# SYSTOPlC LABORATORIES (PVT.) LTD. ETC. ETC v. DR. PREM GUPTA AND ORS. ETC. ETC

- **Citation:** [1993] Supp. 2 S.C.R. 385
- **Court:** Supreme Court of India
- **Decided:** 1993-09-22
- **Case number:** Civil Appeal Nos. 2791E 2796 of 1992
- **Bench:** M.N. Venkatachaliah Cj, S.C. Agrawal
- **Source:** https://unisonlegal.in/judgment/supreme-court-of-india/systoplc-laboratories-pvt-ltd-etc-etc-v-dr-prem-gupta-and-ors-etc-etc-12187
- **Pages:** 21

## Headnote

Drngs & Cosmetics Act, 1940: Section 26A-Notifications issued thereunder-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 notification-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 unreasonable 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dose combinations for treatment of asthma was withdrawn.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 m

## Text

_Characters 0–39,863 of 49,706. This is a partial read: ask again with offset=39863 for what follows._

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 thereunder-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 notification-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 unreasonable 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 of corticosteroids and other drugs in the
management of asthma.
Dismissing the matters, the Court
H
HELD : 1.1. The court cannot make an assessment about the relative
SYSTOPIC LABORATORIES (P.) LTD. v. DR.1'. GUPTA
387
merits of the various studies and reports placed
before it. Such an A
evaluation is required to be done by the Central Government while exercising its powers under Section 26A of the Drugs & Cosmetics Act, 1940
on the basis of expert advice and the Act makes provision for obtaining
such advice through the Board and the Drugs Consultative Committee
(DCC). [399-B]
1.2. A perusal of the minutes of the meetings of the Board, the
Sub-Committee of the DCC as Well as the Experts Committee shows that
the material submitted on behalf of the manufacturers of the drugs in
question was examined by the members and it cannot be said that there
h~S been no proper consideration of the said material by the Expert
Committee or the Sub-committee of th DCC. The complaint that experts
in clinical medicine were not associated with the Expert Committee was
not justified. [399-E-F]
B
c
1.3. The experts did not consider it necessary to conduct clinical D
trials in respect of fixed dose combination of steroids with broncho·
dilators for systematic use. the petitioners and other manufacturers, if
they so desired, could have· submitted fresh material on clinical trials
conducted during the period subsequent to the notification dated July 23,
1983 in justification of their case before the experts. They did no, however,
do so and they only produced material which was anterior to the notificaE
tion dated July 23, 1983. As to whether clinical trials should have been
conducted or not was primarily for the experts to decided and if the experts
felt that in respect of the drugs in question such clinical trials were not
necessary, it cannot be said that there has been no proper evaluation of
the material that was submitted by the manufactures before the Expert
Committee. [400-F-H]
2.1. The notification prohibiting the manufacture an sale of the drug
in question does not suffer from the vice of unreasonableness. In taking
F
this step the Central Government has moved in a cautious manner. In the
earlier notification dated July 23, 1983, whereby manufacture and sale of G
a number of drugs, including fixed dose combinations of certain drugs was
prohibited, an exception was made in respect of fixed dose combinations
of corticosteroids with other drugs for the treatment of asthma. At that
time also the DCC had expressed the view that fixed dose combinations of
corticosteroids with other drugs was' harmful as indiscriminate use of H
388
SUPREME COURT REPORTS (1993] SUPP. 2 S.C.R.
