Supreme Court of India
GLAXOSMITHKLINE PHARMACEUTICALS LIMITED (FORMERLY KNOWN AS SMITHKLINE BEECHAM PHARMACEUTICALS (INDIA) LIMITED)versusUNION OF INDIA & ORS.
- Citation
- 2013 INSC 813
- Decided
- 9 December 2013
- Disposal
- Disposed off
- Bench
- RAJENDRA MAL LODHA
Holding
The Court held that under the Drugs (Prices Control) Orders, the notified price becomes operative immediately (with a 15‑day grace for compliance) and any interpretation, including reliance on the 1979 circular or batch‑number distinctions, that permits sales at pre‑notification prices is inconsistent with the statute and must be rejected.
Summary
GlaxoSmithKline Pharmaceuticals Ltd challenged notices issued by the Drug Inspector after a price‑fixation notification under the Drugs (Prices Control) Order, 1995. The issue was whether the notified ceiling price became operative for all sales immediately, or whether manufacturers could continue to sell pre‑notification stock at the old price during the 15‑day grace period, and whether a 1979 departmental circular and batch‑number provisions could justify such a view. The Supreme Court held that the price notification takes effect immediately, the 15‑day period is only a grace period for manufacturers to adjust, and sales must thereafter be at the notified price; the 1979 circular cannot override the statutory scheme and batch numbers do not affect the consumer’s right to the reduced price. Consequently, the Court dismissed the appeals of the manufacturer and allowed the Union of India’s appeals.
Issues considered
- The effect of a price‑fixation notification under DPCO 1995/1987 on sales made after the 15‑day grace period.
- Whether the 1979 departmental circular can be used to interpret the provisions of DPCO 1995/1987.
- Whether the ‘effective batch number’ in Form V determines the applicability of the revised price.
- Whether an interpretation allowing sales at pre‑notification prices frustrates the object of the DPCO.
- Whether statutory provisions override contemporanea expositio in this context.
Legislation cited
Subjects
Drug price controlDPCOPrice fixationStatutory interpretationDepartmental circularConsumer protectionEffective batch number15‑day grace periodEssential commodities
Judgment
[2013] 12 S.C.R. 1120
A GLAXOSMITHKLINE PHARMACEUTICALS LIMITED
(FORMERLY KNOWN AS SMITHKLINE BEECHAM
PHARMACEUTICALS (INDIA) LIMITED)
v.
UNION OF INDIA & ORS.
8 (Civil Appeal No. 1939 of 2004)
DECEMBER 09, 2013
'
[R.M. LODHA AND KURIAN JOSEPH, JJ.]
C DRUGS (PRICES CONTROL) ORDER, 1995:
Para 14 (1) and 16 - Fixation of price of bulk drug or
formulation - Compliance of - Held: Once the Government
exercises power and fixes maximum sale price of bulk drugs
D specified in the First Schedule, there is ban to sell a bulk drug
at a price exceeding the maximum sale price so fixed plus
local taxes, if any - True import of paragraph 14(1) is that
once the price notification is gazettec1, it takes effect
immediately though its enforcement is postponed by fifteen
E days to enable the manufacturers and others to make suitable
arrangements with regard to unsold stocks - During the
period of fifteen days, it is not open to the manufacturer to
manufacture and clear bulk drug or formulation at pre-
notification prices - Period of 15 days is simply a grace
period or cooling period allowed to manufacturers to adjust .
F their business in a manner where appropriate arrangements
are maoc with regard to unsold stocks in distribution chain -
Drugs (Price Control) Orders, 1987 - Para 16(3).
Fixation of price of bulk drug or formulation - Nature and
G object of- Held: Price fixation by Central Government under
DPCO is in the nature of legislative measure and dominant
object and purpose of such price fixation is equitable
distribution and availability of commodities at fair price.
H 1120
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1121
INDIA
Circulars: A
Circular issued by Department - Held: If departmental
circular provides an interpretation which runs contrary to the
provisions of law, such interpretation cannot bind the court -
The 1979 circular falls in such category - Circular dated B
28.4.1979 issued by the Ministry of Petroleum, Chemicals
and Fertilizers, Department of Chemicals and Fertilizers,
Government of India - Interpretation of statutes -
Contemporanea expositio.
The instant appeals arose out of the judgments of the C
High Courts of Karnataka and Delhi wherein they took
diametrical opposite views on the question whether the
prices fixed under the Drugs (Prices Control) Order
('DPCO') in respect of drugs/formulations would be
operative in respect of all sales subsequent to 15 days D
from the date of the notification by the Government in the
official gazette/receipt of the price fixation order by the
manufacturer.
Writ petitions were filed before the Karnataka High E
Court challenging the notices issued by the Inspector of
Drugs pursuant to the explanatory notice dated
10.03.1998 issued by the National Pharmaceutical Pricing
Authority (NPCA) clarifying that "the notification reduces
the existing prices and the manufacturers must make
effective the prices so fixed/revised, within 15 days (from F
the date of the notification in the official gazette or receipt
of the order of the NPCA) as required under para 14(1)
of the DPC0,1995 and also issue necessary revised price
lists as required under para 14(3) of that Order." The
Karnataka High Court held that every manufacturer and G
distributor would be duty bound to issue a revised price
list within 15 days from the date of the notification issued
by the Government under para 9 of the DPC Order.
The Delhi High Court in the writ petition aris.ing out H
1122 SUPREME COURT REPORTS (2013] 12 S.C.R.
A of the price fixation order dated 17.3;1988 issued under
para 9(1) of the DPCO, 1987, said to have been received
by the manufacturer on 21.3.1988, did !)Ot agree with the
view adopted by the Karnataka High Court, and relying
upon the circular dated 28.4.1979 allowed the writ petition
B and quashed the seizure memo whereby the goods had
been seized.
Disposing of the appeals, the Court
HELD: 1.1. Under the respective Para 3 of DPCO
C 1995, the Central Government is empowered to fix price
of the bulk drugs for regulating the equitable distribution
of indigenously manufactured bulk drugs and the
maximum price at which the bulk drug shall be sold.
Such fixation of maximum sale price of bulk drugs
D specified in the First Schedule has to be done by
notification in the official gazette. Once the Government
exercises the power and fixes maximum sale price of bulk
drugs specified in the First Schedule, there is ban to sell
a bulk drug at a price exceeding the maximum sale price
E so fixed plus local taxes, if any. It is the obligation of the
manufacturer, if he commences production of the bulk
drug after the commencement of the order, to furnish the
details to the Government in Form I and any such
additional information as may be required by the
F Government within 15 days of the commencement of the
production of such bulk drug. If any manufacturer desires
revision of the maximum sale price of a bulk drug fixed
under sub-paragraph (1) or (4) or as permissible under
sub-paragraph (3), it is permitted to make an application
G to the Government in Form I. [para 44] [1147-B-E]
1.2. Insofar as a retail price of scheduled formulations
is concerned, under paragraph 7, the Central
Government is empowered to fix the same in accordance
with the formula laid down therein. The method of
H calculation of retail price of formulation is ciearly provided
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1123
INDIA
in paragraph 7. With a view to enable the manufacturers A
of similar formulations to sell those formulations in pack
size different to the pack size for which ceiling price has
been notified under sub-paragraphs (1) and (2) of
paragraph 9, manufacturers have to work out the price
for their respective formulation packs in accordance with B
such norms as may be notified by the Government from
time to time. The manufacturer is required to intimate the
price of formulation pack, so worked out, to the
Government and such formulation pack can be released
for sale only after the expiry of 60 days after such c
intimation. However, Government may, within its power,
revise the price so intimated by the manufacturer and
upon such revision the manufacturer is not permitted to
sell such formulation at a price exceeding the price so
revised. [para 45] [1147-F-H; 1148-A-B]
D
1.3. Under paragraph 13, the Government has been
conferred with the overriding power requiring the
manufacturers, importers or distributors to deposit the
amount accrued due to charging of prices higher than
·those fixed or notified by the Government under the E
DPCO, 1987 and so also under DPCO, 1995. [para 46]
[1148-C]
1.4. The price fixation by the Central Government
under DPCO is in the nature of legislative measure and F
the dominant object and purpose of such price fixation
is the equitable distribution and availability of
commodities at fair price. The whole idea behind such
price fixation is to control hoarding, cornering or artificial
short supply and give benefit to the consumer. The G
regulation of drug price is ultimately for the benefit of the
consumer. [para 47] [1148-D-E]
1.5. Paragraph 14 of DPC0,1995 makes provision for
carrying out the effect of the price fixed or revised by the
Government. Sub-paragraph (1) of paragraph 14 provides H
1124 SUPREME COURT REPORTS [2013] 12 S.C.R.
A that every manufacturer or importer shall carry into effect
the price of a bulk drug or formulation, as fixed by the
Government, within fifteen days from the date of
notification in the official gazette or receipt of the order
of the Government by such manufacturer or importer.
