Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5, 11 and ...
Date: 2018-02-06 Category: Extra Ordinary State: Union Government Country: India

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

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) fixes the retail prices of various formulations as specified in the attached table, effective February 6, 2018. The prices are exclusive of goods and services tax. Manufacturers must adhere to these prices and issue a price list in Form V to the NPPA. **Key Points / Main Content:** * **Price Fixation:** * The NPPA fixes the retail prices for specific drug formulations listed in the table. * Prices specified are exclusive of goods and services tax (GST). * The retail price is determined based on the strength, unit, manufacturer, and marketing company of the formulation. * **Manufacturer Responsibilities:** * Manufacturers must fix retail prices as specified in column 6 for new drugs. * Manufacturers can add GST if it is actually paid or payable to the government. * Manufacturers must determine the retail price for a pack of the formulation according to paragraph 11 of the DPCO, 2013. * A price list in Form V must be issued to the NPPA through IPDMS and a copy submitted to the State Drug Controller and dealers as per paragraph 24 of the DPCO, 2013. * **Retailer and Dealer Responsibilities:** * Retailers and dealers must display the price list and supplementary price list in a visible location on their premises, as furnished by the manufacturer, according to para 24(4) of DPCO 2013. * **Applicability and Compliance:** * The retail price applies only to the manufacturer/marketer who applied for price fixation/revision using Form I under DPCO, 2013. * Compliance is subject to fulfilling all statutory requirements, including manufacturing license permissions. * Failure to comply with the notified prices will result in liability to deposit the overcharged amount with interest. * **Supersession:** * This notification supersedes any previous price orders for the formulations specified in the table. **Impact Analysis:** **Manufacturers:** * *Impact:* Affected by the fixed retail prices for their formulations. *Action Required:* Must adhere to the fixed prices, issue price lists in Form V, and comply with all statutory requirements, including manufacturing licenses. **Retailers and Dealers:** * *Impact:* Impacted by the need to display the updated price lists prominently. *Action Required:* Must display the price list and any supplementary lists provided by the manufacturer in a conspicuous part of their business premises. **Consumers:** * *Impact:* Directly impacted by the retail prices of the formulations. *Action Required:* Be aware of the fixed prices and supplementary prices.

Key Entities Referenced

Drugs Prices Control Order, 2013: A legal order in India that regulates the prices of drugs. National Pharmaceutical Pricing Authority: The organization in India responsible for fixing and revising the prices of pharmaceutical products, abbreviated as NPPA. Ministry of Chemicals and Fertilizers: A ministry in the Government of India. New Delhi: The capital of India, where the notification was issued. Essential Commodities Act, 1955: An act of the Parliament of India to ensure the delivery of certain commodities to consumers at fair prices. Paracetamol: A widely used over-the-counter analgesic and antipyretic medication (pain reliever and fever reducer). Telmisartan: An angiotensin II receptor blocker (ARB) used to treat hypertension (high blood pressure). Amlodipine: A calcium channel blocker medication used to treat high blood pressure and chest pain.
