Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-09072026-274310
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 3550]
NEW DELHI, WEDNESDAY, JULY 8, 2026/ASHADHA 17, 1948
THE GAZETTE OF INDIA: EXTRAORDINARY
[PART II-SEC. 3(ii)]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 8th July, 2026
S.O. 3712(E).- Whereas the formulation "Glycopyrronium 25 mcg + Formoterol Fumarate 20 mcg +
Budesonide 500 mcg Smartules" is a new drug as per paragraph 2(1)(u) of the Drugs (Prices Control) Order, 2013.
2. And whereas, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) had received an
application from M/s Glenmark Pharmaceuticals Limited vide letter dated 22.01.2026 under paragraph 11(3) of the
Drugs (Prices Control) Order, 2013 seeking fixation of a separate retail price for "Glycopyrronium 25 mcg +
Formoterol Fumarate 20 mcg + Budesonide 500 mcg Smartules".
3. And whereas, the application of M/s Glenmark Pharmaceuticals Limited was placed before the
Multidisciplinary Committee of Experts in its 76th held on 08.04.2026 and 77th meeting held on 15.05.2026. The
applicant in 77th meeting demonstrated the product and explained the specialised manufacturing process involved in
combining three active pharmaceutical ingredients having different formulation characteristics into a single sterile
nebulisation suspension while maintaining stability and efficacy. The Committee noted that the formulation offers
ease of administration, reduced nebulisation time, improved patient adherence, minimal contamination risk, reduced
treatment non-compliance and reduced drug wastage. The Committee further observed that the formulation
represents an incremental innovation, though the company was yet to submit the published clinical study, and
accordingly recommended fixation of a separate retail price of ₹56.35/- per ml for a 2 ml pack under paragraph 11(3)
of the Drugs (Prices Control) Order, 2013 by allowing an increase of 15% over the existing notified retail price of
₹49/- per ml notified vide S.O. 5975(E) dated 24.12.2025.
4. And whereas, the NPPA, in its 148th Authority Meeting held on 07.07.2026, deliberated upon the
application of M/s Glenmark Pharmaceuticals Limited and accepted the recommendations of the Multidisciplinary
Committee of Experts for fixation of a separate retail price under paragraph 11(3) of the Drugs (Prices Control)
Order, 2013 for "Glycopyrronium 25 mcg + Formoterol Fumarate 20 mcg + Budesonide 500 mcg Smartules".
5. Therefore, in exercise of the powers conferred by paragraph 11(3) 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, the National Pharmaceutical Pricing Authority hereby fixes the retail price, exclusive of
Goods and Services Tax, if any, as specified in column (5) of the Table below for the formulation specified in the
corresponding entry in column (2) with the strength and unit specified in columns (3) and (4), applicable to M/s
Glenmark Pharmaceuticals Limited, based on market data;
TABLE
+-----+-----------------------------------+--------------------------------------------------------------------------------------------------------------------------------------------------+----------+------------------+
| S. No. | Medicines | Strength | Unit | Retail Price (₹) |
+=====+===================================+==================================================================================================================================================+==========+==================+
| (1) | (2) | (3) | (4) | (5) |
+-----+-----------------------------------+--------------------------------------------------------------------------------------------------------------------------------------------------+----------+------------------+
| 1 | Glycopyrronium, | Each Smartule contains: | 1 ml | 56.35 |
| | Formoterol Fumarate, | Glycopyrrolate IP Eq. to | | |
| | Budesonide Inhalation Suspension | Glycopyrronium 25 mcg Formoterol | | |
| | | Fumarate Dihydrate IP Eq. to | | |
| | | Formoterol Fumarate 20 mcg | | |
| | | Budesonide IP 500 mcg | | |
+-----+-----------------------------------+--------------------------------------------------------------------------------------------------------------------------------------------------+----------+------------------+
Notes:
(a) The price specified in column (5) shall be applicable to the formulation specified in column (2) with the strength
and unit specified in columns (3) and (4) for M/s Glenmark Pharmaceuticals Limited.
(b) M/s Glenmark Pharmaceuticals Limited may add Goods and Services Tax only if it has actually been paid or is
payable to the Government on the price mentioned in column (5) of the above Table.
(c) M/s Glenmark Pharmaceuticals Limited shall issue a price list in Form-V from the date of notification as per
paragraph 24 of the Drugs (Prices Control) Order, 2013 to NPPA through IPDMS and submit a copy to the State
Drug Controller and dealers.
(d) The price as specified in column (5) for the formulations & strength as specified in column (2) & (3),
respectively, of the above said table may be revised as per para 20 of DPCO, 2013.
(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) The above-mentioned price is applicable only to M/s Glenmark Pharmaceuticals Limited and subject to fulfilment
of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including
manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may
be applicable, by the concerned manufacturer/marketing companies.
(g) In case the price of the formulation specified in column (2) with strength and unit as specified in column (3) and
(4) is not complied as per the instant price notification and notes specified hereinabove, then M/s Glenmark
Pharmaceuticals Limited shall be liable to deposit the overcharged amount along with the interest thereon under the
provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.
(h) Consequent upon the fixation of a separate retail price for the medicine and strength specified in columns (2) and
(3) of the above table in respect of M/s Glenmark Pharmaceuticals Limited, the retail price notified vide S.O.
5975(E) dated 24.12.2025 at Serial No. 35 for M/s Glenmark Pharmaceuticals Limited, prior to the issuance of this
notification, shall stand superseded.
[PN/280/148/2026/F/ F. No. 8(148)/2026/D.P./NPPA-Div.-II]
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.
Login to read full text