In exercise of the powers conferred by paragraphs 5 11 and 15 of the Drugs Prices Control Order 2013 read with SO 1394E

REGD. NO. D. L.-33004/99 EXTRAORDINARY II— — (ii) PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY 782] No. 782] NEW DELHI, WEDNESDAY, FEBRUARY 28, 2018/PHALGUNA 9, 1939 ¼jk’Vªh; vkS’k/k ewY; fu/kkZj.k izkf/kdj.k½ ub Z fnYyh] 28 Qjojh] 2018 Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 ebZ] 2013 vkSj dk- vk- 701¼v½ rkjh[k 10 ekp]Z 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds iSjk 5] 11 vkSj 15 }kjk iznRr 'kfDr;ks a dk iz;ksx djrs gq,] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i es a ,uihih, dgk tkrk gS½] uhp s dh lkj.kh ds LraHk ¼6½ ea s fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½] ¼4½] vkSj ¼5½ ea s rRLFkkuh izfof"V;ks a es a fofufnZ"V izcyrk] bdkbZ ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;ks a ds uke lfgr LraHk ¼2½ es a dh rRLFkkuh izfof"V es a ls izR;sd dh] oLrq ,oa lsok dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i es a fu;r djrh gSA (1) (2) (3) (4) (5) (6) 1. 2.10 2. 3.14 1168 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (1) (2) (3) (4) (5) (6) 3. 8.11 4. 1.04 5. 56.81 6. 7.05 7. 1767.38 8. 18125.79 9. 24.76 ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewyZ 's ku ds fofuekZrk vFkkZr tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ es a fofufnZ"V [kqnjk ewY; fu/kkZfjr djsxa sA ¼[k½ vxj fuekZrkvks a us mi;qZDr lkj.kh ds LraHk ¼6½ es a of.kZr vf/kdre dher ij ljdkj dks okLro es a Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 es a fn, x, izko/kkuks a ds rgr fuekZrkvks a dks mi;qZDr lkj.kh ds LraHk ¼6½ es a fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ks a ds iSdks a ds fy, [kqnjk ewY; fu/kkZfjr djsAa fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V es a vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsAa ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kksa ds vuqlkj izR;sd QqVdj fodzrs k vkSj forjd fofuekZrk }kjk fn, x, :i es a ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkAII (ii) 3 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksua s vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvks a dh iwfrZ ds v/khu izklafxd fof/k;ks@a fu;eks a ds vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsla eatwjh ds rgr lacaf/kr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ks a vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuks a ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksxa sA ¼N½ bl vkns'k es a mijksDr lkj.kh ds LraHk ¼2½ es a dh rRLFkkuh izfof"V es a fofufnZ"V fofufeZfr;ks a ds iSdks a 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;sxa sA [dk- la-@187@55@2018@,Q@Qk- la0 8¼55½@2018@Mhih@,uihih,&fMoh-II] cythr flag] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 28th February, 2018 S.O. 883(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. Name of the Formulation/ Strength Unit Manufacturer & Marketing Retail No. Brand Name Company Price (Rs.) (1) (2) (3) (4) (5) (6) 1. Atorvastatin + Each hard gelatin capsule contains: 1 Capsule M/s Aristo 2.10 Aspirin Capsule Atorvastatin Calcium eq. to Pharmaceuticals Pvt. (Atchol-ASP 150) Atorvastatin 10mg (as two film - Ltd. coated tablets of 5 mg each) Aspirin 150mg (as two enteric coated tablets of 75mg each) 2. Nifedipine + Each 30mg cream contains: 1 GM M/s Uttaranchal Biotech 3.14 Lidocaine Cream Nifedipine IP 0.3 per cent w/w, Ltd. / M/s Neon (LOXHEAL) Lidocaine IP 1.5 per cent w/w, Laboratories Ltd. Imidurea IP (as Preservative) 0.2 per cent w/w in Cream base 3. Pioglitazone + Each film coated tablet contains: 1 Tablet M/s Mascot Health Seris 8.11 Gliclazide + Pioglitazone HCL IP eq. to Pvt. Ltd. / M/s Alembic Metformin Tablet Pioglitazone 15mg, Pharmaceuticals Limited (GLZ Total) Gliclazide IP 60mg (In modified release form) and Metformin HCL 500mg (extended release form) 4. Ibuprofen + Each film coated tablet contains: 1 Tablet M/s Innova Captab Pvt. 1.04 Paracetamol Tablet Ibuprofen IP 400mg Ltd./M/s Abbott (Brufen Plus) Paracetamol IP 325mg Healthcare Pvt. Ltd. 5. Misoprostol Tablet