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) S.O. 2352(E) dated 15th September, 2014 and 619(E), dated 26th February, 2015, hereby fixes the prices as specified in column (5)

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- 1489] ubZ fnYyh] lkseokj] tqykbZ 13] 2015@vk"kk<+ 22] 1937 No. 1489] NEW DELHI, MONDAY, JULY 13, 2015/ASHADHA 22, 1937 jlk;u vkSj moZjd ea=kky; ¼vkS"kèk foHkkx½ ¼jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k½ vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1882¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2352¼v½ fnukad 15.09.2014 ds flizks¶yksDlhu gkbMªksDyksjkbM 250 fexzk- xksfy;ka fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/57/2014-ihvkbZ-I fnukad 06.02.2015 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds vkns'k dk-vk- 2352¼v½ fnukad 15 flrEcj] 2014 vkSj dk- vk- 619¼v½ fnukad 26 Qjojh] 2015 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ vfèkdre dher ¼#-½ 1 2 3 4 5 1. flizks¶yksDlhu gkbMªksDyksjkbM xksyh 250 fexzk- 1 xksyh 2.33 uksV % ¼d½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgh Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA 3079 GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼[k½ lHkh fuekZrkvksa ds fy, vko';d gS fd oks ,uihih, }kjk tkjh vkns'k dk- vk- 776¼v½ fnukad 17.3.2015 ds lkFk ifBr Hkkjr ljdkj ds foÙk ea=kky;] ¼jktLo foHkkx½ ds vfèklwpuk la[;k 14/2015 vkSj 15/2015- lsUVªy ,Dlkbt+ fnukad 1 ekpZ] 2015 ds vkèkkj ij vfèkdre ewY; dks ?kVkdj la'kksfèkr djds lqfuf'pr djsaA ¼x½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼?k½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA ¼M-½ fuekZrkvksa dks okf"kZd Fkksd ewY; lwpdkad ¼MCY;wihvkbZ½ ds vkèkkj ij la'kksfèkr ewY;ksa dk ykHk mBkus ds fy, Mhihlhvks] 2013 ds rgr vuqlwph II ds izk:i II esa Hkjdj 15 fnuksa ds Hkhrj iqujh{k.k ds fy, ljdkj dks vxzsf"kr fd;k tk;sxk vkSj bl mi iSjk ds vèkhu tkudkjh u fn;k tkuk dk vfèkdre QqVdj dher ¼,evkjih½ ds iqujh{k.k u fd;s tkus ds :i esa vFkZ yxk;k tk,xk vkSj lac) fofuekZrk iwoZ iqujhf{kr vfèkdre QqVdj dher ¼,evkjih½ ls vfèkd Hkkfjr jde dks vfèkd Hkkfjr gksus dh rkjh[k ls ml ij C;kt lfgr tek djus ds fy, nk;h gksukA ¼p½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼N½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds lwph II ds izk:i III esa 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 lEcUèk 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 izk:i IV esa Hkjdj ,uihih, dks izLrqr djsxkA ¼t½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 vuqlwfpr fofufeZr;ksa ds iSdksa dh vfèkdre dher fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vfèkØe.k gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (National Pharmaceutical Pricing Authority) ORDER New Delhi, the 13th July, 2015 S.O. 1882(E).—In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on 06.02.2015 vide letter no. 31015/57/2014/PI.I in respect of S.O. 2352(E) dated 15.9.2014 for Ciprofloxacin Hydrochloride Tablet 250mg. Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with 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) S.O. 2352(E) dated 15th September, 2014 and 619(E), dated 26th February, 2015, 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:¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 TABLE Sl. Name of the Scheduled Formulation Strength Unit Ceiling Price No. (Rs.) (1) (2) (3) (4) (5) 1. Ciprofloxacin Hydrochloride Tablet 250mg 1 Tablet 2.33 Note : (a) 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. (b) All the manufacturers are required to follow and ensure to revise their Maximum Retail price (MRP) (inclusive of excise duty and all taxes) of all formulation packs downward, pursuant to Ministry of Finance (Department of Revenue), vide Notification No. 14/2015 and 15/2015 –Central Excise dated 1st March, 2015 read with the NPPA notification S.O. 776(E) dated 17.3.2015. (c) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the ceiling price mentioned in the 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 as per the paragraph 24 (2) of the DPCO, 2013. (e) The manufacturer availing of the revised ceiling price as per WPI shall report to the Government in Form II of Schedule II to Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP as per WPI and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised MRP along with interest thereon from the date of overcharging. (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 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. (g) 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 Schedule-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 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 manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955. (i) 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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1883¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2350¼v½ fnukad 15.09.2014 ds flQkVs kDs lkbe bUtDs 'ku 250 fexkz-@500 fexkz- fofufefZr;k as d s lEcUèk e as i=k l-a 31015/56/2014-ihvkb-ZI fnukda 23.01.2015 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14 vkSj 16 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- 2350¼v½ fnukad 15 flrEcj] 2014 vkSj dk- vk- 619¼v½ fnukad 26 Qjojh] 2015 dks vfèkØe.k djrs4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre dher ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ vfèkdre dher ¼#-½ 1 2 3 4 5 1. flQksVksDlkbe bUtsD'ku 250 fexkz- izfr iSd 16.19 2. flQksVksDlkbe bUtsD'ku 500 fexkz- izfr iSd 21.12 uksV % ¼d½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vfèkdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgh Hkh ykxw gks] vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vfèkdre [kqnjk dher dks cuk, j[kuk gksxkA ¼[k½ lHkh fuekZrkvksa ds fy, vko';d gS fd oks ,uihih, }kjk tkjh vkns'k dk- vk- 776¼v½ fnukad 17.3.2015 ds lkFk ifBr Hkkjr ljdkj ds