B During this period of 15 days, it is not open to the
manufacturer to manufacture and clear the bulk drug or
formulation at pre-notification prices. It is important to
bear in mind that under paragraph 14(2), the
manufacturer is required to print the retail price of the
C formulation on the label of the container of the
formulation. This is expressed by the words "retail price
not to exceed" preceding it "local taxes extra"
succeeding it. Sub-para (2) of para 14 does not indicate
that upto to the expiry of the fifteenth day from the date
of notification of the price fixation order in the official
0
gazette or receipt of the price fixation order by the
manufacturer, he is at liberty to manufacture the
formulation and print on them the pre-notification prices.
[para 48] [1148-F-G; 1149-A-C]
E 1.6. The true import of paragraph 14(1) is that once
the price notification is gazetted, it takes effect
immediately though its enforcement is postponed by
fifteen days to enable the manufacturers and others to
make suitable arrangements with regard to unsold stocks.
F The period of 15 days is simply a grace period or cooling
period allowed to manufacturers to adjust their business
in a manner where appropriate arrangements are made
with regard to the unsold stocks in the distribution chain.
If the stocks cleared by the manufacturer before the
G fifteenth day are sold to the consumer at the higher
unrevised price then, that may result in same formulation
being offered for sale to a consumer at two different
prices. This must be avoided. Further, the manufacturer
may increase manufacture of the bulk drugs during
H fifteen-day period of notified price and clear that stock at
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1125
INDIA
the unrevised/higher price. This will also lead to A
frustrating the regulatory regime which is sought to be
put in place by DPCO.[para 49-50] [1149-D-F, H; 1150-A]
1.7. The DPCO defines 'dealer', 'distrib,utor',
'manufacturer', 'retailer' and 'wholesaler'. The provisions B
contained in paragraphs 3,8, 9 and other relevant
provisions clearly show that DPCO effectively covers the
chain from manufacture of the bulk drug by the
manufacturer to sale of formulation to consumer though
there may be several persons in the distribution chain.
The provisions of DPCO requires not just the end point C·
sale to be at the notified price, but also every sale within
the distribution chain must be at the notified price, if such
sale is made after the date on which sale price is
operative. There cannot be two prices at the end point of
the distribution chain depending on the batch number. D
[para 51] [1150-C-D, E, G-H]
1.8. Paragraph 16 of DPC0,1995 bans sale of bulk
drug or formulation to a consumer at a price exceeding
the price specified in the current price list or price E
indicated on the label of the container or pack thereof
whichever is less, plus all taxes, if any payable. The
expressions 'current price list' and 'whichever is less' in
paragraph 16 are significant. The current price list is
simply the price reflecting the currently operating notified F
price under the DPCO. Once a price is notified for a
formulation, it takes effect immediately and sale of the
formulation to the consumer has only to be at the notified
price. This is the plain and ordinary meaning of paragraph
16. The expression, 'whichever is less' further makes it G
an absolute obligation on all concerned not to sell any
formulation to any consumer at a price exceeding the
price specified in the current price list or price indicated
on the label of the container or pack thereof whichever
is less. [para 52] (1151-A·D]
H
1126 SUPREME COURT REPORTS [2013] 12 S.C.R.
A 1.9. This Court is of the considered view that if an
interpretation of paragraph 14(1 ),(2)(3), paragraph 16(3)
and paragraph 19 of DPC0,1995 results in frustrating its
object and leads to denial of the benefit of current notified
price to the consumer, then such interpretation must be
B avoided. [para 55] [1152-C-D] •
1.10. It is true that the principle of contemporanea
expositio guides that contemporaneous administrative
construction, unless clearly wrong, should be given
considerable weight and should not be lightly
C overturned, but in light of the construction of the relevant
provisions Indicated in the instant judgment, the view in
the circular cannot be followed and upheld. [para 56]
[1152-E-F]
D Union of India and Another v. Cynamide India Limited
and Another; 1987 (2) SCR 841 = (1987) 2 sec 720;
Collector of Central Excise, Patna v. Usl1a Martin Industries
1997 (3) Suppl. SCR 601 = (1997) 7 sec 47; and
Commissioner of Customs, Calcutta and others v. Indian Oil
=
E Corporation Limited and Anr. 2004 (2) SCR 511 (2004) 3
sec 488 - referred to.
1.12. It is well settled that if the departmental circular
provides an interpretation which runs contrary to the
provisions of law, such interpretation cannot bind the
F court. The 1979 circular falls in such category. Moreover,
the 1979 circular is with reference to the DPCO, 1979
whereas the Court is concerned with DPCO, 1987 and
DPCO, 1995. It cannot be said that in view of the saving
clause in DPCO, 1987, the circular is saved and is further
G saved by the saving clause in DPC0,1995. [para 60]
[1154-C-D]
Union of India v. Ranbaxy Laboratories Limited and
=
Others 2008 (8) SCR 315 (200~) 7 SCC 502 - held
H inapplicable
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1127
INDIA
1.14. The Delhi High Court in the impugned order has A
erred in relying upon 1979 circular. Moreover, it has gone
more by practical difficulties which a manufacturer may
suffer and completely overlooked the scheme of the
DPCO which is intended to give benefit to the consumer
of the reduced current price of the formulation. The view 8
of the Delhi High Court is fundamentally flawed and
clearly wrong. The Karnataka High Court has taken the
correct view and the same is upheld. [para 65-66] [1157·
A, C; 1158-A]
Desh Bandhu Gupta and Company and Others v. Delhi C
=
Stock Exchange Association Ltd. 1979 (3) SCR 373 (1979)
4 SCC 565; State of Madhya Pradesh and another v. Mis.
=
G.S. Dall and Flour Mills 1990 (1) Suppl. SCR 590 1992
Supp.(1) SCC 150; Bengal Iron Corporation and another v.
Commercial Tax Officer and Others; 1993 (3) SCR 433 =D
1994 Supp.(1) SCC 310; Commissioner of Central Excise,
Bolpur v. Ratan Melting & Wire Industries 2008
=
(14) SCR 653 (2008) 13 SCC 1; and Union of India v.
Arviva Industries (/) Ltd. 2007(209) E.L.T. 5 (S.C.) - cited.
E
Case Law Reference:
2008 (8) SCR 315 held inapplicable para 26
1979 (3) SCR 373 cited para 27
1997 (3) Suppl. SCR 601 referred to para 29 F
1987 (2) SCR 841 referred to para 34
1990 (1) Suppl. SCR 590cited para 36
1993 (3) SCR 433 cited para 37 G
2008 (14) SCR 653 cited para 38
2004 (2) SCR 511 referred to para 58
2007(209) E.L.T. 5 (S.C.) cited para 59
H
1128 SUPREME COURT REPORTS [2013] 12 S.C.R.
A CIVIL APPELLATE JURISDICTION : Civil Appeal No.
1939 of 2004.
From the Judgment & Order dated 12.11.2002 of the High
Court of Karnataka at Bangalore in Civil Writ Petition No. 38973
of 1998.
B
WITH
C.A. No. 1940, 1941and1942 of 2004, 10901-10902 of 2013.
Indira Jaising, Rakesh Kumar Khanna, ASG, S. Gao'esh
C U.A. Rana, Mrinal Majumar (for Gagrat & Co.), Bina Gupta,
Aman Ahluwalia, Prateek Jalan, Supriya Jain, Priyanka Sinha,
Sonakshi Malhan (for Shreekant N. Terdal), Puneet Taneja,
Pravin Bahadur, Mallika Joshi, Amit Agrawal, Rajan Narain for
the appearing parties.
