Holding

The Supreme Court held that while statutory bodies must comply with Article 144 notices, the determination of drug‑policy is a technical and policy matter unsuitable for judicial adjudication, and thus the petition was dismissed.

Summary

Vincent Panikurlangara, an advocate and General Secretary of a public‑interest law service society, filed a writ petition under Article 32 seeking a total ban on the import, manufacture, sale and distribution of certain drugs that had been recommended for prohibition by the Drugs Consultative Committee, along with cancellation of licences and the creation of a high‑powered authority to investigate hazards and award compensation. The petition also urged the government to frame stricter drug‑quality regulations and to ensure availability of essential medicines at reasonable prices, invoking Articles 21 and 47 of the Constitution. The Supreme Court held that statutory bodies, once summoned under Article 144, must appear before the Court, but the issues raised pertained to highly technical and policy matters that are not suitable for judicial determination. Consequently, the Court dismissed the petition as an inappropriate forum for deciding drug‑policy questions, while directing the Central Government to consider the petitioner’s objections, formulate a clear drug policy, and possibly set up a high‑powered authority, and ordered a modest compensation of Rs 5,000 to the petitioner. The petition was therefore disposed of.

Issues considered

Whether statutory bodies are bound to respond to a Supreme Court notice under Article 144 in a public‑interest litigation.
Whether the Supreme Court can interfere with or dictate drug‑policy matters that are technical and policy‑oriented.
Whether the petition for a total ban on certain drugs and cancellation of licences is maintainable under Article 32.
Whether the Court may direct the government to constitute a high‑powered authority and frame drug‑regulation policy.

Legislation cited

Drugs and Cosmetics Act, 1940s. 10-A, s. 26-A

Subjects

public interest litigationdrug policyDrugs and Cosmetics ActArticle 21Article 47Article 144statutory bodiesjudicial reviewhealthregulatory authority

Judgment

A VINCENT PANIKURLANGARA
v.
UNION OF INDIA & ORS.

MARCH 3, 1987
B [RANGANATH MISRA AND M.M. DUTT, JJ.]

Constitution of India, 1950, Article 144-Civil and judicial
authorities to act in aid of the Supreme Court-Public Interest Litiga-
tion relating to drug policy filed in the interest of nation's health-
Statutory bodies except State of Karnataka responding to Supreme
C Court's notice-Constitutional obligation stressed.

Public Interest Litigation-Health Care for citizens-Whether the
Supreme Court could interfere with the matter touching the policy of the
Government and the duty cast under Article 47 of the Constitution.
D The petitioner, an advocate by profession bas moved the Supreme
Court in public interest seeking directions banning import, manu-
facture, sale and distribution of such drugs which have been banned in
Western countries or recommended to he banned by the Drugs Con-
sultative Committee under the Drugs and Cosmetics Act, 1940. The
petitioner has' also sought directions, (i) for cancellation of licences
E authorlsig import, manufacture, sale and distribution of such drugs; (ii)
for Constitution of a high powered Authority to go into the hazards
suffered by people of the country on account of such drugs being in
circulation and suggest remedial measures including award of
compensation.
F Disposing of the petition, the Court,

HELD: 1. Statutory bodies when called upon by a Court, in
particular the apex Court of the Country, are duty-bound to respond
and join the proceedings before the Court, as required by Article 144 of
the Constitution. These bodies are not litigants and do not have the
G choice or'keeping away from the Court like private parties in ordinary
litigations opting to go ex parte. The present matter is certainly one
which is sufficiently important and the stake of the entire nation is high
when the Court suoe moto extended the opportunity of being heard and
invited the named statutory or other authorities to come forward and
place their view points on relevant aspects, an attitude of callous indif-
H

468
VINCENT PANIKURLANGARA v. U.0.1. 469

ference cannot be appreciated. It is hoped that there would be no repeti- A
tion of such a situation. [47SG-H; 476A-B]

P. Nalla Thampy v. Union of India, [1983] 4 SCC 598, followed.

. 2. Having regard to the magnitude, complexity and technical
nature of the enquiry involved in the matter and keeping in view of the B
far reaching implications of the total ban of certain medicines for which
\l the petitioner has prayed, it is clear that a judicial proceeding of the
nature initiated is not an appropriate one for determination of such
... ·1· matters. [476H; 477A]

