Thursday, January 12, 2023

NPPA fixes retail price of 36 formulations: January 2023
Download NPPA notification No. S.O. 86(E) dt 06-01-2023, the link is given below: The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 36 formulations under the Drugs (Prices Control) Order, 2013, vide S.O. 86(E) dt 06-01-2023 based on the decision of 106th Authority meeting dated 30.12.2022.

Download NPPA notification No. S.O. 86(E) dt 06-01-2023

The notification states as under:

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

Sl. No.Name of the Formulation / Brand NameStrengthUnitManufacturer & Marketing CompanyRetail Price (Rs.)(1)(2)(3)(4)(5)(6)1.Sitagliptin Phosphate and Metformin Hydrochloride TabletsEach film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg      1 TabletM/s Pure and Cure Healthcare Pvt. Ltd. / M/s Natco Pharma Ltd.12.452.Sitagliptin Phosphate and Metformin Hydrochloride TabletsEach film coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg      1 TabletM/s Pure and Cure Healthcare Pvt. Ltd. / M/s Natco Pharma Ltd.13.253.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s USV Pvt. Ltd.26.784.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)1 TabletM/s Exemed Pharmaceuticals / M/s USV Pvt. Ltd.28.575.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited22.90

6.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited24.107.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited30.118.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)      1 TabletM/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited28.729.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Alembic Pharmaceuticals Limited17.85

10.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Alembic Pharmaceuticals Limited18.7511.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited30.1112.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited28.7213.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)  1 TabletM/s Exemed Pharmaceuticals / M/s Intas Pharmaceuticals Ltd.21.00

14.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Intas Pharmaceuticals Ltd.19.0015.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited27.6716.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited25.8917.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)      1 TabletM/s Exemed Pharmaceuticals / M/s Cipla Ltd.28.72

18.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Cipla Ltd.30.1119.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Micro Labs Limited24.1020.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Micro Labs Limited25.8921.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals Limited29.26

22.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)  1 TabletM/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals Limited27.7323.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd.20.5324.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd.19.6425.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Lupin Limited20.53

26.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Lupin Limited22.3227.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Cadila Pharmaceuticals Ltd.27.7328.Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) TabletsEach film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)        1 TabletM/s Exemed Pharmaceuticals / M/s Cadila Pharmaceuticals Ltd.29.2629.Metronidazole , Furazolidone & Dicyclomine Hydrochloride tabletsEach uncoated tablet contains: Metronidazole IP 200mg Furazolidone IP 100mg Dicyclomine Hydrochloride IP 10mg    1 TabletM/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.1.0830.Atorvastatin & Bempedoic Acid TabletEach film coated table contains: Atorvastatin Calcium IP eq. to Atorvastatin 80mg Bempedoic Acid 180mg    1 TabletM/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals Limited48.0031.Telmisartan and Bisoprolol TabletsEach film coated table contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 2.5mg    1 TabletM/s Micro labs Ltd.10.92

32.Lidocaine Patch 5%Each Adhesive Patch Contains: Lidocaine 700mg in an aqueous base (50mg per gm adhesive)    1 PatchM/s Hetero Healthcare Ltd.44.6433.Levetiracetam InfusionEach 100ml contains: Levetiracetam IP 500mg Sodium Chloride IP 820mg Water for Injections IP q. s.    1 mlM/s Akums Drugs & Pharmaceuticals Limited /M/s Cipla Limited0.9034.Levetiracetam InfusionEach 100ml contains: Levetiracetam IP 1000mg Sodium Chloride IP 750mg Water for Injections IP q. s.    1 mlM/s Akums Drugs & Pharmaceuticals Limited /M/s Cipla Limited1.4435.Bisoprolol Fumerate & Amlodipine TabletsEach film coated tablet contains: Bisoprolol Fumerate IP 2.5mg Amlodipine Besylate IP eq. to Amlodipine 5mg    1 TabletM/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited6.1036.Bisoprolol Fumerate & Amlodipine TabletsEach film coated tablet contains: Bisoprolol Fumerate IP 5mg Amlodipine Besylate IP eq. to Amlodipine 5mg    1 TabletM/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited8.34

Note:(a) The manufacturer of the above-mentioned formulations, i.e., the “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.

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(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 ofthe 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 or state licensing authority, as may be applicable, by the concerned manufacturer/marketing company.

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(f) In case the retail price of any of the aforesaid formulations is not complied with, as per the 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 & MarketingCompanies as specified in corresponding entries in Columns (2), (3), and (5) thereof, if any, issued prior to this notification, stand superseded.

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