foÙk ea=kky;] ¼jktLo foHkkx½ ds vfèklwpuk la[;k 14/2015 vkSj 15/2015- lsUVªy ,Dlkbt+ fnukad 1 ekpZ] 2015 ds vkèkkj ij vfèkdre ewY; dks ?kVkdj la'kksfèkr djds lqfuf'pr djsaA ¼x½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼?k½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vfèkdre dher fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA ¼M-½ fuekZrkvksa dks okf"kZd Fkksd ewY; lwpdkad ¼MCY;wihvkbZ½ ds vkèkkj ij la'kksfèkr ewY;ksa dk ykHk mBkus ds fy, Mhihlhvks] 2013 ds rgr vuqlwph II ds izk:i II esa Hkjdj 15 fnuksa ds Hkhrj iqujh{k.k ds fy, ljdkj dks vxzsf"kr fd;k tk;sxk vkSj bl mi iSjk ds vèkhu tkudkjh u fn;k tkuk dk vfèkdre QqVdj dher ¼,evkjih½ ds iqujh{k.k u fd;s tkus ds :i esa vFkZ yxk;k tk,xk vkSj lac) fofuekZrk iwoZ iqujhf{kr vfèkdre QqVdj dher ¼,evkjih½ ls vfèkd Hkkfjr jde dks vfèkd Hkkfjr gksus dh rkjh[k ls ml ij C;kt lfgr tek djus ds fy, nk;h gksuk ¼p½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vfèkdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼N½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds lwph II ds izk:i III esa 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 lEcUèk 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 izk:i IV esa Hkjdj ,uihih, dks izLrqr djsxkA ¼t½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vfèkdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 vuqlwfpr fofufeZr;ksa ds iSdksa dh vfèkdre dher fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vfèkØe.k gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 ORDER New Delhi, the 13th July, 2015 S.O. 1883(E).—In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on 23.01.2015 vide letter no. 31015/56/2014/PI.I in respect of S.O. 2350(E) dated 15.9.2014 for Cefotaxime 250mg and 500mg Injection. Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with 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) S.O. 2350(E) dated 15th September, 2014 and 619(E), dated 26th February, 2015, 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 Scheduled Formulation Strength Unit Ceiling Price No. (Rs.) (1) (2) (3) (4) (5) 1. Cefotaxime Injection 250mg Each Pack 16.19 2. Cefotaxime Injection 500mg Each Pack 21.12 Note : (a) 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. (b) All the manufacturers are required to follow and ensure to revise their Maximum Retail price (MRP) (inclusive of excise duty and all taxes) of all formulation packs downward, pursuant to Ministry of Finance (Department of Revenue), vide Notification No. 14/2015 and 15/2015 –Central Excise dated 1st March, 2015 read with the NPPA notification S.O. 776(E) dated 17.3.2015. (c) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the ceiling price mentioned in the column (5) of the above said table. (d) The ceiling price for a pack of the schedule 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 as per the paragraph 24 (2) of the DPCO, 2013. (e) The manufacturer availing of the revised ceiling price as per WPI shall report to the Government in Form II of Schedule II to Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP as per WPI and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised MRP along with interest thereon from the date of overcharging. (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 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. (g) 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 Schedule-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 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 manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (i) 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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1884¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2104¼v½ fnukad 20.08.2014 ds fclksizksyksy ¶;wekjsV 5fexzk-$ ,eyksfMfiu 5 fexzk- xksfy;ka fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/51/2014-ihvkb-Z I fnukad 09.02.2015 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds vkns'k dk- vk- 2104¼v½ fnukad 20 vxLr] 2014 dks vfèkØe.k djrs gq,] 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ esudkbaM QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd fQUe fyfir xksfy;ksa esa 1. fclksizksyksy ¶;wekjsV$ fclksizksyksy ¶;wekjsV 5fexzk 1 xksyh 7.28 ,eyksfMfiu xksfy;ka ,eyksfMfiu fclk;ysV ,eyksfMfiu 5 fexzk- ds cjkcj uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZfr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1884(E).—In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on 09.02.2015 vide letter no. 31015/51/2014/PI.I in respect of S.O. 2104(E) dated 20.8.2014 for Bisoprolol Fumarate 5mg+Amlodipine 5mg tablet. Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraphs 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, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. 2104(E) dated 20th August, 2014, hereby fixes the price 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 Mankind Pharma Ltd. TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains 1. Bisoprolol Fumarate+ Bisoprolol Fumarate 5mg 1 Tablet 7.28 Amlodipine Tablet Amlodipine Besilate eq. to Amlodipine 5mg 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1885¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k us vkS"kèk foHkkx }kjk dk-vk- 2101¼v½ fnukad 20.08.2014 ds esVQksjfeu 500fexzk-$ fxfydkt+kbM 60 fexzk-$fi;ksxfyVkt+ksu ,plh,y 7.5 fexzk- xksfy;ka fofufeZfr;ksa ds lEcUèk esa i=k la- 31015/ 50/2014-ihvkbZ-I fnukad 09.12.2014 ij fn;s x;s vkns'k esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fuèkkZj.k ds lacaèk esa jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] ds vkns'k dk-vk- 2101¼v½ fnukad 20 vxLr] 2014 dks vfèkØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ bUosfU'k;k gsYFkds;j izkbosV fyfeVsM vkSj eSllZ ekbØks yscksjsVªht+ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd vfyfir ck;ys;MZ xksfy;ksa esa 1. esVQksjfeu ,plh,y$ esVQksjfeu gkbMªksDyksjkbM-500fexzk- 1 xksyh 6.25 fxfydkt+kbM $ ¼lLVsUM fjfyt+ QkWeZ esa½ fi;ksxfyVkt+ksu xksfy;ka fxfydkt+kbM 60 fexzk- ¼lLVsUM fjfyt+ QkWeZ esa½ fi;ksxfyVkt+ksu gkbMªksDyksjkbM fi;ksxfyVkt+ksu 7.5 fexzk- ds cjkcj uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 9 ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1885(E).