2.2 The issues raised in this petition are of vital importance as they
relate to maintenance of approved standards of drugs in general; the
c
-1 writ petition involves the claim for withdrawal of 7000 fixed dose com-
binations and withdrawal of licences of manufacturers engaged in
manufacture of about 30 drugs which have been licensed by the Drugs
Control Authorities; the issues that fall for consideration are not only
relating to technical and specialised matters relating to therapeutic D
value, justification and harmful side effect of drugs hut also involve
examination of the ectness of action taken by the respondents 1 and 2 on
the basis of advice; the matter also involves the interest of manufactur-
.... ers and traders of drugs as also the interest of patients who require
drugs for their treatment. The technical aspects which arise for consid-

- eration in a matter of this type cannot be effectively handled by.a Court. E

.. t-
Similarly the question of policy which is involved in the matter is also
one for the Union Government-keeping the best of interests of citizens
in view to decide. No final say in regard to such aspects come under the
purview of the Court. [4760-F; 478F-G

2.3 This branch namely, Health Care of citizens, is a problem F
with various facets. It involves and over-changing challenge. There
appears to be, as it were, a constant competition between Nature (which
can be said to be responsible for new ailments) on the side and human
ingenuity engaged in research and finding out curative processes. This
being the situation, the problem has an ever-shifting base. It is common
place that what is considered to be the best medicine today for treat- G
-+ ment of a particular disease becomes out of date and soon goes out of the
market with the discovery or invention of new drugs. Again what is
considered to be incurable at any given point of time becomes subjected
to treatment and cure with new finds. There is yet another situation
which must be taken note of as human knowledge expands and marches
ahead. With the onward march of science and complexities of the living H
470 SUPREME COURT REPORTS [1987] 2 S.C.R.

A process and hitherto unknown diseases are noticed. To meet new
challenges, new drugs have to be found. In this field, therefore, change
appears to be the rule. [478G·H; 479A·C)

Therefore, such drugs as are found necessary should be manu-
factured in abundance and availability to satisfy every demand should be
B ensured. Undue competition in the matter of production of drugs by
allowing too many substitutes should be reduced as it introduces un-
healthy practice and ultimately tends to affect quality. The State's obli·
gation to enforce production of qualitative· drugs and elimination of the
injuries ones from the market must take within its sweep an obligation
to make useful drugs available at reasonable price so as to be within the
C common man's reach. That would involve regulating the price. It may
be that there may be an improved quality of a particular medicine
which on account of its cost of production will have to sell at a higher
price but for every illness which can be cured by treatment, the patient
must be in a position to get its medicine. This is an obligation under
Article 47 of the Constitution. [479G-H; 480A·B)
D
Bandhua Mukti Morcha v. Union of India, [1984] 3 SCC 161,
referred to.

ORIGINAL JURISDICTION: Writ Petition No. 3492 of 1983. ~

E Under Article 32 of the Constitution of India.

Petitioner·m·person.

A.K. Ganguli, M.S. Rao, S.N. Kacker, A.B. Divan, G.V. Iyer,
C.V.S. Rao, G. Chandra, P. Parmeswaran, H.K. Puri, Vimal Dave, -1
F Swaraj Kaushal, R.K. Mehta and M.K.D. Nambooditi for the
Respondents.

The Judgment of the Court was delivered by

RANGANATH MISRA, J. The petitioner, an advocate by pro·
G fession is the General Secretary of Public Interest Law Service Society,
Cochin. In his application as amended on 7th February, 1983, under
Article 32 of the Costitution he has asked for directions, in public
interest, banning import, manufacture, sale and distribution of such
drugs which have been recommended for banning by the Drugs Con'
sultative Committee and has also asked for cancellation of all licences
H authorising import, manufacture, sale and distribution in respect of
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.l 471