D
The Judgment of the Court was delivered by
R.M. LODHA, J. 1. Leave granted in SLP(C) Nos.27241-
27242 of 2010.
E 2. This is a group of six appeals, by special leave, four
arising from the judgment of the Karnataka High Court and two
from the Delhi High Court.
3. The two High Courts, Karnataka and Delhi, have taken
F diametrical opposite view on the question whether the prices
fixed under the Drugs (Prices Control) Order (for short, 'DPCO')
in respect of drugs/formulations would be operative in respect
of all sales subsequent to 15 days from the date of the
notification by the Government in the official gazette/receipt of
f3 the price fixation order by the manufacturer.
4. The Drugs (Prices Control) Order, 1995 (for short,
'DPC0,1995') was under consideration before the Karnataka
High Court whereas the Drugs (Prices Control) Order, 1987 (for
short, 'DPCO, 1987') fell for consideration before the Delhi High
H
GIAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1129
INDIA [RM. LODHA, J.]
Court. Although, the sequence of the relevant paragraphs in the A
two DPCOs differ but the relevant provisions are almost
identical. The view of the Karnataka High Court has not been
accepted expressly by the Delhi High Court. Since the common
arguments have been advanced in this group of matters and
the question of law is identical, all these six appeals were heard B
together and are disposed of by the common order.
5. The facts in civil appeals from Karnataka High Court are
these: The appellant, in the year 1998, was manufacturer of
Furoxene Tablets and was also the sole distributor for C
Dependal-M Tablets and Dependal Suspension manufactured
by Kanpha Labs, Bangalore. Dependal-M and Dependal
Suspension and Furoxene are formulations of Furozolidine and
Metronidazole. On 09.03.1998, a notification was issued by the
National Pharmaceutical Pricing Authority (NPCA) under the
DPCO, 1995, whereby the ceiling price in regard to several D
formulations consisting of Furozolidine and/or Metronidazole
was fixed exclusive of excise duty and local taxes. The
notification was gazetted on 09.03.1998 itself.
6. On 10.03.1998, NPCA issued an explanatory notice E
clarifying that the notification reduces the existing prices and
the manufacturers must make effective the prices so fixed/
revised, within 15 days (from the date of the notification in the
official gazette or receipt of the order of the NPCA) as required
under para 14(1) of the DPC0,1995 and also issue necessary F
revised price lists as required under para 14(3) of that Order.
7. On 14.07.1998, the Inspector of Drugs, Varanasi issued
a letter addressed to the appellant-Company that it has not given
the effect to the notification dated 09.03.1998.
G
8. On 22.07.1998, the appellant-Company responded to
the letter received from the Inspector of Drugs and brought to
his notice that the notification dated 09.03.1998 has been given
effect to from the first batch manufactured on the expiry of 15
H
1130 SUPREME COURT REPORTS [2013] 12 S.C.R.
A days from the date of the notification which is permissible under
para 14 of the DPC0,1995.
9. On 30.07.1998, Inspector of Drugs sent another Jetter
to the appellant-Company stating therein that under paragraph
8 16 of DPCO, 1995, all sales of the subject formulations would
have to be made at the new ceiling price fixed on 09.03.1998
irrespective of the date of manufacture of the subject
formulations. The plea of the appellant-Company was,
accordingly, rejected by the Inspector of Drugs and he
C proposed to initiate the prosecution against the appellant-
Company under the Essential Commodities Act, 1955 ('EC
Act'). This was reiterated by the Inspector of Drugs in his further
communication dated 16.11.1998.
10. The appellant-Company then challenged the notices/
D letters dated 14.07.1998, 30.07.1998 and 16.11.1998 by filing
a writ petition before the High Court. The writ petition was
contested by the Central Government and its functionaries.
11. The Karnataka High Court by its judgment dated
E 12.11.2002 dismissed the writ petition. The principal reasoning
is reflected in paragraph 9 of the judgment which reads as
follows:
"9. Having regard to the provisions of para 14 of DPC
Order, petitioner who is a manufacturer of Furoxene
F tablets, ought to carry into effect the revised price fixed as
per Notification dated 09.03.1998 within 15 days from the
date of the said Notification or receipt of the Order of the
Government. There is no dispute that the Notification dated
09.03.1998 was published in the Gazette of India on the
G same date. While sub-para (2) of para 14 requires the
retail price of the formulation as notified by the Government
being displayed on the label of the container of the
formulation and the minimum pack offered for retail sale,
sub-para (3) thereof requires the manufacturer to issue a
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1131
INDIA [RM. LODHA, J.]
price list and supplementary price list to the dealers and A
other persons specified therein indicating reference to
price fixation/revision from time to time. Para 16 of DPC
Order prohibits all persons including manufacturers/
distributors/retailers from selling any formulation at the
price exceeding the price specified in the current price list B
indicated on the label of the pack whichever is less. Thus,
a combined reading of these provisions make it clear that
every manufacturer and distributor is duty bound to issue
a revised price list within 15 days from the date of the
notification issued by the Government under para 9 of the C
DPC Order. It is also clear that manufacturers, distributors
and retailers will be liable to sell formulations from the date
of such revised price list (which is required to publish within
15 days from the date of notification) at the revised prices
and not the prices mentioned on the label of the container
or pack. In view of it, the contention of the Petitioner that D
revised prices will not apply to the existing stocks but only
to new batches of drugs and formulations to be
manufactured after 15 days of the notification cannot be
accepted. The provisions of the DPC Order are clear that
prices should be revised within 15 days even in regard to E
the formulations which were manufactured prior to the date
of notification or those manufactured within 15 days from
the date of notification."
12. It is from the above judgment that four appeals arise F
at the instance of the manufacturer/distributor.
13. The two appeals from the judgment of the Delhi High
Court are at the instance of the Central Government. The facts
in these two appeals in brief are these: For the period
01.04.1979 to 25.08.1987, Drugs (Prices Control) Order,1979 G
(for short, 'DPCO, 1979') was in operation. The bulk drug
Ranitidine and its formulation were not subject to price control
under DPC0,1979, and, consequently, there was no price
fixation at all in respect of Zinetac tablets.
H
1132 SUPREME COURT REPORTS [2013] 12 S.C.R.
A 14. On 26.08.1987, DPCO, 1987 came into force whereby
the bulk drug Ranitidine was included and, accordingly, Zinetac
tablets (its formulations) were subjected to price control.
15. On 17.03.1988, the price fixation order was issued
under para 9(1) of the DPC0,1987 fixing the retail price of
B Zinetac tablets. The price fixation order is said to have been
received by the manufacturer (Biotech Pharma) on 21.03.1988.
16. The respondent is distributor of the Zinetac tablets in
the strength of 150 mg and 300 mg per tablet manufactured
C by Biotech Pharma. Zinetac is a formulation of the bulk drug
Ranitidine. On 04.04.1988, the Biote<:h Pharma sent the
supplementary price list effective from 04.04.1988 in form V. It
is the case of the respondent that the price fixed by the price
fixation order dated 17.03.1988 is applicable with effect from
D 04.04.1988 (on expiry of 15 days from 21.03.1988, i.e., the
date of receipt of the price fixation order dated 17.03.1988).
17. On 23.05.1988, seizures were made of 300 mg
Zinetac tablets from Batch No.3104. The respondent's case is
that Batch No.3104 is prior to Batch No.3115 mentioned as the
E effective batch number in the manufacturer's letter dated
04.04.1988.
18. The respondent-Company challenged the seizure of
goods by filing a writ petition before the Delhi High Court. The
F writ petition was contested by the Central Government before
the Delhi High Court and the judgment of the Karnataka High
Court was also cited. However, Delhi High Court did not agree
with the view adopted by the Karnataka High Court. The Delhi
High Court heavily relied upon a circular dated 28.04.1979
G issued by the Ministry of Petroleum, Chemicals and Fertilizers,
Department of Chemicals and Fertilizers, Government of India.
The said circular though was issued in the context of paragraph
19(2) of DPC0,1979 but the Delhi High Court was of the view
that the said circular was identical to paragraph 16(3) of
H DPCO, 1987, and, therefore, the position explained in respect
, GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1133
INDIA [RM. LODI-IA, J.)
of the DPC0,1979 would continue to hold the field in respect A
of the very same provisions in DPC0,1987. The Delhi High
Court, accordingly, by its judgment dated 22.10.2009 allowed
the writ petition and quashed the seizure memo whereby the
goods were seized. The Union of India is aggrieved by the
judgment and the two appeals arise therefrom. B
19. We have heard Mr. S. Ganesh, learned senior counsel
for the manufacturer/distributor and Ms. Indira Jaising, learned
Additional Solicitor General for the Union of India.
