NPPA fixes retail prices of 30 formulations, defers Sun Pharma, Micro Labs new drug applications
New Delhi: The National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India has fixed prices of 30 formulations while it deferred two new drugs application each from Micro Laboratories and Sun Pharma.
This came during the 77th meeting of DPCO 2013, wherein, the Authority out of applications for 34 new drug pricing, approved only 30 new drugs; and rejected four applications moved by Micro Labs and Sun Pharma for dapagliflozin + metformin hydrochloride ER tablet, dapagliflozin + metformin hydrochloride tablet, Metformin SR + glimepiride + voglibose tablet respectively.
The Economic Adviser under the Department of Economic Affairs presented an analysis after examining the present procedure of calculating the retail price. The data comprised companies that have one percent or more market share and illustrated the changes in prices by altering the threshold of the market share.
The Authority deliberated upon the matter in detail and appreciated the viewpoint presented by the Member.
"The Authority noted that the present practice of taking data of the companies having 1% and more market share is as per the provisions of DPCO 2013 and the same is based on National Pharmaceutical Pricing Policy, 2012 (NPPP 2012) which is approved by the Cabinet. Any alteration of the market share threshold requires a change in the policy. Hence, the retail price calculation has to be as per the applicable provisions of DPCO 2013, " read the minutes of the meeting.
Consequently, under para 5 and 15 of the DPCO 2013, it approved the retail prices of 30 new drugs.
These include some popular drug brands and combination formulations like Cardipill CV 10mg, Metronidazole ER Tablet, MyGainPro 2, MyLosdro A, Paracetamol + Mefenamic Acid suspension (Sumo-L Plus DS) Glimepiride + Voglibose + Metformin Hydrochloride Tablet (Gemer V2) and so on to treat various ailments including prevention of cardiovascular diseases, bacterial infections, type 2 diabetes mellitus (DM), painkiller and others.
Prominent drugmakers like Intas Pharma, Akums Drugs, Mylan, Lupin, Zydus Healthcare, Sun Pharma, Abbott, and others are involved in manufacturing the formulations mentioned in the list.
The details of the list of price formulations fixed under DPCO 2013 by NPPA reads;
| Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) | (6) |
| 1. | Memantine Hydrochloride + Donepezil Hydrochloride Tablet | Each film-coated tablet contains: Memantine Hydrochloride IP 10mg Donepezil Hydrochloride IP 10mg | 1 Tablet | M/s Intas Pharmaceuticals Limited | 16.55 |
| 2. | Rosuvastatin+ Clopidogrel Capsule (Cardipill CV 10mg) | Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) | 1 Capsule | M/s Synokem Pharmaceuticals Limited /M/s Aristo Pharmaceuticals Pvt. Limited | 14.09 |
| 3. | Rosuvastatin+ Clopidogrel Capsule (Cardipill CV 20mg) | 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 Limited /M/s Aristo Pharmaceuticals Pvt. Limited | 18.70 |
| 4. | Rosuvastatin+ Aspirin + Clopidogrel Capsule (Cardipill Gold 10mg) | Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Aspirin IP 75mg (As Enteric coated Pellets) | 1 Capsule | M/s Synokem Pharmaceuticals Limited /M/s Aristo Pharmaceuticals Pvt. Limited | 11.89 |
