In exercise of the powers conferred by paragraphs 4 10 11 14 16 17 and 18 of the Drugs

jftLVªh löa Mhö ,yö&33004@99 REGD. NO. D. 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- 1005] ubZ fnYyh] cq/okj] vizSy 27] 2016@oS'kk[k 7] 1938 No. 1005] NEW DELHI, WEDNESDAY, APRIL 27, 2016/VAISAKHA 7, 1938 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] 27 vizSy] 2016 dk-vk- 1560¼v½.—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk0 vk0 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14, 16, 17 vkSj 18 }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 ¼laf{kIr :i esa ,uihih, gS½] uhps dh lkj.kh ds LraHk ¼5½ es fofufnZ"V rRdky izHkkoh vf/kdre dher vkSj mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ e 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 fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdkbZ vf/kdre dher¼#-½ 1 2 3 4 5 1. esQsfufed ,sflM vksjy fyfDoM esQsfufed ,sflM-100 fexzk-@5 fefy 1 fefy 0.48 2. izsMuhlksyksu vksjy fyfDoM izsMuhlksyksu-5 fexzk-@5 fefy 1 fefy 0.40 3. izsMuhlksyksu vksjy fyfDoM izsMuhlksyksu-15 fexzk-@5 fefy 1 fefy 0.71 4. escsUMkt+ksy vksjy fyfDoM escsUMkt+ksy-100 fexzk-@5 fefy 1 fefy 0.73 5. MkbZbFkk;ydkckZest+hu vksjy fyfDoM MkbbZ Fkk;ydkckeZ ts h+u-120 fexkz-@5 fefy 1 fefy 0.43 6. ,eksDlhflfyu vksjy fyfDoM ,eksDlhflfyu-250 fexzk-@5 fefy 1 fefy 1.26 2041 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 7. ,eksDlhflfyu$ ,ekDs lhflfyu-125 fexkz- 1 fefy 2.00 DysO;wysfud ,flM MªkbZ flji DysO;wysfud ,flM-31.25 fexzk-@5 fefy 8. lsQkMªksDlhy vksjy fyfDoM lsQkMªksDlhy-125 fexkz-@5 fefy 1 fefy 0.58 9. DysfjFkzksekbflu vksjy fyfDoM DysfjFkzksekbflu-125 fexzk-@5 fefy 1 fefy 4.01 10. eSVªksfuMkt+ksy vksjy fyfDoM eSVªksfuMkt+ksy-200 fexzk-@5 fefy 1 fefy 0.25 11. ukbVªks¶;wjsUVksbbu vksjy fyfDoM ukbVªks¶;wjsUVksbbu-25 fexzk-@5 fefy 1 fefy 0.76 12. jsuhfVfMu vksjy fyfDoM jsuhfVfMu-75 fexzk-@5 fefy 1 fefy 0.54 13. dsisflVkckbu xksfy;ka dis fslVkckbu-500 fexkz-@xkys h 1 xksyh 117.27 14. isDyhVsDlsy bUtsD'ku isDyhVsDlsy-100 fexzk-@16.7 fefy 1 fefy 207.08 15. ysDVqykst+ vksjy fyfDoM ysDVqykst-10 xzke@15 fefy 1 fefy 0.98 16. lqØkYQsV vksjy fyfDoM lØq kYQVs -1 xkze 1 fefy 0.66 17. ysfoVªkflVe vksjy fyfDoM ysfoVªkflVe-100 fexzk-@fefy 1 fefy 3.53 18. esLuk bUtsD'ku esLuk-100 fexzk-@fefy 1 fefy 14.93 19. ycsVkyksy bUtsD'ku ycsVkyksy-5 fexzk-@fefy 1 fefy 47.03 20. t+k;yksesVktksfyu ust+y MªkIl tk+;ykes Vs ktkfsyu-0.1% 1 fefy 4.82 21. t+k;yksesVktksfyu ust+y MªkIl tk+;ykes Vs ktkfsyu-0.05% 1 fefy 3.65 22. lkbDyksLiksfju vksjy fyfDoM lkbDyksLiksfju-100 fexzk-@fefy 1 fefy 79.43 23. ,YizksLVkfMy bUtsD'ku ,YizksLVkfMy-0.5 fexzk-@fefy 1 fefy 5254.55 24. dSQhu bUtsD'ku dSQhu-20 fexzk-@fefy 1 fefy 232.89 25. usVkekbflu MªkIl uVs kekbflu-5% 1 fefy 21.16 26. izksisjkdsu MªkIl ikzis js kdus -0.5% 1 fefy 9.26 27. gkbMªksDlh izksikby gkbMªksDlh izksikby feFkkby lsY;qyksl-2% 1 fefy 34.79 feFkkby lsY;qyksl bUtsD'ku 28. dkcksZDlh feFkkby lsY;qyksl MªkIl dkcksZDlh feFkkby lsY;qyksl-0.5% 1 fefy 11.59 29. dkcksZDlh feFkkby lsY;qyksl MªkIl dkcksZDlh feFkkby lsY;qyksl-1% 1 fefy 13.03 30. ¶yqQsukt+kbu fMiksV bUtsD'ku ¶yqQsukt+kbu-25 fexzk-@fefy 1 fefy 46.42 31. jsLisjhMku vksjy fyfDoM jsLisjhMku-1 fexzk-@fefy 1 fefy 1.78 32. cqMslksukbM uscqykbt+j esa iz;ksx cMq ls kus kbM-0.5 fexkz-@fefy 1 fefy 9.93 ds fy, jsfLijsVj lksY;w'ku 33. cqMslksukbM uscqykbt+j esa iz;ksx cqMslksukbM-1 fexzk-@fefy 1 fefy 11.98 ds fy, jsfLijsVj lksY;w'ku 34. iksVkf'k;e DyksjkbM bUtsD'ku