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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-12062026-273376
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 2908]
NEW DELHI, THURSDAY, JUNE 11, 2026/JYAISTHA 21, 1948
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICALS PRICING AUTHORITY)
NOTIFICATION
New Delhi, the 11th June, 2026
S.O. 3006(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 fixed the ceiling prices of BCG Vaccine, Measles Rubella Vaccine and
Measles Vaccine 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 17.10% under Paragraph 6 of
DPCO, 2013;
4. And whereas M/s Serum Institute of India Private Limited filed a Review Application under paragraph
31 of the Drugs (Prices Control) Order, 2013 against the aforesaid notification stating that that the methodology of
applying average price reduction under Paragraph 6 of DPCO, 2013 based on other vaccines in the same sub-therapeutic
category is inappropriate for biologicals/vaccines, as each vaccine is distinct in terms of manufacturing process,
technology, market dynamics and therapeutic use;
5. And whereas the Department of Pharmaceuticals, Government of India, after examination of the
matter and considering the submissions of the applicant and NPPA, issued Review Order No. 31015/01/2025-Pricing
(E-30166) dated 07.04.2026 and observed that while NPPA had followed the methodology prescribed under the Drugs
(Prices Control) Order, 2013, the vaccines in question are of critical public health significance, have shown relatively
stable price trends, impose minimal financial burden on citizens and are supplied by a single manufacturer at relatively
low prices. Accordingly, the Department of Pharmaceuticals, referred back the matter to NPPA for reconsideration in
accordance with the precedent adopted in the case of BCG Vaccine under NLEM, 2015, wherein monopoly reduction
was not considered;
6. And whereas NPPA had earlier, in public interest and to ensure continued availability and viability of
BCG Vaccine, invoked paragraph 19 of the Drugs (Prices Control) Order, 2013 and revised the ceiling price of BCG
Vaccine without applying monopoly reduction vide notification S.O. 1769(E) dated 26th April, 2018 and subsequently
allowed a one-time increase vide notification S.O. 4461(E) dated 13th December, 2019;
7. And whereas the NPPA in its 279th (Overall) and 147th Authority meeting held on 11.06.2026,
deliberated on the matter and decided that ceiling price may be fixed/revised under paragraph 19 of the DPCO 2013
without applying reduction under monopolistic condition to address the grievance of the applicant as well as to ensure
sufficient availability of the drug in the market;
8. Now, therefore, in exercise of the powers conferred by paragraph 19 of the Drugs (Prices Control)
Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated the 11th November, 2022 issued
by the Government of India in the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, 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 @0.64956% for the year 2026
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. No.| Medicines | Dosage form & Strength | Unit | Ceiling Price under | Revised Ceiling price based on Review Order | Review Order number and date | Existing SO number and date |
| | | | | NLEM, 2022 (Rs.) | & considering WPI @0.64956% (Rs.) | | |
+--------+---------------------+--------------------------+-----------+-----------------------+-------------------------------------------------------------+----------------------------------------------+----------------------------------+
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
+========+=====================+==========================+===========+=======================+=============================================================+==============================================+==================================+
| 1. | BCG Vaccine | As licensed | Each dose | 8.20 | 9.89 | 31015/01/2025 - Pricing (E-30166) dated | 1575(E) dated 25.03.2026 |
| | | | (0.10 ML) | | | 07.04.2026 | (Sl. No. 92) |
+--------+---------------------+--------------------------+-----------+-----------------------+-------------------------------------------------------------+----------------------------------------------+----------------------------------+
| 2. | Measles Rubella | As licensed | Each Vial | 72.90 | 87.93 | 31015/01/2025 - Pricing (E-30166) dated | 1575(E) dated 25.03.2026 |
| | Vaccine | | (0.5ml) | | | 07.04.2026 | (Sl. No. 472) |
+--------+---------------------+--------------------------+-----------+-----------------------+-------------------------------------------------------------+----------------------------------------------+----------------------------------+
| 3. | Measles Vaccine | As licensed | Each Vial | 51.40 | 62.00 | 31015/01/2025 - Pricing (E-30166) dated | 1575(E) dated 25.03.2026 |
| | | | (0.5ml) | | | 07.04.2026 | (Sl. No. 473) |
+--------+---------------------+--------------------------+-----------+-----------------------+-------------------------------------------------------------+----------------------------------------------+----------------------------------+
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) 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.
(c) 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.
(d) 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.
(e) 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.
(f) 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.
(g) 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.
(h) 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/279/147/2026/F / F. No. 8(147)/2026/D.P./NPPA-Div.-II]
BHIVA RAM YADAV, Assistant Director
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