NPPA Fixes Retail Prices of 31 Drug Formulations Including Atorvastatin, Empagliflozin; Details
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail prices of 31 new drug formulations under the provisions of the Drugs (Prices Control) Order, 2013.
The formulations brought under retail price fixation span multiple therapeutic segments, including pain management, anti-diabetic combinations, cardiovascular drugs, antibiotics, vitamin supplements, and hormonal therapies.
Key formulations include Aceclofenac, Paracetamol and Chlorzoxazone Tablets (Rs. 4.95 per tablet) by Innova Captab/Dr. Reddy’s Laboratories; Alpha Lipoic Acid, Pyridoxine Hydrochloride, Mecobalamin, Folic Acid and Vitamin D3 Tablets (Rs. 16.62 per tablet) by Windlas Biotech/Alkem Laboratories; Atorvastatin and Clopidogrel Capsules (Rs. 15.20 per capsule) by Synokem Pharmaceuticals/Alkem Wellness; Bilastine and Montelukast Tablets (Rs. 16.67 per tablet) by Akums Drugs & Pharmaceuticals/Hetero Healthcare; and Bisoprolol Fumarate and Telmisartan Tablets (Rs. 10.68 per tablet) by Mascot Health Series/Indchemie Health Specialities and others.
This came 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;
Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
1 | Aceclofenac, Paracetamol and Chlorzoxazone Tablets | Aceclofenac IP 100 mg + Paracetamol IP 325 mg + Chlorzoxazone USP 250 mg | 1 Tablet | M/s Innova Captab Ltd./ M/s Dr. Reddys Laboratories Ltd. | 4.95 |
2 | Alpha Lipoic Acid, Pyridoxine Hydrochloride, Mecobalamin, Folic Acid and Vitamin D3 Tablets | Alpha Lipoic Acid 100 mg + Pyridoxine 3 mg + Mecobalamin 1500 mcg + Folic Acid 1.5 mg + Vitamin D3 1000 IU | 1 Tablet | M/s Windlas Biotech Ltd./ M/s Alkem Laboratories Ltd. | 16.62 |
3 | Atorvastatin Calcium and Clopidogrel Capsules | Atorvastatin 10 mg + Clopidogrel 75 mg | 1 Capsule | M/s Synokem Pharmaceuticals Ltd./ M/s Alkem Wellness Ltd. | 15.20 |
4 | Bilastine and Montelukast Tablets | Bilastine 40 mg + Montelukast 10 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Hetero Healthcare Ltd. | 16.67 |
5 | Bisoprolol Fumarate and Telmisartan Tablets | Bisoprolol 2.5 mg + Telmisartan 40 mg | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./ M/s Indchemie Health Specialities Pvt. Ltd. | 10.68 |
6 | Calcium, Cholecalciferol and Folic Acid Tablets | Calcium 250 mg + Vitamin D3 100 IU + Folic Acid 50 mcg | 1 Tablet | M/s Pure and Cure Healthcare Pvt. Ltd./ M/s J.B Chemicals & Pharmaceuticals Ltd. | 11.86 |
7 | Cefuroxime Axetil and Potassium Clavulanate Tablets | Cefuroxime 500 mg + Clavulanic Acid 125 mg | 1 Tablet | M/s Alps Communication Pvt. Ltd./ M/s Jagsonpal Pharmaceuticals Ltd. | 63.94 |
8 | Cholecalciferol (Vitamin D3) Drops | Vitamin D3 800 IU | 1 ML | M/s Tirupati Medicare Ltd./ M/s Galpha Laboratories Ltd. | 6.09 |
9 | Clopidogrel, Aspirin and Atorvastatin Capsules | Atorvastatin 40 mg + Clopidogrel 75 mg + Aspirin 75 mg | 1 Capsule | M/s Safetab Life Science/ M/s Corona Remedies Pvt. Ltd. | 13.66 |
10 | Dried Factor VIII Fraction / Lyophilized | Factor VIII 1000 IU | 1 Vial | M/s Reliance Life Sciences Pvt. Ltd. | 14666.35 |
11 | Empagliflozin, Linagliptin and Metformin Hydrochloride ER Tablets | Empagliflozin 25 mg + Linagliptin 5 mg + Metformin 1000 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Unison Pharmaceuticals Pvt. Ltd. | 14.05 |
12 | Empagliflozin, Sitagliptin and Metformin Hydrochloride ER Tablets | Empagliflozin 10 mg + Sitagliptin 100 mg + Metformin 1000 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Primus Remedies Pvt. Ltd. | 16.12 |
