NPPA fixes retail price of 23 formulations; 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 23 formulations, including those used to treat high blood pressure, heart attacks, type 2 diabetes, human immunodeficiency virus (HIV) infection, and epilepsy.
These include Akums and Linux Laboratory's anticonvulsant drug Levetiracetam Infusion 500mg/100ml, Aishwarya Healthcare and FDC Limited's Paracetamol Infusion IP , Akums Drugs & Pharmaceuticals and Dr. Reddy's Laboratory's fixed dose combination drug Chlorthalidone plus Amlodipine plus Telmisartan Tablet.
The list also includes Cipla's fixed dose combination drug Efavirenz plus Tenofovir Disoproxil Fumerate plus Lamivudine Tablets, which is used to treat human immunodeficiency virus (HIV) infection, and Sun Pharma's anticonvulsant drug Levetiracetam in 0.75% Sodium Chloride Injection.
In addition to this, the list contains the popular anti-diabetic drug combination Dapagliflozin plus Metformin Hydrochloride (As Extended release form) Tablet and Vildagliptin plus Metformin Hydrochloride marketed by Aristo Pharmaceuticals.
Furthermore, the retail price of Methotrexate Topical Gel, an antineoplastic drug used to treat a number of malignancies as well as severe psoriasis, severe rheumatoid arthritis, and juvenile rheumatoid arthritis, marketed by IPCA Laboratories Ltd, has been fixed.
Wockhardt Limited's Erythropoietin Injection IP 2000IU (r-DNA origin) has also had its retail price set. Erythropoietin is a recombinant form of human erythropoietin that is used to treat anaemia by increasing the development of progenitor cells into red blood cells.
This price fixation is followed by the decisions made by the National Pharmaceutical Pricing Authority at its 224th (overall) and 92nd Meeting of Authority under DPCO, 2013 held on 08.09.2021.
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 (hereinafter referred as 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. | Levetiracetam Infusion 500mg/100ml | Each 100ml contains: Levetiracetam IP 500mg, Sodium Chloride IP 820mg Water for injection IP q.s | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Linux Laboratories Pvt. Ltd. | 91.56 |
2. | Methotrexate Topical Gel | Composition: Methotrexate IP 1.0% w/w | 1 gm | M/s Ajanta Healthcare Pvt. Ltd. / M/s IPCA Laboratories Ltd. | 13.21 |
3. | Erythropoietin Injection IP 2000IU (r-DNA origin) | Each 2.0ml Cartridge for pen contains: Erythropoietin concentrated solution IP 20000 IU with HSA stabilizer | Each Pack | M/s Wockhardt Limited | 2054.82 |
4. | Paracetamol Infusion IP 1%w/v | Each 100ml contains: Paracetamol IP….. 1000mg Water for injection IP q.s | Each Pack | M/s. Aishwarya Healthcare / M/s FDC Limited | 295.58 |
5. | Levetiracetam in 0.82% Sodium Chloride Injection, Intravenous Infusion 500mg/100ml | Each 100ml contains: Levetiracetam IP 500mg Sodium Chloride IP 820mg Water for Injections IP q. s. | Each Pack | M/s. Sun pharmaceutical Industries Limited / M/s Sun Pharma Laboratories Limited | 91.56 |
6. | Levetiracetam in 0.75% Sodium Chloride Injection, Intravenous Infusion 1000mg/100ml | Each 100ml contains: Levetiracetam IP 1000mg Sodium Chloride IP 750mg Water for Injections IP q. s. | Each Pack | M/s. Sun pharmaceutical Industries Limited / M/s Sun Pharma Laboratories Limited | 148.72 |
7. | Chlorthalidone, Amlodipine & Telmisartan Tablet | Each film coated tablet contains: Chlorthalidone IP 6.25mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 40mg | 1 Tablet | M/s. Akums Drugs & Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Ltd. | 8.036 |
8. | Chlorthalidone, Amlodipine & Telmisartan Tablet | Each film coated tablet contains: Chlorthalidone IP 6.25mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 80mg | 1 Tablet | M/s. Akums Drugs & Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Ltd. | 12.946 |
