NPPA fixes retail price of 40 Formulation, Details

Published On 2022-11-25 12:30 GMT   |   Update On 2022-11-25 12:30 GMT
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New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 40 new drugs including those used to treat high blood pressure, type 2 diabetes, cholesterol, bacterial infections and those used to relieve gastric disease, muscle relaxant, pain and inflammation.

This price fixation came in accordance with the decision of 103rd Authority meeting dated 10.11.2022.
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These include Pure & Cure, Sun Pharma's Telmisartan and Hydrochlorothiazide Tablets IP tablets) Zydus Lifescience's Trastuzumab 375mg Injection, Innova Captab Limited, Abbott India's Ibuprofen & Paracetamol Tablets, Hetero Labs Ltd & Mankind Prime Labs's Olmesartan Medoxomil& Amlodipine Tablets, Ravenbhel Healthcare & Abbott Healthcare's Telmisartan,Chlorthalidone & Metoprolol ER Tablets.
This list further includes popular diabetes drug Glimepiride and Metformin Hydrochloride (ER) Tablets marketed by Cipla, Sitagliptin and Metformin Hydrochloride (ER) Tablets marketed by Lupin, Mankind Prime Labs, Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets manufactured and marketed by Sun Pharma Laboratories.
In the 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. 701(E) dated 10th March 2016 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)

(2)

(3)

(4)

(5)

(6)

1.

Telmisartan and Hydrochlorothi azide Tablets IP

Each Uncoated Bilayered Tablet Contains: Telmisartan IP 40mg Hydrochlorothiazide IP

12.5mg

1 Tablet

M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Sun Pharmaceuticals Industries Limited

10.32

2.

Trastuzumab

375mg

Injection

Lyophilized powder for intravenous infusion

(to be supplied with bacteriostatic water for injection 20ml for reconstitution), Multi-use vial

Each Lyophilized vial contains: Trastuzumab 375mg Excipients:

L-Histidine Hydrochloride monohydrate EP 8.44mg L-Histidine USP 5.45mg α, α-Trehalose dihydrate NF 340.90mg

Polysorbate 20NF 1.53mg

pH 6.0

Diluent:

Bacteriostatic water for injection 20ml for reconstitution

Per Vial

M/s Zydus

Lifescience Ltd.

12420.28

3.

Glimepiride, Voglibose&

Each uncoated bilayered tablet contains:

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd.

10.00

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Metformin (Extended- release) tablets

Glimepiride IP 1mg, Voglibose IP 0.2mg Metformin Hydrochloride IP

500mg (As Extended-

release)

/ M/s Apex Laboratories Pvt. Ltd.

4.

Cholecalciferol (Vitamin D3) Oral Solution

Each 5ml contain: Cholecalciferol IP 60000 IU (In nano Droplet form)

1 ML

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Cadila Pharmaceuticals Ltd.

12.03

5.

Ibuprofen and Paracetamol Tablets IP

Each uncoated tablet contains:

Ibuprofen IP 400mg

Paracetamol IP 325mg

1 Tablet

M/s Shiva Biogenetic

Pharmaceuticals Pvt. Ltd. / M/s Mankind Prime Labs Ltd.

1.45

6.

Myo-Inositol, Melatonin & Folic Acid Tablets

Each film coated tablet contains:

Myo-Inositol USP 1gm Melatonin BP 1.5mg Folic Acid IP 1000mcg

1 Tablet

M/s Synokem

Pharmaceuticals Ltd.

/ M/s Mankind

Pharma Ltd.

20.93

7.

Ibuprofen & Paracetamol Tablets

Each uncoated tablet contains:

Ibuprofen IP 400mg

Paracetamol IP 325mg

1 Tablet

M/s Innova Captab Limited / M/s Abbott India Limited

1.45

8.

Olmesartan Medoxomil& Amlodipine Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

20mg

Amlodipine Besilate IP eq. to Amlodipine 5mg

1 Tablet

M/s Hetero Labs Ltd.

/ M/s Mankind Prime

Labs Pvt. Ltd.

11.41

9.