—In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on 09.12.2014 vide letter no. 31015/50/2014/PI.I in respect of S.O. 2101(E) dated 20.8.2014 for Metformin 500mg+Gliclazide 60mg+Pioglitazone HCL 7.5mg Tablet. Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraphs 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, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. 2101(E) dated 20th August, 2014, hereby fixes the price 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 Inventia Healthcare Private Limited and M/s Micro Labs Limited respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated bilayered tablet contains 1. Metformin HCL + Metformin Hydrochloride-500mg 1 Tablet 6.25 Gliclazide+Pioglitazone (In sustained release form) Tablet Gliclazide-60mg (In sustained release form) Pioglitazone Hydrochloride eq. to Pioglitazone 7.5 mg 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 said table.10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1886¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ I;ksj ,aM D;ksj gsYFkds;j izkbosV fyfeVsM vkSj eSllZ Ms~t esfMdy LVksj ¼eSU;wQsDpfjax½ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd vfyfir ck;ys;MZ xksfy;ksa esa 1. fxfyesizkbM$esVQksjfeu fxfyesizkbM-2 fexzk- 1 xksyh 4.50 xkfsy;ka esVQksjfeu ,plh,y-500 fexzk- ¼fxzM 2 ,e½ ¼lLVsUM fjfyt+ QkWeZ esa½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 11 ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1886(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 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 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 Pure & Cure Healthcare Pvt. Ltd. and M/s Dey’s Medical Store (Manufacturing) Ltd. respectively. TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each uncoated bilayered tablet Contains: 1. Glimepiride + Glimepiride 2mg 1 Tablet 4.50 Metformin tablet Metformin HCL 500mg (GRID 2 M) (as sustained release form)12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1887¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ dsfMyk QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir ck;ys;MZ xksfy;ksa esa 1. DyksjFksfyMksu$esVksizksyksy Dykjs FkfsyMkus -12.50 fexkz- 1 xksyh 7.22 xkfsy;ka esVksizksyksy lDlhusV-47.50 fexkz- esVksizksyksy VkjVªsV-50 fexzk- ds cjkcj ¼,DlVsUMsM fjfyt+ QkWeZ esa½¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 13 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gSa 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 fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1887(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 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 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 Cadila Pharmaceuticals Limited. TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each film coated bilayered tablet contains: 1. Chlorthalidone + Chlorthalidone 12.50mg 1 Tablet 7.22 Metoprolol tablet Metoprolol Succinate 47.50mg eq. to Metoprolol Tartrate 50mg (as extended release form)14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1888¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ U;w FksjkI;wfVDl izkbosV fyfeVsM vkSj eSllZ fliyk fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd vkWjyh fMt+bfUVxzsfVax LVªhi esa 1. vksUMkusLVªksu vkWjyh vksUMkusLVªksu ,plh,y 1 iRrk 5.56 fMt+bfUVxzsfVax LVªhi vksUMkusLVªksu-4 fexzk- ds cjkcj ¼bfelsV QkLV½¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 15 2. vksUMkusLVªksu vkWjyh vksUMkusLVªksu ,plh,y 1 iRrk 12.61 fMt+bfUVxzsfVax LVªhi vksUMkusLVªksu-8 fexzk- ds cjkcj ¼bfelsV QkLV½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gSa 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 fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1888(E).—In exercise of the powers, conferred by paragraphs 5, 6, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 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 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 Nu Therapeutics Pvt. Ltd. and M/s Cipla Ltd. respectively.16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each Orally Disintegrating strip contains: 1. Ondansetron Orally Ondansetron HCl eq. to 1 Strip 5.56 Disintegrating Strip Ondansetron 4mg (Emeset Fast) 2. Ondansetron Orally Ondansetron HCl eq. to 1 Strip 12.61 Disintegrating Strip Ondansetron 8mg (Emeset Fast) 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1889¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ esudkbaM QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 17 lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd 5 fefy lLisUlu ?kqyus ds ckn esa 1. ,ftFkzksekbflu vkWjy ,ftFkzksekbflu MkbZgkbMªsV 1 fefy 2.68 lLiUslu ,ftFkzksekbflu ,UgkbMªl-200 fexzk- ds cjkcj uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1889(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 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 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 Mankind Pharma Limited.18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each 5ml of constituted suspension contains: 1. Azithromycin Oral Azithromycin dihydrate eq. to 1 ml 2.68 Suspension Azithromycin anhydrous 200mg 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1890¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ jsfo;u ykbQlkbal izkbosV fyfeVsM vkSj eSllZ T;wosUV~l gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 19 lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ vfèkdre dher ¼#-½ 1 2 3 4 5 izR;sd 5 fefy esa 1. isjkflVkeksy lLisUlu ijs