A
corticosteroids could produce serious side effects and in certain clinical
conditions where administration of steroids is considered necessary, the
drug can be prescribed separately. The Board, however, felt that so far as
combination of steroids with other drugs for treatment of asthma are
concerned, there was need for examining the matter in further detail and
B getting wider opinion in the matter and therefore, it recommended that
such combination may continue. [ 402-D-H]
c
2.2. The matter was thereafter examined in detail by the sub-committee of the DCC as well as the Experts Committee in 1987-88 and the
representatives of the manufacturers were given adequate opportunity of
producing material in support of continued marketing of the said drugs
and very were also personally heard. After taking into consideration all
the relevant date that were made available, the Sub-Committee of Experts
expressed the same view as was held by DCC earlier and they opined that
fixed dose combinations of corticosteroids with any other drug should not
D be allowed because in the recommended upper dosage limit the daily dose
of corticosteroid often exceeds safe pharmacological limit for adreocortical
suppression and that the combinations do not permit titration of the
steroid doses which is often required in practice or the administration of
the minimum daily dose once a day so as to avoid adrenocortical suppresE
sion. Hence the Board recommended that the fixed dose combinations of
corticosteroids with other drugs for use in Asthma should be banned
because asthma therapy is a long term therapy and corticosteroids in
dosage when administered for longer periods are reported to cause more
harm than good to the patients. [403-A-E]
F
2.3. While examining the reasonableness of the prohibition against
manufacture and sale of the said drugs the harmful potentialities of the
drugs have to be considered in the context of the conditions as prevalent
in the country where, on account of illiteracy, people are not aware of the
ill effects of the drugs available in the market and are often misled and
G misguided by quacks and inexperienced doctors. The less drastic course
of permitting manufacture and sale of the drugs with a warning about its
use would not be adequate to protect the general public from the harmful
consequences. The Prohibition imposed by the impugned notification does
not impose an unreasonable restriction and is therefore not violative of
I-I the right guaranteed under Article 19(1)(g) of the Constitution. [403-F-H]
SYSTOPIC LABORATORIES (P.) LTD. v. DR. P, GUPTA
389
State of Madras v. VG. Row, [1952) SCR 597 and Narendra Kumar A
and others v. The Union of India and Others, [1960) 2 SCR 375, relied on.
Mohd. Faruk v. State of Madhya Pradesh and Others, [1970) 1 SCR
156, referred to.
3. Having regard to the observations made by this Court in its order B
dated January 6, 1992 in SLP (C) No. 1588 of 1989, the petitioners as well
as other manufacturers who have filed writ petitions in the High Court
, and whose writ petitions were pending in the High Court were also ap·
proach the Technical Advisory Board and produce any fresh material in
support of their claim for revocation of the ban on manufacture and sale C
of fixed dose combination of corticosteroids with any drug for internal use
for treatment of Asthma. The Board, while considering the matter would
take into account such material. [ 404-B, CJ
4. Since the interim directions issued by the Court were limited to
production for a short period only on the basis of the average monthly D
production, there was no reason to assume that large stocks of drugs was
lying with the petitioners. In the circumstances, it would not be ap·
propriate to give any direction regarding permitting the petitioners to sell
existing stocks of the drug. [ 404-G)
CIVIL APPELLATE JURISDICTION : Civil Appeal Nos. 2791E
2796 of 1992.
From the Judgment and Order dated 3.6.1992 of Punjab and
Haryana High Court in C.W.P. Nos. 6882/88, 1328/89, 1329/89, 1330/89,
802/90 and 12556 of 1990.
WITH
T.C. (C) Nos. 13-14/92, SLP(C) Nos. 9972 & 10745/92 and W.P. (C)
No. 364/93.
F
G
R.F. Nariman, Vivek Sibal, Suman J. Khaitan, for Khaitan & Co., S.
Ganesh, Ravinder Narian, Ms. Amrit Mitra, for JBD & Co., Ms. Kamini
Jaiswal, Ms. Lily Thomas and P.N. Puri for the Appellants.
V.R. Reddy, Addi. Solicitor General, V.C. Mahajan, R.N. Sachthey,
Hemant Sharma, V.K. Verma, T.V. Ratnam, C.V.S. Rao, Mrs. Kawaljit H
390
SUPRE'A:E COURT REPORTS (1993) SUPP. 2 S.C.R.
A. Kochar, J.D. Jain, Badri Nath Babu, Anip Sachthey and Anil K. Jha for
the Respondents.
B
Vivek Sibbal, N.D.B. Raju and Ms. Kum Kum Sen for the Intervenor.
