vlk/kj.k Hkkx II [k.m 3 mi&[k.m (ii) PART II Section 3 Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY jlk;u vksj mozjd ea=kky;

Transkript

1 jftlvªh laö REGD. NO. D. L /99 vlk/kj.k EXTRAORDINARY Hkkx II [k.m 3 mi&[k.m (ii) PART II Section 3 Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 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 ds flizks yksdlhu gkbmªksdyksjkbm 250 fexzk- xksfy;ka fofufezfr;ksa ds lecuèk esa i=k la /57/2014-ihvkbZ-I fnukad 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 bzdkbz vfèkdre dher ¼#-½ 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 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 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 ¼>½ 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 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] MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (National Pharmaceutical Pricing Authority) ORDER New Delhi, the 13th July, 2015 ujs'k vk;z] mi&funs'kd S.O. 1882(E). In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on vide letter no /57/2014/PI.I in respect of S.O. 2352(E) dated 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:

3 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) (b) (c) (d) (e) (f) (g) (h) (i) 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, 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 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. 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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. 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, 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, 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. 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, 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. vkns'k ubz fnyyh] 13 tqykbz] 2015 [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director dk-vk- 1883¼v½- jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k us vks"kèk fohkkx }kjk dk-vk- 2350¼v½ fnukad ds flqksvksdlkbe butsd'ku 250 fexzk-@500 fexzk- fofufezfr;ksa ds lecuèk esa i=k la /56/2014-ihvkbZ-I fnukad 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 djrs

4 4 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 bzdkbz vfèkdre dher ¼#-½ flqksvksdlkbe butsd'ku 250 fexzk- izfr isd flqksvksdlkbe butsd'ku 500 fexzk- izfr isd uksv % ¼d½ ¼[k½ 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 lhkh fuekzrkvksa ds fy, vko';d gs fd oks,uihih, }kjk tkjh vkns'k dk- vk- 776¼v½ fnukad 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 ¼>½ 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 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

5 ¹Hkkx 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 vide letter no /56/2014/PI.I in respect of S.O. 2350(E) dated 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 Cefotaxime Injection 500mg Each Pack Note : (a) (b) (c) (d) (e) (f) (g) (h) 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, 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 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. 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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. 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, 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, 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. 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 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 ds fclksizksyksy ;wekjsv 5fexzk-$,eyksfMfiu 5 fexzk- xksfy;ka fofufezfr;ksa ds lecuèk esa i=k la /51/2014-ihvkbZ-I fnukad ij fn;s x;s vkns'k esa vafdr funsz'kksa ds dk;kzuo;u gsrq iqufozyksdu vkns'k ikfjr fd;k x;ka blfy,] mi;qzdr ewy; fuèkkzj.k ds lacaèk esa jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebz] 2013 ds lkfk ifbr vks"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds isjk 5, 11 vksj 15 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky;] jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k] ds vkns'k dk- vk- 2104¼v½ fnukad 20 vxlr] 2014 dks vfèkøe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnz"v [kqnjk ewy; dks mdr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bzdkbz ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa esllz esudkbam QkekZ fyfevsm fufezr vksj foi.ku fofufnz"v fofufezr;ksa esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vfèkdre [kqnjk ewy; ds :i esa fu;r djrh gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bzdkbz [kqnjk ewy; ¼#-½ izr;sd fque fyfir xksfy;ksa esa 1. fclksizksyksy ;wekjsv$ 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 vkns'k] 2013 ds rgr vuqc) ewy; fuèkkzj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fuèkkzfjr 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

