NPPA Stent Notification
(Published in Part II, Section 3, Sub Section (ii) of the Gazette of India Extraordinary)
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
National Pharmaceuticals Pricing Authority
New Delhi. The 13. February 2017
S.O.
412(E) Whereas the Government of India in the Ministry of Health and
Family Welfare included Coronary Stents in the National List of
Essential Medicines. 2015 (NLEM, 2015) by notification
No. X-11035/344/2015-DFQC dated 19th July 2016.
No. X-11035/344/2015-DFQC dated 19th July 2016.
2.
And whereas the Government of India in the Ministry of Chemicals and
Fertilizers, Department of Pharmaceuticals, by notification No. S.O.
4100 (E) dated 21st December 2016 has incorporated Coronary Stents at
serial no. 31 of Schedule I of the Drug Prices Control Order, 2013
(DPCO, 2013) and therefore, Coronary Stems arc 'scheduled formulations
under the provisions of the DPCO, 2013.
3.
And whereas die National Pharmaceutical Pricing Authority (NPPA) was
established by Resolution No. 33/7/97-PI.I dated 29. August 1997 of the
Government of India in the Ministry of Chemicals and Fertilizers to
fix/revise, monitor prices of drugs/formulations and oversee the
implementation of the DPCO; and whereas the Government of India by S.O.
1349(E) dated 30th May 2013 in exercise of the powers conferred by
Section 3 and 5 of the Essential Commodities Act, 1955 (10 of 1955) has
delegated the powers in respect of paragraphs 4, 5, 6, 7, 8, 9,10, 11,
12, 13, 14, 15, 16, 18, 19, 20, 21, 23, 24, 25, 26, 27, 28, 29,30 and 32
of the DPCO, 2013 to the NPPA to exercise the functions of the Central
Government.
4.
And whereas the aim of the DPC. 2013 issued under section 3 of
Essential Commodities Act, 1955, is to ensure that essential drugs are
available to all at affordable prices. Whereas the Hon'ble Supreme Court
of India by order dated 12th November 2002 in SLP no. 3668/2003 (Union
of India vs. K.S. Gopinath & others) directed the Government to
ensure that life saving drugs do not fall out of price control.
5.
And whereas the Core Committee which examined the issues relating to
the essentiality of Coronary Stems in its report to the Government in
April 2016 observed that there is very high incidence of coronary artery
disease (CAD) in India associated with high morbidity and mortality;
and that CAD has become a major public health problem; and that
Percutaneous Coronary Intervention (PCI) procedure requiring coronary
stent implantation is an important treatment modality for the management
of CAD, and hence coronary stents are 'essential' for public health.
6.
And whereas NPPA carried out an exhaustive exercise of consultation
with stakeholders for fixing the ceiling price of Coronary Stents on 4th
January 2017, 5th January 2017 and 6th January 2017, as per office
memorandum no. 19(837)/2016/Div.11/DP/NPPA dated 23rd December 2016; and whereas NPPA considered all available information and data on prices of Coronary Stents in its 40th Authority
Meeting held on 23rd January 2017. During deliberations, it was found
that huge unethical markups are charged at each stage in the supply
chain of Coronary Stents resulting in irrational, restrictive and
exorbitant prices in a failed market system driven by information
asymmetry between the patient and doctors pushing patients to financial
misery; and whereas under such extraordinary circumstances, there is an
urgent necessity, in public interest, to fix ceiling price of Coronary
Stents to bring respite to patients.
7.
And whereas the Hon’ble Supreme Court of India in its judgment in Glaxo
India Limited vs UOI reported in (2014)2 SCC 753, while dealing with
the implementation of notified prices for the benefit of consumers,
referred to the prefatory statement made by the Hon’ble Supreme Court in
Cynamide India Limited (1987) 2 SCC 722 as worth noticing, wherein the
Court observed:
“2.
Profiteering by itself. is evil Profiteering in the scares resources of
the community, much needed life-sustaining foodstuffs and life-saving
drugs is diabolic It is a menace which has to be fettered and curbed.
One of the principal objectives of the Essential Commodities Act. 1955
is precisely that. It must be remembered that Article 39(b), enjoins a
duty on the State towards securing 'that the ownership and control of
the material resources of the community are so distributed as best to
subserve the common good”.
8.
And whereas the Government is under constitutional obligation to provide
fair, reasonable and affordable price for Coronary Stents and therefore
its immediate intervention is imperative to check unethical
profiteering and exploitive pricing; and whereas Paragraph 19 of the
DPCO, 2013 inter- alia authorises the Government, extraordinary
circumstances, if it considers necessary so to do in public interest, to
fix the ceiling price or retail price of any drug for such period, as
it deems fit.
9.
