Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5 11 and 1...
Date: 2017-12-20 Category: Extra Ordinary State: Union Government Country: India

In exercise of the powers conferred by paragraphs 5 11 and 15 of the Drugs Prices Control

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: This order, issued by the National Pharmaceutical Pricing Authority, fixes the retail prices of specified drug formulations, excluding local taxes and GST. It specifies prices for various strengths and manufacturers, superseding previous price orders. Manufacturers must adhere to the Drugs Prices Control Order (DPCO) 2013, including issuing price lists and providing quarterly reports. Key Points / Main Content: Pricing and Taxes: * Retail prices for scheduled formulations are fixed as specified in the table, excluding local taxes and GST. * Manufacturers can add local taxes if they were paid/payable up to June 30, 2017, and GST if paid/payable from July 1, 2017. * Retail prices for packs of formulations must align with DPCO 2013, paragraph 11. Manufacturer Responsibilities: * Manufacturers must issue a price list in Form V to NPPA through IPDMS and provide copies to the State Drug Controller and dealers, as per DPCO 2013, paragraph 24. * Manufacturers must furnish quarterly reports on production, import, and sale in Form III of Schedule II of DPCO 2013 via IPDMS. * Manufacturers intending to discontinue production/import must notify NPPA in Form IV of Schedule II at least six months prior to discontinuation. * Manufacturers of new drugs under paragraph 2(u) of the DPCO, 2013, shall fix the retail price as specified in column 6 of the table. Retailer/Dealer Responsibilities: * Retailers and distributors must display the price list and supplementary list, as furnished by the manufacturer, conspicuously within their business premises (DPCO 2013, para 24(4)). Applicability and Compliance: * Retail prices apply only to listed manufacturers/marketers for the specified formulations, contingent upon fulfilling all statutory requirements and manufacturing license permissions. * Non-compliance results in liability to deposit overcharged amounts with interest under DPCO 2013 and the Essential Commodities Act, 1955. * Previous price orders for these formulations are superseded by this notification. Impact Analysis: Manufacturers: * Impact: Must adhere to the new pricing structure, issue updated price lists, and ensure compliance with reporting requirements and other DPCO 2013 provisions. * Action Required: Adjust pricing, submit Form V price list to NPPA, provide quarterly reports (Form III), and notify NPPA of any planned discontinuation (Form IV). Retailers/Distributors: * Impact: Must display updated price lists prominently for customer access. * Action Required: Update displayed price lists with the information provided by manufacturers. Consumers: * Impact: Benefit from regulated retail prices for the specified drug formulations. * Action Required: Be aware of the regulated prices and check displayed price lists at retail locations. National Pharmaceutical Pricing Authority (NPPA): * Impact: Responsible for enforcing the order and ensuring compliance. * Action Required: Monitor manufacturer reporting and compliance, and take action against non-compliant entities.

Key Entities Referenced

Drugs Prices Control Order, 2013: A policy document that empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate drug prices. National Pharmaceutical Pricing Authority: The regulatory body responsible for fixing and revising prices of pharmaceutical products in India. It is referred to as NPPA. Ministry of Chemicals and Fertilizers: A government ministry that issued notifications S.O. 1394E and S.O. 701E, which are read in conjunction with the Drugs Prices Control Order, 2013. Essential Commodities Act, 1955: An act read with DPCO 2013, which stipulates penalties for non-compliance with price regulations. New Delhi: The location where the order was issued. Lupin Ltd.: A pharmaceutical company whose products' retail prices are specified in the order. Alembic Ltd.: A pharmaceutical company whose products' retail prices are specified in the order. IPDMS: The mechanism through which manufacturers are required to submit price lists and quarterly reports to the NPPA.
