NPPA fixes retail price of 35 Formulations including Dapagliflozin, Metformin FDCs, Details
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 35 formulations including those used to treat hypertension, heart attack, type 2 diabetes and others.
These include Levetiracetam Infusion 500mg/100m manufactured by Akums and Abbott; AXA Parenterals or Sun Pharma Ltd's Ciprofloxacin plus Dexamethasone FDC Eye Drops, a combination of Telmisartan and Chlorthalidone Tablet (TELMIDUCE CH & MACSART CH 6.25) manufactured by Macleods Pharma among others.
In addition to this, the list also includes diabetes drug combination such as Vildagliptin plus Metformin Hydrochloride (sustained-release) Tablet; Dapagliflozin plus Metformin Hydrochloride Extended-Release Tablet; Vildagliptin and Metformin Hydrochloride Tablet.
This comes after 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. 701(E) dated 10th March 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (NPPA), fixed, 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. | Ciprofloxacin + Dexamethasone Eye Drops | Each ml Contains: Ciprofloxacin Hydrochloride IP Eq. to Ciprofloxacin 0.3% w/v, Dexamethasone 0.1% w/v, |
1 ML | M/s AXA Parenterals Ltd. /M/s Sun Pharmaceutical Industries Limited | 1.69 |
2. |
Esomeprazole & sustained release Domperidone Capsule | Each hard Gelatin Capsule Contains: Esomeprazole Magnesium Trihydrate IP eq. to Esomeprazole 40mg (as enteric coated pellets) Domperidone IP 30mg (as sustained release pellets) |
1 Capsule |
M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Alembic Pharmaceuticals Limited | 6.00 |
3. |
Levetiracetam Infusion 500mg/100ml | Each 100ml contains: Levetiracetam IP 500mg Sodium Chloride IP 820mg Water for Injections IP q. s. |
Each Pack | M/s Akums Drugs & Pharmaceuticals Limited / M/s Abbott Healthcare Pvt. Ltd. | 91.56 |
4. |
Levetiracetam Infusion 1000mg/100ml | Each 100ml contains: Levetiracetam IP 1000mg Sodium Chloride IP 750mg Water for Injections IP q. s. |
Each Pack | M/s Akums Drugs & Pharmaceuticals Limited / M/s Abbott Healthcare Pvt. Ltd. | 148.72 |
5. |
Telmisartan + Cilnidipine + Metoprolol (ER) Tablet | Each film coated bilayered tablet contains: Telmisartan IP 40mg, Cilnidipine IP 10mg Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended release) 50mg |
1 Tablet |
M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Limited | 11.96 |
6. |
Telmisartan + Cilnidipine + Metoprolol (ER) Tablet | Each film coated bilayered tablet contains: Telmisartan IP 40mg, Cilnidipine IP 10mg Metoprolol Succinate IP 23.75mg |
1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Limited | 9.64 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
eq. to Metoprolol Tartrate (as extended release) 25mg | |||||
7. |
Labetalol Tablet | Each film coated tablet contains: Labetalol Hydrochloride IP 200mg |
1 Tablet | M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Sun Pharma Laboratories Limited | 22.38 |
8. |
Rabeprazole + Domperidone capsule | Each hard gelatine capsule contains: Rabeprazole Sodium IP 20mg (as enteric coated pellets) Domperidone IP 30mg (As sustained release pellets) |
1 Capsule |
M/s Theon Pharmaceuticals Ltd. / M/s Eris Healthcare Private Limited | 9.11 |
9. |
Paracetamol + Nimesulide Tablet | Each uncoated tablet contains: Paracetamol IP 325mg, Nimesulide BP 100mg |
1 Tablet | M/s Shivalik Remedies Pvt. Ltd. / M/s Eris Healthcare Private Limited | 3.98 |
10. | Telmisartan + Chlorthalidone Tablet (TELMIDUCE CH & MACSART CH 6.25) | Each uncoated tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 6.25mg |
1 Tablet | M/s Macleods Pharmaceuticals Limited | 8.63 |
11. |
Calcium Carbonate + Vitamin D3 + Methylcobalamin + L- Methylfolate Calcium + Pyridoxal -5- Phosphate Tablets | Each Film coated tablet contains: Calcium Carbonate IP 1250mg, Vitamin D3 IP 2000 IU, Methylcobalamin IP 1500mcg, Calcium L-5- Methyltetrahydrofolate (L- Methylfolate Calcium) USP 1mg Pyridoxal -5- Phosphate 20mg |
1 Tablet |
M/s Tirupati Medicare Limited / M/s Intas Pharmaceuticals Ltd. | 18.02 |
12. |
Vildagliptin + Metformin Hydrochloride (sustained release) Tablet | Each uncoated bilayered tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 500mg (As sustained release form) |
1 Tablet |
M/s Exemed Pharmaceuticals / M/s Mankind Pharma Ltd. | 6.58 |
13. |
Vildagliptin + Metformin Hydrochloride (sustained release) Tablet | Each uncoated bilayered tablet contains: Vildagliptin 50mg, Metformin Hydrochloride IP 1000mg (As sustained release form) |
1 Tablet |
M/s Exemed Pharmaceuticals / M/s Mankind Pharma Ltd. | 7.07 |