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MkDs lhlk;lyhu$ iRz;ds gkM Z tys Vs kbu dISlyw e%as 1 dSIlyw eSll Z ekldkVs gYs Fk flfjt 5.56 ySDVªhd ,flM ckflyl MkDs lhlk;lyhu gkbdyVs d s cjkcj izk- fy-@eSll Z tk;Ml dSIlyw MkDs lhlk;lyhu ¼iSyVs l½ 100 fexkz-] gYs Fkd;s j fy- ySDVªhd ,flM ckflyl ¼buVfsjd fyfir iSyVs l½ 5 fcfy;u likjs ls 8. MkDs lhlk;lyhu$ iRz;ds gkM Z tys Vs kbu dISlyw e%as 1 dSIlyw eSll Z cus uVs QkekLZ ;fwVdYl 5.56 ySDVªhd ,flM ckflyl MkDs lhlk;lyhu gkbdyVs d s cjkcj fy- dSIlyw MkDs lhlk;lyhu ¼iSyVs l½ 100 fexkz-] ySDVªhd ,flM ckflyl ¼buVfsjd fyfir iSyVs l½ 5 fcfy;u likjs ls 9. lhyuhMhikbu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z lQVcs ykbQ 7.11 Vys felkjVu xkys h lhyuhMhikbu 10 fexkz-] Vys felkjVu lkbal@eSll Z yfqiu fy- vkbZih 40 fexzk- 10. lhyuhMhikbu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z ,dEl MªXl ,Ma 7.11 Vys felkjVu xkys h lhyuhMhikbu 10 fexkz-] Vys felkjVu QkekZL;fwVdYl fy-@eSll Z vkbZih 40 fexzk- ,fjLVk s QkekLZ ;fwVdYl ikz- fy- 11. ysohVsjklVs e xkys h iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z ekldkVs gYs Fk flfjt 23.37 ysohVsjklVs e vkbiZ h 1000 fexkz-] izk- fy-@eSll Z tk;Ml gYs Fkd;s j fy- 12. ysohVsjklVs e xkys h iRz;ds fQYe fyfir izkys kxas M fjfyt 1 xkys h eSll Z ,dEl MªXl ,Ma 23.37 xkys h e%sa ysohVsjklVs e vkbiZ h 1000 fexkz-] QkekZL;fwVdYl fy-@eSll Z ,eD;wj QkekLZ ;fwVdYl fy- 13. Qus hyQs jkbu $ iRz;ds 5 fefy- e%as 1 fefy- eSll Z ,dEl MªXl ,Ma 0.75 DyksjQus hjkekbu flji Qus hyQs jkbu gkbMªkDs ykjs kbM vkbZih 5 QkekZL;fwVdYl fy-@eSll Z fexzk-] ykbQZ LVkj Qkek Z ikz- fy- DyksjQus hjkekbu ekyVs vkbiZ h 2 fexkz- 14. leq kVªhiVu $ uizkDs lus iRz;ds vfyfir fcy;s jM xkys h e%as 1 xkys h eSll Z lu Qkek Z ySckjs Vs kfsjt 30.82 xkys h ¼ukDldkeW ½ lekVªhiVku lqLlhuVs vkbiZ h d s cjkcj fy- leq kVªhiVu 85 fexkz-] uizkDs lus lkfsM;e ;,w lih 500 fexkz- 15. lhyuhMhikbu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z lkbukds es 9.79 Vys felkjVu $ lhyuhMhikbu 10 fexkz-] Vys felkjVu QkekZL;fwVdYl fy-@eSll Z DyksjFkkyhMkuW xkys h vkbZih 40 fexzk-] Dykjs FkkyhMkuW vkbZih eus dkbMa Qkek Z fy- 6-25 fexzk- 16. Vys felkjVu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z ,dEl MªXl ,Ma 8.75 ,eykMs hfiu $ Vys felkjVu vkbiZ h 40 fexkz-] QekZL;fwVdYl fy-@eSll Z DyksjkFs kkyhMkQu xkys h ,eykMs hfiu ckblZ yVs vkbiZ h d s cjkcj ,CckVs bfaM;k fy- ,eykMs hihu 5 fexkz-] Dykjs kFs kkyhMkQu vkbZih 12-5 fexkz- 17. Vys felkjVu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z lu Qkek Z ySckjs Vs kfsjt 8.75 ,eykMs hfiu $ Vys felkjVu vkbiZ h 40 fexkz-] fy- DyksjkFs kkyhMkQu xkys h ,eykMs hfiu ckblZ yVs vkbiZ h d s cjkcj ¼VhxkVys ,lh,p 40½ ,eykMs hihu 5 fexkz-] Dykjs kFs kkyhMkQu vkbZih 12-5 fexkz-¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 18. Vys felkjVu $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z lu Qkek Z ySckjs Vs kfsjt 14.00 ,eykMs hfiu $ Vys felkjVu vkbiZ h 80 fexkz-] fy- DyksjkFs kkyhMkQu xkys h ,eykMs