NPPA Fixes Retail Price Of 36 Formulations, Details

Published On 2023-01-11 12:30 GMT   |   Update On 2023-10-21 07:22 GMT
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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 the Authority discussed new drug applications for price fixation under paragraph 2(1)(u) of DPCO, 2013.

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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.
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