Th,e Judgment of the Court was delivered by
S.C. AGRAWAL, J. These cases raise common question involving
challenge to the validity of the notification dated November 3, 1988 issued
by the Government of India, whereby the earlier notification dated July 23,
1983 was amended and item No. 14 of the drugs specified in the Table in
C the said notification was substituted so as to prohibit completely the
manufacture and sale of fixed dose combination of steroids with other
drugs for internal use. The said notification has been issued in exercise of
the power conferred by Section 26-A of the Drugs & Cosmetics Act, 1940
(hereinafter referred to as 'the Act'). In the said notification, it has been
D stated that the Central Government is now satisfied that long term use of
steroids in fixed dose combinations for treatment of asthma is likely to
involve risk to human beings and such formulations do not have therapeutic
justification and further that it is necessary and expedient in public interest
to prohibit the manufacture and sale of the said drugs.
E
F
G
H
A number of manufacturers, including the appellants in Civil Appeals Nos. 2791 - 96 of 1992 and the petitioners in SLP(C) Nos. 9972 and
10745 of 1992 and Transferred Cases (C) Nos: 13 - 14 of 1992, filed writ
petitions in various High Courts to challenge the validity of the said
Notification. One of these writ petition (no. 364 of 1993), filed in the
Madras High Court by Micro Labs (P) Ltd., was dismissed by a Division
Bench of the said High Court by judgment dated June 18, 1991 SLP (C)
No. 1538 of 1991 filed against the said decision was also dismissed by this
Court on January 6, 1992 with the following observations -
"The special leave petition is dismissed. The petitioner, however,
will be permitted to make a fresh application for permitting
manufacture and sale of drugs in question which will be considered
by the Technical Board which will include one or more practising
doctors specialising in treating Asthma cases. The inclusion may
be in the form of membership or in advisory or any other appropriate capacity"
SYSTOPICLABORATORIES (P.) LTD. v. DR. P. GUPTA[AGRAWAL,J.] 391
Following the aforesaid decision of the Madras High Court in Micro A
Labs' case (supra), a Division Bench of the High Court of Punjab &
Haryana, by judgment dated June 3, 1992 dismissed a number of wrjt
petitions wherein the validity of the. notification dated November 3, 1988
had been challenged. Civil Appeals (C) Nos. 2791-96 of 1992 and SLP(C)
Nos. 9972 of 1992 and 10745 of 1992 are directed against the said decision B
of the High Court of Punjab and Haryana. Transferred Cases (C) Nos. 13
and 14 of 1992 relate to writ petition no. 1701 of 1984 [Fulford India
Limited and Another v. Dr. S.S. Gothoskar and Ors. and writ petition no.
1746 of 1984), U)ieth Laboratories Ltd. & Anr. v. Dr. S.S. Gothoskar & Ors.]
which were originally filed in the Bombay High Court. The appellants in
the appeals (who would referred to as the petitioners for the sake of C
convenience) as well as the petitioners in Special Leave Petitions and the
Transferred Cases have been manufacturing fixed does combinations of
corticosteroids with anti-histamines and corticosteroids with bronchodilators under different names. The petitioner in writ petition no. 364 of
1992, which has been filed under Article 32 of the Constitution, holds a D
licence granted by Director, Drugs Control Administration of the Government of Andhra Pradesh for the manufacture and sale of medicines and
drugs. The said petitioner is not manufacturing the prohibited drugs but
has submitted an application for permission to manufacture the said drugs.
Reference, at this stage, may be made to the relevant provisions of E
the Act. As stated in the preamble, the Act has been enacted to regulate
the import, manufacture, distribution and sale of drugs and medicines.