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fu/kkZfjr djsaxsA ¼[k½ vxj fofuekZrk us 30-06-2017 rd dh vof/k ds laca/k esa mi;qZDr lkj.kh ds LraHk ¼6½ esa of.kZr QqVdj dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; dj tksM+ ldrs gSaA ;fn fofuekZrk us 01-07- 2017 ls izHkkfor mi;qZDr lkj.kh ds LraHk ¼7½ esa of.kZr QqVdj dher ij ljdkj dks okLrko esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa 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 esa 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 fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,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 djsxkA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgkasus 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';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa lEcfU/kr fuekZrkvksa dks vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds vuqlwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls 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 lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls de ls de N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;kas 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/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V 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-@183@51@2017@,Q@Qk- la- 8¼51½@2017@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 20th December, 2017 S.O. 3946(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), in supersession of Order No. 3727(E) dated 23rd November, 2017 (except item of Sl. No. 1 and 2), hereby, fixes the price as specified in column (6) and column(7) of the table herein below as the retail price, exclusive of local taxes and goods and services tax respectively, if any, as applicable, 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 Strength Unit Manufacturer & Retail Price Retail Price No. Scheduled Marketing (Pre-GST) (Post-GST ) Formulation / Company (Rs.) (Rs.) Brand Name (1) (2) (3) (4) (5) (6) (7) 1. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Lupin Ltd. 4.84 4.64 Metformin Metformin 500mg 2. Voglibose + Each tablet contains: Voglibose 0.3mg 1 Tablet M/s Lupin Ltd. 5.76 5.52 Metformin Metformin 500mg 3. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Lupin Ltd. 7.14 6.85 Metformin + Metformin 500mg Glimepirid Glimepirid 1mg 4. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Sanofi India 7.14 6.85 Metformin + Metformin 500mg Ltd. Glimepirid Glimepirid 1mg4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 5. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Biocon Ltd. 7.14 6.85 Metformin + Metformin 500mg Glimepirid Glimepirid 1mg 6. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Lupin Ltd. 9.05 8.68 Metformin + Metformin 500mg Glimepirid Glimepirid 2mg 7. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Sanofi India 9.05 8.68 Metformin + Metformin 500mg Ltd. Glimepirid Glimepirid 2mg 8. Voglibose + Each tablet contains: Voglibose 0.2mg 1 Tablet M/s Biocon Ltd. 9.05 8.68 Metformin + Metformin 500mg Glimepirid Glimepirid 2mg 9. Voglibose + Each tablet contains: Voglibose 0.3mg 1 Tablet M/s Lupin Ltd. 8.52 8.17 Metformin + Metformin 500mg Glimepirid Glimepirid 1mg 10. Voglibose + Each tablet contains: Voglibose 0.3mg 1 Tablet M/s Alembic 8.52 8.17 Metformin + Metformin 500mg Ltd. Glimepirid Glimepirid 1mg 11. Voglibose + Each tablet contains: Voglibose 0.3mg 1 Tablet M/s Lupin Ltd. 10.46 10.03 Metformin + Metformin 500mg Glimepirid Glimepirid 2mg 12. Diclofenac + Each tablet contains: 1 Tablet M/s Alembic 9.73 9.33 Tramadol Diclofenac 75mg Ltd. Tramadol 50mg 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 local taxes 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 in respect of period upto 30.6.2017. 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 (7) of the above said table with effect from 1.7.2017. (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 prices are applicable only to the manufacturer / marketeer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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 formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Manufacturer, in case intending to discontinue above said formulations, 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 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, 1955.¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 (h) Consequent to the issue of retail price of the aforesaid formulations 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(s) superseded. [PN/183/51/2017/F/F. No. 8(51)/2017/D.P./NPPA-Div.