In continuation to the notifications issued by National Pharmaceutical Pricing Authority Department of Pharmaceuticals Ministry of Chemical and Fertilizers

रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99 xxxGIDHxxx सी.जी.-डी.एल.-अ.-29022020-216473 xxxGIDExxx CG-DL-E-29022020-216473 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 832] नई दिल्ली, िुक्रवार, फरवरी 28, 2020/फाल्ग नु 9, 1941 No. 832] NEW DELHI, FRIDAY, FEBRUARY 28, 2020/PHALGUNA 9, 1941 jlk;u vkSj moZjd ea=ky; ¼vkS"k/k foHkkx½ ¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ ubZ fnYyh] 28 Qjojh] 2020 dk-vk- 909¼v½&jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k] vkS"k/k foHkkx] jlk;u vkSj moZjd e=a ky; ds fnukad 27 Qjojh] 2019 ds dk-vk- 1041¼v½ ds ek/;e ls vf/klwpukvks a dk s tkjh j[krs gq,] Mhihlhvks] 2013 ds iSjk 19 ds rgr tkjh 42 vkS"kf/k;ks a ds O;kikj ektZu dh dSfiax ¼lhfer j[ku½s ds laca/k eas] ;g fu.kZ; fy;k x;k gS fd Mhihlhvks] 2013 ds iSjkxzkQ 20 ¼1½ ds izko/kkuks a ds vuqlkj bldh fuxjkuh dh tk,xhA [dk-al-a@205@73@2020@,Q@Qk- la- 8¼73½@2020@Mhih@,uihih,&fMoh-II] izlsuthr nkl] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 28th February, 2020 S.O.909(E).—In continuation to the notifications issued by National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemical and Fertilizers vide S.O. 1041(E) dated 27th February 2019 regarding capping of trade margin of 42 drugs issued under Para 19 of the DPCO, 2013, it has been decided that the same shall be monitored as per the provisions of Paragraph 20(1) of the DPCO, 2013. [PN/205/73/2020/F/F. No. 8(73)/2020/DP/NPPA/Div.II ] PRASENJIT DAS, Asst. Director 1189 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vkns'k ubZ fnYyh] 28 Qjojh] 2020 dk-vk-910¼v½-&tcfd Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky; ds fnukad 29 vxLr] 1997 ds ladYi la- 33@7@97&ih vkbZ&I }kjk jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k ¼,uihih,½ dh LFkkiuk] vU; ckrks a ds lkFk&lkFk Fkksd vkS"kf/k;ks a rFkk fofufeZfr;ks a ds eYw ; fu/kkZfjr dju s vkSj mueas ifjorZu ;fn dksbZ gks]a dks vf/klwfpr dju]s vfu;af=r vkS"kf/k;ks a vkSj fofufeZfr;ks a ds eYw ;ks a ij utj j[ku s vkSj vkS"k/k ¼eYw ; fu;a=.k½ vkn's k ¼Mhihlhvks½ ds izko/kkuks a dk dk;kZUo;u dju s ds fy,] dh xbZ FkhA 2- vkSj tcfd] jlk;u ,oa moZjd e=a ky; ds fnukad 30 ebZ] 2013 ds dk;kZy; vkn's k la- 1394¼v½ ds }kjk vko';d oLrq vf/kfu;e] 1955 dh /kkjk 3 rFkk 5 }kjk iznRr 'kfDr;ks a dk iz;ksx djrs gq, Mhihlhvks] 2013 dh fof'k"V iSjkxzkQ ds laca/k eas mDr vkn's k ds iSjkxzkQ 32 lfgr ,uihih, dk s dsUnz ljdkj dh vksj ls 'kfDr;ka izR;ksftr dh xbZ gSaA 3- vkSj tcfd] eSllZ efsjy ykbQ lkbal izk- fy- ls izkIr vkonsu }kjk Mhihlhvks] 2013 ds izko/kkuks a ls NwV ds fy,] iSjkxzkQ 32 (ii) ds vUrxZr mDr vkn's k esa efsjl 100&fljksfyel bY;wVhax Ckk;ksfjtksjoscy osLD;qyj LdsQksYM flLVe ¼dkjs ksujh LVsVa ½ ftls vkS"kfèk vkSj izlk/ku lkexzh vf/kfu;e vkSj fu;e ds fu;e 122 ¼bZ½ ds rgr ^ubZ nok* ds :i es a dsna zh; vkS"kf/k ekud fu;a=.k laxBu ¼Hkkjr½ ds dk;kZy; }kjk fof/kor vuqeksfnr fd;k x;k Fkk vkSj isVsVa vf/kfu;e] 1970 ds rgr isVsVa dk;kZy;] Hkkjr }kjk isVsVa djk;k x;kA ¼isVsVa la- 296768 vkSj vuqnku iznku djus dh frfFk 14-05-2018½ 4- vkSj tcfd] ,uihih, u s