20. It is appropriate at this stage to reproduce the few C
relevant paragraphs of DPC0,1987 and DPC0,1995 side by
side.
DPCO, 1987 DPCO, 1995
16(3) Every manufacturer or D
importer shall give effect to 14(1) Every manufacturer or
the price of a bulk drug or importer shall carry into
formulation, as the case may effect the price of a bulk
be, as fixed by the drug or formulation, as the
government from time to time case may be, as fixed by the
Government from time to
E
within 15 days from the
receipt by such manufacturer time, within fifteen days from
or importer of the the date of notification in the
communication in this behalf Official Gazette or receipt of
from the government and the order of the Government
in this behalf by such F
issue a supplementary price
list in this regard to the manufacturer or importer.
dealers, state drugs
controllers and the
government and indicate
necessary reference to such G
price fixation.
17. Every manufacturer 14(2) Every manufacturer,
importer or distributor of a importer or distributor of a
formulation intended for sale formulation intended for sale H
1134 SUPREME COURT REPORTS [2013] 12 S.C.R.
A shall display in indelible print shall display in indelible print
mark, on the label of mark,onthelabelofcontainer
container of the formulation of the formulation and the
and the minimum pack minimum pack thereof
thereof offered for retail sale, offered for retail sale, the
B the maximum retail price of retail price of that formulation
that formulation with the notified in the Official Gazette
words "retail price not to or ordered by the
exceed" preceding it, and Government in this behalf,
"local taxes extra" with the words "retail price not
c succeeding it. to exceed" preceding it, "local
taxes extra· succeeding it,
Provided that in the case of a and "under Government
container consisting of Prices Control" on a red strip,
smaller saleable packs, the in the case of scheduled
retail price of such smaller formulations:
D pack shall also be displayed
on the label of each smaller Provided that in the
pack and such price shall not case of a container
be more than the pro-rata consisting of smaller saleable
price of the main pack packs, the retail price of such
E rounded off to the nearest smaller pack shall also be
paisa. displayed on the label of
each smaller pack and such
price shall not be more than
the pro-rata retail price of the
F main pack rounded off to the
nearest paisa.
21. Prices to the traders:- 14(3) Every manufacturer or
importer shall issue a price
(1) A manufacturer, distributor list and supplementary price
G or wholesaler shall sell a list, if required, in form V to the
formulation to a retailer, dealers, State Drugs
unless otherwise permitted Controllers and the
under the provisions of this Government indicating
Order or any other made reference to such price
H
Gl.AXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1135
INDIA [R.M. LODHA, J.]
thereunder, at a price equal fixation or revision as A
to the retail price (excluding covered by the order or
, excise duty, if any) minus Gazette notification issued
16% thereof in the case of by the Government from
price controlled drug. time to time.
B
(2) Notwithstanding anything 15(1) Every manufacturer,
contained in sub-paragraph importer or distributor of a
(1), the Government may by a non-scheduled formulation
general or special Order fix, intended for sale shall
in public interest, the price to display in indelible print
the wholesaler or retailer in mark, on the label of
.c
respect of any formulation the container of the formulation
price of which has been fixed and the minimum pack
or revised under this Order. thereof offered for retail sale,
the retail price of that
formulation with the words D
"retail price not to exceed"
preceding it and the words
"local taxes extra·
succeeding it, and the words
"Not under Price Control" on E
a green strip:
Provided that in the
case of a container
consisting of smaller F
saleable packs, the retail
price of such smaller pack
shall also be displayed on
the label of each smaller
pack and such price shall not
G
be more than the pro-rata
retail price of the main pack
rounded off to the nearest
paisa.
(2) Every manufacturer or H
1136 SUPREME COURT REPORTS [2013] 12 S.C.R.
A importer shall issue a price
list and supplementary price
list, if required of the non-
scheduled formulation in
Form V to the dealers, State
B Drugs Controllers and the
Government indicating
changes from time to time.
(3) Every retailer and dealer
shall display the price list and
c the supplementary price list,
if any, as furnished by the
manufacturer or importer, on
a conspicuous part of the
premises where he carries
D on business in a manner so
as to be easily accessible to
any person wishing to consult
the same.
E 19(1) A manufacturer,
distributor or wholesaler shall
sell a formulation to a retailer,
unless otherwise permitted
under the provisions of this
Order or any order made
F
thereunder, at a price equal
to the retail price, as
specified by an order or
notified by the Government
(excluding excise duty, if
G any), minus sixteen per cent
thereof in the case of
scheduled drugs.
(2) Notwithstanding
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1137
INDIA [R.M. LODHA, J.]
anything contained in sub- A
paragraph (1), the}
Government may by a
general or special order fix,
in public interest, the price of
formulation sold to the B
wholesaler or retailer in
respect of any formulation
the price of which has been
fixed or revised under this
Order. c
21. The comparative statement of the above provisions
indicates that para 14(1) of DPC0,1995 is identical to para
16(3) of DPC0,1987. Para 14(2) of DPC0,1995 is identical
to para 17 of DPC0,1987. Para 14(3) of DPC0,1995 is
identical to para 16(3) of DPCO, 1987 and para 15(1) of D
DPC0,1995 is identical to para 17 of DPC0,1987.
22. In light of the similarity of the above provisions, for the
sake of convenience, we shall refer henceforth to the provisions
contained in DPC0,1995. E
23. Mr. S. Ganesh, learned senior counsel for the
manufacturer/distributor argues that on a plain reading of para
14(1) of the DPC0,1995, a manufacturer is given fifteen days
from the date of notification of a price fixation by the F
Government in the official gazette or receipt of the price fixation
order by the manufacturer for carrying into effect the price of
the bulk drug or formulation. Under para 14(2) of the
DPCO, 1995, the manufacturer is required to print indelibly the
retail price of the formulation on the label of the container of
the formulation with the words "retail price not to exceed" G
preceding it and "local taxes extra" succeeding it. Therefore,
upto the expiry of the fifteenth day from the date of the
notification, the price fixation order in the official gazette or
receipt of the price fixation order by the manufacturer, the
H
1138 SUPREME COURT REPORTS [2013] 12 S.C.R.
A manufacturer is at liberty to manufacture the formulations and
print on them the pre-notification prices and clear the same from
his factory after paying excise duty on the basis of such
provided price.
8 24. Mr. S. Ganesh, learned senior counsel relies upon the
Circular dated 28.04.1979 issued by the Central Government
wherein it was clarified that all reductions in the prices of
formulations effected from time to time by the Central
Government would be applicable to the stocks cleared on and
after the date of effectuation of reduction. The clarificatory
C Circular further says that price list shall state clearly the batch
numbers from which the reduction is effective. It is, thus, the
submission of Mr. S. Ganesh that the formulations which are
manufactured and cleared prior to the date of effectuation of
reduction (the 15th day after the date of notification in the official
D gazette or the date of receipt of price fixation/reduction order)
are not subject to the price reduction and, accordingly, the said
pre-effective batch products can be sold at the previously
existing and operating prices which would be printed on them.
E 25. It is argued by Mr. S. Ganesh that the said circular has
not been withdrawn and it has been continuously observed by
the trade as well as by the Central Government for several
decades. It is his submission that if the interpretation as above
is not accepted, the consequence will be that the period of 15
F days expressly allowed by para 14(1) of the DPCO, 1995 and
the specific provision in Form V regarding the effective batch
number to which the price reduction/fixation would apply, will
all be rendered completely meaningless and otiose. With
reference to practical problems, it is submitted that the
G manufacturer pays excise duty on the basis of the printed price
at the time of the manufacture and clearance from his factory
and also on the payment of sales tax on the sale price charged
by the manufacturer to the distributor/wholesalers, which again
will be on the basis of the printed price. The payment of excise
duty and sales tax having become final, the differential amount
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1139
INDIA [R.M. LODHA, J.]
cannot possibly be refunded and re-assessed. Moreover, if a A
distributor/wholesaler/retailer has already paid a higher price
on the basis of the previously prevailing price, he cannot
possibly be required to sell the formulation at the newly reduced
price. According to Mr. S. Ganesh, learned senior counsel such
an interpretation will be contrary to and in fact destructive of the 8
provisions of para 19 of the DPC0,1995.
