NPPA approves prices of 25 new drugs including Dapagliflozin, Metformin, Details
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) approved retail pricing for 25 new drugs under the Drug Price Control Order (DPCO) 2013 at a recent meeting on July 29th, 2021.
These medications are used to treat excessive cholesterol and triglyceride (fat) levels in the blood, as well as asthma, high blood sugar, and pain relief and so on.
This came after the authority deliberated on New Drug application price fixation under Para 5 and Para 15 of DPCO at its 223rd meeting of the Authority (over all), which was the 91st meeting under the DPCO, 2013, under the Chairmanship of Shubhra Singh, Chairman.
After detailed discussion, the Authority decided to approve the retail price in line with the decision as recorded in the Minutes of the 82nd Authority meeting dated 23.12.2020, based on the recommendation of the Multidisciplinary Committee of Experts.
The Authority discussed the cases of retail price fixation of new drugs falling under the purview of Para 2 (u) of the DPCO, 2013 and approved the retail prices of 25 (twenty five) new drugs under Para 5 and 15 of the DPCO 2013.
Furthermore, it was also notified that the representative of DCGI present in the meeting confirmed that the formulations were approved by DCGI.
The list of 25 new drugs includes Micro Lab's fixed dose combination of Paracetamol plus Caffeine tablet, Pure & Cure Healthcare and Alembic Pharma's Metoprolol Succinate plus Cilnidipine plus Telmisartan Tablet, Safetab Life Science/Lupin's FDC Atorvastatin plus Ezetimibe Tablet, Dallas Drugs/Alkem's Rabeprazole Sodium plus Ondansetron Hydrochloride
The list also includes the popular anti-diabetic drug combination Dapagliflozin plus Metformin Hydrochloride, manufactured by Synokem Pharmaceuticals and marketed by Lupin and Primus Remedies.
Retail price fixed under Para 5 and 15 of DPCO, 2013
| S. No. | Name of the Formulation/ Brand Name | Strength | Unit | Manufacturer and Marketing Company | Retail Price (Rs.) |
| (1 ) | (2) | (3) | (4) | (5) | (6) |
|
4(i) |
Budesonide Respule | Each 2 ml Respule contains: Budesonide IP 0.5 mg | Per 2ml pack | Softdeal Pharmaceutical Private Limited |
17.79 |
|
4(ii) |
Paracetamol + Caffeine Tab let | Each uncoated tablet contains: Paracetamol IP 650 mg Caffeine IP 50mg |
1 Tablet |
M/s Micro Labs Limited | 2.81 (Note 2) |
|
4(iii) | Metoprolol Succinate (ER) + Cilnidipine + Telmisartan Tablet | Each film coated tablet contains: Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate 25mg, (As Extended Release), |
1 Table t | M/s Pure & Cure Healthcare Pvt. Ltd. M/s Alembic Pharmaceuticals Ltd. |
10.16 |
| S. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs .) |
| (1) | (2) | (3) | (4) | (5) | (6) |
|
|
| Cilnidipine IP 10mg Telmisartan IP 40mg |
|
|
|
|
4(iv) |
Metoprolol Succinate (ER) + Cilnidipine + Telmisartan Tablet | Each film coated tablet contains: Metoprolol Succinate IP 47.50mg eq. to Me to pro lol Tartrate 50mg, (As Extended Release), Cilnidipine IP 10 mg Telmisartan IP 40 mg |
1 Tablet |
M/s Pure & Cure Hea lthcare Pvt. Ltd. / M/ s Alembic Pharmaceutical s Ltd. |
12.41 |
|
4(v) |
Atorvastatin + Ezetimibe Table | Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvas ta tin 40mg, Ezetimibe IP 10mg |
1 Tablet |
M/s Safetab Life Science / M/s Lupin Lim it e d |
33.14 |
|
4(vi) |
Cefixime + Potassium Clavulanate tablet | Each film coated tablet contains: Cefixime Trihydrate IP eq. to Anhydrous Cefixime 200mg, Potassium Clavulanate Dilutedeq to Clavulanic acid IP 125mg |
1 Tablet |
M/s Zeneka Healthcare Ltd. / M/s Cadila Pharmaceutical s Limited |
21.97 |
| 4(vii ) | Diclofenac Sodium + Paracetamol Tablet IP | Each uncoated tablet contains: Diclofenac Sodium IP 50mg, Paracetamol IP 325mg |
1 Tablet |
M/s Soft deal Pharmaceutical Pvt. Ltd. | 4.14 (Note 2) |
|
4(viii) |
Calcium Carbonate + Vitamin 03 Tablet | Each Film coated tablet contains: Calcium Carbonate IP 1250mg eq. to Elemental Calcium 500mg, Vitamin 0 3 IP lOOOIU |
1 Tablet |
M/s Unison Pharmaceutical s Pvt. Ltd. | 5.36 (Note 2) |
|
4(ix) | Zinc Sulphate Mono hydrate + Sodium Citrate + Potassium Chloride + Dextrose Anhydrous Oral Solution | Each pack of 200ml contains: Zinc Sulphate Monohydrate IP 0.0110 g Sodium Citrate IP 0.5800 g Potassium Chloride IP 0.3000 g Sodium Chloride IP 0.5200 g Dextrose Anhydrous IP 2.7000 g |
Per 200 ml pack |
M/s Halewood Laboratories Pvt. Limited / M/s FDC Limited |
30. 00 |
|
4(x) | Rabeprazole Sodium + Ondansetron Hydrochloride Tablet | Each Enteric coated table t contains: Rabeprazole Sodium IP 20mg Ondansetro n Hydrochloride eq. to Ondansetron IP 4mg |
1 Tablet | M/s Dallas Drugs Pvt. Ltd. / M/s Alkem Laboratories Limited |
10.00 (Note 2) |
| S.No
| Name of the Formulation/Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs) |
| 1 | 2 | 3 | 4 | 5 | 6 |
| 4(xi) | Paracetamol, Phenylepherine Hydrochloride, Chlorpheniramine Maleate, Sodium Citrate and Menthol Syrup | Each 5 ml contains : Paracetamol IP 125mg Phenylephrine Hydrochloride IP 5mg Chlorpheniramine Maleate IP 0.5 mg Sodium Citrate IP 60 MG Menthole IP 1 mg | 1 ML | M/s Shiv Industries / M/s Profic Organic Limited | 0.64 |
| 4(xii) | Dapagliflozin + Metformin Hydrochloride (As extended release form ) Tablet | Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5 mg, Metformin Hydrochloride IP 500 mg( As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd./M/s Lupin Limited | 6.25 (Note 3) |
| 4(xiii) | Dapagliflozin + Metformin Hydrochloride (As extended release form ) Tablet | Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5 mg, Metformin Hydrochloride IP 1000 mg( As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd./M/s Lupin Limited | 7.54 (Note 3) |
| 4(xiv) | Dapagliflozin + Metformin Hydrochloride (As extended release form ) Tablet | Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10 mg, Metformin Hydrochloride IP 500 mg( As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd./M/s Lupin Limited | 9.65 (Note 3) |
| 4(xv) | Dapagliflozine + Metformin Hydrochloride (As extended release form ) Tablet | Each film coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10 mg, Metformin Hydrochloride IP 1000 mg( As Extended release form) | 1 Tablet | M/s Synokem Pharmaceuticals Ltd./M/s Lupin Limited | 11.17 (Note 3) |
| 4(xvi) | Methylcobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride & Folic Acid Tablet | Each film coated tablet contains: Methylcobalamin IP 1500 MCG,, Alpha Lipoic Acid USP 100 mg, Vitamin D3 IP 1000 mg, Pyridoxine Hydrochloride IP 3 mg & Folic Acid IP 1.5 mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Limited / M/s Abbott Healthcare Pvt. | 10.97 |