| 5. | Rosuvastatin+ Aspirin + Clopidogrel Capsule (Cardipill Gold 20mg) | Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) Aspirin IP 75mg (As Enteric coated Pellets) | 1 Capsule | M/s Synokem Pharmaceuticals Limited /M/s Aristo Pharmaceuticals Pvt. Limited | 18.34 |
| 6. | Metronidazole ER Tablet | Each Extended-Release Film Coated Tablet contains: Metronidazole IP 600mg | 1 Tablet | M/s Abbott Healthcare Pvt. Ltd. | 4.47 |
| 7. | Desvenlafaxine ER + Clonazepam Tablet (MDD-XR Plus 50) | Each uncoated Bilayered tablet contains: Desvenlafaxine Succinate USP eq. | 1 Tablet | M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd. | 12.42 |
to Desvenlafaxine 50mg (As Extended Release Form) Clonazepam IP 0.5mg | |||||
8. | Desvenlafaxine ER + Clonazepam Tablet (MDD-XR Plus 100) | Each uncoated Bilayered tablet contains: Desvenlafaxine Succinate USP eq. to Desvenlafaxine 100mg (As Extended-Release Form) Clonazepam IP 0.5mg | 1 Tablet | M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd. | 20.38 |
9. | Glimepiride + Metformin Tablet (MyGainPro 2) | Each uncoated tablet contains: Glimepiride IP 2mg, Metformin Hydrochloride IP 500mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. | 8.00 |
10. | Amlodipine +Atenolol Tablet (MyAdol) | Each uncoated tablet contains: Amlodipine Besilate IP eq. to Amlodipine 5mg, Atenolol IP 50mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. | 5.03 |
11. | Amlodipine + Losartan Potassium Tablet (MyLosdro A) | Each film coated tablet contains: Amlodipine Besylate IP eq. to Amlodipine 5mg, Losartan Potassium IP 50mg | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. | 7.30 |
12. | Calcium Carbonate +Vitamin D3 Tablet (MyVitacillin) | Each film-coated tablet contains Calcium Carbonate from an organic source (Oyster shell) eq. to Elemental Calcium 500mg, Vitamin D3 IP 250 IU | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. | 4.81 |
13. | Metoprolol + Cilnidipine Tablet | Each film-coated bilayered tablet contains: Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (In prolonged-release form), Cilnidipine IP 10mg | 1 Tablet | M/s Safetab Life Science / M/s Lupin Limited | 9.25 |
14. | Tolperisone SR + Diclofenac Tablet | Each uncoated bilayered the sustained-release tablet contains Tolperisone Hydrochloride 450mg, Diclofenac Sodium IP 100mg | 1 Tablet | M/s Inventia Healthcare Pvt. Ltd. / M/s Intas Pharmaceuticals Limited | 27.05 |
15. | Dexamethasone Tablet | Each uncoated tablet contains: Dexamethasone IP 4mg | 1 Tablet | M/s Zydus Healthcare Limited | 3.69 |
16. | Metoprolol PR + Cilnidipine Tablet | Each film-coated bilayered tablet contains: Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate 25mg (In prolonged-release form), Cilnidipine IP 10mg | 1 Tablet | M/s Safetab Life Science / M/s Lupin Limited | 7.22 |
17. | Paracetamol + Mefenamic Acid suspension (Sumo-L Plus DS) | Each 5ml contains: Paracetamol IP 250mg, Mefenamic Acid IP 100mg | 1 ML | M/s Alkem Laboratories Ltd. | 0.67 |
18. | Bisoprolol + Amlodipine Tablet | Each film-coated tablet contains Bisoprolol Fumarate IP 2.5mg, Amlodipine Besilate IP 5mg | 1 Tablet | M/s Swiss Garnier Genexiaa Sciences Pvt. Ltd.M/s Lupin Ltd. | 5.89 |
