NPPA fixes retail prices for Otsuka Pharmaceutical's 3 formulations
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 Otsuka Pharmaceutical's 3 scheduled formulations.
The authority has fixed the retail price based on the decision made at the 132nd Authority meeting dated 29th April 2025.
The retail prices for the following scheduled formulations have been fixed as follows:
a) Potassium Chloride IP 150 mg + Dextrose Monohydrate IP 5000 mg + Sodium Chloride IP 900 mg: Rs. 92.82 per 500 ml pack
b) Potassium Chloride IP 150 mg + Dextrose Monohydrate IP 5000 mg + Sodium Chloride IP 450 mg: Rs. 75.67 per 500 ml pack
c) Sodium Chloride IP 526 mg + Sodium Gluconate USP 502 mg + Sodium Acetate Trihydrate IP 368 mg + Potassium Chloride IP 37 mg + Magnesium Chloride Hexahydrate IP 30 mg + Dextrose Monohydrate IP 5000 mg (Multiple Electrolytes and 5% Dextrose Injection, Type I, USP): Rs. 151.89 per 500 ml pack
This came as Potassium Chloride Injection 150 mg/mL, Glucose Injection 5 % and Sodium Chloride Injection 0.9% are scheduled formulations, and hence the Fixed Dose Combinations (FDCs) of 'Potassium Chloride + Dextrose Monohydrate + Sodium Chloride' and 'Multiple Electrolytes + Dextrose' are new drugs" for an existing manufacturer under Section 2(1)(u) of DPCO, 2013.
Furthermore, the National Pharmaceutical Pricing Authority had received applications from Otsuka Pharmaceutical India Private Limited for separate retail price of the following formulations in packaging having special features like (i) self-collapsibility and self-seal ability, (ii) not having air-vent and (iii) there is no chance of contamination during manufacture/ infusion/ admixing levels:
Each 100ml contains: Potassium Chloride IP 150mg + Dextrose Monohydrate IP 5000mg + Sodium Chloride IP 900mg- in 500ml pack, of non-glass container in plastic bottle with Euro Head;
Each 100ml contains: Potassium Chloride IP 150mg + Dextrose Monohydrate IP 5000mg + Sodium Chloride IP 450mg- in 500ml pack, of non-glass container in plastic bottle with Euro Head; and
Each 100 ml contains: Sodium Chloride IP 526 mg + Sodium Gluconate USP 502 mg + Sodium Acetate Trihydrate IP 368 mg + Potassium Chloride IP 37 mg + Magnesium Chloride Hexahydrate IP 30 mg + Dextrose Monohydrate IP 5000 mg- for 500ml pack, of non-glass container in plastic bottle with Euro Head and Non-PVC bag having a special feature. This formulation is referred as Multiple electrolytes and 5% Dextrose Injection Type I USP for 500ml pack in non-glass container in plastic bottle with Euro Head and Non-PVC bag having special feature also.
The applications were placed before the Multidisciplinary Committee of Experts (hereinafter referred to as MDC) and the MDC examined the applications for the special features claimed by the applicant in its 61st, 62nd, 63rd and 64th meetings dated 14.8.2024, 25.09.2024, 22.10.2024 and 06.12.2024, respectively.
The company gave the demonstration of their formulations with respect to claims made for special packaging in the 64th meeting. After detailed deliberations and demonstrations made by the company, the MDC, in its 67th meeting held on 02.04.2025, recommended retail prices for the three formulations mentioned at point (2) above, under Para 11(3) of DPCO, 2013.
The Authority, in its 132nd meeting held on 29.04.2025, deliberated upon the applications of Otsuka Pharmaceutical India Private Limited and approved the separate price as recommended by the Multidisciplinary Committee of Experts for the said formulations, under Para 11(3) of DPCO, 2013.
Therefore, in exercise of powers conferred by paragraph 11(3) of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th of May, 2013, issued by the Government of India in the Ministry of Chemicals and Fertilizers, the NPPA has fixed the price as specified in column (5) of the table herein below as the price exclusive of goods and services tax, if any, in relation to the formulations specified in column (2) with the unit as specified in column (4) for Otsuka Pharmaceutical India Private Limited,
Sl.No. | Formulation | Packaging Type | Unit | Separate retail price in respect of formulations in column (2) (in Rs.) |
(1) | (2) | (3) | (4) | (5) |
1 | Each 100ml contains: Potassium Chloride IP 150mg + Dextrose Monohydrate IP 5000mg + Sodium Chloride IP 900mg | Non-glass container in plastic bottle with Euro head having special features | Per 500 ml pack | 92.82 |
2 | Each 100ml contains: Potassium Chloride IP 150mg + Dextrose Monohydrate IP 5000mg + Sodium Chloride IP 450mg | Non-glass container in plastic bottle with Euro head having special features | Per 500 ml pack | 75.67 |
3 | Each 100 ml contains: Sodium Chloride IP 526 mg + Sodium Gluconate USP 502 mg + Sodium Acetate Trihydrate IP 368 mg + Potassium Chloride IP 37 mg + Magnesium Chloride Hexahydrate IP 30 mg + Dextrose Monohydrate IP 5000 mg (Multiple electrolytes and 5% Dextrose Injection Type I USP) | Non-glass container in plastic bottle with Euro Head having special feature and Non-PVC bag having special feature | per 500 ml pack | 151.89 |
The notice further added:
(a) The price as specified in column (5) would be applicable to the formulation as specified in column (2) for M/s Otsuka Pharmaceutical India Private Limited.
(b) M/s Otsuka Pharmaceutical India Private Limited 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) M/s Otsuka Pharmaceutical India Private Limited 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 M/s Otsuka Pharmaceutical India Private Limited, 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 M/s Otsuka Pharmaceutical India Private Limited, as mentioned above 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) Any other manufacturer claiming separate retail price having special feature of the above formulations for packages in non-glass with special features shall apply to NPPA for separate ceiling price approval.
(g) For other special features claimed or any other pack size manufactured, the manufacturers shall approach the NPPA for specific price approval for its formulation.
(h) 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.
To view the full notice, click the below link:
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