9. | Chlorthalidone, | Each film coated tablet contains: | 1 Tablet | M/s. Akums Drugs & | 8.928 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
Amlodipine & Telmisartan Tablet | Chlorthalidone IP 12.50mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 40mg | Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Ltd. | |||
10. | Chlorthalidone, Amlodipine & Telmisartan Tablet | Each film coated tablet contains: Chlorthalidone IP 12.50mg Amlodipine Besylate IP eq. to Amlodipine 5mg Telmisartan IP 80mg | 1 Tablet | M/s. Akums Drugs & Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Ltd. | 13.39 |
11. | Metoprolol Succinate (ER), Cilnidipine & Telmisartan Tablet | Each film coated tablet contains: Metoprolol Succinate IP 23.75mg eq. to Metoprolol tartrate 25mg (As Extended Release) Cilnidipine IP 10mg Telmisartan IP 40mg | 1 Tablet | M/s. Pure & Cure Healthcare Pvt. Ltd. / M/s Lupin Limited | 10.68 |
12. | Metoprolol Succinate (ER), Cilnidipine & Telmisartan Tablet | Each film coated tablet contains: Metoprolol Succinate IP 47.5mg eq. to Metoprolol tartrate 50mg (As Extended Release) Cilnidipine IP 10mg Telmisartan IP 40mg | 1 Tablet | M/s. Pure & Cure Healthcare Pvt. Ltd. / M/s Lupin Limited | 12.95 |
13. | Rosuvastatin + Clopidogrel Capsule | Each hard Gelatin Capsule contains : Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (as pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as pellets) | 1 Capsule | M/s Synokem Pharmaceuticals Ltd. / M/s Micro Lab Ltd. | 19.64 |
14. | Efavirenz + Tenofovir Disoproxil Fumerate + Lamivudine Tablet | Each film coated tablet contains: Efavirenz IP 400mg Tenofovir Disoproxil fumarate IP 300mg equivalent to Tenofovir Disoproxil 245mg Lamivudine IP 300mg | 1 Tablet | M/s Cipla Limited | 59.80 |
15. | Nebivolol + Telmisartan Tablet | Each uncoated bilayered tablet contains: Nebivolol Hydrochloride IP eq. to Nebivolol 5mg, Telmisartan IP 40mg | Tablet | M/s Windlas Biotech Pvt. Ltd. M/s Cadila Pharmaceuticals Ltd. | 12.96 |
16. | Atorvastatin + Clopidogrel Capsule | Each Hard Gelatin Capsule Contains: Atorvastatin Calcium IP eq to Atorvastatin 20mg (As pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) | 1 Capsule | M/s Synokem Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 16.55 |
17. | Amlodipine + Atenalol Tablet | Each uncoated tablet contains: Amlodipine Besylate IP eq. to Amlodipine 5mg Atenalol IP 50mg | 1 Tablet | M/s Wings Biotech LLP / M/s Zuventus Healthcare Ltd. | 5.00 |
18. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) 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 Synokem Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 7.54 |
Sl. No . | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
19. | Dapagliflozin + Metformin Hydrochloride (As Extended release form) 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 Synokem Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 6.25 |
20. | 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 Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 11.17 |
21. | 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 Pharmaceuticals Ltd. / M/s Aristo Pharmaceuticals Pvt. Ltd. | 9.65 |
22. | Vildagliptin + Metformin Hydrochloride (SR) Tablet | Each uncoated bilayered tablet contains: Vildagliptin 50 mg, Metformin Hydrochloride IP 500 mg (as sustained release form) | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./M/s Aristo Pharmaceuticals Pvt. Ltd. | 6.86 |
23. | Vildagliptin + Metformin Hydrochloride (SR) Tablet | Each uncoated bilayered tablet contains: Vildagliptin 50 mg, Metformin Hydrochloride IP 1000 mg (as sustained release form) | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./M/s Aristo Pharmaceuticals Pvt. Ltd. | 7.51 |
The notification 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 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 retail 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.