19. | Bisoprolol + Amlodipine Tablet | Each film-coated tablet contains: Bisoprolol Fumarate IP 5mg, Amlodipine Besilate IP 5mg | 1 Tablet | M/s Swiss Garnier Genexiaa Sciences Pvt. Ltd.M/s Lupin Ltd. | 7.69 |
20. | Mesalazine Suppository | Each Suppository contains: Mesalazine IP 1gm | 1 Suppository | M/s Bliss GVS Pharma Ltd. / M/s Sun Pharma Laboratories Limited | 97.88 |
21. | Glimepiride + Voglibose + Metformin Hydrochloride Tablet | Each uncoated Bilayer tablet contains: Glimepiride IP 2mg, | 1 Tablet | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Sun Pharma Laboratories | 12.35 |
(Gemer V2) | Voglibose IP 0.2mg Metformin Hydrochloride IP 500mg (As Extended Release form) | Limited | |||
22. | Capecitabine + Cyclophosphamide Tablet | Each film-coated tablet contains: Capecitabine IP 700mg, Cyclophosphamide IP 32.1mg, Eq. to Anhydrous Cyclophosphamide 30mg | 1 Tablet | M/s Intas Pharmaceuticals Limited | 168.53 |
23. | Capecitabine + Cyclophosphamide Tablet | Each film-coated tablet contains: Capecitabine IP 400mg, Cyclophosphamide IP 21.4mg Eq. to Anhydrous Cyclophosphamide 20mg | 1 Tablet | M/s Intas Pharmaceuticals Limited | 107.53 |
24. | Methylcobalamin + Alpha Lipoic Acid + Pyridoxine + Folic Acid Capsule (MyFocoly) | Each Soft Gelatin Capsule contains: Methylcobalamin IP 1500 mcg, Alpha Lipoic Acid USP 100 mg, Pyridoxine Hydrochloride IP 3 mg, Folic Acid IP 1.5 mg | 1 Capsule | M/s Akums Drugs & Pharmaceuticals Limited/M/s Mylan Pharmaceuticals Pvt. Limited | 12.37 |
25. | Folic Acid+ Methylcobalamin + Pyridoxine Hydrochloride Tablet | Each film-coated tablet contains: Folic Acid IP 5mg, Methylcobalamin IP 1500mcg Pyridoxine Hydrochloride IP 20mg | 1 Tablet | M/s Unison Pharmaceuticals Pvt. Ltd. | 3.87 |
26. | Chlorhexidine Gluconate + Isopropyl Alcohol Topical Solution | Contains: Chlorhexidine Gluconate Solution IP 2.5% v/v eq. to Chlorhexidine Gluconate 0.5% w/v, Isopropyl Alcohol IP 70% v/v | 100ml pack | M/s Stedman Pharmaceuticals Pvt. Limited | 42.37 |
27. | Chlorhexidine Gluconate + Isopropyl Alcohol Topical Solution | Contains: Chlorhexidine Gluconate Solution IP 2.5% v/v eq. to Chlorhexidine Gluconate 0.5% w/v, Isopropyl Alcohol IP 70% v/v | 200ml pack | M/s Stedman Pharmaceuticals Pvt. Limited | 84.75 |
28. | Chlorhexidine Gluconate + Isopropyl Alcohol Topical Solution | Contains: Chlorhexidine Gluconate Solution IP 2.5% v/v eq. to Chlorhexidine Gluconate 0.5% w/v, Isopropyl Alcohol IP 70% v/v | 500ml pack | M/s Stedman Pharmaceuticals Pvt. Limited | 211.87 |
29. 30. | Chlorhexidine Gluconate + Isopropyl Alcohol Topical Solution
Chlorhexidine Gluconate + Isopropyl Alcohol Topical Solution | Contains: Chlorhexidine Gluconate Solution IP 2.5% v/v eq. to Chlorhexidine Gluconate 0.5% w/v, Isopropyl Alcohol IP 70% v/v Gluconate 0.5% w/v, Isopropyl Alcohol IP
70% v/v
Contains: Chlorhexidine Gluconate Solution IP 2.5% v/v eq. to Chlorhexidine Gluconate 0.5% w/v, Isopropyl Alcohol IP
70% v/v | 5000ml pack
5000ml pack | M/s Stedman Pharmaceuticals Pvt. Limited M/s Stedman Pharmaceuticals Pvt. Limited | 2118.64
2118.64 |
The notification further added;
(a) The manufacturer of the 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.
(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 fulfillment 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.
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