NPPA fixes retail price of 40 formulations including Dapagliflozin-metformin FDC
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, certain types of stomach cancer, bacterial infections, and those used to relieve pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, muscle pain, bone pain, and joint pain.
These include Akums Drugs, Cipla's Metoprolol Succinate (as Extended Release), Chlorthalidone, and Telmisartan fixed-dose combination tablets, Akums Drugs, Apex Laboratories' Mefenamic Acid and Paracetamol Oral Suspension, Windlas Biotech, Micro Lab's Nebivolol Hydrochloride and Telmisartan Tablet, Ahlcon Parenterals, SunPharmaceutical's Budesonide Nebuliser Suspension BP 0.5mg/2m, and Skymap Pharmaceuticals' Clopidogrel and Aspirin Tablets.
The list further includes Zydus Healthcare's Paracetamol Infusion IP (1% w/v) in a 100-ml pack, Aceclofenac and Paracetamol Tablets, and Lincoln Pharmaceuticals, Zydus Healthcare's Azithromycin Oral Suspension.
Furthermore, the retail price of Reliance Life Sciences, Cadila Pharmaceutical's anticancer drug Trastuzumab for Injection 150mg, Macleods Pharmaceuticals popular antidiabetic combination Dapagliflozin and metformin Hydrochloride (Extended Release) Tablets, MSN Laboratory's antidiabetic Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets has also been fixed.
This comes 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, has 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. | Calcium Carbonate, Vitamin D3, Methylcobalami n, L Methylfolate & Pyridoxal -5- Phosphate tablets | Each film coated tablet contains: Calcium carbonate IP 1250mg eq. to Elemental calcium 500mg, Vitamin D3 IP 2000IU, Methylcobalamin IP 1500mcg L Methylfolate Calcium 1mg, Pyridoxal -5-Phosphate 20mg | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 17.64 |
2. | Metoprolol Succinate (As Extended Release), Chlorthalidone & Telmisartan Tablets | Each film coated tablet contains: Metoprolol Succinate IP 23.75mg eq. to Metoprolol tartrate 25mg (As Extended Release) Chlorthalidone IP 12.50mg Telmisartan IP 40mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. | 10.88 |
3. | Metoprolol Succinate (As Extended Release), Chlorthalidone & Telmisartan Tablets | Each film coated tablet contains: Metoprolol Succinate IP 47.50mg eq. to Metoprolol tartrate 50mg (As Extended Release) Chlorthalidone IP 12.50mg Telmisartan IP 40mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. | 13.41 |
4. | Mefenamic Acid and Paracetamol Oral Suspension | Each 5ml contains: Paracetamol IP 250mg Mefenamic Acid IP 100mg | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Apex Oral Suspension | 0.76 |
5. | Nebivolol Hydrochloride & Telmisartan Tablet | Each uncoated bilayered tablet contains: Nebivolol Hydrochloride IP eq. to Nebivolol 5mg Telmisartan IP 40mg | 1 Tablet | M/s Windlas Biotech Limited / M/s Micro Labs Limited | 13.83 |
6. | Clopidogrel & Aspirin Tablets | Each film coated tablet contains: Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg Aspirin IP 75mg | 1 Tablet | M/s Skymap Pharmaceuticals Pvt. Ltd. | 4.55 |
7. | Nebivolol and Telmisartan Tablets | Each uncoated bilayer tablet contains: Nebivolol Hydrochloride IP eq. to Nebivolol 5mg, Telmisartan IP 40mg | 1 Tablet | M/s Aristo Pharmaceuticals Pvt. Ltd. | 14.22 |
8. | Sodium Alginate, Sodium Bicarbonate & Calcium Carbonate Oral Suspension | Each 5ml Contains: Sodium Alginate IP 250mg, Sodium Bicarbonate IP 133.5mg, Calcium Carbonate IP 80mg | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Alembic Pharmaceuticals Ltd. | 0.87 |
9. | Aceclofenac, Paracetamol and Thiocolchicoside tablets | Each Film Coated Tablet contains: Aceclofenac IP 100mg Paracetamol IP 325mg Thiocolchicoside IP 4mg | 1 Tablet | M/s Theon Pharmaceuticals Limited / M/s Zydus Healthcare Limited | 16.35 |
10. | Paracetamol Infusion IP (1%w/v) in 100ml pack | Each ml contains: Paracetamol IP 10mg Water for Injection | 1 ml | M/s Zydus Healthcare Limited | 3.10 |
11. | Ceftriaxone & Sulbactam Injection | Each vial contains: Ceftriaxone Sodium IP (Sterile) eq. to Anhydrous Ceftriaxone 1000mg Sulbactam Sodium IP (Sterile) eq. to Anhydrous Sulbactam 500mg | 1 Vial | M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s Eris Healthcare Pvt. Ltd. | 147.20 |