such drugs. He has also asked for a direction to the Central Govern-
ment to constitute a high-powered Authority to go into the hazards A
suffered by people of the country on account of such drugs being in
circulation and suggest remedial measures including award of compen-
sation. He has further prayed that directions should be given for fram-
ing of strict regulations to ensure the quality and standard of approved
drugs and to ensure weeding dut of same, harmful as also injurious B
drugs from the market. The petitioner has alleged that the drug in-
dustry in India is dominated by multi-national Corporations originally
based in•U .S.A. U .K., Federal Republic of Germany, Swedon, Japan,
France and the like. According to the petitioner these Corporations
have large resources and make huge profits. The control exercised by
the Government in this country on such Corporations is minimal and
inadequate. The disease-prone sub-continent of India has been used as c
pasture ground by these Corporations. The Hathi Committee,
appointed by the Central Government in its Report submitted in 1974,
highlighted the havoc played by these Corporations in the Indian scene
and pleaded for nationalising the drug industry in the best interest of
the Indian people. The recommendation has_ tiot been accepted by the D
Government. According to the petitioner several drugs banned in the
advanced west after appropriate analytical research are routed into
India and on account on lack of control and sluggish enforcement of
the law conveniently find their way into the market. What is poison to
the human body in the west is equally poison to people in India but

- not knowing the repercussion thereof on the human system, such drugs
freely circulate and are e'1en prescribed for patients.
E

---1 The Central Government announced its drug policy in 1979 and
set out a guideline, covering tbil relevant aspects of the trade. Accord-
ing to the petitiol)er no attempt has been made to give effect to the
policy and there has really been no enforcement. The, objectives out- F
lined therein have remained on paper. Though the policy indicated
that Government intended to develop indigenous drug technology so
as to become self-sufficient, no effective steps have been taken in this
direction. The poor illiterate people of India are often misled and
misguided as they are not aware of the evil effects of certain drugs
available in the market and often become a tool in the hands of quacks G
and inexperienced doctors. Often they fall a victim to publicity and not
known how dangerous the result of taking the particular drug could be
they take it. According to the petitioner, almost half of the drugs used
in India are still being imported into the country, notwithstanding
indigenous manufacture both by local as also the multi-national
Corporations. The petitioner has contended that modern drugs reach H
472 SUPREME COURT REPORTS [1987] 2 S.CR.

A only one-fifth of the Indian population. According to him, the drug
industry is totally profit-oriented and no care or attention is bestowed
upon good health of the citizens of India.

In 1980, the Drug Consulative Committee set up a sub-
Committee of experts for screening the formulations of drugs preva-
B lent in the Indian market from the point of therapeutic rationale in
order that irrational and harmful combinations of drugs could be ban-
ned. The said Committee of experts recommended banning of twenty
fixed dose combinations of drugs. According to the petitione~ 400-500
drugs with different trade names belong to the group of these twenty
fixed dose combinations. The sub-Committee's report was duly
-_.,.., ..
approved by the Committee as also the Ministry of Health in 1981. The
c Central Drugs Controller issued directions to the State authorities to
strictly enforce the ban of drugs pertaining to these combinations. On
account of slackness in the enforcement machinery these drugs are still
prevalent in the market.

D The Legislation in the field is the Drugs and Cosmetics Act, 1940
(hereinafter referred to as the Act). The act was amended in 1982 and
the definition of 'drug' was amended and sections 10-A and 26-A were
inserted into the Act conferring power on the Central Government to
prohibit import of drugs and cosmetics in public interest as also to
prohibit manufacture, sale or distribution thereof. The amended Act
E came into force with effect from !st February, 1983, but on account of
proceedings taken in Court by manufacturers challenging the vires of
Section 26-A of the Act and interim directions given by the Courts, the
benefit of the new power conferred on the Central Government is not
yet available. According to the petitioner, Artilce 21 of the Constitu-
tion guarantees right to life and this Court has interpreted the
F guarantee to cover a life with normal amenities ensuring good living
which include medical attention, life free from diseases and longivity
upto normal expections. On account of both want of appropriate en-
forcement of the law as also strict measures necessary to eradicate the
existing evils, the fundamental right to life is not available to the
citizens of the country.
G
In his writ petition the petitioner originally impleaded the Union
of India, the Central Drugs Controller as also the Drugs Controller of
Kerala as Respondents I, 2 and 3 respectively.

The Assistant Drugs Controller of India filed an affidavit by way
H of joint return to the Rule Nisi on behalf of the Union of India and the
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.] 473

Central Drugs Controller. He pointed out that 19 categories of fixed
dose combinations were recommended for withdrawal from the A
market and named them in Annexure-I to the counter affidavit. Ac-
cording to him, the provisions of the Act and the rules made thereun-
der confer sufficient legislative authority and power on the Central
Government as also the Central Drugs Controller to effectively op-
erate in the field. In paragraph 8 of the counter-affidavit it has been B
stated that the report of the sub-Committee was considered by the
Drugs Cons11ltative Committee as also by the Drugs Technical Advis-
ory Board and the recommendations of the Board had been accepted

- ~ ..by the Ministry of Health in 1982. A circular letter was issued to all the
State Drug Controllers on 22nd of April, 1982 asking them to ban
· manufacture and sale of the named categories of fixed dose combina-
tions and the cut-off date being 30th September, 1982 for stopping for C
i manufacture of these combinations and 31st March, 1983 for sale of
these combinations was stipulated. On June 26, 1982, a further circular
letter was issued by the Central Drugs Controller to the State Drugs
Control Authorities in the matter of banning of Oestrogens and Prog-
estins. That circular letter has clearly indicated the cut-off dates for D
stopping the manufacture and sale of these drugs as 31.12.1982 and
30.6.1983 respectively.

These respondents have taken the further stand that reports re-
garding prevalence of standard drugs as stated in the Writ Petition E
have come to light as a result of action taken by the State Drugs
Control Authorities. As regards combinations of Oestrogens and
Progestins, in February 1975 the World Health Organisation informed
all the member Governments about the action taken by the Austra-
lian Department of Health for withdrawal from the market of a
~- number of hormonal pregnancy testing preparations. On the basis of F
such information supplied by the World Health Organisation, the
Indian Drugs Controller held consultations with a number of gynae-
cologists within the country who opined that although in advanced
countries hormonal preparations for pregnancy testing had been dis-
continued on account on better methods for detection of pregnancy
being available, the prevailing situation in India did not require comp' G
lete withdrawal from the market of the preparations and it recom-
mended that a warning to the effect that there was possibility of con-
gental malformation in case the preparations were administered in the
earlier stage of pregnancy should be indicated. Accordingly, a decision
was taken that combinations of Oestrogens and Progestins may be
continued for pregnancy test but a warning to the following effect was H
474 SUPREME COURT REPORTS [1987] 2 S.C.R.

A asked to be put on the package as also in any other promotional
literature regarding the drugs:- ~

"Warning:- There is some evidence to show that hormonal
preparations when used during pregnancy may lead to
foetal abnormalities and as such these should not be used
B
during pregnancy or for pregnancy diagnosis."

The Director-General of India Council of Medical Research communi-
cated the following recommendations:-

"Fixed dose combinations of oestrogens and progesterone
le may be totally banned in the country even for the treatment
of secondary amenorrhoea as other, substitutes are avail-
able in the market for management of secondary amenor-
rhoea."

On the basis of same the Ministry of Health took a decision to ban
D
fixed dose combinations of these medicines in the country and cut-off
dates for manufacture and sale were fixed as 31st December 1982 and
30th of June 1983, respectively.

From time to time the Drugs Controller of India has been advis-
ing the State. Drugs Controller for stopping of manufacture of com-
E
binations which have been found to be bad or injurious to health and
instances thereof have been given in the counter affidavit. With the
amendment of the Act in 1982, the Central Government has now been
armed with power to prohibit, in public interest, the import, man-
ufacture, sale and distribution of any drug or cosmetic which is likely
to involve any risk to human beings or it would not have the theapeutic J
F
value claimed in respect of such preparativn. The counter affidavit ._,,.
points out that M/s Nicholas Laboratories of India Ltd. of Bombay and
Mis Unichem Laboratories Ltd., respondent No. 9 before us filed writ
petitions before the High Court at Bombay and obtained interim or-
ders of stay; similarly in M/s Organon (India) Ltd., respondent No. 8
before us moved the Calcutta High Court and obtained an interim
G
order of stay in regard to their preparations. Challenge in these writ
petitions is to the vires of Sections 10-A and 26-A of the Act. The
counter affidavit further points that some of the medicines which are
alleged to have been banned in some developed countries are allowed
to continue in the market of the other developed countries and there is
H no uniformity.
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.) 475

The second counter-affidavit of these respondents has been filed
after the writ petition was amended. On this occasion, the Assistant A
Drugs Controller of India has stated that it is a fact that the Hathi
Committee recommended 116 drugs to be sufficient to treat more than
90 per cent of the diseases prevalent in the country. It was, however,
found out that this position was not correct and many other drugs were
required to meet the situation. It pointed out that though the Hathi B
' Committee identified 116 essential drugs, it did not recommend ban-
~- ning of the remaining. The WHO Expert Committee in its report
(serial No. 722 of 1985) has indicated that 285 basic drugs and 358
single ingredient formulations should be considered to be most im-
portant for the health and care of the human race. It is asserted that all
these companies manufacture medicines within the framework of the
list published by the World Health Organisation. It is pointed out that c
there are about 8000 small scale manufacturers an'd 214 big manu-
facturers in the organised sector for manufacture of medicines. When
for some reason one particular brand of drug is not available in the
market, a substitute thereof has got to be looked for. According to
them, all appropriate steps have been taken by the Union of India and D
the Central Drugs Controller and the petitioner is not entitled to any
relief in this writ petition.

The respondent No. 4 is the Association of the Drug manufac-
turers and respondent No. 5 is the organisation of pharmaceutical
producters the remaining respondents are manufacturers of specified E
drug prepartions. In their respective affidavits, respondents No. 4
and 5 have pleaded against maintainability of the writ petition.

This court as early as 11.4.1983 directed issue of notice to the
Medical Council of India, the Indian Medical Association and the
Drugs Medical Council of India, the Indian medical Association and F
the Drugs Control authorities of the States except that of Kerala as it
was already made a rcspodent to the writ petition. Obviously such
notice was given as in the opinion of the Court, the matter was one of
great importance and the Court looked for participation of these
authorities in the debate with a view to assisting the Court in the
disposal of the m~tter. We are surprised that the notice from the Court G
has not evoked response excepting the State of Karnataka. (Statutory
bodies when called upon by a Court, in particular the apex Court of
the Country, are duty-bound to respond and join the proceedings be-
fore the Court, as required by Article 144 of the constitution. These
bodies are not litigants and do not have the choice of keeping away
from the Court like private parties in ordinary litigations opting to go h
476 SUPREME COURT REPORTS [1987] 2 S.C.R.

A ex-parte. The present matter is certainly one which is sufficiently im-
portant and the stake of the entire nation is high when the Court suo
moto extended the opportunity of being heard and invited the named
statutory or other autJ:\orities to come forward and place their view
points on relevant aspects, an attitude of callous indifference cannot
be appreciated. We hope and trust that there would be no repetition of
B such a situation.

It must be remembered that this is not a normal litigation with
adversaries pitted against one another. What this Court said in P.
Na/la Thampy v. Union of India, [1983]4 SCC 598 has full application.
There it said:-
c "The lis before us is not of the ordinary type where there
are two contending parties, a claim is raised by one and )-
denied by the other, issues are struck, evidence is led and
the findings follow ...... The writ petition is essentially in
the nature of public interest litigation and the petitioner
D has attempted to voice the grievances of the community."

The issues in this petition are of vital importance as they relate to
maintenance of approved standards of drugs in general; the writ peti-
tion involves the claim for withdrawal of 7000 fixed dose combinations
and withdrawal of licences of manufacturers engaged in manufacture
E of about 30 drugs which have been licensed by the Drugs Control
Authorities; the issues that fall for consideration are not only relating .
to technical and. specialised matters relating to therapeutic value,
justification and harmful side effect of drugs but also involve examina-
tion of the ectness of action taken by the respondents 1 and 2 on the
basis of advice; the matter also involves the interest of manufacturers
F and traders of drugs as also the interest of patients who require drugs
for their treatment.

The respondent No. 5 has made references to the recommenda-
tions of the Drugs Consultative Committee and the ultimate consi-
deration of DTAE to plead against the prayer of banning of prepara-
G lions. As already stated the remaining respondents are manufacturers
of specific preparations and have supported in their respective
counter-affidavits their claim that drugs manufactured or handled by
them should not be banned.

Having regard to the magnitude, compl~xity and technical na-
H lure of the enquiry involved in the matter and keeping in view the far
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.] 477

reaching implications of the total ban of certain medicines for which A
the petitioner has prayed, we must at the outset clearly indicate that a
. judicial proceeding of the nature initiated is not an appropriate one for
determination of such matters. There is perhaps force in the conten-
tion of the petitioner that the Hathi Committee too was not one which
( could be considered as an authoritative body competent to reach defi-
nite conclusions. No adverse opinion can, therefore, be framed against B

l
the Central Government for not acting upon its recommendations.