13 | Empagliflozin, Sitagliptin and Metformin Hydrochloride ER Tablets | Empagliflozin 25 mg + Sitagliptin 100 mg + Metformin 1000 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Primus Remedies Pvt. Ltd. | 22.77 |
14 | Magnesium and Vitamin D3 Tablets | Magnesium 250 mg + Vitamin D3 1000 IU | 1 Tablet | M/s Alkem Health Science/ M/s Alkem Laboratories Ltd. | 21.66 |
15 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets | Olmesartan 20 mg + Amlodipine 5 mg + Hydrochlorothiazide 12.5 mg | 1 Tablet | M/s Windlas Biotech Ltd./ M/s Alkem Wellness Ltd. | 16.74 |
16 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets | Olmesartan 40 mg + Amlodipine 5 mg + Hydrochlorothiazide 12.5 mg | 1 Tablet | M/s Windlas Biotech Ltd./ M/s Alkem Wellness Ltd. | 21.29 |
17 | Paracetamol and Mefenamic Acid Suspension | Paracetamol 250 mg + Mefenamic Acid 100 mg | 1 ML | M/s Mistair Health & Hygiene Pvt. Ltd./ M/s Zorvia Healthcare Ltd. | 0.93 |
18 | Sitagliptin, Glimepiride and Metformin Hydrochloride Tablets | Sitagliptin 50 mg + Glimepiride 1 mg + Metformin 500 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Unison Pharmaceuticals Pvt. Ltd. | 10.39 |
19 | Sitagliptin, Glimepiride and Metformin Hydrochloride Tablets | Sitagliptin 50 mg + Glimepiride 2 mg + Metformin 500 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Unison Pharmaceuticals Pvt. Ltd. | 11.90 |
20 | Tacrolimus Ointment | Tacrolimus 0.03% w/w | 1 GM | M/s Skymap Pharmaceuticals Pvt. Ltd./ M/s German Remedies Pharmaceuticals Pvt. Ltd. | 21.44 |
21 | Telmisartan, Cilnidipine and Metoprolol Succinate (ER) Tablets | Telmisartan 40 mg + Cilnidipine 10 mg + Metoprolol 50 mg | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./ M/s Intas Pharmaceuticals Ltd. | 14.49 |
22 | Telmisartan, Cilnidipine and Metoprolol Succinate (ER) Tablets | Telmisartan 40 mg + Cilnidipine 10 mg + Metoprolol 25 mg | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./ M/s Intas Pharmaceuticals Ltd. | 11.77 |
23 | Vitamin D3 (Cholecalciferol) Drops | Vitamin D3 800 IU | 1 ML | M/s Tirupati Medicare Ltd./ M/s Zorvia Healthcare Ltd. | 6.09 |
24 | Paracetamol, Caffeine, Phenylephrine HCl and Chlorpheniramine Maleate Tablets | Paracetamol 650 mg + Caffeine 30 mg + Phenylephrine 10 mg + CPM 2 mg | 1 Tablet | M/s Dallas Drugs Pvt. Ltd./ M/s Centaur Pharmaceuticals Pvt. Ltd. | 7.50 |
25 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Mankind Pharma Ltd. | 120.62 |
26 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Dr. Reddys Laboratories Ltd. | 120.62 |
27 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Torrent Pharmaceuticals Ltd. | 120.62 |
28 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s La Renon Healthcare Pvt. Ltd. | 120.62 |
29 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Eris Lifesciences Ltd. | 120.62 |
30 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Akumentis Healthcare Ltd. | 120.62 |
31 | Relugolix, Estradiol and Norethindrone Acetate Tablets | Each film coated tablet contains: Relugolix 40 mg; Estradiol (as hemihydrate) USP equivalent to Anhydrous Estradiol 1 mg; Norethindrone Acetate USP 0.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Aurobindo Pharma Ltd. | 120.62 |
The notification further added:
(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 Controllerand 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 businessin 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.
To view the official notice, click the link below:
