Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-29082025-265797
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
NEW DELHI, FRIDAY, AUGUST 29, 2025/BHADRA 7, 1947
No. 3874]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 29th August, 2025
S.O. 3979(E).โ Whereas, (i) Meropenem Powder for Injection 500 mg (as trihydrate) and (ii) Meropenem
Powder for Injection 1000 mg (as trihydrate) are scheduled formulation under Schedule-I of DPCO 2013 and its ceiling
price is fixed.
And whereas, M/s Gufic Biosciences Limited have applied for separate ceiling price of (i) Meropenem Powder
for Injection 500 mg (as trihydrate) and (ii) Meropenem Powder for Injection 1000 mg (as trihydrate) having special
features viz. (i) self-collapsibility and self-sealability (ii) not having air-vent; and (iii) there is no chance of
contamination during manufacture/ infusion/ admixing levels in dual chamber bags.
And whereas, the Multidisciplinary Committee of Experts in its 69th meeting held on 03.07.2025 and 70th
meeting held on 05.08.2025observed the special features as mentioned above and recommended an increase of 15%
over and above the ceiling price.
And whereas, National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) in its 136th Authority
meeting dated 28.08.2025 accepted the recommendation of the Multidisciplinary Committee of Experts.
Therefore, in exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 of the Drugs (Prices
Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 5249(E) dated 11th November, 2022 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 'A' for the manufacturer specified in Table 'B' herein below as ceiling price exclusive of
goods and services tax applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry
in column (2) of the said Table with the dosage form & strength and unit/packaging specified respectively in the
corresponding entries in columns (3) and (4) thereof:
Table 'A'
+-----+-------------------------+-----------------------------------+-----------------+------------------------+
| Sl. | Name of the Scheduled | Dosage form and Strength | Unit | Ceiling Price excluding|
| No. | Formulation | | | GST (Rs.) |
+-----+-------------------------+-----------------------------------+-----------------+------------------------+
| (1) | (2) | (3) | (4) | (5) |
+-----+-------------------------+-----------------------------------+-----------------+------------------------+
| 1 | Meropenem | Powder for Injection 500 mg (as | Per Dual | 845.94 |
| | | trihydrate) | chamber bag | |
+-----+-------------------------+-----------------------------------+-----------------+------------------------+
| 2 | Meropenem | Powder for Injection 1000 mg (as | Per Dual | 1114.72 |
| | | trihydrate) | chamber bag | |
+-----+-------------------------+-----------------------------------+-----------------+------------------------+
Table 'B'
+-------+-----------------------------+
| Sl. No. | Name of Manufacturer |
+-------+-----------------------------+
| (1) | (2) |
+-------+-----------------------------+
| 1 | M/s Gufic Biosciences Limited |
+-------+-----------------------------+
Note:
(a) The ceiling price specified in column (5) of Table A is only applicable to the manufacturer mentioned in Table
B. The manufacturer specified in Table B, selling the branded or generic or both the versions of scheduled
formulations with dosage form and strength specified in column (2) and (3) of Table A respectively, at a price
higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the
Government, shall revise their prices of all such formulations downward not exceeding the ceiling price
specified in column (5) in the above table plus local taxes as applicable, if any.
(b) The manufacturer may add Goods and Services Tax only if they have paid actually or if it is payable to the
Government on the ceiling price mentioned in column (5) of the above said table.
(c) The manufacturer shall issue a price list in Form-V in compliance from date of this notification as per paragraph
24 of the DPะกะ, 2013.
(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) Any other manufacturer claiming separate ceiling price having special feature of dual chamber bag helping in
reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction
in the possibility of contamination shall apply to NPPA for separate ceiling price approval.
(f) For other special features claimed or any other pack size manufactured, the manufacturer shall approach the
NPPA for specific price approval for its formulation.
(g) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the
above Table A, launches a new drug as per paragraph 2(1)(u) of the DPCO, 2013 such existing manufacturer
shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of
the DPCO, 2013.
(h) The manufacturer(s) of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect
of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013. Any
manufacturer intending to discontinue production of above said scheduled formulation shall furnish
information to the NPPA, in respect of discontinuation of the production and / or import of scheduled
formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of
discontinuation.
(i) The manufacturer(s) not complying with the ceiling price and notes specified hereinabove shall be liable to
deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Price Control)
Order, 2013 read with Essential Commodities Act, 1955.
(j) Consequent to the issue of ceiling prices of such formulations for specified in column (2) of the above Table
A 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.
[PN/268/136/2025/F/F. No. 8(136)/2025/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
SARVESH KUMAR Digitally signed by SARVESH
SRIVASTAVA