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Core Purpose

Order of the National Pharmaceutical Pricing Authority fixing the retail prices of specified drug formulations under the Drugs (Prices Control) Order, 2013.

Detailed Summary

Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), National Pharmaceutical Pricing Authority (NPPA) Order S.O. 4497(E) dated 14th October 2024, issued in exercise of powers under paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated 30th May 2013 and S.O. 5249(E) dated 11th November 2022, fixes the retail price (exclusive of GST) for a table of drug formulations by specified manufacturers and marketing companies, including Bisoprolol Fumarate and Amlodipine Besilate Tablets at Rs. 6.23 and Rs. 8.34 per tablet (M/s Swiss Garnier Genexiaa Sciences Pvt. Ltd./M/s Abbott Healthcare Pvt. Ltd.), Gentamicin and Dexamethasone Eye Drops at Rs. 2.01 per ml (M/s HAB Pharmaceuticals & Research Ltd/M/s Mankind Prime Labs Pvt Ltd), Levosalbutamol and Ipratropium Bromide Respules at Rs. 5.75 per ml (M/s Higgs Healthcare/M/s Mankind Prime Labs Pvt Ltd), Abacavir, Dolutegravir and Lamivudine Tablet at Rs. 161.10 per tablet (M/s APL Healthcare Ltd./M/s Aurobindo Pharma Ltd.), Atorvastatin, Aspirin and Clopidogrel Capsules at Rs. 5.27 and Rs. 3.80 per capsule (M/s Surien Pharmaceuticals (P) Ltd./M/s Unison Pharmaceuticals Pvt. Ltd.), Cefuroxime Axetil Tablet at Rs. 26.98 per tablet (M/s Innova Captab Ltd/M/s Dr Reddy's Laboratories Ltd), L-carnitine L-Tartrate, Mecobalamin and Folic Acid Tablet at Rs. 14.50 per tablet (M/s J.K. Printpack (Pharma Division)/M/s Cadila Pharmaceuticals Ltd.), and Sitagliptin, Metformin Hydrochloride and Glimepiride Tablets at Rs. 12.19 and Rs. 11.05 per tablet (M/s Synokem Pharmaceuticals Ltd/M/s Unison Pharmaceuticals Pvt Ltd, and M/s Exemed Pharmaceuticals/M/s Medley Pharmaceuticals Ltd); the table and the source document are truncated after the twelfth entry.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-15102024-257881 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 4134] NEW DELHI, MONDAY, OCTOBER 14, 2024/ASVINA 22, 1946 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 14th October, 2024 S.O. 4497(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 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 +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | S. No.| Medicines | Strength | Unit | Manufacturer & | Retail Price (in Rs.) | | | | | | Marketing Company | | +=======+================================+=============================================+===========+================================+=====================+ | (1) | (2) | (3) | (4) | (5) | (6) | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 1 | Bisoprolol and | Each Film Coated Tablet | 1 Tablet | M/s Swiss Garnier | 6.23 | | | Amlodipine Tablet | Contains: | | Genexiaa Sciences Pvt. | | | | | Bisoprolol Fumarate IP 2.5 mg + | | Ltd./M/s Abbott | | | | | Amlodipine Besilate IP eq. to | | Healthcare Pvt. Ltd. | | | | | Amlodipine 5 mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 2 | Bisoprolol and | Each Film Coated Tablet | 1 Tablet | M/s Swiss Garnier | 8.34 | | | Amlodipine Tablet | Contains: | | Genexiaa Sciences Pvt. | | | | | Bisoprolol fumarate IP 5 mg + | | Ltd./M/s Abbott | | | | | Amlodipine Besilate IP eq. to | | Healthcare Pvt. Ltd. | | | | | Amlodipine 5 mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 3 | Gentamicin and | Composition: | 1 ml | M/s HAB | 2.01 | | | Dexamethasone Eye Drops | Gentamicin 0.3%w/v (as | | Pharmaceuticals & | | | | | gentamicin sulphate IP | | Research Ltd/ M/s Mankind | | | | | 3000units/ml) + Dexamethasone | | Prime Labs Pvt Ltd. | | | | | IP 0.1%w/v (as Dexamethasone | | | | | | | Sodium phosphate IP) | | | | | | | Benzalkonium