Ibuprofen and Paracetamol Suspension

Each 5ml contains: Ibuprofen IP 100mg Paracetamol IP 162.5mg

1 ml

M/s Innova Captab Limited / M/s Abbott India Limited

0.41

10.

Olmesartan Medoxomil, Amlodipine & Hydrochlorothi azide Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

20mg

Amlodipine Besilate IP eq. to Amlodipine 5mg Hydrochlorothiazide IP

12.50mg

1 Tablet

M/s Pharma Force Lab. / M/s Mankind Prime Labs Pvt. Ltd.

13.24

11.

Olmesartan Medoxomil& Amlodipine Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

40mg

Amlodipine Besilate IP eq. to Amlodipine 5mg

1 Tablet

M/s Hetero Labs Ltd.

/ M/s Mankind Prime

Labs Pvt. Ltd.

18.77

12.

Paracetamol & Mefenamic Acid Suspension

Each 5ml contains: Paracetamol IP 250mg Mefenamic Acid 100mg

1 ml

M/s Pharma Force Lab. / M/s Mankind Prime Labs Pvt. Ltd.

0.75

13.

Telmisartan,

Each film coated

1 Tablet

M/s Ravenbhel

9.51

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Metformin (Extended- release) tablets

Glimepiride IP 1mg, Voglibose IP 0.2mg Metformin Hydrochloride IP

500mg (As Extended-

release)

/ M/s Apex Laboratories Pvt. Ltd.

4.

Cholecalciferol (Vitamin D3) Oral Solution

Each 5ml contain: Cholecalciferol IP 60000 IU (In nano Droplet form)

1 ML

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Cadila Pharmaceuticals Ltd.

12.03

5.

Ibuprofen and Paracetamol Tablets IP

Each uncoated tablet contains:

Ibuprofen IP 400mg

Paracetamol IP 325mg

1 Tablet

M/s Shiva Biogenetic

Pharmaceuticals Pvt. Ltd. / M/s Mankind Prime Labs Ltd.

1.45

6.

Myo-Inositol, Melatonin & Folic Acid Tablets

Each film coated tablet contains:

Myo-Inositol USP 1gm Melatonin BP 1.5mg Folic Acid IP 1000mcg

1 Tablet

M/s Synokem

Pharmaceuticals Ltd.

/ M/s Mankind

Pharma Ltd.

20.93

7.

Ibuprofen & Paracetamol Tablets

Each uncoated tablet contains:

Ibuprofen IP 400mg

Paracetamol IP 325mg

1 Tablet

M/s Innova Captab Limited / M/s Abbott India Limited

1.45

8.

Olmesartan Medoxomil& Amlodipine Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

20mg

Amlodipine Besilate IP eq. to Amlodipine 5mg

1 Tablet

M/s Hetero Labs Ltd.

/ M/s Mankind Prime

Labs Pvt. Ltd.

11.41

9.

Ibuprofen and Paracetamol Suspension

Each 5ml contains: Ibuprofen IP 100mg Paracetamol IP 162.5mg

1 ml

M/s Innova Captab Limited / M/s Abbott India Limited

0.41

10.

Olmesartan Medoxomil, Amlodipine & Hydrochlorothi azide Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

20mg

Amlodipine Besilate IP eq. to Amlodipine 5mg Hydrochlorothiazide IP

12.50mg

1 Tablet

M/s Pharma Force Lab. / M/s Mankind Prime Labs Pvt. Ltd.

13.24

11.

Olmesartan Medoxomil& Amlodipine Tablets

Each Film Coated Tablet contains:

Olmesartan Medoxomil IP

40mg

Amlodipine Besilate IP eq. to Amlodipine 5mg

1 Tablet

M/s Hetero Labs Ltd.

/ M/s Mankind Prime

Labs Pvt. Ltd.

18.77

12.

Paracetamol & Mefenamic Acid Suspension

Each 5ml contains: Paracetamol IP 250mg Mefenamic Acid 100mg

1 ml

M/s Pharma Force Lab. / M/s Mankind Prime Labs Pvt. Ltd.

0.75

13.