hfiu ckblZ yVs r vkbiZ h d s cjkcj ¼VhxkVys ,lh,p 80½ ,eykMs hihu 5 fexkz-] Dykjs kFs kkyhMkQu vkbZih 12-5 fexzk- 19. g;~ ew u balfqyu batSD”ku iRz;ds fefy- e%sa 1 fefy- eSll Z ,et s ck;kQs kek Z ikz- 63.66 g;~ ew u balfqyu ¼30 ifzr’kr ?kyq u’khu bla fqyu fy-@eSll Z dk,s bta DS ’ku vkSj 70 ifzr’kr blkQs us bla fqyu QkekZL;fwVdYl ikz- fy- bta DS ’ku d s :i e½sa ¼g;~ ew u bla fqyu vkjMh,u, vkWfjftu½ vkbiZ h 100 vkb;Z w eVs kfØlkys ¼itzs jofsVo d s :i e½sa ;,w lih&0-16 ifzr’kr MCY;@w oh] Qus kys ¼itzs jofsVo d s :i e½sa vkbiZ h 0-065 ifzr’kr MCY;@w oh okVj QkWj bta SD’ku 20. g;~ ew u balfqyu bta SD’ku iRz;ds fefy- e%sa 1 fefy- eSll Z ,et s ck;kQs kek Z ikz- 63.66 g;~ ew u balfqyu ¼50 ifzr’kr ?kyq u’khu bla fqyu fy-@eSll Z dk,s bta DS ’ku vkSj 50 ifzr’kr blkQs us bla fqyu QkekZL;fwVdYl ikz- fy- bta DS ’ku d s :i e½sa ¼g;~ ew u bla fqyu vkjMh,u, vkWfjftu½ vkbiZ h 100 vkb;Z w eVs kfØlkys ¼itzs jofsVo d s :i e½sa ;,w lih&0-16 ifzr’kr MCY;@w oh] Qus kys ¼itzs jofsVo d s :i e½sa vkbiZ h 0-065 ifzr’kr MCY;@w oh okVj QkWj bta SD’ku 21. g;~ ew u balfqyu bta DS ’ku iRz;ds fefy- e%sa 1 fefy- eSll Z ,et s ck;kQs kek Z ikz- 63.66 g;~ ew u balfqyu ¼g;~ ew u bla fqyu vkjMh,u, fy-@eSll Z dk,s vkWfjftu½ vkbiZ h 100 vkb;Z w eVs kfØlkys QkekZL;fwVdYl ikz- fy- ¼itzs jofsVo d s :i e½sa ;,w lih&0-025 ifzr’kr MCY;@w oh] Qus kys ¼itzs jofsVo d s :i e½sa vkbiZ h 0-065 ifzr’kr MCY;@w oh okVj QkWj bta SD’ku 22. Mkds Vs kDlys bta Ds ’ku iRz;ds fefy- dkWu’kuVVªs e%sa ifzr idS eSll Z oUsl jes Mkbt fy-@ 10280.34 ¼Mkds Vs kDlys vkbiZ h 120 Mkds Vs kDlys ¼,ugkbMªkts ½ 40 fexzk-] ikys hlkcs VsZ ¼120 eSll Z dSfMyk gYs Fkd;s j fy- fexzk-@3 fefy-½ 80 &556 fexzk- fexzk-@3 bFkkukys ,ugkbMªkts 326 fexzk-$ lkbfVªd ,flM fefy- ekus kgs kbMªVs 2 fexzk- ¼QkWj ih,p ,MtsleVsa ½ okVj QkWj bta Ds ’ku 23. blhVkykis zke $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z ,lVas Qkek@Z eSll Z 3.83 Dykus ktis ke xkys h blhVkykis zke vkSDlkyVs vkbiZ h d s cjkcj ,CckVs gYs Fkd;s j fy- ¼ltVs kyk s Iyl 5½ blhVkykis zke 5 fexkz-] Dykus ktis ke vkbiZ h 0-5 fexzk- 24. Vys felkjVu $ iRz;ds vfyfir xkys h e%as 1 xkys h eSll Z eds ykWMl 4.30 ,EykfsMfiu xkys h Vys felkjVu vkbiZ h 40 fexkz-] QkekZL;fwVdYl fy- ¼Vys feMdw ,,e½ ,EykfsMfiu ckbZlyVs vkbiZ h d s cjkcj ,EykfsMfiu 5 fexkz- 25. Vys felkjVu $ iRz;ds vfyfir xkys h e%as Vys felkjVu 1 xkys h eSll Z eds ykWMl 4.15 gkbMªkDs yksjkFs kkbtkbM ;,w lih 40 fexkz-] gkbMªkDs ykjs kFs kkbtkbM QkekZL;fwVdYl fy- xkys h ¼Vys feMdw ,p 40½ ;,w lih 12-5 fexkz- 26. jkslqoklVkfVu$,Lizhu $ iRz;ds gkM Z tys Vs kbu dISlyw e%as 1 dSIlyw eSll Z lkbukds es 9.97 DykfsiMkxs yzs dSIlyw jkslqoklVkfVu dSfY”k;e vkbiZ h d s cjkcj QkekZL;fwVdYl fy-@eSll Z ¼jkts dq ksj xkYs M 10½ jkslqoklVkfVu 10 fexkz- ¼iSyVs l e½as] VkWjVas QkekLZ ;fwVdYl fy- ,Lizhu vkbiZ h 75 fexkz- ¼xkLVªk&s jfslLVus V iSyVs l½] DykfsiMkxs yzs ckbZlYQVs vkbiZ h d s cjkcj DykfsiMkxs ysz 75 fexzk- ¼iSyVs l e½as 27. jkslqoklVkfVu$,Lizhu $ iRz;ds gkM Z tys Vs kbu