kflVkekys -250 fexkz- 60 fefy 26.50 ¼dqyikjk Mh,l½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1890(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 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 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 Ravian Lifescience Pvt. Ltd. and M/s Zuventus Healthcare Ltd. respectively.20 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each 5ml contains: 1. Paracetamol suspension Paracetamol-250mg 60 ml 26.50 (Koolpara DS) 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1891¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,dwEl MªXl ,aM QkekZL;wfVdYl fyfeVsM vkSj eSllZ ,cksV~ gsYFkds;j izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 21 lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir lLVsUM fjfyt+ xksfy;ksa esa 1. lsfQfDle$ lsfQfDle VªkbZgkbMªsV 1 xksyh 16.75 vkW¶yksDlhu xksfy;ka lsfQfDle ,UgkbMªl-400 fexzk- ds cjkcj ¼ftefud vks 400 ,lvkj½ vk¶W ykDs lhu-400 fexkz- uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk eSU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;k¡ tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1891(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 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 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 Abbott Healthcare Pvt. Ltd. respectively.22 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Scheduled Formulation Strength Unit Retail Price No. (Rs.) (1) (2) (3) (4) (5) Each film coated sustained release tablet contains: 1. Cefixime+ Ofloxacin Cefixime Trihydrate eq. to 1 Tablet 16.75 Tablet Cefixime Anhydrous 400mg (Zimnic O 400 SR) Ofloxacin 400mg 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1892¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ L;wfju QkekZL;wfVdYl izkbosV fyfeVsM vkSj eSllZ VksjsUV QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 23 lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd gkMZ tsysfVu dSilwy esa 1. DyksfiMksxjsy$,VksjokLVsfVu$ DyksfiMksxjsy ckbZlYQsV 1 dSilwy 7.00 ,lfizu dSilwy DyksfiMksxjsy-75 fexzk- ds cjkcj ¼MsiykV lhoh 20 QksVZ½ ,VksjokLVsfVu dSfY'k;e ,VksjokLVsfVu-20 fexzk- ds cjkcj ¼fQYe fyfir xksyh½ ,lfizu-150 fexzk- ¼nks ,afVªd xksyh ds leku½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSsaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZfr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd24 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ORDER New Delhi, the 13th July, 2015 S.O. 1892(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 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 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 Surein Pharmaceuticals Pvt. Ltd. and M/s Torrent Pharmaceuticals Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatin capsule contains: 1. Clopidogrel+Atorvastatin+ Clopidogrel Bisulphate eq. to 1 Capsule 7.00 Aspirin Capsule Clopidogrel 75mg (Deplatt CV 20 Forte) Atorvastatin calcium eq. to Atorvastatin 20mg (as film coated tablet) Aspirin 150mg (as two enteric coated tablet) 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 25 vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1893¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ foaMykl ck;ksVsd fyfeVsM vkSj eSllZ ykbQ LVkj QkekZ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd vfyfir xksfy;ksa esa 1. fMDyksQsusd iksVkf'k;e$ fMDyksQsusd iksVkf'k;e-50 fexzk- 1 xksyh 9.12 esVkDlkyksu xksyh esVkDlkyksu-400 fexkz- uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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,axsA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd26 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ORDER New Delhi, the 13th July, 2015 S.O. 1893(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 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 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. Windlas Biotech Ltd. and M/s. Life Star Pharma Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated tablet Contains: 1. Diclofenac Potassium+ Diclofenac Potassium 50 mg 1 Tablet 9.12 Metaxalone Tablets Metaxalone 400mg Note : (a) The manufacturer of abovementioned 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 abovesaid 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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 27 vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1894¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ jsosucgy gsYFkds;j izkbosV fyfeVsM vkSj eSllZ ,QMhlh fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir ck;ys;MZ xksfy;ksa esa 1. VsfYelkjVu$ VsfYelkjVu-40 fexzk- 1 xksyh 7.96 esVkizksyksy xksfy;ka esVkizksyksy lDlhusV ¼ftVsYeh ,e 25½ esVkizksyksy VkjVªsV ¼bZvkj½-25 fexzk- ds cjkcj 2. VsfYelkjVu$ VsfYelkjVu-40 fexzk- 1 xksyh 9.59 esVkizksyksy xksfy;ka esVkizksyksy lDlhusV ¼ftVsYeh ,e 50½ esVkizksyksy VkjVªsV ¼bZvkj½-50 fexzk- ds cjkcj uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA28 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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,axsA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1894(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 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 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. Ravenbhel Healthcare Pvt. Ltd. and M/s. FDC Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated bilayered tablet contains: 1. Telmisartan + Telmisartan 40mg 1 Tablet 7.96 Metoprolol Tablets Metoprolol Succinate eq. to (ZITELMI M 25) Metoprolol Tartrate (ER) 25mg 2. Telmisartan + Telmisartan 40mg 1 Tablet 9.59 Metoprolol Tablets Metoprolol Succinate eq. to (ZITELMI M 50) Metoprolol Tartrate (ER) 50mg 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 29 (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1895¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 