Each uncoated tablet contains: 1 Tablet M/s Synokem 56.81 Misoprostol IP 600mcg (As 1% Pharmaceuticals Misoprostol dispersion) Limited/ M/s Bharat Serums and Vaccines4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Sl. Name of the Formulation/ Strength Unit Manufacturer & Marketing Retail No. Brand Name Company Price (Rs.) (1) (2) (3) (4) (5) (6) Limited 6. Glimepiride + Each uncoated bilayered tablet 1 Tablet M/s Windlas Biotech 7.05 Metformin Tablet contains: Ltd. / M/s Intas Glimepiride IP 3mg, Pharmaceuticals Limited Metformin Hydrochloride IP 850mg (in Sustained release form) 7. Melphalan + Each vial contains: Each M/s Natco Pharma Ltd 1767.38 Povidone Melphalan HCL IP eq. to Melphalan Pack Injection (Melphalan 50mg, Injection IP 50mg) Povidone IP 20mg and Diluent For Melphalan Injection 10ml each vial contains Sodium Citrate IP 0.2g Proylene Glycol IP 6ml Ethanol (96%) IP 0.52ml water for Injection 8. Trastuzumab Injection Each Lyophilized vial contains: 1 Vial M/s Cadila Healthcare 18125.79 Trastuzumab 150mg Injection Limited / M/s Emcure Pharmaceuticals Ltd. 9. Vitamin D3 Each orally Disintegrating Strip 1 Orally M/s Zim Laboratories 24.76 (Cholecalciferol) (D- contains: Disintegr Limited / M/s USV RISE SURE) Vitamin D3 (Cholecalciferol) IP ating Limited 60000 IU Orally Disintegrating Strip Strip Note: (a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove. (b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) The above mentioned retail price is applicable only to the individual manufacturer / marketeer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies. (f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/187/55/2018/F /F. No. 8(55)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. DirectorII (ii) 5 ubZ fnYyh] 28 Qjojh] 2018 4, 6, 10, 11, 14, 16, 17 ( ) (1) (2) (3) (4) (5) (6) (7) 1. 1.50 31015/19/2017- 2058( ) 30.06.2017 24.08.2017 ( 244) 2. 392.64 31015/56/2017- 2058( ) 30.06.2017 30.10.2017 ( 539) 3. 0.40 31015/37/2017- 2058( ) 30.06.2017 28.09.2017 ( 469) (5) (5) V6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (4) II I II III II IV [ / -II ] ORDER New Delhi the, 28th February, 2018 S.O. 884(E).— In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and in exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table regarding formulation specified in mentioned in the table in so far as it relates to formulation pack mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes/revises the price as specified in column (5) of the table herein below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation(s) specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. Name of the Dosage form Unit Ceiling Review Order Existing SO No. Scheduled & Strength Price number and date number and date Formulation (Rs.) (1) (2) (3) (4) (5) (6) (7) 1. Furosemide Injection 1 ML 1.50 31015/19/2017-Pricing 2058(E) dated 10mg/ml dated 24.08.2017 30.6.2017 (at Sl. No. 244) 2. Snake Venom Injection Each Pack 392.64 31015/56/2017-Pricing 2058(E) dated Antiserum-Soluble/ (10 ML) dated 30.10.2017 30.6.2017 Liquid Polyvalent (at Sl. No. 539)II (ii) 7 3. Phenobarbitone Oral liquid 20 1 ML 0.40 31015/37/2017-Pricing 2058(E) dated mg/5 ml dated 30.6.2017 28-09-2017 (at Sl. No. 469) Note: (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus goods and services tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any. (b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. (d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (i) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/187/55/2018/F/F. No. 8(55)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director ubZ fnYyh] 28 Qjojh] 2018 [ @ &II] CORRIGENDUM New Delhi, the 28th February, 2018 S.O. 885(E).— In the para 10 of Order No. S.O. 639(E) dated the 12th February, 2018 of the National Pharmaceutical Pricing Authority regarding fixation of ceiling prices of coronary stents, published in the Gazette of India, the word “05th January 2018” be read as “5th February 2018”. [PN/187/55/2018/F/F. No. 8(55)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.