 fexzk- 1 ils kfjt 8-69 uksV % ¼d½ mi;qZDr lkj.kh ds LraHk ¼5½ esa vf/kdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vf/kdre dher ls vf/kd LFkkuh; dj] tgka dgha Hkh ykxw gks] ds vuqlkj vukf/kd vf/kd [kqnjk dher dks la'kksf/kr djsxk A 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 D;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V 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 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 13¼2½ ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA ¼Ä½ mi;DZq r lkj.kh d s LrHa k ¼5½ e as fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vulq fwpr fofufefZr;k as d s fofufn"ZV fofHkUu rjhds vkjS icz yrk l s fHkUu vxj ektS nw k fuekrZ kvk as }kjk ,d ub Z vk"Skf/k dk s ykpa djrk g S rk s ml s igy s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼p½ mi;DZq r vulq fwpr fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lpw h II ds QkWeZ III e as Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k as d s 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 djsxkA6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e as n'kk;Z s vf/kdre eYw ; vkjS 'krk± s dk ikyu ugh a djrh g S rk s o s 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 ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 423(E).—In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 3330(E), dated 5th November, 2013, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof : TABLE Sl. Name of the Schedule Formulation Strength Unit Ceiling Price (Rs.) No. (1) (2) (3) (4) (5) 1. Clotrimazole Pessaries 100 mg 1 Pessaries 8.69 Note : (a) The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013. (b) The manufacturers may add local taxes only if they have paid actually to the Government on the ceiling price mentioned in the column (5) of the above table. (c) The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (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 DPCO, 2013 then 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 formulation shall furnish quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/DP/NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1424¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k ¼dher fu;=a .k½ vkns'k] 2013 ds iSjk 4] 11 vkSj 14 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky;] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k la- dk- vk- 1918¼v½ fnukad 28 twu] 2013 dks vf/kØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre dher ds :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ vf/kdre dher ¼#-½ 1 2 3 4 5 1- izkes Fs kkftu bUtDs 'ku 25 fexzk-@fefy 1 fefy 2-84 uksV % ¼d½ mi;qZDr lkj.kh ds LraHk ¼5½ esa vf/kdre [kqnjk dher gksus ds Åij mYysf[kr vuqlwfpr fofufeZfr;ksa ds fuekZrkvksa dks Mhihlhvks] 2013 ds iSjkxzkQ 13 ¼1½ vkSj iSjk 24 ds rgr vf/kdre dher ls vf/kd LFkkuh; dj] tgka dgha Hkh ykxw gks] ds vuqlkj vukf/kd vf/kd [kqnjk dher dks la'kksf/kr djsxk A ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V 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 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgha Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 13¼2½ ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA ¼Ä½ mi;DZq r lkj.kh d s LrHa k ¼5½ e as fofufn"ZV vf/kdre dher d s fy, fofufn"ZV vulq fwpr fofufefZr;k as d s fofufn"ZV fofHkUu rjhds vkjS icz yrk l s fHkUu vxj ektS nw k fuekrZ kvk as }kjk ,d ub Z vk"Skf/k dk s ykpa djrk g S rk s ml s igy s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼p½ mi;DZq r vulq fwpr fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lpw h II ds QkWeZ III e as Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k as d s 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh e as n'kk;Z s vf/kdre eYw ; vkjS 'krk± s dk ikyu ugh a djrh g S rk s o s 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 gksaxsA8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 424(E).—In exercise of the powers, conferred by paragraph 4, 11 and 14 of the Drugs (Prices Control) Order, 2013, read with No. S.O. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 1918 (E), dated 28th June, 2013, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof : TABLE Sl. Name of the Schedule Formulation Strength Unit Ceiling Price (Rs.) No. (1) (2) (3) (4) (5) 1. Promethazine Injection 25 mg/ml 1 ml 2.84 Note : (a) The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO, 2013. (b) The manufacturers may add local taxes only if they have paid actually to the Government on the ceiling price mentioned in the column (5) of the above table. (c) The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (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 DPCO, 2013 then 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 formulation shall furnish quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of schedules formulation in Form-IV of scheduled-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/DP/NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1425¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 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,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼mlds ckn ,uihih, dks Hkstk x;k gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa e as fofufn"ZV icz yrk vkjS bdkb Z ¼;fwuV½ lfgr ml lkj.kh d s LrHa k ¼2½ e as dh rRLFkkuh ifzof"V e as elS l Z vdeq MªXl ,Ma QkekfZL;fwVdYl fyfeVsM vkSj eSllZ T;ow sUV~l gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofu£n"V fofufeZfr;ks a Øe'k% es a ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre [knq jk eYw ; d s :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 1- fxykbeijkbM+fi;kxs fyVktkus + iRz ;ds vfyfir ck;y;s M Z xkfsy;k as eas 1 xksyh 5-36 esVQksjfeu ,plh,y xksfy;ka fxykbeijkbM&1 fexzk- ¼VlQksjfeu 1 xksfy;ka½ fi;kxs fyVktkus ,plh,y fi;ksxfyVktksu&15 fexzk- ds cjkcj esVQksjfeu ,plh,y&500 fexzk- ¼lLVsUM fjfyt QkeZ esa½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWeWwys'ku tks ^^ubZ Mªx** Mhihlhvks] 2013 ds iSjkxzkQ 2 ¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxs A ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ e as fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k as d s iSdk as d s fy, [kqnjk eYw ; fu/kkZfjr djAas fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼Ä½ mi;qZDr xSj vf/kde 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 1 ij tek fd;k x;k Fkk A ¼p½ mi;DZq r fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as lEcfU/kr fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lpw h II ds QkWeZ III e as Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k as d s fuekZ.k dks dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcU/k esa vxj 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 djsxkA10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofu£n"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vf/kfu;e] 1955 d slkFk ifBr Mhihlhvk]s 2013 d sikzo/kkuk asd sv/khu C;kt lfgr vf/kiHzkkfjr jkf'k dk stek dju sd sfy, nk;h gkxas As ¼t½ 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, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 425(E).—In exercise of the powers, conferred by paragraph 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table hereto annexed as the retail price, exclusive of local taxes , if any in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Akums Drugs & Pharmaceuticals Ltd. and M/s. Zuventus Healthcare Ltd. respectively. TABLE Sl. Name of the Schedule Formulation Strength Unit Retail Price (Rs.) No. (1) (2) (3) (4) (5) 1. Glimeperide+ Each uncoated bilayer tablet contains 1 Tablet 5.36 Pioglitazone+ Glimepiride-1mg. Metformin HCL Tablets Pioglitazone HCL eq. to (Tusformin 1 Tablet) Pioglitazone - 15mg. Metformin HCL - 500 mg. (in sustained release form) Note : (a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO,2013 then he 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. (e) The above mentioned non-ceiling price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013. (f) The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of its production / import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1426¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 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,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼mlds ckn ,uihih, dks Hkstk x;k gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa e as fofufn"ZV icz yrk vkjS bdkb Z ¼;fwuV½ lfgr ml lkj.kh d s LrHa k ¼2½ e as dh rRLFkkuh ifzof"V e as elS l Z vdeq MªXl ,Ma QkekfZL;fwVdYl fyfeVMs vkSj eSllZ T;ow Us V~l gYs Fkd;s j fyfeVMs fufeZr vkSj foi.ku fofu£n"V fofufeZfr;k as Øe'k% e as l s izR;ds dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre [knq jk eYw ; d s :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 1- fxykbeijkbM+fi;kxs fyVktkus + izR;sd vfyfir ck;ys;MZ xksfy;ksa 1 xksyh 6-94 esVQksjfeu ,plh,y xksfy;ka fxykbeijkbM&2 fexzk- ¼VlQksjfeu 2 xksfy;ka½ fi;kxs fyVktkus ,plh,y fi;ksxfyVktksu&15 fexzk- ds cjkcj esVQksjfeu ,plh,y&500 fexzk- ¼lLVsUM fjfyt QkeZ esa½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWeWwys'ku tks ^^ubZ Mªx** Mhihlhvks] 2013 ds iSjkxzkQ 2 ¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsa A ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ e as fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k as d s iSdk as d s fy, [kqnjk eYw ; fu/kkZfjr djAas fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk lacaf/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼Ä½ mi;qZDr xSj vf/kde 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 A ¼p½ mi;DZq r fofufefZr;k as dh mRiknu@vk;kr vkjS fcØh d s lEcU/k e as lEcfU/kr fuekrZ kvk as dk s vk"Sk/k ¼eYw ; fu;=a .k½ vkn's k] 2013 ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e as vxj fofufeZfr;kas 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofu£efr;k asvkjS fofu£n"V 'krk± s dk ikyu ugh a djrh g S rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk as d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxas As ¼t½ 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, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 426(E).—In exercise of the powers, conferred by paragraph 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table hereto annexed as retail price exclusive of local taxes , if any in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Akums Drugs & Pharmaceuticals Ltd. and M/s. Zuventus Healthcare Ltd. respectively. TABLE Sl. Name of the Schedule Formulation Strength Unit Retail Price (Rs.) No. (1) (2) (3) (4) (5) 1. Glimeperide+ Each uncoated bilayer tablet contains 1 Tablet 6.94 Pioglitazone+ Glimepiride-2 mg. Metformin HCL Tablets Pioglitazone HCL eq. to (Tusformin 2 Tablet) Pioglitazone - 15 mg. Metformin HCL - 500 mg. (in sustained release form) Note : (a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO, 2013.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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. (e) The above mentioned non-ceiling price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013. (f) The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1427¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 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,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼mlds ckn ,uihih, dks Hkstk x;k gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ gsVsjks ysc~l fyfeVsM vkSj eSllZ ,cksV bafM;k fyfeVsM fufeZr vkSj foi.ku fofu£n"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Zg]S dk sNkMs d+ j [knq jk eYw ; d s :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 1- okxs fyckls + izR;sd vfyfir ck;ys;MZ xksfy;ksa 10 xksyh 52-38 esVQksjfeu ,plh,y xksfy;ka okxs fyckls &0-2 fexzk- ¼vksfcesV oh 0-2 fexzk- xksfy;ka½ esVQksjfeu ,plh,y&500 fexzk- ¼lLVsUM fjfyt QkeZ esa½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWeWwys'ku tks ^^ubZ Mªx** Mhihlhvks] 2013 ds iSjkxzkQ 2 ¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsa A 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; gSa rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ e as fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k as d s iSdk as d s fy, [kqnjk eYw ; fu/kkZfjr djAas fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼?k½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk lacaf/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼Ä½ mi;qZDr xSj vf/kde 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 1 ij tek fd;k x;k Fkk A ¼p½ mi;qZDr fofufeZfr;ks a dh mRiknu@vk;kr vkSj fcØh ds lEcU/k es a lca fa/kr fuekZrkvks a dks vkS"k/k ¼eYw ; fu;=a .k½ vkns'k] 2013 ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e as vxj fofufeZfr;kas 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofu£efr;k asvkjS fofu£n"V 'krk± s dk ikyu ugh a djrh g S rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk as d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxas As ¼t½ 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, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 427(E).—In exercise of the powers, conferred by paragraph 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as retail prices exclusive of local taxes, if any in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof ; manufactured and marketed by M/s. Hetero Labs Ltd. and M/s. Abbott India Ltd. respectively. TABLE Sl. Name of the Schedule Formulation Strength Unit Retail Price (Rs.) No. (1) (2) (3) (4) (5) 1. Voglibose+ Each uncoated bilayer tablet contains 10's Tablet 52.38 Metformin HCL Tablets Voglibose - 0.2mg. (Obimet V 0. 2mg. Tablet) Metformin HCL - 500 mg. (in sustained release form) Note : (a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above table.