14. |
Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) |
1 Tablet |
M/s Exemed Pharmaceutical / M/s Zydus Healthcare Limited | 11.81 |
15. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg |
1 Tablet | M/s Exemed Pharmaceutical / M/s Zydus Healthcare Limited | 10.22 |
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 form) | |||||
16. |
Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 500mg (As Extended release form) |
1 Tablet |
M/s Alkem Healthscience /M/s Alkem Laboratories Ltd. | 6.74 |
17. |
Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet |
M/s Alkem Healthscience /M/s Alkem Laboratories Ltd. | 8.12 |
18. |
Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 500mg (As Extended release form) | 1 Tablet |
M/s Alkem Healthscience /M/s Alkem Laboratories Ltd. | 10.22 |
19. |
Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) | 1 Tablet |
M/s Alkem Healthscience /M/s Alkem Laboratories Ltd. | 11.81 |
20. | Vildagliptin + Metformin Hydrochloride Tablet | Each film coated tablet contains: Metformin Hydrochloride IP 500mg Vildagliptin 50mg, | 1 Tablet | M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Blue Cross Laboratories Pvt. Ltd. | 5.90 |
21. | Vildagliptin + Metformin Hydrochloride Tablet | Each film coated tablet contains: Metformin Hydrochloride IP 1000mg Vildagliptin 50mg, | 1 Tablet | M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Blue Cross Laboratories Pvt. Ltd. | 6.90 |
22. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP / USP 1000mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s USV Pvt. Limited | 11.81 |
23. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP / USP 500mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s USV Pvt. Limited | 10.22 |
24. | Dapagliflozin + Metformin Hydrochloride | Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP / USP |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Intas | 6.74 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Extended Release Tablet | 500mg (As Extended release form) | Pharmaceuticals Limited | |||
25. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP / USP 1000mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Intas Pharmaceuticals Limited | 8.12 |
26. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP / USP 1000mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Intas Pharmaceuticals Limited | 11.81 |
27. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP / USP 500mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Intas Pharmaceuticals Limited | 10.22 |
28. | Dapagliflozin + Metformin Hydrochloride (Extended Release) Tablet | Each film-coated tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 500mg (As Extended release form) |
1 Tablet |
M/s Exemed Pharmaceutical / M/s Zydus Healthcare Limited | 6.74 |
29. | Dapagliflozin + Metformin Hydrochloride (Extended Release)Tablet | Each film-coated tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As Extended release form) |
1 Tablet |
M/s Exemed Pharmaceutical / M/s Zydus Healthcare Limited | 8.12 |
30. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP / USP 500mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Eris Lifesciences Limited | 6.74 |
31. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride IP / USP 1000mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Eris Lifesciences Limited | 8.12 |
32. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP / USP 500mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Eris Lifesciences Limited | 10.22 |
33. | Dapagliflozin + Metformin Hydrochloride Extended Release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) |
1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s Eris Lifesciences Limited | 11.81 |
34. | Atorvastatin and Aspirin Capsule | Each Hard gelatine capsule contains: | 1 Capsule | M/s USV Private Limited. | 20.22 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Atorvastatin calcium IP eq. to Atorvastatin 40mg, Aspirin IP 75mg (As Gastro- resistant tablet IP) | |||||
35. |
Aceclofenac + Paracetamol + Thiocolchicoside Tablet | Each film coated tablet contains: Aceclofenac IP 100mg, Paracetamol IP 325mg Thiocolchicoside IP 4mg |
1 Tablet | M/s Synokem Pharmaceuticals Ltd. /M/s Mylan Pharmaceuticals Private Limited. | 15.18 |
The notice further added;
(a) The manufacturer of above-mentioned formulations i.e. "new drug" under paragraph 2(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 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 issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.