And whereas price fixation notifications issued for certain
formulations under paragraph 19 of the DPCO, 2013 by the NPPA on 10th
July 2014 have been upheld by the Hon'ble High Court of Bombay in its
judgment dated 26th September 2016 in W.P.(C) No. 2700 of 2014 (Indian
Pharmaceutical Alliance vs. Union of India) wherein the Hon'ble High
Court. inter-alia, observed:
“20……
when such failure is considered in the context of role the
pharmaceuticals play in the area of public health, which is a social
right, the Government intervention becomes necessary especially when
exploitive pricing makes medicines tin-affordable and beyond the reach
of most and also puts huge financial burden in terms of out of pocket
expenditure on healthcare....”
and
whereas SLP (C) 30089/2016 filed by Indian Pharmaceutical Alliance has
been dismissed on 24th October 2016 by the Hon’ble Supreme Court of
India.
10.
And whereas W.P.(C) 1772/2015 (PIL) and W.P. (C)11085/2016 have been
filed in nature of Public Interest Litigation (PIL) including Cont. Case
(C.) 815/2015 before the Hon’ble High Court of Delhi seeking directions
to the Respondents (Union of India) to include Coronary Stents in the
National List of Essential Medicines (NLEM) and thereby control the sale
price of Coronary Stents.
11.
And whereas, the NPPA in its Authority Meeting held on 13th February
2017, after duly examining in detail and considering all available
information/data and all relevant options for price fixation of Coronary
Stents, under present extraordinary circumstances of a failed and
exploitative market system has decided that it is immediately necessary
to fix ceding prices of Coronary stents in order to protect public
interest.
12.
Now, therefore, in the exercise of the powers delegated by Government
of India in the Ministry of Chemicals and Fertilizers under paragraph 19
of the Drugs (Prices Control) Order. 2013 by S.O. No. 1394(E) dated
30th May 2013, the Government having been satisfied in view of
extraordinary circumstances as explained above, that it is necessary to
do in public interest, hereby fixes and notifies the ceiling prices,
exclusive of local tax applicable, if any, in respect of Coronary
Stents, as specified below:
TABLE
Sl. No.
|
Coronary Stents (Sl. 31 in Schedule I of DPCO, 2013
|
Unit (In Number)
|
Ceiling Price (In Rs.)
|
(1)
|
(2)
|
(3)
|
(4)
|
1.
|
Bare Metal Stents
|
1
|
7260
|
2.
|
Drug Eluting Dents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BSV), Biodegradable Stents
|
1
|
29600
|
Note:
(a)
The ceiling prices specified in column (4) of the above table shall be
applicable from the date of publication of notification in the Gazette
of India Extraordinary and shall also be applicable to all the stocks of
Coronary Stents available for sale in the trade channel.
(b)
All manufacturers of Coronary stents, selling branded or non-branded or
both versions of gents at prices higher than the ceiling price (plus
local taxes as applicable) so fixed and notified by the Government,
shall revise the price of all such stems downward not exceeding the
ceiling price specified in column (4) in the above table, plus local
taxes as applicable and paid, if any
(c)
All manufacturers/marketers of Coronary Stents having MRP lower than
the ceiling price specified in column (4) in the above table plus local
taxes as applicable and paid, if any, shall continue to maintain the
existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
(d)
The manufactures may add local taxes/VAT and no other charges in the
calculation of MRP if they have actually paid such taxes or if it is
payable to the Government on the ceiling price specified in column (4)
of the above said table in paragraph (12) of this order.
(e)
The ceiling price for a pack of coronary stent shall be arrived at by
concerned manufacturer/importer in accordance with the ceiling price
specified in column (4) of the above table as per the provisions under
DPCO, 2013.
(f)
The manufacturers under Paragraph 24 of DPCO, 2013 shall issue price
list in Form—V as prescribed in Schedule II of the DPCO, 2013 to the
NPPA online through Integrated Pharmaceutical Database Management System
(IPDMS) and submit a copy to all State Drug Controllers and all
distributors/dealers/retailers
(g)
As per paragraph 24(4) of DPCO 2013, every retailer and dealer shall
display price list and the supplement, price list, if any, as furnished
by the manufacturer/importer, 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.
(h)
Wherever institutions such as hospitals/nursing homes/clinics
performing cardiac procedures using Coronary Stents are billing directly
to the patients, they shall be required to comply with the ceiling
prices notified hereinabove and follow the applicable provisions of the
DPCO, 2013 including(g) above.
(i)
Institutions such as hospitals/nursing homes/clinics utilizing Coronary
Stents shall specifically and separately mention the cost of coronary
gent along with its brand name, name of the manufacturer/importer/batch
no. and other details, if any, in their billing to the patients or their
representatives.
4)
The ‘manufacturer’ for the purpose of this order means person who
manufactures or imports or markets Coronary Stents for distribution or
sale in the country.
(k)
Any manufacturer or institution or person 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.
13.
The ceiling price fixed hereinabove shall be maintained for a period of
one year from date of this notification, unless revised by another
gazette notification.
14.
Any manufacturer intending to discontinue production or import of
Coronary Stents shall furnish information to the NPPA, in respect of
discontinuation of production and /or import in Forrn-1V of Schedule-II
of the DPCO, 2013 at least six months prior to the intended date of
discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013
and follow the ceiling price till clearance from the Government.
PN/I73/41/2017
F.No.8 (4I)/2017/DP/NPPA/Div II
(Dr. Sharmila Mary Joseph K)
Member Secretary,
National Pharmaceutical Pricing Authority
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