izcyk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,isDl yscksjsVªht+ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd xzke esa 1. DykscsVklksy izksfi;ksusV$ DykscsVklksy izksfi;ksusV-0.05% MCY;w@MCY;w 1 xzke 3.27 lsfyflfyd ,sflM vkW;UVesUV lsfyflfyd ,sflM-6% MCY;w@MCY;w ¼ftUdksMªe&,l 6%½ 2. DykscsVklksy izksfi;ksusV$ DykscsVklksy izksfi;ksusV-0.05% MCY;w@MCY;w 1 xzke 3.00 fu;ksekbflu vkW;UVesUV fu;ksekbflu lYQsV-0.5% MCY;w@MCY;w ¼ftUdksMªe&,u½ 3. DykscsVklksy izksfi;ksusV$ DykscsVklksy izksfi;ksusV-0.05% MCY;w@MCY;w 1 xzke 2.27 fu;ksekbflu$fedksukt+ksy fu;ksekbflu-0.5% MCY;@w MCY;w ukbVªsV Øhe ¼ftUdksMªe&,u,e½ fedksukt+ksy ukbVªsV-2.00% MCY;w@MCY;w uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA30 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1895(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 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 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 Apex Labs. Pvt. Limited. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each gm contains: 1. Clobetasol Propionate + Clobetasol Propionate 0.05% w/w 1 Gram 3.27 Salicylic Acid Ointment Salicylic Acid 6% w/w (Zincoderm-S 6%) 2. Clobetasol Propionate + Clobetasol Propionate 0.05% w/w 1 Gram 3.00 Neomycin Ointment Neomycin Sulphate 0.5% w/w (Zincoderm-N) 3. Clobetasol Propionate + Clobetasol Propionate 0.05% w/w 1 Gram 2.27 Neomycin+ Miconazole Neomycin Sulphate 0.5% w/w Nitrate Cream Miconazole Nitrate 2.00% w/w (Zincoderm-NM) 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 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 (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 31 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1896¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ esizksesDl ykbQlkbalsl izkbosV fyfeVsM vkSj ,Mdksd bUxzke gsYFkds;j izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd xzke esa 1. DykscsVklksy izksfi;ksusV$ DykscsVklksy izksfi;ksusV-0.05% MCY;w@MCY;w 1 xzke 2.27 fu;ksekbflu$fedksukt+ksy fu;ksekbflu-0.5% MCY;@w MCY;w ukbVªsV Øhe fedksukt+ksy ukbVªsV-2.00% MCY;w@MCY;w ¼jksosV th,e fu;ks½ DyksjksØslksy ¼izsljosfVo½-0.1% MCY;w@MCY;w uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA32 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1896(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 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 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. Mepromax Lifesciences Pvt. Ltd. and M/s. Adcock Ingram Healthcare Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each gm contains: 1. Clobetasol Propionate + Clobetasol Propionate 0.05% w/w 1 Gram 2.27 Neomycin+ Miconazole Neomycin Sulphate 0.5% w/w Nitrate Cream Miconazole Nitrate 2.00% w/w (Rovate GM Neo) Chlorocresol (preservative) 0.1% w/w 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 said table.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 33 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1897¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ vkWydkbaM gsYFkds;j vkSj eSllZ yhQksMZ gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; ¼#-½ 1 2 3 4 5 izR;sd vfyfir xksfy;ksa esa 1. isjkflVkeksy xksfy;ka ijs kflVkekys -650 fexkz- 1 xksyh 1.62 ¼fyeksy&650½ 2. ,sflDyksfoj xksfy;ka ,fslDykfsoj-800 fexkz- 1 xksyh 22.00 ¼tkLs Vj&800½ izR;sd 5 fefy esa 3. vkW¶yksDlhu lLisUlu vk¶W ykDs lhu-100 fexkz- 1 fefy 1.03 ¼vkyW VQs &100½34 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1897(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 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 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. Allkind Healthcare and M/s. Leeford Healthcare Ltd. respectively.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 35 TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated tablet contains: 1. Paracetamol Tablet Paracetamol 650mg 1 Tablet 1.62 (Leemol-650) 2. Aciclovir Tablet Aciclovir -800mg 1 Tablet 22.00 (ZOSTER 800) Each 5ml contains: 3. Ofloxacin Suspension Ofloxacin 100mg 1 ml 1.03 (OLTEF 100) 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director36 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1898¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ buksok dsi Vsc izkbosV fyfeVsM vkSj eSllZ T;wosUV~l gsYFdks;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd ok;y esa 1. lsf¶Vfj;sDlksu lksfM;e$ LVªkby lsf¶Vfj;sDlksu lksfM;e izfr iSd 98.69 lycsDV~e lksfM;e bUtsD'ku lsf¶Vfj;sDlksu-1000 fexzk- ds cjkcj ¼VªLVu ,l½ lycsDV~e lksfM;e lycsDV~e-500 fexzk- ds cjkcj] vkSj izR;sd ,Ei;wy esa 10 fefy bUtsD'ku ds fy, LVªkby ikuh uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 37 ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1898(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 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 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. Innova Cap Tab Pvt. Ltd. and M/s. M/s Zuventus Healthcare Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each vial contains: 1. Ceftriaxone Sodium + Sterile Ceftriaxone sodium eq. to Each Pack 98.69 Sulbactam Sodium Ceftriaxone 1000mg Injection Sulbactam Sodium eq. to (Trusten S) Sulbactam 500mg, and Each ampoule contains: Sterile water for injection 10 ml 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation.38 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1899¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ xsYQk yscksjsVªht+ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fQUe fyfir xksfy;ksa esa 1. vkW¶yksDlhu$ vk¶W ykDs lhu-200 fexkz- 1 xksyh 6.60 vksjfuMkt+ksy xksfy;ka vkjs fuMktk+ys -500 fexkz- ¼xsyksDlhu vkstsM½ izR;sd 5 fefy esa 2. vkW¶yksDlhu$ vkW¶yksDlhu-50 fexkz- 1 fefy 0.99 vksjfuMkt+ksy lLisUlu vkjs fuMktk+ys -125 fexkz- ¼xsyksDlhu vkstsM½ uksV % ¼¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 39 ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1899(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 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 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. Galpha Labs. Limited. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains: 1. Ofloxacin + Ofloxacin 200mg 1 Tablet 6.60 Ornidazole Tablet Ornidazole 500mg (GALOXIN OZ) Each 5ml contains: 2. Ofloxacin+ Ofloxacin 50mg 1 ml 0.99 Ornidazole Suspension Ornidazole 125mg (GALOXIN OZ) 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 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 (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, 2013.40 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1900¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ bUnq MªXl izkbosV fyfeVMs ( elS l Z bUn q MXª l ikzboVs fyfeVMs vkjS jxs kjfM;k QkekLZ ;fwVdYl fuferZ vkjS foi.ku fofufn"ZV fofuferZ ;k as Øe'k% e as l s iRz ;ds dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fQUe fyfir xksfy;ksa esa 1. Qsjl ,ldksjcsV$ Qsjl ,ldksjcsV 1 xksyh 6.47 Qksfyd ,sflM$ ,fyesUVy vkW;ju-100 fexzk- ds cjkcj ftad lYQsV xksfy;k Qkfsyd ,fslM-1500 ,elhth ¼,QdkmaV&,DlVh( lhQj½ ftad lYQsV eksuksgkbM(cid:17)ªsV-61.8 fexzk- ,fyesUVy ftad-22.5 fexzk- ds cjkcj uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsaA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 41 ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1900(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 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 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. Indu Drugs Pvt. Limited; M/s. Indu Drugs Pvt. Limited and M/s. Regardia Pharmaceuticals respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains: 1. Ferrous Ascorbate + Ferrous Ascorbate eq. to 1 Tablet 6.47 Folic Acid + Zinc Elemental Iron 100mg Sulphate tablet Folic Acid 1500mcg (Fcount-XT; SHIFER) Zinc Sulphate Monohydrate 61.8mg eq. to elemental Zinc 22.5mg 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 said table.42 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1901¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ :lksek yscksjsVªht+ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd 100 fefy esa 1. isjkflVeksy bu¶;wtu 1% isjkflVeksy-1 xkze 1 fefy 2.10 izR;sd 100 fefy esa 2. esfuuVksy bUtsD'ku esfuuVksy-15% izfr iSd 26.25 izR;sd 350 fefy esa 3. esfuuVksy bUtsD'ku esfuuVksy-15% izfr iSd 91.88 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 43 ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk eSU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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,axsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1901(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 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 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. Rusoma Labs. Pvt. Limited. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each100 ml contains: 1. Paracetamol Infusion 1% Paracetamol 1gm 1 ml 2.10 Each 100ml contains: 2. Mannitol Injection Mannitol-15% Each Pack 26.25 Each 350ml contains: 3. Mannitol Injection Mannitol-15% Each Pack 91.8844 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1902¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ljekÅj jsesfMt+ izkbosV fyfeVsM vkSj eSllZ esudkbaM QkekZ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fefy esa 1. MkseisfjMksu vkWjy Mªksi Mkes ifsjMkus -10 fexkz- 1 fefy 4.51¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 45 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1902(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 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 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. Sirmour Remedies Pvt. Ltd. and M/s. Mankind Pharma Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each ml Contains: 1. Domperidone Oral Drops Domperidone -10mg 1 ml 4.5146 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1903¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl fyfeVsM vkSj eSllZ CY;w ØkWl yscksjsVªht+ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd gkMZ tsysfVu dSilwy esa 1. isUVksizkt+ksy$ isUVksizkt+ksy lksfM;e lslD;wgkbMªsV 1 dSilwy 8.00 ysoklyizkbM dSilwy isUVksizkt+ksy-40 fexzk- ds cjkcj ¼ihihihvkbZ&,y½ ¼,afVªd fyfir isysV~l esa½ ysoklyizkbM-75 fexkz- ¼lLVsUM fjfyt+ xksfy;ksa esa½¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 47 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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,axsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1903(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 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 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. Theon Pharmaceuticals Ltd. and M/s. Blue Cross Labs. Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatine capsule contains: 1. Pantoprazole+ Pantoprazole Sodium Sesquihydrate 1 Capsule 8.00 Levosulpiride Capsule eq. to Pantoprazole– 40mg (PPPI-L) (as enteric coated pellets) Levosulpiride– 75mg (as sustained release tablet)48 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1904¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ lkbuksdse QkekZL;wfVdYl fyfeVsM vkSj eSllZ T;wosUV~l gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd xsLVªks&jsflLVsUV xksfy;ksa esa 1. VªkbZiflu$czksfeysu$ VªkbZiflu-48 fexkz- 1 xksyh 13.82 :VkslkbM VªkbZgkbMªsV$ czksfeysu-90 fexzk- fMDyksQsusd xksfy;ka :Vkls kbM VkªbgZ kbMVsª -100 fexkz- ¼fVcjksfyu Mh½ fMDyksQsusd lksfM;e-50 fexzk-¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 49 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsaflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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,axsaA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1904(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 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 