Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-04072025-264383
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 2932]
NEW DELHI, FRIDAY, JULY 4, 2025/ASHADHA 13, 1947
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 4th July, 2025
S.O. 2999(E).— Whereas formulation “Paracetamol I.P. 500 mg and Phenylephrine HCl I.P. 10 mg" is a new
drug as per Para 2(1)(u) of DPCO 2013.
2. And whereas National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) had received application
from M/s GlaxoSmithKline Asia Private Limited for separate price of “Each sachet containing Paracetamol I.P. 500 mg
and Phenylephrine HCl I.P. 10 mg".
3. And whereas, the application of M/s GlaxoSmithKline Asia Private Limited was placed before the Multidisciplinary
Committee of Experts in its 65th meeting held on 23.01.2025, 66th meeting held on 03.03.2025 and 68th meeting held
on 03.06.2025. The applicant in 66th meeting gave detailed presentation about their product and its benefits. The
committee noted that the company submitted the pack shots of similar products and claimed advantages like faster
solubility, faster disintegration hence better safety and efficacy, better AUC level, absorption in intestine, useful in
patents who have difficulty in swallowing and claimed lower price compared to other companies. The Committee
deliberated up on the matter and recommended a separate price for “Each sachet containing Paracetamol I.P. 500 mg
and Phenylephrine HCl I.P. 10 mg" for M/s GlaxoSmithKline Asia Private Limited under Para 11(3) of DPCO,2013
based on similar product available in the market.
4. And whereas, NPPA in its 134th authority meeting held on 26.06.2025 deliberated upon the application of M/s
GlaxoSmithKline Asia Private Limited and accepted the recommendations of the Multidisciplinary Committee of
Experts to give separate price for “Each sachet containing Paracetamol I.P. 500 mg and Phenylephrine HCl I.P. 10 mg"
for M/s GlaxoSmithKline Asia Private Limited under para 11(3) of DPCO 2013.
5. Therefore, in exercise of 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 NPPA, hereby fixes, the price as specified in column (5) of the table herein below as the price exclusive
of goods and services tax, if any, for the formulation specified in the corresponding entry in column (2) of the said
Table with the strength, unit, as specified in the corresponding entries in columns (3), and (4) thereof for M/s
GlaxoSmithKline Asia Private Limited based on the market data;
TABLE
+-------+----------------------------------------------+-------------------------------------------------------------------+-------------+----------------------+
| S. No. | Medicines | Strength | Unit | Retail Price (in Rs.)|
+-------+----------------------------------------------+-------------------------------------------------------------------+-------------+----------------------+
| (1) | (2) | (3) | (4) | (5) |
+-------+----------------------------------------------+-------------------------------------------------------------------+-------------+----------------------+
| 1 | Paracetamol and | Each sachet containing Paracetamol I.P. 500 mg and Phenylephrine HCl | 1 Sachet | 6.96 |
| | Phenylephrine | I.P. 10 mg | | |
| | Hydrochloride sachet | | | |
+-------+----------------------------------------------+-------------------------------------------------------------------+-------------+----------------------+
Notes:
(a) The price as specified in column (5) would be applicable to formulation specified in column (2) with strength and unit
as specified in column (3) and (4) for M/s GlaxoSmithKline Asia Private Limited.
(b) M/s GlaxoSmithKline Asia Private may add goods and services tax only if they have paid actually or it is payable to
the Government on the price mentioned in column (5) of the above said table.
(c) M/s GlaxoSmithKline Asia Private Limited 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) The price of the Paracetamol and Phenylephrine Hydrochloride sachet as specified in column (5) for the formulations
as specified in column (2) 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 GlaxoSmithKline Asia Private 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 GlaxoSmithKline Asia
Private 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.
[PN/266/134/2025/F/F. No. 8(134)/2025/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. 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.
KUMER CHAND Digitally signed by KUMER CHAND
MEENA
MEEN
Date: 2025.07.04 22:12:15+0530