SYSTOPLC LABORATORIES (PVT.) LTD. ETC. ETC. versus DR. PREM GUPTA AND ORS. ETC. ETC.

Citation: [1993] SUPP. 2 S.C.R. 385 · Decided: 22-09-1993 · Supreme Court of India · Bench: M.N. VENKATACHALIAH · Disposal: Dismissed

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Judgment (excerpt)

SYSTOPlC LABORATORIES (PVT.) LTD. ETC. ETC. 
A 
v. 
DR. PREM GUPTA AND ORS. ETC. ETC. 
SEPTEMBER 22, 1993 
[M.N. VENKATACHALIAH CJ AND S.C. AGRAWAL, J.] 
Drngs & Cosmetics Act, 1940: Section 26A-Notifications issued there-
under-Notification dated 3. 11.1988 amending earlier notification dated 
23. 7.1983-Jtem 14 of the dlugs substituted-Effect of prohibiting in public 
interest the manufacture of steroid in fu:ed dose combinations for treatment 
of asthmir--On the basis of expert opinion Central Govemment satisfied that 
Use of such drngs involve risk to human beings-Validity of the notifica-
tion-Fresh material in support of revocation of ban-Consideration of by the 
Technical Advisory Board-Directions issued. 
Constitution of India, 1950: 
Art. 19( 1 )(g)-Notification dated 3. 11.1988 issued under S.26A of 
Drngs & Cosmetics Act. 194o-Ban on manufacture and sale of steroids in 
fu:ed dose combinations for treatment of asthma-Whether imposes un-
reasonable restriction and violative of 
In exercise of the powers conferred by Section 26-A of the Drugs & 
Cosmetics Act, 1940, the Central Government issued a notification dated 
3.11.1988 whereby the earlier notification dated 23.7.1983 was amended 
B 
c 
D 
E 
and item no.14 of the drugs specified in the Table was substituted. On the 
basis of the opinion given by an Expert Committee that long term use of F 
steroids in fixed dose combinations for treatment of asthma involved risk 
to human beings and that there was no therapeutic justification for such 
formulations, the Central Government felt it was necessary and expedient 
in public interest to prohibit the manufacture of the said drugs, and 
accordingly it issued the said notification. The manufacture and sale or' G 
fixed dose combination of corticosteroids with any other drug for internal 
use were completely prohibited and the earlier exemption of such fixed 
dose combinations for treatment of asthma was withdrawn. 
Various manufacturers of said fixed dose combinations of the said 
drug filed Writ Petitions in different High Court. One such Writ petition H 
385 
386 
SUPREME COURT REPORTS (1993] SUPP. 2 S.C.R. 
A was dismissed by a High Court and the Special Leave Petition filed against 
it was dismissed by this Court. Following this another High Court also 
dismissed the Writ Petitions filed before it against which the present 
appeal were filed. The Transferred Cases were the Writ Petitions filed in 
another High Court. A manufacturer who was not manufacturing such a 
B drug but has submitted its application for permission to manufacture the 
drug had filed a Writ Petition before this Court. All these appeals/ peti· 
tions challenge the validity of the notification dated 3.11.1988. 
On behalf of the appellants/petitioners, it was contended inter alia 
that scientific data in the form of published paper in the various medical 
C journals showed that fixed dose combination of a corticosteroid and an 
antihistamine has been highly beneficial for the treatment of asthma; that 
the said studies revealed that the patient could obtain an equally effective 
treatment by consuming half the quantity of steroid, and that the com· 
bination has well-recognised synergistic and potentiating properties and 
characteristics and has been more effective. 
D 
On behalf of the respondents, extracts from medical treatises and 
foreign medical journals were filed to show that fixed dose combination of 
cortisteroids and anti-histamines was irrational because anti-histamines 
do not have any role to play in asthma management and that in respect of 
E 
bronchial asthma, the standard treatment viz. broncho·dilator alone may 
not give the desired result and corticosteroids may be resorted to as a 
therapy but the dosage required was to be regulated carefully. It was 
contended that at no stage fixed dose combinations of corticosteroids with 
other drugs were recommended in the treatment of Asthma and that such 
F 
combination were either withdrawn or never introduced for marketing in 
countries like USA, UK etc. As regards the studies and reports relied on 
by the appellants/petitioners, the Respondent contended that they were 
based on research done on animal models and no comparative study 
between corticosteroids alone and fixed dose combinations on human 
beings had been shown and many of the studies were not authentic or were 
G obsolete; and that no standard book or authentic medical journal spoke 
about fixed dose combination o

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