Fixation of Retail prices of 44 formulation and 1 Exemption under para 32 (i) approved in 115 Authority meeting

5131 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. 3407] NEW DEL HI, TUES DAY, AUGUST 8, 2023/ SHRAVANA 17, 1945 CG-DL-E-08082023-247928 (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) 6.12 (1) (2) (3) (4) (5) (6) (1) (2) (3) (4) (5) (6) (6) V (4) I MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals ) (NATIONAL PHARMACE UTICAL PRICING AUTHORITY ) ORDER New Delhi, the 8th August, 2023 S.O. 3560 (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 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 a s 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 c orresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Paroxetine Controlled release & Clonazepam Capsules Each hard gelatin capsule contains: Paroxetine Hydrochloride IP eq. to Paroxetine 12.5mg (As enteric coated controlled release tablet) Clonazepam IP 0.5mg (as immediate release tablet) 1 Capsule M/s Akum Drugs & Pharmaceuticals Ltd. / M/s Eris Lifescienc es Limited 14.53 2 Itraconazole Capsule (Supra -Bioavailable formulation) Each Capsule contains: Itraconazole IP 65mg 1 Capsule M/s Mascot Health Series Pvt. Ltd. / M/s Indchemie Health Specialities Pvt. Ltd. 12.06 3 Levetiracetam, Sodium Chloride Infus ion Each 100ml contains: Levetiracetam IP 500mg Sodium Chloride IP 820mg 1 ml M/s Akum Drugs & Pharmaceuticals Ltd. / M/s Mankind Pharma Ltd. 0.89 4 Sitagliptin Phosphate and Metformin Hydrochloride Tablets Each film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s MSN Laboratories Pvt. Ltd. / M/s Sanofi India Limited 10.82 5 Sitagliptin Phosphate and Metformin Hydrochloride Tablets Each film coated tablet contains: Sitag liptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg 1 Tablet M/s MSN Laboratories Pvt. Ltd. / M/s Sanofi India Limited 9.21 6 Telmisartan and Cilnidipine Tablet Each film coated tablet contains: Telmisartan IP 40mg Cilnidipine IP 10mg 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Indchemie Health Specialities Pvt. Ltd. 10.12 7 Aceclofeanc, Paracetamol & Serratiopeptidase Tablet Each film coated tablet contains: Aceclofenac IP 100mg, Paracetamol IP 325mg Serratiope ptidase IP 15mg (As enteric coated granules eq. to 30000 enzyme activity unit of serratiopeptidase) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. /M/s Abbott Healthcare Pvt. Ltd. 8.38 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) 8 Chlorthalidone, Amlodipine & Telmisartan Tablets Each film coated tablet contains: Chlorthalidone IP 6.25mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 40mg 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 10.34 9 Chlorthalidone, Amlodipine & Telmisartan Tablets Each film coated tablet c ontains: Chlorthalidone IP 12.5mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 40mg 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 10.24 10 Chlorthalidone, Amlodipine & Telmisartan Tablets Each film coated tablet contains : Chlorthalidone IP 6.25mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 80mg 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 16.77 11 Chlorthalidone, Amlodipine & Telmisartan Tablets Each film coated tablet contains: Chlor thalidone IP 12.5mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 80mg 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 15.20 12 Levocetirizine, Montelukast & (SR) Ambroxol Hydrochloride Tablets Each uncoated bilayered table t contains : Levocetirizine Hydrochloride IP 5mg Montelukast Sodium IP eq. to Montelukast 10mg Ambroxol Hydrochloride IP 75mg (As sustained Release) 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 15.89 13 Rabeprazole Sodium and Ondanset ron Tablets Each Film coated tablet contains: Rabeprazole Sodium IP 20mg (As Enteric Coated Form) Ondansetron Hydrochloride IP eq. to Ondansetron 4mg 1 Tablet M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Cipla Ltd. 6.83 14 Vitamin D3 Oral Solution Each 5 ml contains: Cholecalciferol IP 60000IU (In Nano Droplet form) 1 ml M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Eris Lifesciences Limited 11.94 15 Glimepiride, Voglibose & Metformin Hydrochloride (as Extended -release form) tablet Each uncoated Bilayered tabl et contains: Glimepiride IP 1mg Voglibose IP 0.2mg Metformin Hydrochloride IP 1000mg (As Extended Release) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Alkem Laboratories Limited 11.83 16 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Synokem Lifesciences Pvt. Ltd. / M/s Mankind Pharma Ltd. 8.97 17 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 1000mg 1 Tablet M/s Synokem Lifesciences Pvt. Ltd. / M/s Mankind Pharma 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) 18 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydro chloride IP 1000mg 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Cipla