Section 5 of the Act provides for the constitution of the Drugs Technical
Advisory Board (hereinafter referred to as 'the Board') by the Central
Government to advise the Central Government and the State Governments p
on technical matters arising out of the administration of the Act and to
carry out the other functions assigned to it by the Act. Section 7 empowers
the Central Government to constitute and advisory committee to be called
as Drugs Consultative Committee (in short, DCC) to advise the Central
Government and the State Governments and the Board on any mater
tending to secure uniformity throughout India in the administration of the G
Act. Section 26A, which was introduced in the Act by Drugs Amendment
Act, 1982 (Act no. 68 of 1982), provides as under -
"26A. Without prejudice to any other provisions contained in this
Chapter, if the Central Government is satisfied, that the use of H
A
B
c
D
E
F
G
H
392
SUPREME COURT REPORTS (1993] SUPP. 2 S.C.R.
any drug or cosmetic is likely to involve any risk to human being
or animals or that any drug does not have therapeutic value
claimed or purported to be claimed for it or contains ingredients
and in such quantity for which there is no therapeutic justification
and that in the public interest it is necessary or expedient so to
do, then the Government may, by notification in the official
Gazette, prohibit the manufacture, sale distribution of such drug
or cosmetic".
In 1979, the DCC had set up an Experts Committee as a Subcommittee of the DCC for screening the formulations of drugs prevalent
in the Indian market from the point of view of therapeutic rationale in
order to weed out irrational/harmful combination of drugs. The Sub-Committee examined a number of fixed dose combinations of drugs which did
not appear to have adequate rationale or appeared to be harmful and made
the following recommendation in respect of fixed combinations of steroids:
"Fixed dose combinations of steroids with any other category of
drugs should not be allowed as they are considered harmful for
the following reasons :
(a) The adrenal suppression accompanying steroid therapy
leads to symptoms and signs of adrenal insufficiency, if the steroid
is. abruptly withdrawn.
(b) It is difficult to titrate the dose of a steroid when it is present
in fixed dose combinations with other drugs."
The recommendations of the Sub-Committee were considered by the
DCC in its meeting held on October 19, 1981 and in relation to steroid
combinations the DCC took the following decision :
"Fixed dose combinations of Steroids for internal use should not
be allowed. However, for therapeutic convenience the industry
should be prevailed upon to make available
preparations of
steroids in lower strength e.g. Prednisolone Tablet 1 mg. Fixed
dose combination of corticosteroids with other drugs are not
justifiable as indiscriminate use of corticosteroids can produce
serious side effects viz. fluid and electrolyte disturbances, hyperglycemia and glycosuria, increased susceptability to infection, in-
SYSTOPICLABORATORIES (P.) LTD. v. DR. P. GUPTA[AGRAWAL,J.] 393
eluding tuberculosis, peptic ulcers, osteoporosis, a characteristic A
myopathy, Cuihing's habitus, hirsutism etc. In certain clinical conditions where administration of steroid is considered necessary,
the drug can be prescribed separately".
The recommendations of the DCC were considered by the Board at
its meeting held on December 31, 1981 and the Board made following B
recommendation -
"STEROID COMB/NA TIO NS :
Fixed combinations of steroids with other drugs for internal use
should not be allowed.
C
However, the Board felt that so far as combination of steroids
with other drugs for the treatment of asthma are concerned there
was a need for examining the matter in further details and getting
wide medical opinion in the matter. The Board, therefore, felt that D
such combination may continue for the present".
After the incorporation of Section 26-A in the Act, notification dated
July 23, 1983 was issued by the Government of India in the light of the
recommendations made by the Board and the manufacture and sale of 22
drugs were prohibited under Section 26-A of the Act. Out of these 22 E
drugs, items 2 to 17, including item 14, were fixed dose combinations of
certain drugs. Item 14 in the said notification was -
"14. Fixed dose combination of Steroids for internal use except
combination of Steroids with other drugs for the treatment of
Asthma".
Similar exception had been made in item no. 15 relating to fixed
dose combinations of chloramphenicol for fixed dose combination of
Chloramphenicol and streptomycin.
F
It appears that there was criticism in vario,us fora of the exemption G
granted for fixed dose combinations of Steroids for treatment of asthma
and medical critics opined that there is hardly a clinical situation when a
fixed does combination of corticosteroids with drugs like bronchodilators
are required. Taking note of the criticism the Sub-Committee of the DCC
at the meeting held on January 15, 1987 felt it necessary to review again H
394
SUPREME COURT REPORTS [1993] SUPP. 2 S.C.R.
