UNION OF INDIA AND ANOTHER versus M/S. SWISS GARNIER LIFE SCIENCES & ORS.

Citation: [2013] 17 S.C.R. 918 · Decided: 04-07-2013 · Supreme Court of India · Bench: G.S. SINGHVI · Disposal: Appeal(s) allowed
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Judgment (excerpt)

A 
B 
(2013] 17 S.C.R. 918 
UNION OF INDIA AND ANOTHER 
v. 
M/S. SWISS GARNIER LIFE SCIENCES & ORS. 
(CIVIL APPEAL NO. 5117 OF 2013) 
JULY 4, 2013 
[G.S. SINGHVI AND SUDHANSU 
JYOTI MUKHOPADHAYA, JJ.] 
Drugs (Prices Control) Order, 1995 - Paras 2(a), 2(u), 
C 2(v), 9, 11; First Schedule - "Bulk drug" - "Scheduled bulk 
drug - "Scheduled formulation" - 'Doxofylline' - Jurisdiction 
of the Government to fix the ceiling price or revise the price 
of Doxofylline - Price fixation notifications issued whereby the 
Government fixed the prices of "Doxofylline formulatiors" -
D Challenge to - Notifications set aside by the High Court -
Held: Doxofylline is derivative of Theophylline, a bulk drug, 
and Doxofylline in any formulation comes within the definition 
of scheduled formulation - Consequently, it was wel/ within the 
jurisdiction of the Government to fix the ceiling price of 
E Doxofyl/ine formulation under para 9 or para 11 of DPCO, 
1995 - Interference with the Notifications by the High Court 
was uncal/ed for - Drugs and Cosmetics Act, 1940 - Second 
Schedule. 
F 
The respondents filed writ petitions challenging the 
price fixation Notifications dated 30th April, 2009 and 17th 
November, 2009 whereby the Government had fixed the 
prices of "Doxofylline formulations" in exercise of power 
conferred under paras 9 and 11 of the Drugs (Prices 
,., Control) Order, 1995. The High Court set aside the 
' 
H 
Jforesaid Notifications holding that 'Doxofylline' is not a 
bulk drug within the meaning ascribed to it under para 
2(a) of the DPCO, 1995. 
The questions arising for consideration in the 
918 
UNION OF INDIA v. SWISS GARNIER LIFE 
919 
SCIENCES 
present appeal were: (a) whether '.Doxofylline' is a bulk A 
drug within the meaning of para 2(a) of DPCO, 1995; (b) 
whether 'Doxofylline' is a 'scheduled bulk drug' within 
the meaning of para 2(u) of DPCO, 1995; (c) whether 
'Doxofylline' is a "scheduled formulation" within the_ 
meaning of para 2(v) of DPCO, 1995; and (d) whether the fr 
appellant has the power to fix the ceiling price or revise 
the price of Doxofylline under the DPCO, 1995. 
Allowing the appeals, the Court 
HELD: 1. In exercise of powers conferred under 
. Section 3 of the Essential Commodities Act, 1955, the C 
Central Government made order, namely, the. Drugs 
(Prices Control) ,Order, 1995. It was so issued to control 
the prices of the essential drugs including life saving 
drugs. Para 2 of the order is the definition clause, Bulk 
drug is defined in para 2(a) while "formulation" is defined · D 
in para 2(h). Para 2(U) defines 'scheduled bulk drug' 
whereas 'scheduled formulation' is defined in para 2(v). 
Para 3 relates to power to fix the maximum sale prices of 
bulk drugs specified in the First Schedule of the DPCO, 
1995. Special provisions relating to "fixation of price" are 
E 
provided under Para 9 and 11. [Paras 18, 20] [930-A, B, 
C, E-F; 931-B-G; 934-B] 
2. The First Schedule of the DPCO, 1995 indicates the 
'bulk drugs' 
recognized 
by the 
Government. 
"Tl)eophylline" has been shown as one of the bulk drugs F 
for the purposP. of para 2 and 3. It is a 'bulk drug' shown 
at Serial No.34 of the First Schedule of DPCO, 1995 and 
is shown in the Indian pharmacopeia and conforms to the 
_ standard as per Second Schedule to the Drugs and 
Cosmetics Act, 1940. Therefore, Theophylline comes G 
within the meaning of bulk drug as defined in para 2(a) 
and also comes within meaning of 'scheduled bulk drug' 
[para 2(u)] and 'scheduled formulation' [para 2(v)]. [Paras 
21, 30] [935-E-F; 942-B-C-] 
3. 'Doxofylline' as such has not been shown as one H 
. 920 
SUPREME COURT REPORTS 
(2013] 17 S.C.R. 
A of the bulk drugs in the First Schedule of the DPCO, 
1995. However, in reply to a letter written by the 
Department of Chemical and Petro-Chemicals, Ministry of 
Chemical and Fertilizer, New Delhi dated 5th December, 
2008, the Indian Institute of Science (llSc), Bangalore vide 
s 
letter dated 23rd January, 2009 informed that Doxofylline 
was a derivative of scheduled drug Theophylline. From 
the expert opinion of llSc and the National Institute of 
Pharmaceutical Education and Research (NIPER), the 
details enclosed by the respondent- Mars Therapeutics 
c Ltd. with their Form 44, and the stand taken in their 
application for registration, it is clear that 'Doxofylline' is 
a derivative of 'Theophylline'. [Paras 21, 25, 27 and 28] 
[935-E; 938-C; 939-D-E-H; 940-A-B] 
4. The definition of "bulk drug" conta
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