Ltd. 9.60 19 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Cipla Ltd. 8.97 20 Paracetamol, Phenylepherine Hydrochloride and Chlorpheniramine Maleate Syrup Each 5ml contains: Paracetamol IP 250mg Phenylepherine Hydrochloride 5mg Chlorpheniramine Maleate IP 2mg 1 ML M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Micro Labs Limited 1.21 21 Glimepiride, Voglibose & Metformin Hydrochloride (as Extended -release form) tablet Each uncoated Bilayered tablet contains: Glimepiride IP 2mg Voglibose IP 0.2mg Metformin Hydrochloride IP 1000mg (As Extended Re lease) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Alkem Laboratories Limited 13.37 22 Diclofenac Diethylamine , Methyl Salicylate & Menthol Topical Gel Composition : Diclofenac Diethylamine IP 2.32% (eq. to Diclofenac Sodium 2% w/w) Methyl Salicylate IP 10 % w/w Menthol IP 5% w/w 1 Gram M/s Pontika Aerotech Limited / M/s Intas Pharmaceuticals Ltd. 4.08 23 Faropenem Sodium & Potassium Clavulanate Tablets Each film coated tablet contains: Faropenem Sodium eq. to Faropenem 200mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 125mg 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. 90.28 24 Pantoprazole Dual - release Gastro - resistant Tablet Each Dual -release Gastro - resistant tablet contains: Pantoprazole Sodium IP eq. to Pantoprazole 80mg 1 Tablet M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Cadila Pharmaceuticals Ltd. 13.39 25 Tacrolimus Capsule Each hard gelatin capsule contains: Tacrolimus IP eq. to Anhydrous Tacro limus 0.25mg 1 Capsule M/s Rivpra Formulation Pvt. Ltd. / M/s RPG Life Sciences Ltd. 11.05 26 Clobazam Oral Suspension Each ml of the suspension contains: Clobazam IP 2.5mg 1 ml M/s Windlas Biotech Limited / M/s Sanofi India Limited 2.42 27 Cefuroxime A xetil Tablets Each film coated tablet contains: Cefuroxime Axetil eq. to Cefuroxime 250mg 1 Tablet M/s Hetero Labs Limited / M/s Sun Pharmaceuticals Industries Limited 25.69 28 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains : Linagliptin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Exemed Pharmaceuticals / M/s Corona Remedies Pvt. Ltd. 8.97 29 Amoxycillin and Potassium Clavulanate Oral Each combi pack contains: A. Amoxycillin and Potassium Clavulanate Oral suspension IP Each Combi M/s Malik Lifesciences Pvt. Ltd. / M/s Macleods 162.11 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Suspension (Combi pack with Sterile Water for Reconstitution of Dry Syrup) Composition: Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg Potassium Clavulanate Diluted IP eq. to Clavulanic A cid 42.9mg B. 2 Ampoules of sterile water for reconstitution of dry syrup each ampoule contains: sterile water for injection IP 25ml Pack Pharmaceuticals Ltd. 30 Clarithromycin for Oral Su spension USP Each 5 ml of Reconstituted suspension contains: Clarithromycin IP 250mg 1 ml M/s Vapi Care Pharma Pvt. Ltd. / M/s Mankind Pharma Ltd. 6.09 31 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linaglip tin 2.5mg Metformin Hydrochloride IP 500mg 1 Tablet M/s Sai Primus Life Biotech Private Limited / M/s Primus Remedies Pvt. Ltd. 8.97 32 Linagliptin + Metformin Hydrochloride Tablet Each film coated tablet contains: Linagliptin 2.5mg Metform in Hydrochloride IP 1000mg 1 Tablet M/s Sai Primus Life Biotech Private Limited / M/s Primus Remedies Pvt. Ltd. 9.60 33 Oral Rehydration Salts with Zinc Each sachet contains: Zinc Sulphate Monohydrate IP 0.011g Sodium Citrate IP 0.58g Potassium Chloride I P 0.30g Sodium Chloride IP 0.52g Dextrose Anhydrous IP 2.70g 1 Sachet of 4.4 gram M/s Acme Diet Care Pvt. Ltd. / M/s Alkem Laboratories Limited 6.12 34 Cefixime Oral Suspension IP Each 5ml of reconstituted suspension contains: Cefixime IP (As Trihydrat e) eq. to Anhydrous Cefixime 200mg 1 ml M/s Alkem Healthscience (A unit of Alkem Laboratories Ltd.) / M/s Alkem Laboratories Ltd. 4.06 35 Telmisartan and Bisoprolol Fumarate Tablets Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumara te IP 2.5mg 1 Tablet M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Zuventus Healthcare Limited 11.01 36 Telmisartan and Bisoprolol Fumarate Tablets Each film coated tablet contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 5mg 1 Tablet M/s Ravenbhel Healthca re Pvt. Ltd. / M/s Zuventus Healthcare Limited 13.12 37 Vildagliptin (As Sustained release) and Metformin Hydrochloride (as Sustained Release) Tablets Each uncoated bilayered tablet contains: Vildagliptin (As Sustained release form) IP 100mg Metformin H ydrochloride (as Sustained Release form) IP 1000mg 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Macleods Pharmaceuticals Ltd. 13.81 38 Vildagliptin (As Sustained release) and Metformin Each uncoated bilay ered tablet contains: Vildagliptin (As Sustained release) 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Macleods 12.27 Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.) (1) (2) (3) (4) (5) (6) Hydrochloride (as Sustained Release) Tablets IP 100mg Metformin Hydrochloride (as Sustained Release form) IP 500mg Pharmaceuticals Ltd. 39 Vildagliptin (SR) and Metformin Hydroc hloride (SR) Tablets Each film coated bilayered tablet contains: Vildagliptin IP 100mg (As Sustained Release form) Metformin Hydrochloride IP 1000mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Alkem Laboratories Ltd. 13.81 40 Vildagliptin (SR) and Metformin Hydrochloride (SR) Tablets Each film coated bilayered tablet contains: Vildagliptin IP 100mg (As Sustained Release) Metformin Hydrochloride IP 500mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Micro Labs Ltd. 12.27 41 Vildagliptin (SR) and Metformin Hydrochloride (SR) Tablets Each film coated bilayered tablet contains: Vildagliptin IP 100mg (As Sustained Release) Metformin Hydrochloride IP 500mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuti cals Ltd. / M/s Alkem Laboratories Ltd. 12.27 42 Vildagliptin (SR) and Metformin Hydrochloride (SR) Tablets Each film coated bilayered tablet contains: Vildagliptin IP 100mg (As Sustained Release) Metformin Hydrochloride IP 1000mg (as Sustained Release) 1 Tablet M/s Synokem Pharmaceuticals Ltd. / M/s Micro Labs Ltd. 13.81 43 Dapagliflozin, Vildagliptin (As Sustained release) and Metformin Hydrochloride (as Sustained Release) Tablets Each uncoated bilayer tablet contains: Dapagliflozin Propanediol Monohydr ate eq. to Dapagliflozin 10mg Vildagliptin (As Sustained release form) IP 100mg Metformin Hydrochloride (as Sustained Release) IP 1000mg 1 Tablet M/s Mascot Health Series Pvt. Ltd. / M/s Macleods Pharmaceuticals Ltd. 20.14 44 Azelnidipine and Telmisartan Tablet Each film coated tablet contains: Azelnidipine IP 16mg Telmisartan IP 40mg. 1 Tablet M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Ipca Laboratories Limited 17.96 Note: (a) The manufacturer of above -mentioned formulations i.e., “new drug” under paragr aph 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 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 201 3, 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 business in a manner so as to be easily accessible to any person wis hing 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 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 a pplicable, 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 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) fixing the retail price of the formulation with specified strength for tha t 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/247/115/2023/F/ F. No. 8(115)/2023/D.P./NPPA -Div.-II] MAHAVEER SAINI. Dy. Director (Pricing) / / I . . (i) 31.07.2023 (i) i) (i) V . ORDER New Delhi, the 8th August, 2023 S.O. 3561( 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 Fe rtilizers 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 Troikaa Pharmaceuticals Limited , for exemption from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of the formulati on “Paracetamol Injection (Intramuscular) 250mg/ml, 2ml” which was duly approved by the Office of Central Drugs Standard Control Organisation (India) as ‘new drug’ under the Drugs and Cosmetics Act, 1940 and Rules there under. Further, the Patent Office, Government of India has granted Patent to M/s Troikaa Pharmaceuticals Limited for an invention entitled ‘ Novel Composition Comprising Paracetamol and Process for Preparing the same” for the term of 20 years from 9thSeptember 2010 in accordance with the provi sions of the Patents Act, 1970(Patent No. 411067and Date of Grant: 09.11.2022). 4. And whereas the NPPA at its 115th meeting dated 31.07.2023 noted that M/s Troikaa Pharmaceuticals Limited meets the requirement of Para 32(i) of DPCO 2013 and decided that ex emption may be granted to M/s Troikaa Pharmaceuticals Limited under Para 32(i) of DPCO, 2013 for their formulation “Paracetamol Injection (Intramuscular) 250mg/ml” . 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 Troikaa Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of the f ormulation “Paracetamol Injection (Intramuscular) 250mg/ml” for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian patent, whichever may be earlie r. 6. M/s Troikaa Pharmaceuticals Limited shall inform NPPA, the date of commercial marketing of the formulation “Paracetamol Injection (Intramuscular) 250mg/ml” in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013. 7. M/s Troikaa Pharmaceuticals Limited shall also seek retail price approval for the formulation “Paracetamol Injection (Intramuscular) 250mg/ml” , if applicable, three month before the expiry of the exemption granted under Para 32(i) of DPCO 2013 [PN/247/115/2023/F/ F. No. 8(115)/2023/D.P./NPPA -Div.-II] MAHAVEER SAINI. Dy. Director (Pricing) Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapu ri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.