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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-12062026-273374
EXTRAORDINARY
PART II—Section 3—Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 2907]
NEW DELHI, THURSDAY, JUNE 11, 2026/JYAISTHA 21, 1948
4233 GI/2026
(1)
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICALS PRICING AUTHORITY)
ORDER
New Delhi, the 11th June, 2026
S.O. 3005(E).— Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the
Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August,
1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices
of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control)
Order (DPCO);
2. And whereas, the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in
exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the
powers in respect of specified paragraphs of the DPCO, 2013, including paragraph 19 of the said Order to be
exercised by the NPPA on behalf of the Central Government;
3. And whereas, NPPA had notified the ceiling prices of Anti-Tetanus Immunoglobulin 250 IU Injection and
Anti-Tetanus Immunoglobulin 500 IU Injection vide notification S.O. 5497(E) dated 19th December, 2024
under the provisions of the Drugs (Prices Control) Order, 2013 based on the Pharmarack data after applying
monopoly reduction of 7.67% under Para 6 of DPCO, 2013;
4. And whereas, M/s Bharat Serums & Vaccines Limited filed a Review Application under paragraph 31 of the
Drugs (Prices Control) Order, 2013 against the notification S.O. No. 5497(E) dated 19.12.2024, inter alia,
contending that it is the sole manufacturer of Anti-Tetanus Immunoglobulin in India and, ensured continued
production in public interest; however, the formulation has become financially unviable due to a significant
increase in import-dependent API costs, fluctuations in exchange rates, and rising manufacturing and post-
manufacturing expenses, resulting in persistent negative margins. The applicant further submitted that it had
already sought upward price revision under paragraph 19 of the DPCO, 2013;
5. And whereas, the Department of Pharmaceuticals, Government of India, after examination of the matter issued
Review Order No. 31015/03/2025-Pricing (E-30195) dated 07.04.2026 referring back the matter to NPPA for
reconsideration in accordance with precedent of Anti-Tetanus Immunoglobulin and BCG Vaccine under
NLEM, 2015;
6. And whereas, in 2019, Committee on Affordable Medicines and Health Products (CAMHP, earlier known as
SCAMHP), NITI Aayog, Government of India provided guidance on the modalities/ methodology to be
followed. CAMHP in its 2nd meeting held on 07.11.2019 recommended an increase of 50% in the ceiling
prices and also authorized NPPA to examine additional formulations / molecules experiencing similar issues
of manufacturing unviability due to low prices and apply upward price revision on principles determined by
CAMHP;
7. And whereas, the Authority, based on the said guidance, has previously allowed one-time upward revision of
ceiling prices for certain essential scheduled formulations in public interest to ensure their continued
availability in the market;
8. And whereas, the Committee constituted by the Authority for examination of cases under paragraph 19 of the
Drugs (Prices Control) Order, 2013, in its 8th meeting held on 18.05.2026 noted that the request for Anti -
Tetanus Immunoglobin 250IU and 500IU is based on increase in raw material, excipients, and overall
manufacturing costs. The Committee noted that the formulation is manufactured by a single company, has
been under price regulation since NLEM 2011, and shows substantial increase in API price over recent years.
The Committee deliberated on the matter and recommended consideration of appropriate upward price revision
under Paragraph 19;
9. And whereas, the Authority, after deliberating upon the recommendations of the Committee constituted under
paragraph 19 of the Drugs (Prices Control) Order, 2013, increase in API and other input costs, and the need to
ensure continued availability of these critical medicines, invoked the extraordinary powers in public interest
under paragraph 19 of the said Order for upward revision of the ceiling prices of the said formulations by
allowing a one-time increase of 50% over the prevailing ceiling prices;
10. And whereas, the Authority further noted that the said increase is being granted as a comprehensive measure
already taking into account all relevant factors including market structure and supply conditions, and therefore,
reconsideration of monopoly reduction or any adjustment on that account is not warranted separately in the
present case;
11. Now, therefore, in exercise of extraordinary powers in public interest, conferred by paragraph 19 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, and in supersession of the Order(s) of the Government
of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. Number
and date specified in column no. 6(a) & 6(b) mentioned in the table below, the National Pharmaceutical Pricing
Authority, hereby fixes the prices as specified in column (5) of the Table below as ceiling prices exclusive of
Goods and Services Tax applicable, if any in respect of the Scheduled formulations 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
+----+-----------------------------+-------------------+----------+---------------+----------------+
| SI. | Name of the Scheduled | Dosage form & | Unit | Approved | Existing S.O. No. & Date |
| No. | Formulation | Strength | | revised | |
| | | | | Ceiling Price | |
| | | | | (Rs.) | |
+====+=============================+===================+==========+===============+================+
| (1)| (2) | (3) | (4) | (5) | 6(a) | 6(b) |
+----+-----------------------------+-------------------+----------+---------------+---------------+----------------+
| 1. | Anti-Tetanus | As licensed (250 | Per Vial | 1912.02 | 1575(E) | 25.03.2026 |
| | Immunoglobulin | IU) | | | Sl. No. 59 | |
+----+-----------------------------+-------------------+----------+---------------+---------------+----------------+
| 2. | Anti-Tetanus | As licensed (500 | Per Vial | 2881.19 | 1575(E) | 25.03.2026 |
| | Immunoglobulin | IU) | | | Sl. No. 60 | |
+----+-----------------------------+-------------------+----------+---------------+---------------+----------------+
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 (5) in the above table plus Goods and Services Tax as applicable, if any.
(b) The provisions of paragraph 13(2) of DPCO 2013 would not be applicable on the ceiling price specified in column (5)
in respect of the formulations with dosage & strength mentioned in column (2) and (3) respectively.
(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 (5) 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 (5) 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 paragraph 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 price of such formulation 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/279/147/2026/F/ F. No. 8(147)/2026/DP/Div-II/NPPA]
BHIVA RAM YADAV, Assistant 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.
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