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Date: 2015-08-24 Category: Extra Ordinary State: Union Government Country: India

M/s. Seagull Pharmaceuticals Pvt. Ltd. in respect of S.O. 1806(E) dated 10.07.2014 regarding fixation of Retail Price of Diclofenac Sodium 75mg (Superspas-AQ) Injection under DPCO, 2013.

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 (NPPA), Ministry of Chemicals and Fertilizers, fixes the retail prices of several scheduled drug formulations, superseding previous orders. It specifies prices exclusive of local taxes and addresses manufacturers' responsibilities regarding price fixation, tax addition, and compliance with the Drugs Prices Control Order (DPCO) 2013. The order is effective August 24, 2015. **Key Points / Main Content:** * **Price Fixation:** * The NPPA fixes the retail prices of specific drug formulations as detailed in the attached tables, exclusive of local taxes. * Prices are fixed for formulations manufactured and marketed by specific companies. * **Manufacturer Responsibilities:** * Manufacturers must fix retail prices for new drugs under paragraph 2u of the DPCO, 2013, as specified in the tables. * Local taxes can be added if actually paid or payable to the government. * Manufacturers must determine pack retail prices based on specified retail prices, according to paragraph 11 of the DPCO, 2013 and issue a price list in Form V as per paragraph 24(2) of DPCO, 2013. * Manufacturers launching new drugs with specified variations must apply to the NPPA for price approval in Form I as per schedule II of the DPCO, 2013. * Retail prices apply only to manufacturers/marketers who submitted Form I for price fixation/revision under DPCO, 2013, and meet all statutory requirements. * **Compliance and Reporting:** * Manufacturers must submit quarterly reports on production, import, and sale in Form III of schedule II of the DPCO, 2013. * Manufacturers intending to discontinue production/import must notify the NPPA six months in advance using Form IV of schedule II of the DPCO, 2013. * Non-compliance results in liability to deposit overcharged amounts with interest under the Essential Commodities Act, 1955, and DPCO, 2013. * **Supersession of Previous Orders:** * This order supersedes any prior price orders for the formulations specified. **Impact Analysis:** * **Drug Manufacturers/Marketing Companies:** * *Impact:* Must adhere to the newly fixed retail prices for the specified drug formulations. Affected by compliance requirements, reporting obligations, and potential penalties for non-compliance. * *Action Required:* Adjust pricing to align with the order, ensure accurate tax addition, fulfill reporting requirements (Forms III and IV), and comply with all provisions of the DPCO 2013 and Essential Commodities Act, 1955. * **National Pharmaceutical Pricing Authority (NPPA):** * *Impact:* Responsible for enforcing the order, monitoring manufacturer compliance, and reviewing applications for price approvals. * *Action Required:* Implement mechanisms for monitoring compliance, process Form I applications for new drugs, and ensure the order is effectively communicated to all stakeholders. * **Consumers:** * *Impact:* Directly affected by the retail prices of the specified drug formulations. * *Action Required:* Be aware of the fixed prices to ensure fair pricing at the point of purchase.

