Fixation of Retail prices of 51 formulation, 2 special prices and Extension of Knee implants approved in 116 Authority meeting

5891 GI/202 3 (1) रजिस्ट्री सं. डी.एल.- 33004/99 REGD. No . D. L. -33004/99 EXTRAORDINARY PART II —Section 3 —Sub-section ( ii) PUBLISHED BY AUTHORITY (1) (2) (3) (4) (5) (6) No. 3914] NEW DELHI, FRIDAY , SEPTEMBER 15, 2023/ BHADRA 24, 1945 CG-DL-E-15092023-248790 (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZy s'ku ds fofuekZrk vFkkZr tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½ ds rgr mi;qZDr nh xbZ rkfydk ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZD`r lkj.kh ds LraHk ¼6½ esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr f ofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsa rFkk mldh dkiWh jkT; vkS"kf/k fu;a=dk sa vkSj fofuekZrk forjdksa dks tkjh djsaA ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke 'kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lqLi"V Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks aiznf 'kZr djsxkA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr [email protected] ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;w QsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr [email protected] dEifu;ka tks vuqikyu djrh gSA 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 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals ) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 15th Septemb er, 2023 S.O. 4076(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. 5249(E) dated 11th November, 2022 issued by the Government of India i n 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 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) thereo f; TABLE Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 1 Rosuvastatin & Clopidogrel Capsules Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuv astatin 20mg (as Pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) 1 Capsule M/s Synokem Pharmaceuticals Ltd / M/s Torrent Pharmaceuticals Limited 18.95 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 2 Diclofenac Diethylamine, Methyl Salicylate and Menthol Gel Composition: Diclof enac Diethylamine IP 2.32 % w/w eq. to Diclofenac Sodium IP 2.0 % w/w Methyl Salicylate IP 10 % w/w Menthol IP 5 % w/w 1 Gram M/s Daiwik Pharmasphere Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. 4.08 3 Linagliptin and Metformin Hydrochloride Tablets Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd. 8.97 4 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 850mg 1 Tablet M/s Sai Primus Life Biotech Private Limited / M/s Primus Remedies Pvt. Ltd. 12.18 5 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s Glensmith Labs Pvt. Ltd. 9.60 6 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s Glensmith Labs Pvt. Ltd. 8.97 7 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Skymap Pharmaceuticals Pvt. Ltd. 8.97 8 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s Skymap Pharmaceuticals Pvt. Ltd. 9.60 9 Linagliptin and Metformi n Hydrochloride Tablets Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd. 9.60 10 Pantoprazole Sodium (EC) & Levosulpiride (SR) Capsules Each Hard ge latine capsule contains: Pantoprazole Sodium Sesquihydrate IP eq. to Pantoprazole 40mg (As Enteric Coated Pellets) Levosulpiride 75mg (As Sustained Release Pellets) 1 Capsule M/s Lucent Biotech Limited / M/s Torrent Pharmaceuticals Ltd. 15.96 11 Budesonid e and Formoterol Fumarate Each 2 ml respule contains: Budesonide IP 1mg Formoterol Fumarate Dihydrate eq. to Formoterol Fumarate 20 mcg Per 2 ml M/s Axa Parenterals Ltd./ M/s J.B. Chemicals & Pharmaceuticals Ltd. 56.20 12 Itraconazole Capsules (Supra - Bioavailable Formulation) Each Hard gelatine capsule contains: (Supra -Bioavailable formulation) Itraconazole IP 130mg 1 Capsule M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Dr. Reddy's Laboratories Limited 19.30 13 Linagliptin + Metformin Hydrochloride Extende d Release Tablet Each film coated bilayer tablet contains: Linagliptin 2.5mg Metformin Hydrochloride (As extended release)IP 1000mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Intas Pharmaceuticals Ltd. 9.60 14 Linagliptin + Metformin Hydrochl oride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Macleods Pharmaceuticals Ltd. 8.97 15 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s Macleods Pharmaceuticals Ltd. 9.60 16 Linagliptin + Metformin Hydrochloride (ER) Each film coated bilayered tablet contains: Linagliptin 2.5mg 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Cipla Ltd. 9.60 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Tablet Metformin Hydrochloride