| S. No . | Name of the Formulation/ Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
| [1) | [2) | (3) | (4) | (5) | (6) |
|
|
| 3mg Folic Acid IP 1.5 mg |
| Ltd. |
|
|
|
| Each film coated tablet contains: Methylcobalamin IP lS00mcg, Alpha Lipoic Acid USP 100mg, Vitamin D3 IP 1000 JU, Pyridoxine Hydrochlor ide IP 3mg& Folic Acid IP 1.5mg |
|
|
|
| 4(xvii) | Methylcobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride & Folic Acid Tablet |
1 Tablet | M/s Unison Pharmaceutical s Pvt. Ltd. |
10.97 | |
|
| |
|
|
| |
|
|
| Composition: |
|
|
|
|
4(xviii ) | Diclofenac Diethylamine, Methyl Salicylate, Capsaicin, Menthol & Linseed Oil Ge l | Diclofenac Diethylamine IP 1.16% w/w eq. to Diclofenac Sodium 1.0% w/ w, Methyl Salicylate IP 10%w/ w, Capsaicin USP 0.0 25% w / w , Menthol IP 5.0% w/w & Linseed Oil BP 3.0% w/w |
lGM |
M/s Hetero Healthcare Ltd. |
2.70 (Note 2) |
|
4(xix) |
Dapaglifloz in + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 5 mg, Metformin Hydrochloride IP 500mg (As Extended release form) |
1 Tablet |
M/s Synokem Pharmaceutical s Ltd./ M/s Prim us Remedies Pvt Ltd |
6.25 (Note 3) |
|
4(xx) |
Dapagliflozin + Metformin Hydrochloride (As Extended release form) 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 Synokem Pharmaceutical s Ltd . / M/s Primus Remedies Pvt Ltd |
9.65 (Note 3) |
|
| | |
|
| |
|
|
| |
|
| |
|
4(xxi) |
Dapagliflozin + Metformin Hydrochloride (As Extended release form) 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 Synokem Pharmaceutical s Ltd./ M/ s Primus Remedies Pvt Ltd |
11.17 (Note 3) |
|
4(xxii) | Dapagliflozin + Metformin Hydrochloride (As Extended release form) | Each film-coated bilayered tablet contains: Dapagliflozin Propanediol monohydrate eq. to Dapagliflozin 10mg, |
1 Tablet | M/s Synokem Pharmaceutical s Ltd. /M/s lndoco Remedies | 9.65 (Note 3) |
| S. No . | Name of the Formulation/ Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
| (l) | (2) | (3) | (4) | (5) | (6) |
|
| Tablet | Metformin Hydrochloride IP 500mg (As Extended release form) |
| Limited |
|
|
4(xxiii ) |
Oapagliflozin + Metformin Hydrochloride (As Extended release form) Table t | Each film-coated bilayered tablet contains: Oapagliflozin Propanediol monohydrate eq. to Oapagliflozin 10mg, Metformin Hydrochloride IP 1000mg (As Extended release form) |
1 Tablet |
M/s Synokem Pharmaceutical s Ltd. / M/ s lndoco Remedies Limited |
11.17 (Note 3) |
|
4(xxiv ) |
Dapagliflozin + Metformin Hydrochloride (As Extended release form) Tablet | Each film-coated bilayered tablet contains: Oapagliflozin Propanediol monohydrate eq. to Oapagliflozin 5mg, Metformin Hydrochloride IP 1000mg (As Extended release form) |
1 Tablet |
M/s Synokem Pharmaceutical s Ltd./ M/s Primus Remedies Pvt Ltd |
7.54 (Note 3) |
|
4(xxv) |
Calcium Carbonate+ Vitamin 03 Methylcobalamin + Calcium L-5- Methyltetrahydro folate & Pyridoxal- 5- Phosphate Tablet | Each Film coated tablet contains: Calcium Carbonate IP 1 250 mg eq. to Elemental Calcium 500mg, Vitamin 03 IP 2000IU Methylcobalamin IP 1500mcg, Calcium L-5- Methyltetrahydrofolate USP 1mg, Pyridoxal - 5- Phosphate 20m |
1 Tablet |
M/s Unison Pharmaceutical s Ltd. |
17.12 (Note 2) |
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