NPPA fixes retail price of FDC to treat Nutritional deficiencies marketed by Abbott
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals & Fertilizers, the Government of India has fixed the revised retail price of the fixed dose combination (FDC) drug consisting of Methylcobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride & Folic Acid manufactured and marketed by Akums Drugs and Pharmaceuticals and Abbott Healthcare respectively at Rs 12.23.
This came in line with the decision of the 109th Authority meeting dated 21.02.2023, where the Authority discussed the new drug applications for price fixation under para 5 & para 15 of DPCO 2013.
The new drug which retail price was fixed is FDC Methylcobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride and Folic Acid Tablet which is used in the treatment of Nutritional deficiencies.
Each film coated tablet contains: Methylcobalamin IP 1500mcg, Alpha Lipoic Acid USP 100mg, Vitamin D3 IP 1000 IU, Pyridoxine Hydrochloride IP 3mg Folic Acid IP 1.5mg.
Methylcobalamin plus Alpha Lipoic Acid plus Vitamin B6 (Pyridoxine) plus Folic Acid plus Vitamin D3 is a combination of five nutritional supplements. Methylcobalamin is an active form of Vitamin B 12. This helps in proper cell growth and development, helps in protein synthesis and production of blood cells (red and white blood cells). Alpha Lipoic Acid is an antioxidant that repairs cell damage and restores vitamin level in the body, it also improves the functions of the nerves. Vitamin B6 (Pyridoxine) and Vitamin D3 are vitamin nutritional supplements that regulate essential metabolic functions in the body for proper growth and development. Folic Acid is also known as folate or vitamin B9. It helps in producing blood (hemoglobin) in the body.
Sl. No. | Name of the Formulation | Dosage form & Strength | Unit | Retail Price (Rs.) | DoP (i) Review no. & Date (ii) Letter no. and Date | Existing SO number & date | Manufacturer & Marketing Company respectively |
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
1. | Methylcobalamin, Alpha Lipoic Acid, Vitamin D3, Pyridoxine Hydrochloride & Folic Acid Tablet | Each film coated tablet contains: Methylcobalamin IP 1500mcg, Alpha Lipoic Acid USP 100mg, Vitamin D3 IP 1000 IU, Pyridoxine Hydrochloride IP 3mg Folic Acid IP 1.5mg | 1 Tablet | 12.23 | 31015/7/2021- Pricing dated 17.09.2021 | 3400(E) dated 19.08.2021 (at Sl. No. 10) | M/s Akums Drugs & Pharmaceuticals Limited / M/s Abbott Healthcare Pvt. Ltd. |
(a) The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u)(1) of the DPCO, 2013 shall fix the retail price as specified in column (5) 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 (5) 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 (5) 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 prices are applicable only to the manufacturer / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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 manufacturers/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.
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