dISlyw e%as 1 dSIlyw eSll Z lkbukds es 18.00 DykfsiMkxs yzs dSIlyw jkslqoklVkfVu dSfY”k;e vkbiZ h d s cjkcj QkekZL;fwVdYl fy-@eSll Z ¼jkts dq ksj xkYs M 20½ jkslqoklVkfVu 10 fexkz- ¼iSyVs l e½as] VkWjVas QkekLZ ;fwVdYl fy- ,Lizhu vkbiZ h 75 fexkz- ¼xkLVªk&s jfslLVus V iSyVs l½] DykfsiMkxs ysz ckbZlYQVs vkbiZ h d s cjkcj DykfsiMkxs ysz 75 fexzk- ¼iSyVs l e½as4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 28. ,ekDs lhlhfyu $ iRz;ds dkWch iSd e%as ¼,½ ou ckrs y vkWQ 1 fefy- eSll Z V,w Va h QLV lpas wjh 2.91 Dykoyq kuVs lli”sa ku ,eDs lhlhfyu ,Ma iksVsf”k;e Dykoyq kuV QkekZL;fwVdYl ikz- fy- vksjy lli”sa ku ,y-ih- iRz;ds 5 fefy- @eSll Z Xyus ekd Z vkWQ fjdulfVVMw lli’as ku e%as QkekZL;fwVdYl fy- ,ekDs lhlhfyu VªgkbMªVs vkbiZ h d s cjkcj ,ekDs lhlhfyu 400 fexkz-] iksVsf”k;e Dykoyq kuVs fMyfqVM vkb Z d s cjkcj Dykoyq fud ,flM 57 fexkz- 29. iSjkflVkekys $ iRz;ds 5 fefy- e%as 1 fefy- eSll Z f=:ifr eMs hd;s j fy- 0.48 eQs us kfed s ¼iklhekWy iSjkflVkekys vkbiZ h 125 fexkz-] @eSll Z vkbiZ hlh, ,e,Q 125½ eQs us kfed ,flM vkbiZ h 50 fexkz ySckjs Vs kfsjt ikz- fy- Qy~ koksjMs flji cls 30. bVkfsjdkDs lhc $ iRz;ds fQYe fyfir xkys h e%as 1 xkys h eSll Z jos us Hkys gYs Fkd;s j 5.14 iSjkflVkekys xkys h bVkfsjdkDs lhc vkbiZ h 60 fexkz-] ¼ih½ fy-@eSll Z vkbZihlh, ¼bVkes SDl ih½ iSjkflVkekys vkbiZ h 325 fexkz- izk-fy- uksV % ¼d½ mi;DqZ r nh xb Z fofufn"ZV QkWeywZ 's ku d s fofuekZrk vFkkZr tk s Þub Z Mxª ß Mhihlhvk]s 2013 d s iSjkxzkQ 2¼;½w d s rgr mi;qZDr nh xb Z lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk eYw ; fu/kkZfjr djxsa sA ¼[k½ vxj fuekZrkvk sa u s mi;qZDr lkj.kh d s LrHa k (6) e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkxq rku fd;k gS ;k ;g n;s gS rk s o s oLr q ,o a lsok dj dk s tkMs + ldr s gSAa ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuks a d s rgr fuekZrkvksa dk s mi;qZDr lkj.kh d s LrHa k ¼6½ e sa fofufn"ZV [knq jk eYw ; d s vk/kkj ij vuqlwfpr fofufeZfr;k sa d s iSdk sa d s fy, [knq jk eYw ; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 24 d s rgr QkWe Z V esa vf/klpw uk dh rkjh[k l s ,d eYw ; lpw h ,uihih, dk s vkbiZ hMh,e,l d s ek/;e l s tkjh djsAa ¼?k½ vk"Sk/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 (4) d s mic/a kk sa ds vuqlkj iRz ;ds QVq dj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sl s ifjlj] tgk a dkjckj dks bl idz kj fd;k tk jgk g S fd mlls ijke”kZ d s bPNdq fdlh O;fDr ds fy, igpqa vklku gk]s ogk a mld s fdlh lgtn”` ; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia nz f’kZr djxs kA ¼M-½ mi;DqZ r xSj vf/kdre dher ¼[knq jk eYw ;½ dsoy mi;DqZ r fuekZrk@foi.ku d s fy, ykx w gS tSlk fd mUgkusa s vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fu/kkZj.k@l'a kk/s ku d s fy, QkWe Z I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkfZjr lHkh ykx w oS/kkfud vko';drkvks a dh ifwr Z d s v/khu izklfaxd fof/k;k@sa fu;eks a d s vUrxZr tSlk fd dUsnzh;@jkT; ykblfslxa vkWFkksfjVh d s l{ke izkf/kdkjh }kjk eUs;Qw