fnukad 25-02-2020 dk s viuh 73oha cSBd eas ;g mYy[s k fd;k fd elS lZ efsjy ykbQ lkbal izk- fy }kjk izLrqr nLrkost Mhihlhvks] 2013 ds iSjkxzkQ 32 (ii) dh vko';drk dk s iwjk djr s gSa vkSj fu.kZ; fy;k gS fd Mhihlhvks] 2013 ds iSjk 32¼ii) ds varxZr eSllZ esfjy ykbQ lkbal izk- fy dk s viu s mRikn efsjl 100 & fljksfyel bY;wVhax Ckk;ksfjtksjoscy osLD;qyj LdsQksYM flLVe ¼dksjksujh LVsVa ½ dk mi;ksx dju s ds fy, NwV nh tk ldrh gSA 5- vc blfy, dk-vk 1394¼v½] fnukad 30 ebZ] 2013 dks jlk;u ,oa moZjd e=a ky;] Hkkjr ljdkj }kjk tkjh vkS"kf/k ¼ewY; fu;a=.k½ vkn's k] 2013 ds iSjk 32 ds vUrxZr iznÙk 'kfDr;ks a dk iz;ksx djr s gq,] mi;qZDr mDr vkS"kf/k vFkkZr ns“k eas blds okf.kfT;d mRiknu dh “kq:vkr dh rkjh[k ls ikap o"kZ dh vof/k ds fy, efsjl 100 & fljksfyel bY;wVhax Ckk;ksfjtksjoscy osLD;qyj LdsQksYM flLVe ¼dksjksujh LVsVa ½ ds laca/k es a mDr vkn's k ds iSjkxzkQ 32 (ii) ds vUrxZr Mhihlhvks] 2013 ds izko/kkuks a ls eSllZ esfjy ykbQ lkbal izk- fy- dks NwV nh xbZ gSA 6- dEiuh Mhihlhvks] 2013 ds rgr QkWeZ V es a eYw ; lwph tkjh djds mDr vkS"kfèk ds ckj s eas dEiuh }kjk r; dh xbZ vf/kdre [kqnjk ewY; ,uihih, dks lwfpr djsxhA [dk-ala-@205@73@2020@,Q@Qk- la0 8¼73½@2020@Mhih@,uihih,&fMoh-II] izlsuthr nkl] lgk;d funs'kd ORDER New Delhi, the 28th February, 2020 S.O. 910(E).—Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August, 1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO). 2. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 32 of the said order to be exercised by the NPPA on behalf of the Central Government. 3. And whereas an application received from M/s Meril Life Sciences Pvt. Ltd, for exemption from the provisions of DPCO, 2013 under para 32 (ii) of the said order in respect of drug Coronary Stent namely “Sirolimus Eluting BioResorbable Vascular Scaffold System (MeRes100)” which was duly approved by the office of Central Drugs Standard Control Organisation (India) as ‘new drug’ under Rule 122(E) of the Drugs and Cosmetics Act and Rules thereunder, and patented by The Patent Office, India under the Patents Act, 1970 (Patent No. 296768 and Date of Grant: 14.05.2018). 4. And whereas the NPPA at its 73rd meeting dated 25.02.2020 noted that M/s Meril Life Sciences Pvt. Ltd meets the requirement of para 32(ii) of DPCO 2013 and decided that exemption may be granted to M/s Meril[भाग II— खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 Life Sciences Pvt. Ltd under para 32(ii) of DPCO 2013 for their drug Coronary Stent namely “Sirolimus Eluting BioResorbable Vascular Scaffold System (MeRes100)”. 5. Now, therefore, in exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Meril Life Sciences Pvt. Ltd is exempted from the provisions of DPCO, 2013 under para 32 (ii) of the said order in respect of above said drug Coronary Stent namely “Sirolimus Eluting BioResorbable Vascular Scaffold System (MeRes100)” for a period of five years from the date of the commencement of its commercial production in the country. 6. The company shall inform NPPA of the Maximum Retail Price fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013. [PN/205/73/2020/F/F. No. 8(73)/2020/ DP/Div-II/NPPA] PRASENJIT DAS,Asst. 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.