26. Mr. S. Ganesh, heavily relied upon the judgment of this
Court in Ranbaxy Laboratories Limited' which interpreted an
exemption notification. Drawing analogy from that judgment, it
is argued that just as the exemption notification which was C
issued under para 25 of the DPCO, 1995 was addressed to the
manufacturer, similarly, price fixation/revision notification is also
addressed to the manufacturer who is required to effectuate the
same by printing the revised price on all products manufactured
and cleared by him from the 15th day after the date of D
notification/receipt of the order, and also issuing the revised
price list declaring the effective batch number from which
revised price will operate.
27. Mr. S. Ganesh, learned senior counsel submits that the E
manufacturer/distributor having acted as per circular dated
28.04.1979, cannot be lawfully prosecuted/penalized since the
circular constitutes the contemporanea expositio of the Central
Government which framed the DPCO. In this regard, learned
senior counsel places reliance upon the decision of this Court
F
in Desh Bandhu Gupta 2 • His submission is that under the
DPCOs, every price list is in respect of "effective batch
number". The clarification made with regard to DPCO, 1979 is
equally applicable for interpretation of 1995, DPCO, since para
14(1) and 14(3) of DPCO, 1995 is identical to DPC0,1979.
G
28. Mr. S. Ganesh, learned senior counsel argues that there
1. Union of India v. Ranbaxy Laboratories Limited and Others; [(2008 7 SCC
502.
2. De sh Sandhu Gupta and Company and Others v. Delhi Stock Exchange
Association Lid; [(1979) 4 sec 565. H
1140 SUPREME COURT REPORTS (2013] 12 S.C.R.
A is no allegation of any act or omission by the manufacturer/
distributor during the period of 15 days allowed by para 14 of
DPCO, 1995. He further submits that the interpretation of
DPC0,1979, DPC0,1987 and DPC0,1995 is no more a
relevant issue as with effect from. June, 2013, DPCO, 2013 has
8 come into operation and its scheme and provisions are entirely
different from the earlier DPCOs.
29. Relying upon the decision of this Court in Usha
Martin3, it is submitted by the learned senior counsel that the
issuance of 1979 circular shows that two views are possible
C and, therefore, the view beneficial to the subject must be
adopted, particularly, to a case of criminal prosecution/penalty.
30. It is argued by Mr. S. Ganesh that there is no provision
in DPCO or in the EC Act which nullifies or sets aside past
o lawfully completed transaction for sale of goods by the
manufacturer to the distributor or by the distributor to the retailer.
There is also no provision which requires the manufacturer to
reprint products already in the market with the new price. The
printing of the price is covered by Section 3(f) of the Drugs and
E Cosmetics Act, 1940 and, therefore, the reprinting of the price
can be done only by the manufacturer in his licence
manufacturing premises. The manufacturer has no privily
whatsoever with the retailer and may not even know his identity.
It is absolutely impossible for the manufacturer to get
F possession of the goods from large number of retailers, bring
them back to his factory, reprint the lower price and then send
them back to the retailer with a lower price printed on it, so that
the retailer who paid the higher price to the distributor is then
compelled to sell the goods at a loss at the lower price. The
retailer who has already paid for the goods would never part
G with them; especially only for having them reprinted with a much
lower price. He submits that such an interpretation of the DPCO
will be utterly unworkable and impossible to comply with and
3. Collector of Central Excise, Patna v. Usha Martin Industries; [(1997) 7 SCC
H 47]
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1141
INDIA [R.M. LODHA, J.]
any interpretation other than what has been stated in the circular A
must be summarily rejected.
31. Ms. Indira Jaising, learned Additional Solicitor General,
on the other hand, argues that the scheme of the two DPCOs,
1987 and 1995 is very clear and that scheme is that once the 8
price is notified for a formulation, the sale to the consumer can
only be at the notified price. Learned Additional Solicitor
General submits that para 16 of the DPC0,1995 imposes an
absolute obligation on all persons not to sell any formulation to
any consumer at a price exceeding the price specified in the
"current price lisf' or price indicated on the label of the container C
or back thereof, "whichever is less".
32. With reference to the definition of the expression 'price
list' in para 2(u) of DPC0, 1995 learned Additional Solicitor
General submits that the price specified in the current list is D
nothing but the currently notified price of the bulk drug or
formulation under the DPCO. For purpose of interpreting the
expression "price specified in the current price list", it is
essential that the manufacturer has not defaulted in its
obligation to issue price list or supplementary price list. The E
'current price list' is, therefore, simply the price list reflecting
the currently operating notified price under the DPCO. Moreover,
price specified in the current price list is nothing but the MRP
reflected in column 11 of Form V. Thus, regardless of the entry
in column 11, "effective batch number" the price specified in F
column 11 is the price specified in the current price list. for the
purposes of para 16. Batch number is not relevant for the
purpose of identifying this price. It is the submission of the
learned Additional Solicitor General that batch number is
altogether different concept which may be traced to Rule 96 of G
the Drugs and Cosmetics Rules, and the reference to effective
batch number in Form V is only for internal record related
purposes. There is no reference to batch numbers in either,
DPCO, 1987 or DPCO, 1995. Such reference can only be
found in Form V and Form V does not give any definition of H
1142 SUPREME COURT REPORTS (2013] 12 S.C.R.
A effective batch number.
33. Learned Additional Solicitor General submits that the
plain meaning suggests that revised price must be carried into
effect within 15 days. The words "carried into effect" read with
"within 15 days" mean that the prices of the drugs are fixed ''with
8
effect from" fifteen days from the date of notification. The
expression "within 15 days" indicates the outer limit.
34. The contention of the learned Additional Solicitor
General is that there cannot be two different prices in the
C distribution chain. Each of the DPCOs, i.e., DPC0,1979,
DPCO, 1987 and DPC0,1995 contains a provision where the
benefit of the price reduction will mandatorily have to be passed
on to the consumer from the moment the reduction became
operative. While there may be several persons in the
D distribution chain, there is an embargo in the DPCO preventing
any person from selling to the end-point consumer at anything
above the notified price (once such price became operative).
That being the position, there cannot be one price that is
operational at the end-point of the distribution chain and another
E price upstream in the distribution chain. The emphasis by the
learned Additional Solicitor General is that DPCOs ensure that
consumer is given the benefit of the notified price, upon its
notification. The consumer gets the benefit of the notified price,
irrespective of batch numbers since the formulation be
F interpreted with the object of the DPCO as the guiding
principle. Reliance is placed on Cynamide India Limited4.
35. It is also argued by the learned Additional Solicitor
General that no prejudice is caused to the manufacturer/
distributor as the revised price is also based on a cost plus
G methodology. The reduction in the price is only to reflect
reduced cost and it simply prevents the manufacturers from
making windfall gains by charging high prices even though costs
4. Union of India and Another v. Cynamide India Limited and Another; [(1987)
H 2 sec 720.
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1143
INDIA [R.M. LODHA, J.]
have reduced. As regards distributors or others in the A
distribution chain, it is submitted that it is possible that certain
stock has been purchased at the higher and revised price and
is lying with the distributor or wholesaler or retailer but once the
revised price comes into effect, this stock becomes unsellable
at the higher price, and the losses or reductions need to be B
absorbed somewhere in the distribution chain. How the
manufacturers/distributors and dealers, inter-se, make
arrangements for these losses to be absorbed, depends on the
specific contractual and credit arrangements. It is possible to
work out an arrangement where the stock is recalled or c
necessary adjustments are made to reflect the lower price. The
fact that the Chemists and Druggists Federation advocates
such a mechanism shows that it is entirely within the realm of
possibility. It is emphasised that paramount consideration of the
Central Government is that the revised price must be carried
0
into effect insofar as the consumer is concerned. It is for the
manufacturers and distributors to make appropriate
arrangements how the unsold stock is dealt with.