A healthy body is the very foundation for all human activities.
That is why the adage "Sariramadyam Khaludharma Sadhanam". In a
welfare State, therefore, it is the obligation of the State to ensure the
creation and the sustaining of conditions congenial to good health.
This Court in Bandhua Mukti Morcha v. Union of India, [1984] 3 SCC c
161 aptly observed:-

"It is the fundamental right of everyone in this country,
assured under the interpretation given to Article 21 by this
Court in Francis Mullin's case-[1981] 1 SCC 608-to live D
with human dignity, free from exploitation. This right to
live with human dignity enshrined in Article 21 derives its
life breath from the Directive Principles of State Policy and
particularly clauses (e) and (f) of Article 39 and Articles 41
and 42 and at the least, therefore, it must include protec-
tion of the health and strength of the workers, men and E
women, and of the tender age of children against abuse,
opportunities and facilities for children to develop in a
healthy manner and in conditions of freedom and dignity,
educational facilities, just as humane conditions of work
and maternity relief. These are the minimum requirements
which must exist in order to enable a person to live with F
human dignity, and no State-neither the Central
Government-has the right to take any action which will
deprive a person of the enjoyment of these basic
essentials".

While endorsing what has been said above, we would refer to Article G
47 in Part IV of the Constitution. That Article provides:-

"The State shall regard the raising of the level of nutrition
and the standard of living of its people and the improve-
ment of public health as among its primary duties and, in
particular, the State shall endeavour to bring about prohi- H
,
478 SUPREME COURT REPORTS [1987] 2 S.C.R.

bition of the consumption except for medicinal purposes of
A
intoxicating drinks and of drugs which are injurious to
health."

This Article has laid stress on improvement of public health and pro-
hibition of drugs injurious to health as one of the primary duties of the
B State. In Akhil Bharatiya Soshit Karmachari Sangh v. Union of India,
[1981] 1 SCC 246 this Court has pointed out that, "the Fundamental
Rights are intended to foster the ideal of a political democracy and to
prevent the establishment of authoritarian rule but they are of no
value unless they can be enforced by resort to courts. So they are made
justiciable. However, it is also evident that notwithstanding their great
j
importance, the Directive Principles cannot in the very nature of
c things be enforced in a Court of Law, but it does not mean that Direc-
tive Principles are less important than Fundamental Rights or that they )
are not binding on the various organs of the State." 1n a series of
pronouncements during the recent years this Court has culled out from
the provisions of Part IV of the Constitution these several obligations
D of the State and called upon it to effectuate them in 'order that the
resultant pictured by the Constitution Fathers may become a reality.
As pointed out by us, maintenance and improvement of public health
have to rank high as these are indispensable to the very physical exist-
ence of the community and on the betterment of these depends the
building of the society of which the Constitution makers envisaged.
E Attending to public health, in our opinion, therefore, is of high
priority-perhaps the one at the top.

None of the parties before us claimed, and perhaps rightly, that
the prevailing state of affairs in this regard is a commendable one. The
technical aspects which arise for consideration in a matter of this type
F cannot be affectively handled by a court. Similarly the question of
policy which is involved in the matter is also one for the Union
Government-keeping the best of interests of citizens in view to
decide. No final say in regard to such aspects come under the purview
of the court. Yet there are certain contentions raised by the petitioner
which deserve serious consideration and we would now proceed to
G deal with them.

The branch with which we are now dealing, namely, health care
of citizens, is a problem with various facets. It involves an ever-
changing challenge. There appears to be, as it were, a constant com-
petition between Nature (which can be said to be responsible for new
H ailments) on one side and human ingenuity engaged in research and
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.] 479

finding out curative processes. This being the situation, the problem A
'1 has an ever-shifting base. It is common place that what is considered to
be the best medicine today for treatment of a particular disease be-
comes out of date and soon goes out of the market with the discovery
or invention of new drugs. Again what is considered to be incurable at
any given point of time becomes subjected to treatment and cure with
new finds. There is yet another situation which must be taken note of B
i as human knowledge expands and marches ahead. With the onward
\ march of science and complexities of the living process and hitherto
unknown diseases are noticed. To meet new challenges, new drugs
_ ~ _have to be found. In this field, therefore, change appears to be the
1
rule.