I P 1000mg (as Extended release) 17 Itraconazole Capsules (Supra - Bioavailable Formulation) Each Hard gelatine capsule contains: (Supra -Bioavailable formulation) Itraconazole IP 65mg 1 Capsule M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Dr. Reddy's Laboratories Limited 10.81 18 Diclofenac Potassium & Metaxalone Tablets Each uncoated tablet contains: Diclofenac Potassium IP 50mg Metaxalone USP 400mg 1 Tablet M/s Windlas Biotech Limited / M/s Intas Pharmaceuticals Ltd. 15.08 19 Cefuroxime Axetil & Potassium Clavulanate Tablets Each film coated tablet contains: Cefuroxime Axetil IP eq. to Cefuroxime 500mg Potassium Clavulanate Diluted IP Eq. to Clavulanic Acid 125mg 1 Tablet M/s Hetero Labs Limited / M/s Sun Pharmaceuticals Industries Limited 55.23 20 Levosalbutamol and Ipratropium Bromide respule solution Each 2.5ml contains: Levosalbutamol Sulphate IP eq. to Levosalbutamol 1.25mg Ipratropium Bromide IP eq. to Ipratropium (anhydrous) 5 00mcg 1 ML M/s AXA Parenterals Ltd. / M/s Mankind Pharma Ltd. 5.49 21 Moxifloxacin Eye Drops Composition: Moxifloxacin hydrochloride IP eq. to Moxofloxacin 0.5%w/v Preservative : Benzalkonium Chloride Solution IP 0.02% w/v 1 ML M/s East African (India) Overseas / M/s Torrent Pharmaceuticals Limited 17.00 22 Pantoprazole Dual Release Gastro Resistant Tablets Each Dual Release Gastro Resistant Tablet Contains: Pantoprazole Sodium IP eq. to Pantoprazole 80mg 1 Tablet M/s Pure & Cure Healthcare Pvt. Ltd. / M /s Mankind Pharma Ltd. 15.30 23 Telmisartan, Chlorthalidone & Cilnidipine tablets Each film coated tablet contains: Telmisartan IP 40mg Chlorthalidone IP 6.25mg Cilnidipine IP 10mg 1 Tablet M/s Macleods Pharmaceuticals Ltd. 13.05 24 Povidon e Iodine Gargle Composition: Povidone Iodine IP 0.5% w/v (available Iodine 0.05% w/v) 1 ml M/s Pontika Aerotech Limited / M/s Emcure Pharmaceuticals Limited 0.70 25 Teneligliptin, Pioglitazone and Metformin Hydrochloride (as Sustained Release) Tablets Each Film coated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin 20mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15mg Metformin Hydrochloride IP 500mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuticals Lim ited / M/s Micro Labs Limited 16.07 26 Teneligliptin, Pioglitazone and Metformin Hydrochloride (as Sustained Release) Tablets Each Film coated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate IP eq. to Teneligliptin 20mg Pioglitazone Hydroch loride IP eq. to Pioglitazone 15mg Metformin Hydrochloride IP 1000mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuticals Limited / M/s Micro Labs Limited 17.85 27 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 500mg (Sustained Release Form) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Intas Pharmaceuticals Ltd. 16.06 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 28 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydroc hloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 500mg (Sustained Release Form) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited 16.06 29 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 500mg (Sustained Release Form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Intas Pharmaceuticals Ltd. 16.06 30 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Piogli tazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 500mg (Sustained Release Form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Emcure Pharmaceuticals Ltd. 16.09 31 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 500mg (Sustained Release Form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s La Renon Healthcare Private Limited 16.09 32 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 1000mg (Sustained Release Form) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Intas Pharmaceuticals Ltd. 17.13 33 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 1000mg (Sustained R elease Form) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited 17.13 34 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrat e IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 1000mg (Sustained Release Form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Intas Pharmaceuticals Ltd. 17.13 35 Sitagliptin, Pioglit azone and Metformin Hydrochloride (Sustained Released) Each film coated Bilayered Tablet Contain: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Emcure Pharmaceuticals Ltd. 17.16 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Tablet Pioglitazone 15 mg Metformin Hydrochloride IP 1000mg (Sustained Release Form) 36 Sitagliptin, Pioglitazone and Metformin Hydrochloride (Sustained Released) Tablet Each film