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

jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (ii) PART II—Section 3—Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 936] ubZ fnYyh] lkseokj] vizSy 3] 2017@pS=k 13] 1939 No. 936] NEW DELHI, MONDAY, APRIL 3, 2017/CHAITRA 13, 1939 jlk;u vkSj moZjd ea=ky; ¼vkS"k/k foHkkx½ ¼jk’Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ vkns'k ubZ fnYyh] 1 vizSy] 2017 dk-vk- 1051¼v+½-&&Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30ebZ] 2013 vkSj dk-vk- 1192¼v½ rkjh[k 22 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 iSjk 11 ds mi iSjk ¼3½ vkSj ¼4½ vkSj iSjk 14 }kjk iznRr 'kfDr;k sa dk iz;kxs djrs gq,] rFkk 'kfq)&i= vkn's k dk-vk- 1993¼v½ fnukda 3 tuw ] 2016, dk- vk- 2062¼v½ fnukda 9 tuw ] 2016, dk-vk- 2210¼v½ fnukda 24 tuw ] 2016, dk- vk- 2578¼v½ fnukda 1 vxLr 2016, dk- vk- 3161¼v½ fnukda 6 vDrcw j 2016, Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] ¼jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k½ d s vkn's k d s vf/kØe.k e s tgk¡ rd mldk lEcU/k uhp s dh lkj.kh ^d* e sa fofufeZr iSdk sa d s xSj&dk¡p fo'k"sk fo'k"skrkvk sa lfgr [dk-vk- 1993¼v½ fnukda 3 tuw ] 2016 e as xSj&ihohlh d s #i e sa of.kZr] l'a kk/s ku fd;k] uhp s nh xbZ lkj.kh ‘[k’ e sa fofufnZ"V fuekZrk d s fo'k"sk mRikn ,o a idS vkdkj] mu ckrk sa d s flok; vf/kØkUr djr s gq, ftUg sa ,sl s vf/kØe.k d s iwoZ fd;k x;k gS ;k dju s dk ykis fd;k x;k gS] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ,rn~}kjk Fkkds eYw ; lpw dkda ij vk/kkfjr l'a kk/s ku djrk gS] tSlk fd uhp s dh lj.kh ^d* d ss LraHk ¼5½ e s fofufnZ"V gS] vf/kdre dher dk s mDr lkj.kh d s LrHa k ¼3½ vkSj ¼4½ e sa dh Øe'k% rRLFkkuh izfof"V;k sa esa fofufnZ"V [kqjkd :i ,o a izcyrk vkSj bZdkbZ ¼;fwuV½@iSdfstxa lfgr ml lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufnZ"V vuqlfwpr fofufeZr;k sa e sa l s izR;ds , LFkkuh; dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre dher d s #i e sa fu;r djrh gSA 1885 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] lkj.kh ^d^ lkj.kh % okf"kZd Fkksd ewY; lwpdkad ¼MCY;wihvkbZ½ ds vk/kkj ij la'kksf/kr ewY; @ (1.97186%) c<+kdj Ø- औषधी dk uke [kqjkd :i ,oa izcyrk bdkbZ@iSdsftax vf/kdre la- dher ¼#-½ ¼1-97186 % dh nj ls 1-4-2017 ls izHkkoh½ (1) (2) (3) (4) (5) (cid:1)लूकोज (ए) + सोिडयम इंजे(cid:7)शन 5% (ए) + 0.9% 1000 fefy xjS dk¡p fo'k"sk 1. 75.96 (cid:7)लोराइड (बी) (बी) fo'k"skrkvk sa lfgr (cid:1)लूकोज (ए) + सोिडयम इंजे(cid:7)शन 5% (ए) + 0.9% 500 fefy xjS dk¡p fo'ks"k 2. 64.99 (cid:7)लोराइड (बी) (बी) fo'k"skrkvk sa lfgr 1000 fefy xjS dk¡p fo'k"sk 3. (cid:1)लूकोज इंजे(cid:7)शन 5% fo'k"skrkvk sa lfgr 72.28 500 fefy xjS dk¡p fo'ks"k 4. (cid:1)लूकोज इंजे(cid:7)शन 5% fo'k"skrkvk sa lfgr 62.53 1000 fefy xjS dk¡p fo'k"sk 5. सोिडयम (cid:7)लोराइड इंजे(cid:7)शन 0.9% fo'k"skrkvk sa lfgr 74.86 100 fefy xjS dk¡p fo'ks"k 6. सोिडयम (cid:7)लोराइड इंजे(cid:7)शन 0.9% fo'k"skrkvk sa lfgr 31.97 250 fefy xjS dk¡p fo'ks"k 7. सोिडयम (cid:7)लोराइड इंजे(cid:7)शन 0.9% fo'k"skrkvk sa lfgr 47.19 500 fefy xjS dk¡p fo'ks"k 8. सोिडयम (cid:7)लोराइड इंजे(cid:7)शन 