A
the fixed dose combination of corticosteroids and it was decided that the
manufacturers of such drugs be asked to establish published evidence of
rationality for continued marketing of such combinations. It was also
decided that the experts should also be requested to participate in the next
meeting. At the next meeting held no June 3, 1987 the Sub- committee was
B informed by the Chairman that the experts had desired that more technical
data on the rationality/efficiency of the combination of drugs in the Indian
context should be generated or asked for and the Sub-Committee decided
that representatives of the manufacturers should be given a hearing to
record their views at the next meeting and that this could be ensured by
C writing to Pharmaceutical Associations. A special meeting of experts to
examine the views of the affected manufacturers who represented against
withdrawal of certain formulations moving in the market was held on
September 8, 1987. At the said meeting a summary of the view points of
the manufacturers as well as a critical review on various submissions
prepared by the Director General of Health Services was placed before
D the experts. At the said meeting the criteria/guidelines for evaluation of
each category of formulation were evolved and it was decided that the
experts would evaluate the various types of formulations after going
through the written submissions furnished by the affected manufacturers.
The original supporting date furnished by the manufacturers was also
E forwarded to the experts. At the meeting of experts and the members of
the Sub- Committee held on October 16 and 17, 1987 the representations
submitted by different firms against the notification on 12 categories of
drugs as irrational or of doubtful efficiency were discussed by the representatives of the industry and the committee and thereafter the following
F
G
recommendations were made -
"F.D.C. of Conicosteroids with Bronchodilators/Antihistaminics for
systemic use
The Committee observed that the formulations moving in the
market when administered at the recommended daily dose exceeds
the safety limit of cortiocosteroid besides there is no rationality of
F.D.C. of Corticosteroids with bronchodilators/antihistaminics for
the following reasons : -
H
(a) "FDC of Cortiosteroid with Bronchodilator
r
SYSTOPICLABORATORIES (P.) LTD. v. DR. P. GUPTA[AGRAWAL,J.] 395
The recommended dose exceeds the adrenal suppression. A
Moreover such combinations limit the scope of titration of corticosteroids which may be required in clinical situations. Such fixed
dose combination should not be allowed.
(b) F.fJ.C. of Corticosteroids wit~ antihistaminics
Antihisfamim~s has no role in the· management of bronchial asthma
as h'istiiini11.e ·is· released from s6nsitized mast cells in very high
i;01kep.tratlon. near the target cells and antihistaminics cannot
block such 'effect quantitatively. Besides many· more chemical
mediat6rs are released in sensitized target cells not antagonised
by anlihistaminics.
There is a lack of published evidence to prove the higher efficacy
of such combination over Corticosteroid alone. Such combinations
should not be allowed."
The Sub-Committee at its meeting held on Jamtary 15-16, 1988,
noticed that the experts have opined that little will be achieved by conducting trial on these categories and have reiterated their earlier stand of
recommending withdrawal of fixed dose combination of steroids with
bronchodialtors for systematic use. The Sub-Committee has also recorded
that the manufacturers of these formulations were asked through IDMA
an OPPI to furnish evidence justifying their continued marketing of fixed
dose combinations of corticosteroids with other drugs for internal use and
the literature and any other information furnished by the manufacturers
were examined by the expert groups and interested manufacturers were
given an opportunity for pleading their case in person with the experts and
that after going through the information and literature furnished by the
manufacturers and after listening the various arguments, the experts had
unanimously taken the following decisionB
c
D
E
F
"With regard to fixed dose combinations containing corticosteroids
and bronchodilators/other drugs, the experts had opined that fixed G
dose combinations of corticosteroids with any other drug for internal use should not be allowed because in the recommended
upper dosage limit the daily dose of corticosteroids often exceeds
safe pharmacological limit for adrenocortical suppression. Besides,
the combinations do not permit titration of the steroid doses which H
A
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E
F
G
396
SUPREME COURT REPORTS (1993] SUPP. 2 S.C.R.
is often required in practice or the administration of the minimum
daily dost once a day so as to avoid adrenocortical suppression.