7 ¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 ¼N½ ¼t½ fofuekzrk ;k foi.ku deiuh] mijksdr fofufezfr;ksa vksj fofufnz"v '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 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] ORDER New Delhi, the 13th July, 2015 ujs'k vk;z] mi&funs'kd S.O. 1884(E). In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on vide letter no /51/2014/PI.I in respect of S.O. 2104(E) dated 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) (b) (c) (d) (e) (f) 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. 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. 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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, 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. 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, 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 8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (g) (h) 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, 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. vkns'k ubz fnyyh] 13 tqykbz] 2015 [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director dk-vk- 1885¼v½- jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k us vks"kèk fohkkx }kjk dk-vk- 2101¼v½ fnukad ds esvqksjfeu 500fexzk-$ fxfydkt+kbm 60 fexzk-$fi;ksxfyvkt+ksu,plh,y 7.5 fexzk- xksfy;ka fofufezfr;ksa ds lecuèk esa i=k la / 50/2014-ihvkbZ-I fnukad ij fn;s x;s vkns'k esa vafdr funsz'kksa ds dk;kzuo;u gsrq iqufozyksdu vkns'k ikfjr fd;k x;ka blfy,] mi;qzdr ewy; fuèkkzj.k ds lacaèk esa jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k] Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebz] 2013 ds lkfk ifbr vks"kèk ¼dher fu;a=k.k½ vkns'k] 2013 ds isjk 5, 11 vksj 15 }kjk iznrr 'kfdr;ksa dk iz;ksx djrs gq,] rfkk Hkkjr ljdkj ds jlk;u vksj mozjd ea=kky;] jk"vªh; vks"kèk ewy; fuèkkzj.k izkfèkdj.k] ds vkns'k dk-vk- 2101¼v½ fnukad 20 vxlr] 2014 dks vfèkøe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ esa fofufnz"v [kqnjk ewy; dks mdr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rrlfkkuh izfof"v;ksa esa fofufnz"v izcyrk vksj bzdkbz ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rrlfkkuh izfof"v esa esllz buosfu'k;k gsyfkds;j izkbosv fyfevsm vksj esllz ekbøks yscksjsvªht+ fyfevsm fufezr vksj foi.ku fofufnz"v fofufezr;ksa Øe'k% esa ls izr;sd dh] LFkkuh; dj] ;fn dksbz gs] dks NksM+dj vfèkdre [kqnjk ewy; ds :i esa fu;r djrh gsa lkj.kh Ø-la- vuqlwfpr fofufezfr dk uke izcyrk bzdkbz [kqnjk ewy; ¼#-½ izr;sd vfyfir ck;ys;mz xksfy;ksa esa 1. esvqksjfeu,plh,y$ 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 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 [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 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

9 ¹Hkkx 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 vkns'k] 2013 ds rgr vuqc) ewy; fuèkkzj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fuèkkzfjr 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 ¼t½ fofuekzrk ;k foi.ku deiuh] mijksdr fofufezfr;ksa vksj fofufnz"v '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 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] ORDER New Delhi, the 13th July, 2015 ujs'k vk;z] mi&funs'kd S.O. 1885(E). In implementation of directions given in line with review order passed by the Department of Pharmaceuticals on vide letter no /50/2014/PI.I in respect of S.O. 2101(E) dated 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) (b) 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. 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 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] (c) (d) (e) (f) (g) (h) 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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, 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. 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, 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. 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, 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. vkns'k ubz fnyyh] 13 tqykbz] 2015 [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director 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 bzdkbz [kqnjk ewy; ¼#-½ izr;sd vfyfir ck;ys;mz xksfy;ksa esa 1. fxfyesizkbm$esvqksjfeu fxfyesizkbm-2 fexzk- 1 xksyh 4.50 xksfy;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 djsaxsa

11 ¹Hkkx 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 ¼?k½ ¼M-½ 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 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 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 vkns'k] 2013 ds rgr vuqc) ewy; fuèkkzj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fuèkkzfjr 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 ¼t½ fofuekzrk ;k foi.ku deiuh] mijksdr fofufezfr;ksa vksj fofufnz"v '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 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] ORDER New Delhi, the 13th July, 2015 ujs'k vk;z] mi&funs'kd 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 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] Note : (a) (b) (c) (d) (e) (f) (g) (h) 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. 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. 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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, 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. 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, 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. 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, 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. vkns'k [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director 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 bzdkbz [kqnjk ewy; ¼#-½ izr;sd fqye fyfir ck;ys;mz xksfy;ksa esa 1. DyksjFksfyMksu$esVksizksyksy DyksjFksfyMksu fexzk- 1 xksyh 7.22 xksfy;ka esvksizksyksy ldlhusv fexzkesvksizksyksy VkjVªsV-50 fexzk- ds cjkcj ¼,DlVsUMsM fjfyt+ QkWeZ esa½

13 ¹Hkkx 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 ¼?k½ ¼M-½ 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 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 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 vkns'k] 2013 ds rgr vuqc) ewy; fuèkkzj.k@la'kksèku ds fy, QkWeZ I ij tek fd;k x;k Fkk vksj ljdkj }kjk fuèkkzfjr 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 ¼t½ fofuekzrk ;k foi.ku deiuh] mijksdr fofufezfr;ksa vksj fofufnz"v '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 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] ORDER New Delhi, the 13th July, 2015 ujs'k vk;z] mi&funs'kd 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 14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II SEC. 3(ii)] Note : (a) (b) (c) (d) (e) (f) (g) (h) 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. 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. 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, The manufacturer shall issue a price list in Form V as per the paragraph 24 (2) of the DPCO, 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, 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. 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, 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. 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, 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. vkns'k ubz fnyyh] 13 tqykbz] 2015 [PN/155/23/2015/F/F. No. 8(23)/2015/D.P./NPPA-Div.-II] NARESH ARYA, Dy. Director 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 bzdkbz [kqnjk ewy; ¼#-½ 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 QkLV½