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 15 (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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. (e) The above mentioned non-ceiling price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013. (f) The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of its production / import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1428¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k ¼dher fu;=a .k½ vkns'k] 2013 ds iSjk 4] 11 vkSj 15 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼mlds ckn ,uihih, dks Hkstk x;k gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ gsVsjks ysc~l fyfeVsM vkSj eSllZ ,cksV bafM;k fyfeVsM fufeZr vkSj foi.ku fofu£n"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Zg]S dk sNkMs d+ j vf/kdre [knq jk eYw ; d s :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 1- okxs fyckls + izR;sd vfyfir ck;ys;MZ xksfy;ksa 10 xksyh 52-38 esVQksjfeu ,plh,y xksfy;ka okxs fyckls &0-3 fexzk- ¼vksfcesV oh 0-3 fexzk- xksfy;ka½ esVQksjfeu ,plh,y&500 fexzk- ¼lLVsUM fjfyt QkeZ esa½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWeWwys'ku tks ^^ubZ Mªx** Mhihlhvks] 2013 ds iSjkxzkQ 2 ¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsa A 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; gSa rks os LFkkuh; djksa dks tksM+ ldrs gSa A16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk lacaf/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼Ä½ mi;qZDr xSj vf/kde 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 1 ij tek fd;k x;k Fkk A ¼p½ mi;qZDr fofufeZfr;ks a dh mRiknu@vk;kr vkSj fcØh ds lEcU/k es a lca fa/kr fuekZrkvks a dks vkS"k/k ¼eYw ; fu;=a .k½ vkns'k] 2013 ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e as vxj fofufeZfr;kas 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] mijkDs r fofu£er vkSj fofu£n"V 'krk±s dk ikyu ugh a djrh gS rk s o s vko';d oLrq,¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk as d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxas As ¼t½ 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, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 428(E).—In exercise of the powers, conferred by paragraph 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table hereto annexed as retail prices exclusive of local taxes, if any in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof ; manufactured and marketed by M/s. Hetero Labs Ltd. and M/s. Abbott India Ltd. respectively. TABLE Sl. Name of the Schedule Formulation Strength Unit Retail Price (Rs.) No. (1) (2) (3) (4) (5) 1. Voglibose+ Each uncoated bilayer tablet contains 10's Tablet 52.38 Metformin HCL Tablets Voglibose - 0.3mg. (Obimet V 0.3mg. Tablet) Metformin HCL - 500 mg. (in sustained release form) Note : (a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 17 (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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. (e) The above mentioned non-ceiling price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013. (f) The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of its production / import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the above said date of notification, stand withdrawn. [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1429¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 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,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼mlds ckn ,uihih, dks Hkstk x;k gS½] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ U;wVªkeSDl gsYFkds;j vkSj eSllZ T;wosUV~l gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z g]S dk s NkMs d+ j vf/kdre [knq jk eYw ; d s :i e as fu;r djrh g S A lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 1- vkes is zk”kksy+Mkes ifsjMkus dSilyw izR;sd gkMZ tsysfVu dSilwy esa 1 dSilwy 4-21 ¼VªLVksflV Mh dSilwya½ vksesizk”kksy&20 fexzk- ¼,afVªd fyfir isysV~l½ MkseisfjMksu&10 fexzk- ¼isysV~la½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWeWwys'ku tks ^^ubZ Mªx** Mhihlhvks] 2013 ds iSjkxzkQ 2 ¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxs A18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk ¼5½ esa of.kZr [kqnjk ewY; ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gSa rks os LFkkuh; djksa dks tksM+ ldrs gSa A ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ e as fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k as d s iSdk as d s fy, [kqnjk eYw ; fu/kkZfjr djAas fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsa A ¼?k½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds fy, fofufnZ"V fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk lacaf/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼Ä½ mi;qZDr xSj vf/kde 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 vuqc¼ ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ 1 ij tek fd;k x;k Fkk A ¼p½ mi;qZDr fofufeZfr;ks a dh mRiknu@vk;kr vkSj fcØh ds lEcU/k es a lca fa/kr fuekZrkvks a dks vkS"k/k ¼eYw ; fu;=a .k½ vkns'k] 2013 ds lwph II ds QkWeZ III esa Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e as vxj fofufeZfr;kas 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 fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofu£efr;k asvkjS fofu£n"V 'krk± s dk ikyu ugh a djrh g S rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk as d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxas As ¼t½ bl vkns'k e sa mijksDr lkj.kh ds LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufnZ"V vuqlfwpr fofufeZfr;k sa ds iSdk sa dh [kqnjk eYw ; fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gSa] Lor% gh fujLr gks tk;saxsA ¹dk-al-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd ORDER New Delhi, the 17th February, 2014 S.O. 429(E).—In exercise of the powers, conferred by paragraph 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table hereto annexed as retail price, exclusive of local taxes, if any in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof ; manufactured and marketed by M/s. Newtramax Healthcare & M/s. Zuventus Healthcare Ltd. respectively. TABLE Sl. Name of the Schedule Formulation Strength Unit Retail Price (Rs.) No. (1) (2) (3) (4) (5) 1. Omeprazole+ Each hard gelatin capsule contains 1 Capsule 4.21 Domeperidone Capsules Omeprazole - 20 mg. (Trustocid D Capsule) (as enteric coated pellets) Domeperidone-10 mg. (As Pellets)¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 19 Note : (a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO, 2013 then he 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. (e) The above mentioned non-ceiling price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013. (f) The concerned manufacturer of above said formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue above said formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of above said formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand withdrawn [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director 'kqf¼&i= vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1430¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ds vkns'k la- dk-vk- 3558 ¼v½] rkjh[k 2 fnlEcj] 2013 ¼vkbQkls QkekbM bUtDs 'ku] 1 xkze@2 fefy ok;y d s vf/kdre eYw ; fu/kkjZ .k l s lEcfU/kr½] Hkkjr d s jkti=] vlk/kkj.k e as idz kf'kr fgUnh :ikarj esa lkj.kh ds izcyrk dkWye la[;k 3 dh izfof"V 1 dks fuEu izdkj i<+k tk, % ds LFkku ij “1 xzke@2 ,e ok;y” i<+k tk, “1 xzke@2 fefy ok;y” ¹dk-a l-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd20 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] CORRIGENDUM ORDER New Delhi, the 17th February, 2014 S.O. 430 (E).—The National Pharmaceutical Pricing Authority’s Order No. S.O. 3558(E) dated the 2nd December, 2013 (relating to the ceiling price fixation of Ifofsamide Injection, 1gm/2ml vial), published in the Gazette of India, Extraordinary, of the Entry at Sl. No. 1 in the Strength column No. (3) of the table, in English version be read as follows : Instead of “1 gm/2m vial ” Read as “1 gm/2ml vial ” [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director 'kqf¼&i= vkns'k ub Z fnYyh] 17 Qjojh] 2014 dk-vk-1431¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ds vkns'k la- dk-vk- 1673 ¼v½] rkjh[k 14 twu] 2013 ¼VsVul VkDW lkbM bUtDS 'ku d s vf/kdre eYw ; fu/kkjZ .k l s lEcfU/kr½] Hkkjr d s jkti=] vlk/kkj.k e asidz kf'kr vxa tsz h :ikra j vkjS fgUnh :ikra j esa lkj.kh ds bdkbZ dkWye la[;k 4 dh izfof"V 1 dks fuEu izdkj i<+k tk, % ds LFkku ij “izfr iSd” i<+k tk, “1 fefy” ¹dk-a l-a@143@11@2014@fo@Qk- l-a 8¼11½@2014@Mhih@,uihih,-&fMoh-&IIº euh"k xksLokeh] mi&funs'kd CORRIGENDUM ORDER New Delhi, the 17th February, 2014 S.O. 431 (E).—The National Pharmaceutical Pricing Authority’s Order No. S.O. 1673(E) dated the 14th June, 2013 (relating to the ceiling price fixation of Tetanus Toxoid Injection), published in the Gazette of India, Extraordinary, of the Entry at Sl. No. 1 in the Unit column No. (4) of the table, both in Hindi & English version be read as follows : Instead of “Each Pack” Read as “1 ml” [PN/143/11/2014/F/F. No. 8(11)/2014/D.P./NPPA-Div.-II] MANISH GOSWAMI, Dy. Director Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.