NPPA Fixes Retail Price Of 36 Formulations, Details

Published On 2023-01-11 12:30 GMT | Update On 2023-10-21 07:22 GMT

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, the Government of India has fixed retail prices for 36 formulations including those used to treat high blood pressure, type 2 diabetes, cholesterol, bacterial infections.This came in line with the decision of the 106th authority meeting dated 30.12.2022, where...

This came in line with the decision of the 106th authority meeting dated 30.12.2022, where the Authority discussed new drug applications for price fixation under paragraph 2(1)(u) of DPCO, 2013.

These include Pure and Cure Healthcare / Nacto Pharma's Sitagliptin Phosphate and Metformin Hydrochloride, Exemed Pharmaceutical/USV's Dapagliflozin plus Sitaglization & Metformin Hydrochloride, Dallas Drugs/Micro Lab's Metronidazole, Furazolidone & Dicyclomine Hydrochloride, Exemed Pharmaceuticals / Torrent Pharmaceuticals' Atorvastatin & Bempedoic Acid, Micro Lab's Telmisartan and Bisoprolol, Hetero Lab's Lidocaine Patch 5%, Akums Drugs & Pharmaceuticals Limited / Cipla's Levetiracetam Infusion, Mascot / Eris Lifesciences's Levetiracetam Infusion, Mascot Health Series / Eris Lifesciences's Bisoprolol Fumarate & Amlodipine.

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), 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)	(2)	(3)	(4)	(5)	(6)
1.	Sitagliptin Phosphate and Metformin Hydrochloride Tablets	Each film-coated tablet contains: Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 50mg Metformin Hydrochloride IP 500mg	1 Tablet	M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Natco Pharma Ltd.	12.45
2.	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 Pure and Cure Healthcare Pvt. Ltd. / M/s Natco Pharma Ltd.	13.25
3.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s USV Pvt. Ltd.	26.78
4.	Dapagliflozin, Sitagliptin and	Each film coated bilayered tablet contains:	1 Tablet	M/s Exemed Pharmaceuticals /	28.57

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
	Metformin Hydrochloride (as Extended Release) Tablets	Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)		M/s USV Pvt. Ltd.
5.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	22.90
6.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	24.10
7.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited	30.11
8.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg	1 Tablet	M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited	28.72

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
		Metformin Hydrochloride IP 500mg (as Extended Release)
9.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Alembic Pharmaceuticals Limited	17.85
10.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Alembic Pharmaceuticals Limited	18.75
11.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited	30.11
12.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited	28.72
13.	Dapagliflozin, Sitagliptin and Metformin	Each film coated bilayered tablet contains: Dapagliflozin Propanediol	1 Tablet	M/s Exemed Pharmaceuticals / M/s Intas	21.00

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
	Hydrochloride (as Extended Release) Tablets	Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release)		Pharmaceuticals Ltd.
14.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Intas Pharmaceuticals Ltd.	19.00
15.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited	27.67
16.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Eris Life Sciences Limited	25.89
17.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride	1 Tablet	M/s Exemed Pharmaceuticals / M/s Cipla Ltd.	28.72

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
		IP 500mg (as Extended Release)
18.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Cipla Ltd.	30.11
19.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Micro Labs Limited	24.10
20.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Micro Labs Limited	25.89
21.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals Limited	29.26
22.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride	Each film coated bilayered tablet contains: Dapagliflozin Propanediol Monohydrate eq. to	1 Tablet	M/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals	27.73

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
	(as Extended Release) Tablets	Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release)		Limited
23.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd.	20.53
24.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd.	19.64
25.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Lupin Limited	20.53
26.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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	1 Tablet	M/s Exemed Pharmaceuticals / M/s Lupin Limited	22.32

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
		Release)
27.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Cadila Pharmaceuticals Ltd.	27.73
28.	Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets	Each 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 Tablet	M/s Exemed Pharmaceuticals / M/s Cadila Pharmaceuticals Ltd.	29.26
29.	Metronidazole, Furazolidone & Dicyclomine Hydrochloride tablets	Each uncoated tablet contains: Metronidazole IP 200mg Furazolidone IP 100mg Dicyclomine Hydrochloride IP 10mg	1 Tablet	M/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.	1.08
30.	Atorvastatin & Bempedoic Acid Tablet	Each film coated table contains: Atorvastatin Calcium IP eq. to Atorvastatin 80mg Bempedoic Acid 180mg	1 Tablet	M/s Exemed Pharmaceuticals / M/s Torrent Pharmaceuticals Limited	48.00
31.	Telmisartan and Bisoprolol Tablets	Each film coated table contains: Telmisartan IP 40mg Bisoprolol Fumarate IP 2.5mg	1 Tablet	M/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 Patch	M/s Hetero Healthcare Ltd.	44.64
33.	Levetiracetam Infusion	Each 100ml contains: Levetiracetam IP 500mg Sodium Chloride IP 820mg Water for Injections IP q. s.	1 ml	M/s Akums Drugs & Pharmaceuticals Limited /M/s Cipla Limited	0.90

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
34.	Levetiracetam Infusion	Each 100ml contains: Levetiracetam IP 1000mg Sodium Chloride IP 750mg Water for Injections IP q. s.	1 ml	M/s Akums Drugs & Pharmaceuticals Limited /M/s Cipla Limited	1.44
35.	Bisoprolol Fumerate & Amlodipine Tablets	Each film-coated tablet contains: Bisoprolol Fumerate IP 2.5mg Amlodipine Besylate IP eq. to Amlodipine 5mg	1 Tablet	M/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited	6.10
36.	Bisoprolol Fumerate & Amlodipine Tablets	Each film-coated tablet contains: Bisoprolol Fumerate IP 5mg Amlodipine Besylate IP eq. to Amlodipine 5mg	1 Tablet	M/s Mascot Health Series Pvt. Ltd. / M/s Eris Lifesciences Limited	8.34

This notice further added,

(a) The manufacturer of the 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 the 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 a 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 the retail price of such formulation as specified in column(2) of the above table with the strength and name of the Manufacturer & Marketing Companies specified in the corresponding entries in Columns (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 Columns (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.

Also Read: NPPA revises ceiling price of 107 scheduled formulations, Details

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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NPPA Fixes Retail Price Of 36 Formulations, Details

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