NPPA fixes price of 14 formulations including Diabetes drugs and antibiotics, 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 14 formulations, including a popular diabetic medication combination, a breast cancer treatment, and an antibiotic drug combination.The list includes the popular antidiabetic drug combination Dapagliflozin and...
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 14 formulations, including a popular diabetic medication combination, a breast cancer treatment, and an antibiotic drug combination.
The list includes the popular antidiabetic drug combination Dapagliflozin and Metformin Hydrochloride, marketed and manufactured by Synokem Pharmaceuticals and Mankind Pharma. Further, the price of the same combination formulation, marketed and manufactured by MSN Laboratories and J. B. Chemicals & Pharmaceuticls, has also been set by NPPA.
Earlier, the Medical Dialogues Team had reported that the price fixation of the above said antidiabetic drug combination marketed and manufactured by Synokem Pharmaceuticals and Mankind Pharma came during the 33rd meeting of the Multidisciplinary Committee of Experts held on 21.06.2021 where the issue of the retail price fixation of each film-coated bilayered tablet containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin and Metformin Hydrochloride IP (extended release) for four different strength formulations under Para 5 of the DPCO, 2013 was deliberated
In addition, the retail price of Saxagliptin and Metformin Hydrochloride (ER) Tablets, a popular anti-diabetic medication combination manufactured and marketed by Morepen Laboratories, has been set.
Baxalta Bioscience's Human Cogulation Factor IX Freeze Dried IP 1200IU and Intas Pharmaceuticals' oncology drug Trastuzumab are also on the list.
The Mediacal Dialogues Team had reported earlier that the National Pharmaceutical Pricing Authority (NPPA) Committee had suggested the retail price of an oncology drug combination pack of Trastuzumab lyophilized powder for concentrate for solution for infusion vial 375 mg and Bacteriostatic Water for Injection USP 20 ml Vial, manufactured and marketed by Intas Pharmaceuticals, at Rs.17500.00 per vial excluding GST.
This price fixation 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 (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. | 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 Mankind Pharma Ltd. | 7.54 |
2. | 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 Mankind Pharma Ltd. | 11.30 |
3. | 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 Mankind Pharma Ltd. | 9.78 |
4. | 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 Mankind Pharma Ltd. | 6.25 |
5. | Dapagliflozin + Metformin Hydrochloride Extended release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride USP/IP 1000mg (As Extended release form) | 1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s J. B. Chemicals & Pharmaceuticls Ltd. | 11.30 |
6. | Dapagliflozin + Metformin Hydrochloride Extended release Tablet | Each film-coated tablet contains: Dapagliflozin 10mg, Metformin Hydrochloride USP/IP 500mg (As Extended release form) | 1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s J. B. Chemicals & Pharmaceuticls Ltd. | 9.78 |
7. | Dapagliflozin + Metformin Hydrochloride Extended release Tablet | Each film-coated tablet contains: Dapagliflozin 5mg, Metformin Hydrochloride USP/ IP 1000mg (As Extended release form) | 1 Tablet | M/s MSN Laboratories Pvt. Ltd. / M/s J. B. Chemicals & Pharmaceuticls Ltd. | 7.54 |
8. | Human Cogulation Factor IX Freeze Dried IP 1200IU | Each pack contains: Human Cogulation Factor IX Freeze Dried IP 1200IU Sterilized water for injection 10ml (EP/USP) | Each Pack | M/s Baxalta Bioscience India Pvt. Ltd. | 20996. 50 |
9. | Trastuzumab Lyophilized powder for | Combipack of A. Each multiple use vial contains: | Each Pack | M/s Intas Pharmaceuticals | 17500. 00 |
Sl. No. | Name of the Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company | Retail Price (Rs.) |
(1) | (2) | (3) | (4) | (5) | (6) |
concentrate for solution for infusion vial 375mg with Bacteriostatic water for injection USP 20ml vial | Trastuzumab 375mg B. Bacteriostatic water for injection USP 20ml vial | Limited | |||
10. | Saxagliptin + Metformin Hydrochloride (ER) Tablet | Each film coated tablet contains: Saxagliptin Hydrochloride eq. to Saxagliptin 2.5mg Metformin Hydrochloride IP 500mg (as extended Realease) | 1 Tablet | M/s Morepen Laboratories Limited | 17.70 |
11. | Saxagliptin + Metformin Hydrochloride (ER) Tablet | Each film coated tablet contains: Saxagliptin Hydrochloride eq. to Saxagliptin 2.5mg Metformin Hydrochloride IP 1000mg (as extended Realease) | 1 Tablet | M/s Morepen Laboratories Limited | 19.09 |
12. | Saxagliptin + Metformin Hydrochloride (ER) Tablet | Each film coated tablet contains: Saxagliptin Hydrochloride eq. to Saxagliptin 5mg Metformin Hydrochloride IP 500mg (as extended Realease) | 1 Tablet | M/s Morepen Laboratories Limited | 19.45 |
13. | Saxagliptin + Metformin Hydrochloride (ER) Tablet | Each film coated tablet contains: Saxagliptin Hydrochloride eq. to Saxagliptin 5mg Metformin Hydrochloride IP 1000mg (as extended Realease) | 1 Tablet | M/s Morepen Laboratories Limited | 20.84 |
14. | Ofloxacin +Metronidazole Tablet | Each film coated tablet contains: Ofloxacin USP 200mg Metronidazole IP 500mg | 1 Tablet | M/s Unique Pharmaceutical Laboratories (A division of M/s J. B. Chemicals & Pharmaceuticls Ltd) / M/s J. B. Chemicals & Pharmaceuticls Ltd. | 6.72 |
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 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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