sDpfjxa ykblsal eta jw h d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuiq kyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ks a vkSj fofufn"ZV 'krks± dk ikyu ugh a djrh gS a rk s o s vko';d oLrq,¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼N½ bl vkn's k es a mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV fofufeZfr;k sa d s iSdk sa dh [kqnjk eYw ; fu;r gkus s d s ifj.kkeLo#i] vkn's k tk s fd bl vkn's k l s iow Z tkjh gq, g]S Lor% gh fujLr gk s tk;saxsA [dk-al-a@186@54/2018@,Q@Qk- l0a 8¼54½@2018@Mhih@,uihih,&fMoh-&II] cythr flga ] lgk;d fun's kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th February, 2018 S. O. 544(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S. O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5 column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. Name of the Strength Unit Manufacturer & Retail No Formulation / Brand Marketing Company Price . Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Paracetamol + Each Uncoated tablet contains: 1 Tablet M/s Akums Drugs and 1.64 Dicyclomine Tablet Paracetamol IP 500mg, Pharmaceutical Ltd. / (Pacimol Spas) Dicyclomine Hydrochloride IP 20 mg M/s IPCA Laboratories Ltd. 2. Amoxicilin Potasium Each uncoated dispersible tablet 1 Tablet M/s Alkem 16.35 Clavulanate Tablet containing: Healthscience-A unit of (Clavam Forte DT) Alkem Laboratories / Amoxicilin Trihydrate IP eq. to M/s Alkem labortories Amoxicilin 400mg, Ltd. Potasium Clavulanate diluted IP eq. To Clavulanic acid 57 mg 3. Telmisartan + Each film coated Tablet contains: 1 Tablet M/s Sun Pharma 7.64 Chlorthalidone Tablet Telmisartan IP 40mg, Laboratories Limited (Tigatel CH40) Chlorthalidone IP 12.5mg 4. Cilnidipine + Each Tablet contains: 1 Tablet M/Pure and Cure 10.54 Telmisartan tablet Cilnidipine 10mg , Healthcare Pvt. Ltd. / (Telvacil 80mg) Telmisartan IP 80mg M/s Aristo Pharmaceuticals Pvt. Ltd. 5. Metoprolol ER Tablet Each film coated extended release 1 Tablet M/s Intas 8.39 Tablet contains: Pharmaceuticals Limited Metoprolol Succinate IP 71.25mg eq. to Metoprolol Tartrate 75mg. 6. Paracetamol + Each film coated Tablet contains: 1 Tablet M/s Ipca Laboratories 1.88 Caffeine Tablate Paracetamol IP 650mg, Limited (Pacimol Active) Caffeine Anhydrous IP 50mg 7. Doxycyclilne + Lactic Each hard Gelatin capsule contains: 1 Capsule M/s Mascot Health 5.56 Acid Bacillus Doxycycline Hyclate eq. to Series Pvt. Ltd. / M/s capsules Doxycycline 100mg, Lactic Acid Zydus Healthcare Bacillus 5 Billion Spores Limited. 