36. As regards the circular of 28.04.1979, the submission
of the learned Additional Solicitor General is that DPCO, 1979 E
stands repealed and the so-called circular is not saved by the
saving clause as it is not a thing done or action taken und~r
the DPCO. Rather it is clarification of the DPCO itself and it
cannot survive once the DPCO is repealed. The circular of
28.04.1979 was in the context of interpretation of DPCO, 1970 F
and DPC0, 1979 whereas the present matters are concerned
with DPC0,1987 and DPC0,1995. Relying upon a decision of
this Court in Mis. G.S. Dall and Flour Mil/s5, it is argued that
an executive instruction issued in a certain context can not
govern a later notification. Moreover, it is submitted that if a G
circular provides an interpretation that runs contrary to the
provisions of DPCO, the Court may examine the provisions and
interpret them in their proper perspective. The circular is not
5. State of Madhya Pradesh and Another v. Mis. G.S. Dall and Flour Mills; (1992
Supp. (1) sec 150] H
1144 SUPREME COURT REPORTS (2013] 12 S.C.R.
A binding on the court. The circular is not issued under any
statutory authority and cannot be used to interpret the provisions
of the statute.
37. It is submitted that the circular is, in any event,
inconsistent with the provisions of DPCO, 1987 and
8
DPCO, 1995. It only represents the department's view at the time
which may have been erroneous. There is no estoppel against
statute. In this regard, the decision of this Court in Bengal Iron
Corporation and Another is relied upon.
C 38. It is also argued by the learned Additional Solicitor
General that a circular which is contrary to the statutory
provisions has no existence in law. Ratan Melting & Wire
lndustries7 is pressed into service in this regard. In any case,
it is submitted that the manufacturer/distributor have not relied
D on the circular in good faith. In 1988, there is correspondence
in the Glaxo between appellant and respondent where appellant
was clearly put to notice that it was required to comply with
notified price. Despite this correspondence, the appellant
elected not to comply with the notified price. Thus, the appellant
E can hardly rely on the circular once the respondent has put
forward a certain interpretation in 1998. The appellant was fully
aware of the interpretation taken by the respondent and willfully
elected to act in contravention of the DPCO. That being the
case, the appellant cannot now act oblivious of correspondence
F in 1988 and place reliance on 1979 circular.
39. It is the submission of the learned Additional Solicitor
General that the relabeling is permitted under law. Earlier, issue
of printing prices was governed by the Standards of Weights
and Measures Act, 1976. Now it is governed by Legal
G Metrology Act, 2009. Legal Metrology (Packaged
6. Bengal Iron Corporation and Another v. Commerical Tax Officer and Others;
[1994 Supp. (1) sec 310]
7. Commissioner of Central Excise, Bolpur v. Ratan Melting & Wire Industries;
H [(2008) 13 1.
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1145
INDIA [R.M. LODHA, J.]
Commodities) Rules, 2011 (for short, '2011 Rules') contains A
an exemption for pharmaceuticals being cognizant of the fact
that Government can fix prices at any time and such prices
would need to be given effect to within the statutorily prescribed
period. Therefore, relabeling may be required where there is
a revision in price, and prevailing law specifically permits that B
by exempting price from the rigors of 2011 Rules.
40. The Central Government is empowered by Section 3
of EC Act to make an order providing for controlling the price
at which the essential commodity may be bought or sold.
c
41. A Committee on Drugs and Pharmaceuticals Industry
(known as the Hathi Committee) was appointed by the Central
Government to examine the various facets of the drug industry
in India including the measures taken so far to reduce prices
of drugs for the consumer, and to recommend such further D
measures as may be necessary to rationalize the prices of
basic drugs and formulations. The Hathi Committee in its
Report observed that there was no justification for the drug
industry charging prices and having a production pattern which
is based not upon the needs of the community but on E
aggressive marketing tactics and create demand.
42. Following the Hathi Committee Report, the Government
first framed the statement on drug policy and then issued
DPCO, 1979. The DPCO, 1970 was accordingly repealed. F
DPC0,1979 is repealed by DPC0,1987 and DPC0,1987 is
repealed by DPC0,1995.
43. In order to have the proper perspective of the matter,
it is necessary that certain provisions of the DPC0,1995 are
surveyed. Paragraph 2 is an interpretation clause, it defines G
certain expressions occurring in DPCO as under:
·2 ......... .
(a) "bulk drug" means any pharmaceutical, chemical,
H
1146 SUPREME COURT REPORTS [2013] 12 S.C.R.
A biological or plant product including its salts, esters,
stereo-isomers and derivatives, conforming to
pharmacopoeia! or other standards specified in the
Second Schedule to the Drugs and Cosmetics Act.
1940(23 of 1940), and which is used as such or as an
B ingredient in any formulation;
(d) "dealer" means a person carrying on the business of
purchase or sale of drugs, whether as a wholesaler or
C retailer and whether or not in conjunction with any other
business and includes his agent;
(e) "distributor" means a distributor of drugs or his agent
or a stockist appointed by a manufacturer or an importer
0 for stocking his drugs for sale to a dealer;
(m) "manufacturer" means any person who manufactures
a drug; ·
E
(r) "price list" means a price list referred to in paras 14
and 15 and includes a supplementary price list;
F (s) "retail price" means the retail price of a drug arrived
at or fixed in accordance with the provisions of this Order
and includes a ceiling price;
(t) "retailer" means a dealer carrying on the retail business
of sale of drugs to customers;
G
(u) "scheduled bulk drug" means a bulk drug specified in
the First Schedule;
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1147
INDIA [R.M. LODHA, J.]
(y) "wholesaler" means a dealer or his agent or a stockist A
appointed by a manufacturer or an importer for the sale
of his drugs to a retailer, hospital, dispensary, medical,
educational or research institution purchasing bulk
quantities of drugs..........."
B
44. Under paragraph 3, the Central Government is
empowered to fix price of the bulk drugs for regulating the
equitable distribution of indigenously manufactured bulk drugs
and the maximum price at which the bulk drug shall be sold.
Such fixation of maximum sale price of bulk drugs specified in
the First Schedule has to be done by notification in the official C
gazette. Once the Government exercises the power and fixes
maximum sale price of bulk drugs specified in the First
Schedule, there is ban to sell a bulk drug at a price exceeding
the maximum sale price so fixed plus local taxes, if any. It is
the obligation of the manufacturer, if he commences production D
of the bulk drug after the commencement of the order, to furnish
, the details to the Government in Form I and any such additional
information as may be required by the Government within 15
days of the commencement of the production of such bulk drug.
If any manufacturer desires revision of the maximum sale price E
of a bulk drug fixed under sub-paragraph (1) or (4) or as
permissible under sub-paragraph (3), it is permitted to make
an application to the Government in Form I.
45. Insofar as a retail price of scheduled formulations is F
concerned, under paragraph 7, the Central Government is
empowered to fix the same in accordance with the formula laid
down therein. The method of calculation of retail price of
formulation is clearly provided in paragraph 7. With a view to
enable the manufacturers of similar formulations to sell those G
formulations in pack size different to the pack size for which
ceiling price has been notified under sub-paragraphs (1) and
(2) of paragraph 9, manufacturers have to work out the price
for their respective formulation packs in accordance with such
norms as may be notified by the Government from time to time.
H1
1148 SUPREME COURT REPORTS [2013] 12 S.C.R.
A The manufacturer is required to intimate the price of formulation
pack, so worked out, to the Government and such formulation
pack can be released for sale only after the expiry of 60 days
after such intimation. However, Government may, within its
power, revise- the price so intimated by the manufacturer and
B upon such revision the manufacturer is not permitted to sell such
formulation at a price exceeding the price so revised.
46. Under paragraph 13, the Government has been
conferred with the overriding power requiring the manufacturers,
C importers or distributors to deposit the amount accrued due to
charging of prices higher than those fixed or notified by the
Government under the DPCO, 1987 and so also under
DPC0,1995.
47. One finds, therefore, that the price fixation by the
D Central Government under DPCO is in the nature of legislative
measure and the dominant object and purpose of such price
fixation is the equitable distribution and availability of
commodities at fair price. The whole idea behind such price
fixation is to control hoarding, cornering or artificial short supply
E and give benefit to the consumer. The regulation of drug price
being ultimately for the benefit of the consumer, we must now
consider the effect of paragraph 14(1),(2) and (3), paragraph
16 (3), paragraph 19 and Form V.