We have already taken note of the position that the Hathi Com-
c
~ mittee was of the view that a fixed number of formulations were
enough to meet the demand. From the counter-affidavit of respon-
dents 1 and 2, we have gathered that this conclusion of the Hathi
Committee was not accepted as on analysis it was not found to be a
correct statement of the position. The World Health Organisation in D
its report, on the basis of expert advice, is of the view that human
ailments can be treated effectively with 285 basic drugs. We assume
and it is not disputed that the expertise available to the World Health
-.+ Organisation was of a higher order and perhaps more accurate than
what was at the disposal of the Hathi Committee. While we are cogni-
zant of the position that the problem is a shifting one and one cannot E
have a fixed process to deal with the situations that would arise from
time to time, the Central Government on the basis of the expert advice
~ can indeed adopt an approved national policy and prescribe an ade-
quate number of formulations which would on the whole meet the
requiren;ient of the people at large. Obviously, instant attention has to
~ be bestowed to keep abreast of the changing situations and make F
proper and timely amends. While laying the guidelines on this score,
injurious drugs should be totally eliminated from the market. Great
care in this regard has to be taken.

Such drugs as are found necessary should be manufactured in
abundance and availability to satisfy every demand should be ensured. G
Undue competition in the matter of production of drugs by allowing
too many substitutes should be reduced as it introduces unhealthy
practice and ultimately tends to affect quality. The State's obligation
to enforce production of qualitative drugs and elimination of the in-
jurious ones from the market must take within its sweep an obligation
to make useful drugs available at reasonable price so as to be within H
480 SUPREME COURT REPORTS [1987] 2 S.C.R.

the common man's reach. That would involve regulating the price. It
A may be that there may be an improved quality of a particular medicine
which on account of its cost of production will have to sell at a higher
price but for every illness which can be cured by treatment, the patient
must be in a position to get its medicine. This, in our view, is an
obligation which the Court has already found in the relevant articles of
B Part IV of the Constitution.

The prescribed preparations must maintain their quality, and for ~
ensuring it, strict regulations are necessary. Provision in statutes or
rules or instructions issued by executive authorities do not meet the-·~ _
demands of today's situation. The process of regulation has to be
strengthened. Law must be provided with sufficient biting teeth and
c there must be genuine apprehension in the mind of every person en-
gaged in the trade that any infraction w9u!d be visited with exemplary ~
punishment. In the prevailing situation in the country, unless the law is
properly enforced, it would be difficult to regulate the quality of the
drugs. Standardisation of the preparations will also introduce a healthy
D atmosphere in the market. The practising doctor should be acquainted
with the drug policy, availability of drugs and take care to prescribe
available medicine to his patient.

There must be due emphasis on indigenous production so that in
due course, what the Government contemplated in 1979 in its then
E drug policy may be effectuated by India. We have made large strides in
our advancement in the field of science as also manufacture'0f drugs
since independence. Drugs prepared in India today have an interna-
tional market in a limited way. There does not seem to be any lack of
ability to manufacture drugs. We commend to Government, therefore,
that the drug policy of the Government should emphasise, upon a
F time-bound switch over to indigenous production. -f
Research in this field is of vital importance. Constant attention
has to be devoted to get the best of results at the laboratories and put
to use all useful findings. The traditional indigenous system of treat-
ment in India had once upon a time made a lot of advancement. There
G is, therefore, sufficient scope for research on the basis of our own
knowledge. Herbal preparations, as far as practicable, should be en- -/.-
couraged and appropriate laboratories should be set up, both in the
public and the private sector to continue the system of research into
every branch in this field relevant to gathering of knowledge and proper
utilisation thereof in the field of treatment and manufacture of drugs.
H We reiterate that it is not for the Court to lay down the drug policy of
VINCENT PANIKURLANGARA v. U.0.1. [MISRA ,J.] 481

the Government. We are aware of the fact that the State is concerned
A
and anxious to improve the general condition and is willing to exercise
adequate control; Parliament has in several legislations in recent years
enhanced the penalities with a view to ensure elimination of injurious
drugs and maintenance of the quality and standard of drug prepara-
tions. There is, however, no scope for complacency in this field and
constant and regular attention has to be bestowed in order that the B
flow into the market may be only of acceptable drugs.
\
• Every indigenous drug manufacturer must have an obligation by
law to disclose the formula of preparation and other statutory informa-
tion in the national language and at least one or two other languages,
keeping in view the place of manufacture of the drug and the area of its
circulation. Any statutory warning to be administered should also
c
follow the same course. We would like to indicate that it is for the
Government on the basis of expert advice to decide whether use of
poisonous medicine may not be reduced; afterall administering the
warning is not a sufficient excuse to circulate poison by way of
medicine. We hope and trust that the Union of India would come D
forward with a declaration of its drug policy at a very early date.