8. Doxycyclilne + Lactic Each hard Gelatin capsule contains: 1 Capsule M/s Bennet 5.56 Acid Bacillus Doxycycline Hyclate eq. to Pharmaceuticals Ltd. capsules Doxycycline (Pellets) 100mg, Lactic Acid Bacillus (enteric coated Pellets) 5 Billion Spores 9. Cilnidipine + Each filmcoated tablet contains: 1 Tablet M/s Safteb Life Science / 7.11 Telmisartan Tablet Cilnidipine 10mg, M/s Lupin Limited Telmisartan IP 40mg 10. Cilnidipine + Each filmcoated tablet contains: 1 Tablet M/s Akums Drugs & 7.11 Telmisartan Tablet Cilnidipine 10mg, Pharmaceuticals Ltd. / Telmisartan IP 40mg M/s Aristo Pharmaceuticals Pvt. Ltd. 11. Levetiracetam Table Each film coated tablet contains: 1 Tablet M/s Mascot Health 23.37 Levetiracetam IP 1000mg Series Pvt. Ltd. / M/s Zydus Healthcare Limited 12. Levetiracetam Table Each film coated Prolonged release 1 Tablet M/s Akums Drugs & 23.37 tablet contains: Pharmaceuticals Ltd. / Levetiracetam IP 1000mg M/s Emcure6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Pharmaceuticals Limited 13. Phenylephrine + Each 5 ml Contains: 1 ML M/s Akums Drugs & 0.75 Chlorpheniramine Phenylephrine Hydrochloride IP Pharmaceuticals Ltd. / Syrup 5mg, M/s Lifestar Pharma Pvt. Chlorpheniramine Maleate IP 2mg Ltd. 14. Sumatriptan + Each uncoated bilayer tablet 1 Tablet M/Sun Pharma 30.82 Naproxen Tablet contains: Laboratories Limited. (NAXCOM) Sumatriptan Succinate IP eq. to Sumatriptan 85mg, Naproxen Sodium USP 500mg 15. Cilnidipine + Each film coated tablet contains: 1 Tablet M/s Synokem 9.79 Telmisartan + Cilnidipine 10mg, Pharmaceuticals Ltd. / Chlorthalidone Tablet Telmisartan IP 40mg, Chlorthalidone M/s Mankind Pharma IP 6.25mg Limited 16. Telmisartan + Each film coated tablet contains: 1 Tablet M/s Akums Drugs & 8.75 Amlodipine + Telmisartan IP 40mg, Pharmaceuticals Ltd. / Chlorthalidone Tablet Amlodipine Besylate IP eq. to M/s Abbott India (Telpres Trio) Amlodipine 5mg, Chlorthalidone IP Limited 12.5mg 17. Telmisartan + Each film coated tablet contains: 1 Tablet M/s Sun Pharma 8.75 Amlodipine + Telmisartan IP 40mg, Laboratories Limited Chlorthalidone Tablet Amlodipine Besylate IP eq. to (Tigatel ACH 40) Amlodipine 5mg, Chlorthalidone IP 12.5mg 18. Telmisartan + Each uncoated tablet contains: 1 Tablet M/Sun Pharma 14.00 Amlodipine + Telmisartan IP 80mg, Amlodipine Laboratories Ltd. Chlorthalidone Tablet Besylate IP Eq. to Amlodipine 5mg (Tigatel ACH 80) & Chlorthalidone IP 12.5mg 19. Human Insulin Insulin Biophasic Isophane PH. Eur./ 1 ML M/s MJ Biopharma Pvt. 63.66 Injection USP (30% as soluble Insulin Ltd. / M/s Koye Injection and 70% as ISophane Pharmaceuticals Pvt. Insulin Injection) Each Ml contains: Ltd. r-human Insulin (Regular) 100 IU/vial, m-Cresol USP-0.16% w/v, Phenol IP 0.065% w/v 20. Human Insulin Insulin Biophasic Isophane PH. Eur./ 1 ML M/s MJ Biopharma Pvt. 63.66 Injection USP (50% as soluble Insulin Ltd. / M/s Koye Injection and 50% as ISophane Pharmaceuticals Pvt. Insulin Injection) Each Ml contains: Ltd. r-human Insulin (Regular) 100 IU/vial, m-Cresol USP-0.16% w/v, Phenol IP 0.065% w/v 21. Human Insulin Soluble Insulin Ph. Eur./USP 1 ML M/s MJ Biopharma Pvt. 63.66 Injection Each ml contains: Ltd. / M/s Koye r-human Insulin (Regular) 100 Pharmaceuticals Pvt. IU/vial Ltd. 22. Docretaxel Injection Each ml of concentrate contains: Each M/s Venus Remedies 10280.34 (Docretaxel IP Docetaxel (as anhydrous) 40mg, Pack Ltd. / M/s Cadila 120mg/3ml) Polysorbate 80 – 566mg, (120mg/3 Healthcare Ltd. Ethanol Anhydrous 326mg, ml) Citric Acid Monohydrate 2mg (for PH adjustment), water for injection 23. Escitalopram + Each film coated tablet contains: 1 Tablet M/s Accent Pharma / 3.83 Clonazepam Tablet Escitalopram Oxalate IP eq. to M/s Abbott Healthcare (Szetalo Plus 5) Escitalopram 5mg, Clonazepam IP Limited. 