coated Bilayered Tablet Contain: Sitagliptin P hosphate Monohydrate IP eq. to Sitagliptin 100mg Pioglitazone Hydrochloride IP eq. to Pioglitazone 15 mg Metformin Hydrochloride IP 1000mg (Sustained Release Form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s La Renon Healthcare Private Limited 17.16 37 Dapagliflozin, Vildagliptin (As Sustained release) and Metformin Hydrochloride (as Sustained Release) Tablets Each film coated bilayer tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Vildagliptin (As Sustained relea se) IP 100mg Metformin Hydrochloride IP (as Sustained Release) 500mg 1 Tablet M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Primus Remedies Pvt. Ltd. 18.00 38 Dapagliflozin, Vildagliptin (As Sustained release) and Metformin Hydrochloride (as Sustained Release) Tablets Each uncoated bilayer tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg Vildagliptin (As Sustained release) IP 100mg Metformin Hydrochloride (as Sustained Release) IP 500mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Alkem Laboratories Limited 16.29 39 Dapagliflozin, Vildagliptin (As Sustained release) and Metformin Hydrochloride (as Sustained Release) Tablets Each film coated bilayer tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Vilda gliptin (As Sustained release) IP 100mg Metformin Hydrochloride IP (as Sustained Release) 1000mg 1 Tablet M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Primus Remedies Pvt. Ltd. 19.00 40 Dapagliflozin, Sitagliptin and Metformin Hydrochloride (ER) Tablets Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg (As Extende Release form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd . / M/s Alkem Laboratories Limited 14.59 41 Dapagliflozin, Sitagliptin and Metformin Hydrochloride (ER) Tablets Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg Sitagliptin Phosphate Monohydrate eq. to Sitag liptin 50mg Metformin Hydrochloride IP 500mg (As Extende Release form) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Alkem Laboratories Limited 13.62 42 Linagliptin + Metformin Hydrochloride Extended Release Tablet Each film coated bilayer tablet contains: Linagliptin 5mg Metformin Hydrochloride (As extended release) IP 1000mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Intas Pharmaceuticals Ltd. 14.37 43 Linagliptin + Metformin Each film coated bilayered tabl et contains: 1 Tablet M/s Synokem Pharmaceuticals Ltd. / 14.37 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Hydrochloride (ER) Tablet Linagliptin 5mg Metformin Hydrochloride IP 1000mg (as Extended release) M/s Cipla Ltd. 44 Linagliptin + Metformin Hydrochloride (ER) Tablet Each film coated tablet contains: Linagliptin 5mg Metformin Hydrochloride (as Extended release) IP 1000mg 1 Tablet M/s Exemed Pharmaceuticals Ltd. / M/s Micro Labs Ltd. 14.37 45 Linagliptin + Metformin Hydrochloride (ER) Tablet Each film coated bilayered tablet contains: Linagli ptin 5mg Metformin Hydrochloride (as Extended release) IP 1000mg 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Torrent Pharmaceuticals Ltd. 14.00 46 Linagliptin + Metformin Hydrochloride (ER) Tablet Each film coated bilayered tablet contains: Linaglipt in 5mg Metformin Hydrochloride (as Extended release) IP 1000mg 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Lupin Limited 14.37 47 Metoprolol Succinate Extended Release, Amlodipine 5mg & Telmisartan Tablet Each film coated bilayered tablet contains: Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (As Extended release) Amlodipine Besilate IP IP eq. to Amlodipine 5mg Telmisartan IP 40mg 1 Tablet M/s Ajanta Pharma Limited 14.23 48 Ambroxol Hydrochloride, Salbutamol Sulphate, Guaiphenesin & Methol Liquid Each 5ml contains: Ambroxol Hydrochloride IP 15mg Salbutamol Sulphate IP eq. to Salbutamol 1mg Guaiphenesin IP 50mg Methol IP 1mg 1 ml M/s Naxpar Pharma Pvt. Ltd. / M/s Geno Pharmaceuticals Pvt. Ltd. 0.52 49 Glimepiride & Lobeglitazone Sul fate tablet Each uncoated Bilayer tablet contains: Lobeglitazone Sulfate 0.5mg Glimepiride IP 1mg 1 Tablet M/s Glenmark Pharmaceuticals Limited 11.39 50 Combikit of Clarithromycin Tablets IP, Esomeprazole Tablets IP & Amoxicillin Tablets USP Each Strip co ntains: A. Clarithromycin Tablets IP 2 Tablets Each film coated tablet contains: Clarithromycin IP 500mg B. Esomeprazole Tablets IP 2 Tablets Each Enteric coated tablet contains: Esomeprazole Magnesium Trihydrate IP eq. to Esomeprazole 40mg C. Amoxicillin Tablets USP 2 Tablets Each Film coated tablet contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 1000mg Each Strip M/s Malik Lifesciences Pvt. Ltd. / M/s Cipla Limited 151.98 51 