NPPA Grants 50% Ceiling Price Hike for Anti-Tetanus Immunoglobulin Injections

Susmita Roy

NPPA Grants 50% Ceiling Price Hike for Anti-Tetanus Immunoglobulin Injections

Written By : Susmita Roy Published On 2026-06-13T13:30:32+05:30 | Updated On 13 Jun 2026 1:30 PM IST

New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling prices of Anti-Tetanus Immunoglobulin 250 IU and 500 IU injections under the Drugs (Prices Control) Order, 2013.

The authority has exercised its extraordinary powers in public interest under Paragraph 19 of the DPCO, 2013, following review directions of the Department of Pharmaceuticals and recommendations of the concerned committee, to allow a one-time revision of ceiling prices of the said formulations.

The revision has been granted in view of rising manufacturing costs, an increase in API prices, exchange rate fluctuations, and concerns regarding financial viability and continued availability of the formulation, which is manufactured by a single company in India.

The list of revised ceiling prices includes Anti-Tetanus Immunoglobulin 250 IU Injection and Anti-Tetanus Immunoglobulin 500 IU Injection, with existing and revised ceiling prices as notified in the Gazette.

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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.

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 postmanufacturing 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.

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 the precedent of Anti-Tetanus Immunoglobulin and BCG Vaccine under NLEM, 2015.

The 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.

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

The committee constituted by the authority for the 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 immunoglobulin 250 IU and 500 IU is based on an 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 a 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.

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.

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.

In line with the above, the notification stated,

"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:

Sl. No.	Name of Scheduled Formulation	Unit	Dosage form & Strength	Existing S.O. No. & Date	Approved revised Ceiling Price (Rs.)
(1)	(2)	(3)	(4)	(5)	6(a)	6(b)
1	Anti-Tetanus Immunoglobulin	As licensed (250 IU)	Per Vial	1912.02	1575(E) Sl. No. 59	25.03.2026
2	Anti-Tetanus Immunoglobulin	As licensed (500 IU)	Per Vial	2881.19	1575(E) Sl. No. 60	25.03.2026

The notification further added:

(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.

Also Read: NPPA Seeks Expert Examination of Ceiling Price Methodology for IV Fluids

To view the official order, click the link below:

https://medicaldialogues.in/pdf_upload/2026/06/13/anti-tetanus-8787c4422856beb6644c1da23d7fd15b-353750.pdf

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Susmita Roy

Mpharm (Pharmacology)

Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.