Telmisartan,

Each film coated

1 Tablet

M/s Ravenbhel

9.51

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Chlorthalidone

& Metoprolol

ER Tablets

bilayered tablet contains: Telmisartan IP 40mg Chlorthalidone IP 6.25mg Metoprolol Succinate IP

23.75mg eq. to Metoprolol

Tartrate (as Extended release) 25mg

Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd.

14.

Telmisartan, Chlorthalidone

& Metoprolol

ER Tablets

Each film coated bilayered tablet contains: Telmisartan IP 40mg Chlorthalidone IP 6.25mg Metoprolol Succinate IP

47.50mg eq. to Metoprolol Tartrate (as Extended release) 50mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd.

10.88

15.

Paracetamol Bilayered Sustained Release Tablets

Each uncoated bilayered sustained release tablet contains:

Paracetamol IP (as

Immediate release) 300mg Paracetamol IP (as Sustained release) 700mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd.

/ M/s Zydus

Healthcare Limited

4.15

16.

Glimepiride and Metformin Hydrochloride (ER) Tablets

Each uncoated bilayered tablet contains: Glimepiride IP 4mg Metformin Hydrochloride IP

1000mg (In extended- release form)

1 Tablet

M/s Innova Captab

Ltd. / M/s Cipla Ltd.

10.87

17.

Glimepiride and Metformin Hydrochloride (ER) Tablets

Each uncoated bilayered tablet contains: Glimepiride IP 3mg Metformin Hydrochloride IP

1000mg (In extended- release form)

1 Tablet

M/s Innova Captab

Ltd. / M/s Cipla Ltd.

10.18

18.

Glimepiride and Metformin Hydrochloride (ER) Tablets

Each uncoated bilayered tablet contains: Glimepiride IP 3mg Metformin Hydrochloride IP

500mg (In extended-

release form)

1 Tablet

M/s Innova Captab

Ltd. / M/s Cipla Ltd.

9.66

19.

Glimepiride and Metformin Hydrochloride (ER) Tablets

Each uncoated bilayered tablet contains: Glimepiride IP 4mg Metformin Hydrochloride IP

500mg (In extended- release form)

1 Tablet

M/s Innova Captab

Ltd. / M/s Cipla Ltd.

10.36

20.

Amoxycillin

and Potassium Clavulanate Oral Suspension IP

Each Combipack contains:

(A) Amoxycillin and Potaassium Clavulanate Oral Suspension IP

Each Combi Pack

M/s Malik Life Sciences Pvt. Ltd. / M/s Cipla Limited

168.43

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Composition:

Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9mg

(B) 2 Ampoules of 25ml each of sterile water for reconstitution of Dry syrup

21.

Olmesartan Medoxomil, Amlodipine

&Hydrochlorot hiazideTablet

Each film coated tablet contains:

Olmesartan Medoxomil IP

40mg

Amlodipine Besilate IP eq. to Amlodipine 5mg Hydrochlorothiazide IP

12.5mg

1 Tablet

M/s Pharma Force Lab. / M/s Mankind Prime Labs Pvt. Ltd.

17.59

22.

Diclofenac Diethylamine, Methyl Salicylate & Menthol Topical Spray

Composition:

Diclofenac Diethylamine IP

2.32% w/w (eq. to Diclofenac Sodium 2% w/w)

Methyl Salicylate IP 10%

w/w

Menthol IP 5% w/w

1 Gram

M/s Pontika Aerotech Limited / M/s Zydus Healthcare Limited

3.14

23.

Glycopyrrolate

+ Neostigmine Methylsulphate Injection

Each 5ml contains: Glycopyrrolate IP 0.5mg Neostigmine MethylsulphateIP 2.5mg Water for Injection IP q.s.

5 ml

Ampoule

M/s Samarth Life

Sciences Pvt. Ltd.

51.19

24.

Pantoprazole Dual Release Gastro Resistant Tablets

Each Dual Release Gastro Resistant Tablet Contains:

Pantoprazole Sodium Eq. to Pantoprazole 80mg

1 Tablet

M/s Pure and Care Healthcare Pvt. Ltd. / M/s Cipla Limited

15.58

25.