Brinzolamide, Brimonidine Tartrate & Timolol Ophthalmic suspension Each m l contains: Brinzolamide IP 10mg Brimonidine Tartrate IP 2 mg Timolol Maleate eq. to Timolol IP 5 mg Water for injection 1 ml M/s Micro labs Limited 105.25 Note: (a) The manufacturer of above -mentioned formulations i.e., “new drug” under paragraph 2(1)(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 pa yable 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 col umn (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form –V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on busines s 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 / marketer as mentioned above i.e. who have applied for the same by submitting For m-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 not es 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) Conseque nt to the fixation of retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fix ing the retail price of the formulation with specified strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded. [PN/248/11 6/2023/F/F. No. 8(116)/2023/D.P./NPPA -Div.-II] MAHAVEE R SAINI, Dy. Director (Pricing) (1) (2) (3) (4) (5) (1) (2) ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr v f/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA ¼x½ fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ& V esa vf/klwpuk dh rkjh[k ls vuqikyu esa ,d ewY; lwph tkjh djsxkA ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjk 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gS fd mlls ijke 'kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka m lds fdlh lgtn` '; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf 'kZr djsxkA mi;qZDr lkj.kh esa fofufnZ"V vf/kdre dher ds fy, fofufnZ"V vuqlwfpr fofufeZfr;ksa ds fofu fnZ"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=.k½ vkns'k] 2013 ds iSjkxzkQ 2¼;w½ ds vuqlkj vkS"k/k ¼ewY; fu;a=.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 ¼Tk½ mi;qZDr vuqlwfpr fofufeZfr;ksa dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa fuekZrkvksa dks vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds lwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dk s 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 ¼>½ 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 ¼¥½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V ,slh fofufeZfr;ksa ds iSdksa dh vf/kdre dher fu;r gksus ds ifj.kkeLo# i] vf/kdre ;k [kqnjk ewY; fu/kkZfjr vkns'k ;fn dksbZ gks] tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk;saxsA ORDER New Delhi, the 15th September , 2023 S.O. 4077 (E).—Whereas, (i) Piperacillin 2gm + Tazobactum 250mg and (ii) Piperacillin 4gm + Tazobactum 500 mg are scheduled formulation under Schedule -I of DPCO 2013 and its ceiling price is fixed. And whereas, M/s Gufic Biosciences Limited have applied for separate ceiling price of (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm + Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm + Tazobactum 500 mg having special features of dual chamber bags stating t hat it is designed to allow the separation of different solutions that require admixing just before administration helping to reduce the administration time, assurance of right dosages, avoidance of hospital contamination, provides high stability & conveni ence etc. And whereas, the Multidisciplinary Committee of Experts in its 45th meeting & 52nd meeting dated 13.09.2022 &11.07.2023 respectively observed that (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm + Tazobactum 250mg and (ii) Tazofic Injec tion 4.5 gm containing Piperacillin 4gm + Tazobactum 500 mg are scheduled formulation. The Committee further observed that packages in (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm + Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm + Tazobactum 500 mg of M/s Gufic Biosciences Limited have special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction in the possibility of contamination. And whereas, the Multidisciplinary Committee of Experts recommended that an increase of 15% over and above the ceiling price of Tazofic Injection 2.25 gm and Tazofic Injection 4.5 gm be allowed to M/s Gufic Biosciences Limitedfor the form ulation(i) Tazofic Injection 2.25 gm containing Piperacillin 2gm+Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm+Tazobactum 500 mgon account of special packaging in dual chamber bag. And whereas, NPPA in its 116thAuthority me eting dated 06.09.2023 decided to accept the recommendation of the Multidisciplinary Committee of Experts. Therefore, in exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 of the Drugs (Prices Control) Order, 