0.9% fo'k"skrkvk sa lfgr 66.84 lkj.kh ^[k^ Ø-la- fuekZrkvksa dk uke mRikn@czkaM dk uke (1) (2) (3) 1- eSllZ ch- czkmu efsMdy ¼bfaM;k½ izk- fyfeVMs bdk¶s yds Iyl cksry b;jw kgs Ms lfgr 2- eSllZ veUrk gYs Fkd;s j fyfeVMs LVsjhikVs Z cksry 3- eSllZ ,D;yw kbQ gYs Fkd;s j izk- fyfeVsM ,D;yw kbQ cksry b;jw kgs Ms lfgr 4- eSllZ ,ycV Z MfsoM fyfeVMs ,ycV Z MfsoM cksry b;jw kgs Ms lfgr 5- eSllZ Mfsul des fyfeVMs ,DokiYl b;jw kgs Ms lfgr 6- eSllZ Dyfsjl ykbQ lkbalsl fyfeVMs Dyfsjl cksry b;jw kgs Ms lfgr 7- eSllZ Ýslfu;l dkch bfaM;k izk- fyfeVMs Ýh¶yDs l csx 8- eSllZ vkVs ldw k QkekZL;fwVdy bfaM;k izkboVs fyfeVMs ;uw h csx (ftl s igy s eSllZ Dyfsjl vkVs ldw k izkboVs fyfeVMs d s uke l s tkuk tkrk Fkk) 9- eSllZ ,'ko;kZ ykbQlkblsal fy¶;tw u+ b;jw kgs Ms cksry 10- eSllZ cDs lVj ¼bfaM;k½ izk- fyfeVMs ok;k¶yDs l csx 11- eSllZ vkVs ldw k QkekZL;fwVdy bfaM;k izkboVs fyfeVMs b;jw kgs Ms cksry ftl s igys eSll Z Dyfsjl vkVs ldw k izkboVs fyfeVMs d s uke ls tkuk tkrk Fkk) 12- eSllZ Ýslfu;l dkch bfaM;k izk- fyfeVMs b;jw kgs Ms cksry¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 uksV%- ¼d½ vf/kdre ewY; fnukad 01-04-2017 ls ykxw gSa (vf/kdre ewY;ksa esa 2015 dh vis{kk o”kZ 2016 ds fy, 1-97186 izfr’kr dh Fkksd ewY; lwpdkad ¼MCY;wihvkbZ½ dh nj ‘kkfey gSa)A ¼[k½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufeZfr;ksa ds mijksDr mRikn@czkMa dks csp jgs vuqlwfpr fofufeZfr;ksa ds fofuekZrk] mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd lHkh ,slh fofufeZfr;ksa dh dher dk v/kkseq[kh iqujh{k.k djsaxsA ¼x½ bu fofufeZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ”V vf/kdre dher ¼/ku LFkkuh; dj lfgr½ ls de gS] tgka dgh Hkh ykxw gks] vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds iSjkxzkQ 13(2) ds lkFk ifBr Mhihlhvks] 2013 ds iSjkxzkQ ds vuqlkj o”kZ 2016 ds fy, 1-97186 izfr’kr dh nj ls Fkksd ewY; lwpdkad ¼MCY;wihvkbZ½ ds vk/kkj ij viuh fofufeZfr;ksa dk ekStwnk vf/kdre [kqnjk ewY; ¼,evkjih½ dks la’kksf/kr dj ldrs gSa ¼?k½ vxj fofuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; djksa dks tksM+ ldrs gSA ¼M-½ vU; dksbZ Hkh fofuekZrk xSj&dk¡p fo'ks"k fo'ks"krkvksa lfgr iSd ds fo'ks"k vf/kdre dher ds fy, vyx ls nkok djrk gS rks mlds fy, mls fooj.k ds lkFk izekf.kr djuk gksxk fd mlds iSd esa O;kid lqfo/kkvksa tSls fd ¼i½ Lo;a fleVus vkSj Lo;a flysfcfyVh ¼lhy yxuk½ ¼ii½ ,;j osaV ugha gksus ¼iii½ fuekZ.k ds nkSjku@lapkj@,MfefDlax Lrjksa ij lanw"k.k dh laHkkouk ugh gSa ds leFkZu esa nLrkostksa lfgr izekf.kr djsxkA ¼p½ fofuekZrk viuh fofufeZfr;ksa ds fdlh Hkh vU; fo'ks"k fo'ks"krkvksa dk nkok ;k vU; iSd vkdkj ds fy, fo'ks"k ewY; fu/kkZj.k ds fy, ,uihih, esa vkosnu djsxkA ¼N½ vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr lEcfU/kr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ”V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vf/kdre dher fu/kkZfjr djsaA fofufeZrkvksa vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dks ,d ewY; lwph tkjh djsa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dksa vkSj fofuekZrk forjd dks tkjh djsaA ¼t½ vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA ¼>½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ”V vf/kdre dher ds fy, fofufnZ”V vuqlwfpr fofufeZfr;ksa ds fofufnZ”V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvksa }kjk ,d ubZ vkS”kf/k dks ykap djrk gS rks mls igys vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds rgr lwph II esa fofufnZ”V QkeZ I ds ek/;e ls ,uihih, esa ewY; fu/kkZj.k gsrq vkosnu djuk gksxkA ¼.k½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa fuekZrkvksa dks vkS”k/k ¼ewY; fu;a=.k½ vkns’k] 2013 ds lwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dks gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr vuqlwfpr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcU/k esa vxj vuqlwfpr fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA ¼V½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n’kkZ;s vf/kdre ewY; vkSj ‘krks± dk ikyu ugha djrh gSa rks os vko’;d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf’k dks tek djus ds fy, nk;h gksaxsA ¼B½ bl vkns’k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof”V esa fofufnZ”V ,slh fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo#i] vf/kdre ;k [kqnjk ewY; fu/kkZfjr vkns’k ;fn dksbZ gks] tks bl vkns’k ls iwoZ tkjh gq, gSa] Lor% gh vf/kØe.k gks tk;saxsA [dka-la-@175@43@2017@,Q@Qk- la0 8¼43½@2017@Mhih@,uihih,-&fMoh&II] cythr flag] lgk;d funs’kd4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) [NATIONAL PHARMACEUTICAL PRICING AUTHORITY] ORDER New Delhi, the 1st April 2017 S.O. 1051(E).—In exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 and paragraph 14 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 1192(E) dated 22nd March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers and in supersession of the order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O 1993(E) dated 3rd June,2016 read with Corrigendum order S.O 2062 dated 9th June, 2016, S.O 2210(E) dated 24th June 2016, S.O 2578(E) dated 1st August 2016, S.O. 3161(E) dated 6th October 2016 in so far as they relate to formulation packs of Non-Glass with special features (mentioned as Non-PVC in S.O. 1993(E) dated 3rd June 2016) mentioned in the Table A herein below, manufactured by the manufacturers specified in Table B for specified products and pack-sizes, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby revises the price based on Wholesale price index (WPI) of 2016 as specified in column (5) of the Table A herein below as separate ceiling price 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 dosage form and strength and unit/packaging specified respectively in the corresponding entries in columns (3) and (4) thereof: Table A: Price Revision as per Annual Wholesale Price Index (WPI) @ 1.97186% increase. Sl No Medicines Dosage form and Unit/packaging Ceiling price (wef Strength 01.4.2017 with WPI @ 1.97186%) (1) (2) (3) (4) (5) 1. Glucose (A) + Sodium Injection 5% (A) + 0.9% 1000ml Non Glass with special 75.96 Chloride (B) (B) features 2. Glucose (A) + Sodium Injection 5% (A) + 0.9% 500ml Non Glass with special 