Moreover there is hardly any authentic reference ,to support that
fixed dose combination of corticosteroids with bronchodilators or
anti-histaminics are recommended in the treatnv:nt of asthma''.
The Sub-Committee expressed the following view :
"In this context, it may be pertinent to mention that the.expert body
and the DCC had also earlier held the same views now expressed
by the expert group. As advised by the DT AB examina~ion ~f t~e
above mentioned categories have been done and their rec01mnen•
dations with reasons are now placed before the DTAB fori,aking
a final decision in the matter".
The matter was thereafter considered by the Boara at its meeting
held on April 22, 1988 and the following view was c;xpressed -
"The Board agreed that the fixed dose combination of chloramphenical and streptomycin should not be allowed to be marketed.
After exchange of views amongst the members it was agreed that
the fixed dose combinations of corticosteroids with other drugs for
use in asthma should be banned because asthma therapy is a long
term therapy and corticosteroids even in low dosage when administered for longer periods are reported to cause more harm
than good to the patients. The Board approved that the entry no.
14 appearing in the notification GSR No. 578(E) dated 23.7.1983
may be suitably amended''.
Having regard to the aforesaid recommendations of the Board, the
impugned notification dated November 3, 1988 was issued whereby item
no. 14 contained in the earlier notification dated July 3, 1983 was substituted as under -
"Fixed dose combination of corticosteroids with any other drug for
internal use''.
As a result-0f the said notification dated November 3, 1988, manufacture and sale of fixed dose combination of corticosteroids with any other
H drug for internal use have been completely prohibited and the earlier
SYSTOPICLABORATORIES (P.) LTD. v. DR. P. GUPTA[AGRAWAL,J.)397
exemption of such fixed dose combinations for treatment of asthma has A
been withdrawn.
In this context it rnay be mentioned that in with petition no. 3554 of
1988 filed by M/s. Roussel Pharmaceuticals pending before the Bomaby
High Court, the following observations were made by High Court in an B
order dated February 21, 1989 -
"the Government, even at this stage, may apply its mind afresh and
hear all the persons concerned on this question and then take
appropriate decision".
In view of the said observations, the matter of prohibition of fixed
dose combination of steroids with other drugs for internal use was considered afresh by a Committee of Experts. Five manufacturers, including
c
the two petitioner in T.C .. Nos. 13 and 14 of 1992 and M/s. Roussel
Pharmaceuticals India Ltd. had sent their representative tO put forward D
their vii;ws in person, but apart from Mis Roussel Pharmaceuticals, none
of the ~ther manufacturers presented any scientific paper or any fresh
evidence in support of continued marketing of fixed dose wmbination of
stroids for internal'use. The literature which was submitted by M/s. Roussel
Pharmaceuticals India Ltd. had been earlier submitted by them on October
16-17, 1987. The said material and other literature on the subject was E
considered by the Experts Committee at the meeting held on June 6, 1989.
The Experts Committee have expressed the view that the literature did not
establish the rationality of administering corticosteroids with other drugs
in a fixed dose manner for the treatment of bronchial asthama and that the
published papers that were submitted by the manufacturers to justify the F
continued marketing of the said fixed dose combination do not establish
the necessity of using a combination of number of drugs in sub-the:t:apeutic
doses instead of using one drug in therapeutic concentration for achieving
the same clinical benefit. The Experts Committee also opined that the
interpretation of the results made by respective authors are not scientific.
According to the Experts Committee there is no scientific evidence to show G
that there is a therapeutic rationality of co-administering bronchodialtors,
corticosteroids and seductive in a single tablet under a fixed dose and that
on the other hand there were several adverse reactions of corticosteroids
when indiscriminately used. The Experts have, therefore, found that there
is no case for granting exemption for continued marketing of fixed dose H
A
B
c
398
SUPREME COURT REPORTS [1993) SUPP. 2 S.C.R.
combination of corticosteroids with other drugs for the treatment of
Asthma.