Key Entities Referenced

Ministry of Chemicals and Fertilizers: The Union Government ministry that oversees the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority. Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, involved in pharmaceutical policy and regulation. National Pharmaceutical Pricing Authority (NPPA): A regulatory body in India responsible for fixing and revising the prices of pharmaceutical drugs. New Delhi: The city where the order was issued and the location of the National Pharmaceutical Pricing Authority. Drugs Prices Control Order, 2013: An order issued by the Government of India to regulate the prices of drugs. Essential Commodities Act, 1955: An act of the Parliament of India to control the production, supply and distribution of, and trade and commerce. Diclofenac Sodium: A nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Aeon Formulations Pvt. Ltd.: An Indian pharmaceutical company that manufactures and markets pharmaceutical products
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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- 1792] ubZ fnYyh] lkseokj] vxLr 24] 2015@Hkknz 2] 1937 No. 1792] NEW DELHI, MONDAY, AUGUST 24, 2015/BHADRA 2, 1937 jlk;u vkSj moZjd ea=kky; ¼vkS"k/k foHkkx½ ¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2300¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k us vkS"k/k foHkkx }kjk dk-vk- 1806¼v½ fnukad 10.07.2014 ds fMDyksQsusd lksfM;e 75 fexzk- ¼lqijLikl&,D;w½ batsD'ku fofufeZfr;ksa ds lEcU/k esa i=k la- 31015/45/2014-ihvkbZ-I fnukad 14.07.2015 ij fn;s x;s vkns'k] tks fd eSllZ lhxqy QkekZL;qfVdYl izkbosV fyfeVsM }kjk nk;j dh xbZ fjO;w ,Iyhds'ku ds lanHkZ esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fu/kkZj.k ds laca/k esa jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k dk- vk- 1806¼v½ fnukad 10 tqykbZ] 2014 dks vf/kØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ U;wDyksVsd jsesMht izkbosV fyfeVsM vkSj eSllZ lhxqy QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fefy esa 1. fMDyksQsusd lksfM;e$ fMDyksQsusd lksfM;e&75fexzk- 1 fefy 14.30 batsD'u ¼lqijLikl&,-D;w½ csUtkW;y ,Ydksgy&4% MCY;w@oh ¼izsljosfVo ds leku½ 3610 GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfsalxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykbllas eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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 ¼N½ 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, gaS] Lor% gh fujLr gks tk,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) NATIONAL PHARMACEUTICAL PRICING AUTHORITY ORDER New Delhi, the 24th August, 2015 S.O. 2300(E).—In implementation of directions given in review order passed by the Department of Pharmaceuticals on 14.07.2015 vide letter No. 31015/45/2014/PI.I on review application filed by M/s. Seagull Pharmaceuticals Pvt. Ltd. in respect of S.O. 1806(E) dated 10.07.2014 regarding fixation of Retail Price of Diclofenac Sodium 75mg (Superspas-AQ) Injection under DPCO, 2013. Therefore, 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 30.05.2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the above Order i.e. S.O. 1806(E), dated 10.07.2014, the Government of India in the Ministry of Chemicals and Fertilizers, National Pharmaceutical Pricing Authority (hereby referred as the 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 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. Nuclotec Remedies Pvt. Ltd. and M/s. Seagull Pharmaceuticals Pvt. Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each ml contains: 1. Diclofenac Sodium Diclofenac Sodium - 75mg 1 ml 14.30 Injection Benzyl Alcohol - 4% w/v (Superspas - AQ) (as preservative)¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 3 Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (g) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2301¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k us vkS"k/k foHkkx }kjk dk-vk- 3151¼v½ fnukad 10.12.2014 ds bykizktksy 10fexzk- $ MkseisjhMkWu 30fexzk dSIklwy ¼psdflM Mh ,l vkj½ fofufeZfr;ksa ds lEcU/k esa i=k l-a 31015/4/2014-ihvkb-ZI fnukad 14.05.2015 ij fn;s x;s vkns'k] tks fd eSllZ ,fjLVks QkekZL;wfVdYl izkbosV fyfeVsM }kjk nk;j dh xbZ fjO;w ,Iyhds'ku ds lanHkZ esa vafdr funsZ'kksa ds dk;kZUo;u gsrq iqufoZyksdu vkns'k ikfjr fd;k x;kA blfy,] mi;qZDr ewY; fu/kkZj.k ds laca/k esa jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k] ds vkns'k dk- vk- 3151¼v½ fnukad 10 fnlEcj] 2014 dks vf/kØe.k djrs gq,] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,vkWu QkeqZys'kUl izkbosV fyfeVsM vkSj eSllZ ,fjLVks QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd gkMZ ftysfVu dSIklwy esa 1. bykizktksy $MkseisfjMksu bykikztkys -10fexkz- 1 dSilwy 8.84 dSilwy ¼,fUVªd fyfir xksyh ds leku½ ¼psdflM Mh ,l vkj½ Mkes ifsjMkus -30fexkz- ¼fQYe fyfir lLVsaM fjyht xksyh ds leku½-4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 56 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gaSA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfaslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykbllsa eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2301(E).