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. Synokem Pharmaceuticals Ltd. and M/s. Zuventus Healthcare Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each gastro-resistant tablet contains: 1. Trypsin+ Bromelain+ Trypsin 48mg 1 Tablet 13.82 Rutoside Trihydrate+ Bromelain 90mg Diclofenac Tablet Rutoside Trihydrate 100mg (Tibrolin D) Diclofenac sodium 50mg50 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1905¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,dwEl MªXl ,aM QkekZL;wfVdYl fyfeVsM vkSj eSllZ CY;w ØkWl yscksjsVªht+ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd vfyfir ck;ys;MZ xksfy;ksa esa 1. esVQksjfeu ,plh,y$ esVQksjfeu ,plh,y ¼lLVsUM 1 xksyh 4.40 oksxfycksl xksfy;ka fjfyt+ esa½-500 fexzk- ¼ds&esV fM;w 0.2½ okxs fyckls -0.2 fexkz- 2. esVQksjfeu ,plh,y$ esVQksjfeu ,plh,y ¼lLVsUM 10 xkys h 52.38 oksxfycksl xksfy;ka fjfyt+ esa½-500 fexzk- ¼ds&esV fM;w 0.3½ okxs fyckls -0.3 fexkz-¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 51 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1905(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 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 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. Blue Cross Labs. Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each unocated bilayered tablet contains: 1. Metformin HCl + Metformin HCl (as sustained 1 Tablet 4.40 Voglibose Tablet release) – 500mg (K-MET Duo 0.2) Voglibose 0.2mg 2. Metformin HCl + Metformin HCl (as sustained 10’s Tablet 52.38 Voglibose Tablet release) – 500mg (K-MET Duo 0.3) Voglibose 0.3mg52 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1906¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl fyfeVsM vkSj eSllZ fyQksMZ gsYFkds;j fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir xksfy;ksa esa 1. ,eksDlhflfyu$ ,eksDlhflfyu VªkbZgkbMªsV 1 xksyh 26.71 iksVkf'k;e fdysO;wysusV xksfy;ka ,eksDlhflfyu-875 fexzk- ds cjkcj ¼,soksDlhy&lhoh fM;wl½ iksVkf'k;e fdysO;wysusV MkbZY;wVsM fdysO;wysfud ,sflM-125 fexzk- ds cjkcj¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 53 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1906(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 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 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. Theon Pharmaceuticals Ltd. and M/s. Leeford Healthcare Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains: 1. Amoxycillin + Amoxycillin trihydrate eq. to 1 Tablet 26.71 Potassium Clavulanate Amoxycillin 875mg Tablet Potassium Clavulanate Diluted (Evoxil-CV Duos) eq. to Clavulanic Acid 125mg54 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1907¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl fyfeVsM vkSj eSllZ ,cksV~ gsYFkds;j izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd gkMZ tsysfVu dSilwy esa 1. isUVksizkt+ksy$ isUVksizkt+ksy lksfM;e lslD;wgkbMªsV 1 dSilwy 7.63 MkseisfjMksu dSilwy isUVksizkt+ksy-40 fexzk- ds cjkcj ¼fudkis UsVk&Mh,lvkj½ ¼,afVªd fyfir isysV~l esa½ Mkes ifsjMkus -30 fexkz- ¼lLVsUM fjfyt+ isysV~l esa½¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 55 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1907(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 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 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. Theon Pharmaceuticals Ltd. and M/s. Abbott Healthcare Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatine capsule contains: 1. Pantoprazole + Pantoprazole sodium Sesquihydrate 1 Capsule 7.63 Domperidone Capsule eq. to Pantoprazole – 40mg (NICOPENTA DSR) (as entric coated pellets) Domperidone 30mg (as sustained release pellets)56 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1908¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ e as dh rRLFkkuh ifzof"V e as elS l Z vkDs lkfyl ycs kjs Vs hªt+ vkSj eSllZ esdfy;ksM~l QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd vfyfir ck;ys;MZ xksfy;ksa esa 1. esVQksjfeu ,plh,y$ esVQksjfeu ,plh,y ¼lLVsUM 1 xksyh 4.63 fxfyDykt+kbM xksfy;ka fjfyt+ esa½-500 fexzk- ¼thlhtsM ,e 80½ fxfyDykt+kbM-80 fexkz-¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 57 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1908(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 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 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. Oxalis Labs. and M/s. Macleods Pharmaceuticals Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated bilayered tablet contains: 1. Metformin HCl+ Metformin HCl (as 1 Tablet 4.63 Gliclazide Tablet sustained release) – 500 mg (GCZ M 80) Gliclazide 80mg58 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1909¼v½-—jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"kèk ¼dher fu;a=k.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 ea=kky;] jk"Vªh; vkS"kèk ewY; fuèkkZj.k izkfèkdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk 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 bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,eck;ksfVd yscksjsVªht+ izkbosV fyfeVsM vkSj eSllZ xzqi QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vfèkdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir xksfy;ksa esa 1. Qsjl ,ldksjcsV$ Qsjl ,ldksjcsV 1 xksyh 7.31 Qksfyd ,sflM xksfy;ka ,fyesUVy vkW;ju-100 fexzk- ds cjkcj ¼gseksxksYM&,DlVh½ Qksfyd ,sflM-1.5 fexzk-¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 59 uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fuèkkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vfèkdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSaA ¼x½ vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izkoèkkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; ds vkèkkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fuèkkZfjr djsaA fuekZrk vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA 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 lEcfUèkr fuekZrkvksa }kjk ,d ubZ vkS"kfèk dks ykap djrk gS rks mls igys vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ds rgr lwph II esa fofufnZ"V QkeZ I ds ekè;e ls ,uihih, esa ewY; fuèkkZj.k gsrq vkosnu djuk gksxkA ¼M-½ mi;qZDr xSj vfèkdr dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"kèk ¼ewY; fu;=a k.