On behalf of the petitioners, scientific data in the form of published
papers in the various medical journals have been filed to show that fixed
dose combination of a corticosteriod and an anti-histamine is highly beneficial for the treatment of asthma. It has been submitted that the said studies
reveal that the patient can obtain an equally effective treatment by consuming half the quantity of steroid and thereby the consumption of steroid
is kept to the minimum possible level and further the combination has
well-recognised synergistic and potentiating properties and characteristics
as a result of which the treatment is far more effective for these allergic
disorders than if the two drugs were taken seperately. It has also been
urged that as the consumption of steroid is sharply reduced, the expense
involved in the treatment is also curtailed significantly. It has also been
pointed out that fixed dose combinations of corticosteroids and anti-hisD tamine or broncho-dilators are being marketed freely in a number of
countries such as Germany, Japan, France, Switzerland, Austria etc. It has
also been urged that where the patient has to take two different tablets
together at the same time, it is always a serious problem to ensure that he
takes both of them regularly, and as required and that the problem of
E
patient compliance is all the more acute in a country where the level of
illiteracy is very high, as in India. Similarly, on behalf of the respondents
extracts from medical treatises and foreign medical journals have been filed
to show that fixed dose combination of cortisteroids and anti-histamines is
irrational because anti-histamines have no role to play in asthma management and that in respe'ct of bronchial asthma, the standard treatment is
F
broncho-dilator and in cases of severe chronical asthma where bronchodilator alone fails to give disired result corticosteroids may be resorted as
a therapy but the dosage needs to be regulated carfefully. It has been
submitted that at no stage fixed dose combinations of cortiosteroids with
other drugs is recommended in the treatment of Asthma and that such
combinations were either withdrawn or never introduced for marketing in
G the USA, UK etc. As regards the studies and reports that have been
submitted by the petitioners, it has been pointed out that they are based
on research done on animal models and no comparative study between
corticosteroid alone and fixed dose combinations on the human beings
have been shown and further that many of the studies are not authentic
H publications or are obsolete. It has been submitted that no standard boo'k
.•
~
SYSTOPIC LABORATORIES (P.) LID. v. DR. P. GUPTA [AGRAWAL, J.] 399
or authentic medical journal speaks about fixed dose c_ombination of A
corticosteroids and other drugs in the management of asthma.
Having cosidered the submissions made by the learned counsel for
the petitioners aμd the learned Additional Solicitor General in this regard,
we must express our inability to make an assessment about the relative
merits of the various studies and reports which have been placed before
us. Such an evaluation is required to be done by the Central Government
while exercising its powers under Section 26A of the Act on the basis of
expert advice and the Act makes provision for obtaining such advice
through the Board and the DCC.
The learned counsel for the petitioners have urged that these studies
and reports had been submitted on behalf of the petitioners and other
manufacturers. before the Sub-Committee of the DCC as well as the
Experts Committee but there has been no proper consideration of the same
B
c
by the experts as well as the DCC and the Board. In this context, it has D
been submitted that no medical expert in the field of clinical medicine In
the treatment of asthma was associated in the committees and such experts
alone could make a proper evaluation of the said studies. We find no
substance in this contention. We have pursued the minutes of the meetings
of the Board, the Sub-Committee of the DCC as well as the Experts
Committee. The minutes show that the material that was submitted on E
behalf of the manufacturers of the drugs in question was examined by the
memebers and it is not possible to hold that there has been no proper
consideration of the said material by the Experts Committee or the Subcommittee of the DCC. The complaint that experts in clinical medicine
were not associated with the Committee does not appear to be justified. F
The minutes of the meetings of the experts to consider the views of the
affected manufacturers who represented against the proposed withdrawal
of certain formulations moving in the market which were held on September 8, 1987, October 16-17, 1987 and January 15-16, 1989 show that among
the members were included Dr. O.D. Gulati, Dean, CAM Medical College,
Karansad and Dr. J.P. Wali, Assistant Professor of Medicine, AIIMS, New G
Delhi. Dr. M. Durairaj, Consultant, Cardiologist, Director of Cardiology,
Poona Hospital & Research Centre, Pune was also member of the Subcommittee and had attended the meeting held on January 15-16, 1988. It
cannot, therefore, be said that medical experts in clinical medicine were
not associated in the Experts Committee for evaluation of the material that H
400
SUPREME COURT REPORTS [1993] SUPP. 2 S.C.R.