0.5mg¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 7 24. Telmisartan + Each uncoated tablet contains: 1 Tablet M/s Macleods 4.30 Amlodipine Tablet Telmisartan IP 40mg, Amlodipine Pharmaceuticals Ltd. (Telmiduce AM) Besylate IP eq. to Amlodipine 5mg 25. Telmisartan + Each uncoated tablet contains: 1 Tablet M/s Macleods 4.15 Hydrocholrothiazide Telmisartan USP 40mg, Pharmaceuticals Ltd. Tablet Hydrocholrothiazide USP 12.50mg (Telmiduce H 40) 26. Rosuvastatin + Each Hard Gelatine Capsule 1 Capsule M/s Synokem 9.97 Aspirin + Clopidogrel contains: Pharmaceuticals Limited / Capsule Rosuvastatin Calcium IP eq. to M/s Torrent (Rozucor Gold 10) Rosuvastation 10mg (As pellets), Pharmaceuticals Limited Aspirin IP 75mg (As Gastro - resistant pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 27. Rosuvastatin + Each Hard Gelatine Capsule 1 Capsule M/s Synokem 18.00 Aspirin + Clopidogrel contains: Pharmaceuticals Limited / Capsule Rosuvastatin Calcium IP eq. to M/s Torrent (Rozucor Gold 20) Rosuvastation 20mg (As pellets), Pharmaceuticals Limited Aspirin IP 75mg (As Gastro - resistant pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 28. Amoxycillin + Each combipack contains: 1 ML M/s Twenty First 2.91 Clavulante (a) One bottle of Amoxycillin & Century Pharmaceuticals Suspension Potassium Clavunate Oral Pvt. Ltd. / M/s Glenmark Suspension L.P. Pharmaceuticals Ltd. Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulante Diluted IP eq. to Clavulnic Acid 57mg 29. Paracetamol + Each 5ml contains: 1 ML M/s Tirupati Medicare 0.48 Mafenamic Paracetamol IP 125mg, Limited / M/s IPCA Suspension (Pacimol Mafenamic acid IP 50mg Flavoured Laboratories Pvt. Ltd. MF 125) Syrup base 30. Etoricoxib + Each film coated tablet contains: 1 Tablet M/s Ravenbhel 5.14 Paracetamol Tablet Etoricoxib IP 60mg, Paracetamol IP Healthcare (P) Limited / (Etomax P) 325mg M/s IPCA Laboratories Pvt. Ltd. Note: (a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove. (b) The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table. (c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) The above mentioned retail price is applicable only to the individual manufacturer / marketeer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies. (f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955. (g) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/186/54/2018/F/F.No. 8(54)/2018/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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