-II ] BALJIT SINGH, Assistant Director vvvvkkkknnnnss''ss''kkkk ubZ fnYyh] 20 fnlacj] 2017 ddddkkkk----vvvvkkkk---- 3333999944447777¼¼¼¼vvvv½½½½.—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 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds iSjk 5( 11 vkSj 15 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq,] jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼6½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½] ¼4½] vkSj ¼5½ eas rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk] bdkbZ ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;kas ds uke lfgr LraHk ¼2½ esa dh rRLFkkuh izfof"V esa ls izR;sd dh] oLrq ,oa lsok dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA llllkkkkjjjj....kkkkhhhh ØØØØ---- vvvvuuuuqlqlqlqlwwffwwffpppprrrr ffffooooffffuuuuffffeeeeZZffZZffrrrr iiiizzcczzccyyyyrrrrkkkk bbbbddddkkkkbbbbZZ ZZ ffffooooffffuuuueeeekkkkZrZrZrZrkkkk vvvvkkkkSSjjSSjj [[[[kkkkqqnnqqnnjjjjkkkk eeeewwYYwwYY;;;; [[[[kkkkqqnnqqnnjjjjkkkk eeeewwYYwwYY;;;; llllaa--aa-- ddddkkkk uuuukkkkeeee@@@@cccczkzkzkzkaaMMaaMM ddddkkkk ffffooooiiii....kkkkuuuu ddddaaiiaaiiuuuuhhhh ¼¼¼¼tttthhhh,,,,llllVVVVhhhh llllss ss ¼¼¼¼tttthhhh,,,,llllVVVVhhhh ddddss ss uuuukkkkeeee iiiiggggyyyyss½½ss½½ ¼¼¼¼####----½½½½ cccckkkknnnn½½½½ ¼¼¼¼####----½½½½ ¼1½ ¼2½ ¼3½ ¼4½ ¼5½ ¼6½ ¼7½ 1 XyhesijkbM $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 4-00 3-84 eSVQksfeZu xksyh XyhesijkbM 1 fexzk- ,aM eSVQksfeZu 500 fexzk- 2 XyhesijkbM $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 4-50 4-32 eSVQksfeZu xksyh XyhesijkbM 2 fexzk- ,aM eSVQksfeZu 500 fexzk- 3 esVksizksyksy $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 5-81 5-57 DyksjFkkfyMksu esVksizksyksy 25 fexzk- ,aM xksyh DyksjFkkfyMksu 12-5 fexzk- 4 esVksizksyksy $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 5-81 5-57 DyksjFkkfyMksu esVksizksyksy 25 fexzk- ,aM xksyh DyksjFkkfyMksu 12-5 fexzk- 5 esVksizksyksy $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 7-22 6-92 DyksjFkkfyMksu esVksizksyksy 50 fexzk- ,aM xksyh DyksjFkkfyMksu 12-5 fexzk- 6 esVksizksyksy $ izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 7-22 6-92 DyksjFkkfyMksu esVksizksyksy 50 fexzk- ,aM xksyh DyksjFkkfyMksu 12-5 fexzk- 7 eksDlh¶ykWDlkflu izR;sd xksyh esa % 1 xksyh eSllZ yqfiu fy- 34-46 33-05 $ lsfQDle xksyh eksDlh¶ykWDlkflu 400 fexzk- ,aM lsfQDle 400 fexzk- 8 fXyDyktkbM$ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 6-25 5-99 fi;ksfXyVktksu $ fXyDyktkbM 60 fexzk-] ykbZQ lkbla fy- eSVQksfeZu xksyh fi;ksfXyVktksu 7-5 fexzk- ,aM eSVQksfeZu 500 fexzk-6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 9 VsusfyXyhiVhu $ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 11-33 10-87 esVQksfeZu xksyh VsusfyXyhiVhu gkbZMªksczksekbZM gkbZMªsV ds ykbZQ lkbla fy- cjkcj VsusfyXyhiVhu 20 fexzk-] esVQksfeZu ,plh,y 1000 fexzk 10 VsusfyXyhiVhu $ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 10-03 9-62 esVQksfeZu xksyh VsusfyXyhiVhu gkbZMªksczksekbZM gkbZMªsV ds ykbZQ lkbla fy- cjkcj VsusfyXyhiVhu 20 fexzk-] esVQksfeZu ,plh,y 500 fexzk 11 XyhesijkbM $ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 5-93 5-69 eSVQksfeZu xksyh XyhesijkbM 1 fexzk- ,aM ykbZQ lkbla fy- eSVQksfeZu 1000 fexzk- 12 XyhesijkbM $ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 7-50 7-19 eSVQksfeZu xksyh XyhesijkbM 2 fexzk- ,aM ykbZQ lkbla fy- eSVQksfeZu 1000 fexzk- 13 XyhesijkbM $ izR;sd xksyh esa % 1 xksyh eSllZ bfjt 8-73 8-37 eSVQksfeZu xksyh XyhesijkbM 3 fexzk- ,aM ykbZQ lkbla fy- eSVQksfeZu 1000 fexzk- 14 eSVQksfeZu $ izR;sd xksyh esa % 1 xksyh eSllZ tqfcysaV 2-23 2-14 XyhesijkbM $ xksyh eSVQksfeZu 500 fexzk-] XyhesijkbM 1 fexzk- ykbZQ lkbla fy- ,aM fi;ksfXyVktksu 15 fexzk- @eSllZ gsVªks yscl fy- 15 eSVQksfeZu $ izR;sd xksyh esa % 1 xksyh eSllZ ck;ksdse 2-45 2-35 XyhesijkbM $ eSVQksfeZu 500 fexzk-] XyhesijkbM 2 fexzk- QkekZL;wfVdYl fi;ksfXyVktksu ,aM fi;ksfXyVktksu 15 fexzk- baMLVªht fy- xksyh uuuukkkkssVVssVV %%%% ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku ds fofuekZrk vFkkZr tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fofuekZrk us 30-06-2017 rd dh vof/k ds laca/k esa mi;qZDr lkj.kh ds LraHk ¼6½ esa of.kZr QqVdj dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os LFkkuh; dj tksM+ ldrs gSaA ;fn fofuekZrk us 01-07-2017 ls izHkkfor mi;qZDr lkj.kh ds LraHk ¼7½ esa of.kZr QqVdj dher ij ljdkj dks okLrko esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa 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 esa 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 fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,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 djsxkA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgkasus 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';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa lEcfU/kr fuekZrkvksa dks vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds vuqlwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls 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 lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 djus dk bPNqd gS rks cUn djus dh frfFk ls de ls de N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;kas 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/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA ¼t½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V 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-@183@51@2017@,Q@Qk- la- 8¼51½@2017@Mhih@,uihih,&fMoh-&II] cythr flag]]]] lgk;d funs'kd ORDER New Delhi, the 20th December, 2017 S.O. 3947(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) and column (7) of the table herein below as the retail price, exclusive of local taxes and goods and services tax respectively, if any, as applicable, 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 Strength Unit Manufacturer Retail Price Retail Price No. Scheduled & Marketing (Pre-GST) (Post-GST) Formulation / Company (Rs.) (Rs.) Brand Name (1) (2) (3) (4) (5) (6) (7) 1 Glimepiride + Tablet Contains: Glimepiride 1mg 1 Tablet M/s Lupin 4.00 3.84 Metformin Tablets & Metformin 500mg. Limited 2 Glimepiride + Tablet Contains: 1 Tablet M/s Lupin 4.50 4.32 Metformin Tablets Glimepiride 2mg & Limited Metformin 500mg. 3 Metoprolol + Tablet Contains: 1 Tablet M/s Lupin 5.81 5.57 Chlorthalidone Metoprolol 25mg & Limited Tablets Chlorthalidone 12.5mg. 4 Metoprolol + Tablet Contains: 1 Tablet M/s Lupin 5.81 5.57 Chlorthalidone Metoprolol 25mg & Limited Tablets Chlorthalidone 12.5mg. 5 Metoprolol + Tablet Contains: 1 Tablet M/s Lupin 7.22 6.92 Chlorthalidone Metoprolol 50mg & Limited Tablets Chlorthalidone 12.5mg. 6 Metoprolol + Tablet Contains: 1 Tablet M/s Lupin 7.22 6.92 Chlorthalidone Metoprolol 50mg & Limited Tablets Chlorthalidone 12.5mg. 7 Moxifloxacin + Tablets contains: 1 Tablet M/s Lupin 34.46 33.05 Cefixime Tablets Moxifloxacin 400mg & Limited Cefixime 400mg 8 Gliclazide + Tablet containing: 1 Tablet M/s Eris Life 6.25 5.99 Pioglitazone + Gliclazide 60mg, Sciences Ltd. Metformin Tablets Pioglitazone 7.5mg & Metformin 500mg.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 9 Teneligliptin + Tablet Contains: 1 Tablet M/s Eris Life 11.33 10.87 Metformin Tablets Teneligliptin Hydrobromide Sciences Ltd. Hydrate eq. to Teneligliptin 20mg, Metformin HCl 1000mg. 10 Teneligliptin + Tablet Contains: 1 Tablet M/s Eris Life 10.03 9.62 Metformin Tablets Teneligliptin Hydrobromide Sciences Ltd. Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg. 11 Glimepiride + Tablet containing: Glimepiride 1mg 1 Tablet M/s Eris Life 5.93 5.69 Metformin Tablets & Metformin 1000mg. Sciences Ltd. 12 Glimepiride + Tablet containing: Glimepiride 2mg 1 Tablet M/s Eris Life 7.50 7.19 Metformin Tablets & Metformin 1000mg. Sciences Ltd. 13 Glimepiride + Tablet containing: Glimepiride 3mg 1 Tablet M/s Eris Life 8.73 8.37 Metformin Tablets & Metformin 1000mg. Sciences Ltd. 14 Metformin + Tablet containing: Metformin 1 Tablet Manufacturer by 2.23 2.14 Glimepiride + 500mg, Glimepiride 1mg & M/s Jubilant Pioglitazone Pioglitazone 15mg. Life Sciences Tablets Ltd. and marketer by M/s Hetro Labs Ltd 15 Metformin + Tablet containing: 1 Tablet M/s Biochem 2.45 2.35 Glimepiride + Metformin 500mg, Pharmaceuticals Pioglitazone Glimepiride 2mg & Industries Ltd. Tablets Pioglitazone 15mg. 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 local taxes 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 in respect of period upto 30.6.2017. 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 (7) of the above said table with effect from 1.7.2017. (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 prices are applicable only to the manufacturer / marketeer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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 formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Manufacturer, in case intending to discontinue above said formulations, 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 9 (g) 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. (h) Consequent to the issue of retail price of the aforesaid formulations 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(s) superseded. [PN/183/51/2017/F/F. No. 8(51)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant 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.

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