Full Text
8208 GI/202 4 (1)
EXTRAORDINARY
PART II —Section 3 —Sub-section ( ii)
PUBLISHED BY AUTHORITY
No. 5088] NEW DELHI, THURSDAY , DEC EMBER 19, 2024 /AGRAHAYANA 28, 194 6
CG-DL-E-19122024-259534
(1) (2) (3) (4)
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals )
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 19th December , 2024
S.O. 5496(E).—Whereas formulations (i) Budesonide 100mcg (ii) Budesonide 200mcg and ( iii) Formoterol
6mcg + Budesonide 100mcg are scheduled formulation under Schedule -I of DPCO 2013 and their ceiling price s are
fixed.
2. And whereas National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) had received application
from M/s C ipla Ltd for separate price of ‘Synchrobreathe Inhaler Device’ for the formulation (i) Budesonide 100mcg -
200 MDI, (ii) Budesonide 200mcg -200 MDI, an d (iii) Formoterol 6mcg + Budesonide 100mcg -120 MDI .
3. And whereas, the application of M/s Cipla Limited wa s placed before the Multidisciplinary Committee of Experts
in its 62nd meeting held on 25.09.2024 . The Committee noted that a separate price @20% of the price of the
formulations could be considered to promote incremental innovation if the same is supporte d by published literature .
Accordingly, it recommended a separate price for “ Synchrobreathe Inhaler Device ” for the formulations specified in
Para 2 above for M/s Cipla Ltd under Para 11(3) of DPCO,2013 @20% of the prevailing ceiling price of the
formulati on.
4. And whereas, NPPA in its 128th meeting held on 12.12.2024 deliberated upon the application of M/s Cipla Limited
and accepted the recommendations of the Multidisciplinary Committee of Experts to give separate price for
“Synchrobreathe Inhaler Device ” @ 20% of the prevailing ceiling price for M/s Cipla Limited for the formulations
mentioned in Para 2 above 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 fi xes, the price as specified in column (4) of the table herein below as the price
exclusive of goods and services tax, if any, in relation to the Synchrobreathe Inhaler Device for the formulation
specified in column ( 2) with the unit as specified in column (3) for M/s Cipla Ltd ;
TABLE
S. No. Formulation Unit Separate Ceiling Price of
Synchrobreathe Inhaler in
respect of formulations in
column (2)
(in Rs.)
(1) (2) (3) (4)
Synchrobreathe Inhaler for Budesonide
Inhalation (MDI) 100 mcg/dose for 200 doses in
one inhaler 1 inhaler 56.40
2 Synchrobreathe Inhaler for Budesonide
Inhalation (MDI) 200 mcg/dose for 200 doses in
one inhaler 1 inhaler 41.20
3 Synchrobreathe Inhaler for Budesonide 100mcg
+ Formoterol 6mcg for 120 doses in one inhaler 1 inhaler 50.88
Note s:
(a) The price of device as specified in column (4) would be applicable to formulation as specified in column (2) for
M/s Cipla Ltd.
(b) M/s Cipla Ltd may add the price as specified in column ( 4) of the above table to the ceiling price, as applicable of the
formulation as specified in column ( 2) with the unit as specified ( 3) of the above table for Synchrobrea the Inhaler
Device .
(c) M/s Cipla Ltd 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 ( 4) of the above said table.
(d) M/s Cipla Ltd shall issue a price list in Form –V from date of Notification as per paragraph 24 of the DPCO, 2013 t o
NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
(e) The price of the Synchrobreathe Inhaler Device as specified in column ( 4) for the formulation s as specified in column
(2) of the above said table may be revised based on Wholesale Price Index (WPI) as per para 16 of DPCO, 2013 .
(f) 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 manufactur er on a conspicuous part of the premises where he ca rries on business in a manner
so as to be easily accessible to any person wishing to consult the same.
(g) The above -mentioned price of the device is applicable only to M/s Cipla Ltd and subject to fulfilment of all the
applicable statutory requirements as lai d 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 concern ed manufacturer/marketing companies.
(h) M/s Cipla Ltd s hall furnish quarterly return to the NPPA, in respect of production / import and sale of the device with
the formulation as stated hereinabove in Form -III of Schedule -II of the DPCO, 2013 through IPDMS. A ny
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.
(i) In case the price of the device is not complied as per the instant price notification and notes specified hereinabove,
then M/s Cipla Ltd shall be liable to deposit the overcharged amount a long with the interest thereon under the
provision s of the DPCO, 2013 read with the Essential Commodities Act, 1955.
[PN/260/128/2024/F /F. No. 8(128)/2024/D.P./NPPA -Div.-II]
MAHAVEER SAINI , Dy. Director
Uploaded by Dte. of Printing at Government of India Press, Ring R oad, Mayapuri, New Delhi -110064
and Published by the Controller of Publications, Delhi -110054.
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