A was furnished by the manufacturers.
It has alsci been contended that in the meeting of experts held on
September 8, 1987, the criteria/guidelines had been indicated for evaluation
of each category of formulation and that in the said criteria/guidelines
B reference is made to comparative clinical trials with the formulation. It has
been urged that no such clinical trials of fixed dose combinations of
corticosteroids with anti-histamines or broncho-dialators were conducted
prior to the issuance of the impugned notification dated November 3, 1988
and in the absence of such clinical trials, the Central Government could
not have been satisfied that long term use of fixed dose combinations of
C corticosteroids with any other drug for internal use for treatment of asthma
do not have therapic justification. It is no doubt true that at the meeting
of experts held on September 8, 1987 certain criteria/guidelines wer indicated and one of the said criteria/guidelines refers to adequate controlled
comparative clinical trial with the formulation. But those criteria/guidelines
D were indicated in respect of 12 types of formulations which were under
consideration Combinations of corticosteroids with other drugs for systematic use for the treatment of bronchoialasthma was one of those formulations. With regard to fixed dose combination of chloramphenicol
streptomycin and fixed dose combination of steroids with bronchodilators
for systematic use, the minutes of the meeting of the Sub-Committee held
E
on January 15-16, 1988, record that "the experts had opined that little will
be achieved by conducting clinical trials on these categor~es and reiterated
its earlier stand of recommending withdrawal of fixed dose combination of
chloramphenicol with streptomycin and fixed dose combination of steroids
with bronchodilators for systematic use". This ·would show that the experts
F
did not consider it necessary to conduct clinical trials in respect of fixed
dose combination of steroids with bronchodilators for systematic use. The
petitioners and other manufacturers, it they so desired, could have submitted fresh material based on clinical trials conducted during the period
subsequent to notification dated July 23, 1983 in justification of their case
before the experts. They did not, however, do so and the only produced
G material which was anterior to the notification dated July 23, 1983. As to
whether clinical trials should have been conducted or not was primarily for
the experts to decide and if the experts felt that the respect of the drugs
in question such clinical trials were not necessary, it is not possible to hold
that there has been no proper evaluation of the material that was submitted
H by the manufacturers before the Experts Committee.
SYSTOPICLABORATORIES (P.) LTD. v. DR. P. GUPTA(AGRAWAL,J.] 401
Another contention that has been advanced on behalf of the A
petitioners was that under impugned notification dated November 3, 1988,
there is complete prohibition of the manufacture and sale of fixed dose
combination of corticosteroids with any other drug for internal use and that
such a prohibition unreasonably restricts the right of the petitioners to
carry on their trade guaranteed under Article 19(1)(g) of the Constitution. B
The submission is that in order that the said restriction could be regarded
as a reasonable restriction it was necessary for the authorities to consider
whether a less drastic course could be adopted, namely, permitting
manufacture and sale of such drugs with a warning about its use. Reliance,
in this regard, has been placed on the observations of this Court in Mohd.
Farnk v. State of Madhya Pradesh and others, [1970] 1SCR156. We do not
find any merit in this contention.
c
In State of Madras v. V.G. Row, [1952] SCR 597, this Court, while
emphasising that "no abstract standard or general pattern of reasonableness can be laid down as applicable in all cases" has indicated the following
criteria for examining the reaspnabless of the restrictions under Article 19: D
"The nature of the right alleged to have been infrigned, the underlying purpose of the restrictions imposed, the extent and urgency
of the evil sought to be remedied thereby, the disproportion of the
imposition, the prevailing conditions at the time, ......... " (p.607)
E
In Narendra Kumar and Others v.