Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-06052025-262934
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 1980]
NEW DELHI, TUESDAY, MAY 6, 2025/VAISAKHA 16, 1947
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 6th May, 2025
S.O. 2024(E).—Whereas, Potassium chloride Injection 150 mg/mL, Glucose Injection 5% and Sodium
chloride Injection 0.9% are scheduled formulation 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.
2. And whereas, National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) had received applications
from M/s 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:
(i) 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;
(ii) 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
(iii) 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 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.
3. And whereas, the applications were placed before the Multidisciplinary Committee of Experts (hereinafter referred
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 demonstration 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 DPСО, 2013.
4. And whereas, the Authority in its 132nd meeting held on 29.04.2025 deliberated upon the applications of M/s
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.
5. 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 May, 2013 issued by the Government of India in the Ministry of Chemicals and
Fertilizers, the NPPA, hereby fixes, 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 for the formulations specified in column (2) with the unit as
specified in column (4) for M/s 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 |
+-----+---------------------------------------------------------------------------------------------------+-------------------------------------------------------------+--------------+----------------+
Notes:
(a) The price as specified in column (5) would be applicable to 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.
[PN/264/132/2025/F/F. No. 8(132)/2025/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director (Pricing)