12. | Paracetamol sustained release Tablets | Each uncoated bilayered tablet contains: Paracetamol IP 300mg (as Immediate release) Paracetamol IP 700mg (as sustained release) | 1 Tablet | M/s Lincoln Pharmaceuticals Ltd. / M/s Zydus Healthcare Limited | 4.10 |
13. | Azithromycin Oral Suspension | Each 5ml contains: Azithromycin IP as Dihydrate eq. to Anhydrous Azithromycin 100mg | 1 ml | M/s Akums Drugs & Pharmaceuticals Pvt. Ltd. / M/s Torrent Pharmaceuticals Ltd. | 2.16 |
14. | Vitamin D3 Oral Solution | Each 5ml contains: Cholecalciferol IP (In nano Droplet form) 60000IU | 1 ml | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Micro Labs Ltd. | 11.78 |
15. | Telmisartan, Chlorthalidone & Metoprolol (ER) Tablet | Each film coated bilayered tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 12.5mg Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate 25mg (as extended release) | 1 Tablet | M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Ltd. | 10.88 |
16. | Trastuzumab for Injection 150mg | Each Lyophilized vial contains: (A) Trastuzumab (In House) (150mg) L-Histidine HCl Ph. Eur. (3.36mg) α-α Trehalose dihydrate Ph. Eur. (136.2 mg) Polysorbate-20 IP (0.6mg) L-Histidine Ph. Eur. (2.16mg) (B) Sterile water for injection IP 10ml | Per Pack | M/s Reliance Life Sciences Pvt. Ltd. / M/s Cadila Pharmaceuticals Limited | 15554. 49 |
17. | Budesonide Nebuliser suspension BP 0.5mg/2ml | Each 2ml suspension contains: Budesonide IP 0.5mg Water for injection IP q.s. | Each 2 ml Pack | M/s Ahlcon Parenterals (India) Ltd. / M/s Sun Pharmaceutical Industries Limited | 18.01 |
18. | Cefixime and Ofloxacin Oral suspension | Each 5ml reconstituted suspension contains: Cefixime IP as trihydrate eq. to Anhydrous Cefixime 50mg Ofloxacin IP 50mg | 1 ml | M/s Innova Captab Ltd. / M/s Macleods Pharmaceuticals Ltd. | 1.77 |
19. | Aceclofenac and Paracetamol Tablets | Each uncoated bilayered tablet contains: Aceclofenac IP 100mg Paracetamol IP 325mg | 1 Tablet | M/s Zydus Healthcare Ltd. | 4.64 |
20. | Dapagliflozin and metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 500mg (as Extended- Release form) | 1 Tablet | M/s Macleods Pharmaceuticals Ltd. | 9.27 |
21. | Dapagliflozin and metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride IP 1000mg (as Extended Release form) | 1 Tablet | M/s Macleods Pharmaceuticals Ltd. | 10.76 |
22. | Dapagliflozin and metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg Metformin Hydrochloride IP 500mg (as Extended Release form) | 1 Tablet | M/s Macleods Pharmaceuticals Ltd. | 6.36 |
23. | Dapagliflozin and metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 5mg Metformin Hydrochloride IP 1000mg (as Extended- Release form) | 1 Tablet | M/s Macleods Pharmaceuticals Ltd. | 6.55 |
24. | Dapagliflozin and Metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride (Extended Release) IP 1000mg | 1 Tablet | M/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited | 10.76 |
25. | Dapagliflozin and Metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride (Extended Release) IP 500mg | 1 Tablet | M/s Exemed Pharmaceuticals / M/s Glenmark Pharmaceuticals Limited | 9.27 |
26. | Dapagliflozin and Metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride (Extended Release) IP 500mg | 1 Tablet | M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd. | 9.27 |
27. | Dapagliflozin and Metformin Hydrochloride (Extended Release) Tablets | Each film coated tablet contains: Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg Metformin Hydrochloride (Extended Release) IP 1000mg | 1 Tablet | M/s Exemed Pharmaceuticals / M/s Abbott Healthcare Pvt. Ltd. | 10.76 |
28. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated tablet contains: Sitagliptin Phosphate 62.03mg eq. to Sitagliptin 50mg Metformin Hydrochloride USP/Ph. Eur 1000mg (as Extended Release) | 1 Tablet | M/s MSN Laboratories Pvt. Limited | 9.73 |
29. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated tablet contains: Sitagliptin Phosphate 124.06mg eq. to Sitagliptin 100mg Metformin Hydrochloride USP/Ph. Eur 1000mg (as Extended Release) | 1 Tablet | M/s MSN Laboratories Pvt. Limited | 14.19 |
30. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated tablet contains: Sitagliptin Phosphate 62.03mg eq. to Sitagliptin 50mg Metformin Hydrochloride USP/Ph. Eur 500mg (as Extended Release) | 1 Tablet | M/s MSN Laboratories Pvt. Limited | 9.28 |
31. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated tablet contains: Sitagliptin Phosphate eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release) | 1 Tablet | M/s Exemed Pharmaceuticals /M/s Sun pharma Laboratories Limited | 20.17 |
32. | Sitagliptin and Metformin Hydrochloride (as Extended Release) 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 Exemed Pharmaceuticals / M/s Macleods Pharmaceuticals Ltd. | 21.56 |
33. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated bilayered tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 50mg Metformin Hydrochloride IP 1000mg (as Extended Release) | 1 Tablet | M/s Exemed Pharmaceuticals / M/s Macleods Pharmaceuticals Ltd. | 20.06 |
34. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each film coated bilayered tablet contains: Hydrochloride (as Extended Release) Tablets | 1 Tablet | M/s Exemed Pharmaceuticals / Hydrochloride (as Extended Release) Tablets | 20.17 |
35. | Sitagliptin and Metformin Hydrochloride (as Extended Release) 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 Exemed Pharmaceuticals / M/s Macleods Pharmaceuticals Ltd. | 18.67 |
36. | 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 Macleods Pharmaceuticals Ltd. | 20.02 |
37. | 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 Macleods Pharmaceuticals Ltd. | 18.34 |
38. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each bilayered film coated tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg Metformin Hydrochloride IP 500mg (as Extended Release) | 1 Tablet | M/s Theon Pharmaceuticals Limited / M/s Wockhardt Limited | 11.60 |
39. | Sitagliptin and Metformin Hydrochloride (as Extended Release) Tablets | Each bilayered film coated tablet contains: Sitagliptin Phosphate Monohydrate eq. to Sitagliptin 100mg Metformin Hydrochloride IP 1000mg (as Extended Release) | 1 Tablet | M/s Theon Pharmaceuticals Limited / M/s Wockhardt Limited | 12.50 |
40. | Ibuprofen Solution for Infusion 400mg/100ml | Each 100 ml contains: Ibuprofen 400mg water for Injection IP q.s. | Each Pack (100ml) | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Cipla Ltd. | 122.19 |
The notice further added;
(a) The manufacturer of above-mentioned formulations i.e., "new drug" under paragraph 2(u) ofthe 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 ispayable to the Government on the retail price mentioned in column (6) of the above saidtable.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concernedmanufacturer in accordance with the retail price specified in column (6) of the above tableas per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shallissue 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 thesupplementary 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 anyperson 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 forprice fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all theapplicable statutory requirements as laid down by the Govt. under relevant statutes/ rules,including manufacturing license permission from the Competent Authority i.e. theCentral/State Licensing Authority, as may be applicable, by the concernedmanufacturer/marketing companies.
(f) In case the retail price of any of the aforesaid formulations is not complied with, as perinstant price notification and notes specified hereinabove, then the concernedmanufacturer/marketing company shall be liable to deposit the overcharged amount alongwith the interest thereon under the provisions of the DPCO, 2013 read with the EssentialCommodities Act, 1955.
(g) Consequent to the fixation of retail price of such formulation as specified in column (2) ofthe above table with the strength and name of Manufacturer & Marketing Companiesspecified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fixingthe retail price of the formulation with specified strength for that Manufacturer & MarketingCompanies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any,issued prior to this notification, stand(s) superseded.
To view official notice click the link below:
https://www.nppaindia.nic.in/wp-content/uploads/2022/10/1_Retail_Eng.pdf