48. Paragraph 14 of DPCO, 1995 makes provision for
F carrying out the effect of the price fixed or revised by the
Government. Sub-paragraph (1) of paragraph 14 provides that
every manufacturer or importer shall carry into effect the price
of a bulk drug or formulation, as fixed by the Government, within
fifteen days from the date of notification in the official gazette
G or receipt of the order of the Government by such manufacturer
or importer. Does it mean that during this period of 15 days, it
is open to the manufacturer to manufacture and clear the bulk
drug or formulation at pre-notification prices? We do not think
so. In our view, sub-paragraph (1) of paragraph 14 does not
H deserve to be given a construction which is derogatory to the
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1149
INDIA [R.M. LODHA, J.]
object and scheme of DPC0,1995. It is important to bear in A
mind that under paragraph 14(2), the manufacturer is required
to print the retail price of the formulation on the label of the
container of the formulation. This is expressed by the words
"retail price not to exceed" preceding it "local taxes extra"
succeeding it. In our view, sub-para (2) of para 14 does not, in B
any manner, support the contention of the manufacturer/
distributor that upto to the expiry of the fifteenth day from the
date of notification of the price fixation order in the official
gazette or receipt of the price fixation order by the manufacturer,
the manufacturer is at liberty to manufacture the formulation andc
print on them the pre-notification prices.
49. The true import of paragraph 14(1) is that once the
price notification is gazetted, it takes effect immediately though
its enforcement is postponed by fifteen days to enable the
manufacturers and others to make suitable arrangements with D
regard to unsold stocks. We agree with learned Additional
Solicitor General that the period of 15 days is simply a grace
period or cooling period allowed to manufacturers to adjust
their business in a manner where appropriate arrangements
are made with regard to the unsold stocks in the distribution E
chain. The argument of the manufacturer or distributor, if
accepted, that the stocks cleared by the manufacturer before
the fifteenth day can be sold to the consumer at the higher
unrevised price then, in our view, that may result in same
formulation being offered for sale to a consumer at two different F
prices. This must be avoided and, therefore, we do not think
that the interpretation put forth by Mr. S. Ganesh is reasonable.
It does not deserve acceptance.
50. Then, the interpretation to sub-paragraph (1) of G
paragraph 14 urged on behalf of the manufacturer/distributor
may also result in misuse by the manufacturer inasmuch as the
manufacturer may increase manufacture of the bulk drugs
during fifteen-day period of notified price and clear that stock
at the unrevised/higher price. We are afraid, this interpretation H
1150 SUPREME COURT REPORTS [2013) 12 S.C.R.
A will also lead to frustrating the regulatory rer1ime which is sought
to be put in place by DPCO.
51. The senior counsel for the manufacturer contends that
under paragraph 15 of DPC0,1995, it is incumbent to print the
8 maximum retail price on the product and that too indelibly. There
is no provision for reprinting of the labels or of return of drugs
once they leave the factory premises. Thus, the batches which
have been manufactured and stamped with old prices can
continue to be sold at those prices. We do not find any merit
in the argument. The DPCO defines 'dealer', 'distributor',
C 'manufacturer', 'retailer' and 'wholesaler'. The provisions
contained in paragraphs 3,8, 9 and other relevant provisions
clearly show that DPCO effectively covers the chain from
manufacture of the bulk drug by the manufacturer to sale of
formulation to consumer though there may be several persons
D in the distribution chain. The ultimate object of the DPCO is that
there is no deception to a consumer and he is sold the
formulation at a price not exceeding the price specified in the
current price list or price indicated on the label of the container
or pack thereof, whichever is less. Logically it follows that there
E cannot be two prices at the end point of the distribution chain
depending on the batch number. A consumer approaching a
chemisVretailer can hardly be offered two prices for the very
same product based only on the difference in batch numbers.
Consumer must get the benefit of the notified price. That is the
F ultimate objective of DPCO. The batch number cannot override
the benefit to which a consumer is entitled on price reduction
of a formulation. A fair reading of DPCO leaves no manner of
doubt that a formulation cannot be sold to the consumer at the
higher price (for earlier batch numbers). In this view of the
G matter, we find merit in the submission of the learned Additional
Solicitor General that the provisions of DPCO requires not just
the end point sale to be at the notified price, but also every sale
within the distribution chain must be at the notified price, if such
sale is made after the date on which sale price is operative.
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1151
INDIA [RM. LODHA, J.]
52. Paragraph 16 of DPCO, 1995 bans sale of bulk drug A
or formulation to a consumer at a price exceeding the price
specified in the current price list or price indicated on the label
of the container or pack thereof whichever is less, plus all taxes,
if any payable. The expressions 'current price list' and
'whichever is less' in paragraph 16 are significant expressions. B
We find ourselves in agreement with the submission of the
learned Additional Solicitor General that the current price list
is simply the price reflecting the currently operating notified price
under the DPCO. Once a price is notified for a formulation, it
takes effect immediately and sale of the formulation to the c
consumer has only to be at the notified price. This is the plain
and ordinary meaning of paragraph 16. The expression,
'whichever is less' further makes it an absolute obligation on
all concerned not to sell any formulation to any consumer at a
price exceeding price specified in the current price list or price D
indicated on the label of the container or pack thereof
whichever is less.
53. The requirement of issuance of a price list in Form V
by the manufacturer to the dealers, State Drugs Controllers and
the Government which mentions mandatorily effective batch E
number and the d,ate thereof is of no real help in construction
of paragraph 14: Moreover, if the argument of Mr. S. Ganesh
with reference to Form V that every price list is in respect of
"effective batch number" only, is accepted, it may have effect
of overriding the entire scheme of DPCO. In our view, this F
cannot be done.
54. In Cynamide India Limitec/4, though the Court was
concerned with challenge to the notifications issued by the
Central Government fixing the maximum prices at which various G
indigenously manufactured bulk drugs could be sold under the
DPC0,1979 but the prefatory statement made by this Court in
paragraph 2 is worth noticing. In paragraph 2 (Pg. 733) of the
Report, the Court observed:
H
1152 SUPREME COURT REPORTS [2013] 12 S.C.R.
A "2. Profiteering, by itself, is evil. Profiteering in the scarce
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
B 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"'.
c 55. We are of the considered view that if an interpretation
of paragraph 14(1),(2)(3), paragraph 16(3) and paragraph 19
of DPCO, 1995 results in frustrating its object and leads to
denial of the benefit of current notified price to the consumer,
then such interpretation must be avoided. We, therefore, find it
.D difficult to accept the construction put to the above provisions
by Mr. S. Ganesh.
5R. We may now deal with the circular dated 28.04.1979
upon which heavy reliance has been placed by Mr. S. Ganesh,
E learned senior counsel for the manufacturer/distributor. It is true
that the principle of contemporanea expositio guides that
contemporaneous administrative construction, unless clearly
wrong, should be given considerable weight and should not be
lightly overturned but in light of the construction of the relevant
F provisions indicated by us above, the view in the circular cannot
be followed and upheld.
57. In Usha Martin lndustries 3 , while dealing with
exemption notification issued under the Central Excises and
Salt Act, 1944, this Court in paragraphs19 and 20 observed
G as follows:
"19. No doubt the court has to interpret statutory provisions
and notifications thereunder as they are with emphasis to
the intention of the legislature. But when the Board made
H all others to understand a notification in a particular manner
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF1153
INDIA [R.M. LODHA, J.)
and when the latter have acted accordingly, is it open to A
the Revenue to turn against such persons on a premise
contrary to such instructions?
20. Section 37-B of the Act enjoins on the Board a duty
to issue such instructions and directions to the excise B
officers as the Board considers necessary or expedient
"for the purpose of uniformity in the classification of
excisable goods or with respect to levy of duty excised
on such goods". It is true that Section 37-B was inserted
in the Act only in December 1985 but that fact cannot c
whittle down the binding effect of the circulars or
instructions issued by the Board earlier. Such instructions
were not issued earlier for fancy or as rituals. Even the
pre-amendment circulars were issued for the same
purpose of achieving uniformity in imposing excise duty
on excisable goods. So the circular, whether issued
D
before December 1985 or thereafter should have the
same binding effect on the Department."
