NPPA Fixes Retail Prices of 20 New Drug Formulations Under DPCO 2013
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail prices of 20 new drug formulations under the provisions of the Drugs (Prices Control) Order, 2013.
The formulations brought under retail price fixation include widely used cardiovascular, anti-diabetic, ophthalmic and anti-infective combinations such as Atorvastatin and Clopidogrel Capsules (Rs. 30.09 per capsule) by Macleods Pharmaceuticals; Atorvastatin, Clopidogrel and Aspirin Capsules in 10 mg and 20 mg strengths (Rs. 6.19 and Rs. 8.80 per capsule respectively) by Akums Drugs & Pharmaceuticals; Bilastine and Montelukast Oral Suspension (Rs. 1.75 per ml) by Akums Drugs & Pharmaceuticals/Hetero Healthcare; Bisoprolol Fumarate and Telmisartan Tablets (Rs. 10.73 and Rs. 12.55 per tablet) by Windlas Biotech/Alkem Wellness; Cetirizine Ophthalmic Solution 0.24% w/v (Rs. 14.42 per ml) marketed by Micro Labs and Sun Pharma Laboratories; and others.
This came 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. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (NPPA) 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 | Atorvastatin and Clopidogrel Capsules | Each hard gelatin capsule contains:Atorvastatin Calcium IP Equivalent to Atorvastatin 40 mg (as pellets)Clopidogrel Bisulphate IP Equivalent to Clopidogrel 75 mg (as pellets) | 1 Capsule | M/s Macleods Pharmaceuticals Ltd. | 30.09 |
| 2 | Atorvastatin, Clopidogrel and Aspirin Capsules | Each Hard Gelatin Capsule Contains:Atorvastatin Calcium IP Eq. to Atorvastatin 10 mg (As Film Coated Atorvastatin Tablets IP)Clopidogrel Bisulphate IP Eq. to Clopidogrel 75 mg (As Film Coated Clopidogrel Tablets IP)Aspirin IP 75 mg (As Aspirin Gastro-Resistant Tablets IP) | 1 Capsule | M/s Akums Drugs & Pharmaceuticals Ltd. | 6.19 |
| 3 | Atorvastatin, Clopidogrel and Aspirin Capsules | Each Hard Gelatin Capsule Contains:Atorvastatin Calcium IP Eq. to Atorvastatin 20 mg (As Film Coated Atorvastatin Tablets IP)Clopidogrel Bisulphate IP Eq. to Clopidogrel 75 mg (As Film Coated Clopidogrel Tablets IP)Aspirin IP 75 mg (As Aspirin Gastro-Resistant Tablets IP) | 1 Capsule | M/s Akums Drugs & Pharmaceuticals Ltd. | 8.80 |
| 4 | Bilastine & Montelukast Oral Suspension | Each 5 ml Suspension Contains:Bilastine IP 10 mgMontelukast Sodium IP eq. to Montelukast 4 mg | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Hetero Healthcare Ltd. | 1.75 |
| 5 | Bisoprolol Fumarate & Telmisartan Tablets | Each uncoated bilayered tablet contains:Bisoprolol Fumarate IP 2.5 mgTelmisartan IP 40 mg | 1 Tablet | M/s Windlas Biotech Ltd./ M/s Alkem Wellness Ltd. | 10.73 |
| 6 | Bisoprolol Fumarate & Telmisartan Tablets | Each uncoated bilayered tablet contains:Bisoprolol Fumarate IP 5 mgTelmisartan IP 40 mg | 1 Tablet | M/s Windlas Biotech Ltd./ M/s Alkem Wellness Ltd. | 12.55 |
| 7 | Cetirizine Ophthalmic Solution | Each ml contains:Cetirizine Hydrochloride IP Eq. to Cetirizine 0.24% w/vBenzalkonium Chloride Solution IP 0.02% v/v (As preservative) | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Micro Labs Ltd. | 14.42 |
| 8 | Cetirizine Ophthalmic Solution | Each ml contains:Cetirizine Hydrochloride IP Eq. to Cetirizine 0.24% w/vBenzalkonium Chloride Solution IP 0.02% v/v (As preservative) | 1 ml | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Sun Pharma Laboratories Ltd. | 14.42 |