—In implementation of directions given in review order passed by the Department of Pharmaceuticals on 14.05.2015 vide letter No. 31015/4/2014/PI.I on review application filed by M/s. Aristo Pharmaceuticals Pvt. Ltd., in respect of S.O. 3151(E) dated 10.12.2014 regarding fixation of Retail Price of llprazole 10mg + Domperidone 30mg. (Chekcid-D SR) capsule under DPCO, 2013. Therefore, 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 30.05.2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the above Order i.e. S.O. 3151(E), dated 10.12.2014, the Government of India in the Ministry of Chemicals and Fertilizers, National Pharmaceutical Pricing Authority (herein referred as the 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 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. Aeon formulations Pvt. Ltd. and M/s. Aristo Pharmaceuticals Pvt. Ltd. respectively.¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 7 TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatin capsule contains: 1. llaprazole + Domperidone llaprazole 10mg. (as enteric 1 Capsule 8.84 Capsule coated tablet) (Chekcid-D SR) Domperidone 30mg. (as film coated sustained release tablet) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2302¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,LVe gsYFkds;j8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] izkbosV fyfeVsM vkSj eSllZ ,ydse yscksjsVªht fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd vfyfir pckus okyh xksyh esa 1. ,ycsUMktksy$bojesDVhu ,ycUsMktkys -400 fexkz- 1 xksyh 17.08 xkfsy;ka bojesDVhu-6 fexzk- ¼,ycsdse Iyl½ 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfaslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 9 ORDER New Delhi, the 24th August, 2015 S.O. 2302(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 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. Astam Healthcare Pvt. Ltd., and M/s. Alkem Lab. Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated chewable tablet contains: 1. Albendazole + Albendazole 400mg 1 Tablet 17.08 Ivermectin Tablet Ivermectin 6mg (Albekem Plus) (as sustained release form) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2303¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,isDl yScksjsVªht izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd xzke esa 1. DyksfVªektksy Øhe DyksfVªektksy-1% MCY;w@MCY;w 1 xzke 2.82 ¼ck;kis kfsyej-ikyW h-chVk-¼1,4½- 2-,feuk-s 2-MhvkDlh-Mh-Xydw kts ½ lkexzh Øhe csl esa 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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 gksaxsA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 11 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2303(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 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 as well as marketed by M/s. Apex laboratories Pvt. Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each gm contains: 1. Clotrimazole Cream Clotrimazole 1% w/w 1 Gm 2.82 In a cream base containing Biopolymer (Poly-B-(1,4)-2-amino-2-deoxy-D-glucose) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2304¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3½ es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ th- ,l- QkeZC;wVj izkbosV fyfeVsM vkSj eSllZ fou esMhds;j izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fMys;sM fjyht xksyh esa% 1. eslkykekbu fMys;sM fjyht eslkyvehu 1200 fexzk 1 xksyh 19.12 xkfsy;ka 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 13 ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2304(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 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. G.S. Pharmbutor Pvt. Ltd., and M/s. Win Medicare Pvt. Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each Delayed Release tablet contains: 1. Mesalamine Delayed Mesalamine 1200mg 1 Tablet 19.12 Release tablet Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2305¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3) eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ dksjVsu QkekZL;wfVdYl izkbosV fyfeVsM vkSj eSllZ U;ksu yScksjsVªht fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd fefy esa% 1. isjkflVkeksy bUQ;wt+u isjkflVkeksy 10 fexzk 1 fefy 2.10 ¼100fexzk-@fefy½ 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 15 ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2305(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 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. Korten Pharmaceuticals Pvt. Ltd. and M/s. Neon Lab. Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each ml contains: 1. Paracetamol Infusion Paracetamol 10mg 1 ml 2.10 (10mg/ml) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2306¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½] rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ buksok dSiVsc vkSj eSllZ bUMksdks jsehfMt+ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; bdkbZ fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir xksyh esa% 1. isjkflVkeksy+$VªkeksMksy isjkflVkeksy 325 fexzk 1 xksyh 5.81 ,plh,y xksfy;ka VªkeksMksy ,plh,y 37.5 fexzk ¼MkfsyUlVk-ih½ 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 eas fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gaSA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfaslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykbllas eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gaSA 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=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,xkA blds lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 17 ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2306(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 the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Innova Captab and M/s. Indoco Remedies Ltd. respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated tablet contains: 1. Paracetamol + Paracetamol 325mg 1 Tablet 5.81 Tramadol HCl Tablet Tramadol HCl 37.5mg (Dolinsta-P) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2307¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½] rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fjyhQ ck;ksVsd izkbosV fyfeVsM vkSj eSllZ jsfMD;wjk QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd gkMZ tsysfVu dSIklwy esa% 1. vksesizktksy$MkseisjhMksu vksesizktksy 20 fexzk 1 dSilwy 4.15 dSIklwy ¼vYD;ksj-Mh½ ¼,afVªd fyfir isysV~l ds leku½ MkseisjhMksu 10 fexzk 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 es fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfaslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykbllas eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gaSA 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=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,xkA blds lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 19 ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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, gSa] Lor% gh fujLr gks tk,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2307(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 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. Relief Biotech Pvt. Ltd. and M/s. Radicura Pharmaceuticals Pvt. Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatin capsule contains: 1. Omeprazole + Omeprazole 20mg 1 Capsule 4.15 Domperidone Capsule (as enteric coated Pellets) (Ulcure D) Domperidone 10mg Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.20 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2308¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½] rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ 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 vkjihth ykbZQ lkbalsl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd vfyfir xksyh esa% 1. VsYehlkjVu$,eyksfMfiu VsYehlkjVu 40 fexzk 1 xksyh 7.19 xksfy;ka ¼vkjihVhbZ,y-,,e½ ,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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gaSA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfsalxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykbllas eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 21 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2308(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 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 and Cure Healthcare Pvt. Ltd., and M/s. RPG Life Sciences Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated tablet contains: 1. Telmisartan + Telmisartan 40mg 1 Tablet 7.19 Amlodipine Tablet Amlodipine Besilate eq. to (RPTEL-AM ) Amlodipine 5mg Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned 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.22 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2309¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½] rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 bdkbZ 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 fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd fQYe fyfir ckbZys;j xksyh esa% 1. DyksjFksfyMksu$ DyksjksFksfyMksu 12.50 fexzk 1 xksyh 5.81 esVkizksyksy xksfy;ka esVkizksyksy