Pratap
Pharma (Pvt.) Ltd. & ANR Vs. Union of India & Ors [1997] INSC 366 (1
April 1997)
K.
RAMASWAMY, D.P. WADHWA
ACT:
HEADNOTE:
AND
WRIT PETITION (C) Nos.3559 AND 4572/83 O R D E R These three writ petitions,
filed under Article 32 of the constitution of India, raise common question of
law, challenging Section 3(h) of the Drugs and cosmetics Act, 1940, as amended
by Act 68 of 1982 (for short, the 'Act') with effect from February 1, 1983 as
unconstitutional, being arbitrary and violative of Article 14 and 19(1) (9) of
the constitution. The grievance of the petitioners is that while the Act amends
the definition of "payment and proprietary Medicine" under Section
3(h) of Act, the definition 'drugs' under Section 3(b) read with the definition
of "Ayurvedic drug" under section 3(a) has not been changed; as a
consequence, there is no prohibition for patenting the Ayurvedic drugs
manufactured by the petitioners whereas under the impugned order of the Drug
controller dated February 16, 1983 it is so construed and manufacture of those
drugs is prohibited. Therefore, the Amendment Act 68 of 1983 and the order
passed by the Drug controller, Government of India, are Ultra Vires the
legislative power.
Shri
M.N. Krishnamani, learned senior counsel and Shri Pankaj Kalra, learned counsel
appearing for the petitioners, seeks to support their grievance, but we are
unable to agree with the learned counsel. It is seen that patent and
proprietary medicine was defined in the pre-Amendment Act under section 3(h)
thus:
"Patent
or proprietary Medicine" Means a drug which is a remedy for prescription
presented in a form ready for internal or external administration of human
beings or animals and which is not included in the edition of the Indian Pharmacopeia
authorised in this behalf by the Central Government after consultation with the
Board." "Drug" had been defined under section 3(b), and
continues under the Amendment Act, to read as under:
"Section
3(b) "drug" includes.
(i)
All medicines for internal or external use of human being or animals and all
substances intended to be used for or (in the diagnosis, treatment), mitigation
or prevention of disease in human being or animals .....; and (ii) such
substances (other than food) intended to affect the structure or any function
of the human body or intended to be used for the destruction of (vermin) or
insects which cause disease in human being or animals, as may be specified from
time to time by the Central Government by notification in the official
Gazette." "Ayurvedic (including Siddha) or Unani Drug" has been
defined under section 3(a) of the Act, which reads as under:
"Ayurvedic
(including Siddha) or Unani drug" includes all medicines intended for
internal use for or in the diagnoses, treatment, mitigation or prevention of
disease in human beings mentioned in, and processed and manufactured
exclusively in accordance with the formulae described in, the authoritative
books of Ayurvedic (including Siddha) and Unani (Tibb) systems of medicine,
specified in the First Schedule." Under the Amendment Act 68 of 1983
Section 3(h) has been amended, and reads as under:
"Patent
or proprietary medicine" means- (i) in relation to Ayurvedic Siddha or Unani
Tibb systems of medicine all formulation containing only such ingredients
mentioned in the formulae described in the authoritative books of Ayurvedic, siddha
or Unani Tibb systems of medicine, specified in the First schedule but does not
include a medicine, which is administered by parental route and also a
formulation included in the authoritative books as specified in clause(a);
(ii)
in relation to any other systems of medicine a drug which is a remedy or
prescription presented in a form ready for internal or external administration
of human beings or animals and which is not included in the edition of the
Indian pharmacopoeia authorised in this behalf by the central Government after
consultation with the Drugs Technical Advisory Board constituted under section
5." A reading of these provisions would indicate that prior to the
amendment "drug" included all medicines for internal or external use
of human beings or animals and all substances intended to be used for or in
diagnoses, treatment, mitigation or preservation of disease in human beings or
animals etc. "Ayurvedic Drug" includes all medicines intended for
internal or external use for or in the diagnosis, treatment, mitigation or
prevention of disease in human beings, mentioned in, and processed and
manufactures exclusively in accordance with the formulae described in, the
authoritative books of Ayurvedic (including Siddha) and Unani (Tibb) system of
medicine, specified in the First schedule. While continuing the same system of
drugs without any change in the Amendment Act, what has been excluded is the
medicine which is administered by parental route; and a formula included in the
authoritative books as specified in clause (a) of section 3 is excluded. As a
consequence, the necessary result is that any Ayurvedic or Siddha or Unani drug
which is administered by parental route and also giving a formula included in
the authoritative books specified in the schedule attached thereto stand
excluded. Simultaneously, one of the items i.e. 164A relating to Indian
medicines is included with which we are not concerned. It is contended that the
Ayurvedic, Siddha and Unani systems of medicine are ancient systems and are
part of our ancient heritage which provide more lasting and permanent cure to
all types of disease or ailments than the transient and instant relief through
allopathic medicines. The former are time taking while the latter is instant.
However, our systems of medicine must also keep pace with scientific
development with modern technology and face cooperative spirit of development.
The process and manufacture must go along the developed scientific system. So
the drug manufactured by Ayurvedic, Siddha and Unani system of pharmacopoeia
for cure of disease must, of necessity, be of standard quality prescribed by
the relevant provision of the Act or system of preparation should be certified
to be fit for use, sale, storage etc.