It appears to us that there is an immediate need for a central
enforcement machinery in the interest of community at large. We hope
and expect that every State Government would cooperate with the
Central Govemment in this regard and the Central Government would E

l
take a lead to establish such an authority which would have jurisdic-
iion all over the country with a view to regulating manufacture and
punishing defaults and lapses. Licencing of manufacture should also be
centralised so that uniformity can be maintained. These are matters of
common concern and we hope that the Central Government, without
loss of time, would take care to evolve a system which would effec- F
tively operate. Leave is granted to the Central Government to apply to
the Court, if there be any difficulty experienced in implementation of
such a scheme.

Section 5 of the Act authorises constitution of a Central Drugs
Technical Advisory Board as also a State Board for each State. The G
object of setting up of such Boards is to advise the respective Govern-
ments on technical matters arising out of the administration of the Act
and to carry out such other functions as are assigned to the Boards by
the Act. Sub-section (2) provides for the manning of the Central
Board. We are of the view that adequate representation should be
provided to consumers and at foast two capable representatives from H
482 SUPREME COURT REPORTS [1987] 2 S.C.R.

A out of their category should be nominated by the Central Government.
The manning of this Board should be such that in its functioning it
would be in a position to effectively advise the Central Government on
all technical matters.

Section 7 provides for the setting up of the Drugs Consultative
B Committee and its statutory purpose is to advise the Central Govern-
ment, the State Governments and the Drugs Technical Advisory
Board on any matter tending to secure uniformity throughout India in
the administration of the Act. We are of the view that on this Commit-
tee too there should be adequate representation on behalf of the con-
suming public. If necessary, prompt steps may be taken to bring about
suitable amendments to authorise such representation both on the
c Technical Board as also the Consultative Committee.
}
The Central Government should set up regional Drug Labora-
tories in addition to the Central Laboratory as provided by section 6 of
the Act to facilitate and promote research and coordinate activity in
D that regard.

We have no doubt that the existing Drug Consultative Commit-
tee is a useful body but the Central Government should consider
whether it requires to be broad-based and confined with larger scope
of operation or it is necessary to constitute another high powered
E authority, as prayed for by the petitioner so that such a vital matter
like public health does not go without adequate attention.

Before we part with the case, we must point out that the amend- 1

ing provisions of 1982 which were brought into force in 1983 have Jo
remained mostly inoperative on account of orders of injunction
F granted by High Court. The Central Government may get impleaded --+
in the pending proceedings before the different High Courts and re-
quest the said High Courts for expeditious disposal of the matters. At
one point of time, we were thinking of making an order dissolving the
interim directions but that would have necessitated impleading these
parties in this case and hearing them. We have, therefore, thought it
G proper to suggest that the Central Government may get impleaded in
the pending proceedings, if they are already not parties and apply to
. the High Courts. We sincerely hope that when any such application is
moved before the High Court where a dispute of this type is pending,
the High Court would make every endeavour to expedite the disposal
of the proceedings and have the same disposed of as early as possible
H and preferably within a period of two months from the date when it is
VINCENT PANIKURLANGARA v. U.0.1. (MISRA ,J.] 483

approached so that the dispute may end. If there be any difficulty in A
giving effect to this part of the judgment, the Central Government has
1 leave of this Court to make an appropriate application for directions.

The objection raised by the petitioner with reference to specific
medicines has not been examined by us mainly for the reason that we
B
have found this proceeding not an appropriate one for such purpose.
We, however, hope that the Central Government shall take into con-
~ sideration the objections raised by the petitioner and have the same
referred to the Consulative Gommittee or to such other body as it
.,._. _ considers expedient for immediate examination and a decision in that
« t 'regard shall be taken, not later than six months.
c
The petitioner has indeed done a commendable job in bringing
the matter before the Court. We appreciate his move and are inclined
to think that he should be suitably compensated with a view to
reimbursing him for the expenses. We direct the Ministry of Health of
the Central Government to deposit a sum of Rs.5000 (Rupees Five
D
Thousand only) in this Court within two months hence which the
petitioner will be at liberty to withdraw.

S.R.
Petition disposed of.