lDlhusV 23.75 fexzk esVkizksyksy VkjVsªV 25 fexzk ds cjkcj ¼,DlVsUMsM fjyht QkWeZ ds leku½ uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼5½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 gksxkA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 23 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2309(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 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 as well as marketed by M/s. Cadila Pharmaceuticals Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each film coated bilayer tablet contains: 1. Chlorthalidone + Chlorthalidone 12.50mg 1 Tablet 5.81 Metoprolol Tablet Metoprolol succinate 23.75 eq. to Metoprolol Tartrate 25mg (as extended release form) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.24 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2310¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3) es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ U;ksu yScksjsVªht+ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; la- ¼#-½ 1 2 3 4 5 izR;sd ok;y esa% 1. oSudksekbflu bUQ;wtu oSudksekbflu ,plh,y izfr iSd 256.30 ¼oSufdax½ oSudksekbflu 250 fexzk ds cjkcj uksV % ¼d½ fofuekZrk 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 25 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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2310(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 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 as well as marketed by M/s. Neon Lab. Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each vial contains: 1. Vancomycin Infusion Vancomycin HCl eq. to Each Pack 256.30 (Vanking) Vancomycin 250mg Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.26 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2311¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3) esa dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ U;ksu yScksjsVªht+ fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd 50lseh2 ds isp esa % 1. fMDyksQsusd MkbZbFkk;ykfeu fMDyksQsusd MkbZbFkk;ykfeu-100fexkz- 1 isp 42.00 isp ¼fMDyksQsusd VªkUlMeZy½ 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 27 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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2311(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 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. Sparsha Pharma International Pvt. Ltd., and M/s. Zuventus Healthcare Ltd., respectively. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each patch 50cm2 contains: 1. Diclofenac Diethylamine Diclofenac Diethylamine 100mg 1 Patch 42.00 Patch (Diclofenac Transdermal) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.28 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of Schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2312¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,fjLVks QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd 5 fefy esa% 1. vkWDlhVsdsu$+,Y;wehfu;e vkWDlhVsdsu 10fexzk- 200 fefy iSd 76.19 gkbMªksDlkbM$eSaxuhf'k;e ,Y;wehfu;e gkbMªksDlkbM 0.291 xzke gkbMªksDlkbM tWy ¼,Y;wehfu;e gkbMªksDlkbM ¼isUVkWi vks ,Dl 200fefy tWy] isLV ds cjkcj 0.380 xzke vkWQ MªkbM ,usLFksfVd ,UVkflM tsy½ ,Y;wehfu;e gkbMªksDlkbM tWy ds leku tksM+k x;k½ eSaxuhf'k;e gkbMªksDlkbM 98fexzk- ¼eSaxuhf'k;e gkbMªksDlkbM isLV½ lkexzh lWkjfcVky LohVuj ds leku izR;sd 5 fefy esa ¼,d cM+h pEep½ esa¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 29 2. ,DVhosVsM MkbZesFkhdksu$ ,DVhosVsM MkbZesFkhdksu 50fexzk] 1 fefy 0.29 eSaxuhf"k;e gkbMªksDlkbM$ eSaxuhf'k;e gkbMªksDlkbM 250fexzk a +MªkbM ,Y;wehfu;e gkbMªksDlkbM ¼eSaxuhf'k;e gkbMªksDlkbM isLV lkexzh tksM+h½ $lkWjfcVky lksY;w'ku MªkbM ,Y;wehfu;e gkbMªksDlkbM tWy 250 fexzk ¼iSuVki ,eih,l fyfDoM ¼,Y;wfefu;e gkbMªksDlkbM isLV lkexzh tksM+h½ 200fefy] ,UVkflM ,UVhxSl lkWjfcVksy lkWY;q"ku ¼70%½ fyfDoM½ ¼ukWu fØLVhykbftax½ 1-25 xzke 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 es fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gaSA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2312(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 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 as well as marketed by M/s. Aristo Pharmaceuticals Pvt. Ltd.30 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each 5ml contains: 1. Oxetacaine +Aluminium Oxetacaine 10mg 200 ml Pack 76.19 Hydroxide + Magnesium Aluminium Hydroxide 0.291gm Hydroxide Gel (added as Aluminium Hydroxide paste (Pantop OX Gel 200ml eq. to 0.380 gm of Dried Aluminium Hydroxide Gel) Anesthetic Antacid Gel) Magnesium Hydroxide 98mg (added as Magnesium Hydroxide paste) contains Sorbitol as sweetener Each 5ml (one teaspoonful) contains: 2. Activated Dimethicone + Activated Dimethicone 