Olmesartan Medoxomil and Amlodipine Besylate

Tablet

Each film coated tablet contains:

Olmesartan Medoxomil BP

20mg

Amlodipine Besylate IP eq. to Amlodipine 5mg

1 Tablet

M/s Cadila Pharmaceuticals Limited

11.61

26.

Pantoprazole Dual-Release Gastro- Resistant Tablets

Each Dual-release Gastro-resistant tablet contains:

Pantoprazole Sodium IP

eq. to Pantoprazole 80mg

1 Tablet

M/s Zydus

Healthcare Limited

15.58

27.

Pantoprazole powder for Oral

Each sachet contains: Pantoprazole Sodium IP eq. to Pantoprazole 40mg

1 Sachet of 5gm

M/s Alkem

Laboratories Ltd.

9.05

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Suspension (Sodium Bicarbonate as buffer)

(Sodium Bicarbonate as buffer)

28.

Atorvastatin

&Bempedoic

Acid Tablet

Each film coated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 80mg Bempedoic Acid 180mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Zydus Healthcare Limited

50.71

29.

Atorvastatin

&Bempedoic

Acid Tablet

Each film coated tablet contains:

Atorvastatin Calcium IP eq. to Atorvastatin 80mg Bempedoic Acid 180mg

1 Tablet

M/s Exemed Pharmaceuticals / M/s Sun Pharma Laboratories Limited

50.71

30.

Telmisartan and Bisoprolol Tablets

Each film coated tablet contains:

Telmisartan IP 40mg

Bisoprolol Fumarate IP

5mg

1 Tablet

M/s Micro labs Ltd.

11.81

31.

Sitagliptin and Metformin Hydrochloride (ER) Tablets

Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg

Metformin Hydrochloride IP

1000mg (as Extended

Release)

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Lupin Limited

21.56

32.

Sitagliptin and Metformin Hydrochloride (ER) Tablets

Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

500mg (as Extended

Release)

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Unison Pharmaceuticals

Pvt. Ltd.

18.67

33.

Sitagliptin and Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

500mg

1 Tablet

M/s Mediforce Healthcare Pvt. Ltd. / M/s Mankind Prime Labs Pvt. Ltd.

18.34

34.

Sitagliptin and Metformin Hydrochloride Tablets

Each film coated tablet contains:

Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

1000mg

1 Tablet

M/s Mediforce Healthcare Pvt. Ltd. / M/s Mankind Prime Labs Pvt. Ltd.

20.02

35.

Sitagliptin and

Metformin

Each film coated bilayered tablet contains:

1 Tablet

M/s Ravenbhel

Healthcare Pvt. Ltd. /

20.06

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Hydrochloride

(ER)Tablets

Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg

Metformin Hydrochloride IP

1000mg (as Extended

Release)

M/s Unison Pharmaceuticals Pvt. Ltd.

36.

Sitagliptin and Metformin Hydrochloride (ER)Tablets

Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg

Metformin Hydrochloride IP

500mg (as Extended

Release)

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Unison Pharmaceuticals

Pvt. Ltd.

20.17

37.

Sitagliptin and Metformin Hydrochloride (ER)Tablets

Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg

Metformin Hydrochloride IP

1000mg (as Extended

Release)

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Unison Pharmaceuticals

Pvt. Ltd.

21.56

38.

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets

Each film coated tablet contains:

Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg

Metformin Hydrochloride IP

1000mg (as Extended

Release)

1 Tablet

M/s Sun Pharma

Laboratories Limited

22.32

39.

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets

Each film coated tablet contains:

Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg

Metformin Hydrochloride IP

500mg (as Extended

Release)

1 Tablet

M/s Alkem

Laboratories Limited

29.31

40.

Dapagliflozin, Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets

Each film coated tablet contains:

Dapagliflozin Propanediol

Monohydrate eq. to Dapagliflozin 10mg Sitagliptin Phosphate Monohydrate eq. to

1 Tablet

M/s Alkem

Laboratories Limited

30.70

Sl. No.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Sitagliptin 100mg

Metformin Hydrochloride IP

1000mg (as Extended

Release)

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 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.

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