| 9 | Cilnidipine and Telmisartan Tablets | Each film coated tablet contains:Cilnidipine IP 10 mgTelmisartan IP 40 mg | 1 Tablet | M/s East African (I) Overseas/ M/s SRK Puremed LLP | 8.57 |
| 10 | Dehydroepiandrosterone (DHEA) (Micronized) and Folic Acid Hard Gelatin Capsules | Each Hard Gelatin Capsule Contains:Dehydroepiandrosterone 25 mg (Micronized)Folic Acid IP 1.5 mg | 1 Capsule | M/s Akums Drugs & Pharmaceuticals Ltd./ M/s Mankind Pharma Ltd. | 12.42 |
| 11 | Empagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets | Each film coated bilayer tablet contains:Empagliflozin 10 mgSitagliptin Phosphate Monohydrate IP Eq. to Sitagliptin 100 mgMetformin Hydrochloride (As Extended Release) IP 1000 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Kollectcare Pvt. Ltd. | 14.22 |
| 12 | Empagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets | Each film coated bilayer tablet contains:Empagliflozin 25 mgSitagliptin Phosphate Monohydrate IP Eq. to Sitagliptin 100 mgMetformin Hydrochloride (As Extended Release) IP 1000 mg | 1 Tablet | M/s Exemed Pharmaceuticals/ M/s Kollectcare Pvt. Ltd. | 16.36 |
| 13 | Ivermectin & Albendazole Tablets | Each uncoated chewable tablet contains:Ivermectin IP 6 mgAlbendazole IP 400 mg | 1 Tablet | M/s Skymap Pharmaceuticals Pvt. Ltd./ M/s Glensmith Labs Pvt. Ltd. | 28.34 |
| 14 | Levofloxacin Eye Drops | Levofloxacin Hemihydrate IP Eq. to Levofloxacin 0.5% w/vBenzalkonium Chloride 0.005% w/v (as preservative) | 1 ml | M/s Skymap Pharmaceuticals Pvt. Ltd./ M/s German Remedies Pharmaceuticals Pvt. Ltd. | 11.60 |
| 15 | Mecobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride & Folic Acid Tablets | Each film coated tablet contains:Mecobalamin IP 1500 mcgAlpha Lipoic Acid IP 100 mgVitamin D3 IP 1000 IUPyridoxine Hydrochloride IP 3 mgFolic Acid IP 1.5 mg | 1 Tablet | M/s JK Print Packs (Pharma Division)/ M/s Mankind Prime Labs Pvt. Ltd. | 16.62 |
| 16 | Metoprolol Succinate ER, Cilnidipine & Telmisartan Tablets | Each Film Coated Tablet Contains:Metoprolol Succinate IP 47.5 mg Eq. to Metoprolol Tartrate 50 mg (As Extended Release)Cilnidipine IP 10 mgTelmisartan IP 40 mg | 1 Tablet | M/s Pure and Cure Healthcare Pvt. Ltd./ M/s Ipca Laboratories Ltd. | 14.35 |
| 17 | Metoprolol Succinate ER, Cilnidipine & Telmisartan Tablets | Each Film Coated Tablet Contains:Metoprolol Succinate IP 23.75 mg Eq. to Metoprolol Tartrate 25 mg (As Extended Release)Cilnidipine IP 10 mgTelmisartan IP 40 mg | 1 Tablet | M/s Pure and Cure Healthcare Pvt. Ltd./ M/s Ipca Laboratories Ltd. | 11.45 |
| 18 | Rosuvastatin and Clopidogrel Tablets | Each film coated tablet contains:Rosuvastatin Calcium IP eq. to Rosuvastatin 10 mgClopidogrel Bisulphate IP eq. to Clopidogrel 75 mg | 1 Tablet | M/s Sun Pharma Laboratories Ltd. | 16.32 |
| 19 | Tacrolimus Ointment | Tacrolimus IP 0.1% w/w | 1 gm | M/s Skymap Pharmaceuticals Pvt. Ltd./ M/s German Remedies Pharmaceuticals Pvt. Ltd. | 33.33 |
| 20 | Telmisartan & Cilnidipine Tablets | Each film coated tablet contains:Telmisartan IP 40 mgCilnidipine IP 10 mg | 1 Tablet | M/s Mascot Health Series Pvt. Ltd./ M/s Primus Remedies Pvt. Ltd. | 10.00 |
The notice further added,
(a) The manufacturer of above-mentioned formulations i.e., “new drug” under paragraph 2(1)(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 fixation of retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.
To view the official notice, click the link below:
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