58. ln Indian Oil Corporation8, this Court culled out the
following principles in relation to the circulars issued by the E
Government under the fiscal laws (Income Tax"Act and Central
Excise Act) as follows:
"1.Although a circular is not binding on a court or an
assessee, it is not open to the Revenue to raise a F
contention that is contrary to a binding circular by the
Board. When a circular remains in operation, the Revenue
is bound by it and cannot be allowed to plead that is not
valid nor that it is contrary to the terms of the statute.
2. Despite the decision of this Court, the Department G
cannot be permitted to take a stand contrary to the
instructions issued by the Board.
8. Commissioner of Customs, Calcutta and Others v. Indian Oil Corporation
Limited and Anr; [(2004) 3 sec 488] H
1154 SUPREME COURT REPORTS [2013) 12 S.C.R
A 3. A show-cause notice and demand contrary to the
existing circulars of the Board are ab initio bad.
4. It is not open to the Revenue to advance an argument
or file an appeal contrary to the circulars."
B 59. The above legal position culled out in Indian Oil
Corporation 8 has been followed in Arviva lndustries 9 •
60. In our view, it is well settled that if the departmental
circular provides an interpretation which runs contrary to the
c provisions of law, such interpretation cannot bind the Court.
1979 circular falls in such category. Moreover, the 1979 circular
is with reference to the DPCO, 1979 whereas we are
concerned with DPCO, 1987 and DPC0,1995. We are not
impressed by the argument of Mr. S. Ganesh that in view of
0 the saving clause in DPC0,1987, the circular is saved which
is further saved by the saving clause in DPC0,1995.
61. Mr. S. Ganesh, learn~id senior counsel for the
manufacturer/distributor also relied upon a decision of this
Court in Ranbaxy Laboratories' wherein this Court had an
E occasion to interpret an exemption notification issued under
paragraph 25 of the DPCO, 1995. By the notification dated
29.08.1995, the exemption was granted to Ranbaxy in respect
of Pentazocine and its formulations upto 31.10.1999. This
Court held that the said exemption was available in respect of
F such products manufactured upto 31.10.1999, even though the
same might be sold afterwards. It is argued that just as the
exemption notification issued under Section 25 of the
DPC0,1995 was addressed t<l the manufacturer, similarly, a
price fixation/revision notification is also addressed to the
G manufacturer who is required to effectuate the same by printing
the revised price on all products manufactured and cleared by
him from the 15th day after the date of the notification/receipt
of the order, and also issuing a revised price list declaring the
H 9. Union of India v. Arviva Industries (I) Ltd; [2007 (209) E.L. T. 5 (S.C.)].
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF 1155
INDIA [R.M. LODHA, J.]
effective batch number from which the revised price will A
operate. It is submitted that the reasoning of the Court in
Ranbaxy Laboratories1 is directly applicable to the present
situation because the conceptual issue arising in both the cases
is same.
B
62. In Ranbaxy Laboratories1, the exemption notification
dated 29.08.1995 is reproduced in paragraph 20 of the Report
which reads as follows:
·s.o. No. 7153 (E), in exercise of the powers conferred
by sub-para (1) of Para 25 of the Drugs (Prices Control) C
Order, 1995, the Central Government having regard to the
factors specified in clause (e) of sub-para (2) of Para 25
of the said Order and also having been satisfied for the
need to do so in the public interest hereby exempts the
bulk drug and formulations based thereupon specified in D
Column 2 of the Table below which is manufactured by the
Company specified in the corresponding entry in Column
3 from the operation of price control stipulated in sub-para
(1) of Para 3, sub-para (1) of Para 8 and sub-para (1) of
Para 9 of the said Order, up to the period as indicated in E
Column 4 thereof.
TABLE
S/. No. Name of the Name of the Period up
product company to which the F
Exemption
is granted
1 2 3 4
Pentazocine M/s Ranbaxy 31-10-1999" G
1.
and its Laboratories Ltd.
fonnulations
63. \n paragraph 27 of the Report in Ranbaxy
Laboratories1, this Court held as under: H
1156 SUPREME COURT REPORTS [2013) 12 S.C.R.
A "27. The court while construing an exemption notification
cannot lose sight of the ground realities including the
process of marketing and sale. The exemption order dated
29-8-~995 is clear and unambiguous. By reason thereof
what has been exempted is the drug which was
B manufactured by the Company and the area of exemption
is from the operation of the price control. They have a direct
nexus. They are correlated with each other. While
construing an exemption notification not only a pragmatic
view is required to be taken but also the practical aspect
c of it. A manufacturer would not know as to when the drug
would be sold. It has no control over it. Its control over the
drug would end when it is dispatched to the distributor. The
distributor may dispatch it to the wholeseller. A few others
may deal with the same before it reaches the hands of the
retailer. The manufacturer cannot supervise or oversee as
D
to how others would be dealing with its product. All statutes
have to be considered in light of the object and purport of
the Act. Thus, the decisions relied upon by the learned
Additional Solicitor General in Union of India v. Cynamide
India Ltd.; Prag Ice & Oil Mills v. Union of India, Shree
E Meenakshi Mills Ltd. v. Union of india and Panipat Coop.
Sugar Mills v. Union of India will have no application."
64. The issue before us is quite different and, in our view,
the judgment of this Court in Ranbaxy Laboratories1 does not
F apply to the present controversy for more than one reason. First,
in Ranbaxy Laboratories1, the Court·was concerned with the
exemption notification issued under paragraph 25 of the
DPC0,1995 whereas in the present matters, the issue centres
around paragraphs 14, 16 and 19 of that DPCO. Second, the
G notification under consideration in Ranbaxy Laboratories1 was
an exemption notification and not a notification for fixation of
price. Third, the exemption notification is relatable to the
manufacturer to the drugs whereas price fixation notification is
related to sale of drug/formulation at a given price.
H
GLAXOSMITHKLINE PHARMACEUTICALS LTD. v. UNION OF1157
INDIA [RM. LODHA, J.]
65. The Delhi High Court in the impugned order has relied A
upon 1979 circular and further held that 1979 circular was in
the context of paragraph 19(1) of DPCO, 1979, which is almost
identical to paragraph 16(3) of DPCO, 1987 and, therefore, the
circular explaining the position in respect of the DPCO, 1979
would continue to hold the field in respect of the very same B
provisions in DPC0,1987. We are unable to accept the view
of the Delhi High Court for the reasons which we have already
discussed above. Moreover, the Delhi High Court has gone
more by practical difficulties which a manufacturer may suffer
and completely ove1'1ooked the scheme of the DPCO which is C
intended to give benefit to the consumer of the reduced current
price of the formulation. It is pertinent to notice that Delhi High
Court distinguished the view of the Karnataka High Court and
observed as follows:
"We agree with the submissions made by Mr. Ganesh that D
the Karnataka High Court decision did not consider Form
5 nor its reference to "Effective Batch No.". Nor did the said
decision refer to the Circular of 1979 which we have
already indicated to be applicable to the DPCO 1987
also. We, therefore, do not agree with the view adopted E
by the Karnataka High Court. In fact, the Supreme Court
decision cited by Mr. Ganesh clearly recognizes the
practical aspects of pricing in the context of time lags.
Once the reality of time lags in the process of manufacture,
clearance, distribution and sale is recognised, the F
importance of 'Effective Batch Nos.' as mentioned in Form
5 comes to the fore. The Effective Batch No. represents
the cut-off for the new pricing. The seizure memo which is
impugned herein relates to Batch No. BT 3104 (for 300mg
tablets) which is prior to the "Effective Batch No. BT 3115". G
The said seizure was, thus, in respect of tablets which had
been manufactured prior to the "effective" Batch No. BT
3115 which, we have explained above, is to be taken as
the cut-off point insofar as !he new prices are concerned."
H
1158 SUPREME COURT REPORTS (2013] 12 S.C.R.
A 66. The above view of the Delhi High Court is
fundamentally flawed and clearly wrong in light of our foregoing
discussion. The Karnataka High Court has taken the correct
view and the same is upheld.
67. We, accordingly, dismiss the appeals preferred by the
8
manufacturer/distributor and allow the appeals of the Union of
India. The parties shall bear their own costs.
R.P. Appeals disposed of.
Search Indian case law
Ask in plain English, not just keywords. 25,000 AI words free, no card.
Try "Drug price control"Sign in to search