50mg 1 ml 0.29 Magnesium Hydroxide + Magnesium Hydroxide 250mg Dried Aluminium (added as Magnesium Hydroxide Paste) Hydroxide+Sorbitol Dried Aluminium Hydroxide Gel-250mg Solution (added as Aluminium Hydroxide Paste) (Pantop MPS Liquid Sorbitol Solution (70%) 200ml Antacid Antigas (non-crystallising) 1.25g. Liquid) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of Schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 31 vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2313¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3) es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ ,eck;ksfVDl yScksjsVªht+ izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd 5 fefy esa% 1. vkWDlhVsdsu$+,Y;wehfu;e vkWDlhVsdsu 10fexzk- 200 fefy iSd 76.19 gkbMªksDlkbM$eSaxuhf'k;e ,Y;wehfu;e gkbMªksDlkbM 0.291 xzke gkbMªksDlkbM tWy ¼,Y;wehfu;e gkbMªksDlkbM ¼MsyflM vks½ isLV ds cjkcj 0.380 xzke vkWQ MªkbM ,Y;wehfu;e gkbMªksDlkbM tWy ds leku tksM+k x;k½ eSaxuhf'k;e gkbMªksDlkbM 98fexzk- ¼eSaxuhf'k;e gkbMªksDlkbM isLV½ lkexzh lWkjfcVky LohVuj ds leku 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 eas fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 djsxkA32 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼N½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2313(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 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 as well as marketed by M/s. Embiotics Lab. Pvt. Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each 5ml contains: 1. Oxetacaine +Aluminium Oxetacaine 10mg 200 ml Pack 76.19 Hydroxide + Magnesium Aluminium Hydroxide 0.291gm Hydroxide Gel (added as Aluminium Hydroxide paste (Delcid O) eq. to 0.380 gm of Dried Aluminium Hydroxide Gel) Magnesium Hydroxide 98mg (added as Magnesium Hydroxide paste) contains Sorbitol as sweetener Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of Schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 33 (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2314¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 (3) es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fujek fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd 100 fefy- es 1. ¶ywdksuktksy$lksfM;e ¶ywdksuktksy 200 fexzk 1 fefy 1.06 DyksjkbM bUtsD'ku lksfM;e DyksjkbM 0.9% MCY;w @oh batsD'ku ds fy, ikuh& D;w-,l- 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 eas fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA34 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2314(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 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 as well as marketed by M/s. Nirma Limited. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each 100 ml contains: 1. Fluconazole + Fluconazole - 200mg 1 ml 1.06 Sodium Chloride Injection Sodium Chloride - 0.9% w/v Water for injection - q.s. Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned 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.¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 35 (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2315¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.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 bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ fFk;ksu QkekZL;wfVdYl fyfeVsM vkSj eSllZ ,fjLVks QkekZL;wfVdYl izkbosV fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa Øe'k% esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd gkMZ tsysfVu dSIklwy esa % 1. izsxkckfyu$fedksckykfeu$ ixsz kckfyu-75fexkz 1 dSilwy 10.92 foVkfeu ch6$Qksfyd ,flM$ fedksckykfeu-750 ekbØksxzke csuQksfVehu dSIklwy foVkfeu ch6-1.5fexkz- ¼esxkU;wjkWu ihth@xSckeSDl xksYM½ Qkfsyd ,flM-0.75fexkz] csuQksfVehu-7.5fexkz- 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 gksxkA36 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2315(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 the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s. Theon Pharmaceuticals Ltd., and M/s. Aristo Pharmaceuticals Pvt. Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each hard gelatin Capsule contains: 1. Pregabalin+Mecobalamin+ Pregabalin 75mg 1 Capsule 10.92 Vitamin B6 + Folic Acid + Mecobalamin 750mcg, Benfotiamine Capsule Vitamin B6 1.5mg (Meganeuron PG/ Folic Acid 0.75mg Gabamax Gold) Benfotiamine 7.5mg Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 37 (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director vkns'k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2316¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 ebZ] 2013 ds lkFk ifBr vkS"k/k 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"k/k ewY; fu/kkZj.k izkf/kdj.k ¼ftldks laf{kIr :i esa ,uihih, dgk tkrk gS½] uhps dh lkj.kh ds LraHk ¼5½ eas fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½ eas dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa eSllZ bUVkl QkekZL;wfVdYl fyfeVsM fufeZr vkSj foi.ku fofufnZ"V fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk ewY; ds :i esa fu;r djrh gSA lkj.kh Ø- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ [kqnjk ewY; l-a ¼#-½ 1 2 3 4 5 izR;sd vfyfir ckbys;MZ xksyh esa % 1. fXkfyfeizkbM$esVQkWjfeu fXkfyfeizkbM 0-5fexzk- 1 xksyh 4.83 xksfy;ka ¼tkssfjy ,e 0.5 QksVsZ½ esVQkWjfeu ,plh,y 1000fexzk ¼lLVsUM fjyht QkeZ 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; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa 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 gSaA38 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ 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=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 lEcfU/kr fuekZrkvksa }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rks mls igys vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 2¼u½ ds vuqlkj vkS"k/k ¼ewY; fu;a=k.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 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=k.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 tSls fd dsUnzh;@jkT; ykblfslxa vkfWFkfjVh d s l{ke ikzf/kdkjh }kjk eUs;Qw Ds pfjxa ykblls eta jw h d s rgr lca fa/kr fofuferZ fuekrZ k@foi.ku dEifu;ka tks vuqikyu djrh gSaA 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=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,xkA blds lEcU/k 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 fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa 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,axsA [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM+] mi&funs'kd ORDER New Delhi, the 24th August, 2015 S.O. 2316(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 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 as well as marketed by M/s. Intas Pharmaceuticals Ltd. TABLE Sl. Name of the Scheduled Strength Unit Retail Price No. Formulation (Rs.) (1) (2) (3) (4) (5) Each uncoated bilayered tablet contains: 1. Glimepiride + Glimepiride 0.5mg 1 Tablet 4.83 Metformin Tablet Metformin HCL 1000mg (Zoryl M 0.5 Forte) (In sustained release form) Note : (a) The manufacturer of abovementioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove.¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 39 (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the abovesaid table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (5) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then he shall apply for prior price approval of such new drug to the NPPA in Form I as specified under schedule-II of the DPCO, 2013. (e) The abovementioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation/revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies. (f) The concerned manufacturer of abovesaid formulation shall furnish a quarterly return to the NPPA, in respect of its production/import and sale in Form-III of schedule-II of the DPCO, 2013. Manufacturer, in case intending to discontinue abovesaid formulation then he shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of abovesaid formulation in Form-IV of schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of retail price of the aforesaid formulation as specified in column (2) of the abovementioned table in this notification, the price order(s) if any, issued for concerned manufacturer/marketer prior to the abovesaid date of notification, stand superseded. [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director 'kqf)&i=k ubZ fnYyh] 24 vxLr] 2015 dk-vk- 2317¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ds vkns'k la- dk-vk- 619¼v½] rkjh[k 26 Qjojh] 2015 ¼isDyhVsDly batsD'ku] 30fexzk@5fefy ds vf/kdre ewY; fu/kkZj.k ls lEcfU/kr½, Hkkjr ds jkti=k] vlk/kkj.k esa izdkf'kr lkj.kh ds bdkbZ dkWye la[;k 4 dh izfof"V 381 dks fuEu izdkj i<+k tk;sa % ds LFkku ij Þizfr iSdß i<+k tk, "1 fefyß [dk-a l-a@156@24@2015@fo@Qk- l-a 8¼24½@2015@Mhih@,uihih,-&fMoh--II] jkds'k dDdM] mi&funs'kd40 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] CORRIGENDUM New Delhi, the 24th August, 2015 S.O. 2317(E).—The National Pharmaceuticals Pricing Authority’s Order No. S.O. 619(E), dated the 26th February, 2015 (relating to the ceiling price of Paclitaxel Injection, 30mg/5ml), published in the Gazette of India, Extraordinary, of the Entry at SI. No. 381 in the Unit Column No. (4) of the table, both in Hindi & English version be read as follows: Instead of “Each Pack” Read as “1 ml” [PN/156/24/2015/F/F. No. 8(24)/2015/D.P./NPPA-Div.-II] RAKESH KAKKAR, Dy. Director Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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