The
administration equally must note that the foreign multi- national
pharmaceutical companies are getting our herbal medicine patented and are
getting worldwide market which benefit must not be denied to Indians and Indian
companies.
The
primary question, therefore, is whether such an amendment is ultra vires the
provisions of the constitution.
Under
Entry 19 of list III read with Entry 49 of List I of the seventh schedule, the
parliament is competent to enact and to amend the Act. Therefore, the
legislative competence is beyond pate of question. The arbitrariness of a
legislation violating Article 14 cannot be adjudged to be arbitrary when the
Parliament is of the view that it is to ensure safety of the life of human
beings or animals. The regulation of manufacture of drug and patenting are
necessary and are in public interest as the evil is sought to be remedied by
legislative measure. When drugs are administered to human being/animals, they
are required to be regulated as adumbrated under the Act. As a consequence,
thought by implication the right to practice of medicine or manufacture of the
drugs has been guaranteed under Article 19(1) (g) , it is a regulation within
the meaning of Article 19(6) of the constitution. As a consequence, it is a
reasonable restriction on the right to carry on the trade or business of
manufacture of the ayurvedic drugs by the petitioners.
Shri Pankaj
Kalra contends that unless there is an express prohibition under the provisions
of the Act, the authority cannot infer that there is a prohibition. We are
unable to agree with the counsel. If the drug manufactured by the petitioners
is found to be in conformity with the prescribed standard, and is likely to
cause injurious to health or to endanger the life of a patient, and therefore,
there is no need for an express prohibition under the Act.
It is
now well settled legal position that regulation includes total prohibition, if
it sis found necessary in the public interest. Manufacture of drugs for
administration to human beings/animals is regulated by the act and therefore,
it attracts Article 19(6). We hold that the Act is intra vires the constitution
and does not violate the fundamental rights guaranteed under Articles 14 and
19(1) (g) of the constitution.
The
question then arises: whether the drugs manufactured by the petitioners can be
prohibited for the purpose of administration to the human beings or animals
within the exclusionary clause under section 3(h) of the Act. The question is
primarily one of fact, to be decided on the basis of material available. The
Drug Controller in the impugned letter has merely opined on the basis of
definitions contained, they are prohibitable and therefore, directed that they
cannot be manufactured thereafter. There must be evidence on record before the
authority to reach a conclusion that the drugs manufactured by the petitioners
are prohibitable items under the Act. Unless expert body has gone into and
tested these items and decided that the standards adopted by them under the
respective pharmacopoeia formula are not consistent with or conformable to the
requested established standards and unless it is certified that they are unfit
for use of human beings/animals, they are not prohibitable per se. Therefore,
the expert body should go into that question and decide which of the items
manufactured by the petitioners are conformable to the established standards of
pharmacopoeia formula and satisfy the required tests as admissible in that
behalf. We are not experts in this field. We cannot hazard to reach a decision
on the issue. Though Shri Pankaj Kalra has brought to our notice some of the
articles written by persons having knowledge in this branch of science, we do
not want to take risk to reach any conclusion on the basis of the above
articles. The appropriate course would be that the competent expert body should
go into that question and decide the same.
Section
33-C of the Act contemplates constitution of the Expert Body by a committee
constituted thereunder by the Government of India. Therefore the Government of
India is directed constitute an expert body consisting of experts in the Ayurvedic
system of medicine and also some from Allopathy as contemplated under section
33-c. The expert body should go into the question and decide whether the items
of drugs manufactured by the petitioners are in conformity with the provisions
of the Act and the established formulae in the Ayurvedic Pharmacopoeia. The
Government of India or Drug controller, as the case may be, would then take a
decision on the basis of its recommendation. In case they find any of these
drugs to be injurious to the health of human beings/animals; necessary
opportunity would be given to the manufacturers to rectify it; in case they do
not rectify the injurious element and the drugs are still found to be so
defective as cannot be administered, then necessary orders would be passed
prohibition them from manufacturing the same. In the event of such a decision
being taken, an opportunity would be given to the persons concerned so that
they can also place their material before the committee and thereafter the Drug
controller/Board or Government of India, as the case may be, would take a
decision on the basis of the expert body's opinion and the material placed by
the petitioners in that behalf.
Since
experts in Ayurvedic system of medicine are to be members of the committee to
be constituted by the Government of India under section 33-c of the Act, it
would be open to the petitioners to suggest to the central Government names of
the experts known to them and it is for the central Government to consider
whether such person may be drafted as a member of the committee so constituted.
It
appears that there is an inter se dispute as to who is entitled to be the
proprietor of the petitioner in W.P. No. 4572/83. It appears that the dispute
is pending adjudication in the civil court and impleading some of them in this
writ petition as representing the petitioner is for the purpose of disposal of
the matter pending in this court, It would be subject to the decision by the
civil court.
In
view of the stay orders granted by this court and as we are remitting the
matter to the Government of India, the interim stay would continue till the
decision is taken by the Drug controller on the basis of the report submitted
by the expert body and the decision to be taken by Government of India/Drug
controller. It is needless to mention that since the matters are pending for a
long time, the Government of India would constitute the committee as expeditiously
as possible and the report may be submitted with in six months from the date of
the constitution of the committee.
The
writ petitions are disposed of accordingly. No costs.
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