iksVkf'k;e DyksjkbM-150 fexzk-@fefy 1 fefy 2.25 35. Fkk;kfeu bUtsD'ku Fkk;kfeu-100 fexkz-@fefy 1 fefy 23.02 36. vkbizkVªksfi;e uscqykbt+j esa vkbizkVªksfi;e-250 ekbØks xzke@fefy 1 fefy 2.35 iz;ksx ds fy, jsfLijsVj lksY;w'ku¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 3 37. ¶;qflfMd ,sflM Øhe ¶;fqlfMd ,fslM-2% 1 xzke 8.46 38. csUtkW;y isjkDlkbM tWy cUstk;W y ijs kDlkbM-2.5% 1 xzke 3.48 39. MkbuksizksLVksu tWy Mkbukis kzLs Vkus -0.5 fexkz- 1 xzke 75.21 40. ,flDyksfoj vkW;UVesUV~ ,flDykfsoj-3% 1 xzke 9.66 41. lSfylkbfyd ,sflM vkW;UVesUV~ lSfylkbfyd ,sflM-6% 1 xzke 1.67 42. áweu dksfj;ksfud áweu dksfj;ksfud izfr iSd 189.11 xksukMksVªksfiu bUtsD'ku xkus kMkVs kªfsiu-1000 vkb;Z w 43. áweu dksfj;ksfud áweu dksfj;ksfud izfr iSd 371.39 xksukMksVªksfiu bUtsD'ku xkus kMkVs kªfsiu-5000 vkb;Z w 44. osD;wjksfu;e bUtsD'ku osD;wjksfu;e-10 fexzk- izfr iSd 168.24 ds fy, ikmMj 45. osD;wjksfu;e bUtsD'ku osD;wjksfu;e-4 fexzk- izfr iSd 81.20 ds fy, ikmMj 46. cqMslksukbM bUgsys'ku cMq ls kus kbM-100 ekbØk s xkze@Mkts + izfr ehVjM Mkst+ 1.22 47. cqMslksukbM bUgsys'ku cMq ls kus kbM-200 ekbØk s xkze@Mkts + izfr ehVjM Mkst+ 1.50 48. cMq ls kus kbM$ cqMslksukbM-400 ekbØks xzke$ izfr ehVjM Mkst+ 2.74 QksjeksVsjky bUgsys'ku QksjeksVsjky-6 ekbØks xzke@Mkst+ 49. cMq ls kus kbM$ cqMslksukbM-200 ekbØks xzke$ izfr ehVjM Mkst+ 2.19 QksjeksVsjky bUgsys'ku QksjeksVsjky-6 ekbØks xzke@Mkst+ 50. cMq ls kus kbM$ cqMslksukbM-100 ekbØks xzke$ izfr ehVjM Mkst+ 1.74 QksjeksVsjky bUgsys'ku QksjeksVsjky-6 ekbØks xzke@Mkst+ uksV % ¼d½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgh Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA 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; g® rks os LFkkuh; djksa dks tksM+ ldrs g®A ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr lEcfU/kr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vf/kdre dher 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 fuekZrkvksa@foi.ku dEifu;ksa dks lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vf/kdre [kqnjk ewY; dks ikyu djus ds fy, Mhihlhvks] 2013 ds iSjkxzkQ 16(4) ds rgr vuqlwph II ds fu/kkZfjr izk:i II esa Hkjdj 15 fnuksa ds Hkhrj iqujh{k.k ds fy, ljdkj dks vxzsf"kr fd;k tk;sxk vkSj bl mi iSjk ds v/khu tkudkjh u fn;s tkus dk vf/kdre QqVdj dher ¼,evkjih½ ds iqujh{k.k u fd;s tkus ds :i esa vFkZ yxk;k tk,xk vkSj lac) fofuekZrk iwoZ la'kksf/kr@iqujhf{kr vf/kdre QqVdj dher ¼,evkjih½ ls vf/kd Hkkfjr jde dks] tSlk Hkh ekeyk gks] vf/kd Hkkfjr gksus dh rkjh[k ls ml ij C;kt lfgr tek djus ds fy, nk;h gksxkA ¼M-½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk 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 gksxkA4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ¼p½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa 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 vuqlwfpr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcU/k esa vxj vuqlwfpr 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 dfFkr lkj.kh esa n'kkZ;s vf/kdre ewY; vkSj '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 vuqlwfpr fofufeZr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk,axsaA [dk-a l-a@161@29/2016@fo@Qk- l-a 8¼29½@2016@Mhih@,uihih,-&fMoh--II] cythr flag] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 27th April, 2016 S.O. 1560(E).