64.99 Chloride (B) (B) features 3. Glucose Injection 5% 1000ml Non Glass with special 72.28 features 4. Glucose Injection 5% 500ml Non Glass with special 62.53 features 5. Sodium Chloride Injection 0.9% 1000ml Non Glass with special 74.86 features 6. Sodium Chloride Injection 0.9% 100ml Non Glass with special 31.97 features 7. Sodium Chloride Injection 0.9% 250ml Non Glass with special 47.19 features 8. Sodium Chloride Injection 0.9% 500ml Non Glass with special 66.84 features TABLE ‘B’ Sl. No. Name of Manufacturer Product /Brand Name (1) (2) (3) 1. M/s B.Braun Medical (I) Pvt Ltd. Ecoflac Plus bottle with Eurohead 2. M/s Amanta Healthcare Ltd. Steriport bottle 3. M/s Aculife Healthcare Pvt Ltd. Aculife bottle with Eurohead 4. M/s Albert David Limited Albert David bottle with Eurohead 5. M/s Denis Chem Limited Aquapulse with Eurohead 6. M/s Claris Life Sciences Limited Claris bottle with Eurohead 7. M/s Fresenius Kabi India Pvt Limited Freeflex bags 8. M/s Otsuka Pharmaceutical India Private Ltd. (previously Unibag known as Claris Otsuka Private Limited) 9. M/s Aishwarya Lifesciences Lifusion Eurohead bottle 10. M/s Baxter (India) Pvt. Ltd. Viaflex bags¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 11. M/s Otsuka Pharmaceutical India Private Ltd. (previously Eurohead bottle known as Claris Otsuka Private Limited) 12. M/s Fresenius Kabi India Pvt Limited Eurohead bottle NOTE : (a) The ceiling prices are applicable with effect from 01.4.2017 (ceiling prices are inclusive of Wholesale Price Index (WPI) @1.97186% for the year 2016 over 2015). (b) The manufacturers of scheduled formulations, selling abovesaid products/brandname of scheduled formulations at price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any. (c) The 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), may revise the existing M.R.P. of their formulations, on the basis of WPI @ 1.97186% for year 2016 in accordance with paragraph 16(2) of DPCO, 2013, read with para 13(2) of DPCO, 2013. (d) The manufacturers may add local taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. (e) Any other manufacturer claiming separate ceiling price for Non-Glass with special feature shall apply to NPPA for separate ceiling price approval with details and demonstrate, that such pack has all of the features as (i) self collapsibility and self-sealability (ii) not having air-vent; and (iii) there is no chance of contamination during manufacture/infusion/admixing levels alongwith documentation and demonstration. (f) For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulation. (g) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (h) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (i) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (j) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (k) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (l) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/175/43/2017/F./F. No. 8(43)/2017/D.P./NPPA-Div.II] BALJIT SINGH, Asstt. Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.