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fuèkkjZ .k@l'a kkèsku d s fy, QkeW ZI ij tek fd;k x;k Fkk vkjS ljdkj }kjk fuèkkfZjr lHkh ykxw oSèkkfud vko';drkvksa dh iwfrZ ds vèkhu izklafxd fofèk;ksa@fu;eksa ds vUrxZr tSls fd dsUnzh;@jkT; ykblsflax vFkkWfjVh ds l{ke izkfèkdkjh }kjk esU;wQsDpfjax ykblsl eatwjh ds rgr lacafèkr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcUèk esa lEcfUèkr fuekZrkvksa dks vkS"kèk ¼ewY; fu;a=k.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 djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcUèk 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 djsxkA ¼N½ fofuekrZ k ;k foi.ku dEiuh] mijkDs r fofufefZr;k as vkjS fofufn"ZV 'krk ±s dk ikyu ugh a djrh g aS rk s o s vko';d oLr,q ¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izkoèkkuksa ds vèkhu C;kt lfgr vfèkizHkkfjr 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 fofufeZr;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-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1909(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 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 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. Embiotic Labs. Pvt. Ltd. and M/s. Group Pharmaceuticals Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains: 1. Ferrous Ascorbate+ Ferrous Ascorbate eq. to 1 Tablet 7.31 Folic Acid Tablet elemental Iron 100mg (HEMOGOLD-XT) Folic Acid 1.5mg60 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 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 (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 the 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 retail 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 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) 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 intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied 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. (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 superseded. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director vkns'k ubZ fnYyh] 13 tqykbZ] 2015 dk-vk- 1910¼v½-—tcfd Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; ds fnukad 15 ebZ] 2013 ds dk;kZy; vkns'k la- 1221¼v½ ds }kjk vko';d oLrq vfèkfu;e] 1955 dh èkkjk 3 rFkk 5 }kjk iz)r 'kfDr;ksa dk iz;ksx djrs gq, vkS"kèk ¼ewY; fu;a=k.k½ vkns'k] 2013 ¼Mhihlhvks] 2013½ dks fuèkkZfjr fd;k x;kA 2. rFkk tcfd] jlk;u ,oa moZjd ea=kky; ds fnukad 30 ebZ] 2013 ds dk;kZy; vkns'k la- 1394¼v½ ds }kjk vko';d oLrq vfèkfu;e] 1955 dh èkkjk 3 rFkk 5 }kjk iz)r 'kfDr;ksa dk iz;ksx djrs gq, Mhihlhvks dh fof'k"V iSjkxzkQ ds lacaèk esa mDr vkns'k ds iSjkxzkQ 9 lfgr ,uihih, dks dsUnz ljdkj dh vksj ls 'kfDr;ka izR;ksftr dh xbZ gSaA 3. rFkk tcfd Mhihlhvks] 2013 ds iSjk 9 (2) esa izkoèkku gS fd ljdkj le; ds lE;d~ Øe esa vkS"kfèk;ksa ls lEcfUèkr cktkj vkèkkfjr vk¡dM+s ds laxzg.k ;k izkIr djus ds fdlh vU; leqfpr ra=k dks yk,xh vkSj vk¡dM+s dk laxzg.k ;k mls izkIr djus ds lEcUèk esa ljdkj dk fofu'p; vafre gksxkA 4. rFkk tcfd] Mhihlhvks 2013 ds iSjkxzkQ 2(n) esa ifjHkkf"kr ^fuekZrk* dks vuqlwph-II ds rgr fofHkUu Qkeks± esa fofufnZ"V vfuok;Z tkudkjh@lwpuk dks vkWuykbu tek djus ds :i dks l{ke cukus ds fy, Mhihlhvks] 2013 ds iSjk 9 (2) }kjk iz)r 'kfDr;ksa dk iz;ksx djrs gq, ,d leqfpr ra=k dks jk"Vªh; lwpuk foKku dsUnz ds lg;ksx ls ,dhdr` MkVk csl izcaèku iz.kkyh ¼vkbZihMh,e,l½ rS;kj fd;k x;k gSA¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 61 5. lHkh fuekZrkvksa dks vko';d oLrq,¡ vfèkfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds laxr izkoèkkuksa ds rgr vuqlwph- II esa QkWeZ&I] QkWeZ&II] QkWeZ&III] QkWeZ&IV] vkSj QkWeZ&V esa mi;qZDr mYysf[kr iSjk 4 ds vuqlkj vkbZihMh,e,l ds ekè;e ls vkWuykbu tkudjh ,uihih, dks tek@izLrqr djsxkA [dka- la-@155@23@2015@fo@Qk- la- 8¼23½@2015@Mhih@,uihih,-&fMoh--II] ujs'k vk;Z] mi&funs'kd ORDER New Delhi, the 13th July, 2015 S.O. 1910(E).—Whereas the Department of Pharmaceuticals in the Ministry of Chemicals and Fertilizers vide S.O. No. 1221(E) dated 15.05.2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has notified the Drugs (Prices Control) Order, 2013 (DPCO, 2013) 2. And whereas the Ministry of Chemicals and Fertilizers vide S.O. 1394(E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paragraphs of the DPCO, 2013, including paragraph 9 of the said order to be exercised by the NPPA on behalf of the Central Government. 3. And whereas paragraph 9 (2) of the DPCO, 2013 provides that the Government may in due course of time come out with other appropriate mechanism for collecting or obtaining the market based data related to drugs and the decisions of Government with respect to collection or obtaining of data shall be final. 4. And whereas, in exercise of power contained in paragraph 9(2) of the DPCO, 2013, an appropriate mechanism in collaboration with the National Informatics Centre as Integrated Pharma Database Management System (IPDMS) is in place to enable ‘manufacturer’ as defined in paragraph 2(n) of the DPCO, 2013 to make online submission of mandatory information / data specified in the various forms under Schedule-II of the DPCO, 2013. 5. All the manufacturers as mentioned in paragraph 4 hereinabove are required to submit on-line, through IPDMS to the NPPA, Form-I, Form-II, Form-III, Form-IV and Form-V under Schedule-II, as provided under the relevant provisions of the DPCO, 2013 read with Essential Commodities Act, 1955. [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, 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.