—In exercise of the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices exclusive of local tax applicable, if any, in respect of the Scheduled formulations 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: TABLE Sl. Name of the Scheduled Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Mefenamic Acid Oral liquid Mefenamic acid -100mg/5ml 1 ml 0.48 2. Prednisolone Oral liquid Prednisolone-5mg/5ml 1 ml 0.40 3. Prednisolone Oral liquid Prednisolone-15mg/5ml 1 ml 0.71 4. Mebendazole Oral liquid Mebendazole -100mg/5ml 1 ml 0.73 5. Diethylcarbamazine Oral Liquid Diethylcarbamazine-120mg/5ml 1 ml 0.43 6. Amoxicillin Oral liquid Amoxicillin-250mg/5ml 1 ml 1.26 7. Amoxicillin+ Amoxicillin-125mg + 1 ml 2.00 Clavulanic Acid Dry Syrup Clavulanic Acid-31.25mg/5ml 8. Cefadroxil Oral liquid Cefadroxil-125mg/5ml 1 ml 0.58 9. Clarithromycin Oral liquid Clarithromycin-125mg/5ml 1 ml 4.01 10. Metronidazole Oral liquid Metronidazole-200mg/5ml 1 ml 0.25 11. Nitrofurantoin Oral liquid Nitrofurantoin-25mg/5ml 1 ml 0.76 12. Ranitidine Oral liquid Ranitidine-75mg/5ml 1 ml 0.54 13. Capecitabine Tablet Capecitabine-500mg/tablet 1 Tablet 117.27¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 5 14. Paclitaxel Injection Paclitaxel-100mg/16.7ml 1 ml 207.08 15. Lactulose Oral liquid Lactulose-10gm/15ml 1 ml 0.98 16. Sucralfate Oral liquid Sucralfate -1gm 1 ml 0.66 17. Levetiracetam Oral liquid Levetiracetam-100mg/ml 1 ml 3.53 18. Mesna Injection Mesna-100mg/ml 1 ml 14.93 19. Labetalol Injection Labetalol-5mg/ml 1 ml 47.03 20. Xylometazoline Nasal Drops Xylometazoline-0.1 % 1 ml 4.82 21. Xylometazoline Nasal Drops Xylometazoline-0.05 % 1 ml 3.65 22. Cyclosporine Oral liquid Cyclosporine-100 mg/ml 1 ml 79.43 23. Alprostadil Injection Alprostadil-0.5 mg/ml 1 ml 5254.55 24. Caffeine Injection Caffeine-20 mg/ml 1 ml 232.89 25. Natamycin Drops Natamycin-5 % 1 ml 21.16 26. Proparacaine Drops Proparacaine-0.5% 1 ml 9.26 27. Hydroxypropyl Hydroxypropyl 1 ml 34.79 Methylcellulose Injection Methylcellulose-2% 28. Carboxymethylcellulose Drops Carboxymethylcellulose-0.5% 1 ml 11.59 29. Carboxymethylcellulose Drops Carboxymethylcellulose-1% 1 ml 13.03 30. Fluphenazine Depot Injection Fluphenazine-25 mg/ml 1 ml 46.42 31. Risperidone Oral Liquid Risperidone-1 mg/ml 1 ml 1.78 32. Budesonide Respirator Budesonide-0.5mg/ml 1 ml 9.93 Solution for use in Nebulizer 33. Budesonide Respirator Budesonide-1mg/ml 1 ml 11.98 Solution for use in Nebulizer 34. Potassium Chloride Injection Potassium Chloride-150 mg/ml 1 ml 2.25 35. Thiamine Injection Thiamine-100 mg/ml 1 ml 23.02 36. Ipratropium Respirator Ipratropium -250 mcg/ml 1 ml 2.35 Solution for use in Nebulizer 37. Fusidic Acid Cream Fusidic Acid-2% 1 Gm 8.46 38. Benzoyl Peroxide Gel Benzoyl Peroxide-2.5% 1 Gm 3.48 39. Dinoprostone Gel Dinoprostone-0.5mg 1 Gm 75.21 40. Acyclovir Ointment Acyclovir-3% 1 Gm 9.66 41. Salicylic Acid Ointment Salicylic Acid -6% 1 Gm 1.67 42. Human Chorionic Human Chorionic Each Pack 189.11 Gonadotropin Injection Gonadotropin -1000 IU 43. Human Chorionic Human Chorionic Each Pack 371.39 Gonadotropin Injection Gonadotropin-5000 IU 44. Vecuronium Vecuronium-10 mg Each Pack 168.24 Powder for Injection 45. Vecuronium Vecuronium-4 mg Each Pack 81.20 Powder for Injection 46. Budesonide Inhalation Budesonide-100 mcg/Dose Each Metered Dose 1.226 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 47. Budesonide Inhalation Budesonide-200 mcg/Dose Each Metered Dose 1.50 48. Budesonide+ Budesonide-400 mcg + Each Metered Dose 2.74 Formoterol Inhalation Formoterol-6 mcg/Dose 49. Budesonide+ Budesonide-200 mcg + Each Metered Dose 2.19 