Chloride IP 0.01%w/v | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 4 | Levosalbutamol and | Each 2.5 ml respule contains: | 1 ml | M/s Higgs Healthcare/ | 5.75 | | | Ipratropium Bromide Respules | Levosalbutamol Sulphate IP eq. to | | M/s Mankind Prime | | | | | Levosalbutamol 1.25 mg + | | Labs Pvt Ltd. | | | | | Ipratropium Bromide IP eq. to | | | | | | | Ipratropium (Anhydrous) 500 mcg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 5 | Abacavir, Dolutegravir | Each film coated tablet | 1 Tablet | M/s. APL Healthcare | 161.10 | | | and Lamivudine Tablet | Contains: Abacavir Sulfate USP eq. to | | Ltd./ M/s Aurobindo | | | | | Abacavir 600 mg | | Pharma Ltd. | | | | | Dolutegravir Sodium eq. to | | | | | | | Dolutegravir 50 mg Lamivudine | | | | | | | USP 300 mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 6 | Atorvastatin, Aspirin | Each hard gelatin Capsule | 1 Capsule | M/s Surien | 5.27 | | | and Clopidogrel Capsule | Contains: Clopidogrel Bisulphate | | Pharmaceuticals (P) | | | | | IP eq. to Clopidogrel 75 mg + | | Ltd./ M/s Unison | | | | | Atorvastatin Calcium IP eq. to | | Pharmaceuticals Pvt. | | | | | Atorvastatin 20 mg (as film | | Ltd. | | | | | coated tablet) + Aspirin IP 75 mg | | | | | | | (as enteric coated tablet) | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 7 | Atorvastatin, Aspirin | Each hard gelatin Capsule | 1 Capsule | M/s Surien | 3.80 | | | and Clopidogrel Capsule | Contains: Clopidogrel Bisulphate | | Pharmaceuticals (P) | | | | | IP eq. to Clopidogrel 75 mg + | | Ltd./ M/s Unison | | | | | Atorvastatin Calcium IP eq. to | | Pharmaceuticals Pvt. | | | | | Atorvastatin 10 mg (as film | | Ltd. | | | | | coated tablet) + Aspirin IP 75 mg | | | | | | | (as enteric coated tablet) | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 8 | Cefuroxime Axetil Tablet | Each Film Coated Tablet | 1 Tablet | M/s Innova Captab Ltd/ | 26.98 | | | | Contains: Cefuroxime Axetil IP | | M/s Dr Reddy's | | | | | eq to Cefuroxime 250mg | | Laboratories Ltd | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 9 | L-carnitine L-Tartrate, | Each film coated Tablet | 1 Tablet | M/s J.K. Printpack | 14.50 | | | Mecobalamin and Folic | Contains: | | (Pharma Division)/ M/s | | | | Acid Tablet | L-Carnitine L-Tartrate eq. to L- | | Cadila Pharmaceuticals | | | | | carnitine 500 mg Mecobalamin IP | | Ltd. | | | | | 1500 mcg | | | | | | | Folic Acid IP 1.5 mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 10 | Sitagliptin, Metformin | Each film coated tablet | 1 Tablet | M/s Synokem | 12.19 | | | Hydrochloride and | contains: | | Pharmaceuticals Ltd/ | | | | Glimepiride Tablet | Sitagliptin Phosphate | | M/s Unison | | | | | Monohydrate IP eq. to Sitagliptin | | Pharmaceuticals Pvt Ltd | | | | | 50mg Metformin Hydrochloride | | | | | | | IP 1000mg | | | | | | | Glimepiride IP 2mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 11 | Sitagliptin, Metformin | Each film coated tablet | 1 Tablet | M/s Synokem | 11.05 | | | Hydrochloride and | contains: | | Pharmaceuticals Ltd/ | | | | Glimepiride Tablet | Sitagliptin Phosphate | | M/s Unison | | | | | Monohydrate IP eq. to Sitagliptin | | Pharmaceuticals Pvt Ltd | | | | | 50mg Metformin Hydrochloride | | | | | | | IP 1000mg | | | | | | | Glimepiride IP 1mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 12 | Sitagliptin, Metformin | Each film coated tablet | 1 Tablet | M/s Exemed | 12.19 | | | Hydrochloride and | contains: | | Pharmaceuticals/ M/s | | | | Glimepiride Tablet | Sitagliptin Phosphate | | Medley Pharmaceuticals | | | | | Monohydrate IP eq. to Sitagliptin | | Ltd | | | | | 50mg Metformin Hydrochloride | | | | | | | IP 1000mg + Glimepiride IP 2mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 13 | Sitagliptin, Metformin | Each film coated tablet | 1 Tablet | M/s Exemed | 11.05 | | | Hydrochloride and | contains: Sitagliptin Phosphate | | Pharmaceuticals/ M/s | | | | Glimepiride Tablet | Monohydrate IP eq. to Sitagliptin | | Medley Pharmaceuticals | | | | | 50mg + Metformin Hydrochloride | | Ltd | | | | | IP 1000mg + Glimepiride IP 1mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 14 | Dapagliflozin, Sitagliptin | Each film coated bilayered | 1 Tablet | M/s Synokem | 16.96 | | | and Metformin (ER) Tablet | tablet contains: Dapagliflozin | | Pharmaceuticals Ltd/ | | | | | Propanediol Monohydrate eq. to | | M/s Primus Remedies | | | | | Dapagliflozin 10mg + Sitagliptin | | Pvt Ltd | | | | | Phosphate Monohydrate eq. to | | | | | | | Sitagliptin 100 mg + Metformin | | | | | | | Hydrochloride IP 500 mg (as | | | | | | | Extended Release) | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 15 | Dapagliflozin, Sitagliptin | Each film coated bilayered | 1 Tablet | M/s Synokem | 17.89 | | | and Metformin (ER) Tablet | tablet contains: Dapagliflozin | | Pharmaceuticals Ltd/ | | | | | Propanediol Monohydrate eq. to | | M/s Primus Remedies | | | | | Dapagliflozin 10mg + Sitagliptin | | Pvt Ltd | | | | | Phosphate Monohydrate eq. to | | | | | | | Sitagliptin 100 mg + Metformin | | | | | | | Hydrochloride IP 1000 mg (as | | | | | | | Extended Release) | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 16 | Bisoprolol and Telmisartan | Each Film Coated Bilayered | 1 Tablet | M/s Mascot Health | 9.65 | | | Tablet | Tablet Contains: | | Series Pvt Ltd/ M/s | | | | | Bisoprolol Fumarate IP 2.5 mg + | | Macleods | | | | | Telmisartan IP 40 mg | | Pharmaceuticals Ltd | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 17 | Bisoprolol and Telmisartan | Each Film Coated Bilayered | 1 Tablet | M/s Mascot Health | 11.21 | | | Tablet | Tablet Contains: | | Series Pvt Ltd/ M/s | | | | | Bisoprolol Fumarate IP 5 mg + | | Macleods | | | | | Telmisartan IP 40 mg | | Pharmaceuticals Ltd | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 18 | Esomeprazole and | Each hard gelatin capsule | 1 Capsule | M/s Windlas | 5.36 | | | Domperidone (SR) Capsules | contains: | | Biotech Ltd./M/s | | | | | Esomeprazole Magnesium IP eq. | | Biological E. Ltd. | | | | | to Esomeprazole 40 mg (as enteric | | | | | | | coated pellets) | | | | | | | Domperidone Maleate IP eq. to | | | | | | | Domperidone 30 mg (Sustained | | | | | | | release) | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 19 | Ceftriaxone and Tazobactam | Each vial Contains: | 1 vial | M/s GMH Organics/ | 66.92 | | | | Sterile Ceftriaxone Sodium IP eq | | M/s Aurobindo Pharma | | | | | to Ceftriaxone 250 mg | | Ltd | | | | | Sterile Tazobactam Sodium IP eq | | | | | | | to Tazobactam 31.25mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ | 20 | Ceftriaxone and Tazobactam | Each vial Contains: | 1 vial | M/s GMH Organics/ | 111.16 | | | | Sterile Ceftriaxone Sodium IP eq | | M/s Aurobindo Pharma | | | | | to Ceftriaxone 500 mg | | Ltd | | | | | Sterile Tazobactam Sodium IP eq | | | | | | | to Tazobactam 62.5mg | | | | +-------+--------------------------------+---------------------------------------------+-----------+--------------------------------+---------------------+ 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 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 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) 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 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 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 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/259/127/2024/F/F. No. 8(127)/2024/D.P./NPPA-Div.-II] MAHAVEER SAINI, Dy. Director

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