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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-08082024-256186
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 3066]
NEW DELHI, THURSDAY, AUGUST 8, 2024/SHRAVANA 17, 1946
5021 GI/2024
(1)
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 8th August, 2024
S.O. 3216(E).—In implementation of directions of review order issued by the Department of
Pharmaceuticals (DOP) under para 31 of Drugs (Prices Control) Order, 2013 vide order specified in column (7) of the
table below and in exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices
Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022
issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of
the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority)
S.O. No. and date specified in the Column (8) of the table, the National Pharmaceutical Pricing Authority, hereby
fixes/revises the price including WPI impact @0.00551% for the year 2024 as specified in column (6) of the table
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 specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
| Sl. | Medicines | Dosage | Unit | Ceiling | Revised | Review Order | Existing SO |
| No. | | form & | | Price | Ceiling price | number and date | number and date |
| | | Strength | | under | based on | | |
| | | | | NLEM, | Review Order | | |
| | | | | 2022 | & considering | | |
| | | | | (Rs.) | WPI | | |
| | | | | | @0.00551% | | |
| | | | | | (Rs.) | | |
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
+=======+=================+=====================+=======+=====================+=========================================================+===================================+===================================+
| 1. | Valganciclovir | Tablet 450 | 1 | 400.73 | 408.27 | 31015/19/2023- | 1547(E) dated |
| | | mg | Tablet| | | Pricing dated | 26.03.2024 |
| | | | | | | 27.05.2024 | (Sl. No. 668) |
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
| 2. | Metoprolol | Tablet 25 | 1 | 4.20 | 4.25 | 31015/14/2023- | 1547(E) dated |
| | | mg | Tablet| | | Pricing dated | 26.03.2024 |
| | | | | | | 27.05.2024 | (Sl. No. 446) |
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
| 3. | Lamivudine | Tablet 100 | 1 | 10.40 | 11.07 | 31015/16/2023- | 1547(E) dated |
| | | mg | Tablet| | | Pricing dated | 26.03.2024 |
| | | | | | | 27.05.2024 | (Sl. No. 369) |
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
| 4 | Montelukast | Tablet 4 mg | 1 | 10.03 | 10.23 | 31015/16/2023- | 1547(E) dated |
| | | | Tablet| | | Pricing dated | 26.03.2024 |
| | | | | | | 27.05.2024 | (Sl. No. 464) |
+-------+-----------------+---------------------+-------+---------------------+---------------------------------------------------------+-----------------------------------+-----------------------------------+
Note:
(a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled
formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and
notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling
price specified in column (6) in the above table plus Goods and Services Tax as applicable, if any.
(b) All the existing manufacturers of above-mentioned scheduled formulations having MRP lower than the ceiling
price specified in column (6) in the above table plus Goods and Services Tax as applicable, if any, shall continue
to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(c) The manufacturers 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 (6) of the above said table.
(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in
accordance with the ceiling price specified in column (6) of the above table as per provisions contained in
paragraph 11 of the Drugs (Prices Control) Order, 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.
(e) 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.
(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the
above table 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.
(g) The manufacturers 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 through
IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall
furnish information to the NPPA, in respect of discontinuation of 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.
(h) The manufacturers 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 (Prices Control)
Order, 2013 read with Essential Commodities Act, 1955.
(i) Consequent to the issue of ceiling prices of such formulations 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.
[PN/257/125/2024/F/F. No. 8(125)/2024/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director
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