Formoterol Inhalation Formoterol-6 mcg/Dose 50. Budesonide+ Budesonide-100 mcg + Each Metered Dose 1.74 Formoterol Inhalation Formoterol-6 mcg/Dose Note : (a) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the ceiling price mentioned in the column (5) of the above said table. (c) The ceiling price for a pack of scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Price Control) Order, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013. (d) The manufacturer shall follow ceiling price as mentioned in column (5) and report to the Government in Form II as prescribed under Schedule II of the Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised/revised MRP, as the case may be, along with interest thereon from the date of overcharging. (e) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (f) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulation in Form-III of Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of scheduled formulation in Form-IV of Schedule- II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand superseded. [PN/161/29/2016/F/F. No. 8(29)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director vkns'k ubZ fnYyh] 27 vizSy] 2016 dk-vk- 1561¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk0vk0 1394¼v½ rkjh[k 30 eb]Z 2013 ds lkFk ifBr vkS"k/k ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 4, 10, 11, 14, 16, 17 vkjS 18 }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- 644¼v½] fnukad 2 ekp]Z 2016, dks tgk¡ rd mldk lEcU/k uhps dh lkj.kh ds fofufeZr iSdksa ls gS] mu ckrksa ds flok; vf/kØkUr djrs gq, ftUgsa ,sls vf/kØe.k ds iwoZ fd;k x;k gS ;k djus dk yksi fd;k x;k gS] uhps dh lkj.kh ds LraHk ¼5½ es fofufnZ"V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk vkSj bZdkbZ ¼;wfuV½ lfgr ml lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V vuqlwfpr fofufeZr;ksa esa ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 7 NksM+dj vf/kdre dher ds #i esa fu;r djrh gSA lkj.kh Ø-la- vuqlwfpr fofufeZfr dk uke izcyrk bdZ kbZ vf/kdre dher¼#-½ 1 2 3 4 5 1. izsMuhlksyksu Mªksi iMsz uhlkys kus -1% 1 fefy 3.12 2. dkcksZIysfVu bUtsD'ku dkcksZIysfVu-10 fexzk-@fefy 1 fefy 49.38 3. fllIySfVu bUtsD'ku fllIySfVu-1 fexzk-@fefy 1 fefy 6.39 4. isDyhVsDlsy bUtsD'ku isDyhVsDlsy-30 fexzk-@5 fefy 1 fefy 207.08 uksV % ¼d½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rks] tgka dgh Hkh ykxw gks] vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA 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 gSA ¼x½ vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr lEcfU/kr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vf/kdre dher 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 fuekZrkvksa@foi.ku dEifu;ksa dks lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vf/kdre [kqnjk ewY; dks ikyu djus ds fy, Mhihlhvks] 2013 ds iSjkxzkQ 16(4) ds rgr vuqlwph II ds fu/kkZfjr izk:i II esa Hkjdj 15 fnuksa ds Hkhrj iqujh{k.k ds fy, ljdkj dks vxzsf"kr fd;k tk;sxk vkSj bl mi iSjk ds v/khu tkudkjh u fn;s tkus dk vf/kdre QqVdj dher ¼,evkjih½ ds iqujh{k.k u fd;s tkus ds :i esa vFkZ yxk;k tk,xk vkSj lac) fofuekZrk iwoZ la'kksf/kr@iqujhf{kr vf/kdre QqVdj dher ¼,evkjih½ ls vf/kd Hkkfjr jde dks] tSlk Hkh ekeyk gks] vf/kd Hkkfjr gksus dh rkjh[k ls ml ij C;kt lfgr tek djus ds fy, nk;h gksxkA ¼M-½ mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofufnZ"V fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk 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 ¼p½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa 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 vuqlwfpr fofufeZfr;ksa ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;sxkA blds lEcU/k esa vxj vuqlwfpr 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 dfFkr lkj.kh esa n'kkZ;s vf/kdre ewY; vkSj '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 vuqlwfpr fofufeZr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kke Lo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk;saxsaA [Qk- l-a@161@29/2016@fo@Qk- l-a 8¼29½@2016@Mhih@,uihih,-&fMoh--II] cythr flag] lgk;d funs'kd8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] ORDER New Delhi, the 27th April, 2016 S.O. 1561(E).—In exercise of the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 644(E), dated 2nd March, 2016, in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled 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: TABLE Sl. Name of the Scheduled Strength Unit Ceiling Price No. Formulation (Rs.) (1) (2) (3) (4) (5) 1. Prednisolone Drop Prednisolone-1% 1 ml 3.12 2. Carboplatin Injection Carboplatin-10mg/ml 1 ml 49.38 3. Cisplatin Injection Cisplatin-1mg/ml 1 ml 6.39 4. Paclitaxel Injection Paclitaxel-30mg/5ml 1 ml 207.08 Note : (a) All the existing manufacturers of above mentioned scheduled formulation having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the ceiling price mentioned in ccolumn (5) of the above said table. (c) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V as per paragraph 24 (2) of the DPCO, 2013. (d) The manufacturer shall follow ceiling price as mentioned in column (5) and report to the Government in Form II as prescribed under Schedule II of the Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised/revised MRP, as the case may be, along with interest thereon from the date of overcharging. (e) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (f) The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulation in Form-III of Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of scheduled formulation in Form-IV of Schedule- II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (g) The manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with the Essential Commodities Act, 1955. (h) Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand superseded. [PN/161/29/2016/F/F. No. 8(29)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director¹Hkkx II—[kMa 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 9 vkns'k ubZ fnYyh] 27 vizSy] 2016 dk-vk- 1562¼v½-—jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k] Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; }kjk tkjh dk0vk0 1394¼v½ rkjh[k 30 eb]Z 2013 ds lkFk ifBr vkS"k/k ¼dher fu;a=k.k½ vkns'k] 2013 ds iSjk 5, 11 vkjS 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 ¼6½ es fofufnZ"V [kqnjk ewY; dks mDr lkj.kh ds LraHk ¼3½] ¼4½] vkSj ¼5½ es dh Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V izcyrk] bZdkbZ ¼;wfuV½ vkSj fufeZr vkSj foi.ku dEifu;ksa lfgr Øe'k% LraHk ¼2½ esa dh rRLFkkuh izfof"V 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-la- vuqlwfpr fofufeZfr dk izcyrk bZdkbZ fufeZr vkSj foi.ku [kqnjk ewY; uke@czkaM dk uke ¼;wfuV½ }kjk Øe'k% ¼#-½ 1 2 3 4 5 6 1. fMDyksQsusd lksfM;e$ izR;sd 1 fefy esa % 1 fefy eSllZ fufru 14.30 csUtk;y ,YdksgWy fMDyksQsusd ykbQlkablsl fyfeVsM vkSj bUtsD'ku lkfsM;e-75 fexkz- eSllZ xsYQk yscksjsVªht+ ¼U;w :gekdksV½ csUtk;y ,YdksgWy-2% oh@oh fyfeVsM ¼izsljosfVo ds leku½ bUtsD'ku ds fy, ikuh 2. MsDlVªksfeFkkjQsu ,pchvkj$ izR;sd 5 fefy esa % 1 fefy eSllZ ,fudkj 0.50 DyksjQsfujkekbu MDs lVkªfseFkkjQus QkekZL;wfVdYl izk- fyfeVsM esfy,sV flji ,pchvkj-10 fexkz- vkSj eSllZ xzqi ¼lqfMu Mh $½ DyksjQsfujkekbu QkekZL;wfVdYl fyfeVsM esfy,sV-2 fexzk- uksV % ¼d½ fofuZekrk mi;qZDr nh xbZ fofufn"V QkWewZys'ku tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼u½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ es fofufnZ”V [kqnjk ewY; fu/kkZfjr djsaxsaA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (6) 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 gSA 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 ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=k.k½ vkns'k] 2013 ds iSjkxzkQ 24¼2½ ds rgr QkWeZ V esa ,d ewY; lwph tkjh djsaA ¼M-½ mi;qZDr xSj vf/kdr 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 gSA ¼M-½ 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;sxkA blds lEcU/k esa vxj fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus igys lwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 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 gkxas As ¼N½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V fofufeZr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kke Lo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsaA [dk-a l-a@161@29/2016@fo@Qk- l-a 8¼29½@2016@Mhih@,uihih,-&fMoh--II] cythr flag] lgk;d funs'kd ORDER New Delhi, the 27th April, 2016 S.O. 1562(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 (6) of the table herein below 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, unit and name of manufacturer & marketing company respectively, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. Name of the Scheduled Strength Unit Manufacturer & Retail No. Formulation / Brand Marketing Company Price Name respectively (Rs.) 1 2 3 4 5 6 1 Diclofenac Sodium + Each 1ml contains: 1 ml M/s Nitin Lifesciences 14.30 Benzyl Alcohol Injection Diclofenac Sodium-75mg Ltd. & (New Rhumacort) Benzyl Alcohol-2% v/v (as M/s Galpha preservative) Laboratories Ltd. Water for injection 2 Dextrometharpahan Each 5ml contains: 1 ml M/s Enicar 0.50 HBr+Chlorphenaramine Dextrometharpahan HBr Pharmaceuticals Pvt. Maleate Syrup 10mg Ltd. & M/s Group (Sudin D+) Chlorphenaramine Maleate- Pharmaceuticals Ltd 2mg Note : (a) The manufacturers 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 manufacturers may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table. (c) The retail price for a pack of the aforesaid formulations shall be arrived at by the concerned manufacturers 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 manufacturers shall issue a price list in Form–V as per paragraph 24 (2) of the DPCO, 2013. (d) The above mentioned 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 11 (e) The concerned manufacturers of above said formulation shall furnish quarterly return to the NPPA, in respect of its production / import and sale in Form-III of Schedule-II of the DPCO, 2013. Manufacturers, in case intending to discontinue above said formulation, shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (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 retail price of the aforesaid formulations as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand(s) superseded. [PN/161/29/2016/F/F. No. 8(29)/2016/D.P./NPPA-Div.-II] BALJIT SINGH, Asstt. Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.