2013, read with S.O. 13 94(E) dated the 30th May, 2013, S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers in so far as it relates to (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm+Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm+Tazobactum 500 mg having special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction in the possi bility of contamination., manufactured by the manufacturers specified in Table ‘B’, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the price as specified in column (5) of the table ‘A’ herein below as ceiling pric e exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit/packaging specified respectively in the correspo nding entries in columns (3) and (4) thereof: Table ‘A’ Sl. No. Name of the Scheduled Formulation Dosage form and Strength Unit Ceiling Price excluding GST (Rs.) (1) (2) (3) (4) (5) 1 Piperacillin (A) + Tazobactam (B) Powder for Injection 2 g (A) + 250 m g(B) Per Dual chamber bag 220.26 2 Piperacillin (A) + Tazobactam (B) Powder for Injection 4 g (A) + 500 mg(B) Per Dual chamber bag 459.28 Table ‘B’ Sl. No. Name of Manufacturer (1) (2) 1 M/s Gufic Biosciences Limited Note: (a) The ceiling price specif ied in column (5) of Table A is only applicable to the manufacturer mentioned in Table B. The manufacturer specified in Table B, selling the branded or generic or both the versions of scheduled formulations with dosage form and strength specified in column (2) and (3) of Table A respectively, at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise their prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any. (b) The manufacturer may add Goods and Services Tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of th e above said table. (c) The manufacturer shall issue a price list in Form -V in compliance from date of this notification as per paragraph 24 of the DPCO, 2013. (d) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the s upplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (e) Any other manufacturer claiming s eparate ceiling price having special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction in the possibility of contamination. shall apply to NPPA for separ ate ceiling price approval. (f) For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulation. (g) Where an existing manufacturer of scheduled formulation wi th dosage or strength or both as specified in the above Table A, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 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. (h) The manufacturer(s) of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form -III of Schedule -II of the DPCO, 2013. Any manufactu rer intending to discontinue production of 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. (i) The manufacturer(s) not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of th e Drugs (Price Control) Order, 2013 read with Essential Commodities Act, 1955. (j) Consequent to the issue of ceiling prices of such formulations for specified in column (2) of the above Table A in this notification, the price order(s) fixing ceiling or re tail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/248/116/2023/ F/F. No. 8(116)/ 2023/DP/NPPA/Div. II] MAHAVEER SAINI, Dy. Director (Pricing) ORDER New Delhi, the 15th September , 2023 S.O. 4078 (E).—the National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Mi nistry of Chemicals and Fertilizers, Government of India vide S.O. 2668(E) dated 16th August, 2017, S.O. 3987(E) dated 13th August 2018, S.O. 2934(E) dated 13th August 2019, S.O. 2768(E) dated 14th August 2020, S.O. 3147 (E) dated 15th September 2020, S.O. 3670(E) dated 10th September 2021 and S.O. 4343(E) dated 15th September 2022 issued notifications under Para 19 of the DPCO, 2013 regarding fixation/revision of ceiling prices of the Orthopaedic Knee Implants for Knee Replacement System. In continuat ion to the above notifications, it has been decided that the same may be monitored as per the provisions of Paragraph 20(1) of th e DPCO, 2013. This order shall be applicable for the period of one year from 16th September 2023 (i.e. up to 15th September 202 4), unless revised by another notification. 2. The ceiling prices for Orthopaedic Knee Implants will be reviewed after a period of one year. 3. The Notes (b) to (t) of the Notification S.O. 2668(E) dated 16th August 2017 shall remain in force during the curre ncy of this order. [PN/248/116/2023/F /F. No. 8(116)/ 2023/DP/NPPA/Div.II ] RAJESH KUMAR T, Dy. Director Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064 and Published by the Controller of Publicat ions, Delhi -110054.